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NEWS -- Theriva™ Biologics Achieves Target Patient Enrollment in the VIRAGE Phase 2b Trial of VCN-01 with Gemcitabine/nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer
NEWS -- Oncolytics Biotech® Reports Favorable Results for BRACELET-1 Breast Cancer Study Reinforcing Path to Funding of a Registration-Enabling Study
SAN DIEGO and CALGARY, AB, Sept. 19, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced positive clinical results from BRACELET-1, its randomized Phase 2 study evaluating pelareorep in patients with HR+/HER2- advanced or metastatic breast cancer.
Full Press Release can be found here: https://www.prnewswire.com/news-releases/oncolytics-biotech-reports-favorable-results-for-bracelet-1-breast-cancer-study-reinforcing-path-to-funding-of-a-registration-enabling-study-302253060.html
NEWS -- Lineage Presents Preclinical Data on Its Auditory Neuronal Cell Transplant Program, ReSonance™, at the 59th Annual Inner Ear Biology Workshop
CARLSBAD, Calif., September 18, 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 reported that preclinical results with ReSonance (ANP1), the Company’s auditory neuronal cell transplant for the treatment of hearing loss, were presented at the 59th Annual Inner Ear Biology Workshop by Ofer Wiser, Ph.D. Senior Scientist, Technological Innovation at Cell Cure Neurosciences, Inc., the Company’s Israel-based subsidiary, which is responsible for research, process development, and good manufacturing practice (GMP) production.
"We are excited to report on the continued successful pre-clinical development of ReSonance, our first internally-developed cell transplant program, which we believe illustrates the efficiency and breadth of our technology platform," stated Brian Culley, Lineage CEO. "Building on the success of our OpRegen® RPE cell transplant candidate for dry AMD, our process development team generated new methods of differentiation which enabled us to create a new product candidate for hearing loss. We advanced from a product concept through the successful manufacture of the desired and specific cell type, generating new intellectual property, and thereafter advancing ANP1 into initial preclinical testing. An inherent aspect of our successful manufacturing efforts was the generation of a cryopreserved, ready to administer thaw-and-inject formulation at a clinically testable dose, which demonstrated successful engraftment and survival in a preclinical hearing loss model. Given the many challenges of reliably and affordably manufacturing cell and gene therapy product candidates, we are excited to highlight the progress Lineage has made in this area and believe our unique manufacturing capabilities will continue to provide us with a leading position in the cell transplant space."
Hearing loss is a significant unmet medical need and by 2050, nearly 2.5 billion people are estimated to be impacted by listening impairments across the globe. The loss of auditory nerve cells can lead to auditory neuropathy, even when hair cells and the cochlear nucleus remain intact. A cell-based therapy designed to replace lost or dysfunctional auditory neurons may restore hearing and enhance the degree of success of a cochlear implant procedure by repopulating the cochlea with transplanted, functional auditory neurons.
Preclinical testing of ANP1 is ongoing through a collaboration with the University of Michigan and Yehoash Raphael, Ph.D., The R. Jamison and Betty Williams Professor of Otolaryngology, Department of Otolaryngology-Head and Neck Surgery and Lab Director at the University of Michigan Kresge Hearing Research Institute.
Auditory neuropathy is a challenging hearing disorder in which the inner ear successfully detects sound but has a problem with sending signals from the ear to the brain, currently accounting for approximately 10% of cases of sensorineural hearing loss (SNHL) in children. Current state of the art medical knowledge suggests that auditory neuropathies play a substantial role in hearing impairments and deafness. Hearing depends on a series of complex steps that change sound waves in the air into electrical signals. The auditory nerve then carries these signals to the brain. Auditory neuropathy can be caused by a number of factors including damage to the auditory neurons or loss of these neurons. Researchers are still seeking effective treatments for those affected with auditory neuropathy.
The 59th Annual Inner Ear Biology Workshop presentation is now available on the Events and Presentations section of Lineage’s website.
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.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "aim," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "can," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "tend to," or the negative version of these words and similar expressions. 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 potential use of ANP1 to restore hearing or enhance the degree of success of a cochlear implant procedure; the broad potential for Lineage’s regenerative medicine platform and Lineage’s ability to advance and expand the same, including Lineage’s ability to manufacture new specific and differentiated cell types on anticipated timelines and budgets; the potential for Lineage’s investigational allogeneic cell therapies to generate clinical outcomes beyond the reach of traditional methods, including gene therapy, and provide safe and effective treatment for multiple, diverse serious or life threatening conditions; and the potential of our platform technology and/or manufacturing capabilities to create success in the cell transplant space. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that OpRegen may never be proven to provide durable anatomical functional improvements in dry-AMD patients, that the ongoing Israel-Hamas war may materially and adversely impact our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (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 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/20240918699918/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 Showcases New Interim ReSPECT-GBM Phase 2 Trial Data at the 2024 Congress of Neurological Surgeons Annual Meeting
Company to present new data, highlighting progress in its therapeutics program for recurrent glioblastoma (rGBM)
AUSTIN, Texas, Sept. 18, 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, will present data at the 2024 Congress of Neurological Surgeons (CNS) Annual Meeting September 28 - October 2, in Houston, Texas.
Presentation:
Title Treatment of Recurrent Glioblastoma (rGBM) via Convection Enhanced Delivery (CED) with Rhenium (186Re) Obisbemeda (Rhenium-186 Nanoliposome, 186RNL): ReSPECT-GBM Phase 2 Trial Update
Presenter John Floyd, M.D., Associate Professor and Chairman Neurosurgery, UT Health Science San Antonio
Date/Time Monday, 30 September 2024, 7:00-08:30 a.m. CDT
Location George R. Brown Convention Center, Room 310C
About Recurrent Glioblastoma (GBM)
GBM affects approximately 15,000 patients annually in the U.S. and is the most common and lethal form of brain cancer. The average life expectancy with GBM is less than 24 months, with a one-year survival rate of 40% and a five-year survival rate of around 5%. There is no clear standard of care for recurrent GBM and the few currently approved treatments provide only marginal survival benefit and are associated with significant side effects, which limit dosing and prolonged use. Approximately 90% of patients experience GBM tumor recurrence at or near the original tumor location, yet there are no FDA-approved treatments in the recurrent or progressive setting that can significantly extend a patient’s life.
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 Convection-Enhanced Delivery
Convection Enhanced Delivery (CED) is a therapeutic strategy that was developed to facilitate targeted delivery of pharmaceuticals to the brain. The CED procedure involves a minimally invasive surgical exposure of the brain, followed by placement of small diameter catheters directly into the brain tumor.
