Neos Therapeutics, Inc.

BRISTOL, Tenn.--( BUSINESS WIRE )-- USAntibiotics , the sole licensed American manufacturer of penicillin-based Amoxicillin and Amoxil Clavulanate, the life-saving antibiotics commonly known as Amoxil ® and Augmentin ® , today announced the appointment of Steven Lutz to vice president of strategic accounts. In this role, Lutz oversees the organization’s commercial strategy to drive continued growth and market share in alignment with the company’s business objectives. An accomplished sales and marketing executive, Lutz has more than three decades of experience leading multi-faceted business development strategies in the pharmaceutical and biotechnology sectors. At USAntibiotics, Lutz leads the overarching sales strategy with a focus on initiatives to optimize commercial efficiency, strengthen customer relationships and oversee third-party logistics. “ Steven’s proven success in driving strategic growth in the pharmaceutical market makes him a great addition to our team,” said Patrick Cashman, president, USAntibiotics. “ His leadership will be instrumental as we further expand our market presence and advance our mission of producing life-saving antibiotics for the benefit of all Americans. We are delighted to welcome Steven to USAntibiotics and our executive leadership team.” Before joining USAntibiotics, Lutz was on the leadership team at Neos Therapeutics. Prior to that, he co-founded Cornerstone Therapeutics, now Chiesi USA. About USAntibiotics USAntibiotics is the only U.S. manufacturer of Amoxicillin and Amoxicillin Clavulanate, commonly known as Amoxil ® and Augmentin ® . Based in Bristol, Tennessee, it operates a world-class, 394,000 square foot antibiotics production facility with the sole focus of making quality, life-saving antibiotics widely available for the benefit of all Americans. USAntibiotics is part of the Jackson Healthcare ® family of companies. For more information, visit www.us-antibiotics.com .

IRVINE, Calif., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the appointment of James Robinson to its Board of Directors effective October 1, 2023. Mr. Robinson is a seasoned biopharmaceutical executive with over 30 years of experience in the industry, most recently serving as Chief Executive Officer and Director of Urovant Sciences until its merger with Sumitomo Pharma America on July 1, 2023. “I am pleased to welcome Jim to our Board and look forward to working with him,” said David-Alexandre C. Gros, M.D., Chief Executive Officer. “Jim joins our Board at a pivotal time in our mission to bring a novel and much-needed new treatment option to the growing number of patients undergoing kidney transplantation. His experience as a leader in the biopharmaceutical industry will be invaluable in this next phase of Eledon’s trajectory.” As Chief Executive Officer and Director of Urovant Sciences, Mr. Robinson guided the company through FDA approval of its first drug, a successful product launch, and its acquisition and “take-private” transaction by Sumitomo Dainippon Pharma. Prior to Urovant, he was President and Chief Operating Officer of Paragon Biosciences. Before his time at Paragon, Mr. Robinson served as President and COO of Alkermes, leading operations that generated more than $1 billion in annual revenue. Prior to Alkermes, Mr. Robinson spent over 12 years at Astellas Pharma, one of the leaders in the field of solid organ transplant, where he served as President of the Americas and was responsible for approximately $4 billion in revenue generation. Mr. Robinson currently serves on the Board of Directors of UroGen Pharma (Nasdaq: URGN). He previously served on the Board of Directors for Neos Therapeutics and for AGTC before the company was sold to Syncona. Mr. Robinson also previously served on the Board of Directors of the Pharmaceutical Research and Manufacturers of America (PhRMA), where he served as Chairman of PhRMA’s State Committee. He earned a Bachelor of Science in marketing from DePaul University. “I am inspired by Eledon’s mission to address a therapeutic area with thousands of patients in need of a better option to protect their transplanted organs,” said Mr. Robinson. “Backed by strong scientific rationale and promising clinical results to date, tegoprubart has the potential to change the outlook for patients with transplanted kidneys and help alleviate shortages of available kidneys by preserving the kidneys in transplant patients. I look forward to leveraging my background and experience while working closely with the Eledon management team to continue advancing tegoprubart through the clinic.” About Eledon Pharmaceuticals and tegoprubart Eledon Pharmaceuticals is a clinical stage biotechnology company with immunology expertise that is developing therapies to protect and prevent rejection of transplanted organs, as well as to treat amyotrophic lateral sclerosis (ALS). The Company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target with broad therapeutic potential. 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 planned clinical trials and the Company’s other future expectations, plans and prospects, 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 sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. 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

Company Expects a Six-Month Review of the Prior Approval Supplement Submission by the U.S. Food & Drug Administration Which, if Approved, Enables the Transfer of Cotempla Production to Contract Manufacturer Upon Completion of Manufacturing Transfer of Adzenys XR-ODT and Cotempla XR-ODT, Company Expects to Improve ADHD Product Margins by an Estimated Fifteen Percent ENGLEWOOD, CO / ACCESSWIRE / July 10, 2023 / Aytu BioPharma, Inc. (the Company or "Aytu") (NASDAQ:AYTU), a pharmaceutical company focused on developing and commercializing novel therapeutics, has submitted the Cotempla XR-ODT® ("Cotempla") Prior Approval Supplement (PAS) to the U.S. Food & Drug Administration (FDA). If approved, the PAS would enable Aytu to transfer the production of Cotempla to the Company's third-party manufacturer. The Company expects a six-month review of the PAS submission, which would enable FDA approval by late calendar 2023 or early calendar 2024. The Company previously announced the FDA approval of the Adzenys XR-ODT® ("Adzenys") site transfer PAS and has begun shifting Adzenys production to the Company's contract manufacturer. "I'm pleased to report this additional milestone as we work to increase the profitability of our products by reducing the cost of goods sold and the expenses associated with the production of our ADHD products by leveraging the operating efficiencies of our contract manufacturer," commented Josh Disbrow, Aytu's Chief Executive Officer. "With this additional step now achieved, we have even greater visibility into the timing of the site transfer and expect to begin outsourced manufacturing of Adzenys and Cotempla by late 2023 or early 2024. Importantly, we have already begun shifting production of Adzenys to Aytu's contract manufacturer. Thus, we expect to start realizing margin improvements for the ADHD brands in early calendar 2024. As we have previously communicated, upon the completion of the site transfers of both products and exiting the former Neos Therapeutics Grand Prairie, Texas facility, we expect to realize an estimated fifteen percent margin improvement of the ADHD brands. I am grateful for our team's tremendous effort and applaud their hard work in advancing the site transfer of these important brands." About Aytu BioPharma, Inc. Aytu BioPharma is a pharmaceutical company commercializing a portfolio of commercial prescription therapeutics and consumer health products. The Company's prescription products include Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) and Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) for the treatment of attention deficit hyperactivity disorder (ADHD), Karbinal® ER (carbinoxamine maleate), an extended-release antihistamine suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary fluoride-based prescription vitamin product lines available in various formulations for infants and children with fluoride deficiency. Aytu's consumer health segment markets a range of over-the-counter medicines and consumer health products addressing a range of common conditions including diabetes, allergy, hair regrowth, and gastrointestinal conditions. To learn more, please visit aytubio.com. Forward-Looking Statement This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this press release, are forward-looking statements. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others, risks associated with the Company's ability to realize cost savings and to transfer manufacturing of its ADHD products to a third-party contract manufacturer and the timing associated with these. We also refer you to (i) the risks described in ''Risk Factors'' in Part I, Item 1A of Aytu's most recent Annual Report on Form 10-K and in the other reports and documents it files with the Securities and Exchange Commission. Contacts for Investors: Mark Oki, Chief Financial Officer Aytu BioPharma, Inc. moki@aytubio.com Robert Blum or Roger Weiss Lytham Partners AYTU@lythampartners.com SOURCE: Aytu BioPharma, Inc. View source version on accesswire.com: