Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
NEWS -- Provectus Biopharmaceuticals Announces Acceptance of PV-10 Poster Presentation at Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting
KNOXVILLE, TN, Aug. 07, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that preclinical data from ongoing research on investigational cancer immunotherapy PV-10 (rose bengal sodium) as an immune vaccine adjuvant will be presented on a poster presentation at the Society for Immunotherapy of Cancer (SITC) 2023 annual meeting to be held in San Diego, CA from November 1-5. This PV-10 research has been led by Aru Narendran, MD, PhD and his team of researchers at the Cumming School of Medicine at the University of Calgary in Alberta, Canada.
The accepted abstract is:
NEWS -- Tokens.com to Release its Financial Results for Q3-2023 on August 10, 2023
TORONTO, August 04, 2023--(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 assets and builds web3 businesses, is pleased to share that it will release its financial results for the three and nine months ended June 30, 2023 ("Q3 2023") on Thursday August 10th, 2023.
An investor webinar hosted by CEO Andrew Kiguel on Zoom has been scheduled to discuss the Company’s Q3 2023 financial results starting at 10:00 am ET on August 11th, 2023.
Investor Webinar Details:
Date: August 11th, 2023
Time: 10:00 a.m. ET
Zoom Webinar Registration: https://us06web.zoom.us/webinar/register/WN_xb5kUpV2QMu4MRVFLfDGWg
To join the webinar, register using the link provided above. Upon registration a Zoom link will be emailed to the registered email address. The webinar will be available via computer, tablet, and smartphone devices. In addition, a dial-in phone number will be provided in the email upon registration. Callers dialing in using a telephone will automatically be placed in a listen only mode. The question period will not be available to dial-in callers.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these categories.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Metaverse Group wholly-owns a subsidiary called cocoNFT, a platform that allows Instagram users to mint and sell NFTs easily. Additionally, Metaverse Group is a strategic investor in Metaverse Architects, a leading 3D modeling and game development studio. Web3 gaming operations occur within a subsidiary called Hulk Labs.
All our businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue.
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.
Forward-Looking Statements
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/20230804704103/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 Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Tokens.com to Release its Financial Results for Q3-2023 on August 10, 2023
TORONTO, August 04, 2023--(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 assets and builds web3 businesses, is pleased to share that it will release its financial results for the three and nine months ended June 30, 2023 ("Q3 2023") on Thursday August 10th, 2023.
An investor webinar hosted by CEO Andrew Kiguel on Zoom has been scheduled to discuss the Company’s Q3 2023 financial results starting at 10:00 am ET on August 11th, 2023.
Investor Webinar Details:
Date: August 11th, 2023
Time: 10:00 a.m. ET
Zoom Webinar Registration: https://us06web.zoom.us/webinar/register/WN_xb5kUpV2QMu4MRVFLfDGWg
To join the webinar, register using the link provided above. Upon registration a Zoom link will be emailed to the registered email address. The webinar will be available via computer, tablet, and smartphone devices. In addition, a dial-in phone number will be provided in the email upon registration. Callers dialing in using a telephone will automatically be placed in a listen only mode. The question period will not be available to dial-in callers.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and builds web3 businesses. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) play-to-earn crypto gaming. Tokens.com owns digital assets and operating businesses within each of these categories.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Metaverse Group wholly-owns a subsidiary called cocoNFT, a platform that allows Instagram users to mint and sell NFTs easily. Additionally, Metaverse Group is a strategic investor in Metaverse Architects, a leading 3D modeling and game development studio. Web3 gaming operations occur within a subsidiary called Hulk Labs.
All our businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue.
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.
Forward-Looking Statements
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/20230804704103/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 Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Oncolytics Biotech® to Participate in a Fireside Chat at Canaccord Genuity's 43rd Annual Growth Conference
SAN DIEGO and CALGARY, AB, Aug. 4, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that Chief Executive Officer Dr. Matt Coffey will participate in a fireside chat at Canaccord Genuity's 43rd Annual Growth Conference, which is taking place August 7-10, 2023 at the InterContinental Boston in Boston, MA. Additional details on the fireside chat can be found below.
Date: Thursday, August 10, 2023
Time: 12:00 p.m. ET
Location: InterContinental Boston, Abigail Adams C Room
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 request on the conference website, contact your Canaccord representative, or email 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 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 multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
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 to download multimedia: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-a-fireside-chat-at-canaccord-genuitys-43rd-annual-growth-conference-301893276.html
SOURCE Oncolytics Biotech® Inc.
NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Second Quarter Financial Results and Recent Operational Highlights
Conference call and webcast to take place on Monday, August 14, 2023, at 8:30 a.m. ET
SAN DIEGO and CALGARY, AB, Aug. 4, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that it will host a conference call and webcast on Monday, August 14, 2023, at 8:30 a.m. ET to discuss a corporate update and financial results for the second quarter of 2023.
Conference Call & Webcast
Date: Monday, August 14, 2023
Time: 8:30 a.m. ET
Dial-In – North American Toll-Free: (888) 664-6383
Dial-In – International: (416) 764-8650
RapidConnect: to join the conference call without operator assistance, please click here
Conference ID (if needed): 5411-4798
Webcast: please click here
A webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 114-798#.
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 multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: https://www.oncolyticsbiotech.com.
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-to-host-conference-call-to-discuss-second-quarter-financial-results-and-recent-operational-highlights-301893245.html
SOURCE Oncolytics Biotech® Inc.
NEWS -- Lineage Cell Therapeutics to Report Second Quarter 2023 Financial Results and Provide Business Update on August 10, 2023
CARLSBAD, Calif., August 03, 2023--(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 it will report its second quarter 2023 financial and operating results on Thursday, August 10, 2023, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, August 10, 2023, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its second quarter 2023 financial and operating results and to provide a business update.
Interested parties may access the conference call on August 10th, 2023, by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through August 17, 2023, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 1144985.
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 and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is 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 potential 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/20230803131502/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Lineage Cell Therapeutics to Report Second Quarter 2023 Financial Results and Provide Business Update on August 10, 2023
CARLSBAD, Calif., August 03, 2023--(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 it will report its second quarter 2023 financial and operating results on Thursday, August 10, 2023, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, August 10, 2023, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its second quarter 2023 financial and operating results and to provide a business update.
Interested parties may access the conference call on August 10th, 2023, by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through August 17, 2023, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 1144985.
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 and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is 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 potential 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/20230803131502/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
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 to Present at the Canaccord Genuity 43rd Annual Growth Conference
AUSTIN, Texas, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, announced today that Marc Hedrick, M.D., President and Chief Executive Officer, has been invited to present at the Canaccord Genuity 43rd Annual Growth Conference, on Wednesday, August 9, 2023 at 8:00 a.m. ET at the InterContinental Boston in Boston, Mass.
Investors interested in arranging a meeting with the Company’s management during the conference should contact the Canaccord Genuity conference coordinator. A webcast of the presentation can be found 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 developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.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 186Re including the ability of 186Re 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-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; 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 cancer diagnostics and therapeutics 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) 213-0505
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Theriva™ Biologics Announces Key Progress in VIRAGE, an Ongoing, Multinational Phase 2b Trial of VCN-01 in Combination with Chemotherapy in Pancreatic Ductal Adenocarcinoma
– Initiated dosing at U.S. sites for VIRAGE –
– Second doses of intravenous VCN-01 administered to patients in Spain and were well tolerated –
– VIRAGE remains on track to complete enrollment in the first quarter of 2024 –
ROCKVILLE, Md., Aug. 02, 2023 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced key progress in VIRAGE, a multinational, Phase 2b, randomized, open-label, controlled clinical trial evaluating VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first-line therapy for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). Patient dosing has initiated in the U.S. and with four sites open in the U.S. and eight sites open in Spain the trial remains on track to be fully-enrolled in the first quarter of 2024. Dosing in Spain initiated in January 2023 and the first patients have now received their second doses of intravenous VCN-01, which were well tolerated with a safety profile consistent with prior clinical trials.
VCN-01 is Theriva’s systemic, selective, stroma-degrading oncolytic adenovirus. VCN-01 has been granted Orphan Drug designations from the US Food and Drug Administration and the European Medicines Agency for the treatment of pancreatic cancer.
“Initiating dosing in the U.S., and the completion of the second VCN-01 doses for the first patients in Spain, are important accomplishments that add to the strong momentum for VIRAGE, which remains on track to complete enrollment in the first quarter of 2024,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “With a dearth of novel therapies available and a five-year survival rate for metastatic PDAC of only 3%, pancreatic cancer is an indication that is ripe for innovation. Through VIRAGE’s advancement, we aim to demonstrate VCN-01’s ability to address the unmet needs of pancreatic cancer patients by synergistically combining with standard-of-care chemotherapy. We are extremely encouraged by the favorable safety profile following the advancement to the second dose that further differentiates and positions VCN-01 as a leading oncolytic adenovirus. More broadly, this trial will enable us to determine the feasibility of repeated dosing of VCN-01, which could shift the paradigm for standardized treatment cycles that are well established in cancer chemotherapy and immunotherapy, and thereby lead to improved clinical outcomes for patients with PDAC and other solid cancers.”
About VIRAGE
VIRAGE is a two-arm Phase 2b open-label, randomized, controlled, multicenter clinical trial in patients with histologically confirmed, newly-diagnosed metastatic PDAC. VIRAGE is expected to enroll up to 92 adult participants at up to 25 sites across the US and Spain. In both the control and treatment arms, patients will receive gemcitabine/nab-paclitaxel standard-of-care chemotherapy over 28-day cycles. In the treatment arm only, patients will also receive systemically administered VCN-01 seven-days prior to the first and fourth cycles of gemcitabine/nab-paclitaxel treatment. Primary endpoints for the trial include overall survival and VCN-01 safety/tolerability. Additional endpoints include progression free survival, objective response rate, and measures of biodistribution, VCN-01 replication, and immune response. Since this is an open-label trial, progress will be monitored very closely and steps to accelerate the clinical program may be implemented if supported by the emerging data. More information about the trial is available on Clinicaltrials.gov (NCT05673811), through the Spanish Clinical Trials Registry and European Union Drug Regulating Authorities Clinical Trials Database (EudraCT Number: 2022-000897-24).
About VCN-01
VCN-01 is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to over 80 patients in Phase 1 and investigator-sponsored clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection).
About Theriva™ Biologics, Inc.
Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company’s wholly-owned Spanish subsidiary Theriva Biologics, S.L., has been developing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. In addition to VCN-01, the Company’s clinical-stage candidates include: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients); and (2) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. For more information, please visit Theriva Biologics’ website at https://www.therivabio.com.
