NEWS -- Scorpion Biological Services Announces New Kansas Commercial Biomanufacturing Facility

MANHATTAN, Kan., April 26, 2022 /PRNewswire/ -- Biopharmaceutical contract development and manufacturing organization (CDMO) Scorpion Biological Services (Scorpion) today announced a planned development partnership with a private developer, the State of Kansas, and local and university affiliates, which will support the construction of a new biodefense-focused large molecule and biologics biomanufacturing facility in Manhattan, Kansas.

The 500,000 sq. ft. commercial biomanufacturing facility will service up to 144,000L cGMP capacity across 48 bioreactors

The $650 million commercial-scale facility, which will service approximately 144,000 liters of biomanufacturing capacity across 48 bioreactors, is being designed for large molecule biologics manufacturing.

The design and engineering of the facility is being led by CRB Group, a nationally recognized firm focused on designing and building biomanufacturing facilities. Realty Trust Group (RTG), a leading healthcare / life sciences real estate advisory and development firm, is serving as the lead developer on the project.

After considering locations in 23 states, the Scorpion leadership team selected Manhattan, Kansas, largely as a result of the city's concentration of biodefense organizations, including Kansas State University's Biosecurity Research Institute (BRI) and the National Bio and Agro-Defense Facility (NBAF) — the U.S. government's agricultural biothreat research laboratory. One specific goal of the facility will be to help scale production of ANTHIM®, an antitoxin against anthrax, which could be employed in defense against a potential anthrax attack.

To meet Biomedical Advanced Research and Development Authority (BARDA) and Department of Defense requirements for the Strategic National Stockpile (SNS), Scorpion intends to start manufacturing ANTHIM by mid-2024. As such, the company is planning a phased building approach to complete the production train for ANTHIM first –– by April 2024 — with plans to complete a new train every 15 months thereafter. Scorpion projects that the Manhattan facility will be complete, fully functional and staffed by April 2027.

The facility is being designed to be as flexible and versatile as possible. The majority of the facility will be dedicated to commercial CDMO services, but the company is exploring the design of trains focused on other products for the SNS, among others, given that 70% of the drug products in the SNS will expire over the next four years. Where possible, Scorpion plans to use a U.S.-based supply chain, beginning with the decision to install Pall bioreactors.

David Halverson, President of Scorpion, said, "We are very excited to break ground on this new facility. There is a strong demand for world-class biomanufacturing, which we expect to continue well into the future. The 500,000 square foot Manhattan facility is being designed to service up to 144,000 liters across 48 bioreactors –– powered by an excellent Kansas workforce. We're looking forward to rapidly growing and expanding Scorpion, and Manhattan is the perfect location for our newest facility."

Upon completion, Scorpion projects that the facility will have a billion-dollar impact on the State of Kansas, and employ over 500 individuals, largely from the local Kansas talent pool. The company has begun a project to transfer bioprocessing programs from Texas A&M to Kansas State University and the Manhattan Area Technical College at the associate's, bachelor's, and graduate level to help train Scorpion's future workforce.

"We are thrilled and excited that Scorpion has chosen Kansas for this game-changing facility that will have a massive positive impact in our state," said Governor Laura Kelly. "Being in the center of the country, with quick access to either coast, there is no better state for Scorpion to locate in order to address potential threats to public health."

About Scorpion Biological Services

Scorpion Biological Services is working to expand the reach of precision medicine to more people within multiple therapeutic areas. Its team is comprised of experts in bioanalytics, cell biology, virology, translational biology, biomanufacturing, and drug development. Scorpion's services are designed to support a myriad of biologic drugs from conception through clinical trials and commercial production, to bring new drugs to market faster and more reliably. For more information, visit https://www.scorpionbio.com and follow us on LinkedIn.

Contact:
Kenna Harris
Head of Sales and Marketing
Email: mailto://Hello@scorpionbio.com
Tel.: +1 (858) 472 1969

SOURCE Scorpion Biological Services

NEWS -- Lineage to Present at B. Riley Securities 2022 Neuro & Ophthalmology Virtual Investor Conference on April 27, 2022

Fireside Chat with B. Riley Research Analyst Scheduled for 3:30pm Eastern Time

Topics Will Include Two New Cell Therapy Programs Launched Following Roche and Genentech Partnership for RG6501 (OpRegen®) Program

CARLSBAD, Calif., April 26, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today Brian M. Culley, Lineage’s Chief Executive Officer, will present at the B. Riley Securities 2022 Neuro & Ophthalmology Virtual Investor Conference, in a fireside chat hosted by Mayank Mamtani, Managing Director, Senior Biotech Research Analyst and Group Head of Healthcare Research at B. Riley Securities, on Wednesday April 27th, 2022 at 3:30pm EST.

Interested parties can register to view both the live event and replay on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, which is now being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy, and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220426005359/en/

Contacts

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Mike Biega
(mailto://Mbiega@soleburytrout.com)
(617) 221-9660

|Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242

NEWS -- Provectus Biopharmaceuticals Announces Notice of Allowance of First U.S. Patent Application for Use of PV-10® Immunotherapy in Hematology

KNOXVILLE, TN, April 26, 2022 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that the United States Patent and Trademark Office (USPTO) has allowed US patent application 16/688,319, “Composition and Method for Treating Hematologic Cancers,” covering the use of PV-10, a formulation of Provectus’ immunogenic-small molecule and pharmaceutical-grade rose bengal sodium (RBS), for the treatment of hematologic diseases. In vivo data of mice with acute lymphoblastic leukemia receiving oral PV-10 showed increased survival compared to controls.1

This allowed patent application will be the first Provectus patent award in hematology from the USPTO. Innovate Calgary, the innovation company of the University of Calgary, is a co-assignee and Aru Narendran, MD, PhD of the University of Calgary’s Cumming School of Medicine is a co-inventor on the allowed patent application.

About Provectus

Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different disease areas based on a class of small molecules called halogenated xanthenes (HXs). The Company’s lead molecule is RBS. A second HX molecule has been synthesized.

Provectus’ drug discovery and development programs include investigational drugs and drug targets in oncology (clinical-stage), dermatology (clinical-stage), hematology, virology, microbiology, ophthalmology (clinical-stage), and animal health, and use multiple routes of administration, such as intralesional (IL), topical (.top), oral (P.O.), inhaled (.inh), intranasal (IN), and intravenous (IV).

Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, https://www.clinicaltrials.gov. For additional information about Provectus, please visit the Company's website at https://www.provectusbio.com.

Reference

1 “Provectus Biopharmaceuticals Provides Update on Research into Oral Administration of PV-10® Immunotherapy for Treatments of Hematology, Oncology, and Virology.” Provectus, 04 Oct. 2021, Press release.

FORWARD-LOOKING STATEMENTS: The information in this press release may include “forward-looking statements,” within the meaning of U.S. securities legislation, relating to the business of Provectus and its affiliates, which are based on the opinions and estimates of Company management and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “project,” “predict,” “potential,” “targeting,” “intend,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.

The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.

Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.

Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including those described in Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.

###

Contact:

Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999

NEWS -- Plus Therapeutics to Present at the 2022 Q2 Investor Summit

AUSTIN, Texas, April 26, 2022 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, announced today that Marc Hedrick, M.D., President and Chief Executive Officer, will present at the 2022 Q2 Investor Summit on Tuesday, May 3, 2022, at 12:30 p.m. ET at the Westin New York Grand Central, New York, N.Y.

Investors interested in arranging a meeting with the Company’s management during the conference should contact the Investor Summit conference coordinator. A webcast of the presentation will be available under the For Investors tab of the Plus website at https://www.plustherapeutics.com. A webcast replay will also be accessible for 90 days following the event.

About Plus Therapeutics

Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on the development, manufacture, and commercialization of complex and innovative treatments for patients battling cancer and other life-threatening diseases.

Our proprietary nanotechnology platform is currently centered around the enhanced delivery of a variety of drugs using novel liposomal encapsulation technology. Liposomal encapsulation has been extensively explored and undergone significant technical and commercial advances since it was first developed. Our platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186RNL including the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-LM or the ReSPECT-PBC trials; possible negative effects of 186RNL; the continued evaluation of 186RNL including through evaluations via a seventh patient cohort; and the intended functions of the Company’s platform and expected benefits from such functions.

The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the regenerative medicine field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.

Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com

Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com

NEWS -- Lineage Announces a Fifth Cell Therapy Program: Allogeneic Photoreceptor Transplants for the Treatment of Diseases Which May Lead to Blindness

Dynamic Culturing Process Developed by Lineage Offers Path to Clinical- and Industrial-Scale Production of Photoreceptors

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced a new cell therapy development program: photoreceptor neural cell (PNC) transplants for the treatment of vision loss due to photoreceptor dysfunction or damage. Similar to the company’s recently announced pipeline expansion into auditory neurons for the treatment of hearing loss, Lineage has filed for intellectual property protection covering the composition and methods for generating PNCs. Based on recent in vivo data generated using the company’s PNCs, these cells may be capable of forming reconstructed retina with high survivability and neural connectivity to surrounding functional layers. Notably, Lineage has demonstrated feasibility which could support a large-scale method for producing both types of photoreceptors, known as rods and cones.

“It is natural that, on the heels of the announcement of our alliance with Roche and Genentech for our RPE cell therapy, a deal worth up to $670 million dollars plus double-digit royalties if certain development, approval, and sales milestones are achieved and other conditions are met, that we also would pursue treatments for vision loss through the other major cell type of the retina, the photoreceptors,” stated Brian Culley, Lineage’s CEO. “Our fundamental technology and accumulated know-how give us the opportunity to make many different cell types, and we have demonstrated our ability to create new programs rapidly and efficiently in two distinct areas, expanding our cell therapy pipeline to five separate preclinical and clinical programs, while still maintaining what we believe is an appropriate and responsible rate of investment for a company of our size. This latest program is part of our long-term planning for clinical and commercial success and serves as another example of the capability of our technology platform. We believe our ability to, in just a matter of months, advance from a product concept to generating new intellectual property and manufacturing the desired cell types, is illustrative of the power and efficiency of our platform. We believe the combination of our capital discipline and current balance sheet will support multiple years of further progress, during which we anticipate reaching achievements with each of our clinical and preclinical programs.”

Dr. Rami Skaliter, who leads the manufacturing function for Lineage, added, “I’m exceptionally proud of the team’s success at overcoming obstacles related to the limited scale of photoreceptor production. Building upon our experience with other cell lineages, we have developed intellectual property, and filed for patent protections, on a manufacturing process which is compatible with large-scale production of photoreceptors in a closed system, improvements which could enable industrial manufacturing. We believe this accomplishment will provide new opportunities for clinical, and ultimately commercial, production of photoreceptors in areas of large unmet need such as Retinitis Pigmentosa, Stargardt’s Macular Dystrophy, and retinal detachments, either independently or through strategic alliances.”

As part of a scientific collaboration with Professors Benjamin Reubinoff, M.D., Ph.D. and Eyal Banin, M.D., Ph.D., of the Hadassah-Hebrew University Medical Center, the differentiation of pluripotent cells into photoreceptors with clinically compatible characteristics was established utilizing a novel differentiation protocol which generated positive identity of key markers of both rods and cones photoreceptor populations. The data generated by the company further demonstrated that a single cell suspension of photoreceptor precursor cells has the potential to survive and mature post-transplantation in a rodent model of retinal degeneration.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, which is now being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy, and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to (i) the potential amount of payments to Lineage under the alliance with Hoffman-La Roche Ltd. (“Roche”) and Genentech, Inc., (ii) the potential for new opportunities for clinical, and ultimately commercial, production of photoreceptors in areas of large unmet need, (iii) Lineage’s position to become a leader in the emerging field of regenerative medicine and anti-aging technology, and (iv) future areas of potential treatment using PNC transplant. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the risk that competing alternative therapies may adversely impact the commercial potential of OpRegen, which could materially adversely affect the payments payable to Lineage under the Roche/Genentech collaboration and license agreement, the risk that Roche/Genentech may not be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; the risk that Lineage might not succeed in developing products and technologies that are useful in medicine and demonstrate the requisite safety and efficacy to achieve regulatory approval in accordance with its projected timing, or at all; the risk that Lineage’s intellectual property may be insufficient to protect its assets; risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220425005336/en/

Contacts:

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Mike Biega
(mailto://Mbiega@soleburytrout.com)
(617) 221-9660

Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242

NEWS -- Plus Therapeutics Reports First Quarter 2022 Financial Results and Business Highlights

First patient dosed in ReSPECT-LM Phase 1/2a dose escalation trial of 186RNL for leptomeningeal metastases

Closed in-licensing transaction for novel targeted radioembolic technology for the treatment of solid organ tumors

Expanded ReSPECT-GBM clinical trial partnership with Medidata to design innovative registrational trial of 186RNL for recurrent glioblastoma

Management to host conference call today at 5:00 p.m. ET

Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced financial results for the first quarter ended March 31, 2022, and provided an overview of recent business highlights.

“In the first quarter of 2022, we announced a major corporate milestone, specifically the successful enrollment of the first patient in our ReSPECT-LM Phase 1/2a dose escalation trial of 186RNL in patients with leptomeningeal metastases,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “This adds a very important new clinical program to our growing drug development pipeline targeting significant unmet medical conditions.”

RECENT HIGHLIGHTS

Rhenium-186 NanoLiposome (186RNL), a novel radiotherapy in development for several rare cancer targets

• Treated first patient in the ReSPECT-LM Phase 1/2a dose escalation trial of 186RNL in patients with leptomeningeal metastases (LM).
• Finalized key 186RNL drug product development and characterization activities for GMP manufacturing to support planned Phase 2 registrational clinical trial and commercialization of 186RNL in recurrent glioblastoma (GBM).
• Expanded partnership with Medidata Solutions, Inc., a Dassault Systèmes company, utilizing Medidata’s Synthetic Control Arm® (SCA) platform intended to speed enrollment, improve patient access and reduce clinical trial costs in Plus Therapeutics’ planned Phase 2 registrational trial of 186RNL in GBM.
• Presentation at the American Association for Cancer Research (AACR) 2022 Annual Meeting describing a biology-based, mathematical model to predict response of recurrent GBM to 186RNL treatment (Poster).

Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere (188RNL-BAM), a novel radiotherapy in development for solid organ cancers

• Announced the in-licensing of a novel targeted radioembolic technology for the treatment of solid organ tumors and biodegradable alginate microspheres (BAM) technology for both diagnostic and/or therapeutic payloads.
• The Company began developing 188RNL-BAM as a next-generation radioembolization therapy for rare solid organ cancers including liver cancer.

FIRST QUARTER 2022 FINANCIAL RESULTS

• The Company’s cash balance was $21.2 million at March 31, 2022, compared to $18.4 million at December 31, 2021.
• Total operating expenses for the first quarter 2022 were $3.9 million, compared to total operating expenses of $2.5 million for first quarter 2021. Approximately $0.7 million of this increase is due to research and development expenses and $0.7 million to legal, intellectual property and professional fees.
• Net loss for the first quarter of 2022 was $4.1 million, or $(0.19) per share, compared to a net loss of $2.7 million, or $(0.33) per share, for the first quarter of 2021.

UPCOMING EVENTS AND MILESTONES

During the remainder of 2022, the Company expects to accomplish the following key business objectives:

• Upon U.S. Food and Drug Administration (FDA) approval, initiate a Phase 2/registrational trial in patients with recurrent GBM.
• Complete FDA CMC and clinical meetings for 186RNL.
• Manufacture GMP 186RNL for Phase 2 registrational trials.
• Obtain FDA approval for ReSPECT-GBM multiple dosing clinical trial arm.
• Complete initial safety cohort in ReSPECT-LM Phase 1/2a dose escalation trial.
• Obtain FDA approval for study of 186RNL in patients with pediatric brain cancer (ReSPECT-PBC).
• Complete technology transfer and key CMC, FDA IND-enabling studies for 188RNL-BAM.

