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MAX BioPharma is Pursuing Strategic Partnerships and Series A Financing LOS ANGELES, Oct. 24, 2024 /PRNewswire/ -- MAX BioPharma, Inc. ( ) recently published an article demonstrating the anti-atherosclerotic, anti-inflammatory, and cholesterol-lowering effects of its orally bioavailable oxysterol lead compound, Oxy210, in the peer-reviewed journal, Cells. Oxy210 is derived from the Company's Oxysterol Therapeutics® platform of proprietary small molecule oxysterols that has enabled discovery of diverse oxysterol-based drug candidates in different therapeutic areas, such as bone regeneration, viral and bacterial infection, cancer, pathologic fibrosis, and chronic inflammation. Oxy210 displays unique mechanisms of action that mediate its anti-inflammatory and anti-fibrotic effects based on multipronged targeting of not just one, but multiple cellular signaling pathways. When dysregulated, these vital signals are known to drive the progression of complex diseases such as metabolic dysfunction-associated steatohepatitis (MASH) and its comorbidity, atherosclerosis, which is the leading cause of death in people with MASH. Continue Reading During previous research conducted at the David Geffen School of Medicine at the University of California, Los Angeles and directed by Principal Investigator Dr. Jake Lusis, Professor of Medicine, and Dr. Simon Hui, Project Scientist, Oxy210 was found to significantly inhibit the development of fibrosis in a humanized mouse model of MASH that involves progressive inflammation, fat deposition, and fibrosis in the livers of these mice. The inhibition of fibrosis by Oxy210 was associated with reduced hepatic lipid deposition and the inhibited expression of pro-fibrotic and pro-inflammatory factors including transforming growth factor beta (TGF-β), NLRP3 inflammasome, interleukin-6 (IL-6), tumor necrosis alpha (TNF-α), interleukin-1 beta (IL-1β) and monocyte chemotactic protein 1 (MCP-1). Moreover, Oxy210 inhibited adipose tissue inflammation, suggesting its anti-inflammatory potential that reaches beyond the liver. In their recently published article, the investigators report on significant inhibition of atherosclerosis, a chronic inflammatory disease, in addition to parallel inhibition of MASH. Treatment with Oxy210 was associated with lowering circulating cholesterol levels and reducing macrophage proliferation and content in the artery wall. Together with the in vitro findings of the anti-inflammatory effects of Oxy210 in aortic endothelial cells and macrophages, it appears that Oxy210 could be a promising drug candidate for targeting MASH, atherosclerosis, and perhaps other chronic inflammatory diseases associated with metabolic dysfunction. An anti-inflammatory, anti-fibrotic, cholesterol-lowering oxysterol drug candidate targeting MASH and atherosclerosis Post this "There is an urgent need for therapies to treat fatty liver disease and its more advanced form, MASH, and I find the results of our studies with MAX BioPharma quite exciting" states Dr. Lusis. "Our humanized hyperlipidemic mouse model of MASH reflects the natural history of metabolic dysfunction-associated steatotic liver disease (MASLD) progression in humans and reproduces the salient features of human MASH. Attenuation of hepatic fibrosis and inflammation, as well as anti-atherosclerotic effects suggest that Oxy210 should be further explored as a therapeutic candidate for targeting both conditions " explains Dr. Hui." Dr. Frank Stappenbeck, Director of Chemistry at MAX BioPharma, comments: "Oxysterol-based molecules have been our treasure-trove, driving the Company's drug discovery efforts across several therapeutic indications", adding that "Surprisingly, Oxy210 acts a bit like a Swiss-army knife by combining anti-inflammatory, anti-fibrotic, and lipid-lowering effects, a rare combination of helpful properties". Additional pre-clinical studies required by the FDA for clinical development of Oxy210 are currently underway at MAX BioPharma and the Company is seeking strategic partnerships with biotechnology and pharmaceutical companies with the expertise and resources to further the development of oxysterol-based molecules towards FDA approval and commercialization. In addition, MAX BioPharma is in the process of raising a series A tranche financing round to support the advancement of its therapeutic development programs. "We are very excited and hopeful that our efforts will result in an effective and safe therapy for MASH, a condition with currently only one FDA-approved