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 the Virage trial remaining on track to be fully-enrolled in the first quarter of 2024, the trial enabling the Company to determine the feasibility of repeated dosing of VCN-01, the feasibility of repeated doses shifting the paradigm for standardized treatment cycles that are well established in cancer chemotherapy and immunotherapy, and the trial leading to improved clinical outcomes for patients with PDAC and other solid cancers. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to complete enrollment in the Virage trial when anticipated and anticipated results, the Company’s ability to address the unmet medical needs for treatment of PDAC, the Company’s ability to take advantage of the potential benefits of orphan drug designation, the Company’s ability to reach clinical milestones when anticipated, the Company’s ability to successfully operate the combined US and Spanish business entities , the Company’s product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results; the ability to complete clinical trials on time and achieve the desired results and benefits, continuing clinical trial 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 the Company’s ability to promote or commercialize their product candidates for the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of the Company’s products, developments by competitors that render such products obsolete or non-competitive, the Company’s ability to maintain license agreements, the continued maintenance and growth of the Company’s patent estate, the ability to continue to remain well financed and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
For further information, please contact:
Investor Relations:
Chris Calabrese
LifeSci Advisors, LLC
mailto://ccalabrese@lifesciadvisors.com
917-680-5608
NEWS -- Theriva Biologics to Host Conference Call and Webcast to Discuss Second Quarter 2023 Operational Highlights and Financial Results
ROCKVILLE, Md., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that it plans to host a conference call on Tuesday, August 8, 2023, at 8:30 a.m. ET to discuss its financial results for the quarter ended June 30, 2023 and provide a corporate update.
Individuals may participate in the live call via telephone by dialing 1-877-451-6152 (domestic) or 1-201-389-0879 (international) and using the conference ID: 13739888. Participants are asked to dial in 15 minutes before the start of the call to register. Investors and the public can access the live and archived webcast of this call via the “News & Media” section of the company’s website, https://www.therivabio.com, under “Events” or by clicking here, up to 90 days after the call.
About Theriva Biologics, Inc.
Theriva Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company’s subsidiary Theriva Biologics, S.L., has been developing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead clinical-stage candidates are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment; (2) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients); and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. For more information, please visit Theriva Biologics’ website at https://www.therivabio.com.
For further information, please contact:
Investor Relations:
Chris Calabrese
LifeSci Advisors, LLC
mailto://ccalabrese@lifesciadvisors.com
917-680-5608
Source: Theriva Biologics, Inc.
NEWS -- FuelPositive Announces Completion of Debt Settlement
WATERLOO, Ontario, Aug. 01, 2023 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (the “Company”), a leading Green Ammonia company, is pleased to announce that it has completed the previously announced settlement (the “Settlement”) of $1,436,248 of outstanding indebtedness owing to certain arms-length parties and has issued 22,096,123 units (each, a “Unit”) at a price of $0.065 per Unit. Each Unit consists of one common share of the Company, and one common share purchase warrant (each, a “Warrant”) entitling the holder to acquire an additional common share at a price $0.09 until July 28, 2026. In the event the volume-weighted average closing price of the Company's common shares on the TSX Venture Exchange exceeds $0.40 for ten consecutive trading days, the Company retains the option to accelerate the expiry date of the Warrants to thirty days after a public announcement of the election. All securities issued in connection with the Settlement are subject to restrictions on resale until November 29, 2023 in accordance with applicable securities laws.
The Company also announces that it has reached agreements with a certain additional arm's-length creditors to settle further outstanding indebtedness totalling $344,361 through the issuance of 5,297,864 Units at a price of $0.065 per Unit. All Units issued in connection with this additional settlement will be subject to restrictions on resale for a period of four months and one day following issuance in accordance with applicable securities laws. Completion of this additional settlement remains subject to the approval of the TSX Venture Exchange.
"We would like to express our gratitude to the numerous suppliers and lenders who have actively participated in this conversion opportunity. Their support and collaboration have been instrumental in directing additional operating capital towards our commercialization endeavors and strengthening our balance sheet," commented Ian Clifford, CEO and Board Chair of FuelPositive.
For enquiries related to this Press Release, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://Ian@fuelpositive.com
https://www.fuelpositive.com
Investor Relations United States & International:
RB Milestone Group (RBMG)
mailto://fuelpositive@rbmilestone.com
Investor Relations Canada:
Transcend Capital Inc.
mailto://et@transcendcapitalinc.com
About FuelPositive
FuelPositive is a Canadian technology company committed to providing commercially viable and sustainable, “cradle to cradle” clean technology solutions, including an on-farm/onsite, containerized Green Ammonia (NH3) production system that eliminates carbon emissions from the production of Green Ammonia.
By focusing on technologies that are clean, sustainable, economically advantageous and realizable, the Company aims to help mitigate climate change, addressing unsustainable agricultural practices through innovative technology and practical solutions that can be implemented now. The FuelPositive on-farm/onsite, containerized Green Ammonia production system is designed to produce pure, anhydrous ammonia for multiple applications, including fertilizer for farming, fuel for grain drying and internal combustion engines, a practical alternative for fuel cells and a solution for grid storage. Green Ammonia is also considered a key enabler of the hydrogen economy.
FuelPositive systems are designed to provide for Green Ammonia production on-farm/onsite, where and when needed. This eliminates wildly fluctuating supply chains and offers end-users clean fertilizer, energy and Green Ammonia supply security while eliminating carbon emissions from the production process. The first customers will be farmers. Farmers use 80% of the traditional grey ammonia produced today as fertilizer.
See pre-sale details here: https://fuelpositive.com/pre-sales/.
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) accept 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 of 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.
NEWS -- Oncolytics Biotech® Announces US$15 Million Bought Deal Offering of Units
Not for distribution to U.S. Newswire Services or Dissemination in the United States
CALGARY, AB, July 31, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. ("Oncolytics" or the "Company") (NASDAQ: ONCY) (TSX: ONC) today announced that it has entered into an agreement with Leede Jones Gable Inc. as underwriter and bookrunner (the "Underwriter"), pursuant to which the Underwriter has agreed to purchase, on a bought-deal basis, 6,667,000 units (the "Equity Units") for gross proceeds to the Company of US$15,000,750 (the "Offering") at a price of US$2.25 per Equity Unit.
Each Equity Unit will consist of one common share of the Company (a "Common Share") and one Common Share purchase warrant (each whole purchase warrant, a "Warrant"). Each Warrant will entitle the holder thereof to purchase one Common Share at an exercise price of US$2.81 (the "Exercise Price") at any time up to 60 months following the Closing (as defined below).
The Company has granted the Underwriter an option (the "Over-Allotment Option"), exercisable in part or in whole at the Underwriter's sole discretion, at any time beginning on the Closing until 30 days following the Closing, to purchase up to that number of additional Equity Units, Common Shares or Warrants, or any combination thereof, as is equal to 15% of the aggregate number of Equity Units sold in the Offering to cover over-allotments, if any.
The Equity Units will be offered by way of a prospectus supplement to the Company's short form base shelf prospectus to be filed in all provinces of Canada except Quebec pursuant to National Instrument 44-101 – Short Form Prospectus Distributions and National Instrument 44-102 - Shelf Distributions.
The Company intends to use the net proceeds from the Offering to continue its pelareorep clinical programs in metastatic breast cancer and pancreatic cancer and general corporate and working capital purposes.
The closing of the Offering is expected to occur on or about August 4, 2023 (the "Closing") and is subject to the Company receiving all necessary regulatory approvals, including the approval of the Exchange.
The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S. registration or an applicable exemption from the U.S. registration requirements. This press release does not constitute an offer for sale of securities, nor a solicitation for offers to buy any securities in the United States, nor in any other jurisdiction in which such offer, solicitation or sale would be unlawful. Any public offering of securities in the United States must be made by means of a prospectus containing detailed information about the company and management, as well as financial statements.
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 multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic 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; the Offering and the timing thereof and anticipated use of proceeds therefrom; our plans to advance towards a registrational study in metastatic pancreatic 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
Logo: https://mma.prnewswire.com/media/1762876/Oncolytics_Biotech_New_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/oncolytics-biotech-announces-us15-million-bought-deal-offering-of-units-301889041.html
SOURCE Oncolytics Biotech® Inc.
NEWS -- Navidea Biopharmaceuticals, Inc. Announces NYSE American Has Commenced Delisting Proceedings and Intent to Appeal NYSE American Determination
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, received written notification from NYSE American LLC ("NYSE American" or the "Exchange") stating that the staff of NYSE Regulation has determined to commence proceedings to delist the common stock of Navidea Biopharmaceuticals, Inc. (the “Company”) — ticker symbol NAVB —from the Exchange. The Company's Board of Directors has determined to appeal the Exchange's determination to commence delisting proceedings.
NYSE Regulation has determined that the Company is no longer suitable for listing pursuant to Section 1009(a) of the NYSE American Company Guide (the “Company Guide”) as the Company was unable to demonstrate that it had regained compliance with Sections 1003(a)(i), (ii) and (iii) of the Company Guide by the end of the maximum 18-month compliance plan period, which expired on July 28, 2023. The Exchange’s application with the Securities and Exchange Commission to delist the Company’s common stock is pending, subject to completion of all applicable procedures, including any appeal by the Company of the NYSE Regulation staff’s decision.
The Company has a right to an appeal of the staff’s determination by the Exchange, provided that the Company files a written request for such review within seven calendar days after receiving the notice. The Company's Board of Directors has determined to appeal the Exchange's determination to commence delisting proceedings. There can be no assurance that Navidea’s request for continued listing will be granted.
The Company’s common stock will continue to be listed and traded on NYSE American during the pendency of the Company’s appeal, subject to NYSE American’s discretion to immediately suspend trading if it believes suspension to be in the public interest, for the protection of investors, or to promote just and equitable principles of trade.
Navidea intends to make arrangements to have its common stock quoted in the over-the-counter market if its common stock is delisted from the Exchange.
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, visit https://www.navidea.com.
About G2G Ventures
G2G Ventures is a Colorado-based private equity firm focused on empowering organizations to reach their full potential through investment and consulting services. Specializing in creating long-term partnerships with trusted investors and established businesses, G2G Ventures draws on strong internal balance sheet liquidity, augmented by trusted investor capital, to craft bespoke capital solutions which include private equity investment, venture capital participation, and mezzanine debt options. Beyond financial investment, G2G Ventures provides accretive consulting services to help clarify strategic goals and key performance indicators (KPIs), evolve financial processes, and enhance operational effectiveness. To learn more about how G2G Ventures is a growth partner for enduring business, connect with our team.
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 common stock is subject to delisting from the NYSE American under a currently pending delisting proceeding; 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/20230728368165/en/
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures - Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NEWS -- Plus Therapeutics Appoints Dr. Pius Maliakal as VP of Clinical Operations
By Daniella Parra
Plus Therapeutics (Nasdaq: PSTV) said it appointed Dr. Pius Maliakal as VP of Clinical Operations.
With over 20 years of global oncology experience, he will lead key clinical initiatives, advancing the ReSPECT-GBM and ReSPECT-LM trials for central nervous system cancers, the company said.
“Pius has a unique blend of experience in oncologic clinical development and trial operations that will make an immediate positive impact to our team,” said Marc Hedrick, M.D., President and Chief Executive Officer. “As we move our co-lead programs in glioblastoma and leptomeningeal metastases to the next clinical stages, our clinical operational team also needs to expand and advance. We are confident in Pius’ track record of clinical leadership, successful regulatory submissions, early- to late-stage trial preparation and execution with novel investigational therapeutics.”