First Quarter 2022 Results Conference Call

The Company will hold a conference call and live audio webcast at 5:00 p.m. Eastern Time today to discuss its financial results and provide a general business update.

Event: Plus Therapeutics First Quarter 2022 Results Conference Call
Date: April 21, 2022
Time: 5:00 p.m. Eastern Time
Live Call: 866-342-8591 (toll free); 203-518-9713 (Intl.); Conference ID: PSTVQ122

The webcast can be accessed live via the Investor Relations section of the Plus Therapeutics website at https://ir.plustherapeutics.com/events and will be available for replay beginning two hours after the conclusion of the conference call.

About Plus Therapeutics, Inc.

Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative, targeted radiotherapeutics for adults and children worldwide with rare and difficult-to-treat cancers. Our proprietary radiotherapeutic platform uniquely uses nanoliposomes to encapsulate and deliver the radioisotope, Rhenium, into or near a tumor via a single, direct infusion. The lead radiotherapeutic in our pipeline, Rhenium-186 NanoLiposome (186RNL), is being evaluated in U.S. multi-center clinical trials for the treatment of recurrent glioblastoma and leptomeningeal metastases. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “plan,” “can,” “design,” “intend,” “potential,” “expect,” “target,” “focus,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the Company’s anticipated expenditures, including research and development, and general and administrative expenses; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approvals and interactions and government regulation; the potential size of the market for the Company’s product candidates; the Company’s research and development efforts; results from the Company’s pre-clinical and clinical studies and implications of such results regarding the efficacy or safety of the Company’s product candidates; the safety profile, pathways, and efficacy of the Company’s product candidates and formulations; anticipated advantages of the Company’s product candidates over other products available in the market and being developed; the populations that will most benefit from the Company’s product candidates and indications that will be pursued with each product candidate; anticipated progress in the Company’s current and future clinical trials; plans and strategies to create novel technologies; the Company’s IP strategy; competition; future development and/or expansion of the Company’s product candidates and therapies in its markets; sources of competition for any of the Company’s product candidates; the Company’s pipeline; the Company’s ability to generate product or development revenue and the sources of such revenue; the Company’s ability to effectively manage its gross profit margins; the Company’s ability to obtain and maintain regulatory approvals; expectations as to its future performance; portions of the “Liquidity and Capital Resources” section of its quarterly report for the period ended March 31, 2022, including its potential need for additional financing and the availability thereof; the Company’s ability to continue as a going concern; its ability to remain listed on the Nasdaq Capital Market; the Company’s ability to repay or refinance some or all of its outstanding indebtedness and its ability to raise capital in the future; the Company’s ability to transfer the drug product manufacture to a contract drug manufacturing organization; and the potential enhancement of its cash position through development, marketing, and licensing arrangements.

The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the regenerative medicine field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.



Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com

Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com

NEWS -- Oncolytics Biotech® to Present at the Bloom Burton & Co. Healthcare Investor Conference

SAN DIEGO, Calif. and CALGARY, AB, April 21, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that Dr. Matt Coffey, President and Chief Executive Officer, will be presenting a corporate overview at the Bloom Burton & Co. Healthcare Investor Conference, which is taking place May 2-3, 2022 at the Metro Toronto Convention Centre, North Building in Toronto, Ontario. Additional details on the presentation can be found below.

Date: Tuesday, May 3, 2022
Time: 11:00 a.m. ET
Location: Metro Toronto Convention Centre, North Building Hall B
Webcast Link: Available by clicking here

Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please submit a meeting request on the conference website, contact your Bloom Burton & Co. representative, or email mailto://jpatton@oncolytics.ca.

A live webcast of the Company's presentation will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived for three months.

About the Conference

The Bloom Burton & Co. Healthcare Investor Conference brings together U.S., Canadian and international investors who are interested in the latest developments in the Canadian healthcare sector. Attendees will have an opportunity to obtain corporate updates from the premier Canadian publicly traded and private companies through presentations and private meetings.

About Bloom Burton & Co.

Bloom Burton & Co. is a firm dedicated to accelerating returns in the healthcare sector for both investors and companies. Bloom Burton has an experienced team of medical, scientific, pharmaceutical, legal and capital markets professionals who perform a deep level of diligence, which combined with our creative and entrepreneurial approach, assists our clients in achieving the right monetization events. Bloom Burton and its affiliates provide capital raising, M&A advisory, equity research, business strategy and scientific consulting, advisory on direct investing and company creation and incubation services. Bloom Burton Securities Inc. is a member of the Investment Industry Regulatory Organization of Canada (IIROC) and is also a member of the Canadian Investor Protection Fund (CIPF).

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; our plans to advance towards a registration study in metastatic breast cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

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SOURCE Oncolytics Biotech® Inc.

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/April2022/21/c4776.html

NEWS -- FuelPositive Provides Management Update at Annual General Meeting

TORONTO, April 20, 2022 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (“FuelPositive” or the “Company”) held its virtual Annual General Meeting (AGM) yesterday and provided attendees with an update from management. Dr. Ibrahim Dincer, the lead inventor of FuelPositive’s flagship technology, spoke at the AGM via video, as did Curtis Hiebert, the Company’s first demonstration project partner. The video of the management presentation can be viewed here: https://fuelpositive.com/fuelpositive-agm-april-19-2022/. A PDF of the presentation can be downloaded here: https://fuelpositive.com/wp-content/uploads/2022/04/AGM-deck-April-19-12-pm.pdf

The presentation focused on FuelPositive’s green ammonia production technology – a scalable, containerized system that employs a carbon-free process to make pure/anhydrous ammonia. The technology will disrupt the traditional grey ammonia supply chain by placing the production systems onsite, where the customer will be able to be self-sufficient by having control over supply, timing and costs.

The presentation covered a review of key 2021 milestones met by the Company and set out the milestones for 2022. Included were updates on:

• Hiring key staff and appointing expert advisors
• Securing leases for premises to build our demonstration systems
• Meeting with government officials at federal and provincial levels
• Validating the first demonstration system
• Identifying the next demonstration project partners
• Refining the costing model and setting pricing
• Filing the non-provisional patent for our containerized green ammonia production system technology
• Accepting pre-orders
• Setting up the next batch manufacturing and preparing for serial manufacturing
• Launching R&D regarding on-farm nitrous oxide emission reductions
• Identifying and acquiring new intellectual property to diversify our portfolio
• Generating analyst coverage

“It’s astounding when you think that we’ve gone from a cold start, with the acquisition of the intellectual property for the technology 13 months ago, to being ready for the field five months from now. Within that time frame, we’ve accomplished so much: we basically have a new company, a new team, and a unique product that is going to make a disruptive difference in the world. And it’s all been done during a global pandemic with serious supply chain issues. I’m very proud of our progress,” said Ian Clifford, FuelPositive CEO and Board Chair.

Dr. Ibrahim Dincer, the lead inventor of the patent-pending containerized green ammonia production system technology, spoke via video to the meeting: “FuelPositive (is making) an historic attempt to commercialize our technology… FuelPositive has moved ahead and recruited key people and assembled a team of experts...from almost every discipline, to make this solution available to humanity. I am very hopeful we will have a remarkable achievement coming soon.”

Market Readiness

The Company spoke at length about preparing for its demonstration pilot projects. The objectives of the first pilot project are to place the system on the farm and run it on the sustainable energy supply available there, evaluate the interface between the customer and the system, prove the ease of use of the system and ensure the system performs over time as expected.

The first demonstration system is scheduled to be on the farm of Tracy and Curtis Hiebert in the late summer of 2022. Nelson Leite, FuelPositive Chief Operating Officer, stated: “We are on track for the first system to be farm-ready by late summer 2022.” Leite added that supply chain challenges and the preparation of the site could mean slight delays commissioning the system on the site. Specifically, transporting the system from FuelPositive in Ontario to Manitoba could be affected by transportation logistics. As well, the farmer must apply for and have in place the permits for the production, storage and handling of the green anhydrous ammonia. The farmer must also have new storage tanks delivered, installed and ready for operation.

“What I can say, is that everything that we have control over is going according to plan, and we fully expect our first containerized green ammonia production system to be “farm-ready” by late summer. The demonstration system will be validated and running in our facility. We will then be able to create and share images of the system for everyone to see and this will be a very exciting milestone,” added Leite.

Farmer Interface

FuelPositive outlined new information about how the system will function and how farmers will work with it. It has been designed to make its operation simple, despite its advanced technology. Customers will receive onsite training, but there will be little for them to do, because FuelPositive will monitor, optimize and maintain remotely more than 145 aspects of the system from its own location.

The system lifecycle is expected to last several decades, with only periodic upgrades necessary. For instance, a catalyst upgrade will be implemented at the 15-year mark.? The Company will be continually advancing the technology. Due to its modular design and remote connectivity, each customer will be able to take advantage of new technologies as they become available.? Delays, in that context, for upgrading a component, as an example, will be minimal.? Unlike a large grey ammonia refinery, the green ammonia containerized FuelPositive system can be started and stopped quickly and safely as needed.

About FuelPositive

FuelPositive is a Canadian technology company committed to providing commercially viable and sustainable “cradle to cradle” clean technology solutions, including green ammonia (NH3), for use across a broad spectrum of industries and applications. By focusing on technologies that are clean, sustainable and economically advantageous/realizable, the Company aims to change the course of climate change through practical solutions that can be implemented now.

The FuelPositive green ammonia production system takes air, water and sustainable electricity and synthesizes it into pure, anhydrous ammonia for multiple applications, including fertilizer for farming, fuel for grain drying and internal combustion engines and a solution for grid storage. Green ammonia is also being considered as a key enabler of the hydrogen economy.

The production system has three basic sections: a hydrogen extractor that uses electrolysis to extract the hydrogen from water, a nitrogen extractor that extracts the nitrogen from air, and an ammonia synthesis converter the combines the hydrogen and nitrogen to produce ammonia. FuelPositive’s provisional patent is for the unique technology used in the ammonia synthesis converter.

FuelPositive systems are designed to provide for green ammonia production on-site, where it’s needed. This eliminates wildly fluctuating supply chains and offers end-user energy and supply security.

Already proven in the lab, FuelPositive is building three full-sized systems to be rolled out in demonstration pilot projects in 2022.

Cautionary Statement

Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) that are based on expectations, estimates and projections as at the date of this news release. The information in this release about future plans and objectives of the Company, including the expected expenditures of the proceeds of the private placement, are forward-looking statements.
These forward-looking statements are based on assumptions and estimates of management of the Company at the time they were made and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.

Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.

Forward-looking information is provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking information or to explain any material difference between subsequent actual events and such forward-looking information, except to the extent required by applicable law.

For Media or Investor enquiries, please contact:

Ian Clifford
Chief Executive Officer and Board Chair
mailto://mailbox1@fuelpositive.com
https://www.fuelpositive.com

Investor Relations (United States)
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com

NEWS -- Heat Biologics (“NightHawk Biosciences”) Completes Acquisition of Elusys Therapeutics

• Elusys becomes wholly-owned biodefense subsidiary of NightHawk
• Plans to expand ANTHIM® distribution abroad

DURHAM, N.C., April 20, 2022 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (NYSE American: HTBX) (to be renamed “NightHawk Biosciences”), a fully-integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced it has completed the acquisition of Elusys Therapeutics, Inc. a commercial-stage biodefense company and developer of ANTHIM® (obiltoxaximab), a treatment for inhalation anthrax. ANTHIM® is approved for use in the U.S. and Canada, and under the brand name Obiltoxaximab SFL in Europe and the United Kingdom.

Nighthawk acquired all outstanding shares of Elusys, which will continue to operate as a wholly-owned subsidiary of NightHawk. No stock or warrants were issued in connection with the acquisition, and Elusys had no outstanding term debt.

The strategic acquisition of Elusys significantly expands the Company’s role in the biodefense space, complementing NightHawk’s RapidVax® platform, which is designed to target emerging biological threats. Pursuant to this acquisition, NightHawk also announced it plans to migrate manufacturing of ANTHIM® to its planned 500,000 square foot Scorpion biomanufacturing facility in Manhattan, Kansas, which is being constructed to support development of commercial-scale biologics and large molecules.

To date, Elusys has been awarded over $350 million in research and development grants, contracts and procurement orders from the Biomedical Advanced Research and Development Authority (BARDA) and the U. S. Strategic National Stockpile (SNS). Through ongoing, multi-year partnerships with the U.S. government, Elusys has been supplying ANTHIM® to the SNS - the government’s repository of critical medical supplies for biodefense preparedness.

Jeff Wolf, CEO of NightHawk, commented, “We are excited to announce the closing of this transformative acquisition, which provides us with a solid foothold in the biodefense space. Elusys has an established a successful track record collaborating with U.S. government agencies including BARDA, NIH, SNS and DOD. We plan to leverage Elusys’ existing relationships and distribution channels as a launching pad for RapidVax®, our “plug and play” platform designed for rapid development and delivery of new vaccines. In addition, we look forward to leveraging our new Kansas facility, which will enable us to manufacture these therapies internally and therefore benefit from significant operating synergies, as well as enhanced oversight, quality control, and speed to market. We are also exploring opportunities to expand ANTHIM® distribution abroad. This transaction is perfectly aligned with our overall vision to establish a fully-integrated ecosystem to deliver medical innovations faster, better, and more efficiently.”

David Lasseter, former Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction, and a member of NightHawk’s Biothreat Advisory Board, commented, “This transaction is extremely timely, given the global uncertainty and unprecedented threats from foreign nations and rogue actors. Anthrax is one of the most significant biological warfare threats facing our country, with real potential for mass casualties. ANTHIM® represents a key medical countermeasure for the treatment of inhalation Anthrax.”

A special committee of Heat’s Board of Directors negotiated and approved the transaction and Cassel Salpeter & Co. provided a fairness opinion in connection with the transaction. Blank Rome LLP acted as legal counsel to Heat. Elusys was advised by RBC Capital Markets, LLC. Additional details on the transaction are outlined in Company’s Form 8-K, which will be filed with the Securities and Exchange Commission and will be available on the Company’s website.

About ANTHIM

Anthrax is a life-threatening infectious disease caused by Bacillus anthracis. Cases of inhalational anthrax in humans can occur through intentional spread of B. anthracis spores as a biowarfare or bioterrorism agent. B. anthracis spores introduced through the lungs lead to inhalational anthrax, which is deadly in humans.

ANTHIM is a monoclonal antibody that binds to the protective antigen (PA) component of anthrax toxin. ANTHIM’s toxin neutralizing activity prevents entry of anthrax toxin into susceptible cells, avoiding further spread of the toxin throughout the body and the ensuing tissue damage that leads to death. ANTHIM is supplied as single-dose vials for IV infusion.

Indications and Usage

ANTHIM is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis.

IMPORTANT SAFETY INFORMATION Including BOXED WARNING

WARNING: HYPERSENSITIVITY and ANAPHYLAXIS
Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion. ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs.

WARNINGS AND PRECAUTIONS

Hypersensitivity and anaphylaxis have been reported during the IV infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs. Pre-medication with diphenhydramine is recommended prior to administration of ANTHIM. Diphenhydramine pre-medication does not prevent anaphylaxis and may mask or delay onset of symptoms of hypersensitivity.

ADVERSE REACTIONS

The safety of ANTHIM has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax. The most frequently reported adverse reactions were headache, pruritus, infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, urticaria, nasal congestion, infusion site pain, and pain in extremity.

USE IN SPECIFIC POPULATIONS

Pediatric Use: There have been no studies of the safety or PK of ANTHIM in the pediatric population.

To see the complete prescribing information for ANTHIM, click here.

About Heat Biologics, Inc. / NightHawk Biosciences, Inc.

Heat Biologics (to become “NightHawk Biosciences”) is a fully-integrated biopharmaceutical company focused on the development of new drugs from discovery through biomanufacturing. The Company leverages its integrated ecosystem of subsidiaries to accelerate the creation of novel therapies that arm the immune system, breaking through barriers that prolong traditional drug development. This empowers us to bring our ideas to life with efficient control, superior quality, and uncharacteristic agility.