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,” “anticipating,” “planning” 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 Rhenium (186Re) Obisbemeda including the ability of Rhenium (186Re) Obisbemeda 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, ReSPECT-LM and ReSPECT-PBC, clinical trials; possible negative effects of Rhenium (186Re) Obisbemeda; the continued evaluation of Rhenium (186Re) Obisbemeda including through evaluations in additional patient cohorts; the intended functions of the Company’s platform and expected benefits from such functions; and the development, utility and potential of the CNSide leptomeningeal metastases diagnostic test.
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, 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, 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.
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 Debut its Next Generation Robot at CES 2025
Realbotix to Debut its Next Generation Robot at CES 2025
Realbotix Corp. (TSX-V: XBOT | Frankfurt Stock Exchange: 76M | OTC: XBOTF) (“Realbotix” or the “Company”), a leading creator of humanoid robots and companionship-based AI, will debut its next-generation ultra-realistic humanoid robot on January 7th, 2025, the first day of the Consumer Electronics Show (CES) 2025.
CES is one of the largest and most influential technology expos in the world. The event is renowned for showcasing cutting-edge innovations across various industries, drawing over 170,000 attendees annually, including leaders in technology, media, and business from around the globe. The show takes place in Las Vegas, Nevada, between January 7th to 10th.
In addition to unveiling a new robot, Realbotix will also be showcasing “Aria”, its flagship robot and Brand Ambassador known for its advanced AI capabilities and human-like interactions. Aria will have new upgraded AI and language capabilities that will make her interactions with CES attendees memorable and impactful.
“We’re incredibly excited to debut our next-generation humanoid robot at CES 2025,” said Andrew Kiguel, CEO. ”This marks a significant milestone in our mission to blend advanced AI with lifelike design, creating meaningful connections between humans and technology. Aria has been a trailblazer, and we look forward to showcasing the future of companionship and interaction through our latest innovations.”
Realbotix invites all CES attendees to visit our booth to experience firsthand how Realbotix is shaping the future of robotics and human connection. Our team will be available for live demonstrations and discussions about how our technology is pushing the boundaries of AI-powered companionship and social interaction.
To learn more about Realbotix click here.
About Realbotix
Transcending the barrier between man and machine, Realbotix creates customizable, full-bodied, human-like robots with AI integration that improve the human experience through learning, connection and play. Manufactured in Nevada, USA, Realbotix has built a reputation for having the highest quality humanoid robots and the most realistic silicone skin technology 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://www.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 digital avatar on Instagram and TikTok.
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as “may”, “will”, “plan”, “expect”, “anticipate”, “estimate”, “intend” and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at www.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
View source version on businesswire.com: https://www.businesswire.com/news/home/20240912059801/en/
NEWS -- Theriva™ Biologics Awarded Manufacturing Funding from the Spanish Government’s National Knowledge Transfer Program
Theriva Biologics and the Universitat Autònoma de Barcelona to receive a total of €2.28 Million to support the THERICEL project, a suspension cell platform for manufacturing viral-based therapies
ROCKVILLE, Md., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), (“Theriva” or the “Company”) a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the THERICEL project has been awarded funding of €2.28 million from the National Knowledge Transfer Program of the Spanish government’s Ministry of Science, Innovation & Universities to support a collaboration between the Company and the Universitat Autònoma de Barcelona (UAB) to advance the Company’s suspension cell platform for the clinical manufacture of adenovirus- and adeno-associated virus (AAV) therapies. Under the award, Theriva will receive a loan of €1.33 million as a lump sum payment in Q4 2024 which shall be repaid over 7 years commencing three years from the date of award and UAB will receive a grant of €0.95 million dedicated to the THERICEL project and paid in annual installments over the next 3 years.
The THERICEL project is intended to establish the viability of using proprietary Theriva’s A549 suspension cell platform for the clinical manufacture of adenoviral and AAV therapies. Suspension cell manufacture is expected to dramatically increase efficiency and decrease the cost of manufacturing compared to currently used adherent cell platforms. Theriva efforts under the award will focus on scaling-up the manufacture of VCN-01, the Company’s lead oncolytic virus product candidate currently undergoing Phase 2b clinical evaluation in patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). UAB researchers will evaluate the potential utility of the suspension cell line for the manufacture of AAV products for use in gene therapy.
“We are honored to receive this funding award, which provides additional capital and external validation of our therapeutic approach,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “This award will accelerate the start-up for our innovative suspension cell platform, which we believe will further position Theriva at the forefront of oncolytic virus development and may provide collaborative opportunities in product manufacture. Together with our collaborators at the Universitat Autònoma de Barcelona, we look forward to working towards our shared mission of addressing the high unmet needs of patients.”
The Ministry of Science, Innovation & Universities funding was obtained through a competitive review process under a State scientific and technical innovation plan to support public-private collaborative projects (Proyectos en colaboración público-privada 2023). Funding for Theriva is awarded in the form of an unsecured loan at an interest rate of 4.015%, with a fixed 3-year grace period before the first repayment is due along with accrued interest. After the grace period, the maximum repayment period is 7 years.
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 potential of Theriva’s suspension cell platform to dramatically increase efficiency and decrease the cost of manufacturing of virus and AAV therapies, Theriva receiving a loan of €1.33 million as a lump sum payment in Q4 2024 and UAB receiving a total of €0.95 million paid in annual installments over the next 3 years; the THERICEL project establishing the viability of using proprietary Theriva’s A549 suspension cell platform for the clinical manufacture of adenoviral and AAV therapies; suspension cell manufacture dramatically increasing efficiency and decreasing the cost of manufacturing compared to currently used adherent cell platforms; the award accelerating the start-up for the Company’s innovative suspension cell platform; the award further positioning Theriva at the forefront of oncolytic virus development and providing collaborative opportunities in product manufacture; and working with collaborators at UAB towards the shared mission of addressing the high unmet needs of patients. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to accelerate the start-up for its innovative suspension cell platform; the Company’s ability to utilize the award funding successfully; the Company’s and VCN’s ability to reach clinical milestones when anticipated, including the ability of the suspension cell platform to manufacture virus and AAV products at appropriate the required quality and scale for clinical use, generating 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 -- Scorpius Holdings Commends the U.S. House of Representatives’ Passage of the BIOSECURE Act
Scorpius Poised to Support Expanded U.S. Government-Backed Project Pipeline as U.S. Drugmakers Seek to Shift to Domestic Suppliers Amid Industry-Changing Legislation
DURHAM, N.C., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization ("CDMO"), today commended the U.S. House of Representatives on the passage of the BIOSECURE Act (the “Act”), a pivotal piece of legislation passed with strong bipartisan support following a 306-81 vote earlier this week.
