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NEWS -- Provectus Biopharmaceuticals Launches VisiRose, Provectus’s Founded Entity for Pharmaceutical-grade Rose Bengal Sodium-based Treatments in Ophthalmology
KNOXVILLE, Tenn., Dec. 11, 2024 (GLOBE NEWSWIRE) -- Provectus Biopharmaceuticals, Inc. (“Provectus” or the “Company”) (OTCQB: PVCT) announced today the launch of VisiRose, Inc. (“VisiRose”), Provectus’s first Founded Entity. This new clinical-stage biotechnology company is focused on commercializing Rose Bengal Photodynamic Antimicrobial Therapy (“RB PDAT”) for the treatment of infectious keratitis and other serious eye infections using Provectus’s bioactive synthetic small molecule and active pharmaceutical ingredient (“API”) Rose Bengal Sodium (RBS). The University of Miami (the “University”) is a minority equity shareholder of VisiRose.
RB PDAT, a groundbreaking, non-invasive investigational treatment for eye infections, is based on innovative ocular research from the Ophthalmic Biophysics Center at Bascom Palmer Eye Institute (“BPEI”) of the University’s Miller School of Medicine. RB PDAT combines a formulation of Provectus’s pharmaceutical-grade RBS API and OBC’s light-based medical device to treat eye infections caused by bacteria, fungi, and parasites, including multidrug-resistant organisms.
Dominic Rodrigues, Acting Chief Executive Officer of VisiRose, who is also President and Vice Chairman of the Board of Directors of Provectus, said, “RB PDAT represents a consequential solution for patients at risk of vision loss from infectious keratitis. We believe this innovative therapy combines precise infection-fighting capabilities with vision-preserving benefits, paving the way for a brighter future for those struggling with this challenging condition.”
Ed Pershing, Chairman of the Boards of Directors of VisiRose and Provectus added, “VisiRose exemplifies Provectus’s forward-thinking business model, bridging innovation and impact. Spinning off this clinical-stage, ophthalmology-focused entity enhances our ability to address unmet medical needs while unlocking value for our stockholders. By focusing on a high-growth area like eye care, we are both advancing RB PDAT and maximizing the intrinsic value of RBS and, ultimately, Provectus’s market position.”
A copy of VisiRose’s press release from December 10, 2024 of its launch may be found here: https://www.accesswire.com/952319/visirose-introduces-revolutionary-therapy-for-severe-eye-infections.
VisiRose’s website is accessible here: https://visirose.com/.
About VisiRose
VisiRose is a newly launched clinical-stage biotechnology company of the University of Miami and Provectus Biopharmaceuticals, focused on commercializing the Miller School of Medicine’s Bascom Palmer Eye Institute and its Ophthalmic Biophysics Center’s innovative ocular research using Provectus’s bioactive synthetic small molecule Rose Bengal Sodium (“RBS”). For more information, please visit https://visirose.com.
About Bascom Palmer Eye Institute
Bascom Palmer Eye Institute serves as the Department of Ophthalmology for the University of Miami Miller School of Medicine. The mission of BPEI is to enhance the quality of life by improving sight, preventing blindness, and advancing ophthalmic knowledge through compassionate patient care and innovative research. For 2024-2025, U.S. News & World Report (“U.S. News”) ranked BPEI as the nation’s best in ophthalmology, marking the 23rd time and 21st consecutive year that BPEI has received the No. 1 ranking since U.S. News began surveying American physicians for its annual “Best Hospitals” rankings 35 years ago.
About Provectus
Provectus Biopharmaceuticals is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases that are based on a class of bioactive synthetic small molecules called halogenated xanthenes. The Company’s lead molecule is RBS. Provectus’s small molecule drug platform includes:
NEWS -- VisiRose Introduces Revolutionary Therapy for Severe Eye Infections
Collaboration between Bascom Palmer Eye Institute and Provectus Biopharmaceuticals
KNOXVILLE, TN / ACCESSWIRE / December 10, 2024 / VisiRose, a clinical-stage biotechnology company, is introducing Rose Bengal Photodynamic Antimicrobial Therapy (RB PDAT), a groundbreaking, non-invasive investigational treatment for infectious keratitis and other serious eye infections developed by the University of Miami Miller School of Medicine's Bascom Palmer Eye Institute (BPEI). VisiRose, a newly launched company of Provectus Biopharmaceuticals (OTCQB:PVCT) and the University, is focused on commercializing this innovative ocular research by combining a formulation of Provectus's pharmaceutical-grade bioactive synthetic small molecule Rose Bengal Sodium (RBS) and BPEI's light-based medical device to treat eye infections caused by bacteria, fungi, and parasites.
RB PDAT offers a potential solution to the growing global problem of antimicrobial resistance (AMR), providing a broad-spectrum ocular therapy that may be safe, effective, and cost-efficient. The treatment has shown rapid infection resolution and improved patient outcomes in clinical trials across the U.S., India, Brazil, and Mexico.
"RB PDAT is a revolutionary, non-invasive treatment showing remarkable promise for patients with severe infectious keratitis. This innovative therapy harnesses the power of light to combat infection and offers new hope for preserving vision," said Jean-Marie Parel, IngETS-G, Ph.D., FAIMBE, FARVO, Director and co-founder of the Ophthalmic Biophysics Center at BPEI.
Guillermo Amescua, M.D., Professor of Clinical Ophthalmology, Medical Director of the Ocular Microbiology Laboratory, and a board-certified ophthalmologist at BPEI added, "VisiRose is crucial for translating the innovation of RB PDAT from the laboratory to a widely accessible treatment, ultimately benefiting countless patients worldwide."
"VisiRose is the bridge that connects innovation with impact. It enables us to bring the hope of RB PDAT to patients who desperately need it, transforming lives and shaping the future of eye care," said Ed Pershing, Chairman of the Board of Directors of VisiRose and Provectus.
Dominic Rodrigues, Acting CEO of VisiRose added, "RB PDAT offers a beacon of hope for patients facing the threat of vision loss from infectious keratitis. This innovative therapy, with its targeted action and dual benefits, represents a significant advancement in eye care, paving the way for a brighter future for those struggling with this challenging condition."
In more than 500 patients, RB PDAT has shown promising results in treating severe eye infections where traditional therapies have failed. VisiRose is poised to address a significant gap in the $60 billion global ophthalmic market, focusing on regions and populations impacted by rising AMR and the lack of access to effective treatments.
About VisiRose
VisiRose is a newly launched, clinical-stage biotechnology company of the University of Miami and Provectus Biopharmaceuticals, focused on commercializing the Miller School of Medicine's Bascom Palmer Eye Institute and its Ophthalmic Biophysics Center's innovative ocular research using Provectus's bioactive synthetic small molecule Rose Bengal Sodium (RBS). For more information, please visit: https://visirose.com.
About Bascom Palmer Eye Institute
The Bascom Palmer Eye Institute, part of the University of Miami Health System, is consistently ranked #1 in ophthalmology in the U.S. by U.S. News & World Report. Known for its cutting-edge research and clinical excellence, Bascom Palmer provides world-class care across all ophthalmic subspecialties and is at the forefront of developing innovative treatments for eye diseases. With a commitment to advancing both patient care and medical research, it is recognized globally as a leader in ophthalmology. For more information, please visit: https://umiamihealth.org/en/bascom-palmer-eye-institute.
About Provectus Biopharmaceuticals
Provectus Biopharmaceuticals (OTCQB: PVCT) is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases that are based on a class of bioactive synthetic small molecules called halogenated xanthenes. The Company's lead molecule is named Rose Bengal Sodium.
Provectus's drug platform includes:
NEWS -- Theriva™ Biologics Announces U.S. FDA Guidance on Design of Phase 3 Study of VCN-01 for the Treatment of Metastatic Pancreatic Cancer
ROCKVILLE, Md., Dec. 05, 2024 (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 the outcomes of a recent Type D meeting with the U.S. Food and Drug Administration (FDA) to obtain guidance on the design of a Phase 3 clinical study of lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy for the treatment of metastatic pancreatic adenocarcinoma (PDAC). The Company recently announced the completion of target enrollment into the multinational VIRAGE Phase 2b clinical study evaluating intravenous VCN-01 in combination with gemcitabine/nab-paclitaxel as a first line therapy for PDAC patients.