For more information on the Company and is subsidiaries, please visit: https://www.nighthawkbio.com, and also follow us on Twitter.

Forward Looking Statement

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements regarding plans to migrate manufacturing of ANTHIM® to the planned 500,000 square foot biomanufacturing facility in Manhattan, Kansas, plans to leverage Elusys’ existing relationships and distribution channels as a launching pad for RapidVax, leveraging the new Kansas facility to enable Heat to manufacture therapies internally, expected benefit to be derived from significant operating synergies, as well as enhanced oversight, quality control, and speed to market, exploring opportunities to expand ANTHIM® distribution abroad and establishing a fully-integrated ecosystem to deliver medical innovations faster, better, and more efficiently. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to migrate manufacturing of ANTHIM® to the Manhattan, Kansas facility, the ability to expand ANTHIM® sales beyond the U.S., the ability to leverage Elusys’ existing relationships and distribution channels as a launching pad for RapidVax , the ability to expand ANTHIM® distribution abroad, the ability to derive benefit from operating synergies, as well as enhanced oversight, quality control, and speed to market, the ability to establish a fully-integrated ecosystem to deliver medical innovations faster, better, and more efficiently, whether the combined business of Heat and Elusys will be successful, Heat’s and Elusys’ ability to maintain license agreements, the continued maintenance and growth of Heat’s and Elusys’ patent estate, Heat’s product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results, the ability to initiate clinical trials and if initiated, the ability to complete them on time and achieve the desired results and benefits continuing enrollment as expected, the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat’s ability to promote or commercialize its product candidates for the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of Heat’s, developments by competitors that render such products obsolete or non-competitive, and other factors described in Heat’s annual report on Form 10-K for the year ended December 31, 2021, subsequent quarterly reports on Form 10-Qs and any other filings Heat makes with the SEC. Heat can give no assurance that the conditions to the Merger will be satisfied. The information in this presentation is provided only as of the date presented, and Heat undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.

Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://investorrelations@heatbio.com

NEWS -- Navidea Biopharmaceuticals Announces Positive Preliminary Results of Its Ongoing Phase 2B Study Comparing Tc99m Tilmanocept Imaging with Histopathology of Joints from Patients with Rheumatoid Arthritis

Data support hypothesis that Tc99m tilmanocept imaging can differentiate fibroid pathotype of rheumatoid arthritis from non-fibroid pathotypes

DUBLIN, Ohio, April 20, 2022--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced preliminary results from the ongoing NAV3-32 Phase 2B study titled, "A Comparison of Tc99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue From Subjects Clinically Diagnosed With Rheumatoid Arthritis (RA)." Preliminary results on the first eleven patients indicates that quantitative Tc99m tilmanocept uptake in the hands and wrists of patients is proportional to the amount of macrophage involvement in an individual rheumatoid arthritis ("RA") patient’s joint inflammation. Additionally, Tc99m tilmanocept uptake in RA-inflamed joints was able to discretely differentiate patients with the fibroid pathotype (i.e., low macrophage involvement) from those having either the diffuse myeloid or lympho-myeloid pathotypes of RA (i.e., higher macrophage involvement).

The primary objective of this study is to assess the relationship between joint-specific tilmanocept uptake values and the pathobiology of RA-involved joint tissue. This is being accomplished by taking biopsy samples from joints of patients with RA following imaging with Tc99m tilmanocept. The images are being evaluated using Navidea’s proprietary imaging analysis method to determine the amount of Tc99m tilmanocept uptake in the joint to be biopsied. The biopsy tissues are being evaluated by a pathologist using immunohistochemical ("IHC") staining to determine the cellular composition, including macrophage content, in the inflammatory tissue of the RA-involved joint. The cellular composition of RA-inflamed joints is known to vary between patients and is frequently separated into one of three pathotypes termed fibroid, diffuse myeloid, and lympho-myeloid. Knowledge of an individual RA patient’s pathotype may be clinically important because it may predict to which RA therapy a patient is likely to respond. It is Navidea’s hypothesis that the imaging signal will correlate with the number and density of activated macrophages in the joints of RA patients, and that this imaging signal can provide important information about not only the disease status of the patient, but also indicate which pathotype of RA that the patient has. Enrollment is to continue until a minimum of four patients of each of the three pathotypes- fibroid, diffuse myeloid, and lympho-myeloid- have been enrolled and had both assessable imaging and biopsy performed.

At the current time, a total of eleven patients have had Tc99m tilmanocept imaging followed by synovial tissue biopsy in an inflamed joint of their hands or wrists. Quantitative image analysis was performed prior to biopsy. Image analyses conducted before the biopsies has been able to separate the subjects into at least 2 distinct and nonoverlapping classes of subjects. Seven of the subjects had relatively lower levels of Tc99m tilmanocept uptake. All seven of these subjects were found to have the fibroid pathotype. Of the remaining 4 subjects, 3 had the diffuse myeloid pathotype and 1 had the lympho-myeloid pathotype. Furthermore, those subjects with either the diffuse myeloid or lympho-myeloid pathotypes had, on average, more than 3 times more Tc99m tilmanocept uptake as the average subject with the fibroid pathotype. The pathologist who evaluated these biopsies was blinded to the imaging results prior to completing their report. These early results support the hypothesis that those patients with low levels of Tc99m tilmanocept localization in their hand and wrist joints have the fibroid pathotype of RA, and those with higher levels of localization are representative of one of the other two pathotypes.

Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are encouraged by these preliminary results. They support one of our main hypotheses- that the joints of patients with the pathotype of RA involving low levels of synovial macrophages, the fibroid pathotype, have low levels of Tc99m tilmanocept uptake, while those with the other pathotypes have relatively higher levels." Dr. Rosol continued, "We believe that this Phase 2B study is critical for establishing the definitive relationship of our imaging readout to the underlying pathobiology of an RA-involved joint, as well as to assess our hypothesis that we can use Tc99m tilmanocept imaging to classify RA subtype. This information may further assist physicians to determine what type of therapy might be most beneficial for a given patient earlier and more noninvasively than is currently possible. This study will also be important for us as we seek to achieve qualification with the FDA of CD206 as a biomarker for RA."

The Company will hold a business update conference call today, Wednesday, April 20, 2022, at 5:00 p.m. (EDT). Chief Medical Officer Dr. Michael Rosol will host the call and webcast.

To participate in the first call and webcast, please refer to the information below:

Event: Navidea Business Update – Company Strategy and Clinical Update
Date: Wednesday, April 20, 2022
Time: 5:00 p.m. (EDT)
U.S. & Canada Dial-In: 877-407-0312
International Dial-In: +1 201-389-0899
Conference ID: 13729076
Webcast Link: https://www.webcast-eqs.com/navidbioph20220420/en

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at https://www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

RA is a chronic disease affecting over 1.3 million Americans and as much as 1% of the worldwide population1. If the product is successfully developed, Navidea would expect to play a major role in the management of RA patients worldwide.

1. https://www.rheumatoidarthritis.org/ra/facts-and-statistics/

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit https://www.navidea.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and ability to obtain additional financing; our ability to continue as a going concern; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.

These forward-looking statements include, but are not limited to, statements about preliminary data from Navidea’s ongoing clinical trials. Data from the NAV3-32 Phase 2B clinical trial are preliminary and will require confirmation in additional patients as well as further analyses to draw any clinical conclusion. Preliminary data from Navidea’s clinical trials that it announces or publishes from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.

You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220420005414/en/

Contacts

Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com

NEWS -- Navidea Biopharmaceuticals Announces Updated Third-Party Asset Valuation of Tc99m Tilmanocept for Indications in Rheumatoid Arthritis for U.S. and EU Markets

DUBLIN, Ohio, April 20, 2022--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the results of an updated third-party asset valuation of its Rheumatoid Arthritis ("RA") diagnostic product candidate for both the U.S. and EU markets.

The Company engaged the independent third-party valuation firm, LifeSci Consulting (LifeSci Partners), to perform a U.S.-focused primary market research valuation and a secondary market analysis for the EU of its advanced pipeline product Tc99m tilmanocept for prediction of treatment efficacy of anti-tumor necrosis factor alpha ("TNFa") therapy in RA. A summary of the valuation report and the assumptions on which it is based is available on the Company’s website, https://www.navidea.com. The U.S. market evaluation has been updated from the December 2021 press release using primary information from academic and high-volume health care provider rheumatologists obtained through questionnaires and interviews (primary research).

The Company is advancing its program evaluating Tc99m tilmanocept imaging, a radiopharmaceutical that selectively targets the CD206 receptor expressed on activated macrophages, for indications in RA. A previously completed Phase 2B study demonstrated results in support of the hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active RA, and that this imaging can provide an early indicator of treatment efficacy in patients with active RA. The Company’s active Phase 3 trial will evaluate the ability of Tc99m tilmanocept imaging to serve as an early predictor of treatment response in RA patients switching to an anti-TNFa therapy.

The valuation report used cited research and assumptions believed to conform to industry best practices. Under base-case assumptions that are discussed in the report, peak combined U.S. and EU sales could reach $1.2 billion annually, and in the upside scenario peak annual U.S. and EU sales could reach $2.6 billion. Rheumatologist feedback included recognition of the need for a tool that would enable treatment response prediction. Opportunities for added value include possible indication expansion to other classes of RA therapeutics, registration of Tc99m tilmanocept imaging as a biomarker of activated macrophages in the joints of patients with RA, and expansion into additional geographic areas.

Dr. Michael Rosol, Navidea’s Chief Medical Officer, said, "This report provides an updated third-party assessment of the potential commercial value of Tc99m tilmanocept in both the U.S. and EU markets. As with our earlier release, we present this in the spirit of transparency, while also giving investors a view into the company’s internal rigor in evaluating investments in the product pipeline." Dr. Rosol continued, "We believe we are on the right path to bringing a valuable tool to bear to meet a large unmet medical need in patients with RA. Success would mean that we can provide rheumatologists and those suffering with RA a noninvasive, quantifiable, early indicator of whether or not an anti-TNFa treatment is working. This could bring enormous benefit to these patients by assisting physicians in putting them on the right course of treatment much earlier than is possible today."

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit https://www.navidea.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the fact that the valuation by LifeSci Partners of our Tc99m tilmanocept pipeline product is subject to and based on numerous assumptions about the commercial success of the product, expected associated costs, and the outcome of various risks, including the outcome of clinical trials, that could affect the timetable for revenues, among other assumptions, that actual outcomes are likely to vary from such assumptions, resulting in variations from the possible results set forth in the valuation report; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.

Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.

You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220420005182/en/

Contacts

Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com

https://ntts-prod.s3.amazonaws.com/t2p/prod/t2media/tops/pdf/MFS-TOPS-75.pdf

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NEWS -- Provectus Biopharmaceuticals Seeks Stockholder Approval at 2022 Annual Meeting for Authority to Undertake Reverse Split of Outstanding Equities and Reduce Number of Authorized Equities by Same Ratio

KNOXVILLE, TN, April 19, 2022 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that, in conjunction with the filing of the Company’s preliminary 2022 proxy statement (Pre-14A), Provectus’ Board of Directors (Board) seeks approvals at the Company’s 2022 Annual Meeting of Stockholders on June 22nd for the authority to:

• Reverse stock split proposal: Amend the Company’s Certificate of Incorporation (as amended by the Series D and D-1 Certificates of Designation) to effect a reverse stock split of the Company’s common stock, Series D Convertible Preferred Stock, and Series D-1 Convertible Preferred Stock at a ratio of between 1-for-10 and 1-for-50, and to make corresponding amendments to the Series D and D-1 Certificates of Designation to provide for the proportional adjustment of certain terms upon a reverse stock split, and

• Authorized share reduction proposal: If and only if the reverse stock split proposal is approved, amend the Company’s Certificate of Incorporation (as amended by the Series D and D-1 Certificates of Designation) to decrease the number of authorized shares of Provectus’ common and preferred stocks by the same reverse stock split ratio determined by the Board.

At the 2022 Annual Meeting, stockholders will also vote on proposals for the election of directors, approval of the compensation of the Company’s named executive officers, and ratification of the Company’s independent registered public accounting firm. Subject to review by and/or comments from the Securities and Exchange Commission (SEC) on the Pre-14A, the Company will file its definitive 2022 proxy statement thereafter.

About Provectus

Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different disease areas based on a family of small molecules called halogenated xanthenes. Multi-route of administration drug discovery and development programs include investigational drugs and drug targets in oncology (clinical-stage), dermatology (clinical-stage), hematology, virology, microbiology, ophthalmology (clinical-stage), and animal health. Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, https://www.clinicaltrials.gov. For additional information about Provectus, please visit the Company's website at https://www.provectusbio.com.

FORWARD-LOOKING STATEMENTS: The information in this press release may include “forward-looking statements,” within the meaning of U.S. securities legislation, relating to the business of Provectus and its affiliates, which are based on the opinions and estimates of Company management and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “project,” “predict,” “potential,” “targeting,” “intend,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.

The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.

Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.

Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the SEC, including those described in Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.

Additional Information and Where to Find It

As described in the preliminary proxy statement referred to above, the Company’s 2022 Annual Meeting of Stockholders (2022 Annual Meeting) will be held to, among other things, consider a reverse stock split proposal and authorized share reduction proposal. Stockholders are urged to read the definitive proxy statement when it becomes available, because it will contain important information about the Company and the 2022 Annual Meeting proposals.

This press release is not a proxy statement or solicitation of a proxy, consent, or authorization with respect to any securities or in respect of the 2022 Annual Meeting proposals. STOCKHOLDERS ARE URGED TO READ CAREFULLY AND, IN ITS ENTIRETY, THE PRELIMINARY PROXY STATEMENT FILED WITH THE SEC AND, WHEN THEY BECOME AVAILABLE, THE DEFINITIVE PROXY STATEMENT AND OTHER RELEVANT MATERIALS, BECAUSE THEY DO AND WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY AND THE 2022 ANNUAL MEETING PROPOSALS. A notice of internet availability of proxy materials with instructions for accessing the definitive proxy statement will be mailed to stockholders as of the record date of April 25, 2022. Stockholders may obtain free copies of the Company’s preliminary proxy statement and its other SEC filings electronically by accessing the SEC’s home page at http://www.sec.gov. Copies can also be obtained, free of charge, upon written request to Provectus Biopharmaceuticals, Inc., Attn: Secretary, 10025 Investment Drive, Suite 250, Knoxville, Tennessee 37932, (866) 594-5999.

Participants in Solicitation

This press release may constitute soliciting material under SEC Rule 14a-12, and the Company and its directors, executive officers, and advisors may be deemed to be participants in the solicitation of proxies from the holders of the Company’s common stock, Series D Convertible Preferred Stock, and Series D-1 Convertible Preferred Stock in respect of the 2022 Annual Meeting proposals.

Investors may obtain additional information regarding the interest of those participants by reading the Company’s preliminary proxy statement and, when they become available, the Company’s definitive proxy statement and other relevant proxy materials, and the Company’s annual reports on Form 10-K and quarterly reports on Form 10-Q, as filed with the SEC.

###

Contact:

Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999

NEWS -- Heat Biologics Announces Planned Name Change to NightHawk Biosciences, Reflecting Company’s Evolution, Therapeutic Pipeline Expansion, Vertical Integration and New Biodefense Capabilities

Key Corporate Updates Announced Via Livestream Event from Manhattan, Kansas, available for replay at https://Nighthawkbio.com

DURHAM, N.C., April 19, 2022 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (“Heat”) (NYSE American: HTBX), a clinical-stage biopharmaceutical company focused on developing novel biodefense assets and first-in-class therapies to modulate the immune system, today announced that it is changing the name of the Company to NightHawk Biosciences, Inc., effective May 3, 2022, to better reflect the Company’s evolution, including expansion of its therapeutic pipeline, the vertical integration of capabilities from drug discovery to manufacturing and commercialization, as well as the Company’s new biodefense capabilities. In connection with the name change, the Company’s ticker will change to “NHWK,” effective May 3, 2022. The livestream event, held at the Purple Masque Theatre at Kansas State University in Manhattan, Kansas and other locations, is available on the Company’s new website at: https://NightHawkBio.com.