The Act is designed to ensure the security of America’s pharmaceutical supply chain, strengthen national biosecurity, and improve overall preparedness for future public health emergencies. The Act now moves to the U.S. Senate, representing a critical step in bolstering the country's biotechnology and biomanufacturing infrastructure to ensure long-term public health resilience in the face of challenges from America’s adversaries.
The BIOSECURE Act aims to secure the U.S. pharmaceutical supply chain by restricting U.S. Government-funded drug developers from contracting with select China-based biomanufacturing companies of concern for production of their drugs. The Act is designed to reduce U.S. dependence on foreign owned and operated biomanufacturing supply chains which will enhance national security and generate more on-shoring jobs focused on improving robustness in us health care systems.
Jeff Wolf, CEO of Scorpius, stated, “We owe a debt of gratitude to Reps. Wenstrup, Krishnamoorthi, and Moolenaar for their leadership in advancing the BIOSECURE Act, that enhances America’s health security and protects our supply chain from foreign threats. The BIOSECURE Act enables Scorpius to leverage our expertise and resources to support America’s biopharmaceutical companies that collaborate with the U.S. Government in the production of their drugs. We believe that our cutting-edge biomanufacturing expertise, purpose-built capabilities, combined with our modern US-based production facilities gives us a distinct advantage in addressing the changing demands of biopharmaceutical companies and government agencies tasked with managing biological threats. We are fully dedicated to fast-tracking the development of medical countermeasures and delivering scalable, forward-thinking solutions that protect public health and reinforce national security.
"The BIOSECURE Act enhances our ability to deliver impactful, timely responses in critical moments of need. With the passage of the BIOSECURE Act, we foresee significant opportunities to further expand our already robust pipeline of projects. As a result of this legislation, we expect a growing demand for domestic production capabilities and biomanufacturing services, positioning Scorpius as a key partner for pharmaceutical companies navigating these changes,” concluded Mr. Wolf.
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 the BIOSECURE Act representing a pivotal opportunity for Scorpius to leverage its expertise and resources to support America’s biopharmaceutical companies who are responding to indications of interest to the U.S. Government in the production of their drugs; the Company’s cutting-edge biomanufacturing expertise, purpose-built capabilities, combined with its modern US-based production facilities, giving it a distinct advantage in addressing the changing demands of biopharmaceutical companies and government agencies tasked with managing biological threats; the legislation enhancing the Company’s ability to deliver impactful, timely responses in critical moments of need; the passage of the BIOSECURE Act resulting in significant opportunities to further expand the Company’s already robust pipeline of projects; positioning Scorpius as a key partner for pharmaceutical companies navigating the changes from the expected growing demand for domestic production capabilities and biomanufacturing services; and the Company’s advanced facilities and expertise making it well-equipped to meet the increasing need for reliable, secure supply chains in the U.S., further strengthening the Company’s position in the market. 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 form the BIOSECURE Act; 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 Selected for Rapid Response Partnership Vehicle (RRPV) to Accelerate Medical Countermeasure Development in Support of BARDA
September 09 2024 - 8:30AM
GlobeNewswire
Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization ("CDMO"), today announced that it has been selected as a member of the Biomedical Advanced Research and Development Authority’s (BARDA) Rapid Response Partnership Vehicle (RRPV). The RRPV supports BARDA in its mission to accelerate the development of medical countermeasures (MCMs) to address emerging biological threats such as pandemic influenza, infectious diseases, and other public health emergencies.
As an active member of the RRPV, Scorpius will collaborate with BARDA and other federal partners to support MCM product and technology development in critical areas such as vaccines and therapeutics. Scorpius’ extensive capabilities in biomanufacturing and its state-of-the-art production facilities should uniquely position it to meet the evolving needs of government agencies tasked with responding to biological threats.
“We are honored to have been selected for the Rapid Response Partnership Vehicle,” said Jeff Wolf, CEO of Scorpius Holdings. “This opportunity allows us to leverage our manufacturing capabilities to support BARDA, the US government, and groups that service the US government in rapidly addressing public health emergencies. Our team is committed to accelerating the development of medical countermeasures and delivering scalable solutions to protect public health and national security.”
Scorpius’ facilities are equipped to handle the production of biological products, offering both standard and custom solutions for the development of biopharmaceuticals. The company's manufacturing platform is designed for flexibility, enabling swift responses to emerging health threats. By becoming part of the RRPV, Scorpius expects to play an important role in ensuring preparedness for future public health emergencies such as pandemics and other biological risks.
BARDA, a division of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR), works to support the development of medical countermeasures such as vaccines, drugs, and diagnostic tools to counteract health security threats. The inclusion of Scorpius in the RRPV highlights the company’s ability to innovate in the rapidly evolving landscape of biomanufacturing.
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 the collaboration expediting the development of critical solutions for public health threats, including pandemic preparedness and emerging infectious diseases; Scorpius collaborating with BARDA and other federal partners to support MCM product and technology development in critical areas such as vaccines and therapeutics; Scorpius’ extensive capabilities in biomanufacturing and its state-of-the-art production facilities uniquely positioning it to meet the evolving needs of government agencies tasked with responding to biological threats; the opportunity allowing the Company to leverage our manufacturing capabilities to support BARDA, the US government, and groups that service the US government in rapidly addressing public health emergencies; Scorpius playing an important role in ensuring preparedness for future public health emergencies such as pandemics and other biological risks by becoming part of the RRPV Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of the Company to, due to the collaboration, expedite the development of critical solutions for public health threats, including pandemic preparedness and emerging infectious diseases; 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 -- Oncolytics Biotech® to Participate in Fireside Chats at Two Investment Conferences in September
SAN DIEGO and CALGARY, AB, Sept. 6, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Chief Financial Officer Kirk Look will participate in a fireside chat at the H.C. Wainwright 26th Annual Global Investment Conference, which is taking place September 9-11, 2024 at the Lotte New York Palace Hotel in New York, NY. Chief Medical Officer Tom Heineman, M.D., Ph.D., will participate in a fireside chat at the 2024 Cantor Global Healthcare Conference, which is taking place September 17-19, 2024 at the InterContinental New York Barclay Hotel in New York, NY. Additional details on the fireside chats can be found below.
Event: H.C. Wainwright 26th Annual Global Investment Conference
Date: Wednesday, September 11, 2024
Time: 9:00 a.m. ET
Location: Lotte New York Palace Hotel, Holmes I Room - 4th Floor
Webcast Link: Available by clicking here
Event: Cantor 2024 Global Healthcare Conference
Date: Thursday, September 19, 2024
Time: 10:55 a.m. ET
Location: InterContinental New York Barclay Hotel, Track 6 Morgan Suite
Webcast Link: Available by clicking here
Company management will also be participating in one-on-one investor meetings at the conferences. To schedule a meeting, please submit a request on the conference website, contact your H.C. Wainwright or Cantor Fitzgerald representative, or email jpatton@oncolytics.ca.