Contact:
Healthcare Edge
mailto://Editor@Executives-edge.com
NEWS -- Navidea Biopharmaceuticals, Inc. Hires Craig A. Dais, CPA as Chief Financial Officer
Following the Company’s Fix, Fund, Propel approach, Mr. Dais’s hire strengthens financial expertise, leadership, and oversight, along with continuing Navidea’s focus on advancing innovative technology to market
DUBLIN, Ohio, July 27, 2023--(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 hiring of Craig A. Dais, CPA in the position of Chief Financial Officer (CFO), reporting directly to the Company’s Chief Medical Officer. Mr. Dais’s hiring aligns with the Company’s stated objectives and its Fix, Fund, Propel approach to advancing innovative technology to market.
Financial Expertise, Leadership, and Oversight
Craig A. Dais’s hiring in the role of CFO, strengthens the Company’s financial expertise and oversight, supported by G2G Ventures as Executive Consultants, with demonstrated expertise in accounting, financial modeling, capital development, and strong growth-oriented leadership within private and publicly-held organizations. In his role, he is responsible for overseeing all aspects of Navidea’s financial success, including the preparation of all financial statements, reporting and analysis, the active management of the Company’s cash flows, and the development of expert teams responsible for managing and tracking financial activities.
"Craig is an active and experienced accounting and finance leader with the ability to see both the details and the big picture," said Michael Blue, M.D., FACEP, Navidea’s Chief Medical Officer. "He is a self-motivated leader with expertise in developing strong teams that can help the Company grow by providing insights, reporting, and financial acumen. His financial leadership will help bring Navidea's technology and assets to the forefront."
Mr. Dais continues an impactful career as financial executive, leader, and Certified Public Accountant, having served in various roles of increasing responsibility over 30 years. His recent experience includes serving as Chief Financial Officer at Colorado Pain Care, LLC, (Fractional) Chief Financial Officer at Ascent CFO Solutions, Chief Financial Officer at Duffy Crane & Hauling, Vice President of Finance at Pendum LLC and other leadership positions with public and private organizations. Craig began his career in finance with KPMG Peat Marwick. Mr. Dais earned a Bachelor of Science in Accounting, along with a Minor in Business, from Metropolitan State University of Denver, and is (inactive status) a Certified Public Accountant.
"I am thrilled to have the opportunity to join Navidea’s team as Chief Financial Officer, and eager to get started," said Mr. Dais. "I believe my experience and career has led me to this role, and I believe Navidea’s transformative technology can improve lives around the world. My goal is to get to work using my experience to make that happen."
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, visit https://www.navidea.com.
About G2G Ventures
G2G Ventures is a Colorado-based private equity firm focused on empowering organizations to reach their full potential through investment and consulting services. Specializing in creating long-term partnerships with trusted investors and established businesses, G2G Ventures draws on strong internal balance sheet liquidity, augmented by trusted investor capital, to craft bespoke capital solutions which include private equity investment, venture capital participation, and mezzanine debt options. Beyond financial investment, G2G Ventures provides accretive consulting services to help clarify strategic goals and key performance indicators (KPIs), evolve financial processes, and enhance operational effectiveness. To learn more about how G2G Ventures is a growth partner for enduring business, connect with our team.
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/20230727546541/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures - Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NEWS -- Plus Therapeutics Strengthens Clinical Program with the Appointment of Pius Maliakal as Vice President of Clinical Operations
AUSTIN, Texas, July 27, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced the appointment of Pius Maliakal, M. Pharm., Ph.D., as Vice President of Clinical Operations. Dr. Maliakal will be responsible for the strategy and planning of key clinical operational initiatives, focusing on advancing the Company’s lead clinical trials, ReSPECT-GBM and ReSPECT-LM, and further developing the broader pipeline.
Dr. Maliakal is an accomplished R&D professional who brings over 20 years of global and domestic experience to Plus Therapeutics. Prior to joining the Company, he served as Director of Clinical Science at PTC Therapeutics, leading the clinical development, clinical trial operations, strategies, and data interpretations of all oncology assets across the enterprise. Previously, as Director of Clinical Development at Eagle Therapeutics, he led and facilitated the core design and conduct of Phase 1 and 2 clinical trials within breast cancer, lung cancer and other solid tumors. During his prior tenure at Immunomedics, he was instrumental in the Phase 1 through Phase 3 clinical trials of Trodelvy (sacituzumab govitecan) leading to accelerated FDA approval for treatment of triple-negative breast cancer as well as other investigational agents, including unesbulin and emvododstat. Dr. Maliakal earned his M. Pharm. from Nagpur University, India and his Ph.D. from the University of Otago, New Zealand.
“Pius has a unique blend of experience in oncologic clinical development and trial operations that will make an immediate positive impact to our team,” said Marc Hedrick, M.D., President and Chief Executive Officer. “As we move our co-lead programs in glioblastoma and leptomeningeal metastases to the next clinical stages, our clinical operational team also needs to expand and advance. We are confident in Pius’ track record of clinical leadership, successful regulatory submissions, early- to late-stage trial preparation and execution with novel investigational therapeutics.”
Dr. Maliakal added, “I’m excited to be joining the team at such an important time, and I’m eager to contribute my expertise to support ongoing pipeline development and generate a long-term clinical strategy within the Company. Based on the Company’s promising data readouts in both glioblastoma and leptomeningeal metastases, PLUS has tremendous potential to help patients with central nervous system cancers.”
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.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 186Re including the ability of 186Re 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-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; 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 cancer diagnostics and therapeutics 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 -- Plus Therapeutics to Present at the 2023 SNO/ASCO CNS Cancer Conference
AUSTIN, Texas, July 27, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the Company will share three poster presentations at the Society for Neuro Oncology (SNO)/American Society of Clinical Oncology (ASCO) Central Nervous System (CNS) Cancer Conference taking place August 10-12, 2023 in San Francisco, California.
The presentations will describe new data from the ReSPECT-LM and ReSPECT-GBM clinical studies evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of leptomeningeal metastases (LM) and recurrent glioblastoma (rGBM), respectively, as well as details around the planned ReSPECT-PBC trial to evaluate rhenium (186Re) obisbemeda for the treatment of recurrent, refractory, or progressive childhood ependymoma and high-grade glioma (HGG).
All presentations will be showcased during the Poster Reception on Thursday, August 10, 2023, beginning at 5:30 p.m. PT/8:30 p.m. ET.
Details of presentations:
NEWS -- Lineage Cell Therapeutics and Cancer Research UK Report Topline Phase 1 Study Results With VAC2 for the Treatment of Advanced Non-small Cell Lung Cancer
NEWS -- FuelPositive Announces Successful Completion of Private Placement
WATERLOO, Ontario, July 19, 2023 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (the “Company”), a leading Green Ammonia company, is pleased to announce that it has completed the final tranche of its non-brokered private placement and has issued a further 31,443,069 units (each, a “Unit”), at a price of $0.065 per Unit, for gross proceeds of $2,043,800. Each Unit consists of one common share of the Company and one common share purchase warrant (each, a “Warrant”), allowing holders to purchase an additional common share at an exercise price of $0.09 until July 18, 2026 (the “Offering”). In the event the volume-weighted average closing price of the Company's common shares on the TSX Venture Exchange exceeds $0.40 for ten consecutive trading days, the Company retains the option to accelerate the expiry date of the Warrants to thirty days after a public announcement of the election.
In aggregate, the Company has issued a total of 85,313,768 Units in connection with the completion of both tranches of the Offering and has raised gross proceeds of $5,545,395.
The second and final tranche of the Offering was completed pursuant to the Listed Issuer Financing Exemption (the “LIFE Exemption”) as outlined in Part 5A of National Instrument 45-106 - Prospectus Exemptions (“NI 45-106”) and pursuant to the Accredited Investor Exemption as outlined in Part 2 of NI 45-106. The Units issued to subscribers in the second tranche under the LIFE Exemption are not subject to resale restrictions in accordance with Canadian securities laws. All other securities issued in the Offering will be subject to a statutory hold period of four-months-and-one-day following issuance.
In connection with the completion of the second tranche of the Offering, the Company paid $15,925, issued 140,000 common shares at an issue price of $0.065 and issued 385,000 Warrants to certain arms-length third parties (the “Finders”) who assisted in introducing subscribers to the Offering. The common shares and Warrants issued to the Finders, and any common shares of the Company issuable upon exercise of those Warrants, are subject to restrictions on resale in accordance with Canadian securities laws until November 19, 2023.
"We have successfully completed our financing, generating an overwhelming interest from our esteemed investor base," stated Ian Clifford, CEO and Board Chair of FuelPositive. "We thank our existing investors for their unwavering support, and we warmly welcome our new shareholders to join us on our journey. As we embark on the mission to transform and transition the Green Ammonia industry, this new capital will enable the Company to reach commercialization. The next 12 months promise to be an exhilarating time for FuelPositive, and we are eager to share our progress with our valued shareholders. With our groundbreaking containerized green ammonia (NH3) production system, FuelPositive is positioned to redefine the ammonia sector. I encourage everyone to stay tuned for news on the remarkable upcoming breakthroughs."
For enquiries related to this Press Release, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://Ian@fuelpositive.com
https://www.fuelpositive.com
Investor Relations United States & International:
RB Milestone Group (RBMG)
mailto://fuelpositive@rbmilestone.com
Investor Relations Canada:
Transcend Capital Inc.
mailto://et@transcendcapitalinc.com
About FuelPositive
FuelPositive is a Canadian technology company committed to providing commercially viable and sustainable, “cradle to cradle” clean technology solutions, including an on-farm/onsite, containerized Green Ammonia (NH3) production system that eliminates carbon emissions from the production of Green Ammonia.
By focusing on technologies that are clean, sustainable, economically advantageous and realizable, the Company aims to help mitigate climate change, addressing unsustainable agricultural practices through innovative technology and practical solutions that can be implemented now. The FuelPositive on-farm/onsite, containerized Green Ammonia production system is designed to produce pure, anhydrous ammonia for multiple applications, including fertilizer for farming, fuel for grain drying and internal combustion engines, a practical alternative for fuel cells and a solution for grid storage. Green Ammonia is also considered a key enabler of the hydrogen economy.
FuelPositive systems are designed to provide for Green Ammonia production on-farm/onsite, where and when needed. This eliminates wildly fluctuating supply chains and offers end-users clean fertilizer, energy and Green Ammonia supply security while eliminating carbon emissions from the production process. The first customers will be farmers. Farmers use 80% of the traditional grey ammonia produced today as fertilizer.
See pre-sale details here: https://fuelpositive.com/pre-sales/.
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) accept 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 of 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.
NEWS -- CytoSorbents Appoints Alexander D’Amico as Chief Financial Officer
PRINCETON, N.J., July 19, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced the appointment of Alexander D’Amico as Chief Financial Officer, to begin employment on August 7, 2023.