Type D meetings are focused on a narrow set of issues that are used to discuss issues at key decision points to provide timely feedback critical to moving a drug development program forward. The FDA advised that the on-going VIRAGE Phase 2b study should not be expanded into a Phase 3 study; rather, the optimal path forward for the VCN-01 PDAC program is to conduct a stand-alone Phase 3 study of VCN-01 with gemcitabine/nab-paclitaxel. The FDA provided general agreement with Theriva’s proposed design for a Phase 3 clinical study and indicated that inclusion of additional standard-of-care chemotherapy for PDAC was not necessary as it would complicate the study design and analysis. The FDA meeting also highlighted the FDA’s preferences regarding certain statistical elements of confirmatory clinical studies, including methods for sample size estimation and the study population(s) used for data analysis.
“The FDA’s advice on key elements of a potential confirmatory Phase 3 study evaluating VCN-01 plus gemcitabine/nab-paclitaxel as a first-line treatment for metastatic PDAC patients is critical as the VIRAGE study has entered final patient follow-up and we are actively planning the next steps in VCN-01 development,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “The feedback from the FDA and European regulatory agencies will facilitate the design of a Phase 3 study protocol that is expected to maximize our ability to provide a new therapeutic option to patients suffering this terrible disease.”
An additional meeting with the FDA will be requested after the completion of the VIRAGE study to discuss the details of the proposed confirmatory Phase 3 study protocol.
About Pancreatic Ductal Adenocarcinoma
Cancer of the pancreas consists of two main histological types: cancer that arises from the ductal (exocrine) cells of the pancreas or, much less often, cancers may arise from the endocrine compartment of the pancreas. Pancreatic ductal adenocarcinoma (“PDAC”) accounts for more than 90% of all pancreatic tumors. It can be located either in the head of the pancreas or in the body/tail. Pancreatic cancer usually metastasizes to the liver and peritoneum. Other less common metastatic sites are the lungs, brain, kidney, and bone. In its early stages, pancreatic cancer does not typically result in any characteristic symptoms. In many instances, progressive abdominal pain is the first symptom. Therefore, in most cases, pancreatic cancer is diagnosed in its late stages (locally advanced non-metastatic or metastatic stage of the disease) when surgical resection and possibly curative treatment is not possible. It is generally assumed that only 10% of cases are resectable at presentation, whereas 30-40% of patients are diagnosed at local advanced/unresectable stage and 50-60% present with distant metastases.
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 142 patients to date in Company- 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). More information on these clinical trials is available at Clinicaltrials.gov.
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 is advancing 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 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.
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 feedback from the FDA and European regulatory agencies facilitating the design of a Phase 3 study protocol; the protocol maximizing the Company’s ability to provide a new therapeutic option to patients suffering pancreatic cancer. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to effectively design the Phase 3 study protocol; the Company’s and VCN’s ability to reach clinical milestones when anticipated, including the ability to continue to enroll patients as planned, generating positive clinical data that establishes VCN-01 may lead to improved clinical outcomes for patients with PDAC and other solid cancers; the Company’s and VCN’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; 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 and VCN’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 and VCN’s products, developments by competitors that render such products obsolete or non-competitive, the Company’s and VCN’s ability to maintain license agreements, the continued maintenance and growth of the Company’s and VCN’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, 2023 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
Source: Theriva Biologics, Inc.
NEWS -- FuelPositive Announces Strategic Private Placement Investment, Debt Settlement and Progress in Manitoba
WINNIPEG, MB, Dec. 4, 2024 /CNW/ - FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (the "Company") is pleased to announce a new financing (terms outlined below) which will enable the Company to advance towards the activation of its first system and the commencement of revenue generation. This funding, with existing commitments from a dedicated long-term shareholder and new investors, including Manitoba-based farmers, will allow the Company to complete the final phase of pressure vessel certification, secure third-party engineering certifications, and move forward with the final step: connecting the system to Manitoba's green grid.
"The unwavering support from our investors has been instrumental in driving us closer to realizing our vision for the future of sustainable agriculture," stated Ian Clifford, Co-Founder, CEO and Board Chair of FuelPositive. "This milestone highlights the transformative potential of our technology to address key challenges in farming, energy sustainability, and beyond."
FuelPositive is also actively applying for significant provincial funding in Manitoba to cover the remaining activation costs and help transition the Company into revenue generation. In connection with the application, the founders have engaged a diverse network of supporters across government, academia, farming, and the agricultural industry, receiving many endorsements from leading experts and farmers across Canada. These collaborations underscore FuelPositive's innovative system's broad appeal and ability to contribute to sustainable development, clean energy adoption, and global food security.
The Company remains dedicated to its mission of delivering groundbreaking solutions. It is grateful for its stakeholders' continued confidence and backing, who have played a pivotal role in bringing this revolutionary technology to life.
Terms of the Offering:
FuelPositive Corporation will offer (the "Offering") up to 26,666,667 units (each, a "Unit") by way non-brokered private placement at a price of $0.03 per Unit for gross proceeds of up to $800,000. Each Unit will consist of one common share of the Company and one common share purchase warrant (each, a "Warrant"). Each Warrant will be exercisable at a price of $0.05 for a period of sixty months, provided that in the event the ten-day volume-weighted average closing price of the common shares of the Company on the TSX Venture Exchange exceeds $0.40, the Company will have the right to accelerate the expiry of the Warrants.
The Company has received initial commitments of over $300,000 for the Offering and expects to complete the offering on or before December 31, 2024. The Company intends to utilize the gross proceeds from the Offering to address current outstanding payables incurred in the ordinary course of business and to provide working capital to sustain operations and bring the Manitoba-based system to activation. Except for compensation to directors and officers of the Company in the ordinary course of business, the Company does not anticipate any portion of the proceeds of the Offering will be utilized for payments to non-arms-length parties or persons engaged in investor relations activities.
The Company also announces that it will settle (the "Debt Settlement") outstanding indebtedness totaling $278,940.51 through the issuance of a further 9,298,017 Units at a deemed price of $0.03 per Unit. The Indebtedness is owing by the Company to certain arms-length suppliers and was incurred in connection with the ongoing operations of the Company.
All securities issued in connection with the Offering and the Debt Settlement will be subject to restrictions on resale for a period of four-months-and-one-day in accordance with applicable securities laws. In connection with completion of the Offering, the Company may pay finders' fees to eligible third-parties who have assisted in introducing subscribers to the Offering. Completion of the Offering and the Debt Settlement remain subject to the approval of the TSX Venture Exchange.
About FuelPositive Corporation
FuelPositive is leading the future of agriculture with the world's first farmer-owned, on-farm Green Ammonia production systems. The Company's modular and innovative technology offers a predictable, reliable, and affordable solution for directly producing green fertilizer and fuel on-farm, reducing reliance on external supply chains.
Groundbreaking AgTech and Green Energy:
FuelPositive's containerized Green Ammonia production systems are transforming the Green Ammonia industry by decentralizing production. This new fertilizer production approach aims to empower farmers to generate green nitrogen fertilizer and carbon-free fuel on-site, ensuring stable costs and supply. Each ton of ammonia produced by FuelPositive systems eliminates up to 2 tons of CO2e emissions, providing an environmentally sustainable solution that is also easily accessible and remotely monitored, enabling farmers to focus on their operations without added complexity.
First System Delivery: A Milestone in Sustainable Agriculture:
In June 2024, FuelPositive delivered its first commercial system, the FP300, to Tracy and Curtis Hiebert's 11,000-acre grain farm near Sperling, Manitoba. This milestone marks a significant advancement for both FuelPositive and sustainable agriculture. The system activation this fall will further demonstrate the transformative impact of the Company's technology on farming practices, driving a more sustainable future.
Manitoba: A Global Center of Excellence:
FuelPositive is positioning Manitoba as a leader in decentralized Green Ammonia production. The Company's vision includes establishing a world-leading manufacturing hub that will generate highly skilled engineering, science, and trade jobs and contribute to the local economy over the coming years.
See sales details here: https://fuelpositive.com/sales/.
FuelPositive Corporation is based in Ontario and Manitoba (Canada) and trades on the TSX Venture Exchange under the symbol NHHH and in the USA on the OTCQB under the symbol NHHHF.
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 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 to provide 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.
SOURCE FuelPositive Corp.
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/December2024/04/c5908.html
NEWS -- Plus Therapeutics to Showcase ReSPECT-LM Phase 1 Interim Data for Leptomeningeal Metastases at the 2024 San Antonio Breast Cancer Symposium
Company to present ReSPECT-LM Phase 1 trial data on Rhenium (186Re) Obisbemeda with a focus on treating leptomeningeal metastases (LM) in breast cancer patients
AUSTIN, Texas, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, will present data at the 2024 San Antonio Breast Cancer Symposium, December 10-13, 2024 in San Antonio, Texas.