Webcasts of the Company's presentations will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived for three months.
About Oncolytics Biotech Inc.
Oncolytics is a 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 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
View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-fireside-chats-at-two-investment-conferences-in-september-302240554.html
SOURCE Oncolytics Biotech® Inc.
Otcmarkets website was glitchy all day yesterday as well.
NEWS -- Plus Therapeutics to Present at the H.C. Wainwright 26th Annual Global Investment Conference
AUSTIN, Texas, Sept. 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, today announced that Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer will present a corporate overview at the H.C. Wainwright 26th Annual Global Investment Conference. The conference is being held on September 9 – 11, 2024 at the Lotte New York Palace Hotel.
Presentation Time: Monday, September 9, 2024, available on-demand starting at 7:00 AM ET
Webcast Link: Here
A replay of this presentation will be available for 90 days following the date of the presentation on the Company’s website at: https://ir.plustherapeutics.com/events
Management will be available for one-on-one meetings at the conference. To request a meeting and to register for the conference, click here: https://hcwevents.com/annualconference/
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,” “anticipating,” “planning” 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 Rhenium (186Re) Obisbemeda including the ability of Rhenium (186Re) Obisbemeda 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, ReSPECT-LM and ReSPECT-PBC, clinical trials; possible negative effects of Rhenium (186Re) Obisbemeda; the continued evaluation of Rhenium (186Re) Obisbemeda including through evaluations in additional patient cohorts; the intended functions of the Company’s platform and expected benefits from such functions; and the development, utility and potential of the CNSide leptomeningeal metastases diagnostic test.
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, 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, 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.
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 -- FuelPositive Closes Final Tranche of Private Placement
FuelPositive Corporation (TSX.V: NHHH) (OTCQB: NHHHF) (the "Company") announces that it has closed a non-brokered private placement (the “Offering”) and has issued 8,925,055 units (each, a “Unit”) at a price of $0.055 per Unit for gross proceeds of $490,878. Each “Unit” consists of one common share of the Company, and one common share purchase warrant exercisable at a price of $0.07 until August 29, 2029.
The Offering represents the final tranche of the placement previously announced by the Company on May 28, 2024.
No finders’ fees or commissions were paid in connection with completion of the Offering. All securities issued in connection with the Offering are subject to restrictions on resale until December 30, 2024 in accordance with applicable securities laws.
About FuelPositive Corporation
FuelPositive is a Canadian technology company dedicated to delivering commercially feasible and sustainable clean technology solutions that follow a circular approach, ensuring the entire lifecycle of our products is environmentally friendly. This includes an on-farm/onsite, containerized Green Ammonia (NH3) production system that effectively eliminates carbon emissions during the production process.
By focusing on technologies that are clean, sustainable, economically advantageous and realizable, the Company aims to help mitigate climate change, addressing unsustainable agricultural practices through innovative technology and practical solutions that can be implemented now. The FuelPositive on-farm/onsite, containerized Green Ammonia production system is designed to produce pure, anhydrous ammonia for multiple applications, including fertilizer for farming, fuel for grain drying and internal combustion engines, a practical alternative for fuel cells and a solution for grid storage. Green Ammonia is also considered a key enabler of the hydrogen economy.
FuelPositive systems are designed to provide for Green Ammonia production on-farm/onsite, where and when needed. This eliminates wildly fluctuating supply chains and offers end-users clean fertilizer, energy and Green Ammonia supply security while eliminating carbon emissions from the production process. The first customers will be farmers. Farmers use 80% of the traditional grey ammonia produced today as fertilizer.
See purchasing details here: https://fuelpositive.com/sales/.
FuelPositive Corporation is based in Waterloo 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.
For further information, please contact:
Ian Clifford
Co-Founder, Chief Executive Officer and Board Chair
mailto://Ian@fuelpositive.com
Tel: 416.535.8395
https://www.fuelpositive.com
Jodee Mason
Senior Account Director
Counsel Public Affairs, Inc.
mailto://jmason@counselpa.com
Tel: 204.898.7183
https://www.counselpa.com
Investor Relations United States & International:
RB Milestone Group (RBMG)
mailto://fuelpositive@rbmilestone.com
Investor Relations Canada:
Transcend Capital Inc.
mailto://et@transcendcapitalinc.com
Cautionary Statement
Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accept responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) that are based on expectations, estimates and projections as of the date of this news release. The information in this release about future plans and objectives of the Company, including with respect to further testing and implementation of the FP300 system, 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.
NEWS -- FuelPositive Approaches Activation as Strategic Alliances Strengthen
WINNIPEG, MB, Aug. 26, 2024 /CNW/ - FuelPositive Corporation (TSXV: NHHH) (OTCQB: NHHHF) (the "Company") is pleased to provide a comprehensive update highlighting significant progress as the Company closes in on system activation and broadens its network of strategic partners.
Key Highlights:
NEWS -- Scorpius Holdings CEO Provides Corporate Update; Highlights Expanding Sales Pipeline, Enhanced Manufacturing Capabilities, and Path Toward Positive Cash Flow
Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization ("CDMO"), today released a letter to shareholders from its CEO Jeff Wolf:
"We are excited to share an update on Scorpius as we continue to position the company to take a lead role in catering to the rapidly growing biologic and cell therapy markets. Over the past several years, we have made significant investments designed to establish Scorpius as a leading biologic manufacturing CDMO. Notably, we have expanded our mammalian and microbial production capability to enable us to offer a broad range of biologic manufacturing services to our customers. Our robust investments and ongoing efforts have already resulted in a threefold increase in revenue for the first half of 2024. Our current sales pipeline now includes more than $100 million in weighted opportunities across the biopharmaceutical and government sectors.
Given the extensive opportunities before us, we recently completed a financing, raising approximately $14.4 million in gross proceeds. These funds will enable us to better service our existing clients as well as attract larger prospective customers as we diversify our customer base with a strong mix of commercial and government opportunities. Additionally, we have started transitioning several key clients from the process development phase into full-scale manufacturing, enabling an additional revenue stream and marking a significant shift in our operational focus.
We believe that Scorpius is now exceptionally well-positioned to service new and existing clients, expand its service offering and achieve positive cash flow in the near future. Given these overarching goals, we are taking steps to align senior executive compensation with our growth objectives, contingent on meeting sales targets and booking goals.
We’ve built and staffed a state-of-the-art CDMO with a scalable and high-margin business model. Scorpius’ profile and reputation for quality biomanufacturing is indeed growing in the industry. With the closing of this financing, we are now well positioned to deliver significant returns to our shareholders in the years to come."