NightHawk will focus on rapid and efficient drug development through its integrated ecosystem of subsidiary companies, which includes Skunkworx Bio (Skunkworx), Heat Biologics (Heat), Pelican Therapeutics (Pelican), Scorpion Biological Services (Scorpion) and Elusys Therapeutics (Elusys). The Company believes this fully-integrated ecosystem enables a more rapid delivery of medical innovations with increased quality and efficiency.

During the event, the Company announced several key corporate developments, including:

• Discovery subsidiary Skunkworx continues to make progress across a variety of infectious disease, biodefense and oncology-related indications, with an intended public announcement of these programs set to occur later this year.
• Scorpion is expected to host the grand opening of its San Antonio facility following completion of construction in Q3, 2022.
• PTX-35 is nearing final enrollment in its last cohort of its Phase 1 solid tumor trial, and just recently announced a presentation of new data at the American Association of Cancer Research (AACR).
• A planned research collaboration with Kansas State University’s Biosecurity Research Institute on its RapidVax biodefense program.
• Expanded efforts by biodefense Elusys Therapeutics to support international sales of ANTHIM® (obiltoxaximab). ANTHIM® is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. ANTHIM® should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. Additional details are available at https://anthim.com/
• Richard Myers, who previously served as the Chairman of the Joint Chiefs of Staff before serving as President of Kansas State University, will become Chairman of NightHawk’s BioThreat Advisory Board.

Jeff Wolf, Chief Executive Officer of NightHawk, commented, “Over the past 18 months, we’ve built a powerful drug discovery engine in our SkunkWorx subsidiary. We’ve been building our Scorpion subsidiary to deliver world-class biomanufacturing. And we announced the acquisition of Elusys Therapeutics, a biodefense company, which we intend to grow into a biodefense powerhouse.”

Mr. Wolf added, “The pandemic highlighted the fact that the development of new drugs is tremendously slow, encumbered, and expensive. These are enormous barriers to American progress. We believe the solution is full integration of discovery, preclinical testing and manufacturing, optimized to quickly and efficiently deliver drugs to the people who need them.”

Mr. Wolf continued, “The NightHawk model represents a new way of thinking and is designed to combine speed and agility with the full-integration of discovery, development and manufacturing. We are excited to continue to build and enhance this ecosystem under the NightHawk banner.”

About Heat Biologics / NightHawk Biosciences, Inc.

Heat Biologics (to become “NightHawk Biosciences”) is a fully-integrated biopharmaceutical company focused on the development of new drugs from discovery through manufacturing. The Company leverages its integrated ecosystem of subsidiaries to accelerate the creation of novel therapies that arm the immune system, breaking through barriers that prolong traditional drug development. This empowers us to bring our ideas to life with efficient control, superior quality, and uncharacteristic agility.

For more information on the Company and is subsidiaries, please visit: https://www.nighthawkbio.com, and also follow us on Twitter.

Forward Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectation, and assumptions and include statements regarding the planned name change, the fully-integrated ecosystem enabling a more rapid delivery of medical innovations with increased quality and efficiency, Skunkworx’s continued progress across a variety of infectious disease, biodefense and oncology-related indications, with an intended public announcement of these programs set to occur later this year, the grand opening of Scorpion’s San Antonio facility following completion of construction in Q3, 2022, a planned research collaboration with Kansas State University’s Biosecurity Research Institute on its RapidVax biodefense program, Richard Myers becoming Chairman of NightHawk’s BioThreat Advisory Board, growing Elysus into a biodefense powerhouse, the solution to barriers to development of new drugs being a full integration of discovery, preclinical testing and manufacturing, optimized to quickly and efficiently deliver drugs to the people who need them. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including Heat’s ability to enable a more rapid delivery of medical innovations with increased quality and efficiency, the ability to integrate discovery, preclinical testing and manufacturing, and optimize such integration to quickly and efficiently deliver drugs to the people who need them, the contributions to be derived from Richard Myers and NightHawk’s BioThreat Advisory Board, the ability to complete construction of, and open, Scorpion’s San Antonio facility in Q3, 2022, Skunkworx’s ability to continue progress across a variety of infectious disease, biodefense and oncology-related indications, the contributions to be derived from the collaboration with the Kansas State University’s Biosecurity Research Institute , Heat's ability to augment its clinical programs and enhance and expand its therapeutic pipeline, the ability of Heat's therapies to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities and its cash and short-term investments providing significant runway to fund Heat’s current clinical programs and further expand Heat’s therapeutic portfolio , its ability to continue to maintain its listing on the Nasdaq Capital Market and its ability to retain its key scientists or management personnel, and the other factors described in Heat's most recent annual report on Form 10-K for the year ended December 31, 2021 filed with the SEC, and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release, and Heat undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.

Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://investorrelations@heatbio.com

NEWS -- Navidea Biopharmaceuticals Announces the Notice of Allowance for U.S. Patent Application for Diagnosis and Treatment of Leishmaniasis

Decision of Grant given in Japan for separate patent application covering targeted delivery of payloads attached to the Manocept platform

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that it has received a Notice of Allowance for the patent application titled, “Compounds And Compositions For Treating Leishmaniasis And Methods Of Diagnosis And Treating Using Same” (U.S. Patent Application No. 15/729,633). Navidea also announced that it has received a Decision of Grant from the Japan Patent Office for the patent application titled, “Compounds And Compositions For Targeting Macrophages And Other Mannose-Binding C-Type Lectin Receptor High Expressing Cells And Methods Of Treating And Diagnosing Using Same” (Japanese Patent Application No. 2020-107176).

The U.S. patent application involving leishmaniasis protects the use of Navidea’s mannosylated dextran-based drug-delivery vehicles to deliver small molecule therapeutic payloads as possible therapies for leishmaniasis. Leishmaniasis is a vector-borne chronic disease caused by a protozoan parasite that replicates in CD206+ macrophages. It is transmitted to humans through the bite of infected phlebotomine sandflies found in parts of the tropics, subtropics, and southern Europe. Leishmaniasis is rare in the U.S., but in more tropical countries where the sandfly vectors are found, leishmaniasis is a common, serious, and potentially life-threatening disease. The World Health Organization estimates that there are 700,000-1,000,000 new cases of leishmaniasis each year. Because of this situation, leishmaniasis is classified as a neglected tropical disease, and is on the FDA’s list of tropical diseases eligible to receive a priority review voucher. If further research supports the efficacy of Navidea’s therapeutic constructs for treating leishmaniasis, the awarding of a priority review voucher could have significant economic value for Navidea. The Notice of Allowance concludes the substantive examination of the patent application and is expected to result in the issuance of a U.S. patent after administrative processes are completed.

The Japanese patent application titled “Compounds And Compositions For Targeting Macrophages And Other Mannose-Binding C-Type Lectin Receptor High Expressing Cells And Methods Of Treating And Diagnosing Using Same” is an important application for Navidea that claims targeted delivery of a wide range of therapeutic payloads attached to Manocept platform-based constructs using a degradable hydrazone linker. The Japanese patent application has similar claims to a corresponding patent that was previously granted in the U.S. Ongoing work by Navidea has shown that the claimed Manocept-hydrazone constructs have potential applications for treating such diseases as cancer as well as leishmaniasis. The Japanese Patent Office Decision of Grant for this patent application strengthens Navidea’s patent protection for the therapeutic constructs it is developing.

Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “These patents will be key to advancing and protecting our intellectual property and to the continued development of our clinical pipeline. Our targeted therapeutics have the potential to address the large unmet medical need caused by leishmaniasis as well as other diseases of significance globally.”

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit https://www.navidea.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.

Investors are urged to consider statements that include the words “will,” “may,” “could,” “should,” “plan,” “continue,” “designed,” “goal,” “forecast,” “future,” “believe,” “intend,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.

You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220419005384/en/

Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com

NEWS -- Plus Therapeutics Announces Oral Presentation at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2022 Annual Meeting

AUSTIN, Texas, April 19, 2022 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced that it will discuss new data in an oral presentation at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2022 Annual Meeting, being held June 11-14, 2022, in Vancouver, British Columbia, Canada.

A copy of the presentation titled “Rhenium-186-NanoLiposome (186RNL) in the treatment of relapse/recurrent glioblastoma (rGBM): a novel approach to cancer therapy,” will be made available under the Presentations tab of the For Investors section of the Company’s website following the meeting at https://www.plustherapeutics.com.

About Plus Therapeutics

Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on the development, manufacture, and commercialization of complex and innovative treatments for patients battling cancer and other life-threatening diseases.

Our proprietary nanotechnology platform is currently centered around the enhanced delivery of a variety of drugs using novel liposomal encapsulation technology. Liposomal encapsulation has been extensively explored and undergone significant technical and commercial advances since it was first developed. Our platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186RNL including the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-LM or the ReSPECT-PBC trials; possible negative effects of 186RNL; the continued evaluation of 186RNL including through evaluations via a seventh patient cohort; and the intended functions of the Company’s platform and expected benefits from such functions.

The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the regenerative medicine field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.

Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com

Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com

NEWS -- CytoSorbents to Report First Quarter 2022 Operating and Financial Results

MONMOUTH JUNCTION, N.J., April 19, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, will report first quarter 2022 operating and financial results after the market close on May 3, 2022. CytoSorbents' management will host a live conference call and presentation webcast at 4:30 p.m. Eastern the same day.

Conference call details:

Date: Tuesday, May 3, 2022
Time: 4:30 p.m. Eastern
Toll free: 1-877-451-6152
International: 1-201-389-0879
Conference ID: 13728663

The live audio webcast and presentation can be accessed via the following link: https://viavid.webcasts.com/starthere.jsp?ei=1541445&tp_key=979468cd12

It is recommended that participants dial in approximately 10 minutes prior to the start of the call. An archived recording of the conference call will be available under the Investor Relations portion of the company's website at https://cytosorbents.com/investor-relations/financial-results/.

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 162,000 cumulative CytoSorb devices have been utilized as of December 31, 2021. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 20 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 25 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.

CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

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Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
mailto://tpowers@cytosorbents.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com

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SOURCE CytoSorbents Corporation

NEWS -- FuelPositive Announces First Demonstration Project Partner

Multi-generational family farm in Manitoba, Canada looking forward to gaining control of fertilizer supply, timing and costs

TORONTO, April 19, 2022 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (“FuelPositive” or the “Company”) is pleased to announce it has signed a letter of intent with Tracy and Curtis Hiebert, farmers based in Manitoba, Canada, making them the Company’s first demonstration project partners. FuelPositive’s first, full-sized, green ammonia production system will be placed on the Hiebert’s 11,000-acre family operated plant-crop farm near the town of Sperling, south of Winnipeg. Currently being built, the demonstration system will be fully validated and ready for the farm in late-summer 2022. FuelPositive’s core technology is a scalable, containerized system that employs a carbon-free process to make pure or anhydrous ammonia. Over 80% of the ammonia produced today is used on farms as fertilizer because of the significant concentration of nitrogen it contains.

The objectives of the first pilot project are to place the system on the farm and power it with electricity supplied by Manitoba’s carbon-free grid, in combination with the Hieberts’ 200-kilowatt solar array and evaluate the operational interface between the customer and the system. This will serve to prove the ease of use of the system and ensure the system performs as expected over time, while exposed to Manitoba’s varied and extreme climate.

“We are excited to be working with Tracy and Curtis and their family on our first demonstration project. They take a modern approach to farming, want to be more sustainable, and are early adopters of new agricultural technologies and techniques to increase efficiency while reducing greenhouse gas emissions. The family has been working with anhydrous ammonia since the late 1960s, when it was first introduced in Manitoba, so the Hieberts are already knowledgeable and comfortable working with anhydrous ammonia. As well, they want to gain control of their supply of fertilizer after experiencing huge price increases and a lack of reliable supply over the past number of years. The advantage of the FuelPositive system, over and above being carbon-free, is that it eliminates the supply chain. The customer produces the supply they need on their own land, as needed,” said Ian Clifford, FuelPositive CEO and Board Chair.

“We want the farm to be around for our children, so, we are trying to be as good to the environment and to our soil as we can,” said Curtis Hiebert. “As well, we've had issues in the past few years where we were waiting for anhydrous ammonia in the field because our retailer didn't have it in stock. We’ve also seen huge price increases. We pre-bought our ammonia for this fall at around $1,200 a tonne, and I understand that the price is double that now. The volatility is what we don't like in the market. It's scary. The FuelPositive system will give us stability. That’s what we like about it. It’s stabilizing the supply and stabilizing the price.”

FuelPositive will hold its Annual General Meeting virtually on April 19, 2022 at 1:00 p.m. Eastern Time (U.S. and Canada).

Register in advance for this webinar: https://us02web.zoom.us/webinar/register/WN_ZiqNMxTLQsOuW8x9hrzg6A.

About FuelPositive

FuelPositive is a Canadian technology company committed to providing commercially viable and sustainable “cradle to cradle” clean technology solutions, including green ammonia (NH3), for use across a broad spectrum of industries and applications. By focusing on technologies that are clean, sustainable and economically advantageous/realizable, the Company aims to change the course of climate change through practical solutions that can be implemented now.

The FuelPositive green ammonia system takes air, water and sustainable electricity and synthesizes it into pure, anhydrous ammonia for multiple applications, including fertilizer for farming, fuel for grain drying and internal combustion engines and a solution for grid storage. Green ammonia is also being considered as a key enabler of the hydrogen economy.

FuelPositive systems are designed to provide for green ammonia production on-site, where it’s needed. This eliminates wildly fluctuating supply chains and offers end-user energy and supply security.

Already proven in the lab, FuelPositive is building three full-sized systems to be rolled out in demonstration pilot projects in 2022.

Cautionary Statement

Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) that are based on expectations, estimates and projections as at the date of this news release. The information in this release about future plans and objectives of the Company, including the expected expenditures of the proceeds of the private placement, are forward-looking statements.
These forward-looking statements are based on assumptions and estimates of management of the Company at the time they were made and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect.

Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.

Forward-looking information is provided for the purpose of providing information about management’s expectations and plans relating to the future. The Company disclaims any intention or obligation to update or revise any forward-looking information or to explain any material difference between subsequent actual events and such forward-looking information, except to the extent required by applicable law.

For Media or Investor enquiries, please contact:

Ian Clifford
Chief Executive Officer and Board Chair
mailto://mailbox1@fuelpositive.com
https://www.fuelpositive.com

Investor Relations
RBMG – RB Milestone Group LLC
Trevor Brucato, Managing Director
mailto://fuelpositive@rbmilestone.com
https://www.rbmilestone.com

NEWS -- Navidea Biopharmaceuticals Announces the Regulatory Approval of Lymphoaim in India

DUBLIN, Ohio, April 18, 2022--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the regulatory approval of Lymphoaim ("Lymphoseek" in the rest of the world; Tc99m tilmanocept) by the Central Drugs Standard Control Organisation, India.

Tc99m tilmanocept is approved for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity. External imaging and intraoperative evaluation may be performed using a gamma detection device. Tc99m tilmanocept is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.

Sayre Therapeutics will lead Lymphoaim commercialization efforts in India through a previously announced exclusive license and distribution agreement with Navidea. Sayre Therapeutics specializes in innovative treatment and medical device commercialization in South Asia.

Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted that Lymphoaim has received regulatory approval in India and will be available to patients in need." Dr. Rosol continued, "This will also bring a new revenue stream to the Company to help us advance other pipeline products."

Mr. Shukrit Sudhir Chimote, Chief Executive Officer for Sayre, said, "Lymphoaim, a radioactive diagnostic agent, would benefit surgeons in guiding sentinel lymph node biopsies. This product fits well with Sayre’s mission of providing novel treatment solutions, and will certainly help boost our presence in the surgical oncology segment."