Presentation:
Title: Rhenium (186Re) obisbemeda (rhenium nanoliposome,186RNL) for the treatment of leptomeningeal metastases (LM): Update on Phase 1 dose escalation (Abstract Number: SESS-2271, Presentation ID: PS14-01)
Presenter: Andrew Brenner, M.D., Ph.D., Professor and Kolitz / Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, Science Center at San Antonio
Date/Time: Friday, 13 December 2024 7:30-8:30 a.m. CST
Location: Stars at Night Ballroom 3-4, Henry B. Gonzalez Convention Center
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
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 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 presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. 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 “potential,” 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 potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses, and the potential commercialization of the Company’s products.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are 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 to fund its operations in the near term and long term, on terms acceptable to us or at all; the outcome of the Company’s partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company, including the ability to come into compliance with The Nasdaq Capital Market listing requirements; market conditions; product performance; litigation or potential litigation; competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; manufacturing and supply chain risks; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. 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
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
NEWS -- Realbotix to Present at the Small Cap Growth Virtual Investor Conference December 5th
Realbotix (OTCQB: XBOTF | TSV-V:XBOT), a leading creator of humanoid robots and companionship-based AI, today announced that Andrew Kiguel, CEO, will present live at the Small Cap Growth Virtual Investor Conference hosted by VirtualInvestorConferences.com, on December 5th, 2024.
DATE: December 5th
TIME: 11:00 AM ET
LINK: https://bit.ly/3Yknp3z
Available for 1x1 meetings: December 5th and 6th.
This will be a live, interactive online event where investors are invited to ask the company questions in real-time. If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event.
It is recommended that online investors pre-register and run the online system check to expedite participation and receive event updates.
Learn more about the event at https://www.virtualinvestorconferences.com.
About Realbotix
Transcending the barrier between man and machine, Realbotix creates human-like, socially intelligent robots that improve the human experience through learning, connection and play. Manufactured in Nevada, USA, Realbotix has built a reputation for building robots with the most realistic human appearance on the market. Our target addressable markets are massive, most of them in the tens or hundreds of billions USD.
Our mission is to create robots and AI that are indistinguishable from humans in appearance and social interaction. Realbotix replicates the physical and emotional aspects of being human, in hardware and software. This versatility makes our robots and their personalities customizable and programmable to suit a wide variety of use cases.
Visit https://Realbotix.AI to learn more.
About Virtual Investor Conferences®
Virtual Investor Conferences (VIC) is the leading proprietary investor conference series that provides an interactive forum for publicly traded companies to seamlessly present directly to investors.
Providing a real-time investor engagement solution, VIC is specifically designed to offer companies more efficient investor access. Replicating the components of an on-site investor conference, VIC offers companies enhanced capabilities to connect with investors, schedule targeted one-on-one meetings and enhance their presentations with dynamic video content. Accelerating the next level of investor engagement, Virtual Investor Conferences delivers leading investor communications to a global network of retail and institutional investors.
CONTACTS:
Realbotix
Jennifer Karkula, Head of Communications
Email: mailto://contact@realbotix.ai
Telephone: 647-578-7490
Virtual Investor Conferences
John M. Viglotti
SVP Corporate Services, Investor Access
OTC Markets Group
(212) 220-2221
mailto://johnv@otcmarkets.com
NEWS -- Plus Therapeutics Expands Strategic Agreement with Telix IsoTherapeutics Group for Rhenium-186 Radioisotope Supply
Five-year renewable agreement secures reliable cGMP rhenium-186 (Re-186) supply for late-stage clinical and commercial forecasts
AUSTIN, Texas, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company focused on developing innovative radiotherapeutics, today announced the renewal of its Master Services Agreement (MSA) with Telix IsoTherapeutics Group Inc. (‘IsoTherapeutics’, a Telix Group company). This MSA secures a reliable supply of cGMP Re-186, the radioisotope used in Plus Therapeutics’ lead radiotherapeutic candidate Rhenium (186Re) Obisbemeda.
“This continuing agreement with Telix IsoTherapeutics Group builds on our recently announced partnership with SpectronRx and reflects our comprehensive supply chain strategy,” said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. “By securing supply of Re-186 through IsoTherapeutics and leveraging SpectronRx for final drug manufacturing of Rhenium (186Re) Obisbemeda, we are establishing a scalable, end-to-end supply chain that positions us to meet the demands of late-stage clinical trials and future commercial needs.”
Key highlights of the agreement:
NEWS -- Oncolytics Biotech® Reports Completion of Initial Safety Phase Enrollment for GOBLET Trial's New Pancreatic Cancer Cohort
Early safety and tolerability results from six randomized patients support continued enrollment of pelareorep combined with modified FOLFIRINOX, with or without atezolizumab
The study will begin with 30 patients, with an option to expand to an additional 34 participants
SAN DIEGO and CALGARY, AB, Dec. 3, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that the Data Safety Monitoring Board (DSMB) has recommended continued enrollment in Cohort 5 of the GOBLET study following their review of initial safety data. Enrollment in this cohort will resume pending final approval from the Paul Ehrlich Institute (PEI), Germany's medical regulatory body. Additional updates are expected in 2025, with safety data anticipated in the first half and initial efficacy results in the second half.
The GOBLET study is a Phase 1/2 randomized, open-label, multicenter trial using a Simon two-stage design to evaluate treatments across multiple gastrointestinal cancers. In cohort 5, the study is assessing pelareorep combined with modified FOLFIRINOX (mFOLFIRINOX), with or without atezolizumab (Tecentriq®), in patients with newly diagnosed pancreatic ductal adenocarcinoma (PDAC). This cohort is funded by a US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program designed to speed up the development of new pancreatic cancer treatments.
"We see a promising opportunity for pelareorep to improve treatment options for PDAC patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "The current standard of care is primarily chemotherapy, such as gemcitabine + nab-paclitaxel or mFOLFIRINOX. Pelareorep has already shown synergy with gemcitabine, nab-paclitaxel, and atezolizumab in GOBLET Cohort 1, and demonstrating efficacy with mFOLFIRINOX would further establish its potential to benefit PDAC patients. This study also builds on Cohort 1 by evaluating pelareorep's ability to work with checkpoint inhibitors, which would be a major advance, especially as immune therapies provide little benefit in most patients with this 'cold' tumor."
About GOBLET Cohort 5
The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. A three-patient safety run-in was incorporated to evaluate the safety and tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations.
About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:
NEWS -- Plus Therapeutics Presents Positive ReSPECT-LM Phase 1 Interim Data for Leptomeningeal Metastases at the 2024 SNO Annual Conference
Single intrathecal dose of Rhenium (186Re) Obisbemeda shows a favorable response rate and median overall survival in leptomeningeal metastases (LM) patients
Achieves up to 8x absorbed radiation dose to the CNS subarachnoid space vs. standard of care external beam radiation
Receives FDA agreement to initiate the ReSPECT-LM Phase 1 multiple administration dose escalation trial of Rhenium (186Re) Obisbemeda for LM
AUSTIN, Texas, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, presented data updating the progress of its ReSPECT-LM Phase 1 clinical trial of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) in leptomeningeal disease (LM). The data were presented at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting November 21-24 in Houston, Texas.
“The combination of a high absorbed radiation dose, favorable safety profile, and consistent response data is very encouraging, particularly in a Phase 1 trial,” said Dr. Andrew Brenner, M.D., Ph.D. “Furthermore, the observed median overall survival rate and long tail survivors receiving multiple doses via compassionate use are uncommon in LM patients, driving our commitment to move rapidly into dose expansion and multiple-dose trials.”
The data were presented in a session titled, “Rhenium (186Re) Obisbemeda (rhenium nanoliposome,186RNL) for the treatment of leptomeningeal metastases (LM): Summary of the Phase 1 dose escalation study and Phase 2 administered dose selection,” by Andrew Brenner, M.D., Ph.D., Professor and Kolitz/Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, San Antonio.
