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Collaborative telehealth platform will provide patients with immediate access to QSYMIA®, a chronic weight loss medication, enhancing their healthcare journey CAMPBELL, Calif., Oct. 30, 2024 (GLOBE NEWSWIRE) -- VIVUS LLC, a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs, and UpScriptHealth, a leading, nationwide, direct-to-consumer telemedicine company, today announced the launch of ChooseQ.online. This robust online telemedicine platform is designed specifically for distributing QSYMIA® (phentermine and topiramate extended-release capsules CIV), the leading non-injectable branded weight loss medication in the U.S. for adults. Under this collaboration, QSYMIA is now accessible to patients through UpScript LLC’s proprietary Telehealth Platform. QSYMIA is indicated as an FDA-approved adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in some adults and certain pediatric patients aged 12 years and older. “The launch of ChooseQ.online represents a significant milestone in our commitment to enhancing patient care and accessibility. We are thrilled to offer our patients the convenience they deserve,” said John Amos, CEO of VIVUS. “By leveraging UpScriptHealth’s expertise, within just a few clicks patients can now access medications, like QSYMIA, and consult with a physician from anywhere, ensuring that quality health care is always within reach.” ChooseQ.online offers the ability to: Access high quality health care and directly communicate with a healthcare providerHave medication mailed directly to patients through a mail order pharmacy, which offers patients a time-saving solution, or sent to a retail pharmacyProvide patient assistance with managing the coverage administration process through UpScriptHealth’s benefit support capabilities “Partnering with VIVUS marks a significant milestone in our joint commitment to technological innovation in healthcare. Together, we are redefining telehealth standards, offering patients nationwide a convenient, efficient, and personalized approach to managing their weight and health,” said Peter Ax, CEO and founder of UpScriptHealth. With over 20 years of experience and more than one million patients served, UpScriptHealth specializes in creating effective web-based campaigns for pharmaceutical companies. Its comprehensive services include virtual prescribing, coverage and benefit support, as well as long-term adherence support. For patients actively seeking online support and solutions, UpScriptHealth offers a fast and convenient option. “Our collaboration with UpScriptHealth ensures that patients receive the highest standard of care at a convenient time and location,” added Santosh T. Varghese, MD, President VIVUS Global Pharmaceutical Development and Chief Medical Officer at VIVUS LLC. “This initiative, paired with our recent labeling update, not only expands access to QSYMIA, but also empowers patients to proactively engage in their treatment plans, fostering long-term health outcomes.” The label update for QSYMIA removed specific body mass index (BMI) requirements and warnings or precautions regarding increase in heart rate, risk of hypoglycemia in people with type 2 diabetes taking anti-diabetic therapy, and risk of hypotension in people taking antihypertensive medication. The projected global impact of obesity is staggering, with an estimated one billion people expected to be affected by 2030. This marks nearly a twofold increase from around 511 million in 2020. Significantly, obesity escalates the risk of type 2 diabetes, hypertension, and dyslipidemia. Consequently, this heightened risk contributes to an overall increased susceptibility to cardiovascular disease and mortality. Achieving and maintaining healthy weight goals can play a crucial role in mitigating this risk. QSYMIA was approved by the U.S. Food and Drug Administration in 2012 for chronic weight management. The once-daily pill is covered by the majority (81%) of commercial healthcare plans and is indicated for long-term use. QSYMIA is designed to help patients manage hunger and reduce cravings throughout the day. Combined with a healthy diet and exercise, it has been proven to help patients lose weight and maintain weight loss. About VIVUS VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs. For more information about the Company, please visit http://www.vivus.com. About UpScriptHealthUpScriptHealth provides a fully compliant direct-to-consumer Telemedicine platform for pharmaceutical companies and consumer products companies. This unique platform allows for convenient access to high quality health care including state of the art medicines. In 2002 UpScriptHealth was the first company in the US to be licensed to write prescriptions on the internet through an online physician consultation. Since then, we’ve treated more than a million patients in all fifty states. Learn more at www.UpScriptHealth.com. About QSYMIA QSYMIA is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with obesity, and in adults with overweight in the presence of at least one weight-related comorbid condition The effect of QSYMIA on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of