Mr. D’Amico brings over 20 years of broad finance, SEC reporting, merger and acquisition, fundraising, and accounting experience to CytoSorbents. Most recently, Mr. D’Amico was the Chief Financial Officer of Trulieve Cannabis Corporation (CSE: TRUL; OTCQX: TCNNF), an industry leading, vertically integrated cannabis company and multi-state operator in the U.S., overseeing more than 7,600 employees, including more than 250 finance, accounting, shared service, human resource and investor relations professionals. Through strategic organic growth and eleven separate acquisitions with a transaction value totaling $2.5 billion, including the largest industry transaction in the U.S., Mr. D’Amico helped to engineer a rapid expansion of annual revenue from $250M to more than $1.2 billion, leveraging more than 4 million square feet of cultivation and processing space, and 180 retail stores across 12 states. Mr. D’Amico financed this growth through a series of equity and debt financings, totaling approximately $650 million, and drove the consolidation and integration of these acquisitions, navigating through complex state regulatory environments, and achieved cost savings and gross margins of 55% last year.
Prior to Trulieve, Mr. D’Amico co-led Telaria’s global expansion into 7 new countries, top line revenue growth of over 50% in two years, the acquisition and integration of Slimcut (a global video outstream technology solutions company), and ultimately positioned this leader in digital video advertising services and software for exit/sale via merger to Rubicon Project for a total equity value of $400M, as Vice President Finance/Controller. As Finance Director-Global Controllership at Cognizant, a $14.5 billion high-growth provider of information technology, consulting, and business process services, Mr. D’Amico led global accounting and finance consolidation as revenues grew nearly $4.6B in just 3 years and generated more than $50M in synergistic cost savings. As Senior Finance Manager at Quest Diagnostics, a Fortune 500 company and leading clinical laboratory, he co-championed the company’s Global Business Transformation from 50 domestic and 10 internationally decentralized business units to a Shared Service “Center of Excellence” (COE) reporting more than $7.4B in consolidated revenues. At Quest, he also led the introduction, standardization, and centralization of the Sarbanes Oxley methodology to global markets.
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, stated, “We are thrilled to bring Alex on as Chief Financial Officer and as a key member of the CytoSorbents management team. Throughout his impressive career at major high growth publicly-traded companies, Alex has consistently demonstrated his key strengths in finance, international and domestic accounting, M&A, business strategy, execution, and SEC compliance and reporting. His record at Trulieve alone, which he helped to grow from a relatively small company to a massive commercial organization, highlights many of these key skills. Importantly, Alex has the perspective of scale of operations that will be invaluable as we drive expected rapid growth in the coming years based upon international sales of CytoSorb®, and if successful, sales of DrugSorb™-ATR in the U.S. and Canada. In addition, his extensive experience in M&A perfectly aligns with our longer-term growth strategy that includes both organic growth and acquisition.”
Alexander D’Amico stated, “I am excited to join CytoSorbents during this pivotal time in the Company’s history. In particular, I hope to leverage my diversified experience and expertise to help CytoSorbents expand its high margin international CytoSorb business, take advantage of new business prospects, and finance and build the U.S. and Canadian commercial organizations pending regulatory approvals. I believe CytoSorbents has an excellent future ahead and was immediately attracted to both its mission of saving lives and the deep sense of passion and purpose of the team. I consider this a compelling opportunity to use my skills and knowledge to help grow the Company, work with great colleagues, and serve people in need.”
Dr. Chan stated, “Separately, as we mentioned in a press release in October announcing her pending retirement, we are indebted to Kathy Bloch for her decade of service to the Company as CFO, helping to oversee and finance the rapid growth and commercialization of CytoSorb in 75 countries internationally to date, and for helping to manage this management transition.”
Mr. D’Amico began his career as an auditor for Deloitte, a global provider of audit and assurance, tax consulting, and risk and financial advisory services to corporations worldwide, where he served clients such as BASF and Brother International. He is a Certified Public Accountant in the State of New Jersey, and is a Chartered Global Management Accountant from the American Institute of Certified Public Accountants. Mr. D’Amico received his B.S. in accounting, graduating Summa Cum Laude from Rutgers University.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. At the end of Q1 2023, more than 203,000 CytoSorb devices had been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study, and has now completed patient enrollment at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
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 approximately $48 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, statements about potential exposures resulting from our cash positions, 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 9, 2023, 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.
Please Click to Follow Us on Facebook and Twitter
CytoSorbents Corporation Contact:
Kathleen Bloch, Interim CFO
(732) 398-5429
mailto://kbloch@cytosorbents.com
NEWS -- Navidea Biopharmaceuticals, Inc. Welcomes Dana J Moss, JD to Board of Directors; Amit Bhalla Steps Down
In line with the Company’s Fix, Fund, Propel approach, Dana J Moss, JD joins Navidea’s Board, adding depth in legal advice, strategic business, life sciences and technology in support of stated strategy to advance innovative technology to market. Separately, Amit Bhalla steps down from Board.
DUBLIN, Ohio, July 13, 2023--(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 Dana J Moss, JD has joined the Company’s Board of Directors, adding depth in legal advice, strategic business, life sciences and technology in line with Navidea’s stated objectives and its Fix, Fund, Propel approach to advancing innovative technology to market. Separately, Amit Bhalla has stepped down from the Company’s Board.
Experienced Legal Professional, Focused Life Sciences and Technology Expertise
Dana J Moss, JD joins Navidea’s Board of Directors with demonstrated leadership and legal expertise within innovative organizations focused on life sciences and technology driven products. Moss’s career and expertise within both private and public entities bolsters the Board’s ability to guide business strategy, mitigate risks and deliver stockholder value.
"Dana Moss’s addition allows Navidea to level-up expertise in several important areas within the Board," said Dr. Jason Myers, Owner and Founder of G2G Ventures. "She is a demonstrated expert and professional in the truest sense, with a career that includes strategy, finance, mergers and acquisitions, governance, litigation, and risk mitigation. Dana understands where we are and where we are heading, and has the skills and experience to guide Navidea’s technology and assets to the forefront."
Dana J Moss previously served as the Chief Legal Officer and Corporate Secretary at Sequencing Health, Inc., where she was responsible for all legal, regulatory, compliance, and intellectual property matters, led strategy related to fundraising, mergers and acquisitions, and oversaw finance, corporate governance and human resources functions. Her previous experience includes serving as General Counsel, Corporate Secretary at Genapsys, Inc., as a Partner at Cooley LLP with a focus on Commercial Litigation, Program Manager at Mantech International Corporation, and as a Special Agent and Operations Officer of the U.S. Air Force Office of Special Investigations. Ms. Moss earned a Bachelor of Science at the United Air Force Academy, where she was a distinguished graduate, a Master of Arts in Philosophy at the University of Texas at Austin as a USAFA Graduate School Scholarship recipient, and a Juris Doctorate at the University of Maryland Francis King Carey School of Law, where she graduated cum laude. Dana is a 2021 Fellow of the Leadership Council on Legal Diversity and has served on the organizing Board of MissionLink, a nonprofit membership organization for C-level executives of high growth technology companies.
Separately, Amit Bhalla has decided to step down from the Board to focus on other business interests.
"We thank Amit Bhalla for his many contributions during his time with the Board," said John K. Scott, Jr, Navidea’s Vice Chair of the Board. "Amit’s strategic guidance and expertise within the emerging medical technology space have helped us press our business forward, and we wish him the very best as we continue developing processes and growth strategies led by Navidea’s team of experts and our experienced partners in G2G Ventures."
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, visit https://www.navidea.com.
About G2G Ventures
G2G Ventures is a Colorado-based private equity firm focused on empowering organizations to reach their full potential through investment and consulting services. Specializing in creating long-term partnerships with trusted investors and established businesses, G2G Ventures draws on strong internal balance sheet liquidity, augmented by trusted investor capital, to craft bespoke capital solutions which include private equity investment, venture capital participation, and mezzanine debt options. Beyond financial investment, G2G Ventures provides accretive consulting services to help clarify strategic goals and key performance indicators (KPIs), evolve financial processes, and enhance operational effectiveness. To learn more about how G2G Ventures is a growth partner for enduring business, connect with our team.
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/20230713154771/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures - Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NEWS -- Tokens.com Developing Mobile Web3 Game
TORONTO, July 13, 2023--(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 builds web3 businesses and owns an inventory of digital assets, is pleased to announce that its subsidiary, Hulk Labs ("Hulk") is in the advanced development phase of creating a proprietary mobile phone-based web3 video game titled Astraeus Defense (https://astraeusdefense.com/).
According to the Federal Trade Commission - Gaming is the largest sector of the entertainment industry with an estimated 3.2 billion gamers globally (2). Surpassing the combined revenues of the Music and Film industries, gaming generates a sum exceeding $170 billion annually (1). Citi GPS’ estimates the number of web3 wallets to surge from one million in 2022 to between 50 million - 100 million by 2025 (2).
Mobile games offer a larger addressable global player base, outnumbering PC and console players. The Hulk team has identified this burgeoning opportunity in the video game industry and is positioning itself to be ahead of this shift as gamers move from web2 consoles and PCs to mobile play-to-earn web3 video games.
Astraeus Defense is a competitive multiplayer sci-fi combat game that allows players to take on the role of one of eight unique extra-terrestrial species. Targeted at the Zalpha Generation (a combination of generation Alpha and Z), Astraeus Defense will be a mobile first game, with innovative web3 economic mechanics developed by Hulk Labs. Astraeus Defense leverages the most popular mechanisms from successful web2 and web3 minigames, which it pairs with a custom tokenomics system, bringing a novel experience to web3 gaming.
In creating the game, Hulk has employed AI technology to develop the concept and establish some of the 2D game art. The team has also employed an AI assistive tool to enhance efficiency of certain aspects of the game's 3D animation process.
Under new leadership, Hulk Labs is utilizing its in-house expertise to launch games for brands and further develop its product offerings. The studio will focus on creating proprietary and branded mobile games targeted at the Zalpha Generation.
"We have strategically evolved our approach at Hulk Labs by ramping up the development of our game studio. As part of this, we are excited for the launch of our game specifically targeted at play-to-earn, mobile users. Gaming is a massive market undergoing a shift. We have repositioned Hulk to service this growing opportunity," says Andrew Kiguel, CEO of Tokens.com. "Hulk Labs boasts an exceptional team of highly skilled developers and tokenomics experts, which allows us to build out our own product lines and gives us the capabilities to service branded games for brands and businesses exploring web3 gaming."
Additionally, Hulk Labs has expanded its team and has hired additional staff to support game development, product development, and core game analytics. The expanded team enables Hulk to deliver on client brand projects and further the development of its data product.
Astraeus Defense will be initially beta tested for use in 2023 and is scheduled for full release in Q1 of 2024. For more information on Astraeus Defense visit the website at https://astraeusdefense.com/ or learn more from the whitepaper at https://astraeuswhitepaper.info/. For additional updates and to stay connected follow us on twitter at https://twitter.com/AstraeusDefense and discord https://discord.com/invite/zSsJRkBKM3.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and owns an inventory of digital assets. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) web3 gaming. The Company also owns a portfolio of web3 related domain names.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Web3 gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
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 Hulk Labs
Hulk Labs (Or "Hulk"), is a web3 gaming studio, with a focus on 3 key areas: i) Web3 game economics and branded games for clients. ii) Data analytics via the creation of a web3 gaming dashboard for players. iii) The creation of unique mobile games. With an estimated 3.2 billion gamers globally, and growing daily, Hulk Labs is positioned itself to be ahead of the shift in gaming as gamers move from web2 consoles and PCs to mobile play-to-earn web3 video games. Additionally, Hulk offers expert consultation services in web3 gaming to brands seeking to tap into this exciting space. Hulk Labs is a subsidiary of Tokens.com, a publicly- traded company that builds web3 businesses. Hulk Labs operates at the forefront of the web3 gaming revolution.
Stay up to date and connect with us on Twitter.
For further information please visit https://hulklabs.com.
Forward-Looking Statements
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 in this news release include statements relating to completion of the acquisition and closing date thereof and the benefits to be realized from the transaction, including the potential synergies between Metaverse Group and Tokens.com (including Hulk Labs, the gaming unit of Tokens.com). 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.
Sources:
Microsoft Activision Administrative Complaint: https://www.ftc.gov/system/files/ftc_gov/pdf/D09412MicrosoftActivisionAdministrativeComplaintPublicVersionFinal.pdf
MONEY TOKENS AND GAMES, Citi GPS: https://www.citifirst.com.hk/home/upload/citi_research/rsch_pdf_30143792.pdf
View source version on businesswire.com: https://www.businesswire.com/news/home/20230713130405/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
+1-647-578-7490
mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
mailto://contact@tokens.com
Media: Ali Clarke – Talk Shop Media
mailto://ali@talkshopmedia.com
NEWS -- Tokens.com Developing Mobile Web3 Game
TORONTO, July 13, 2023--(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 builds web3 businesses and owns an inventory of digital assets, is pleased to announce that its subsidiary, Hulk Labs ("Hulk") is in the advanced development phase of creating a proprietary mobile phone-based web3 video game titled Astraeus Defense (https://astraeusdefense.com/).
According to the Federal Trade Commission - Gaming is the largest sector of the entertainment industry with an estimated 3.2 billion gamers globally (2). Surpassing the combined revenues of the Music and Film industries, gaming generates a sum exceeding $170 billion annually (1). Citi GPS’ estimates the number of web3 wallets to surge from one million in 2022 to between 50 million - 100 million by 2025 (2).
Mobile games offer a larger addressable global player base, outnumbering PC and console players. The Hulk team has identified this burgeoning opportunity in the video game industry and is positioning itself to be ahead of this shift as gamers move from web2 consoles and PCs to mobile play-to-earn web3 video games.
Astraeus Defense is a competitive multiplayer sci-fi combat game that allows players to take on the role of one of eight unique extra-terrestrial species. Targeted at the Zalpha Generation (a combination of generation Alpha and Z), Astraeus Defense will be a mobile first game, with innovative web3 economic mechanics developed by Hulk Labs. Astraeus Defense leverages the most popular mechanisms from successful web2 and web3 minigames, which it pairs with a custom tokenomics system, bringing a novel experience to web3 gaming.
In creating the game, Hulk has employed AI technology to develop the concept and establish some of the 2D game art. The team has also employed an AI assistive tool to enhance efficiency of certain aspects of the game's 3D animation process.
Under new leadership, Hulk Labs is utilizing its in-house expertise to launch games for brands and further develop its product offerings. The studio will focus on creating proprietary and branded mobile games targeted at the Zalpha Generation.
"We have strategically evolved our approach at Hulk Labs by ramping up the development of our game studio. As part of this, we are excited for the launch of our game specifically targeted at play-to-earn, mobile users. Gaming is a massive market undergoing a shift. We have repositioned Hulk to service this growing opportunity," says Andrew Kiguel, CEO of Tokens.com. "Hulk Labs boasts an exceptional team of highly skilled developers and tokenomics experts, which allows us to build out our own product lines and gives us the capabilities to service branded games for brands and businesses exploring web3 gaming."
Additionally, Hulk Labs has expanded its team and has hired additional staff to support game development, product development, and core game analytics. The expanded team enables Hulk to deliver on client brand projects and further the development of its data product.
Astraeus Defense will be initially beta tested for use in 2023 and is scheduled for full release in Q1 of 2024. For more information on Astraeus Defense visit the website at https://astraeusdefense.com/ or learn more from the whitepaper at https://astraeuswhitepaper.info/. For additional updates and to stay connected follow us on twitter at https://twitter.com/AstraeusDefense and discord https://discord.com/invite/zSsJRkBKM3.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and owns an inventory of digital assets. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) web3 gaming. The Company also owns a portfolio of web3 related domain names.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Web3 gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
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 Hulk Labs
Hulk Labs (Or "Hulk"), is a web3 gaming studio, with a focus on 3 key areas: i) Web3 game economics and branded games for clients. ii) Data analytics via the creation of a web3 gaming dashboard for players. iii) The creation of unique mobile games. With an estimated 3.2 billion gamers globally, and growing daily, Hulk Labs is positioned itself to be ahead of the shift in gaming as gamers move from web2 consoles and PCs to mobile play-to-earn web3 video games. Additionally, Hulk offers expert consultation services in web3 gaming to brands seeking to tap into this exciting space. Hulk Labs is a subsidiary of Tokens.com, a publicly- traded company that builds web3 businesses. Hulk Labs operates at the forefront of the web3 gaming revolution.
Stay up to date and connect with us on Twitter.
For further information please visit https://hulklabs.com.
Forward-Looking Statements
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 in this news release include statements relating to completion of the acquisition and closing date thereof and the benefits to be realized from the transaction, including the potential synergies between Metaverse Group and Tokens.com (including Hulk Labs, the gaming unit of Tokens.com). 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.
Sources:
Microsoft Activision Administrative Complaint: https://www.ftc.gov/system/files/ftc_gov/pdf/D09412MicrosoftActivisionAdministrativeComplaintPublicVersionFinal.pdf
MONEY TOKENS AND GAMES, Citi GPS: https://www.citifirst.com.hk/home/upload/citi_research/rsch_pdf_30143792.pdf
View source version on businesswire.com: https://www.businesswire.com/news/home/20230713130405/en/
Contacts
Tokens.com Corp.
Andrew Kiguel, CEO
+1-647-578-7490
mailto://contact@tokens.com
Jennifer Karkula, Head of Communications
mailto://contact@tokens.com
Media: Ali Clarke – Talk Shop Media
mailto://ali@talkshopmedia.com
NEWS -- Plus Therapeutics to Present at the 2nd Annual Targeted Radiopharmaceuticals Summit
AUSTIN, Texas, July 13, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that Marc Hedrick, M.D., President and Chief Executive Officer, will give two presentations at the Targeted Radiopharmaceuticals Summit taking place July 25-27, 2023 in Boston, Massachusetts.
The presentations will describe data from the ReSPECT-GBM clinical study evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma (rGBM), as well as provide an overview of the Company’s scientific approach, current pipeline and a snapshot of where it is headed.
Details of presentations:
Title
Re-186 Radiolabelled NanoLiposomes for Rare Brain & Spinal Cord Tumors
Date
July 26, 2023, 9:30 a.m. ET
Session
Targeted Radiopharmaceuticals in the US: The Past, the Present & the Future
Title
Novel Approaches to Central Nervous System Targeted Radiotherapeutics
Date
July 26, 2023, 2:30 p.m. ET
Session
Addressing TRP Toxicity: Chelators, Clearance & Drug Design
A copy of the presentations will be made available under the Presentations tab of the Investors section of the Company’s website following the meeting at https://ir.plustherapeutics.com/.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.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 186Re including the ability of 186Re 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-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; 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 cancer diagnostics and therapeutics 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
Tokens.com Announces Results of 2023 Annual Meeting
TORONTO--(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 builds web3 businesses and owns an inventory of digital assets, is pleased to announce that all resolutions considered by the shareholders of Tokens.com Corp. at the Annual General and Special Meeting of Shareholders (the “Meeting”) held virtually by teleconference on July 11, 2023 were passed.
Voting as to each of the director nominees were as follows:
Please see the report of voting results filed under Tokens.com Corp’s profile at www.sedar.com for the detailed results of all matters voted upon by shareholders at the Meeting.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and owns an inventory of digital assets. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) web3 gaming. The Company also owns a portfolio of web3 related domain names.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Web3 gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, Facebook, Instagram and YouTube.
Forward-Looking Statements
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 in this news release include statements relating to completion of the acquisition and closing date thereof and the benefits to be realized from the transaction, including the potential synergies between Metaverse Group and Tokens.com (including Hulk Labs, the gaming unit of Tokens.com). 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.
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 Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
Tokens.com Announces Results of 2023 Annual Meeting
TORONTO--(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 builds web3 businesses and owns an inventory of digital assets, is pleased to announce that all resolutions considered by the shareholders of Tokens.com Corp. at the Annual General and Special Meeting of Shareholders (the “Meeting”) held virtually by teleconference on July 11, 2023 were passed.
Voting as to each of the director nominees were as follows:
Please see the report of voting results filed under Tokens.com Corp’s profile at www.sedar.com for the detailed results of all matters voted upon by shareholders at the Meeting.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and owns an inventory of digital assets. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) web3 gaming. The Company also owns a portfolio of web3 related domain names.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Web3 gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, Facebook, Instagram and YouTube.
Forward-Looking Statements
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 in this news release include statements relating to completion of the acquisition and closing date thereof and the benefits to be realized from the transaction, including the potential synergies between Metaverse Group and Tokens.com (including Hulk Labs, the gaming unit of Tokens.com). 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.
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 Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Navidea Biopharmaceuticals, Inc. Rejects Unsolicited Offer To Acquire Certain Assets
Following the Company’s Fix, Fund, Propel approach, the proposal substantially undervalues Navidea and is not in the best interests of stockholders.
DUBLIN, Ohio, June 30, 2023--(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 Company’s Board of Directors, in consultation with G2G Ventures as Executive Consultants, has unanimously rejected an unsolicited, non-binding offer from ProPhase Labs to acquire certain assets from the Company on the terms disclosed in their press release on June 29, 2023.
"After careful review and consideration of ProPhase Labs’ unsolicited proposal, our Board determined that the proposal substantially undervalues Navidea’s assets, is opportunistic, and is not in the best interest of our stockholders," said Josh Wilson, Navidea’s Director. "While we certainly understand and are appreciative of the interest in Navidea’s unique technologies, the Board is confident that the Company’s stated objectives and its Fix, Fund, Propel approach to advancing our innovations to market will generate far superior long-term value for stockholders."
The Company, with G2G Ventures as Executive Consultants, recently announced the receipt of $7.5 million cash from Cardinal Health in lieu of a contingent milestone payment, and provided additional insight on its recent performance in line with its Fix, Fund, Propel approach.
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, visit https://www.navidea.com.
About G2G Ventures
G2G Ventures is a Colorado-based private equity firm focused on empowering organizations to reach their full potential through investment and consulting services. Specializing in creating long-term partnerships with trusted investors and established businesses, G2G Ventures draws on strong internal balance sheet liquidity, augmented by trusted investor capital, to craft bespoke capital solutions which include private equity investment, venture capital participation, and mezzanine debt options. Beyond financial investment, G2G Ventures provides accretive consulting services to help clarify strategic goals and key performance indicators (KPIs), evolve financial processes, and enhance operational effectiveness. To learn more about how G2G Ventures is a growth partner for enduring business, connect with our team.
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; 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/20230630207937/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures - Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NEWS -- Tokens.com Acquires Startup Slang Team and Its Ecommerce IP
TORONTO, June 29, 2023--(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 builds web3 businesses and owns an inventory of digital assets, is pleased to announce that the team behind Startup Slang has joined its subsidiary, Metaverse Group. Metaverse Group will also have exclusive access to the "Shoppable" metaverse technology developed by Startup Slang that links in-game purchase transactions to Shopify Plus storefronts.
Startup Slang was the first to connect a mobile game to a Shopify Plus store. This technology is the first of its kind and can be seen in the popular interior home decor game called "Design Home". Design Home is a mobile game that has been downloaded over 100 million times in the Apple and Android app stores. The game allows players to decorate interior design spaces with pieces that can be purchased directly from popular interior decor brands in the physical world. This new technology further bridges the gap between the physical and virtual world using middleware solutions and creates a seamless shopping experience.
This technology allows Metaverse Group to build customizable gamified experiences for brands looking to reach new audiences and sell their product in an immersive and seamless way. As leaders in web3 development, Metaverse Group’s services position brands to make an easy shift from two-dimensional to three-dimensional marketing.
"We know that three dimensional marketing is the way of the future, this is evident with all the money tech giants like Apple are spending in creating wearable headsets," said Andrew Kiguel, CEO of Tokens.com. "It has been challenging finding the right solutions to connect products in digital experiences to ecommerce but by acquiring the Startup Slang team and their IP, this gives Metaverse Group an added advantage to further enhance gamified shopping experiences."
"By joining our Shoppable metaverse technology with Tokens.com and Metaverse Group, we plan to scale these types of deployments and allow brands to add an additional ecommerce source of revenue to their businesses through the metaverse. This will be a pivotal move towards the public's mass adoption of the metaverse," said Damiano Raveenthiran, founder and former CEO of Startup Slang.
Brands and businesses interested in learning more about new ecommerce offerings can contact mailto://info@metaversegroup.com.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and owns an inventory of digital assets. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) web3 gaming. The Company also owns a portfolio of web3 related domain names.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Web3 gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, Facebook, Instagram and YouTube.
About Metaverse Group
Metaverse Group is a web3 technology company with products and services that bring businesses to life in web3 environments, including metaverses, NFTs and the next iteration of retail, ecomm3. We integrate web3 technology solutions with a web3 marketing agency and virtual real estate development services so that our clients can own ecomm3, engage new audiences, and be first movers. The company also holds a vast metaverse real estate portfolio spanning over 10+ metaverses.
Our expansive ownership of virtual land and relationships with different metaverses allow us to deliver category leading solutions that have been recognized by CNBC, CNN, Forbes, the Economist, and the Wall Street Journal. Tokens.com, a publicly- traded company, is the majority owner of Metaverse Group.
For further information please visit https://metaversegroup.com.
Forward-Looking Statements
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 in this news release include statements relating to completion of the acquisition and closing date thereof and the benefits to be realized from the transaction, including the potential synergies between Metaverse Group and Tokens.com (including Hulk Labs, the gaming unit of Tokens.com). 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/20230629483379/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 Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Tokens.com Acquires Startup Slang Team and Its Ecommerce IP
TORONTO, June 29, 2023--(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 builds web3 businesses and owns an inventory of digital assets, is pleased to announce that the team behind Startup Slang has joined its subsidiary, Metaverse Group. Metaverse Group will also have exclusive access to the "Shoppable" metaverse technology developed by Startup Slang that links in-game purchase transactions to Shopify Plus storefronts.
Startup Slang was the first to connect a mobile game to a Shopify Plus store. This technology is the first of its kind and can be seen in the popular interior home decor game called "Design Home". Design Home is a mobile game that has been downloaded over 100 million times in the Apple and Android app stores. The game allows players to decorate interior design spaces with pieces that can be purchased directly from popular interior decor brands in the physical world. This new technology further bridges the gap between the physical and virtual world using middleware solutions and creates a seamless shopping experience.
This technology allows Metaverse Group to build customizable gamified experiences for brands looking to reach new audiences and sell their product in an immersive and seamless way. As leaders in web3 development, Metaverse Group’s services position brands to make an easy shift from two-dimensional to three-dimensional marketing.
"We know that three dimensional marketing is the way of the future, this is evident with all the money tech giants like Apple are spending in creating wearable headsets," said Andrew Kiguel, CEO of Tokens.com. "It has been challenging finding the right solutions to connect products in digital experiences to ecommerce but by acquiring the Startup Slang team and their IP, this gives Metaverse Group an added advantage to further enhance gamified shopping experiences."
"By joining our Shoppable metaverse technology with Tokens.com and Metaverse Group, we plan to scale these types of deployments and allow brands to add an additional ecommerce source of revenue to their businesses through the metaverse. This will be a pivotal move towards the public's mass adoption of the metaverse," said Damiano Raveenthiran, founder and former CEO of Startup Slang.
Brands and businesses interested in learning more about new ecommerce offerings can contact mailto://info@metaversegroup.com.
About Tokens.com
Tokens.com Corp is a publicly traded company that invests in web3 assets and owns an inventory of digital assets. The Company focuses on three operating segments: i) crypto staking, ii) the metaverse and, iii) web3 gaming. The Company also owns a portfolio of web3 related domain names.
Staking operations occur within Tokens.com. Metaverse operations occur within a subsidiary called Metaverse Group. Web3 gaming operations occur within a subsidiary called Hulk Labs. All three businesses are tied together by the utilization of blockchain technology and are linked to high-growth macro trends within web3. Through sharing resources and infrastructure across these business segments, Tokens.com is able to efficiently incubate these businesses from inception to revenue generation.
Visit https://Tokens.com to learn more.
Keep up-to-date on Tokens.com developments and join our online communities on Twitter, LinkedIn, Facebook, Instagram and YouTube.
About Metaverse Group
Metaverse Group is a web3 technology company with products and services that bring businesses to life in web3 environments, including metaverses, NFTs and the next iteration of retail, ecomm3. We integrate web3 technology solutions with a web3 marketing agency and virtual real estate development services so that our clients can own ecomm3, engage new audiences, and be first movers. The company also holds a vast metaverse real estate portfolio spanning over 10+ metaverses.
Our expansive ownership of virtual land and relationships with different metaverses allow us to deliver category leading solutions that have been recognized by CNBC, CNN, Forbes, the Economist, and the Wall Street Journal. Tokens.com, a publicly- traded company, is the majority owner of Metaverse Group.
For further information please visit https://metaversegroup.com.
Forward-Looking Statements
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 in this news release include statements relating to completion of the acquisition and closing date thereof and the benefits to be realized from the transaction, including the potential synergies between Metaverse Group and Tokens.com (including Hulk Labs, the gaming unit of Tokens.com). 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/20230629483379/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 Contact: Ali Clarke – Talk Shop Media
Email: mailto://ali@talkshopmedia.com
NEWS -- Plus Therapeutics Reports Positive Interim Updates from Two ReSPECT™ Clinical Trials at SNMMI Annual Meeting
Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today reported positive interim updates from the ReSPECT-GBM and ReSPECT-LM clinical studies evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma (rGBM) and leptomeningeal metastases (LM) at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting, which took place June 24-27, 2023 in Chicago, Illinois.
An oral presentation titled, Safety and Feasibility Results from a Phase 1/2 Clinical Trial of 186RNL (Rhenium-186 Nanoliposome) (186Re) Obisbemeda in Recurrent Glioma: The ReSPECT-GBM Trial [P988], brief highlights include:
NEWS -- Provectus Biopharmaceuticals Establishes Research Collaboration with University of Tennessee College of Veterinary Medicine to Investigate Pharmaceutical-Grade Small Molecule Immunotherapy Rose Bengal Sodium for Canine Soft Tissue Sarcomas
KNOXVILLE, TN, June 28, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that the Company has initiated a new sponsored research program with the University of Tennessee College of Veterinary Medicine (UTCVM) to assess the safety and preliminary efficacy of intralesional injection of a formulation of Provectus’s pharmaceutical-grade RBS for canine soft tissue sarcomas. UTCVM’s lead principal investigator of this work is clinical pathologist, comparative cancer biologist, and Assistant Professor Nora Springer, DVM, PhD, DACVP.
This preclinical and clinical veterinary study is being undertaken as part of the State of Tennessee’s funding to develop animal health drug products in partnership with state universities that have agriculture and veterinary medicine programs and the Company.
Soft tissue sarcomas are common malignant neoplasms in dogs that are locally invasive and have a high prevalence of recurrence after surgical excision. These tumors are often located on the extremities, where complete surgical excision is challenging because minimal soft tissues hinder the ability to gain adequate tumor margins while maintaining the ability to close the surgical wound. Adjuvant chemotherapeutic protocols do not improve either time to recurrence or overall survival with incompletely excised soft tissue sarcomas. Radical measures, such as limb amputation, are often required to ensure complete excision for limb sarcomas and this option is frequently unpalatable to patient owners. Therefore, intralesional injection resulting in tumor ablation may be an ideal treatment modality for soft tissue sarcomas.
Dr. Springer graduated from Marietta College with a Bachelor of Science in Chemistry, LaGuardia Community College with an Associate in Applied Science in Veterinary Technology, Kansas State University with a Doctor of Veterinary Medicine (DVM), and Cornell University with a Doctor of Philosophy (PhD) in Translational Medicine. She completed the American College of Veterinary Pathologists (ACVP) certifying examination to become a Diplomate Member (DACVP), and has co-authored a number of medical journal publications to date.
Dominic Rodrigues, Vice Chairman of Provectus’s Board said, “We are excited to commence this canine cancer study with the University of Tennessee College of Veterinary Medicine and Dr. Nora Springer to accelerate our animal health drug development program. We believe that the Company’s adult cancer clinical and pediatric preclinical data to date can meaningfully contribute to Dr. Springer’s canine cancer work, and vice versa because spontaneous cancers in dogs share many features with human cancers.”
About Provectus
Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases that are based on a class of synthetic small molecule immuno-catalysts called halogenated xanthenes (HXs). Provectus’s lead HX molecule is named rose bengal sodium (RBS).
The Company’s proprietary, patented, pharmaceutical-grade RBS is the active pharmaceutical ingredient (API) in the drug product candidates of Provectus’s clinical development programs and preclinical formulations of the Company’s drug discovery programs. Provectus’s pharmaceutical-grade RBS displays different therapeutic effects at different concentrations and can be formulated for delivery by different routes of administration. The International Nonproprietary Names Expert Committee of the World Health Organization selected “rose bengal sodium” for the nonproprietary name of the Company’s API.
RBS may target disease in a bifunctional manner. Direct contact may lead to cell death or repair depending on the disease being treated and the concentration of Provectus’s RBS utilized in the treatment. Multivariate immune signaling, activation, and response may follow that may manifest as stimulatory, inhibitory, or both.
The Company believes that it is the first entity to advance an RBS formulation into clinical trials for the treatment of a disease. Provectus believes that it is the first and only entity to date to successfully, reproducibly, and consistently make pharmaceutical-grade RBS at a purity of nearly 100%.
Provectus’s small molecule HX medical science platform includes clinical development programs in oncology, dermatology, and ophthalmology; proof-of-concept in vivo drug discovery programs in oncology, hematology, wound healing, and animal health; and preclinical in vitro drug discovery programs in infectious diseases and tissue regeneration and repair.
Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, https://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 Securities and Exchange Commission (SEC), including those described in Item 1A of:
#####
Contact:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999
NEWS -- Provectus Biopharmaceuticals Announces Stockholder Approval to Undertake Reverse Split of Outstanding Equities and Reduce Number of Authorized Equities by Same Ratio
KNOXVILLE, TN, June 26, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that the Company’s shareholders have approved the proposals of Provectus’s Board of Directors (Board) to seek the authority to undertake a reverse stock split and an authorized share reduction.
At the Company’s Annual Meeting of Stockholders held in Knoxville, Tennessee on June 21, 2023, shareholders also approved the Board’s recommendations of four other proposals: the election of directors, an advisory vote on the approval of the compensation of Provectus’s named executive officers, an advisory vote on the frequency of the aforementioned advisory vote on compensation, and the ratification of the Company’s independent registered public accounting firm.
Ed Pershing, Chairman of Provectus’s Board said, “I want to express my sincere appreciation and the sincere appreciation of our directors, officers, employees, and staff to all of our stockholders for your active participation in the voting process as well as your support of our business direction and management, as evidenced by these favorable voting results. Your continued interest in and support of Provectus is welcomed and greatly appreciated.”
Mr. Pershing added, “The Company’s Board understands its responsibility to evaluate and determine whether and when a reverse stock split of Provectus’s outstanding equities and reduction of authorized shares are in the best interests of the Company and our stockholders.”
A copy of Provectus’s Form 8-K filed on June 22, 2023, which provided details of shareholder voting on the Board’s six proposals and included a brief description of and the vote tabulation for each proposal, may be found here:
https://www.sec.gov/ix?doc=/Archives/edgar/data/315545/000149315223022116/form8-k.htm.
Proposal #1 (election of directors) passed with [an average of] 44% FOR of shares outstanding and 96% FOR of shares voted.
Proposal #2 (advisory vote on compensation) passed with 43% FOR of shares outstanding and 94% FOR of shares voted.
Proposal #3 (one-year frequency of advisory vote on compensation) passed with 43% FOR of shares outstanding and 94% FOR of shares voted.
Proposal #4 (independent accounting firm) passed with 67% FOR of shares outstanding and 99% FOR of shares voted.
Proposal #5 (reverse stock split) passed with 61% FOR of shares outstanding and 90% FOR of shares voted.
Proposal #6 (authorized share reduction) passed with 61% FOR of shares outstanding and 91% FOR of shares voted.
About Provectus
Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases that are based on a class of synthetic small molecule immuno-catalysts called halogenated xanthenes (HXs). Provectus’s lead HX molecule is named rose bengal sodium (RBS).
The Company’s proprietary, patented, pharmaceutical-grade RBS is the active pharmaceutical ingredient (API) in the drug product candidates of Provectus’s clinical development programs and preclinical formulations of the Company’s drug discovery programs. Provectus’s pharmaceutical-grade RBS displays different therapeutic effects at different concentrations and can be formulated for delivery by different routes of administration. The International Nonproprietary Names Expert Committee of the World Health Organization selected “rose bengal sodium” for the nonproprietary name of the Company’s API.
RBS may target disease in a bifunctional manner. Direct contact may lead to cell death or repair depending on the disease being treated and the concentration of Provectus’s RBS utilized in the treatment. Multivariate immune signaling, activation, and response may follow that may manifest as stimulatory, inhibitory, or both.
The Company believes that it is the first entity to advance an RBS formulation into clinical trials for the treatment of a disease. Provectus believes that it is the first and only entity to date to successfully, reproducibly, and consistently make pharmaceutical-grade RBS at a purity of nearly 100%.
Provectus’s small molecule HX medical science platform includes clinical development programs in oncology, dermatology, and ophthalmology; in vivo proof-of-concept programs in oncology, hematology, wound healing, and animal health; and in vitro programs in infectious diseases and tissue regeneration and repair.
Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, https://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 Securities and Exchange Commission (SEC), including those described in Item 1A of:
#####
Contact:
Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999
NEWS -- Oncolytics Biotech's® Pelareorep Selected for Inclusion in Precision PromiseSM Pivotal Phase 3 Platform Trial
Adaptive clinical trial designed to accelerate registration pathways for pancreatic cancer therapies and expected to reduce cost of a Phase 3 study for pelareorep by ~50% compared to a traditional trial
If successful, new clinical study expected to support approval of pelareorep in combination with a checkpoint inhibitor, gemcitabine, and nab-paclitaxel in first-line metastatic pancreatic cancer
Data presented at SITC 2022 showed a near tripling of overall response rate for pelareorep + gemcitabine + nab-paclitaxel + a PD-L1 inhibitor compared to historical control trials
SAN DIEGO, CA and CALGARY, AB, June 22, 2023 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced pelareorep has been selected for inclusion as a new investigational treatment in Precision PromiseSM, an innovative adaptive Phase 3 clinical trial. The Precision Promise study is designed to evaluate pelareorep in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nab-paclitaxel. If successful, the clinical study is expected to support approval of the studied combination as a treatment for first-line metastatic pancreatic ductal adenocarcinoma (PDAC).
Precision Promise has a primary endpoint of overall survival and can include multiple investigational treatments as well as control arms evaluating: (1) gemcitabine plus nab-paclitaxel or (2) mFOLFIRINOX. Each investigational therapy is subject to pre-specified interim analyses prior to proceeding to the registrational portion of the trial. This design, which was developed with guidance from the U.S. Food and Drug Administration, minimizes the number of participants needed to generate licensure-enabling data, thereby accelerating late-stage development by up to two years and reducing costs compared to non-platform trials.
"We are delighted at being selected by the Precision Promise panel of experts," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "Our next step is to engage with stakeholders to finalize the protocol for Precision Promise's pelareorep-containing investigational treatment so that we can enter into this study. We are thrilled to have the opportunity to leverage Precision Promise, which we expect will allow us to reduce the time and costs needed to reach a potential approval."
Julie Fleshman, JD, MBA, President and CEO of PanCAN commented, "With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options. This urgent unmet need was the driving inspiration behind the Precision Promise platform trial, which was designed specifically to identify, accelerate, and de-risk the development of promising pancreatic cancer treatments. We are thrilled to be bringing pelareorep into Precision Promise as a new investigational therapy to study against the current standard of care."
Dr. Thomas Heineman, Chief Medical Officer of Oncolytics Biotech, commented, "Prior trials in pancreatic cancer show pelareorep-based combinations outperforming historical controls on key metrics such as one and two-year survival and objective response rate. In addition, mechanistic data from these studies highlight how pelareorep's immunologic mechanism of action allows it to synergize with chemotherapy and checkpoint inhibition in this indication. I look forward to working with the Precision Promise team of investigators to seek to confirm the therapeutic value of pelareorep in a randomized setting so that we can potentially provide pancreatic cancer patients with a new treatment option."
Oncolytics expects to finalize the definitive agreements within the next 90 days and open the Precision Promise investigational treatment of pelareorep, checkpoint inhibitor, gemcitabine, and nab-paclitaxel in early 2024.
Pelareorep in Pancreatic Cancer
Pelareorep's inclusion in Precision Promise is supported by prior clinical data in pancreatic cancer that suggests it synergizes with checkpoint inhibition and chemotherapy. These prior data include phase 1/2 results showing a 69% objective response rate (ORR, n = 13) in a cohort of first-line advanced/metastatic PDAC patients treated with pelareorep combined with atezolizumab, gemcitabine, and nab-paclitaxel. This compares to an average ORR of ~25% reported in relevant historical control trials1-4. In addition, a phase 2 study of pelareorep plus gemcitabine that included 29 evaluable chemotherapy-naïve pancreatic cancer patients showed a median overall survival (mOS) of 10.2 months and a one-year survival rate of 45%, compared to historical control trials showing mOS of approximately 6.7 months and one-year survival rates of approximately 20 – 22%, respectively1,5-6. A subsequent phase 2 study of pelareorep plus checkpoint inhibition without chemotherapy in pancreatic cancer patients who progressed after first-line treatment showed a 42% disease control rate (n = 12), post-treatment increases in PD-L1+ cells, and a correlation between clinical response and increased activation of anti-cancer CD8+ T cells.
References
1. Von Hoff D et al. N Engl J Med 2013; 369:1691-1703 DOI: 10.1056/NEJMoa1304369
2. O'Reilly et al. Eur J Cancer. 2020 June; 132: 112–121. DOI:10.1016/j.ejca.2020.03.005
3. Karasic et al. JAMA Oncol. 2019 Jul 1; 5(7):993-998. DOI: 10.1001/jamaoncol.2019.0684
4. Tempero et al. Ann Oncol. 2021 May; 32(5):600-608. DOI: 10.1016/j.annonc.2021.01.070
5. Conroy et al. N Engl J Med 2011; 364:1817-1825. DOI: 10.1056/NEJMoa1011923
6. Goldstein et al. JNCI J Natl Cancer Inst (2015) 107(2): DOI:10.1093/jnci/dju413
About the Pancreatic Cancer Action Network
The Pancreatic Cancer Action Network (PanCAN) leads the way in accelerating critical progress for pancreatic cancer patients. PanCAN takes bold action by funding life-saving research, providing personalized patient services and creating a community of supporters and volunteers who will stop at nothing to create a world in which all pancreatic cancer patients will thrive. For 18 years in a row, PanCAN has earned a Four-Star Rating from Charity Navigator – the highest rating an organization can receive. This rating designates PanCAN as an official "Give with Confidence" charity, indicating strong financial health, ongoing accountability and transparency.
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 multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic 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; the design and anticipated benefits of the Precision Promise study, including our belief that the study, if successful, will support approval of the studied combination as a treatment for first-line metastatic pancreatic ductal adenocarcinoma; our plan to engage with stakeholders to finalize the protocol for Precision Promise's pelareorep-containing investigational treatment so that we can enter into the study; our expectation that we will be in a position to finalize the definitive agreements within the next 90 days and open the Precision Promise investigational treatment of pelareorep, checkpoint inhibitor, gemcitabine, and nab-paclitaxel in early 2024; our plans to advance towards a registrational study in metastatic pancreatic 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-biotechs-pelareorep-selected-for-inclusion-in-precision-promisesm-pivotal-phase-3-platform-trial-301857678.html
SOURCE Oncolytics Biotech® Inc.