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 position the Company to take a lead role in catering to the rapidly growing biologic and cell therapy markets, the current sales pipeline now including more than $100 million in weighted opportunities across the biopharmaceutical and government sectors, the funds raised enabling the Company to better service its existing clients as well as attract larger prospective customers the Company being well-positioned to service new and existing clients, expand its service offering and achieve positive cash flow in the near future and being well positioned to deliver significant returns to the Company’s shareholders in the years to come. Important factors that could cause actual results to differ materially from current expectations include, among others, 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 Achieves 16% Year-Over-Year Increase in Revenue for the Second Quarter of 2024
Reduces operating expenses by 25%
Pipeline surpasses $100 million in weighted opportunities across the government and manufacturing sectors
DURHAM, N.C., Aug. 20, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization (“CDMO”), today provided strategic, financial, and operational updates for the second quarter ended June 30, 2024.
Jeff Wolf, CEO of Scorpius Holdings, Inc., stated, “We are extremely proud of the progress Scorpius achieved in the second quarter of 2024. Despite facing a quarter with significant working capital challenges, our revenues still increased by 16% and we reduced our operating expenses by 25% over the same period last year. With our recently completed financing, we now have a much stronger balance sheet to capitalize on a number of exciting projects in front of us. We anticipate this funding will not only allow us to accelerate our revenue growth but should enable us to achieve our goal of positive cash flow.”
“Our success this year highlights the significant progress we’ve made in both innovation and customer-focused program management across our service platforms. This progress is most clearly reflected in the strength of our pipeline, which now surpasses $100 million in weighted opportunities across the government and manufacturing sectors. We anticipate closing many of these opportunities by year’s end. As we look ahead, we are confident in our ability to sustain this momentum as we continue to execute our strategic initiatives and deliver value to our shareholders.”
Second Quarter 2024 Financial Results
For the three months ended June 30, 2024, the Company recognized $0.8 million of revenue, primarily from process development, compared to $0.7 million of process development revenue recognized in the 2023 comparable quarter. The increase in process development revenue is attributable to the completion of services over a larger number of customer contracts.
Cost of revenues were $0.8 million and $0.4 million for the three months ended June 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 $3.6 million for the three months ended June 30, 2024, compared to $5.2 million for the three months ended June 30, 2023.
Selling, general and administrative expenses were $5.0 million and $7.0 million for the three months ended June 30, 2024, and 2023, respectively. The decrease of $2.0 million was primarily due to decreases in consultant services of $1.1 million, professional services of $0.4 million, sales and marketing of $0.2 million, and stock-based compensation of $0.3 million.
For the three months ended June 30, 2024, there was no change in fair value of contingent earn-out receivable, related party.
Total non-operating expense was ($0.6) million for the three months ended June 30, 2024, which primarily consisted of $0.6 million from the loss on disposal of leasehold improvements, $0.2 million of interest expense on finance leases, partially offset by $0.2 million from gain on partial extinguishment of debt. Total non-operating expense was ($0.2) million for the three months ended June 30, 2023, which primarily consisted of ($0.2) million of interest expense, ($0.1) million of loss on disposal of equipment, partially offset by ($0.1) million of interest income.
Net loss attributable to Scorpius was approximately $8.9 million, or ($26.98) per basic and diluted share, for the three months ended June 30, 2024, compared to approximately $13.9 million, or ($106.67) per basic and diluted share, for the three months ended June 30, 2023.
As of June 30, 2024, the Company had approximately $1.5 million in cash and cash equivalents and short-term investments. As of August 19, 2024, the Company’s cash and cash equivalents and short-term investments were approximately $13.2 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 being able to capitalize on a number of exciting projects in front of the Company, the funding allowing the Company to accelerate its revenue growth and enable it to achieve its goal of positive cash flow, the Company’s pipeline, surpassing $100 million in weighted opportunities across the government and manufacturing sectors, the closing of many of the pipeline opportunities by year’s end, and the Company’s ability to sustain the momentum as it continues to execute its strategic initiatives and deliver value to its shareholders. Important factors that could cause actual results to differ materially from current expectations include, among others, 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, Inc. Announces Closing of Public Offering
Scorpius Holdings, Inc. (NYSE American: SCPX), (“Scorpius”, or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced the closing of its underwritten public offering of 14,375,000 shares of common stock (and/or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof), including full exercise of the underwriter’s over-allotment option. Each share of common stock (or Pre-Funded Warrant) was offered at a public offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price), for gross proceeds of $14,375,000, before deducting underwriting discounts and offering expenses.
The Company intends to use the net proceeds of the offering to fund working capital and for general corporate purposes.
ThinkEquity acted as sole book-running manager for the offering.
A registration statement on Form S-1 (File No. 333-280887) relating to the securities being offered was filed with the Securities and Exchange Commission (“SEC”) and became effective on August 6, 2024. This offering is being made only by means of a prospectus. Copies of the final prospectus may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus has been filed with the SEC and is available on the SEC’s website located at http://www.sec.gov.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated large molecule 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 Statements
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 intended use of proceeds. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to complete the proposed offering, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly report on Form 10-Q 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 press release on account of new information, future events, or otherwise, except as required by law.
For Investor Relations Inquiries:
David Waldman
+1 (919)-289-4017
mailto://investorrelations@nighthawkbio.com
NEWS -- Theriva Biologics Announces Reverse Stock Split
ROCKVILLE, Md., Aug. 16, 2024 (GLOBE NEWSWIRE) -- Theriva Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, announced today a reverse stock split of its issued and outstanding common stock, par value $0.001 per share, at a ratio of one (1) share of common stock for every twenty five (25) shares of common stock, effective as of 12:01 a.m. (Eastern Time) on August 26, 2024 (the “Effective Date”). The Company’s common stock will begin trading on a split-adjusted basis when the market opens on August 26, 2024. The reverse stock split was authorized by the Company’s Board of Directors on August 15, 2024. Pursuant to the laws of the State of Nevada, the Company’s state of incorporation, the Company’s Board of Directors has the authority to effect a reverse stock split without shareholder approval if the number of authorized shares of common stock and the number of outstanding shares of common stock are proportionally reduced. The Company will file a certificate of change to its articles of incorporation, as amended, with the Secretary of State of Nevada to effect the reverse stock split. The Company’s common stock will continue to trade on the NYSE American under the stock ticker “TOVX” but will trade under the new CUSIP number 87164U 508.
As a result of the reverse split, each twenty five (25) pre-split shares of common stock outstanding will automatically combine into one (1) new share of common stock without any action on the part of the holders, and the number of outstanding common shares will be reduced from 25,131,230 shares to 1,005,249 shares without taking into account fractional shares.