About Sayre Therapeutics

Sayre Therapeutics Private Ltd. is South Asia’s integrated platform for disease management backed by a unique distribution and commercialization model for novel and / or differentiated drugs, companion diagnostics, and drug-delivery devices in the super-specialty areas of Oncology and Immunology.

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit https://www.navidea.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.

Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.

You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220418005445/en/

Contacts

Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com

NEWS -- Heat Biologics’ Scorpion Subsidiary Announces Planned Development of New Kansas Commercial/Biodefense Biomanufacturing Facility

• 500,000+ square foot facility to support commercial-scale biomanufacturing
• Livestreaming ceremony with Governor Laura Kelly Live from Manhattan, Kansas today at 11:00am ET/ 10:00am CT today at https://www.kansascommerce.gov/projectannouncement-4-18-22/

DURHAM, N.C., April 18, 2022 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (Heat) (NYSE American: HTBX), a clinical-stage biopharmaceutical company focused on developing novel biodefense assets and first-in-class therapies to modulate the immune system, today announced a planned development partnership of its Scorpion Biological Services subsidiary with a private developer, the State of Kansas and local and university affiliates, to support the development of a new biodefense-focused large molecule and biologics biomanufacturing facility in Manhattan, Kansas. Manhattan is the home of Kansas State University (K-State), its Biosecurity Research Institute (BRI), and the National Bio and Agro-Defense Facility (NBAF).

The Company intends to utilize the new 500,000+ square foot facility for large molecule and biologics manufacturing, with a particular focus on biodefense. In addition to servicing the Company’s own product pipeline, it plans to operate as a full-service Contract Development and Manufacturing Organization (CDMO) to provide third-party manufacturing services on a fee-for-service basis. Once fully operational, the new facility is expected to employ more than 500 individuals.

The facility is expected to have a billion-dollar economic impact within the State of Kansas. According to Emergen Research, the current demand for biologics is rapidly growing, with an expected market size reaching $567 billion by 2028.

The design and engineering of the facility is being led by CRB Group, a nationally recognized firm focused on designing and building biomanufacturing facilities, with Realty Trust Group (RTG), a leading healthcare/ life sciences real estate advisory and development firm, serving as the lead developer on the project.

Later today, the Company will host a ceremony with Kansas Governor Laura Kelly and Lt. Governor David Toland. Also attending the event will be US Senator Jerry Moran, former K-State President General Richard Myers and current K-State President Richard Linton, among others. The event will be held in Manhattan, Kansas, at 11:00 AM Eastern Time / 10:00 AM Central Time on April 18, 2022, and will be live streamed here: https://www.kansascommerce.gov/projectannouncement-4-18-22/

“We are thrilled and excited that Scorpion has chosen Kansas for this game-changing facility that will have a massive positive impact in our state,” said Governor Laura Kelly. “Being in the center of the country, with quick access to either coast, there is no better state for Scorpion to locate in order to address potential threats to public health.”

David Halverson, President of Heat’s Scorpion subsidiary, noted, “We are very excited to break ground on this new facility. There is a strong demand for world-class biomanufacturing, which we expect to continue well into the future. We intend to help fill that demand with our San Antonio, Texas and Manhattan, Kansas facilities. The 500,000 square foot Manhattan facility is being designed to service up to 144,000 liters across 48 bioreactors–powered by an excellent Kansas workforce. We're looking forward to rapidly growing and expanding Scorpion, and Manhattan is the perfect location for our newest facility.”

Jeff Wolf, Chief Executive Officer of Heat, commented, “Today, we are very proud to unveil our plans for our newest biomanufacturing facility in Manhattan, Kansas. With a model that starts with discovery at our Skunkworx subsidiary in North Brunswick, New Jersey and ends with commercial scale manufacturing here in Manhattan, this facility represents the next stage in our evolution, designed to enable us to combine speed and agility with the full-integration of discovery, development and manufacturing.”

Mr. Wolf added, “The COVID pandemic and recent geopolitical events highlight the urgent need for rapid response to potential biological threats, natural or man-made. Among other intended uses, we believe this facility should enable us to effectively scale production of ANTHIM®, an anthrax antitoxin, for use against a potential anthrax attack per our Elusys acquisition, as well as RapidVax®, a rapid plug-and-play programmable vaccine designed to target a comprehensive range of emerging biological threats.”

Mr. Wolf continued, “Today’s announcement is a major milestone, enhancing our domestic production of vital biologics to protect Americans from deadly disease. We appreciate the tremendous bipartisan support for this initiative, and we are extremely grateful to the State of Kansas and their officials for their hard work in bringing this project to fruition.”

About Scorpion Biological Services

Scorpion Biological Services, Inc. is working to expand the reach of precision medicine to more people within multiple therapeutic areas that are untreatable or treatment-resistant today. Its team is comprised of experts in bioanalytics, cell biology, virology, translational biology, biomanufacturing, and drug development. Scorpion’s services are designed to support a myriad of biologic drugs from conception through clinical trials and commercial production, to bring new drugs to market faster and more reliably.

About Heat Biologics, Inc.

Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies and vaccines to modulate the immune system. Heat’s gp96 platform is designed to activate immune responses against cancer or infectious diseases. The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in a Phase 2 trial, various infectious disease/biological threat programs in preclinical development and a pipeline of proprietary immunomodulatory antibodies and cell-based therapies, including PTX-35 and HS-130 in Phase 1 clinical trials.

For more information, please visit: https://www.heatbio.com, and also follow us on Twitter.

Forward Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectation, and assumptions and include statements regarding the planned development of a new Kansas, commercial/biodefense biomanufacturing facility, Scorpion’s intended use of the facility for large molecule and biologics manufacturing, with a particular focus on biodefense, plans to operate as a full-service Contract Development and Manufacturing Organization (CDMO) to provide third-party manufacturing services on a fee-for-service basis, the facility employing more than 500 individuals once fully operational, the facility having a billion-dollar economic impact within the State of Kansas, the current demand for biologics rapidly growing with an expected market size reaching $567 billion by 2028, the Kansas facility servicing up to 144,000 liters across 48 bioreactors, y, the facility enabling Heat to combine speed and agility with the full-integration of discovery, development and manufacturing, the facility enabling Heat to effectively scale production of ANTHIM® and RapidVax®, the strong demand for world-class biomanufacturing continuing well into the future, Heat helping to fill the demand for world-class biomanufacturing with its San Antonio, Texas and Manhattan, Kansas facilities, rapidly growing and expanding Scorpion. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including Heat’s ability to develop a new 500,000+ square foot biodefense-focused large molecule and biologics biomanufacturing facility in Manhattan, Kansas in partnership with the State of Kansas and local and university affiliates as planned, Heat’s ability to employ more than 500 individuals at the facility, the ability of the facility to service up to 144,000 liters across 48 bioreactors Heat’s ability to combine speed and agility with the full-integration of discovery, development and manufacturing at the facility, Heat’s ability to scale production of ANTHIM® and RapidVax®, Heat’s ability to fill the demand for world-class biomanufacturing with its San Antonio, Texas and Manhattan, Kansas facilities, Heat’s ability to rapidly grow and expand Scorpion, Heat’s ability to successfully consummate the merger of Elusys, Heat's ability to provide further near-term updates on its biodefense efforts, execute on key upcoming milestones and drive shareholder value, Heat's ability to augment its clinical programs and enhance and expand its therapeutic pipeline, the ability of Heat's therapies to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities and its cash and short-term investments providing significant runway to fund Heat’s current clinical programs and further expand Heat’s therapeutic portfolio , its ability to continue to maintain its listing on the Nasdaq Capital Market and its ability to retain its key scientists or management personnel, and the other factors described in Heat's most recent annual report on Form 10-K for the year ended December 31, 2021 filed with the SEC, and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release, and Heat undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.

Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://investorrelations@heatbio.com

NEWS -- Heat Biologics’ Announces Planned Investor and Media Livestream Event to Discuss Latest Developments

DURHAM, N.C., April 14, 2022 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (“Heat”) (NYSE American: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system and novel biodefense assets, today announced it plans to host an investor and media livestream event on Tuesday, April 19, 2022 at 10:30 AM Eastern Time to discuss the latest developments. The event will be broadcast at: https://vimeo.com/event/2027558/fc6de52c31

About Heat Biologics, Inc.

Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies and vaccines to modulate the immune system. Heat’s gp96 platform is designed to activate immune responses against cancer or infectious diseases. The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in a Phase 2 trial, various infectious disease/biological threat programs in preclinical development and a pipeline of proprietary immunomodulatory antibodies and cell-based therapies, including PTX-35 and HS-130 in Phase 1 clinical trials.

For more information, please visit: https://www.heatbio.com, and also follow us on Twitter.

Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://investorrelations@heatbio.com

NEWS -- Provectus Biopharmaceuticals Names Aru Narendran, MD, PhD to Scientific Advisory Board

KNOXVILLE, TN, April 14, 2022 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced the addition of Aru Narendran, MD, PhD to the Company’s Scientific Advisory Board. Dr. Narendran is a professor in the departments of Pediatrics, Oncology, and Biochemistry & Molecular Biology at the University of Calgary’s Cumming School of Medicine (Calgary, Alberta, Canada), and holds the Kids Cancer Care Foundation Endowed Chair in Clinical and Translational Research in pediatric oncology.

Over the last five years, Provectus’ collaboration with Dr. Narendran and his lab research team at the University of Calgary has yielded:

• Preclinical exploration of rose bengal sodium (RBS) – the Company’s proprietary small molecule halogenated xanthene – for the treatments of pediatric oncology (neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma)1,2, pediatric hematology (acute lymphoblastic and myeloid leukemias)3,4, virology (coronavirus disease 2019)5, and adult oncology (breast, colorectal, head and neck, and testicular cancers)6,7,
• Issued patents and published patent applications in pediatric oncology (United States Patent [USP] No. 11,058,66 and Application No. 17/344418), pediatric hematology (16/688319 and 17/232393), virology (17/212723), adult oncology (17/214590), and cancer and viral vaccines (17/488430), and
• RBS treatment-unique discoveries, including STING signaling8, HSP association8, and WNK1 signaling7, and the use of RBS as an immune vaccine adjuvant9.

Dr. Narendran received a PhD in neuroimmunology for his work in Dr. Steven Hoffman’s laboratory at Arizona State University. He also undertook postdoctoral research in cancer biology at the Ontario Cancer Institute (OC), the research division of Princess Margaret Cancer Centre (Toronto, Ontario, Canada), that contributed to pioneering research on the generation and characterization of transgenic mouse models.

Dr. Narendran did his medical training at McMaster University (MD; Hamilton, Ontario, Canada), Tufts University (pediatrics residency; Massachusetts), and the Hospital for Sick Children (pediatric hematology and oncology clinical fellowship; Toronto). He is also the recipient of a number of awards, including the Odile Schweisguth prize in pediatric oncology and a young investigator award from the Children’s Oncology Group (COG).

Dr. Narendran’s current responsibilities at the University of Calgary include teaching graduate courses in cancer biology, new therapeutics, and ethics; directing a preclinical and drug discovery laboratory; and managing clinical trials for children with relapsed and refractory malignancies. He is also a primary investigator and the director of biology for the Pediatric Oncology Experimental Therapeutics Consortium (POETIC).

Ed Pershing, Chair of Provectus’ Board of Directors, said, “We are grateful to Dr. Narendran for accepting the invitation to join our Scientific Advisory Board, and deeply value his insights and continuous feedback. His research on behalf of the Company has been prolific; and his team and he have been consequential to broadening and deepening Provectus’ drug discovery and development efforts.”

Acronyms

STING = stimulator of interferon genes. HSP = heat shock protein. WNK1 = WNK lysine deficient kinase 1.

References

1. Swift et al. Potent in vitro and xenograft antitumor activity of a novel agent, PV-10, against relapsed and refractory neuroblastoma. OncoTargets and Therapy 12, 1293, 2019.

2. Swift et al. In vitro and xenograft anti-tumor activity, target modulation and drug synergy studies of PV-10 against refractory pediatric solid tumors. 2018 ASCO Annual Meeting, J Clin Oncol 36, 2018 (suppl; abstr 10557).

3. Swift et al. In Vitro Activity and Target Modulation of PV-10 Against Relapsed and Refractory Pediatric Leukemia 2018 ASH Annual Meeting, Blood 132, 2018 (suppl; abstr 5207).

4. USP Application No. 17/232393: Composition and Method for Oral Treatment of Leukemia.

5. USP Application No. 17/212723: Novel Uses of Halogenated Xanthenes in Oncology and Virology.

6. Tran et al. Pre-clinical evaluation of PV-10 for in vitro anti-tumor activity in refractory and high-risk adult solid tumors. 2021 ASCO Annual Meeting, J Clin Oncol 39, 2021 (suppl 15; abstr e14544).

7. Tran et al. Identification and In Vivo Validation of Unique Anti-Oncogenic Properties and Mechanisms Involving Protein Kinase Signalling and Autophagy Mediated by the Investigational New Agent PV-10. 2022 AACR Annual Meeting, Proceedings (abstr 1121).

8. Thakur et al. Association of Heat Shock Proteins as Chaperone for STING: A potential link in a key immune activation mechanism revealed by a novel anticancer agent PV-10. 2020 AACR Annual Meeting, Proceedings (abstr 5393).

9. USP Application No. 17/488430: Halogenated Xanthenes as Vaccine Adjuvants.

About Provectus

Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different disease areas based on a family of small molecules called halogenated xanthenes. Multi-route of administration drug discovery and development programs include investigational drugs and drug targets in oncology (clinical-stage), dermatology (clinical-stage), hematology, virology, microbiology, ophthalmology (clinical-stage), and animal health. Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Company's website at https://www.provectusbio.com.

FORWARD-LOOKING STATEMENTS: The information in this press release may include “forward-looking statements,” within the meaning of U.S. securities legislation, relating to the business of Provectus and its affiliates, which are based on the opinions and estimates of Company management and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “project,” “predict,” “potential,” “targeting,” “intend,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.

The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.

Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.

Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including those described in Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.

###

Contact:

Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999

NEWS -- Oncolytics Biotech® Announces Publication of Preclinical Data Demonstrating the Synergistic Anti-Cancer Activity of Pelareorep Combined with CAR T Cell Therapy in Solid Tumors in Science Translational Medicine

- Pelareorep-CAR T combination may expand the commercial potential of CAR T cells to solid tumors

- Combining CAR T cells with pelareorep prevented antigen escape by creating CAR T cells with dual specificity through a novel mechanism

- Loading CAR T cells with pelareorep led to dramatic improvements in their persistence and anti-cancer activity as well as cures in multiple murine solid tumor models

SAN DIEGO, Calif. and CALGARY, AB, April 14, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the publication of preclinical data demonstrating the synergistic anti-cancer activity of pelareorep combined with chimeric antigen receptor (CAR) T cell therapy in solid tumors. The paper, entitled "Oncolytic virus-mediated expansion of dual-specific CAR T cells improves efficacy against solid tumors in mice," was published in Science Translational Medicine in collaboration with researchers at several prestigious institutions, including the Mayo Clinic and Duke University. A link to the paper can be found by clicking here.

"Having these results published in such a high-impact journal provides important external validation of their significance," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech Inc. "While CAR T cells have generated long-term cures in hematologic malignancies1, the immunosuppressive tumor microenvironments (TMEs) of solid organ cancers have thus far limited their efficacy in these indications. Pelareorep has repeatedly been shown to reverse immunosuppressive TMEs, and in the present publication pelareorep is shown to enable the effectiveness of CAR T cells in multiple murine solid tumor models. This is a powerful finding that, if translated to the clinic, could significantly improve the prognosis of patients with a variety of highly prevalent cancers by providing a novel and potentially durable treatment option. By demonstrating the ability to improve T cell perseverance, reduce antigen escape, and overcome challenging solid tumor TMEs, the inclusion of pelareorep addresses the three most challenging roadblocks to effective CAR T therapy."

Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, added, "Despite revolutionizing the treatment of certain cancers and surpassing a billion dollars in sales last year, CAR T therapies currently only serve a small subset of patients suffering from hematologic malignancies. With these latest results, we now have strong preclinical evidence that pelareorep can fully unlock the value of CAR T therapies by expanding their commercial potential to the significantly larger market of cancer patients who are battling solid tumors."

Preclinical studies published in the paper evaluated the persistence and efficacy of pelareorep-loaded CAR T cells ("CAR/Pela therapy") in multiple murine solid tumor models. The effects of combining CAR/Pela therapy with a subsequent intravenous dose of pelareorep ("pelareorep boost") were also investigated. Key data and conclusions from the paper include:

• The persistence and anti-cancer activity of CAR T cells improved drastically when loaded with pelareorep. Compared to either treatment alone, treatment with CAR/Pela therapy led to statistically significant survival benefits in murine skin and brain cancer models.
• CAR/Pela therapy followed by a pelareorep boost led to enhanced efficacy in murine skin and brain cancer models and tumor cures in >80% of treated mice in each model.
• Loading CAR T cells with pelareoep led to improved cancer cell targeting and prevented antigen escape in vivo by generating CAR T cells with dual specificity that target their designed antigen and the native T cell receptor antigen. These results indicate that CAR/Pela therapy may provide longer-lasting therapeutic benefits compared to treatment with CAR T cells alone.

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. and co-author of the paper commented, "These exciting results are an excellent example of how we are leveraging collaborations with key opinion leaders and premier research institutions to broaden pelareorep's potential therapeutic impact. This allows us to remain primarily focused on our lead breast cancer program, which has shown how pelareorep's ability to promote tumor T cell infiltration leads to synergy with checkpoint inhibitors in the clinic. These newly published preclinical findings show pelareorep's synergistic benefits extend even beyond checkpoint inhibitors and highlight an opportunity to increase our addressable patient population. As we pursue this opportunity moving forward, we intend to utilize relationships with academic or industry partners so that we can continue to execute on our clinical and corporate objectives with efficiency."

About CAR T cells and CAR T therapy

The CAR T process begins when blood is drawn from a patient and their T cells are separated so they can be genetically engineered to produce chimeric antigen receptors (CARs). These receptors enable the T cells to recognize and attach to a specific protein or antigen on tumor cells. Once the engineering process is complete, a laboratory can increase the number of CAR T cells into the hundreds of millions. Finally, the CAR T cells will be infused back into the patient where, ideally, the engineered cells further multiply and recognize and kill cancer cells. Historically, solid tumors have been considered beyond the reach of CAR T therapy due to their tumor microenvironment, which is detrimental to CAR T cell entry and activity, amongst other challenges.2

About Science Translational Medicine

Science Translational Medicine is the leading weekly online journal publishing translational research at the intersection of science, engineering, and medicine. The goal of Science Translational Medicine is to promote human health by providing a forum for communicating the latest research advances from biomedical, translational, and clinical researchers from all established and emerging disciplines relevant to medicine. In addition to original research, Science Translational Medicine also publishes Reviews, Editorials, Focus articles, and Viewpoints.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

References

1. Melenhorst, J.J., Chen, G.M., Wang, M. et al. Decade-long leukaemia remissions with persistence of CD4+ CAR T cells. Nature (2022). https://doi.org/10.1038/s41586-021-04390-6

2. National Cancer Institute. CAR T Cells: Engineering Patients' Immune Cells to Treat Their Cancers. Updated July 31, 2019. Accessed February 18, 2021. https://www.cancer.gov/about-cancer/treatment/research/car-t-cells

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; including potentially significantly improving the prognosis of patients with a variety of highly-prevalent cancers by providing them with a novel and potentially durable treatment option and the opportunity to potentially expand our addressable patient population; our intention to utilize relationships with academic or industry partners so that we can continue to execute on our clinical and corporate objectives with efficiency; our leveraging of collaborations with key opinion leaders to broaden pelareorep's potential therapeutic impact; our plans to advance towards a registration study in metastatic breast cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-announces-publication-of-preclinical-data-demonstrating-the-synergistic-anti-cancer-activity-of-pelareorep-combined-with-car-t-cell-therapy-in-solid-tumors-in-science-translational-medicine-301525571.html

SOURCE Oncolytics Biotech® Inc.

NEWS -- Plus Therapeutics to Announce First Quarter 2022 Financial Results and Host Conference Call on April 21, 2022

AUSTIN, Texas, April 14, 2022 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult to treat cancers, announced that the Company will report first quarter 2022 financial results on Thursday, April, 21, 2022, after market close. Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.

A live webcast will be available at https://ir.plustherapeutics.com/events

Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in: 866-342-8591
International dial-in: 203-518-9713
Conference ID: PSTVQ122
Conference Call Name: Plus Therapeutics Q1 2022 Earnings

Following the live call, a replay will be available on the Company’s website under the ‘For Investor’ section. The webcast will be available on the Company’s website for 90 days following the live call.

About Plus Therapeutics, Inc.

Plus Therapeutics is a clinical-stage pharmaceutical company focused on development, manufacture, and commercialization of complex and innovative treatments for patients battling cancer and other life-threatening diseases.
Our proprietary nanotechnology platform is currently centered around the enhanced delivery of a variety of drugs using novel liposomal encapsulation technology. Liposomal encapsulation has been extensively explored and undergone significant technical and commercial advances since it was first developed. Our platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186RNL including the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-LM or the ReSPECT-PBC trials; possible negative effects of 186RNL; the continued evaluation of 186RNL including through evaluations via a seventh patient cohort; and the intended functions of the Company’s platform and expected benefits from such functions.

The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the regenerative medicine field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.

Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com

Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com

NEWS -- CytoSorbents To Expand Direct Sales of CytoSorb® to the United Kingdom, the Sixth Largest Medical Device Market in the World

MONMOUTH JUNCTION, N.J., April 14, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, announces that it has registered a new subsidiary, CytoSorbents Medical UK Limited, with plans to establish a direct sales presence within the United Kingdom (UK) and Ireland. CytoSorbents previously sold CytoSorb® via distributor partners within the region. With a new direct commercialization presence, CytoSorbents expects to focus its resources and expertise to expand the use of CytoSorb® in hospitals throughout this territory, while providing world-class support and education for physicians and healthcare professionals. The UK is the third largest medical device market in Europe and the sixth largest in the world. CytoSorbents will now directly commercialize its products in 15 countries, with sales in more than 70 countries worldwide.

CytoSorbents recently hired Mr. Shaun Whittemore as Country Manager - UK & Ireland, to drive and coordinate market development in the region. Mr. Whittemore brings 20 years of sales, marketing and product specialist experience supporting large, global medical technology companies including LivaNova, Johnson & Johnson, and Smith+Nephew. Prior to joining CytoSorbents, Mr. Whittemore was most recently Commercial Manager, UK & Ireland at LivaNova.

"I am delighted to be part of this exciting opportunity to further develop and grow the market for CytoSorb in the United Kingdom and the Republic of Ireland and expect to leverage my insight and expertise from a career extending over two decades within the healthcare sector. I believe the benefits of our innovative blood purification technology will make a positive impact on the lives of treated patients throughout the region," said Whittemore.

Dr. Christian Steiner, Executive Vice President, Sales and Marketing of CytoSorbents stated, "As we establish a direct sales team in the UK and Ireland, we are excited to work more closely with physicians to improve awareness and usage of CytoSorb in its many applications in critical care and cardiac surgery. We also expect to continue working with the UK's National Health Service (NHS), one of the world's largest and well-renowned healthcare systems, to educate them on the clinical benefits and cost-effectiveness of our technology. To begin with, we plan to highlight last year's NICE Medtech innovation briefing on the use of CytoSorb to reduce the risk of bleeding during cardiothoracic surgery in patients on blood thinning medications in the UK health system. Our direct sales expansion into one of the largest medical device markets in the world is just one of many new initiatives intended to drive our core growth overall."

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 162,000 cumulative CytoSorb devices have been utilized as of December 31, 2021. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 20 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 25 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.

CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

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Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations and Corporate Communications
(732) 482-9984
mailto://tpowers@cytosorbents.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com

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SOURCE CytoSorbents Corporation

NEWS -- Lineage and Cancer Research UK Announce Completion of Patient Enrollment in Phase 1 Clinical Study of VAC2 for the Treatment of Non-small Cell Lung Cancer

CARLSBAD, Calif., April 13, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that Cancer Research UK recently completed patient enrollment in the ongoing Phase 1 clinical trial of VAC2, an allogeneic cancer vaccine product candidate, for the treatment of non-small cell lung cancer ("NSCLC"). Under the terms of an existing agreement, Cancer Research UK will complete the ongoing clinical trial and Lineage has now assumed responsibility for further clinical development of the VAC2 product candidate and any future development opportunities derived from the VAC platform.

"We are pleased that Cancer Research UK has successfully completed patient enrollment in the VAC2 Phase 1 clinical study and overcame substantial challenges stemming from the COVID pandemic. We look forward to initial clinical results from this study being available later this year," stated Brian M. Culley, Lineage CEO. "Clinical data previously collected by Cancer Research UK demonstrated peripheral immunogenicity in patients with NSCLC treated with VAC2, providing support to the underlying mechanism of using allogeneic dendritic cells to present tumor-associated antigens to the body’s immune system. Simultaneous with Cancer Research UK efforts to complete enrollment in the current study, the focus at Lineage has been on making improvements and modernizations to the VAC manufacturing process, an approach which we similarly employed in the development of OpRegen. We believe our focus on manufacturing will help prepare VAC2 for additional clinical trials and provide a competitive advantage for any future VAC programs which we advance, either alone or through alliances. With Cancer Research UK having completed enrollment of the current study, the team at Lineage also has begun work towards the submission of an Investigational New Drug Application for clinical testing of VAC2 in the U.S., which we anticipate submitting to the FDA later this year."

Dr. Nigel Blackburn, Director of Cancer Research UK’s Centre for Drug Development, added: "We are delighted to see that this innovative VAC2 program has reached such an important milestone in its development and are extremely proud to have played an important role in establishing its tolerability in lung cancer patients. We look forward to seeing Lineage advance VAC2 under their leadership in the future."

About VAC2

VAC2 is an allogeneic, or non-patient specific "off-the-shelf," cancer vaccine product candidate designed to stimulate patient immune responses to an antigen commonly expressed in cancerous cells but not in normal adult cells. VAC2, which is produced from a pluripotent cell technology using a directed differentiation method, is comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct the body’s immune system to attack and eliminate harmful pathogens and unwanted cells. Because the tumor antigen is loaded exogenously into the dendritic cells prior to administration, VAC2 is a platform technology that could be modified to carry selected antigens, including patient-specific tumor neo-antigens or viral antigens. VAC2 is currently being tested in a Phase 1 study in adult patients with NSCLC in the advanced and adjuvant settings (NCT03371485), conducted by Cancer Research UK.

About Cancer Research UK’s Centre for Drug Development

Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 25 years, taking over 140 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of 21 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials.

About Cancer Research UK’s Commercial Partnerships Team

Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research. Cancer Research UK’s specialist Commercial Partnerships Team works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. Cancer Research UK’s commercial activity operates through Cancer Research Technology Ltd., a wholly owned subsidiary of Cancer Research UK. It is the legal entity which pursues drug discovery research in themed alliance partnerships and delivers varied commercial partnering arrangements.

About Cancer Research UK

• Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research.
• Cancer Research UK’s pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.
• Cancer Research UK receives no funding from the UK government for its life-saving research. Every step it makes towards beating cancer relies on vital donations from the public.
• Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last 40 years.
• Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK’s ambition is to accelerate progress so that by 2034, 3 in 4 people will survive their cancer for at least 10 years.
• Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
• Together with its partners and supporters, Cancer Research UK's vision is to bring forward the day when all cancers are cured.

For further information about Cancer Research UK’s work or to find out how to support the charity, please call 0300 123 1022 or visit htt[s://www.cancerresearchuk.org. Follow us on Twitter and Facebook.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include four allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, which is now being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer and (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the efficacy of using allogeneic dendritic cells to present tumor-associated antigens to the body’s immune system the collaboration and license agreement with Roche and Genentech and activities expected to occur thereunder, the broad potential for Lineage’s regenerative medicine platform as well as the VAC technology platform, and Lineage’s ability to expand the same; the projected timing of milestones of future studies, including their initiation and completion, projected manufacturing plans and improvements; the potential for Lineage’s investigational allogeneic cell therapies to generate clinical outcomes beyond the reach of traditional methods and provide safe and effective treatment for multiple, diverse serious or life threatening conditions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the risk that competing alternative therapies may adversely impact the commercial potential of OpRegen, which could materially adversely affect the milestone and royalty payments payable to Lineage under the collaboration and license agreement, the risk that Roche and Genentech may not be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction, the risk that Lineage might not succeed in developing products and technologies that are useful in medicine and demonstrate the requisite safety and efficacy to achieve regulatory approval in accordance with its projected timing, or at all; the risk that Lineage may not be able to manufacture sufficient clinical and, if approved, commercial quantities of its product candidates in accordance with current good manufacturing practice; the risks related to Lineage’s dependence on other third parties, and Lineage’s ability to establish and maintain its collaborations with these third parties; the risk that government-imposed bans or restrictions and religious, moral, and ethical concerns about the use of hES cells could prevent Lineage or its partners from developing and successfully marketing its stem cell product candidates; the risk that Lineage’s intellectual property may be insufficient to protect its products; the risk that the COVID-19 pandemic or geopolitical events may directly or indirectly cause significant delays in and substantially increase the cost of development of Lineage’s product candidates, as well as heighten other risks and uncertainties related to Lineage’s business and operations; risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220413005356/en/

Contacts

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Mike Biega
(mailto://Mbiega@soleburytrout.com)
(617) 221-9660

Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242

NEWS -- Navidea Biopharmaceuticals Announces Adoption of Plan Designed to Protect NOLs and Other Tax Assets, Closing of Bridge Loan Financing, and Business Update Q&A Series

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that its Board of Directors has adopted a Section 382 Rights Agreement that is designed to protect the availability of the Company’s net operating loss carryforwards (“NOLs”) and other tax assets (“Section 382 Rights Plan”), and that it has entered into a stock exchange and loan agreement with the Company’s largest shareholder and Vice Chair of the Board of Directors (the “Board”), John K. Scott, Jr., pursuant to which, among other things, Mr. Scott has agreed to provide an initial $1.5 million in bridge loan funding. The Company will host two Business Update Question and Answer calls to discuss these and other matters.

As of December 31, 2021, Navidea had approximately $164 million of U.S. federal NOLs and approximately $9.1 million of R&D tax credits that could be available to offset its future federal taxable income. Navidea’s ability to use these NOLs as well as other tax attributes would be substantially limited if it experienced an “ownership change” within the meaning of Section 382 of the Internal Revenue Code. In general, a company would undergo an ownership change if its “5-percent shareholders” (determined under Section 382) increased their ownership of such company’s stock by more than 50 percentage points over a rolling three-year period. The Section 382 Rights Plan is intended to reduce the likelihood of such an ownership change at Navidea by deterring any person or group from acquiring beneficial ownership of 4.9% or more of Navidea’s outstanding common stock.

Under the Section 382 Rights Plan, the Board declared a dividend of one preferred share purchase right for each share of Navidea’s common stock outstanding as of the close of business on April 12, 2022. The rights will be exercisable only if a person or group acquires 4.99% or more of Navidea’s common stock. Any person which currently beneficially owns in excess of 4.99% of Navidea’s common stock may continue to own their shares of common stock but may not acquire an additional 0.5% or more of common stock without triggering the Section 382 Rights Plan. If the rights become exercisable, all holders of rights, other than the person or group triggering the rights, will be entitled to purchase shares of common stock at a 50% discount or Navidea may exchange each right held by such holders for five shares of common stock. The Board has the discretion to exempt any person or group from the provisions of the Section 382 Rights Plan. The Company may seek shareholder approval of the Section 382 Rights Plan at its next annual meeting of stockholders.