QSYMIA in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established. For more information on QSYMIA, please visit https://QSYMIA.com/ Important Safety Information for QSYMIA Do not take QSYMIA if you are pregnant, planning to become pregnant, or become pregnant during QSYMIA treatment; have glaucoma; have thyroid problems (hyperthyroidism); are taking certain medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the past 14 days; are allergic to topiramate, sympathomimetic amines such as phentermine, or any of the ingredients in QSYMIA. QSYMIA can cause serious side effects, including birth defects (cleft lip/cleft palate), serious eye problems (secondary angle closure glaucoma), visual field defects (independent of elevated intraocular pressure), suicidal thoughts or actions, and severe rash with blisters and peeling skin. QSYMIA may slow the increase in height in children 12 years and older. Common side effects of QSYMIA in adults include numbness or tingling in the hands, arms, feet, or face (paraesthesia), dizziness, changes in the way foods taste or loss of taste (dysgeusia), trouble sleeping (insomnia), constipation, and dry mouth. Common side effects of QSYMIA in children aged 12 years and older include depression, dizziness, joint pain, fever, flu, and ankle sprain. For more information please read the QSYMIA Medication Guide, Full Prescribing Information, and Risk of Birth Defects with QSYMIA patient brochure. Forward-Looking Statements Important Information and Cautionary Note Regarding Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and/or covered by the “Bespeaks Caution” doctrine applied by the courts under the antifraud provisions of the federal securities laws, and other applicable provisions of the federal securities laws. Such forward-looking statements are based on current expectations, management’s beliefs and certain assumptions made by the Company’s management. These statements may be identified by the use of forward-looking words such as “will,” “shall,” “may,” “believe,” “expect,” “forecast,” “intend,” “anticipate,” “predict,” “should,” “plan,” “likely,” “opportunity,” “estimated,” and “potential,” and/or the negative use of these words or other similar words. All forward-looking statements included in this document are based on our current expectations, and the Company assumes no obligation to update any such forward-looking statements except to the extent otherwise required by law. Forward-looking information about QSYMIA, including its potential benefits, approvals in potential markets outside the U.S. and anticipated product availability, involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied in this press release. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any other markets or approved, whether QSYMIA will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of QSYMIA; uncertainties regarding the impact of COVID-19 on our business, operations, and financial results; and competitive developments. The above factors, risks and uncertainties are difficult to predict, contain uncertainties that may materially affect actual results and may be beyond the Company’s control. New factors, risks and uncertainties emerge from time to time, and it is not possible for management to predict all such factors, risks and uncertainties. Although the Company believes that the assumptions underlying the forward-looking statements contained herein are reasonable, any of the assumptions could be inaccurate, and therefore any of these statements may prove to be inaccurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation or warranty by the Company or any other person that the Company’s objectives and plans will be achieved. These forward-looking statements speak only as of the date such statements were made or any earlier date indicated, and the Company does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes in underlying assumptions or otherwise, unless otherwise required by law. Contacts VIVUS LLCT: +1 (650) 934-5200 Media – FINN Partners Glenn Silver glenn.silver@finnpartners.com T: +1 973-818-8198

- First two out of three subjects treated with tegoprubart as part of immunosuppression regimen to prevent transplant rejection achieved insulin independence and remain insulin free, with glucose control in the normal range; Third subject was recently transplanted and is on trajectory for insulin independence - Islet engraftment in the first two subjects with tegoprubart estimated three to five times higher than engraftment in three comparable subjects receiving standard of care tacrolimus-based immunosuppression - Treatment with tegoprubart was generally well tolerated - Study data to be presented by UChicago Medicine’s team in oral presentation at the 5th IPITA/HSCI/Breakthrough T1D Stem Cells Summit IRVINE, Calif., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced positive data for the first three islet transplant recipients treated with an immunosuppression regimen that includes tegoprubart, the Company’s investigational anti-CD40L antibody, for prevention of islet transplant rejection in subjects with type 1 diabetes (T1D). The investigator-initiated trial, conducted by the research team at the University of Chicago Medicine’s Transplantation Institute, demonstrated potentially the first human cases of insulin independence achieved using an anti-CD40L monoclonal antibody therapy without the use of tacrolimus, the current standard of care for prevention of transplant rejection. The first two subjects achieved insulin independence and normal hemoglobin A1C (HbA1c) levels, a measure of average blood glucose, post-transplant. The third subject, who recently received an islet transplant, decreased insulin use by more than 60% three days following the procedure and continues on an insulin independence trajectory. Subjects on study received islet transplants combined with induction therapy, mycophenolate mofetil (MMF), and tegoprubart, given every third week by intravenous (IV) infusion. The first two subjects achieved insulin independence and presented stable islet graft function at approximately three months and six months post-transplant, respectively. Islet engraftment, measured by graft function standardized to the number of islets infused, was three to five times higher than three comparable subjects outside this study who received tacrolimus-based immunosuppression, suggesting treatment with tegoprubart is less toxic to transplanted islets resulting in improved graft survival and function. Treatment was generally well tolerated in all subjects with no unexpected adverse events or hypoglycemic episodes. After initial islet transplant, the first participant reduced insulin requirements by over 60% and normalized blood glucose control. The first patient then achieved insulin independence approximately two weeks after the second islet transplantation procedure. The data are being featured in an oral presentation at the International Pancreas and Islet Transplantation Association (IPITA), Harvard Stem Cell Institute (HSCI), and Breakthrough T1D (formerly JDRF) 5th Annual Summit on Stem Cell Derived Islets on Tuesday, October 29, 2024. “We are very pleased that tegoprubart played a pivotal role in yet another landmark advance in transplantation research through the work of Dr. Witkowski, Dr. Fung and their team at UChicago Medicine,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Following promising results in kidney allotransplant procedures as well as heart and kidney xenograft procedures, these data from subjects following islet transplantation further demonstrate tegoprubart’s potential to protect transplanted organs and cells. Dr. Witkowski’s study also further reinforces prior study results showing that tegoprubart may offer a favorable safety and efficacy profile compared to tacrolimus-based immunosuppression regimens.” “These data are another step in our quest to achieve a path for functional cures in type 1 diabetes,” said Piotr Witkowski, M.D., Ph.D., Director, Pancreas and Islet Transplant Program, UChicago Medicine and one of the study’s lead investigators. “For more than 30 years, we have been looking for options that can deliver target levels of immunosuppression without the side effects associated with standard of care, including toxicity to the kidneys, central nervous system and islet cells, and increased risk of diabetes and hypertension. These data further support tegoprubart as a novel immunosuppression option that can play a central role in advancing islets transplantation as a potentially transformational alternative for subjects with type 1 diabetes.” “Breakthrough T1D is proud to fund and support this research and is encouraged by the tegoprubart study showing that subjects who received islet transplants with a tacrolimus-free immunosuppressive regimen are making insulin again,” said Breakthrough T1D Chief Scientific Officer Sanjoy Dutta, Ph.D. “Islet replacement therapies are a key priority for Breakthrough T1D, and we’re committed to driving research that moves us toward a world where these therapies are available to the broader T1D community. Achieving this goal requires novel approaches to keep transplanted cells functional with a tolerable immunosuppression regimen. These results are an important step toward that goal, and we look forward to seeing additional data.” Efficacy and Safety Results The first participant was a 42-year-old female with a baseline weight of 88 kg/194 lbs (BMI of 30). At 90 days post-transplant, the participant’s HbA1c level improved to 6.0% (from 8.4% at baseline) and daily insulin dose decreased to 16 units per day (from 80 units per day at baseline). After 16 weeks, the participant received a second islet transplant, and approximately two weeks later achieved insulin independence, maintaining improved HbA1c levels of 5.4% afterwards. The second participant was a 30-year-old female with a baseline weight of 50 kg/110 lbs (BMI of 21). This patient stopped insulin support (from 60 units per day at baseline) four weeks after the islet transplant. Her HbA1c levels improved to 5.8% and below (from 8.5% at baseline) starting at seven weeks after the transplant. The third participant was a 37-year-old male with a baseline weight of 92 kg/203 lbs (BMI of 30) with a baseline HbA1C of 9.3%. This patient was discharged home on day three post-transplant, requiring 29 units of insulin (from 90 units per day at baseline). The treatment was generally well tolerated in all subjects with no unexpected adverse events, severe hypoglycemic episodes, or graft rejection. In January 2024, Eledon announced that it would be supplying tegoprubart for this investigator-led clinical trial with the UChicago Medicine Transplantation Institute for pancreatic islet transplantation in subjects with type 1 diabetes (NCT06305286). Tegoprubart is the cornerstone component of the chronic immunosuppressive regimen for trial participants and is being evaluated for the prevention of transplant rejection in the trial. Funding for the study includes grants from Breakthrough T1D (formerly known as JDRF) and The Cure Alliance. About Islet Transplantation for Type 1 Diabetes Pancreatic islet transplantation is a minimally invasive procedure developed to provide blood glucose control for subjects with type 1 diabetes and minimize or eliminate dependence on insulin. During the procedure, pancreatic islets containing insulin-producing beta cells are isolated from the pancreas of a deceased organ donor and infused through a small catheter into the patient’s liver. The islet cells lodge in small blood vessels in the liver and release insulin. Post-procedure, subjects remain on immunosuppression therapy to prevent transplant rejection. About Eledon Pharmaceuticals and tegoprubart Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com. Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with islet cell transplantation or kidney transplantation, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contact: Stephen JasperGilmartin Group(858) 525 2047stephen@gilmartinir.com Media Contact: Jenna UrbanBerry & Company Public Relations(212) 253 8881jurban@berrypr.com Source: Eledon Pharmaceuticals

Eledon Pharmaceuticals’ experimental immunosuppressant helped two patients with type 1 diabetes go insulin-free following an islet cell transplant, the company announced Tuesday. The company’s stock $ELDN rose about 12% on Tuesday morning after Eledon announced the data and an $85 million offering . It said the investigator-initiated trial, which is being conducted by researchers at UChicago Medicine Transplant Institute, could have produced the first results showing that two patients became insulin-independent after undergoing treatment with an anti-CD40L monoclonal antibody and without taking tacrolimus, which is the current standard of care to prevent transplant rejections. Tacrolimus, a type of immunosuppressant, comes with a laundry list of toxicity issues, including kidney and beta cell toxicity, post-transplant new-onset diabetes, hypertension, brain fog and tremors, according to Eledon CEO David-Alexandre Gros. “We’re trying to get people off insulin, and yet, right when we’re giving them new islet cells, we’re giving them a drug that is going to harm,” Gros told Endpoints News . “We’re looking to develop a new generation of immunomodulator, one that will be both more effective as well as safer than the current standard of care.” Gros pointed to Vertex’s work in stem cell-derived islet cell therapy — the company announced over the summer that three of its patients had gone insulin-free using VX-880 — but patients also have to be on chronic immunosuppressive therapy. Vertex is working on VX-264, which is designed to treat patients without immunosuppressants, but Gros thinks there will be a place for Eledon’s drug, called tegoprubart, if VX-264 fails. “What we’re hoping to do is to unlock this market if tegoprubart can provide as good or better protection but without all of the side effects,” Gros said. “And so far, the data is very encouraging.” In the study, patients received islet transplants combined with induction therapy — mycophenolate mofetil plus tegoprubart — every three weeks by an IV infusion. The company said treatment with tegoprubart was “generally well-tolerated” in all subjects, with no unexpected adverse events, graft rejection or hypoglycemic episodes. A third patient decreased their insulin use by more than 60% three days after the transplant procedure. Along with achieving insulin independence at approximately three months and six months post-transplant, the first two patients also recorded normal HbA1c levels. All three patients saw improved islet engraftment — engraftment was three to five times higher than three comparable subjects who received only tacrolimus — and Eledon said this suggests that tegoprubart is “less toxic” to transplanted islets and led to improved graft survival and function. Back in 2020, Eledon bought tegoprubart through its acquisition of Anelixis, though the ALS Therapy Development Institute had discovered the drug. Eledon first ran a Phase 2 trial with the drug in ALS patients before pivoting to transplant rejection. It still has plans to develop the drug in ALS. The company is continuing the trial in islet cell transplant, which is designed for up to nine patients, and it has three ongoing trials in kidney transplantation. Editor’s note: This story has been updated with the name of the UChicago Medicine Transplant Institute.