treatment, indicated for non-cirrhotic MASH and apparently effective in less than 30% of patients. Nevertheless, with dozens of failed clinical drug candidate in this field, this first ever FDA-approved drug reintroduced some degree of hope for people suffering with this condition, once considered untreatable" says Dr. Farhad Parhami, Founder, President and CEO of MAX BioPharma, adding "we hope to continue the advancement of MASH therapeutics with our novel drug candidate". About MAX BioPharma, Inc. MAX BioPharma is a privately held preclinical stage California-based biopharmaceutical company developing novel small molecule lipids as drug candidates for intervention in debilitating and fatal human diseases. The company will be a leader in a new field of Oxysterol Therapeutics® by leveraging a robust and growing intellectual property portfolio that will lead to treatments for numerous indications. MAX BioPharma's first success based on small molecule lipids has contributed to the discovery of novel osteogenic oxysterol compounds that target multipotent mesenchymal cells, including mesenchymal stem cells, to induce the formation of bone-forming osteoblasts and bone. The company is translating this technology into the next generation of therapeutic agents for stimulation of bone formation, locally and systemically, in indications such as spinal fusion, non-union fractures, and osteoporosis. MAX BioPharma is also pursuing the development of small molecule oxysterols that function as anti-tumorigenic Hedgehog and TGF-b pathway antagonists that will be more effective than currently known antagonists in treating a variety of cancers, including lung and pancreatic cancer, and hematologic malignancies, as well as fibrotic diseases of liver, lung, and kidney among others. For more information, please visit us at Media Contact: Farhad Parhami [email protected] SOURCE MAX BioPharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Publication in the Journal of Ocular Pharmacology and Therapeutics highlights the ability of the Optejet to achieve a therapeutic dose of medication with far less exposure to harmful preservatives Additional presentation at the American Academy of Optometry summarizes a Phase 4 study of Mydcombi demonstrating that clinically relevant mydriasis can be achieved with a half-dose per eye NEW YORK, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced a publication in the Journal of Ocular Pharmacology and Therapeutics as well as an upcoming presentation at the American Academy of Optometry’s “Academy 2024 Indianapolis” Annual Meeting. Publication in the Journal of Ocular Pharmacology and Therapeutics The peer-reviewed paper highlights the ability of Eyenovia’s proprietary Optejet dispenser to deliver a therapeutic dose of latanoprost with far less exposure to the preservative benzalkonium chloride (BAK) than traditional eye drops. BAK, in larger volumes, can cause unwanted side effects, including cytotoxicity, cytoplasmic shrinkage, and loss of cell-cell contact, and expression of chemokine (C-C motif) ligand 2 and interleukin-6 (markers of inflammation). In contrast, this in-vitro study of latanoprost plus BAK delivered in the same amount by the Optejet dispenser (8 microliters) avoided the cytotoxicity associated with larger volumes found in eye drops and was similar to no treatment controls and BAK-free latanoprost drops. “We have shown in prior studies the ability of the Optejet dispenser to achieve a therapeutic dose of medication with approximately 80% less volume and exposure to harmful preservatives than traditional eye drops,” stated Michael Rowe, Chief Executive Officer of Eyenovia. “The implication here is that preserved medications may not need to be reformulated to get many of the benefits of non-preserved products if delivered with the Optejet. We believe this creates potential opportunities for the Optejet to improve the administration of topical ocular therapeutics well beyond our own development pipeline.” Presentation at the American Academy of Optometry’s “Academy 2024” Eyenovia also announced today an upcoming presentation at the American Academy of Optometry’s “Academy 2024 Indianapolis,” which is being held November 6-9, in Indianapolis, IN. The presentation details the results of an open-label Phase 4 study of 1% tropicamide and 2.5% phenylephrine ophthalmic metered spray, similar to Mydcombi, Eyenovia’s commercially available product for inducing mydriasis. Twenty-nine subjects completed the study and administered one spray. Baseline pupil diameter (PD) for all eyes was 2.74±0.48 mm. Mean