The Company and Mr. Scott have agreed to terms on a secured bridge loan of up to $2.5 million (with an initial $1.5 million of funding upon closing and the additional $1 million if and when mutually agreed) to provide working capital to the Company while further financing is sought. This bridge loan matures in two years and is not convertible, helping to protect the Company’s NOLs. As additional inducement for the bridge loan, the Company agreed to issue to Mr. Scott shares of two newly established series of preferred stock in exchange for all of Mr. Scott’s shares of Series E Preferred Stock, which effectively allows Mr. Scott to maintain all or a portion of his prior liquidation preference without further diluting the Company’s stockholders, and helping to protect the Company’s NOLs.

Alexander Cappello, the Chair of the Company’s Board of Directors, said, “The Section 382 Rights Plan puts in place appropriate measures to protect these valuable NOLs, a critical asset to the Company.” Mr. Cappello continued, “The bridge loan from Mr. Scott helps us as we continue work towards a larger financing.”

Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “We are delighted to have the continued funding in place to keep our clinical and R&D efforts going while we work with the Board for full funding.”

The Company will hold the business update conference calls and webcasts on Thursday, April 14, 2022, and Wednesday, April 20, 2022, both at 5:00 p.m. (EDT). Chief Medical Officer Dr. Michael Rosol will host the calls and webcasts to provide updates on recent developments and clinical progress. Mr. Cappello and Mr. Scott will join. Topics to be covered will be Financing (Thursday, April 14) and Company Strategy and Clinical Update (Wednesday, April 20).

To participate in the first call and webcast, please refer to the information below:

Event: Navidea Business Update – Financing
Date: Thursday, April 14, 2022
Time: 5:00 p.m. (EDT)
U.S. & Canada Dial-In: 877-407-0312
International Dial-In: +1 201-389-0899
Conference ID: 13729072
Webcast Link: https://www.webcast-eqs.com/navidbioph20220414/en

Call and webcast details for Wednesday, April 20, 2022 will be provided in a future press release.

A live audio webcast of each conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference calls can be replayed and will be available for 90 days following the calls on Navidea’s website.

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit https://www.navidea.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and ability to obtain additional financing; our ability to continue as a going concern; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.

Investors are urged to consider statements that include the words “will,” “may,” “could,” “should,” “plan,” “continue,” “designed,” “goal,” “forecast,” “future,” “believe,” “intend,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.

You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220412005944/en/

Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com

NEWS -- Navidea Biopharmaceuticals Receives Acceptance Letter from NYSE American

DUBLIN, Ohio, April 12, 2022--(BUSINESS WIRE)--As previously disclosed, on January 28, 2022, Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, received a notification from the NYSE American stating that the Company was not in compliance with the $6.0 million stockholders’ equity requirement of Section 1003(a)(iii) of the NYSE American Company Guide. As required by the NYSE American, the Company submitted a plan to the NYSE American by February 28, 2022 advising of actions it has taken or will take to regain compliance with the continued listing standards by July 28, 2023.

On April 8, 2022, the Company received notification (the "Acceptance Letter") from the NYSE American that the Company’s plan to regain compliance was accepted. The Acceptance Letter also stated that the Company is also not in compliance with Sections 1003(a)(i) and 1003(a)(ii) of the NYSE American Company Guide, which require an issuer to have stockholders’ equity of (i) $2.0 million or more if it has reported losses from continuing operations and/or net losses in two out of its three most recent fiscal years, and (ii) $4.0 million or more if it has reported losses from continuing operations in three out of its four most recent fiscal years. The Acceptance Letter noted that the Company had stockholders’ equity of $624,743 as of December 31, 2021 and has reported net losses from continuing operations in its five most recent fiscal years ended December 31, 2021.

The NYSE American has granted the Company a plan period through July 28, 2023 to regain compliance with Sections 1003(a)(i), (ii) and (iii). If the Company is not in compliance with all continued listing standards by that date or if the Company does not make progress consistent with the plan during the plan period, the NYSE American may commence delisting procedures.

Navidea’s common stock will continue to be listed on the NYSE American while it attempts to regain compliance with the listing standards noted, subject to Navidea’s compliance with other continued listing requirements. The common stock will continue to trade under the symbol "NAVB," but will have an added designation of ".BC" to indicate that Navidea is not in compliance with the NYSE American’s listing standards. The NYSE American notification does not affect Navidea’s business operations or its SEC reporting requirements and does not conflict with or cause an event of default under any of Navidea’s material agreements.

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit https://www.navidea.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and ability to obtain additional financing; our ability to continue as a going concern; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.

Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.

You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220412005941/en/

Contacts

Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com

NEWS -- Tokens.com Acquires Decentraland’s Music District

TORONTO,, April 12, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN) (Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or "the Company"), a publicly-traded company that invests in Web3 crypto assets and businesses linked to the Metaverse and NFTs, is pleased to share that its subsidiary, Metaverse Group, has purchased the Music District in Decentraland, as a joint venture with 13th Floor Ventures, an institutionally-backed investment fund focused on virtual real estate opportunities in the Metaverse.

The Music District is comprised of 34 parcels, equivalent to 91,936 sq ft of flat land in physical terms. The district is positioned in a strategic location as the land borders Festival Land, Decentraland’s live music district that has featured live performances from many prominent artists and Genesis Plaza, the heart of Decentraland where all users enter the virtual world and retains high foot traffic volumes.

This district purchase solidifies Metaverse Group’s position as one of the largest landowners in Decentraland, as the group continues to collect strategically located parcels in Decentraland. Owning parcels in locations like the Music District allows the company to offer advertising space in the most popular and most highly sought-after areas.

"We plan on developing this land to host movie premiers, music launches and concerts," commented Andrew Kiguel, CEO of Tokens.com and Executive Chair of Metaverse Group. "We believe that music and fashion will be leading drivers of value in the Metaverse, thus the strategic importance of this acquisition."

The Music District acquisition is one of the largest virtual land purchases of 2022 to date.

"The Music District is the perfect site to execute our shared vision to create immersive experiences across all forms of talent and entertainment," said Evan Abraham, Co-founder and Managing Partner of 13th Floor Ventures. "We are thrilled to partner with an industry leader like Metaverse Group on this acquisition and look forward to growing our joint venture through additional virtual land developments. This is the first of many significant investments in the category as 13FV establishes itself as a key investor in Metaverse assets."

Brands or virtual landowners interested in partnering with Metaverse Group should contact mailto://Info@metaversegroup.com.

About Tokens.com

Tokens.com Corp is a publicly traded company that invests in Web3 assets and businesses focused on the Metaverse, NFTs, DeFi, and gaming based digital assets. Tokens.com is the majority owner of Metaverse Group, one of the world’s first virtual real estate companies. Hulk Labs, a wholly-owned Tokens.com subsidiary, focuses on investing in play-to-earn revenue generating gaming tokens and NFTs. Additionally, Tokens.com owns and stakes crypto assets to earn additional tokens. Through its growing digital assets and NFTs, Tokens.com provides public market investors with a simple and secure way to gain exposure to Web3.

Visit https://Tokens.com to learn more.

Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.

About Metaverse Group

The Metaverse Group is a vertically integrated NFT based Metaverse real estate company. The group, with its global headquarters in Decentraland’s Crypto Valley, also owns an eight figure real estate portfolio across many leading virtual worlds. The company intends to continue to purchase, develop and rent out its portfolio of real estate assets. Tokens.com, a publicly- traded company, is the majority owner of Metaverse Group.

For further information please visit https://metaversegroup.com.

About 13th Floor Ventures

13th Floor Ventures was formed to address growing investment demand from institutions, family offices, and high-net-worth individuals seeking to comfortably access opportunities in the Metaverse. Drawing upon our founders’ experience in the C-suite, successful execution of varied private equity investment structures, and deep relationships within diverse blockchain communities, 13FV is well positioned to generate best-in-class risk-adjusted returns for investors. Each investment – Class A virtual real estate, Metaverse infrastructure, or Metaverse platforms – is driven by our distinguished industry standard of deal structuring and meticulous diligence.

For more information, please visit https://www.13fv.xyz/.

This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220412005276/en/

Contacts

Tokens.com Corp.

Andrew Kiguel, CEO
Telephone: +1-647-578-7490
Email: mailto://contact@tokens.com

Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com

Media: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com

NEWS -- Tokens.com Acquires Decentraland’s Music District

TORONTO,, April 12, 2022--(BUSINESS WIRE)--Tokens.com Corp. (NEO Exchange Canada: COIN) (Frankfurt Stock Exchange: 76M) (OTCQB US: SMURF) ("Tokens.com" or "the Company"), a publicly-traded company that invests in Web3 crypto assets and businesses linked to the Metaverse and NFTs, is pleased to share that its subsidiary, Metaverse Group, has purchased the Music District in Decentraland, as a joint venture with 13th Floor Ventures, an institutionally-backed investment fund focused on virtual real estate opportunities in the Metaverse.

The Music District is comprised of 34 parcels, equivalent to 91,936 sq ft of flat land in physical terms. The district is positioned in a strategic location as the land borders Festival Land, Decentraland’s live music district that has featured live performances from many prominent artists and Genesis Plaza, the heart of Decentraland where all users enter the virtual world and retains high foot traffic volumes.

This district purchase solidifies Metaverse Group’s position as one of the largest landowners in Decentraland, as the group continues to collect strategically located parcels in Decentraland. Owning parcels in locations like the Music District allows the company to offer advertising space in the most popular and most highly sought-after areas.

"We plan on developing this land to host movie premiers, music launches and concerts," commented Andrew Kiguel, CEO of Tokens.com and Executive Chair of Metaverse Group. "We believe that music and fashion will be leading drivers of value in the Metaverse, thus the strategic importance of this acquisition."

The Music District acquisition is one of the largest virtual land purchases of 2022 to date.

"The Music District is the perfect site to execute our shared vision to create immersive experiences across all forms of talent and entertainment," said Evan Abraham, Co-founder and Managing Partner of 13th Floor Ventures. "We are thrilled to partner with an industry leader like Metaverse Group on this acquisition and look forward to growing our joint venture through additional virtual land developments. This is the first of many significant investments in the category as 13FV establishes itself as a key investor in Metaverse assets."

Brands or virtual landowners interested in partnering with Metaverse Group should contact mailto://Info@metaversegroup.com.

About Tokens.com

Tokens.com Corp is a publicly traded company that invests in Web3 assets and businesses focused on the Metaverse, NFTs, DeFi, and gaming based digital assets. Tokens.com is the majority owner of Metaverse Group, one of the world’s first virtual real estate companies. Hulk Labs, a wholly-owned Tokens.com subsidiary, focuses on investing in play-to-earn revenue generating gaming tokens and NFTs. Additionally, Tokens.com owns and stakes crypto assets to earn additional tokens. Through its growing digital assets and NFTs, Tokens.com provides public market investors with a simple and secure way to gain exposure to Web3.

Visit https://Tokens.com to learn more.

Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, and YouTube.

About Metaverse Group

The Metaverse Group is a vertically integrated NFT based Metaverse real estate company. The group, with its global headquarters in Decentraland’s Crypto Valley, also owns an eight figure real estate portfolio across many leading virtual worlds. The company intends to continue to purchase, develop and rent out its portfolio of real estate assets. Tokens.com, a publicly- traded company, is the majority owner of Metaverse Group.

For further information please visit https://metaversegroup.com.

About 13th Floor Ventures

13th Floor Ventures was formed to address growing investment demand from institutions, family offices, and high-net-worth individuals seeking to comfortably access opportunities in the Metaverse. Drawing upon our founders’ experience in the C-suite, successful execution of varied private equity investment structures, and deep relationships within diverse blockchain communities, 13FV is well positioned to generate best-in-class risk-adjusted returns for investors. Each investment – Class A virtual real estate, Metaverse infrastructure, or Metaverse platforms – is driven by our distinguished industry standard of deal structuring and meticulous diligence.

For more information, please visit https://www.13fv.xyz/.

This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as "may", "will", "plan", "expect", "anticipate", "estimate", "intend" and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at www.sedar.com. Actual events or results may differ materially from those projected in the forward-looking statements and we caution against placing undue reliance thereon. We assume no obligation to revise or update these forward-looking statements except as required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220412005276/en/

Contacts

Tokens.com Corp.

Andrew Kiguel, CEO
Telephone: +1-647-578-7490
Email: mailto://contact@tokens.com

Jennifer Karkula, Head of Communications
Email: mailto://contact@tokens.com

Media: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com

NEWS -- Oncolytics Biotech® to Participate in a Fireside Chat at the Canaccord Genuity Horizons in Oncology Virtual Conference

SAN DIEGO, Calif. and CALGARY, AB, April 12, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that Thomas Heineman, M.D., Ph.D., the Company's Chief Medical Officer, will be participating in a fireside chat at the Canaccord Genuity Horizons in Oncology Virtual Conference. Additional details on the fireside chat are provided below.

Date: Thursday, April 14, 2022
Time: 10:00 a.m. ET
Webcast: Please click here

Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please contact your Canaccord representative or email mailto://jpatton@oncolytics.ca.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; our plans to advance towards a registration study in metastatic breast cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

SOURCE: Oncolytics Biotech® Inc.




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SOURCE Oncolytics Biotech® Inc.

Aren't the stock markets closed friday (Good Friday, a Christian holiday.)

NEWS -- Lineage to Present at the NobleCon18 Investor Conference on April 20, 2022

CARLSBAD, Calif., April 11, 2022--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, the Company’s Chief Executive Officer, will be presenting at NobleCon18 - Noble Capital Markets’ Eighteenth Annual Investor Conference on April 20th, 2022 at 4:30pm ET in Seminole Ballroom A. NobleCon18 is taking place at the Hard Rock Hotel & Casino in Hollywood, Florida, April 19th – 21st, 2022.

An archived webcast of the corporate presentation will be available starting April 21st, 2022 on the Events and Presentations page of the Lineage website, and as part of a complete catalog of presentations available on the conference website: https://www.nobleconference.com and on Channelchek https://www.channelchek.com, the investor portal created by Noble Capital Markets. Additional videos are available on the Media page of the Lineage website.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include four allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, which is now being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer and (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy. For more information, please visit https://www.lineagecell.com or follow the Company on Twitter @LineageCell.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220411005035/en/

Contacts

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Mike Biega
(mailto://Mbiega@soleburytrout.com)
(617) 221-9660

Russo Partners – Media Relations
Nic Johnson or David Schull
mailto://Nic.johnson@russopartnersllc.com
mailto://David.schull@russopartnersllc.com
(212) 845-4242

NEWS -- Provectus Biopharmaceuticals Announces Presentation of Multiple Protein Kinase Signaling Targets, including WNK1, for PV-10® Immunotherapy at American Association for Cancer Research (AACR) 2022 Annual Meeting

KNOXVILLE, TN, April 11, 2022 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that preclinical research on systemic administration of investigational cancer immunotherapy PV-10 (rose bengal sodium) for the treatment of high-risk and refractory adult solid tumor cancers is being presented at the annual meeting of the American Association for Cancer Research (AACR), being held April 8-13, 2022 in New Orleans, Louisiana.

This PV-10 research has been led by Aru Narendran, MD, PhD and his team from the Cumming School of Medicine at the University of Calgary in Calgary, Alberta, Canada.

Dr. Narendran and his colleagues previously showed that PV-10 induced cell death at pharmacologically-relevant concentrations in a panel of phenotypically-diverse adult solid tumor cell lines comprising breast, colorectal, head and neck, and testicular cancers (Tran et al. 2021 ASCO). The University of Calgary team subsequently investigated target validation and modulation of PV-10 treatment on protein kinase signaling and associated impacts on specific oncogenic pathways in these adult solid tumor cancers.

A copy of the AACR poster presentation is available on Provectus’ website at https://www.provectusbio.com/media/docs/publications/AACR2022_PV-10_Adult_Tumor_Poster.pdf.

