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News Release

Tonix Pharmaceuticals' CEO reveals next-generation COVID vaccine technology chosen for key program

Tonix Pharmaceuticals

Tonix Pharmaceuticals CEO Dr Seth Lederman recently joined Steve Darling from Proactive to share exciting news about their COVID vaccine, TNX-1800, selected for testing in Project Next Gen, a White House initiative managed by the Department of Health and Human Services, NIH, and NIAID. The vaccine is based on a live virus platform, providing a unique approach to waking up the immune system. Live virus vaccines, like TNX-1800, offer more durable immunity that lasts a long time and can potentially block virus transmission, addressing limitations seen in mRNA vaccines. This choice of TNX-1800 is a testament to Tonix's nearly decade-long dedication to vaccine development. The technology platform can also be adapted to protect against other infectious diseases, such as monkeypox, smallpox, and tuberculosis, making it a versatile solution for future pandemics. This development highlights the significance of vaccine platforms for tackling various infectious threats. Tonix's approach promises to offer more robust, long-lasting immunity and potential transmission prevention, which could revolutionize our approach to infectious disease control. The platform's adaptability positions it as a valuable tool for future vaccine strategies. Contact Details Proactive Studio +1 347-449-0879 na-editorial@proactiveinvestors.com

November 20, 2023 01:57 PM Eastern Standard Time

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Tonix Pharmaceuticals finish Phase 3 trial of TNX-102 SL for management of Fibromyalgia

Tonix Pharmaceuticals

Tonix Pharmaceuticals CEO Dr Seth Lederman recently joined Steve Darling from Proactive to shed light on the latest developments in their research efforts. The company has successfully concluded the clinical phase of a Phase 3 registration-quality study for TNX-102 SL, a drug developed for the management of fibromyalgia. This study, which is double-blind and placebo-controlled, saw the enrollment of 457 patients across various sites in the United States. Lederman conveyed to Proactive that the topline results from this study are anticipated by late December. Should the results be favorable, this trial is expected to be the conclusive well-controlled efficacy trial needed for the submission of a New Drug Application to the U.S. Food and Drug Administration. The urgency and importance of this development are underscored by the fact that an estimated 6-12 million individuals in the US are afflicted with fibromyalgia, a condition that predominantly affects women. In addition to the TNX-102 study, Lederman also discussed another significant milestone: the enrollment of the first participant in a Phase 2 study, supported by the Department of Defense, focusing on TNX-1900 for the improvement of bone health in children with autism spectrum disorder. This investigator-initiated trial represents a foray into addressing the complex needs of children with autism, potentially offering a new therapeutic avenue to enhance their quality of life. Contact Details Proactive Studio +1 347-449-0879 na-editorial@proactiveinvestors.com

November 20, 2023 01:53 PM Eastern Standard Time

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Oxford Cannabinoid Technologies strengthens board with CMO Dr. Tim Corn

Oxford Cannabinoid Technologies Holdings PLC

Oxford Cannabinoid Technologies Holdings PLC (LSE:OCTP, OTC:OCTHF) CEO Clarissa Sowemimo Coker and CMO Dr Tim Corn speak to Thomas Warner from Proactive after the pharmaceutical group announced the appoint of Corn to its board of directors. The move follows his appointment as Chief Medical Officer in June 2023. Sowemimo-Coker highlights the importance of having a clinician on the board of a biopharmaceutical company. The appointment follows the successful announcement of Phase I single ascending dose results in October, reflecting OCT's commitment to addressing unmet medical needs with novel therapeutic approaches. Dr. Corn cites the combination of addressing unmet medical needs and the use of a novel cannabinoid approach as key factors that have attracted him to the business. He outlines his dual focus in the role, continuing as CMO to ensure efficient clinical programs aligned with regulatory requirements and bringing a physician's perspective to the board. He suggests that his expertise in clinical development and board work positions him well to balance patient interests and financial considerations. Discussing the company's cash runway, Sowemimo-Coker says the company is funded into April 2024. She assures stakeholders that the board is actively exploring various funding options, and updates will be provided as progress unfolds. While the details remain confidential, she hints at potential updates before the end of the year. The interview showcased OCT's commitment to advancing cannabinoid-based therapies, building a strong leadership team, and maintaining transparency in financial matters. Stakeholders are eagerly anticipating further developments as OCT continues its journey towards clinical and financial success. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

November 20, 2023 10:24 AM Eastern Standard Time

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AGC Biologics to Prepare Late Phase and Commercial Runs for Immunocore

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced a new late-stage clinical and process performance qualification (PPQ) project at its Heidelberg, Germany site with Immunocore Holdings Plc (Nasdaq: IMCR). Immunocore intends to use the Heidelberg site to complete late-stage manufacturing and prepare for commercialization for IMC-F106C, Immunocore’s PRAME-targeted bispecific therapy. Under the agreement, AGC Biologics will leverage its microbial fermentation and manufacturing experience to perform bench-scale qualification and process characterization, and other required studies to support phase III manufacturing, as well as PPQ runs. Pending a successful PPQ campaign and regulatory approvals, the Immunocore project is expected to move into commercial stages at the AGC Biologics Heidelberg site. This is the next step in the partnership for this candidate between the two companies, with AGC Biologics providing early-phase support for this same project. Immunocore and AGC Biologics previously worked together on commercial manufacturing readiness for KIMMTRAK® (tebentafusp-tebn) at the CDMO’s Copenhagen site. “This is a great example of the power of the AGC Biologics network and our ability to collaborate at our global sites to support important client projects,” said Dieter Kramer, General Manager, AGC Biologics Heidelberg. “I am extremely proud of our team here in Heidelberg and the work they’ve done to support this project. We are pleased Immunocore has agreed to work with us on these next important steps in their product’s lifecycle, as our team has the late-stage and commercial expertise to deliver what is needed.” AGC Biologics runs multiple cGMP microbial fermentation lines at its Heidelberg facility. The AGC Biologics Heidelberg site has produced biologics products for 40 years and has built a track record for navigating clients through the early clinical phases and into later stages to help prepare for commercial production. In addition to fermentation, the site serves as a center of excellence for plasmid DNA (pDNA) and messenger RNA (mRNA). To learn more about AGC Biologics’ microbial system-based biologics, plasmid DNA (pDNA) and messenger RNA (mRNA) manufacturing site in Heidelberg, visit www.agcbio.com/facilities/heidelberg. For more information on the company’s Protein Biologics, pDNA, Cell Therapy, Viral Vector and mRNA drug product services go to www.agcbio.com. About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan and we currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Contact Details AGC Biologics Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com

November 20, 2023 05:08 AM Eastern Standard Time

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Breaking ground in vision restoration: Kiora Pharmaceuticals reveals promising results with KIO-301

Kiora Pharmaceuticals

Kiora Pharmaceuticals CEO Brian Strem joined Steve Darling from Proactive to share news the company's plan to broaden the clinical development of KIO-301, a treatment designed for various inherited retinal diseases. The expansion includes initiating a Phase 2 trial which will be controlled, double-masked, randomized, and will involve an ascending dose. This trial is set to include up to 20 patients suffering from Retinitis Pigmentosa (RP), who will receive doses monthly over a span of 90 days. Strem explained that this move is propelled by encouraging topline results from a Phase I/II clinical trial, which indicated that KIO-301 is a first-in-class small molecule with significant potential to improve vision for patients with RP, even those with extremely low vision or complete blindness. Moreover, Kiora Pharmaceuticals has plans to engage with the FDA in the fourth quarter of 2023. The goal of this meeting is to achieve consensus regarding the study designs, endpoints, and additional requirements necessary to conduct further studies in the United States and Europe. These studies would not only target RP but also extend to other inherited retinal diseases such as Choroideremia (CHM) and Stargardt disease. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

November 17, 2023 01:54 PM Eastern Standard Time

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Medicus Pharma sees appointment of Dr Huma Qamar as key to company’s future

Medicus Pharma

In an exclusive interview with Dr Huma Qamar, chief scientific officer for Medicus Pharma Ltd, exciting developments in skincare and oncology are discussed. Dr Qamar shares her passion for addressing unmet medical needs, particularly in the field of basal cell carcinoma. The focus is on SkinJet, a flagship company acquired by Medicus Pharma, utilizing revolutionary microarray needles. The needles, transdermally delivering the chemotherapeutic agent doxorubicin, show promising data in preventing relapse and remission of basal cell carcinoma. Looking ahead, Dr Qamar outlines the company's goals for 2024, emphasizing the resumption of clinical development activities and recruitment efforts. The aim is to complete the phase two trial and present promising data. Dr Qamar, driven by a dedication to oncology and patient well-being, discusses the emotional impact of cancer and the hope that Medicus Pharma's contributions will bring positive changes to the lives of patients. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

November 17, 2023 01:21 PM Eastern Standard Time

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Xeris Biopharma CEO unveils game-changing drug innovations and record financial success

Xeris Biopharma Holdings

Xeris Biopharma CEO Paul Edick joined Steve Darling from Proactive to share insights on the company's focus on innovative drug formulation technology after reporting strong third-quarter results. With three growing products addressing severe hypoglycemia, Cushing's Syndrome, and periodic peripheral paralysis, the company's core lies in commercial success. Edick discussed a promising drug in development—levothyroxine—in a once-weekly subcutaneous injection format, targeting consistency and reduced side effects. Despite being in phase two, the drug could revolutionize current prescription norms. Additionally, partnerships with industry giants like Regeneron and Amgen are underway, emphasizing Xeris' position as a formulation leader. Financially robust, Xeris reported a record quarter and anticipates cash flow breakeven by the fourth quarter. Edick affirmed the company's self-sustainability and projected ending 2024 with ample cash. Despite market challenges, Xeris' growth and strategic focus signal confidence in its trajectory, positioning it as a force in biopharmaceutical innovation. Contact Details Proactive Investors +1 347-449-0879 na-editorial@proactiveinvestors.com

November 17, 2023 01:07 PM Eastern Standard Time

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Arecor Therapeutics takes major step with first commercial sale of AT220

Arecor Therapeutics PLC

Arecor Therapeutics PLC CEO Sarah Howell speaks to Thomas Warner from Proactive after the biopharmaceutical group announced the first commercial sale of a product that incorporates its proprietary Arestat technology, known as AT220. Part of a licence agreement with an unnamed global pharma partner initiated in 2017, the milestone has triggered a payment to Arecor. It will also receive royalties on sales. Howell explains the significance of the news, emphasising its importance for patients and the business. She says the achievement aligns with Arecor's vision of building a large, self-sustaining biopharmaceutical company focused on improving patient care. While the partner involved in this achievement remains undisclosed, Howell shed light on Arecor's appeal to pharmaceutical collaborators and says the Arestat technology enables the company to enhance biosimilar products, providing more benefits to patients and giving partners a competitive edge in a high-value market. She says the financial impact is significant, with the milestone triggering licensed payments and initiating recurring royalty streams for Arecor. As the year approaches its end, Howell hints at potential updates. The partnered portfolio shows promising progress, with recent announcements of licensed milestones and positive developments in clinical studies. Ongoing partnerships with pharmaceutical and biotech companies are expected to expand, contributing to Arecor's growth. The company is actively developing its proprietary products, focusing on specialty hospital medications and diabetes treatments. One of their lead diabetes products, AT278, targets patients with high insulin needs, presenting a disruptive solution in a growing market segment. Results from the clinical study are anticipated in Q1 2024. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

November 17, 2023 12:47 PM Eastern Standard Time

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NRx Pharmaceuticals founder unveils potential treatment for suicidal thoughts and depression

NRx Pharmaceuticals Inc

NRx Pharmaceuticals founder and chief scientist Dr Jonathan Javitt joined Steve Darling from Proactive to discuss groundbreaking developments in treating suicidal ideation and depression. NRx focuses on targeting the NMDA (N-methyl-D-aspartate) receptor in the brain, identified as crucial for turning off suicidal thoughts. Traditional antidepressants, which target the serotonin axis, often increase suicide risk, highlighting the need for a new approach. Javitt told Proactive the company is approaching the clinical trial enrollment goals for its partnered product NRX-101, while opening new clinical initiatives in chronic pain, urinary tract infection, and NRX-100 for suicidal depression. The company said the trial is near completion of enrollment of the originally-targeted 70 participants in the Phase 2b/3 trial of NRX-101. Top-line data from this cohort of patients is expected shortly after the last patient visit. Javitt told Proactive chronic pain affects more than 50 million American adults, compared to the approximately 3 million who report thoughts of suicide on an annual basis. There has been no new non-opioid class of drugs to treat nociceptive pain in the past two decades and NRX-101 has the potential to be the first NMDA-antagonist drug to seek approval for this indication. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

November 16, 2023 02:07 PM Eastern Standard Time

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