change in PD from baseline to 30 minutes was 3.69±1.25 mm. At 30 minutes post-dosing, mean PD was 6.42±1.25 mm, with 67% and 43% of eyes dilated to ≥ 6mm and 7mm, respectively. The majority of patients returned to functional vision (PD ≤ 5 mm) as early as 3.5 hours post-instillation, with 93% reaching that point by six hours. Safety outcomes were favorable, as only mild adverse events were reported (dry eye and mild instillation site pain) all of which resolved without intervention. “We conducted this study to address questions from doctors about modulating dosing for patients who may benefit from a lower dose of tropicamide or phenylephrine,” stated Dr. Julie Whitcomb, Senior Director of Medical Affairs at Eyenovia. “What we found in this study was that a half dose may also provide clinically relevant pupil dilation, was well-tolerated, and had a desirable shorter duration of effect.” Presentation details: Title:An Open Label, Phase 4 Study of the Safety and Efficacy of Fixed Combination Tropicamide 1% and Phenylephrine 2.5% Ophthalmic Spray (MydCombi®)Poster:#109, Exhibit Hall HPresenter:Dr. Josianne Manasse, OD, SUNY College of OptometryDate/time:Friday, November 8th, 1:00-3:00pm For additional information on the Expo: https://aaopt.org/meetings/academy-2024-indianapolis/ About Eyenovia, Inc. Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic technology company developing a pipeline of advanced products based on its Optejet platform. Eyenovia is currently focused on the commercialization of Mydcombi® for mydriasis, clobetasol propionate ophthalmic suspension, 0.05% for post-surgical pain and inflammation, as well as the ongoing late-stage development of medications in the Optejet device for pediatric progressive myopia as well as out-licensing for additional indications. For more information, visit Eyenovia.com. The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations. PLEASE GO TO MYDCOMBI.COM FOR IMPORTANT SAFETY INFORMATION for MYDCOMBI™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% PLEASE GO TO CLOBETASOLBID.COM FOR IMPORTANT SAFETY INFORMATION for Clobetasol Propionate Ophthalmic Suspension 0.05% Forward-Looking StatementsExcept for historical information, all the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including the timing and scale of acceptance and use of our approved products. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission. In addition, such statements could be affected by risks and uncertainties related to, among other things: risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment, timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our products and product candidates; the potential advantages of our products, product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our products and product candidates; our estimates regarding the potential market opportunity for our products and product candidates; reliance on third parties to develop and commercialize our products and product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products and product candidates; intellectual property risks; changes in legal, regulatory, legislative and geopolitical environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products and product candidates; and our competitive position. Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements. Eyenovia Contact:Eyenovia, Inc.Andy Jones Chief Financial Officerajones@eyenovia.comEyenovia Investor Contact:Eric RibnerLifeSci Advisors, LLCeric@lifesciadvisors.com(646) 751-4363Eyenovia Media Contact:Eyenovia, Inc.Norbert LoweVice President, Commercial Operationsnlowe@eyenovia.com

RNS60 Also Slowed the Decline of Respiratory Function in ALS Patients Results Published in Brain, Behavior, and Immunity TACOMA, Wash. , Sept. 17, 2024 /PRNewswire/ -- Revalesio, a clinical-stage pharmaceutical company developing treatments for acute and chronic neurological disorders, today announced the publication of data in the journal Brain, Behavior, and Immunity , showing that Revalesio’s investigational therapeutic, RNS60, extended median survival by 6 months compared to placebo in a post-hoc analysis of a Phase 2 investigator-sponsored trial. The trial was coordinated by the Research Center for ALS, Istituto di Ricerche Farmacologiche Mario Negri IRCCS in Milano, Italy . After a 6-month double-blind treatment phase, participants were followed for a mean duration of 2.8 years and monitored for survival. Median survival was 6 months longer in the RNS60 treatment group compared to placebo (3 years vs. 2.4 years, p = 0.0519). As reported by the trial investigators in an earlier publication, the decline of forced vital capacity (FVC) - the maximum volume of air that a patient can exhale after a maximum inspiration, used as a primary test to evaluate breathing function of people living with ALS - was significantly slower in the RNS60 group compared to the placebo group at the end of treatment (FVC, difference 0.41 per week, standard error 0.16, p = 0.0101), showing a positive effect of RNS60 on respiratory and bulbar function. The new analysis showed that the extension of survival correlated with the rate of decline of FVC (median survival was 3.7 years in participants with a slow decline of FVC and 1.6 years in participants with faster FVC decline, p < 0.0001). Survival in the RNS60 group was significantly longer compared to the placebo group in participants with low baseline levels of neurofilament light chain, NfL (p = 0.012) or monocyte chemoattractant protein-1, MCP-1 (p < 0.01). Blood levels of NfL, a marker of neuronal damage, have been shown to correlate with the progression rate of ALS. MCP-1 is an inflammatory marker whose blood levels have been reported to increase during the course of ALS. These biomarker results suggest that this could be a subgroup to target in future studies investigating the effects of RNS60 on survival. “These promising findings suggest that RNS60 may have a beneficial effect on survival and slowing the decline of respiratory function in patients with ALS,” said Letizia Mazzini , Professor of Neurology and Director of the Tertiary ALS Center at the University of Piemonte Orientale and participating center in the Phase 2 clinical trial. “These results warrant further investigation, and I look forward to the future development of RNS60 for the treatment of ALS.” “With these encouraging results, RNS60 has shown benefit across two randomized clinical trials in ALS and ischemic stroke, underscoring its potential to impact patients with both acute and chronic neurological disorders. We are committed to advancing RNS60 in additional clinical trials to further evaluate RNS60’s potential to benefit people with ALS and other neurological disorders,” said Bert van den Bergh , Revalesio’s Executive Chairman on the Board of Directors, and former President of Neuroscience Products at Eli Lilly and Company. “On behalf of Revalesio, I would like to thank the investigators for conducting this important additional analysis, as well as the patients and their families for their participation. I would also like to thank the ALS Association for contributing to the original study through the ALS Ice Bucket Challenge.” RNS60 Phase 2 Clinical Trial Design The investigator-sponsored study was a multi-center, randomized, double-blind, placebo-controlled Phase 2 clinical trial, evaluating 147 people living ALS. Patients were enrolled across 22 Italian expert ALS centers and randomized to either RNS60 (n=74) or placebo (n=73) for 24 weeks. Participants were diagnosed with ALS and classified as slow or fast progressors with respect to FVC based on the FVC slope of decline during trial treatment. The primary endpoints were safety and certain biomarker levels associated with ALS and secondary endpoints were the ALS functional rating scale, FVC and survival. Following the 6-month treatment phase, participants were monitored for survival to support the post-hoc analysis. About RNS60 RNS60 is an investigational therapeutic being developed to provide disease modifying and potentially restorative treatments for neurological diseases. In preclinical studies, RNS60 activated intracellular signaling pathways to increase mitochondrial biogenesis and function and reduce inflammation. RNS60 safely protected neurons and oligodendrocytes and modulated the activity of immune cells to restore homeostasis. RNS60 has been granted Orphan Drug and Fast Track designations for ALS from the U.S. Food and Drug Administration. About Revalesio Revalesio is a clinical-stage pharmaceutical company with a vision to change the future of treatment for acute and chronic neurological disorders. The company’s lead clinical program for RNS60 is ischemic stroke with additional programs in ALS and other neurological disorders. The company’s pioneering technology, founded in physics, addresses fundamental mechanisms involved with proper cellular function to slow disease progression and improve quality of life. For more information, please visit revalesio.com and engage with us on LinkedIn . Media Lori Murray lori.murray@captivate-comms.com View original content to download multimedia: SOURCE Revalesio