View original content: http://www.newswire.ca/en/releases/archive/June2023/22/c8207.html
NEWS -- FuelPositive Announces Closing of First $3.5 Million Tranche of Private Placement and Debt Conversion
WATERLOO, Ontario, June 21, 2023 (GLOBE NEWSWIRE) -- FuelPositive Corporation (TSX.V: NHHH) (OTCQB:NHHHF) (the “Company”), a leading Green Ammonia company is pleased to announce that it has completed the first tranche of its $7,500,000 non-brokered private placement and has issued 53,870,699 units (each, a “Unit”), at a price of $0.065 per Unit, for gross proceeds of $3,501,595. Each Unit consists of one common share of the Company and one common share purchase warrant (each, a “Warrant”), allowing holders to purchase an additional common share at an exercise price of $0.09 until June 21, 2026. In the event the volume-weighted average closing price of the Company's common shares on the TSX Venture Exchange exceeds $0.40 for ten consecutive trading days, the Company retains the option to accelerate the expiry date of the Warrants to thirty days after a public announcement of the election.
“We are extremely pleased with closing the first $3,500,000 tranche of our active $7,500,000 financing,” says Ian Clifford, CEO and Board Chair of FuelPositive. “We are grateful to our existing shareholders for their ongoing support and welcome many new strategic investors who share FuelPositive’s values and goals. This is an important financial milestone that provides the necessary runway to reach several major milestones this year. We look forward to updating our shareholders on our progress over the coming months. Stay tuned as the coming months should be the most exciting in our Company’s history.”
The first tranche of the Offering was completed pursuant to the Listed Issuer Financing Exemption (the “LIFE Exemption”) as outlined in Part 5A of National Instrument 45-106 - Prospectus Exemptions (“NI 45-106”). As a result, the Units issued to subscribers in the first tranche of the Offering are not subject to resale restrictions in accordance with Canadian securities laws.
The Company intends to conduct a further tranche of the Offering to bring the total gross proceeds from the Offering up to $7,500,000. This additional tranche of the Offering is expected to be completed on or before June 30, 2023. It will be open to purchasers pursuant to the Accredited Investor Exemption outlined in Part 2 of NI 45-106, as well as to purchasers resident in Canada pursuant to the LIFE Exemption. An offering document related to the portion of the Offering conducted under the LIFE Exemption is accessible under the Company’s profile at www.sedar.com and on the Company’s website at: https://www.fuelpositive.com. Prospective investors should read this offering document before making an investment decision.
The securities issued in the Offering pursuant to the LIFE Exemption will not be subject to a hold period in accordance with Canadian securities laws. All other securities issued in the Offering will be subject to a statutory hold period of four-months-and-one-day following issuance.
In connection with the completion of the first tranche of the Offering, the Company paid $96,210 and issued 1,480,150 Warrants to certain arms-length third parties (the “Finders”) who assisted in introducing subscribers to the Offering. The Warrants issued to the Finders and any common shares of the Company issuable upon exercise of those Warrants are subject to restrictions on resale in accordance with Canadian securities laws until October 22, 2023. The Company anticipates paying finders’ fees to eligible third parties in connection with the completion of the additional tranche of the Offering. Closing of the additional tranche of the Offering remains subject to the approval of the TSX Venture Exchange.
Debt Settlement
The Company also announces that it has reached agreements with a certain arms-length creditors to the Company to settle (the “Settlements”) outstanding indebtedness totaling $1,436,248 through the issuance of 22,096,123 Units at a price of $0.065 per Unit. All Units issued in connection with the Settlement will be subject to restrictions on resale for a period of four-months-and-one-day following issuance in accordance with applicable securities laws. Completion of the Settlement remains subject to the approval of the TSX Venture Exchange.
“Preserving capital for operations and commercialization is a priority for the Company. The conversion of over $1 million of existing debt to shares is a beneficial mechanism to help preserve operating capital. We thank our various suppliers and lenders for participating in this conversion opportunity,” added Ian Clifford.
For enquiries related to investment in this Offering, please contact:
Ian Clifford
Chief Executive Officer and Board Chair
mailto://ian@fuelpositive.com
https://www.fuelpositive.com
Investor Relations United States & International:
RB Milestone Group (RBMG)
mailto://fuelpositive@rbmilestone.com
Investor Relations Canada:
Transcend Capital
mailto://et@transcendcapitalinc.com
About FuelPositive
FuelPositive is a Canadian technology company committed to providing commercially viable and sustainable, “cradle to cradle” clean technology solutions, including an on-farm/onsite, containerized Green Ammonia (NH3) production system that eliminates carbon emissions from the production of Green Ammonia.
By focusing on technologies that are clean, sustainable, economically advantageous and realizable, the Company aims to help mitigate climate change, addressing unsustainable agricultural practices through innovative technology and practical solutions that can be implemented now. The FuelPositive on-farm/onsite, containerized Green Ammonia production system is designed to produce pure, anhydrous ammonia for multiple applications, including fertilizer for farming, fuel for grain drying and internal combustion engines, a practical alternative for fuel cells and a solution for grid storage. Green Ammonia is also considered a key enabler of the hydrogen economy.
FuelPositive systems are designed to provide for Green Ammonia production on-farm/onsite, where and when needed. This eliminates wildly fluctuating supply chains and offers end-users clean fertilizer, energy and Green Ammonia supply security while eliminating carbon emissions from the production process. The first customers will be farmers. Farmers use 80% of the traditional grey ammonia produced today as fertilizer.
See pre-sale details here: https://fuelpositive.com/pre-sales/.
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) accept 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 of 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.
NEWS -- Navidea Biopharmaceuticals, Inc. Announces Distribution of Series K Preferred Stock to Holders of its Common Stock
DUBLIN, Ohio, June 16, 2023--(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 that its Board of Directors declared a dividend of one one-thousandth of a share of newly designated Series K Preferred Stock, par value $0.001 per share, for each outstanding share of the Company’s common stock held of record as of 5:00 p.m. Eastern Time on June 27, 2023. The shares of Series K Preferred Stock will be distributed to such recipients at 5:00 p.m. Eastern Time on June 27, 2023. The outstanding shares of Series K Preferred Stock will vote together with the outstanding shares of the Company’s common stock, as a single class, exclusively with respect to a reverse stock split and will not be entitled to vote on any other matter, except to the extent required under the Delaware General Corporation Law. Subject to certain limitations, each outstanding share of Series K Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per one one-thousandth of a share of Series K Preferred Stock).
All shares of Series K Preferred Stock that are not present in person or by proxy at the meeting of stockholders held to vote on the reverse stock split as of immediately prior to the opening of the polls at such meeting will automatically be redeemed by the Company. Any outstanding shares of Series K Preferred Stock that have not been so redeemed will be redeemed if such redemption is ordered by the Company’s Board of Directors or automatically upon the approval by the Company’s stockholders of an amendment to the Company’s certificate of incorporation effecting the reverse stock split at such meeting.
The Series K Preferred Stock will be uncertificated, and no shares of Series K Preferred Stock will be transferable by any holder thereof except in connection with a transfer by such holder of any shares of the Company’s common stock held by such holder. In that case, a number of one one-thousandths of a share of Series K Preferred Stock equal to the number of shares of the Company’s common stock to be transferred by such holder would be transferred to the transferee of such shares of common stock.
Further details regarding the Series K Preferred Stock will be contained in a report on Form 8-K to be filed by the Company with the Securities and Exchange Commission.
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, 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/20230616215293/en/
Contacts
Navidea Biopharmaceuticals, Inc.
G2G Ventures – Executive Consultant
Theodore Gerbick
mailto://tgerbick@g2g.ventures
NEWS -- Navidea Biopharmaceuticals, Inc. Receives $7.5 Million Cash from Cardinal Health in Lieu of Contingent Milestone Payment
Continuing the Company’s Fix, Fund, Propel approach, the cash payment from Cardinal Health aligns strategic goals while solidifying immediate capital for funding Phase IIb and Phase III trials.
DUBLIN, Ohio, June 16, 2023--(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 that on June 14, 2023 it entered into an amendment (the "Amendment") to the Asset Purchase Agreement, dated November 23, 2016 (the "Purchase Agreement"), between the Company and Cardinal Health 414, LLC ("Cardinal Health 414"), an affiliate of Cardinal Health, Inc. (NYSE: CAH). Under the terms of the Amendment, Cardinal Health 414 paid the Company $7.5 million in cash on June 14, 2023 and the Company waived its right to receive any contingent Milestone Payment that might otherwise become due and payable under the Purchase Agreement. The cash payment from Cardinal Health 414 provides immediate capital for the Company’s Phase IIb (NAV3-32) and Phase III (NAV3-33) trials and related operations. Building on a history of partnership between the Company and Cardinal Health, the Amendment also aligns and supports growth goals related to LYMPHOSEEK® for both organizations.
Prior to entering into the Amendment with Cardinal Health 414, the Company and Keystone Capital Partners ("Keystone") agreed to terminate the letter of intent between them which outlined the material terms of the Company’s proposed sale of the Milestone Payment to Keystone for $8 million. Supported by G2G Ventures as Executive Consultants, the Company determined that the Amendment with Cardinal Health 414 provided greater certainty of closing and accelerated funding without the inclusion of dilutive warrants. Keystone remains a trusted partner of the Company and is expected to continue to assist the Company in its future financing efforts. The powerful combination of accelerated funding, strategic partnership and continued capital access allows the Company to expand its clinical trial base while delivering shareholder value.
"The amendment with Cardinal Health and equity line from Keystone Partners offers immediate capital and continuing positive support for Navidea’s pioneering work," said Dr. Jason Myers, Owner and Founder of G2G Ventures. "This is a great example of how a focused approach can drive the business forward, surface opportunities, strengthen relationships, and create shareholder return."
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, visit https://www.navidea.com.
About Cardinal Health
Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. With more than 50 years in business, operations in more than 30 countries and approximately 46,500 employees globally, Cardinal Health is essential to care. Information about Cardinal Health is available at https://cardinalhealth.com.
About G2G Ventures
G2G Ventures is a Colorado-based private equity firm focused on empowering organizations to reach their full potential through investment and consulting services. Specializing in creating long-term partnerships with trusted investors and established businesses, G2G Ventures draws on strong internal balance sheet liquidity, augmented by trusted investor capital, to craft bespoke capital solutions which include private equity investment, venture capital participation, and mezzanine debt options. Beyond financial investment, G2G Ventures provides accretive consulting services to help clarify strategic goals and key performance indicators (KPIs), evolve financial processes, and enhance operational effectiveness. To learn more about how G2G Ventures is a growth partner for enduring business, connect with their team.
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/20230616130485/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures- Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures