Queen's University

MONDAY, Sept. 23, 2024 -- The risk for severe maternal morbidity (SMM) and adverse pregnancy outcomes is increased for gestational carriers, or pregnancy surrogates, compared with women conceiving naturally or via in vitro fertilization (IVF), according to a study published online Sept. 24 in the Annals of Internal Medicine . Maria P. Velez, M.D., Ph.D., from Queen's University Kingston in Ontario, Canada, and colleagues conducted a population-based cohort study to examine the risk for SMM and severe neonatal morbidity (SNM) in gestational carriers. Of the eligible singleton births, 846,124, 16,087, and 806 (97.6, 1.8, and 0.1 percent, respectively), were via unassisted conception, IVF, and gestational carriage, respectively. The researchers found that the risks for SMM were 2.3, 4.3, and 7.8 percent for unassisted conception, IVF, and gestational carriage, respectively. The weighted relative risks were 3.30 and 1.86, respectively, comparing gestational carriage with unassisted conception and IVF. For SNM, the respective risks were 5.9, 8.9, and 6.6 percent; the weighted relative risks were not significantly increased for gestational carriage versus unassisted conception or IVF. Comparing gestational carriers with either comparison group, hypertensive disorder, postpartum hemorrhage, and preterm birth at less than 37 weeks were also significantly higher. "Given the increasing use of gestational carriers, and the potentially higher risk for SMM and other adverse pregnancy outcomes, a judicious selection of these carriers may be warranted -- something recommended within clinical practice guidelines," the authors write.

NEW YORK, Aug. 19, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced the appointment of Ivor Elrifi as its Chief Executive Officer (CEO), effective immediately. "We are delighted to welcome Ivor Elrifi as the new CEO of Tiziana Life Sciences," said Gabriele Cerrone, Founder and Executive Chairman of the Board. " Ivor has an invaluable track record in creating substantial value for biotech and pharma companies with his strategic vision in building intellectual property portfolios and transforming the IP into transformative business development deals and M&A transactions. Tiziana looks forward to creating further value with Ivor as we proceed with our human clinical trials." Tiziana Life Sciences is currently focused on advancing intranasal foralumab through clinical trials for non-active Secondary Progressive Multiple Sclerosis (na-SPMS), Alzheimer’s Disease and ALS. Under Ivor’s leadership, the company aims to accelerate these programs and capitalize on opportunities to address significant unmet medical needs. Ivor was formerly the global head of the Patent Group at Cooley since 2014 and before that the global head of Patents at Mintz Levin from 1999 – 2014. He has counseled companies in various key industries, including pharmaceutical, biotechnology, life sciences and medical device companies, research institutions, universities, hospitals and governments throughout the world, particularly in the US and Europe. Ivor has guided clients in developing and implementing intellectual property strategies and in the prosecution, licensing and enforcement of patents. He has extensive experience in advising clients on strategic transactional work and regularly counsels’ clients with respect to investments, business development and mergers and acquisitions, including acquisition transactions involving Novartis, Eli Lilly, Biogen and Astellas. He has received various awards throughout his career, including being named an "LMG Life Sciences: Life Science Star," and ranked nationally in Chambers USA since 2007. Elrifi earned his B.S. and Ph.D. in Biology from Queen's University and his J.D. from Osgoode Hall Law School. "I am honored to lead Tiziana Life Sciences at this pivotal time in its growth trajectory," said Ivor Elrifi. "The company's commitment to developing transformative therapies holds great promise, and I look forward to working with the talented team to advance our clinical programs and deliver value to patients and shareholders." Mr. Elrifi succeeds Gabriele Cerrone, who was acting CEO and will remain in his role as Executive Chairman of the board and will continue to play a key role in advancing Tiziana's scientific agenda. About Foralumab Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program with either an improvement or stability of disease seen within 6 months in all patients. The FDA has recently allowed an additional 20 patients to be enrolled in this EA program. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923). Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2] About Tiziana Life Sciences Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com For further inquiries: Tiziana Life Sciences LtdPaul Spencer, Business Development and Investor Relations+44 (0) 207 495 2379email: info@tizianalifesciences.com Investors:Irina KofflerLifeSci Advisors, LLC646.970.4681email: ikoffler@lifesciadvisors.com [1] https://www.pnas.org/doi/10.1073/pnas.2220272120 [2] https://www.pnas.org/doi/10.1073/pnas.2309221120 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0208ae67-37fe-44e0-8301-45b4cbf6edda

Company benefits from robust ecosystem within the university, including premium facilities, talent, and expertiseMELBOURNE, Australia, Aug. 06, 2024 (GLOBE NEWSWIRE) -- Gelteq Limited (“Gelteq” or the “Company”), a global biotechnology company that specializes in the formulation, development, and manufacturing of ingestible gel technology, announces it is further strengthening its existing partnership with Australia’s Monash University, which is ranked #2 in the world in pharmaceutical science. The Company is establishing its new full-time research and development laboratory within the Monash Innovation Labs, a key collaboration hub that provides access to advanced scientific and research facilities, technical expertise and STEM talent to growing Australian businesses. Nathan Givoni, Gelteq’s Co-Founder and Chief Executive Officer, stated, “Monash University is a premiere international research institution, and this partnership has allowed us to collaborate with top-tier researchers and innovators while also providing us access to talented students that contribute to our talent pipeline. Monash has already been an essential partner to Gelteq, providing access to dedicated state-of-the art wet labs to conduct R&D. We are pleased to strengthen our existing partnership and continue to grow our company on a global scale with the support offered through this collaboration.” Being located at Monash Innovation Labs, Gelteq will be able to streamline its manufacturing capabilities and will also have access to Monash’s top-of-the-line analytical testing labs, enhancing capabilities to take a product from an idea through to production, with the added ability to ensure that all regulatory requirements are addressed. Professor Adrian Neild, Director of the Monash Innovation Labs and Deputy Dean (Strategic Initiatives) in the Faculty of Engineering at Monash University, stated, “We are pleased to partner with Gelteq and welcome the company into the Monash Innovation Labs community. Gelteq are at the forefront of medical delivery technology and we look forward to seeing the outcomes of their groundbreaking research and the mutual benefits of partnering with our STEM student talent.” About GelteqHeadquartered in Melbourne, Australia, Gelteq is a global biotechnology company that specializes in the formulation, development, and manufacturing of an innovative ingestible gel platform designed for nutrient and drug delivery. The Company is focused on advancing and commercializing its delivery solutions within five core verticals: pharmaceuticals, over-the-counter medications, nutraceuticals, animal medications, and sports nutrition. Gelteq’s unique formulation directly addresses the issues associated with traditional drug delivery methods such as difficulty swallowing, taste of unpalatable ingredients, and dosage control. For more information, visit www.gelteq.com. Forward-Looking StatementsThis press release contains statements that constitute "forward-looking statements," including with respect to the proposed initial public offering and the anticipated use of the net proceeds. No assurance can be given that the offering discussed above will be completed on the terms described, or at all, or that the net proceeds of the offering will be used as indicated. All statements other than statements of historical facts are forward-looking statements. You can identify these forward-looking statements by words or phrases such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “likely to” or other similar expressions. The Company has based these forward-looking statements largely on its current expectations about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These risks and uncertainties include forward-looking statements include, but are not limited to, the risks and uncertainties described in “Cautionary Note Concerning Forward-Looking Statements;” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the documents that referred to in the prospectus with the understanding that the Company’s future results may be materially different from and worse than what we expect. Other sections of the prospectus include additional factors which could adversely impact our business and financial performance. Moreover, the Company operates in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for the Company’s management to predict all risk factors and uncertainties, nor can the Company assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. The Company and the underwriters qualify all of the forward-looking statements by these cautionary statements. The prospectus contains certain data and information obtained from various government and private publications. Statistical data in these publications also include projections based on a number of assumptions. The robotics industry may not grow at the rate projected by market data, or at all. Failure of this market to grow at the projected rate may have a material and adverse effect on the Company’s business and the market price of the shares of common stock. In addition, the rapidly evolving nature of this industry results in significant uncertainties for any projections or estimates relating to the growth prospects or future condition of the market. Furthermore, if any one or more of the assumptions underlying the market data are later found to be incorrect, actual results may differ from the projections based on these assumptions. You should not place undue reliance on these forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in the prospectus relate only to events or information as of the date on which the statements are made in the prospectus. Neither the Company nor the underwriters undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events except as required by law. You should read the prospectus and the documents that we refer to in the prospectus and have filed as exhibits to the registration statement, of which the prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. Media Contact:CORE Public RelationsPR@gelteq.com