Highlights from the 2022 AACR Presentation:

• PV-10 delivers cytotoxic activity in vitro against a panel of high-risk and refractory adult solid tumor cell lines
  • PV-10 is cytotoxic at pharmacologically-relevant concentrations across all cancer cell lines
• PV-10 treatment shows target modulation of key markers associated with apoptosis and autophagy induction
  • Western blot analyses yield time-dependent target modulation of pro-apoptotic protein markers and autophagic regulators in all cancer types
• PV-10 targets multiple protein kinase signaling pathways, including the phosphorylation of WNK lysine deficient kinase 1 (WNK1)
  • PV-10 treatment leads to consistent inhibition of WNK1 phosphorylation at the T60 site in all cancer types based on protein kinase profiling of PV-10-treated cancer cells compared to vehicle-treated cells
  • Corresponding ß-catenin levels for each cancer type are also shown
• PV-10 treatment inhibits the migration of cancer cells similar to pan-WNK inhibitor WNK463 in different head and neck cancer cell lines

Dominic Rodrigues, Vice Chair of Provectus’ Board of Directors, said, “WNK1 is recognized as an inhibitor of autophagy and a promoter of cancer cell proliferation, migration, and invasion in breast cancer, glioblastoma, and non-small cell lung cancer. WNK1 potentially regulates important oncogenic pathways, including Wnt signaling by controlling ß-catenin levels. We are grateful to Dr. Narendran and his University of Calgary team for their many discoveries related to PV-10 cancer treatment, including now identifying multiple, specific, actionable drug targets.”

About PV-10

Intralesional (IL) administration of PV-10 for the treatment of solid tumor cancers can yield immunogenic cell death within hours of tumor injection, and induce tumor-specific reactivity in circulating T cells within days. This PV-10-induced functional T cell response may be enhanced and boosted in combination with immune checkpoint blockade (CB). In CB-refractory disease, PV-10 may restore disease-specific T cell function. IL PV-10 has been administered to over 450 patients with melanoma and cancers of the liver in both monotherapy and combination therapy settings. IL PV-10 is administered under visual, tactile, or ultrasound guidance to superficial malignancies, and under CT or ultrasound guidance to visceral hepatic tumors.

Systemic administration of PV-10 is undergoing preclinical study as prophylactic and therapeutic treatments for high-risk and refractory adult solid tumor cancers, and as a therapeutic treatment for relapsed and refractory blood cancers.

About Provectus

Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different disease areas based on a class of small molecules called halogenated xanthenes. Multi-route of administration drug discovery and development programs include investigational drugs and drug targets in oncology (clinical-stage), dermatology (clinical-stage), hematology, virology, microbiology, ophthalmology (clinical-stage), and animal health. Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Company's website at https://www.provectusbio.com.

Trademarks

PV-10® is registered trademark of Provectus Pharmatech, Knoxville, Tennessee, U.S.A.

FORWARD-LOOKING STATEMENTS: The information in this press release may include “forward-looking statements,” within the meaning of U.S. securities legislation, relating to the business of Provectus and its affiliates, which are based on the opinions and estimates of Company management and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “project,” “predict,” “potential,” “targeting,” “intend,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.

The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.

Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.

Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the SEC, including those described in Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.

###

Contact:

Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999

NEWS -- Oncolytics Biotech® Announces Positive Long-Term Survival Data from Phase 1b Glioblastoma Multiforme Trial at the AACR Annual Meeting

- Results demonstrate meaningful and durable efficacy signal in a highly challenging indication

- A higher dose level of pelareorep led to 50% 24-month median overall survival (mOS) and a patient still alive at 42 months compared to 16.7% mOS at the lower dose

- Investigator-sponsored trial confirms pelareorep's favorable safety profile

SAN DIEGO and CALGARY, AB, April 8, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced positive long-term survival data from ReoGlio, an investigator-sponsored phase 1b trial evaluating the combination of pelareorep and granulocyte-macrophage colony-stimulating factor (GM-CSF) alongside standard chemoradiotherapy and adjuvant temozolomide for the treatment of glioblastoma multiforme (GBM). The results, which are the subject of a presentation at the American Association for Cancer Research (AACR) Annual Meeting, show a substantial and durable efficacy signal in newly diagnosed GBM patients and demonstrate the safety and tolerability of the studied treatment combination in this indication.

"These results provide further evidence suggesting that the long-term survival benefits pelareorep delivers to breast cancer patients may be extended to a variety of indications," said Susan Short, M.R.C.P., Ph.D., Professor of Clinical Oncology and Neuro-Oncology at the University of Leeds. "I am highly encouraged by the two-year survival rate and median overall survival observed in ReoGlio and view the relative increases these metrics show in the high dose cohort as a promising sign of this therapy combination's dose-dependent activity in GBM. ReoGlio's long-term results are also consistent with the positive progression-free survival data that were previously reported and confirm pelareorep's favorable safety profile in this new indication. Collectively, these findings highlight pelareorep's potential to drive clinical benefit in GBM patients, who are historically very challenging to treat and in urgent need of novel therapies."

Key data and conclusions from the AACR poster and corresponding abstract include:

• Evaluable patients treated with pelareorep at dose level-2 (3x1010 TCID50) had a median overall survival (mOS) of 16.1 months and a 24-month survival rate of 50% (n=6)
• Evaluable patients treated with pelareorep at dose level-1 (1x1010 TCID50) had a mOS of 12.6 months and a 24-month survival rate of 16.7% (n=6)
• Across both dose levels, mOS was 13.1 months and the 24-month survival rate was 33% (n=12)
• One patient treated at dose level-2 remains alive at 42 months
• The studied treatment combination was deemed safe and well-tolerated at both dose levels by a Safety Review Committee that included two independent physicians

The long-term follow-up data from the ReoGlio study being presented at AACR are an extension of prior data that were featured in a podium presentation at the 2020 Society of Neuro-Oncology Annual Meeting (https://www.oncolyticsbiotech.com/press-releases/detail/525/oncolytics-biotech-announces-positive-clinical-results). These data demonstrated an estimated median progression-free survival (mPFS) of 7.8 months across all evaluable patients in the study (n=12), with those treated at dose level-2 showing an estimated mPFS of 9.4 months (n=6) and those treated at dose level-1 showing an estimated mPFS of 6.1 months (n=6).

Matt Coffey, Ph.D., MBA, President and Chief Executive Officer of Oncolytics Biotech Inc. added, "ReoGlio's results strengthen the broad clinical dataset demonstrating pelareorep's potential to address unmet needs across a range of cancers. We believe they warrant additional clinical study, and plan to discuss them with thought leaders and potential partners to identify the best and most efficient potential path forward in GBM. This strategy will allow us to opportunistically expand pelareorep's commercial potential while staying focused on the advancement of our lead breast cancer program to a registrational study. We would like to sincerely thank the University of Leeds, Cancer Research UK, and The Brain Tumor Charity for designing and funding the ReoGlio trial, as well as all of the patients who participated."

An electronic copy of the presentation and the corresponding abstract, entitled, Combination of reovirus (pelareorep) and granulocyte-macrophage colony-stimulating factor (GM-CSF) alongside standard chemoradiotherapy and adjuvant chemotherapy (temozolomide) for patients with glioblastoma multiforme (GBM): long term follow up results of the ReoGlio phase Ib trial, is available to registered attendees of the AACR annual meeting on the meeting website. A copy of the presentation will also be posted to the Posters & Publications page of Oncolytics' website (https://www.oncolyticsbiotech.com/technology/posters-publications) following the conclusion of the meeting.

Details for the online presentation are shown below.

Abstract Number: CT569

Session Title: OPO.CT01.01 - Phase I Clinical Trials

About ReoGlio

The ReoGlio trial was an investigator-sponsored phase 1b, open-label trial evaluating the combination of pelareorep and GM-CSF, alongside standard chemoradiotherapy and adjuvant temozolomide, for the treatment of newly diagnosed GBM. Fifteen patients were treated in the trial, twelve of which were evaluable for efficacy analyses. The primary objective of the study was to determine the maximum tolerated dose of pelareorep and GM-CSF with standard chemoradiotherapy. Secondary objectives were to gain a preliminary assessment of the activity of the pelareorep-GM-CSF combination and to assess treatment compliance. The trial was designed and managed by the University of Leeds and funded through grants provided by Cancer Research UK and The Brain Tumor Charity.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; the timing and results of the presentation to be made at the American Association for Cancer Research Annual Meeting; our plans to discuss the results of the ReoGlio study with thought leaders and potential partners to identify the best and most efficient potential path forward in GBM and the anticipated results of this strategy; our plans to advance towards a registration study in metastatic breast cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

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SOURCE Oncolytics Biotech® Inc.

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NEWS -- Oncolytics Biotech® Presents New Data Demonstrating Durable Clinical Benefit in Relapsed/Refractory Multiple Myeloma Patients at the AACR Annual Meeting

- Pelareorep's immunotherapeutic effects produced progression-free survival of >3 years in a subset of multiple myeloma patients who had failed prior therapy

- Results strengthen the clinical dataset demonstrating pelareorep's ability to remodel the tumor microenvironment

SAN DIEGO and CALGARY, AB , April 8, 2022 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the publication of an electronic poster at the American Association for Cancer Research (AACR) Annual Meeting featuring new clinical biomarker data from a completed investigator-sponsored phase 1b trial of pelareorep and the proteasome inhibitor bortezomib in relapsed/refractory multiple myeloma patients.

"The results from this trial provide a powerful example of how pelareorep's immunologic effects trigger a durable clinical benefit in an extremely challenging patient population," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech Inc. "All patients enrolled into the study had failed prior therapies, yet despite this, treatment with pelareorep-based therapy prevented disease progression for over three years in a subset of the patients. In addition, this study shows that pelareorep's ability to recruit high concentrations of anti-cancer immune cells into the tumor microenvironment (TME) can yield strong clinical outcomes. This impressive finding has implications for cancers beyond multiple myeloma as it builds on existing data that support pelareorep's potential to enhance the effectiveness of a wide array of therapies through its ability to stimulate a pro-inflammatory TME."

Previously reported data highlighted in the poster's corresponding abstract demonstrated the efficacy of the studied combination and showed a subset of trial participants achieving prolonged progression-free survival (PFS) of greater than three years (https://www.oncolyticsbiotech.com/press-releases/press-releases/detail/562/oncolytics-biotech-announces-phase-1b-data-demonstrating). These data also demonstrate a clinical response correlating with changes in T cell clonality and post-treatment increases in innate and adaptive immune cells within the TME. New biomarker analyses featured in the poster show these anti-cancer immune cells clustering more closely around cancer cells containing pelareorep compared to those that did not. Collectively, these results indicate that the sustained clinical benefits observed were driven by pelareorep's recruitment of anti-cancer immune cells into the TME.

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, "This trial generated important proof-of-concept data that reaffirm pelareorep's favorable safety profile, increase our understanding of its mechanism of action, and further support the use of T cell clonality as a biomarker. These important learnings strengthen the systemic effect observed in other datasets supporting each of our clinical programs and can be applied to accelerate their advancement. Moving forward, we plan to use our findings in multiple myeloma to drive conversations with potential partners and collaborators interested in leveraging pelareorep's immunotherapeutic effects to address unmet needs in this and other indications. Internally, we remain primarily focused on our lead breast cancer program and look forward to its expected randomized phase 2 data readout in the fourth quarter of the year."

The electronic AACR poster, entitled, Single Cell Analysis Shows That Reovirus Immune Priming Changes the Tumor Immune Micro Environment in Multiple Myeloma, is available to registered attendees of the AACR annual meeting on the meeting website (Abstract #6354). A copy of the poster will also be posted to the Posters & Publications page of Oncolytics' website (LINK) following the conclusion of the meeting.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer. For further information, please visit: https://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential and benefits of pelareorep as a cancer therapeutic; Oncolytics' expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; our plan to use our findings in multiple myeloma to drive conversations with potential partners and collaborators; our primary focus on our lead breast cancer program and our expectations regarding its randomized phase 2 data readout in the fourth quarter of the year; our plans to advance towards a registration study in metastatic breast cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact
Jon Patton
Director of IR & Communication
+1-858-886-7813
mailto://jpatton@oncolytics.ca

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com

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SOURCE Oncolytics Biotech® Inc.

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NEWS -- Plus Therapeutics Announces Poster Presentation at the American Association for Cancer Research (AACR) Annual Meeting

AUSTIN, Texas, April 08, 2022 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced that the company will present a poster at the upcoming American Association for Cancer Research (AACR) 2022 Annual Meeting, which is being held April 8-13, 2022, in New Orleans, La., and virtually.

Details of the poster presentation

Title: A biology-based, mathematical model to predict the response of recurrent glioblastoma to treatment with 186Re-labeled nanoliposomes

Session Title: Mathematical Models

Session Date and Time: Tuesday, April 12, 2022, 9:00 a.m. – 12:30 p.m. CT

Location: New Orleans Convention Center, Exhibit Halls D – H, Poster Section 29

Poster Board Number: 13

Permanent Abstract Number: 2742

Link to Abstract: https://www.abstractsonline.com/pp8/#!/10517/presentation/18391

A copy of the poster presentation will be made available under the Presentations tab of the For Investors section of the Company’s website following the meeting at https://www.plustherapeutics.com.

About Plus Therapeutics

Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on the development, manufacture, and commercialization of complex and innovative treatments for patients battling cancer and other life-threatening diseases.

Our proprietary nanotechnology platform is currently centered around the enhanced delivery of a variety of drugs using novel liposomal encapsulation technology. Liposomal encapsulation has been extensively explored and undergone significant technical and commercial advances since it was first developed. Our platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at https://PlusTherapeutics.com and https://ReSPECT-Trials.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186RNL including the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-LM or the ReSPECT-PBC trials; possible negative effects of 186RNL; the continued evaluation of 186RNL including through evaluations via a seventh patient cohort; and the intended functions of the Company’s platform and expected benefits from such functions.

The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the regenerative medicine field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.

Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com

Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com

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NEWS -- CytoSorbents Receives Approximately $740,000 from the New Jersey Business Tax Certificate Transfer Program

MONMOUTH JUNCTION, N.J., April 7, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today announced that it has received approximately $740,000, net of transactions costs, in cash proceeds from the sale of its 2020 Net Operating Loss (NOL) and R&D tax credits from the Technology Business Tax Certificate Transfer Program, sponsored by the New Jersey Economic Development Authority (NJEDA).

Kathleen Bloch, Chief Financial Officer of CytoSorbents commented, "We are pleased to once again work with the New Jersey Economic Development Authority to monetize our state NOLs and R&D tax credits and generate a source of non-dilutive funding to benefit our cash position. These funds will support our global clinical trial program, as well as manufacturing capacity expansion at our new Princeton, New Jersey facility as we pursue FDA marketing approval of our technology in the United States, among other investments. We have a strong balance sheet and expect to fund our 2022 operating expenses with cash on hand. We plan to continue to participate in this innovative program offered by the NJEDA. We appreciate the support of the NJEDA in facilitating our commitment to developing and commercializing products that are helping to save lives."

The New Jersey Technology Business Tax Certificate Transfer Program enables approved Technology and Biotechnology Businesses with Net Operating Losses to sell their Unused Net Operating Loss (NOL) and Unused Research and Development Tax Credits (R&D Tax Credits) for at least 80% of the value of the tax benefits to a profitable corporate taxpayer in the State of New Jersey that is not an Affiliated Business. This allows Technology and Biotechnology Businesses with Net Operating Losses to turn their tax losses and credits into cash to buy equipment or facilities, or for other allowable expenditures. The New Jersey Economic Development Authority (NJEDA) determines eligibility, and the New Jersey Division of Taxation determines the value of the tax benefits (NOL and R&D Tax Credits).

About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 162,000 cumulative CytoSorb devices have been utilized as of December 31, 2021. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 20 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 25 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.

CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

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Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
mailto://tpowers@cytosorbents.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com

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SOURCE CytoSorbents Corporation