The reverse stock split is being effected to ensure that the Company can meet the per share price requirements of the NYSE American, the Company's current listing exchange.
No fractional shares will be issued as a result of the reverse stock split. Shareholders who otherwise would be entitled to a fractional share because they hold a number of shares not evenly divisible by the 1 (one) for twenty five (25) reverse split ratio, will automatically be entitled to receive an additional fractional share of the Company’s common stock to round up to the next whole share.
The Company’s transfer agent, Equiniti Trust Company, which is also acting as the exchange agent for the reverse split, will send instructions to stockholders of record who hold stock certificates regarding the exchange of their old certificates for new certificates, should they wish to do so. Stockholders who hold their shares in brokerage accounts or “street name” are not required to take action to effect the exchange of their shares.
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 our planned stock split. 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 stock split having the desired effect, the ability to continue to enroll patients as planned, generating 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
NEWS -- Realbotix Corp. to Release its Financial Results for Q3-2024 on August 28, 2024
TORONTO--(BUSINESS WIRE)--Realbotix Corp. (TSX-V: XBOT | Frankfurt Stock Exchange: 76M | OTC: XBOTF) (“Realbotix” or the “Company”), a leading creator of humanoid robotics and relationship-based AI, is pleased to share that it will release its financial results for the three and nine months ended June 30, 2024 (“Q3-2024”) on August 28, 2024.
An investor webinar hosted by CEO Andrew Kiguel on Zoom has been scheduled to discuss the Company’s Q3 2024 financial results starting at 1:00 pm ET on August 28, 2024.
Date: August 28, 2024
Time: 1:00 p.m. ET
Zoom Webinar Registration: https://us06web.zoom.us/webinar/register/WN_TjbW3o4WTr6xRrLkISqc-Q
To join the webinar, register using the link provided above. Upon registration a Zoom link will be emailed to the registered email address. The webinar will be available via computer, tablet, and smartphone devices. In addition, a dial-in phone number will be provided in the email upon registration. Callers dialing in using a telephone will automatically be placed in a listen only mode. The question period will not be available to dial-in callers.
About Realbotix
Transcending the barrier between man and machine, Realbotix creates customizable, full-bodied, human-like robots with AI integration that improve the human experience through learning, connection and play. Manufactured in Nevada, USA, Realbotix has built a reputation for having the highest quality humanoid robots and the most realistic silicone skin technology 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 digital avatar on Instagram and TikTok.
Forward-Looking Statements
This news release includes certain forward-looking statements as well as management’s objectives, strategies, beliefs and intentions. Forward looking statements are frequently identified by such words as “may”, “will”, “plan”, “expect”, “anticipate”, “estimate”, “intend” and similar words referring to future events and results. Forward-looking statements are based on the current opinions and expectations of management. All forward-looking information is inherently uncertain and subject to a variety of assumptions, risks and uncertainties, including the speculative nature of cryptocurrencies, as described in more detail in our securities filings available at www.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.
Contacts
Realbotix Corp.
Andrew Kiguel, CEO
Email: mailto://contact@realbotix.ai
Jennifer Karkula, Head of Communications
Email: mailto://contact@realbotix.ai
Telephone: 647-578-7490
Again with the $1 a share. Wouldn't they have gobbled it up at $2 or even $3 a share?
NEWS -- Scorpius Holdings, Inc. Announces Pricing of Public Offering
DURHAM, N.C., Aug. 16, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc. (NYSE American: SCPX), (“Scorpius”, or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced the new pricing of an underwritten public offering of 12,500,000 shares of common stock (or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof). Each share of common stock (or Pre-Funded Warrant) is being offered at a public offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price). The gross proceeds to the Company from the offering are expected to be approximately $12,500,000, before deducting underwriting discounts and offering expenses. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 1,875,000 shares of common stock and/or Pre-Funded Warrants solely to cover over-allotments, if any. As previously announced, the Company had terminated the pricing of its underwritten public offering that it had announced on August 6, 2024. Subsequently, the Company requested, and the NYSE American approved, a financial viability exception to the NYSE American stockholder approval rules that would allow the Company to proceed with the closing of the underwritten public offering upon the terms set forth above.
The offering is expected to close on August 19, 2024, subject to satisfaction of customary closing conditions and trading of the Company’s common stock on the NYSE American is expected to resume that same day.
The Company intends to use the net proceeds of the offering to fund working capital and for general corporate purposes.
ThinkEquity is acting as sole book-running manager for the offering.
A registration statement on Form S-1 (File No. 333-280887), as amended, including a preliminary prospectus, relating to the securities being offered was filed with the Securities and Exchange Commission (“SEC”) and became effective on August 6, 2024. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated large molecule 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 Statements
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 timing and completion of the proposed offering, the timing that trading will resume and the intended use of proceeds. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to complete the proposed offering, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly report on Form 10-Q 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 press release on account of new information, future events, or otherwise, except as required by law.
For Investor Relations Inquiries:
David Waldman
+1 (919)-289-4017
mailto://investorrelations@nighthawkbio.com
NEWS -- Lineage Cell Therapeutics to Present at the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference
CARLSBAD, Calif., August 13, 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 H.C. Wainwright 4th Annual Ophthalmology Virtual Conference being held on Thursday, August 15, 2024. Lineage’s presentation will be available for viewing on-demand, beginning on Thursday, August 15, 2024, at 7:00am ET, for registered conference attendees.
Interested parties can also register to view a replay of the presentation on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, "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) 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/20240813574683/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Plus Therapeutics Presents Positive Clinical Trial Results at the 2024 SNO/ASCO CNS Metastases Conference
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, presented data from the FORESEE study of its CNSide platform for the diagnosis and management of LM. The data were presented in a podium presentation at the 2024 Society for NeuroOncology (SNO)/American Society for Clinical Oncology (ASCO) CNS Metastases Conference August 8-10, 2024 in Denver, Colorado.
The study, titled “A Therapy Treatment Response Trial in Patients with Leptomeningeal Metastases (LM) Using CNSide (FORESEE Study, NCT05414123),” was a prospective, multi-center observational trial enrolling 39 patients with Breast (21 patients) or Non-Small Cell Lung Cancer (18 patients) with a suspected or confirmed diagnosis of LM. The primary endpoint of the study assessed how CNSide test results influenced clinical decision-making. Secondary endpoints assessed CNSide vs. the gold standard of LM diagnosis, CSF cytology, and its use for personalization of treatment selection based on tumor molecular phenotype. The study was presented by Priya U. Kumthekar, M.D., Associate Professor of Neurology and Medicine at Northwestern University and FORSEE Trial Principal Investigator.
Key results from the FORESEE trial:
Due to a trading halt, as of Friday, August 9, 2024, and until further notice, Scorpius Holdings, Inc., (CUSIP 42237K508) is no longer eligible for stock loan or collateral pledge at OCC (The Foundation for Secure Markets). Only share reducing transactions will be allowed on outstanding stock loan and borrow positions. Any equity pledges for collateral purposes will receive no value. If you have any questions regarding this memo, please contact your firm’s designated credit risk representative.
NEWS -- Plus Therapeutics Presents Positive Interim ReSPECT-LM Phase 1 Data for Leptomeningeal Metastases at 2024 SNO/ASCO CNS Metastases Conference
Respect-LM dosing shows continued feasibility and safety of up to 44 mCi of intrathecal Rhenium (186Re) Obisbemeda
High absorbed radiation doses, mean circulating tumor cell reductions, and median overall survival of 12 months continue to show clinical promise
AUSTIN, Texas, Aug. 12, 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, presented data in a podium presentation updating the progress of its ReSPECT-LM clinical trial of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) in leptomeningeal disease (LM). The data were presented at the 2024 Society for NeuroOncology (SNO)/American Society for Clinical Oncology (ASCO) CNS Metastases Conference August 8-10, 2024 in Denver, Colorado.
The presentation, titled, “Phase 1 Dose Escalation of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) for the Treatment of Leptomeningeal Metastases (LM): Ongoing Clinical Study Update for Initial Safety and Feasibility,” provided a safety and efficacy update on the single dose trial for the first 4 cohorts (n = 16 patients). The trial is currently enrolling in Cohort 5. The study was presented 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 ReSPECT-LM highlights through Cohort 4:
NEWS -- Scorpius Holdings, Inc. Provides Update on its Previously Announced Public Offering
August 09 2024 - 3:38PM
Scorpius Holdings, Inc. (NYSE American: SCPX), (“Scorpius”, or the “Company”), an integrated contract development and manufacturing organization (CDMO), today announced a delay in its previously announced public offering. The Company has requested, and the NYSE has approved, a financial viability exception to the NYSE American shareholder approval rules that would allow it to proceed with the closing of an underwritten public offering. The Company intends to pursue the sale of 12,500,000 shares of common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof, exclusive of the over-allotment option) at a price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price). The underwriting agreement was terminated in connection with the previously announced offering and a new underwriting agreement will be entered into if the offering is consummated. There can be no assurance that the Company will be able to consummate an offering under these terms or otherwise. The Company will adhere to all applicable provisions relating to the exemption, as outlined in Section 710 of the NYSE American Company Guide, and a closing is intended to occur ten days following the mailing of a notification letter to the Company’s shareholders.
The Company intends to use the net proceeds of the offering to fund working capital and for general corporate purposes.
ThinkEquity is acting as sole book-running manager for the offering.
A registration statement on Form S-1 (File No. 333-280887), as amended, including a preliminary prospectus, relating to the securities being offered was filed with the Securities and Exchange Commission (“SEC”) and became effective on August 6, 2024. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated large molecule 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 Statements
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 repricing of the offering, the ability to consummate an offering under the specified terms or otherwise the timing and completion of the proposed offering and the intended use of proceeds. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to complete the proposed offering, and other factors described in the Company’s annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly report on Form 10-Q 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 press release on account of new information, future events, or otherwise, except as required by law.
For Investor Relations Inquiries:
David Waldman
+1 (919)-289-4017
mailto://investorrelations@nighthawkbio.com
Class action is on the way.
NEWS -- Lineage Cell Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update
NEWS -- Plus Therapeutics to Announce Second Quarter Financial Results and Host Conference Call on August 14, 2024
AUSTIN, Texas, Aug. 08, 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 second quarter 2024 financial results on Wednesday, August 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: Wednesday, August 14, 2024 @ 5:00 PM ET
Webcast: https://edge.media-server.com/mmc/p/mtnrwhh5
Dial-in Link: https://register.vevent.com/register/BI1c575c6aa37840b9872f3ad10091195c
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 robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
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, Inc. Announces Pricing of Public Offering
DURHAM, NC / ACCESSWIRE / August 6, 2024 / Scorpius Holdings, Inc. (NYSE American:SCPX), ("Scorpius", or the "Company"), an integrated contract development and manufacturing organization (CDMO), today announced the pricing of an underwritten public offering of 12,500,000 shares of common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof). Each share of common stock (or Pre-Funded Warrant) is being offered at a public offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price). The gross proceeds to the Company from the offering are expected to be approximately $12,500,000, before deducting underwriting discounts and offering expenses. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 1,875,000 shares of common stock and/or Pre-Funded Warrants solely to cover over-allotments, if any. The offering is expected to close on August 8, 2024, subject to satisfaction of customary closing conditions.
The Company intends to use the net proceeds of the offering to fund working capital and for general corporate purposes.
ThinkEquity is acting as sole book-running manager for the offering.
A registration statement on Form S-1 (File No. 333-280887), as amended, including a preliminary prospectus, relating to the securities being offered was filed with the Securities and Exchange Commission ("SEC") and became effective on August 6, 2024. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Scorpius Holdings, Inc.
Scorpius Holdings Inc. is an integrated large molecule 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 Statements
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 timing and completion of the proposed offering and the intended use of proceeds. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to complete the proposed offering, and other factors described in the Company's annual report on Form 10-K for the year ended December 31, 2023, subsequent quarterly report on Form 10-Q 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 press release on account of new information, future events, or otherwise, except as required by law.
For Investor Relations Inquiries:
David Waldman
+1 (919)-289-4017
mailto://investorrelations@nighthawkbio.com
SOURCE: Scorpius BioManufacturing
NEWS -- Scorpius Holdings Weighted-Average Pipeline Surpasses $100 Million in Business Develop Opportunities Across Both Manufacturing Client and Government Sectors
Anticipates substantial booked business and associated revenues in Q3/Q4
DURHAM, NC / ACCESSWIRE / August 6, 2024 / Scorpius Holdings, Inc (NYSE American:SCPX), ("Scorpius" or the "Company"), an integrated contract development and manufacturing organization (CDMO), today announced that it has surpassed $100 million in weighted average pipeline of its near-term business development opportunities across both government and manufacturing client sectors. The weighted average pipeline is represented by written proposals which are subject to the execution of definitive agreements. The Company expects these opportunities to translate into substantial booked business and associated revenues over the next two quarters; however there can be no assurance of this.
Key opportunities include:
NEWS -- Oncolytics Biotech® to Participate in a Fireside Chat at Canaccord Genuity's 44th Annual Growth Conference
SAN DIEGO and CALGARY, AB, Aug. 2, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Chief Medical Officer Dr. Thomas Heineman will participate in a fireside chat at Canaccord Genuity's 44th Annual Growth Conference, which is taking place August 13-15, 2024 at the InterContinental Boston Hotel in Boston, MA. Additional details on the fireside chat can be found below.