KEY HIGHLIGHTS
ReSPECT-LM Single Administration Dose Escalation Trial
Overview:
NEWS -- Plus Therapeutics to Present Positive FORESEE Clinical Trial Summary Demonstrating Utility of CNSide™ Cerebrospinal Fluid Assay in Diagnosis and Clinical Management of Patients with Leptomeningeal Metastases
NEWS -- Lineage Cell Therapeutics Announces First Closing of up to $66 Million Registered Direct Offering
$30 Million Upfront With Up to an Additional $36 Million of Aggregate Gross Proceeds Upon the Exercise in Full of Clinical Milestone-linked Common Warrants
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced the first closing of its previously announced registered direct offering for the purchase and sale of up to an aggregate of 39,473,688 of Lineage’s common shares and accompanying warrants (the “common warrants”) to purchase an aggregate of up to 39,473,688 of Lineage’s common shares at a combined purchase price of $0.76 per common share and accompanying common warrant. Lineage issued an aggregate of 31,578,951 common shares and common warrants to purchase up to 31,578,951 common shares to certain healthcare focused institutional investors in the first closing. Each common warrant will be exercisable for one common share at an exercise price of $0.91 per common share and will be exercisable commencing six months following their date of issuance and will expire on the earlier of (a) the three-year anniversary of the initial exercise date, and (b) the 90th day following the date of the public disclosure of the intent to advance OpRegen® (also known as RG6501) into a multi-center phase 2 or 3 clinical trial which includes a control or comparator arm, or if the date of such public disclosure occurs prior to the initial exercise date of the common warrants, the 90th day following the initial exercise date.
H.C. Wainwright & Co. served as the exclusive placement agent for the offering.
The offering of the securities to Broadwood Partners, L.P. (“Broadwood”), an affiliate of Neal Bradsher, a member of Lineage’s board of directors, is expected to close upon obtaining shareholder approval to satisfy applicable NYSE American rules and to the satisfaction of customary closing conditions. The common warrants that may be issued to Broadwood pursuant to the definitive purchase agreement entered into between Lineage and Broadwood will not be exercisable until the later of (i) their date of issuance, which will be the date shareholder approval is obtained, and (ii) the six-month anniversary of the date of issuance of the common warrants to the unaffiliated institutional investors in the offering.
Lineage received $24 million in aggregate gross proceeds in the first closing of the offering, which was with respect to the investments by the unaffiliated institutional investors, and expects to receive approximately $6 million in additional gross proceeds from the offering with respect to the investment by Broadwood, in each case, before deducting the placement agent’s fees and other offering expenses payable by Lineage. The potential additional gross proceeds to Lineage from the common warrants, if fully exercised on a cash basis, will be approximately $36 million. No assurance can be given that Lineage will obtain the shareholder approval required to satisfy applicable NYSE American rules in order to sell the securities in the offering to Broadwood or that any of the common warrants will be exercised. Lineage currently plans to use the net proceeds from the offering for working capital and general corporate purposes, including research and development expenses and capital expenditures.
The securities described above were offered and sold by Lineage in a registered direct offering pursuant to a “shelf” registration statement on Form S-3 (File No. 333-277758) filed with the Securities and Exchange Commission (the “SEC”) on March 7, 2024, and which was declared effective by the SEC on May 14, 2024. The offering of the securities in the registered direct offering was made only by means of a base prospectus and a prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, “off-the-shelf,” cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Factor Bioscience Limited. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical fact, in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Lineage’s forward-looking statements are based upon its current expectations and beliefs and involve assumptions that may never materialize or may prove to be incorrect. Such statements include, but are not limited to, statements relating to the closing of the offering of the securities to Broadwood, the total potential amount and use of proceeds from the offering, the exercise of the common warrants in cash prior to their expiration and the exercise of the common warrants upon the achievements of such milestone events or otherwise prior to their expiration. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the risks that the offering may not close due to the failure to satisfy the applicable closing conditions, including, with respect to the offering of securities to Broadwood, obtaining shareholder approval to satisfy applicable NYSE American rules, and that the common warrants may not be exercised or, if exercised, the exercise price may not be paid in cash, and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the SEC. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. All forward-looking statements are expressly qualified in their entirety by these cautionary statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241121738269/en/
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
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 Multi-Institutional Experience Using the CNSide™ Cerebrospinal Fluid Assay in Patients with Leptomeningeal Metastases
CNSide Cerebrospinal Fluid (CSF) Assay analyzed 258 CSF samples across 66 leptomeningeal metastases (LM) patients at five institutions
CNSide identified extensive, actionable mutational changes, and clinically relevant longitudinal biomarkers
AUSTIN, Texas, Nov. 21, 2024 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), will present data demonstrating the utility of the CNSide CSF Assay Platform in identifying mutations of key biomarkers in the CSF and their implications in treatment selection for LM. The data will be presented at the 2024 Society for NeuroOncology (SNO) Annual Meeting November 21-24 in Houston, Texas.
“The data from CNSide suggests that biomarker mutation profiles in LM are dynamic, offering valuable insights for treatment strategies,” said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. “The genetic drift observed in LM suggests an important role for radiotherapeutics such as Rhenium (186Re) Obisbemeda in addressing this challenging disease.”
Key highlights:
NEWS -- Scorpius Holdings Launches Scorpius Ventures to Support U.S. Biotech Innovation through Flexible Equity-Based Onshoring Model
Scorpius Holdings, Inc.
New business unit offers services for promising biotech companies through combined fee-for-service and equity-based model, fostering partnerships that align with BIOSECURE Act goals to onshore and strengthen U.S.-based biosecurity and production capacity
DURHAM, N.C., Nov. 19, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization ("CDMO"), today announced the launch of Scorpius Ventures, a new business unit designed to support emerging biotech companies with a flexible American onshoring model. By combining service fees with an equity stake, Scorpius Ventures lowers financial barriers for its partners to onshore production of their biologics, creating a mutually beneficial pathway to accelerate biotech advancements.
Scorpius Ventures’ hybrid model offers capital-efficient access to its cGMP manufacturing services through in-kind equity investment, sharing in the growth potential of its clients.
“At Scorpius, we’re committed to enabling biotech innovation by aiming to reduce financial obstacles and creating true partnerships,” said Jeff Wolf, CEO of Scorpius Holdings. “Through Scorpius Ventures, we’re providing biotech companies the resources they need to advance critical therapies through a hybrid fee and equity model, thereby, fostering shared success while advancing our mission to strengthen U.S. biosecurity and manufacturing independence.”
This new venture model aligns with the BIOSECURE Act, supporting onshore production of essential biological substances to bolster national security and economic resilience. Scorpius Ventures prioritizes U.S.-based manufacturing, in an effort to enhance supply chain stability and promote domestic job growth.
Biotech partners benefit from Scorpius’ industry-leading CMC (Chemistry, Manufacturing, and Controls) and manufacturing expertise, ensuring streamlined development, reduced risks, and clear communication regarding milestones and timelines. By combining Scorpius’ operational support with a fee-and-equity model, clients can leverage the Company’s manufacturing strengths to aid in their own fundraising efforts.
Scorpius Ventures represents a bold step in onshoring development of American-made biologics, advancing BIOSECURE Act goals while reshaping how emerging biotech companies access capital and manufacturing.
Scorpius Holdings, Inc.
Scorpius Holdings, Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.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 such as Scorpius Ventures enabling biotech innovation by reducing financial obstacles and creating true partnerships; Scorpius fostering shared success while advancing its mission to strengthen U.S. biosecurity and manufacturing independence; Scorpius Ventures enhancing supply chain stability and promoting domestic job growth; clients leveraging the Company’s manufacturing strengths to aid in their own fundraising effort Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of the Company to derive the anticipated benefits from the flexible equity based manufacturing model; the Company’s ability to expand its large molecule biomanufacturing CDMO services, attract new customers, profit from its pipeline and continue to grow revenue; the ability to capture a meaningful market share; the ability to generate meaningful cash flow and become cash flow positive; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly reports on Form 10-Qs and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://ir@scorpiusbiologics.com
NEWS -- Scorpius Holdings Reports Third Quarter 2024 Results, Highlighting Strategic Partnerships, Cost Savings, and Progress Toward Profitability
Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization (“CDMO”), today provided a strategic, financial, and operational update for the third quarter ended September 30, 2024.
Jeff Wolf, CEO of Scorpius Holdings, Inc., stated, “Scorpius continued to make strides in Q3, driven by key partnerships, disciplined financial management, and growth across our manufacturing and development services. We are proud to report a 142% year-over-year increase in revenue for the nine months ended September 30, 2024, reaching $5.2 million, which illustrates the demand for our services and the successful expansion of our client base. Alongside this revenue growth, we achieved a 23.5% reduction in operating expenses for the nine months, a reflection of our commitment to financial discipline and cost optimization. Our ongoing cost savings initiatives, expected to exceed $2 million annually, have strengthened our foundation and keep us on track to achieve positive cash flow. These actions, coupled with our recent client wins and government engagements, position us well to capture new high-margin opportunities in both the government and biopharmaceutical sectors.”
Wolf added, “The new clients we onboarded this quarter demonstrate Scorpius' reputation as a trusted biomanufacturing partner for early-stage and clinical development. These agreements further highlight our ability to support companies with secure, U.S.-based solutions for development and manufacturing needs. These partnerships are indicative of our growing influence in the industry and our role as a resource for companies seeking flexible, responsive CDMO services.”
“Additionally, our selection to join the Medical CBRN Defense Consortium (MCDC) underscores Scorpius' commitment to advancing U.S. biosecurity. As a member of the MCDC, Scorpius is now eligible to collaborate on a range of medical countermeasures addressing chemical, biological, radiological, and nuclear (CBRN) threats. Furthermore, the passage of the BIOSECURE Act in the House of Representatives on September 9, 2024, highlights the importance of strengthening the U.S. biomanufacturing sector, a mission that aligns closely with our own commitment to supporting public health and national defense through high-quality, domestic biomanufacturing capabilities.”
Concluding, Wolf stated, “Our future looks promising with a weighted average pipeline of business development opportunities now exceeding $100 million across diverse sectors. As we look ahead, we are focused on expanding our service offerings, utilizing our state-of-the-art GMP facility to its full potential, and driving long-term value for our shareholders. The momentum we have built this year has positioned the Company to become a leading CDMO, and we are excited to capitalize on the growth and opportunities that lie ahead.”
Third Quarter 2024 Financial Results
For the three months ended September 30, 2024, the Company recognized $0.9 million of revenue, primarily from process development services, compared to $0.7 million of CDMO revenue recognized in the 2023 comparable quarter. The increase in CDMO revenue is attributable to the completion of process development services over a larger number of customer contracts.
Cost of revenues were $0.9 million and $0.5 million for the three months ended September 30, 2024, and 2023, respectively, and primarily consisted of the direct cost of labor, overhead and material costs at Scorpius. The increase in cost of revenues is due to the expanded service offerings and completed milestone work on multiple CDMO contracts.
Research and development expenses were $4.3 million for the three months ended September 30, 2024, compared to $5.2 million for the three months ended September 30, 2023.
Selling, general and administrative expenses were $5.6 million and $6.1 million for the three months ended September 30, 2024, and 2023, respectively. The decrease of $0.5 million was primarily due to decreases in consultant services of $0.8 million, sales and marketing of $0.3 million, stock-based compensation of $0.3 million, partially offset by increases in rent of $0.3 million, professional services of $0.3 million, personnel of $0.1 million, and public company expenses of $0.1 million.
For the three months ended September 30, 2024, the change in fair value of contingent earn-out receivable, related party increased by $0.2 million, prior to its reclassification to related party receivable.
Total non-operating expense was $0.9 million for the three months ended September 30, 2024, which primarily consisted of $0.7 million from the loss on partial debt extinguishment, $0.2 million of interest expense on finance leases, $0.1 million from the change in fair value of the convertible and non-convertible promissory notes to a related party, partially offset by an increase of $0.1 million in change in fair value of related party receivable. Total non-operating expense was $0.1 million for the three months ended September 30, 2023, which primarily consisted of $0.2 million of interest expense partially offset by $0.1 million of interest income.
Net loss attributable to Scorpius was approximately $10.1 million, or ($1.43) per basic and diluted share, for the three months ended September 30, 2024, compared to approximately $13.1 million, or ($100.82) per basic and diluted share, for the three months ended September 30, 2023.
As of September 30, 2024, the Company had approximately $4.8 million in cash and cash equivalents and short-term investments. As of November 14, 2024, the Company’s cash and cash equivalents and short-term investments were approximately $0.8 million.
Scorpius Holdings, Inc.
Scorpius Holdings, Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic and cell therapy programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.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 such as continuing to make strides in Q3, driven by key partnerships, disciplined financial management, and growth across the Company’s manufacturing and development services; ongoing cost savings initiatives, expected to exceed $2 million annually; being on track to achieve positive cash flow; being positioned to capture new high-margin opportunities in both the government and biopharmaceutical sectors; the Company’s growing influence in the industry and its role as a resource for companies seeking flexible, responsive CDMO services; the future looking promising with a sales pipeline now exceeding $100 million in weighted opportunities across diverse sectors; in the future expanding the Company’s service offerings, utilizing its state-of-the-art GMP facility to its full potential, and driving long-term value for its shareholders; and the Company being positioned to become a leading CDMO, and to capitalize on the growth and opportunities that lie ahead. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to capitalize on the Company’s sales pipeline; expand its large molecule biomanufacturing CDMO services, attract new customers, profit from its pipeline and continue to grow revenue; the ability to capture a meaningful market share; the ability to generate meaningful cash flow and become cash flow positive; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure-play CDMO, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly reports on Form 10-Qs and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://ir@scorpiusbiologics.com
NEWS -- Oncolytics Biotech Inc (ONCY) Q3 2024 Earnings Call Highlights: Strategic Advances and ...
NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Third Quarter Financial Results and Recent Operational Highlights
Conference call and webcast to take place on Tuesday, November 12, 2024, at 8:30 a.m. ET
SAN DIEGO and CALGARY, AB, Nov. 11, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that it will host a conference call and webcast on Tuesday, November 12, 2024, at 8:30 a.m. ET to discuss a corporate update and financial results for the third quarter 2024.
Conference Call & Webcast
Date: Tuesday, November 12, 2024
Time: 8:30 a.m. ET
Dial In – North American Toll-Free: (888) 510-2154
Dial In – International: (437) 900-0527
RapidConnect: to join the conference call without operator assistance, please click here
Conference ID (if needed): 68336
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) 660-6345 (North America) or (289) 819-1450 (International) and using replay code: 68336#.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing 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, both of which have received Fast Track designation from the FDA. For further information, please visit: https://www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Company Contact
Jon Patton
Director of IR & Communication
mailto://jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
mailto://tim@lifesciadvisors.com
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SOURCE Oncolytics Biotech® Inc.
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NEWS -- Lineage Cell Therapeutics to Report Third Quarter 2024 Financial Results and Provide Business Update on November 14, 2024
CARLSBAD, Calif., November 07, 2024--(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 third quarter 2024 financial and operating results on Thursday, November 14, 2024, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, November 14, 2024, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its third quarter 2024 financial and operating results and to provide a business update.
Interested parties may access the conference call on November 14, 2024, 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 November 21, 2024, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 2238934.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241107087038/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
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 and SpectronRx Announce Radiotherapeutic Manufacturing Partnership
Partnership will expand Plus’ capability to meet late-stage clinical and commercial forecasts for Rhenium (186Re) Obisbemeda and reinforce supply chain redundancy
AUSTIN, Texas and INDIANAPOLIS, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing targeted radiotherapeutics for central nervous system (CNS) cancers, and SpectronRx, a leading radiopharmaceutical contract developer and manufacturer, announced the signing of a Manufacturing Services Agreement (MSA) for the production of Rhenium (186Re) Obisbemeda, an innovative radiotherapy for CNS cancers, including leptomeningeal metastases and recurrent glioblastoma.
“In 2025, we intend to begin late-stage clinical trials and are actively preparing for commercial level product demand, therefore now is the time to expand our supply chain and partner with leading radiopharmaceutical manufacturers such as SpectronRx that can deliver for us and our patients,” said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. “We believe that SpectronRx’s capabilities will significantly reinforce our existing manufacturing partnerships and position us well for the long term.”
Under this strategic partnership, SpectronRx will utilize its state-of-the-art facilities to produce late-stage clinical and commercial supplies of Rhenium (186Re) Obisbemeda. SpectronRx currently has more than 170,000 sq ft of radiopharmaceutical contract development and manufacturing (rCDMO) space and 150 employees across five locations. It provides services to 29 countries, working hand-in-hand with more than 31 pharmaceutical companies to develop and produce life-saving nuclear medicines, including those radiolabeled with 186Re. By joining forces with Plus Therapeutics, SpectronRx aims to further its mission of advancing nuclear medicine.
“We are proud to align with Plus Therapeutics, leveraging our expertise in nuclear medicine manufacturing to support the advancement of Rhenium (186Re) Obisbemeda and increase patient access to this important therapy,” said Anwer Rizvi, President of SpectronRx. "This collaboration underscores our dedication to advancing nuclear medicine and providing patients with high-quality, life-saving radiotherapies. We look forward to supporting Plus Therapeutics' mission to address the unmet needs of CNS cancer patients."
The partnership aims to enhance the supply chain redundancy for Plus Therapeutics and ensure that the demands of late-stage clinical trials and future commercial needs could be met effectively. This agreement marks a crucial step in expanding the reach and impact of Rhenium (186Re) Obisbemeda.
About Rhenium (186Re) Obisbemeda
Rhenium (186Re) Obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high-dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) Obisbemeda has the potential to reduce off-target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) Obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
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 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/.
About SpectronRx
SpectronRx is a diagnostic and therapeutic radiopharmaceutical developer and manufacturer with three distinct specialties: Radiopharmaceutical Contract Development (rCDMO), Radiopharmaceutical Contract Manufacturing (rCMO), and Isotope Production. The company performs all scales of development, from initial conjugations through scale-up and commercial distribution. It also has the capacity to run clinical trials. Additionally, SpectronRx's deep industry knowledge, technical prowess and state-of-the-art facilities enable the company to significantly condense the timeline for bringing new medicines to market, which has the dual benefit of saving lives and driving greater profitability for clients.
With a large staff of radiochemists, radiopharmacists, scientists and engineers, dozens of qualified clean rooms, and over 170,000 sq. ft. of production space in Indiana, with additional facilities in Danbury, Connecticut and Europe, SpectronRx now supplies therapeutic and diagnostic radiopharmaceuticals to 29 countries. The company has been EMA and FDA inspected and can produce and procure any currently used radioisotopes. For more information visit https://SpectronRx.com, or follow the company on LinkedIn.
Cautionary Statement Regarding Forward-Looking Statements
This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. 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 “potential,” “intend,” “aim,” “expect,” “believe,” “could” 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 and impact of Rhenium (186Re) Obisbemeda; the Company’s clinical trials including statements regarding the timing of late-stage clinical trials and commercial level product demand; expected enhancement of manufacturing capabilities to support late stage clinical trials and preparation for commercial level product demand; ability of SpectronRx to support the development, manufacturing, distribution and operations needs of the Company, including the production of production of Rhenium (186Re) Obisbemeda by SpectronRx; expected expansion of supply chain and partnerships with leading radiopharmaceutical manufacturers; and increased patient access to Rhenium (186Re) Obisbemeda.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are 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 to fund its operations in the near term and long term, on terms acceptable to us or at all, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, including the ability to come into compliance with The Nasdaq Capital Market listing requirements, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. 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.
Plus Therapeutics Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
SpectronRx Media Contact
Brian Fitzgerald
mailto://BFitzgerald@SpectronRx.com
(808) 754-0437
NEWS -- Plus Therapeutics to Announce Third Quarter Financial Results and Host Conference Call on November 14, 2024
AUSTIN, Texas, Nov. 05, 2024 (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 report third quarter 2024 financial results on Thursday, November 14, 2024, after market close. Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.
Webcast and Conference Call
Date/Time: Thursday, November 14, 2024 @ 5:00 PM ET
Webcast: https://edge.media-server.com/mmc/p/rdthweko
Dial-in Link: https://register.vevent.com/register/BI0e7763782e4d40cebe225238e201e7da
Participants are encouraged to pre-register any time before the call through the dial-in link. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.
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 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
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
NEWS -- Scorpius Holdings Announces Collaboration with Celltheon Corporation, a U.S.-Based Cell Line Development Company; First Client Signed Under New Partnership Agreement
Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization ("CDMO"), today announced a partnership with Celltheon Corporation to provide cell line development services to clients using Celltheon’s proprietary GOLDILOCKS™ transposase-based platform.
This collaboration enables clients to integrate with Scorpius’ program management team and quality system while preparing to transfer a research cell bank (RCB) to the Company’s facilities in San Antonio, TX, for further biomanufacturing work. In addition to full-scale cell line development services, Celltheon offers Scorpius clients services in antibody discovery, variant screening and development, and comparability studies. The first client signed under this partnership aims to scale up to GMP manufacturing with Scorpius.
Jeff Wolf, CEO of Scorpius, commented, “We are excited to collaborate with Celltheon, a partner that shares Scorpius’ mission to deliver responsive, high-quality, flexible services to early-stage biotechs and academic researchers. This partnership allows our clients to secure their supply chain and intellectual property by working with Celltheon, a California-based company, and then transferring their high-expressing, stable cell line to our state-of-the-art GMP facility in Texas to continue manufacturing.”
“We look forward to helping Scorpius clients overcome their early development challenges so they can seamlessly move to GMP activity. Together, Celltheon and Scorpius are committed to ensuring that the next generation of biotherapeutics get to patients faster and more affordably,” added Divya Goel, VP of Business Development and Board Member at Celltheon.
Celltheon
Celltheon develops leading edge technologies and innovative solutions for the next generation of biotherapeutics. Celltheon offers platformed and custom end-to-end solutions for drug developability, cell line development, and process development to its clients, to bridge the gap between early drug development and manufacturing. For more information, please visit https://www.celltheon.com.
Scorpius Holdings, Inc.
Scorpius Holdings, Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.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 such as collaboration enabling clients to integrate with Scorpius’ program management team and quality system while preparing to transfer a research cell bank (RCB) to the Scorpius facilities in San Antonio, TX, for further biomanufacturing work; the partnership allowing Scorpius clients to secure their supply chain and intellectual property by working with Celltheon and then transferring their high-expressing, stable cell line to the Scorpius state-of-the-art GMP facility in Texas to continue manufacturing; delivering responsive, high-quality, flexible services to early-stage biotechs and academic researchers; helping Scorpius clients overcome their early development challenges so they can seamlessly move to GMP activity and ensuring that the next generation of biotherapeutics get to patients faster and more affordably Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of the Company to derive the anticipated benefits from the partnership including expanding the services to be provided; the Company’s ability to expand its large molecule biomanufacturing CDMO services, attract new customers, profit from its pipeline and continue to grow revenue; the ability to capture a meaningful market share; the ability to generate meaningful cash flow and become cash flow positive; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly reports on Form 10-Qs and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://ir@scorpiusbiologics.com
NEWS -- Theriva Biologics Selected as Finalist in International Competition for Merck KGaA's EMEA Advance Biotech Grant
Winner to be Presented at BIO-Europe 2024 in Stockholm, Sweden
ROCKVILLE, Md., Oct. 31, 2024 (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 selection as one of five finalists for Merck KGaA's EMEA Advance Biotech Grant. Finalists for the grant will present to a six-judge panel from Merck’s Emerging Biotech group during BIO Europe 2024 in Stockholm, Sweden.
Manel Cascalló, PhD., General Director - EU Subsidiary, Theriva Biologics, will present an overview of VCN-01, currently being studied in a Phase 2b clinical trial in first-line metastatic pancreatic cancer in combination with standard-of-care chemotherapy. Dr Cascalló will highlight VCN-01’s novel mechanisms of action and Theriva’s internal capabilities to develop its manufacturing process in his presentation on Monday, November 4, 2024 from 15:20-16:40 CET/CEST (GMT+2).
Merck KGaA’s EMEA Advance Biotech Grant Program celebrates standout emerging biotech companies, and winners receive financial support and guidance on navigating their path to commercialization, including consultation with M Ventures. After multiple rounds of dynamic competition involving diverse biotech companies and technologies, the five selected finalists, will pitch their breakthroughs to Merck KGaA representatives and the overall BIO-Europe audience. The winner will be announced following the five presentations.
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 is advancing 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 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.
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 presenting an overview of VCN-01to a six-judge panel from Merck’s Emerging Biotech group during BIO Europe 2024 in Stockholm, Sweden and highlighting VCN-01’s novel mechanisms of action and Theriva’s internal capabilities to develop its manufacturing process. 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 reach clinical milestones when anticipated, the Company’s product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results, the Company’s ability to complete clinical trials on time and achieve the desired results and benefits, continuing clinical trial enrollment as expected; the Company’s 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, 2023 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 -- Scorpius Holdings Announces Implementation of New Cost Savings Measures Expected to Save Over $2 Million Annually
Efficiency Initiatives Designed to Accelerate Path to Profitability
DURHAM, N.C., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or the “Company”), an integrated biomanufacturing company, today announced the implementation of strategic cost-saving measures expected to save over $2 million annually.
The recently implemented measures include the divestiture of certain non-core assets and the initiation of programs designed to optimize operational efficiency across the organization. The Company expects these measures to significantly enhance its financial position and enable a sharper focus on high-margin growth areas within its sales pipeline.
“We’re committed to accelerating our path to profitability and achieving positive cash flow through disciplined cost management and operational efficiency,” said Jeff Wolf, CEO of Scorpius. “With these cost-saving initiatives, we’re strengthening our financial foundation and positioning Scorpius to expand our robust service offerings. I am particularly encouraged by our growing sales pipeline and look forward to updating stakeholders on our continued progress in the weeks ahead.”
Scorpius Holdings, Inc.
Scorpius Holdings, Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.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 such as the measures significantly enhancing the Company’s financial position and enabling a sharper focus on high-margin growth areas within its sales pipeline; accelerating the Company’s path to profitability and achieving positive cash flow through disciplined cost management and operational efficiency ; positioning Scorpius to expand its robust service offerings; being encouraged by the growing sales pipeline. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of the Company to derive the anticipated benefits from the implemented measures; the Company’s ability to continue to grow its pipeline and expand its service offerings, attract new customers, profit from its pipeline and continue to grow revenue; the ability to capture a meaningful market share; the ability to generate meaningful cash flow and become cash flow positive; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly reports on Form 10-Qs and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://ir@scorpiusbiologics.com
NEWS -- Plus Therapeutics Showcases Leptomeningeal Metastases Programs at the 2024 SNO Annual Meeting in Houston, Texas
Company will present results from the ReSPECT-LM Phase 1 clinical trial of Rhenium (186Re) Obisbemeda for leptomeningeal metastases (LM) and discuss its plan for continued clinical development
Company will present results from the FORESEE Trial of circulating tumors cells for improved diagnosis and disease monitoring of LM
Company to host an educational symposium featuring clinical experts discussing LM and Plus’ recent announcements for its LM therapeutic and diagnostic programs
AUSTIN, Texas, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, will have multiple opportunities to present data at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting November 21-24, 2024 in Houston, Texas.
Follow this Link for the full Press Release, along with data on presentations and symposium:
https://finance.yahoo.com/news/plus-therapeutics-showcases-leptomeningeal-metastases-113000902.html
NEWS -- AI & Technology Virtual Investor Conference Agenda Announced for October 31st
NEW YORK, Oct. 28, 2024 (GLOBE NEWSWIRE) -- Virtual Investor Conferences, the leading proprietary investor conference series announced the agenda for the AI & Technology Virtual Investor Conference to be held October 31st.
Individual investors, institutional investors, advisors, and analysts are invited to attend.
REGISTER NOW AT: https://bit.ly/3BYlp8w
It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates. There is no cost to log-in, attend live presentations, or schedule 1x1 meetings with management.
“We’re looking forward to hosting the upcoming AI & Technology Virtual Investor Conference,” said Jason Paltrowitz, Executive Vice President at OTC Markets Group. “A group of innovative companies and executives will have the opportunity to elaborate on their business strategies and connect directly with an expanded investor base.”
To facilitate investor relations scheduling and to view a complete calendar of Virtual Investor Conferences, please visit www.virtualinvestorconferences.com.
About Virtual Investor Conferences®
Virtual Investor Conferences (VIC) is the leading proprietary investor conference series that provides an interactive forum for publicly traded companies to seamlessly present directly to investors.
Providing a real-time investor engagement solution, VIC is specifically designed to offer companies more efficient investor access. Replicating the components of an on-site investor conference, VIC offers companies enhanced capabilities to connect with investors, schedule targeted one-on-one meetings and enhance their presentations with dynamic video content. Accelerating the next level of investor engagement, Virtual Investor Conferences delivers leading investor communications to a global network of retail and institutional investors.
Media Contact:
OTC Markets Group Inc. +1 (212) 896-4428, mailto://media@otcmarkets.com
Virtual Investor Conferences Contact:
John M. Viglotti
SVP Corporate Services, Investor Access
OTC Markets Group
(212) 220-2221
mailto://johnv@otcmarkets.com
NEWS -- FuelPositive Welcomes New Visionary Board to Lead Company into a Bold Future
https://www.newswire.ca/news-releases/fuelpositive-welcomes-new-visionary-board-to-lead-company-into-a-bold-future-849499763.html
NEWS -- Provectus Biopharmaceuticals Announces Investor Webinar for Fourth Quarter 2024 Conference Call
KNOXVILLE, Tenn., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Provectus Biopharmaceuticals, Inc. (“Provectus” or the “Company”) (OTCQB: PVCT) announced today that its Fourth Quarter 2024 Investor Update will be accessible by Zoom Webinar. The conference call will be held on Thursday, November 14, 2024 starting at 2 p.m. EST.
The Fourth Quarter 2024 Investor Update webinar may be accessed by registering in advance here:
https://us06web.zoom.us/webinar/register/WN_u628Om3GTyCrclcuZckXNg?_ga=2.250060678.1412167732.1728519054-492896892.1650903731#/registration.
About Provectus
Provectus Biopharmaceuticals is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases that are based on a class of bioactive synthetic small molecules called halogenated xanthenes. The Company’s lead molecule is named Rose Bengal Sodium. Provectus’s small molecule drug platform includes:
NEWS -- Scorpius Holdings Announces Partnership with U.S. Biotech Company
Agreement reinforces Scorpius' position as a respected U.S. biomanufacturing partner for early-stage and clinical development
DURHAM, N.C., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or the “Company”), an integrated biomanufacturing company, today announced a strategic partnership with a U.S.-based biotech company. Under this agreement, the biotech company will work with Scorpius' program management team, with plans to transfer a research cell bank (RCB) to Scorpius’ state-of-the-art facilities in San Antonio, TX for future biomanufacturing activities.
“This partnership underscores Scorpius' ability to support biotech companies at every stage of their journey, from innovative research to clinical trials,” said Jeff Wolf, CEO of Scorpius. “We are seeing a growing number of biotech companies seeking U.S.-based biomanufacturing partners, and Scorpius is equipped to provide early-stage development, preclinical manufacturing, and cGMP clinical manufacturing for both mammalian and microbial programs.”
Wolf added, “Our clients highlight our flexibility and responsiveness—qualities often lacking in larger multinational CDMOs. With this partnership, we continue to fulfill the critical need for secure, U.S.-based development and manufacturing support for groundbreaking biologics research.”
Scorpius Holdings, Inc.
Scorpius Holdings, Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please visit https://www.scorpiusbiologics.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 such as the biotech company working with Scorpius' program management team, with plans to transfer a research cell bank (RCB) to Scorpius’ state-of-the-art facilities in San Antonio, TX for future biomanufacturing activities; and continuing to fulfill the critical need for secure, U.S.-based development and manufacturing support for groundbreaking biologics research with this partnership. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of the Company to derive the anticipated benefits from the partnership including expanding the services to be provided the Company’s ability to expand its large molecule biomanufacturing CDMO services, attract new customers, profit from its pipeline and continue to grow revenue; the ability to capture a meaningful market share; the ability to generate meaningful cash flow and become cash flow positive; the Company’s financing needs, its cash balance being sufficient to sustain operations and its ability to raise capital when needed, the Company’s ability to leverage fixed costs and achieve long-term profitability; the Company’s ability to obtain regulatory approvals or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to successfully promote its services and compete as a pure- play CDMO, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly reports on Form 10-Qs and any other filings the Company makes with the SEC. The information in this presentation is provided only as of the date presented, and the Company undertakes no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://ir@scorpiusbiologics.com
NEWS -- Realbotix Joins AI Partnerships Corp. Affiliate Network
Realbotix Joins AI Partnerships Corp. Affiliate Network
Realbotix Corp. (TSX-V: XBOT) (Frankfurt Stock Exchange: 76M0.F) (OTC: XBOTF) (“Realbotix” or the “Company”), a leading creator of humanoid robots and companionship-based AI, is pleased to announce that it has accepted an invitation to join the AI Partnerships Corporation Affiliate Network, an international network of AI companies that fosters collaboration and innovation in artificial intelligence.
Realbotix’s inclusion in this network reflects the Company’s commitment to collaborating with other companies in the advancement of AI technology globally and shaping the future of human-robot interaction.
“This partnership enables us to connect with and collaborate with other innovators in the AI field,” said Andrew Kiguel, CEO of Realbotix. “We look forward to the opportunities that arise from joining this network.”
AI Partnerships Corporation has created a world-wide network of Affiliates that brings together cutting-edge companies in the AI sector to share business opportunities, explore new applications and drive the development of ethical, transformative technologies. By joining the Affiliate network, Realbotix will collaborate with other industry leaders, contribute to AI innovation and explore new opportunities to integrate advanced robotics into everyday life.
“Having Realbotix join the AI Partnerships Corp. Affiliate Network provides an opportunity for AIP and our 160 company Affiliate Network to leverage the advanced robotics technology that Realbotix provides,” said Dr. Tom Corr the CEO of AI Partnerships Corporation. “As we expand the offerings of the Affiliates in our network, we look to make AI more accessible and affordable to businesses of all sizes and take part in the mass adoption of enterprise AI.”
Through the AIP Affiliate network, Realbotix looks forward to deepening its expertise, expanding its innovation pipeline, and continuing to deliver AI-powered solutions that revolutionize the way humans interact with technology.
About Realbotix
Transcending the barrier between man and machine, Realbotix creates human-like, socially intelligent robots that improve the human experience through learning, connection and play. Manufactured in Nevada, USA, Realbotix has built a reputation for building robots with the most realistic human appearance on the market. Our target addressable markets are massive, most of them in the tens or hundreds of billions USD.
Our mission is to create robots and AI that are indistinguishable from humans in appearance and social interaction. Realbotix replicates the physical and emotional aspects of being human, in hardware and software. This versatility makes our robots and their personalities customizable and programmable to suit a wide variety of use cases.
Visit https://Realbotix.AI to learn more.
Keep up-to-date on Realbotix.AI developments and join our online communities on Twitter, LinkedIn, and YouTube.
Follow Aria, our humanoid robot, on Instagram and TikTok.
About AI Partnerships Corporation
AI Partnerships Corp. matches small to medium businesses and enterprises with over 160 Affiliates in a network of companies experienced in delivering Artificial Intelligence and Machine Learning-powered solutions to solve various business needs, whether it is a specific task that needs to be automated to increase revenue or a robust set of AI-powered processes that reduce costs. Together, AIP and its Affiliates develop winning strategies for enterprise customers in the Finance, Manufacturing, Healthcare, Retail, Sales and Marketing, Government, Data Science and other sectors.
Learn more by watching Affiliate interviews on YouTube, following us on LinkedIn, and by visiting https://www.aipartnershipscorp.com.
Forward-Looking Statements
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, as described in more detail in our securities filings available at https://www.sedarplus.ca. 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. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Realbotix Corp.
Andrew Kiguel, CEO
Email: mailto://contact@realbotix.ai
Jennifer Karkula, Head of Communications
Email: mailto://contact@realbotix.ai
Telephone: 647-578-7490
AI Partnerships Corp.
AIP Team
Email: mailto://info@aipartnershipscorp.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20241021814826/en/
NEWS -- Vivos Inc. Certifies New Clinic for IsoPet® Precision Radionuclide TherapyTM
Richland WA N, Oct. 18, 2024 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc. Certifies new clinic for IsoPet therapy.
NorthStar Vets - Veterinary Emergency & Trauma Specialty Center in Robbinsville, NJ. provides 24/7/365 emergency, trauma, and critical care and a suite of veterinary specialty services for small animals. They have been approved and licensed to offer IsoPet Precision Radionuclide Therapy as a cancer treatment for small animals.
Dr. Korenko stated “An important objective is to expand the number of clinics that are certified for IsoPet Therapy. Generally, different clinics specialize in small animal or equine therapy. Certification is much lower cost than other alternatives that require large capital investments. It requires veterinarians and oncologists that are enthusiastic about the effectiveness of IsoPet. Vivos assists them with obtaining or amending their radioactive material license and provides the certification training that includes our proprietary Injection Guidance Table. We now have several clinics in the pipeline.”
Michael K. Korenko, Sc.D.
President & CEO Vivos Inc
Email: mailto://MKorenko@RadioGel.com
Follow Vivos Inc @VivosIncUSA, Radiogel® and Isopet® on X (Twitter):
About Vivos Inc. (OTCQB: RDGL)
Vivos Inc. has developed an Yttrium-90-based injectable Precision Radionuclide Therapy™ medical device to treat tumors in animals (IsoPet®) and humans (RadioGel®). Using the company's proprietary hydrogel technology, PRnT™ uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows the safe delivery of higher doses needed for treating non-resectable and radiation-resistant cancers.
RadioGel® is a hydrogel liquid containing tiny yttrium-90 phosphate microparticles that may be administered directly into a tumor. The hydrogel is a yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
RadioGel® also has a short half-life – delivering more than 90% of its therapeutic radiation within 10 days. This compares favorably to other available treatment options requiring up to six weeks or more to deliver a full course of radiation therapy. Therapy can be safely administered as an outpatient procedure, and the patient may return home without subsequent concern for radiation dose to family members.
University veterinary hospitals use the IsoPet® Solutions division to demonstrate animal cancers' safety and therapeutic effectiveness. Testing on feline sarcoma at Washington State University was completed in 2018, and testing on canine soft tissue sarcomas at the University of Missouri was completed in 2019. The Company has obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a medical device according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling, which included canine and feline sarcomas as the initial indications for use. The FDA does not require pre-market approval for veterinary devices, so no additional approval was required to generate revenue through the sale of IsoPet® to University animal hospitals and private veterinary clinics.
IsoPet® for treating animals uses the same technology as RadioGel® for treating humans. The Food and Drug Administration advised using different product names to avoid confusion and cross-use.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners, and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
NEWS -- Theriva Biologics Announces Orphan Medicinal Product Designation Granted by the European Commission to VCN-01 for the Treatment of Retinoblastoma
ROCKVILLE, Md., Oct. 16, 2024 (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 that the European Commission has adopted the European Medicines Agency (EMA) recommendation to grant orphan medicinal product designation to lead clinical candidate VCN-01, Theriva’s systemic, selective, stroma-degrading oncolytic adenovirus, for the treatment of retinoblastoma. The United States Food and Drug Administration (FDA) has previously granted orphan drug designation and rare pediatric disease designation to VCN-01 for the treatment of retinoblastoma.
“We are very pleased with the European Commission’s grant of orphan medicinal product designation to VCN-01, emphasizing the urgent need for new treatment options for retinoblastoma,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “We have previously reported encouraging results from an investigator sponsored Phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma, and we are working closely with leading physicians and regulatory agencies worldwide to refine our clinical strategy for VCN-01 as an adjunct to chemotherapy in children with this challenging disease.”
The EMA recommends orphan designation for products intended to treat, prevent or diagnose a disease that is life-threatening or chronically debilitating and either the prevalence of the condition in the European Union (EU) does not exceed 5 in 10,000 or it is unlikely that marketing of the product would generate sufficient returns to justify the investment needed for its development. Additionally, there should be no authorizable method of diagnosis, prevention or treatment of the condition, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition. Orphan designation is designed to provide drug developers with various benefits to support the development of novel therapies, including 10-years of market exclusivity once they receive marketing authorization in the EU, protocol assistance, administrative and procedural assistance, and reduced fees for regulatory activities.
About Retinoblastoma
Retinoblastoma is a tumor that originates in the retina and is the most common type of eye cancer in children. It occurs in approximately 1/14,000 - 1/18,000 live newborns and accounts for 15% of the tumors in the pediatric population < 1 year old. The average age of pediatric patients at diagnosis is 2, and it rarely occurs in children older than 6. In Europe, retinoblastoma has an estimated incidence rate of 1 per 13,844 live births (14.1 per million children under the age of 5) with approximately 300 children diagnosed per year (Stacey et al. 2021). Preserving life and preventing the loss of an eye, blindness and other serious effects of treatment that reduce the patient’s life span or the quality of life, remains a challenge. In addition, children with retinoblastoma have been more likely to lose their eye and die of metastatic disease in low-resource countries.
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 140 patients to date in 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). More information on these clinical trials is available at Clinicaltrials.gov.
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 continuing to work closely with leading physicians and regulatory agencies to refine the Company’s clinical strategy for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma and the potential benefits achievable from the grant of orphan drug designation. 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 address the unmet medical needs for treatment of pediatric retinoblastoma, 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 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, 2023 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
Source: Theriva Biologics, Inc.
NEWS -- Lineage Cell Therapeutics to Present at the Maxim Group 2024 Virtual Healthcare Summit
CARLSBAD, Calif., October 14, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, Lineage’s Chief Executive Officer, will be presenting at the Maxim Group 2024 Virtual Healthcare Summit, in a fireside chat hosted by Jason McCarthy, Ph.D., Senior Managing Director, Head of Biotechnology Research. Lineage’s fireside chat will be available for viewing on Tuesday, October 15, 2024, at 11:00 a.m. ET, for registered conference attendees.
About the Maxim Group 2024 Healthcare Virtual Summit
Maxim Senior Analysts will host a wide range of biotechnology, diagnostic, medical device, and healthcare information technology companies in a series of presentations and interactive discussions with CEOs and key management as well as several topical industry panels. For more information on the event and to register, please visit the conference website: https://m-vest.com/events/healthcare-10152024.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241014461058/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://mailto://Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212) 845-4242
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