ALNA Allena Pharmaceuticals Inc

Allena Pharmaceuticals, Inc. (NASDAQ: ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today announced the appointment of David J. Clark, M.D., M.R.C.P, as Chief Medical Officer, effective immediately. Dr. Clark succeeds Annamaria Kausz, M.D., who will transition to supporting the company in an advisory capacity.

“We are delighted to welcome David to Allena,” said Louis Brenner, M.D., President and Chief Executive Officer of Allena Pharmaceuticals. “Over the course of his career, David has successfully designed and executed clinical programs across a range of rare disease and orphan indications, demonstrating an ability to work collaboratively with regulatory agencies across the globe. His insights and leadership will be hugely valuable as we advance reloxaliase and ALLN-346 through later-stages of development and continue to explore the promise of our proprietary oral enzyme platform for patients living with rare and severe metabolic and kidney diseases. We are grateful to Annamaria for her many contributions to Allena and wish her success in her future endeavors.”

Dr. Clark brings more than 20 years of clinical experience to Allena, with experience at biopharmaceutical companies based in the United States and Europe. Most recently, he served as Chief Medical Officer of Aldeyra Therapeutics from 2016 to 2020, where he led the clinical development and regulatory functions for a portfolio of Phase 3 and Phase 2 programs across a range of immune-mediated ocular and systemic diseases. Before joining Aldeyra, Dr. Clark served as Chief Medical Officer of Wilson Therapeutics, where he led the company’s Phase 2 program for Wilson Disease and the clinical development planning for its Phase 3 program with the U.S. Food and Drug Administration and the European Medicines Association. Before that, he held senior medical positions at TransTech Pharma and NormOxys, as well as clinical development roles at Pfizer, GlaxoSmithKline and SmithKline Beecham. He holds his M.D. from the University of Edinburgh Medical School in Scotland and conducted a research fellowship in respiratory medicine at the University of Dundee.

“I am passionate about working with great teams to deliver new medicines that can meaningfully impact the lives of patients,” said Dr. Clark. “The data generated for reloxaliase and ALLN-346 are highly encouraging and suggest that both products have the potential to address major unmet needs among people living with enteric hyperoxaluria and hyperuricemia and advanced chronic kidney disease, respectively. Moreover, these results clearly demonstrate the power of Allena’s proprietary technology to fuel a pipeline of oral, non-absorbed enzymes that can be delivered with the potential for significant clinical benefit. I look forward to working closely with the team to continue advancing reloxaliase and ALLN-346 toward market, while also exploring new opportunities to apply our platform more broadly.”

About Allena PharmaceuticalsAllena Pharmaceuticals, Inc. is a late-stage biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders. Allena’s lead product candidate, reloxaliase, is currently being evaluated in a pivotal Phase 3 clinical program for the treatment of enteric hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders. Allena is also developing ALLN-346 for the treatment of hyperuricemia in the setting of gout and advanced chronic kidney disease, with Phase 1b multiple-ascending dose and Phase 2 proof-of-concept studies planned for 2021.

Forward-Looking StatementsThis release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements regarding the appointment of Dr. Clark; Allena’s pipeline of oral enzyme therapeutic candidates and Allena’s plans to build a commercial organization. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: market and other conditions, the timing for completion of Allena’s clinical trials of its product candidates, risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Allena’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risk associated with Allena’s financial condition and its need to obtain additional funding to support its business activities, including the future clinical development of reloxaliase and its ability to continue as a going concern; risks associated with Allena’s dependence on third parties; and risks related to the COVID-19 coronavirus. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Allena’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Item 1A of Part I of Allena’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as well as discussions of potential risks, uncertainties and other important factors in Allena’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Allena undertakes no duty to update this information unless required by law.

Investor ContactHannah DeresiewiczStern Investor Relations, Inc.212-362-1200hannah.deresiewicz@sternir.com

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