Date: Tuesday, August 13, 2024
Time: 8:30 a.m. ET
Location: InterContinental Boston, Hutchinson Room
Webcast Link: Available by clicking here
Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please submit a request on the conference website, contact your Canaccord representative, or email mailto://jpatton@oncolytics.ca.
A live webcast of the Company's presentation will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived for three months.
About 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 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
View original content: https://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-a-fireside-chat-at-canaccord-genuitys-44th-annual-growth-conference-302213197.html
SOURCE Oncolytics Biotech® Inc.
NEWS --Oncolytics Biotech® Reports Second Quarter 2024 Financial Results and Operational Highlights
https://www.newswire.ca/news-releases/oncolytics-biotech-r-reports-second-quarter-2024-financial-results-and-operational-highlights-830755680.html
NEWS -- Lineage Cell Therapeutics to Report Second Quarter 2024 Financial Results and Provide Business Update on August 8, 2024
CARLSBAD, Calif., August 01, 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 second quarter 2024 financial and operating results on Thursday, August 8, 2024, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, August 8, 2024, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its second quarter 2024 financial and operating results and to provide a business update.
Interested parties may access the conference call on August 8th, 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 August 15th, 2024, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 6024260.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel or "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) 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/20240801608382/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Theriva™ Biologics Receives Rare Pediatric Drug Designation by the U.S. FDA for VCN-01 for the Treatment of Retinoblastoma
ROCKVILLE, Md., July 31, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Drug Designation (RPDD) for VCN-01 for the treatment of retinoblastoma. VCN-01, Theriva’s lead product candidate, is a systemic, selective, stroma-degrading oncolytic adenovirus. Previously, the FDA granted orphan drug designation to VCN-01 for treatment of retinoblastoma.
“The FDA’s decision to grant rare pediatric drug designation to VCN-01 highlights the urgent need for new treatment options for pediatric patients with retinoblastoma,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “We are encouraged by this important step forward and, in parallel, continue to work closely with leading physicians and regulatory agencies to refine our clinical strategy for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma. Most recently, results from the investigator sponsored Phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma were determined to be positive by the study Monitoring Committee. Data from this study will further inform our clinical development pathway in this area of high unmet need.”
The FDA grants RPDD for rare diseases (fewer than 200,000 affected persons in the United States) that are serious and life-threatening and primarily affect children ages 18 years or younger. If a Biologics License Application for VCN-01 for the treatment of retinoblastoma is approved by the FDA, Theriva may be eligible to receive a Priority Review Voucher that can be redeemed to receive a priority review for any subsequent marketing application or may be sold or transferred.
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 the U.S., retinoblastoma shows an incidence rate of 3.3 per 1,000,000 with only about 200 to 300 children diagnosed per year according to the American Cancer Society. 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 80 patients in Phase 1 and investigator-sponsored clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at https://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 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, the data from the investigator sponsored Phase 1 trial at Hospital Sant Joan de Déu in Barcelona evaluating intravitreal VCN-01 in pediatric patients with refractory retinoblastoma informing the Company’s clinical development pathway and being eligible to receive a Priority Review Voucher. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s and VCN’s ability to reach clinical milestones when anticipated, including the ability to continue to enroll patients as planned and receive a Priority Review Voucher, 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 the cash providing a runway into the first quarter of 2025, 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 -- Scorpius Holdings Announces Removal of NYSE American Trading Suspension; Expected to Resume Normal Trading on August 2, 2024
DURHAM, N.C., July 30, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc. (NYSE American: SCPX) (“Scorpius” or “the Company”), an integrated contract development and manufacturing organization (“CDMO”), today announced that the staff of NYSE Regulation has withdrawn its delisting determination and will be lifting the trading suspension of the Company's common stock on the NYSE American. The NYSE Regulation staff determined that the Company's common stock was now trading above the threshold of low selling price issues as further defined by Section 1003(f)(v) of the NYSE American Company Guide. Scorpius’ common stock is expected to resume trading on the NYSE American on Friday, August 2, 2024, under the symbol "SCPX" and Cusip “42237K 508.”
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, Texas. 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 regarding the Common Stock resuming trading on the NYSE American on Friday, August 2, 2024, under the symbol "SCPX." Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of the Company to resume trading on Friday, August 2, 2024 and have its Common Stock remain listed and recommence trading on the NYSE American; 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 -- CytoSorbents Unveils Newly Redesigned, Unified Company and Product Website
“Working to Save Lives Together” Theme Highlights Two Decades of Successful Collaboration with the International Medical and Research Communities to Help Patients Survive Life-Threatening Illnesses
PRINCETON, N.J., July 29, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of deadly conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, is proud to announce the launch of its newly redesigned and consolidated website at https://www.cytosorbents.com. The theme of “Working to Save Lives Together” highlights two decades of successful collaboration with the international medical and research communities to continuously refine how our therapies, such as CytoSorb®, ECOS-300CY®, and VetResQ® are being used to help patients survive life-threatening illnesses.
A Modern, Unified Online Presence
The new website, built from the ground up, unifies our corporate and product information into a single, cohesive and comprehensive information hub for healthcare professionals, investors, and other key stakeholders. Visitors will find a streamlined modern design, intuitive navigation, and extensive content on our company, technology, therapies, pipeline that includes DrugSorb™-ATR and HemoDefend-BGA™, clinical studies, investor conferences, and much more.
Key Features of the New Website:
NEWS -- Plus Therapeutics Showcases Leptomeningeal Metastases Programs at 2024 SNO/ASCO Conference
Company to present new data, highlighting progress in its therapeutics and diagnostics programs for Leptomeningeal Metastases
AUSTIN, Texas, July 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 (CNS) cancers, will have multiple opportunities to present data at the 2024 Society for Neuro-Oncology (SNO) / American Society for Clinical Oncology (ASCO) CNS Metastases Conference August 8-10, in Denver, Colorado.
“This year’s SNO/ASCO Metastases conference is a key opportunity for Plus to highlight advancements in our LM therapeutics and diagnostics programs,” said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. “The conference gathers key influencers and clinicians to discuss important topics in the field and we are honored to have multiple opportunities to share our results with the scientific community.”
Events and data presentations include:
Symposium:
The Company will be hosting a symposium titled, “Emerging Novel Diagnostic and Therapeutic Approaches for Leptomeningeal Metastases” on August 8, 2024, at 6:15-7:15 p.m. MDT in the Plaza Ballroom (DEF) of the Sheraton Denver Downtown Hotel. Speakers include: