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Serapha Bio Appoints Kenneth T. Mills as Chief Executive Officer and Names Senior Leadership Team to Advance Potential Best-in-Class in vivo Base Editing Program for Alpha-1 Antitrypsin Deficiency- Daphne Karydas appointed as President and Chief Financial Officer - Weston Miller, MD, appointed as Chief Medical Officer - Additional appointments: Nina Hunter, PhD, as Chief Development Officer and Shiva G. Fritsch as Chief Corporate Affairs Officer - Lead program SERP-01 on track for Phase 2/3 initiation in late 2026 or early 2027 NEW YORK, Sept. 15, 2026 (GLOBE NEWSWIRE) -- Serapha Bio, Inc. (“Serapha”), a clinical-stage genetic medicines company committed to transforming the treatment of alpha-1 antitrypsin deficiency (AATD), today announced the appointment of key senior executives to its leadership team including Kenneth T. Mills as Chief Executive Officer and a member of Serapha’s Board of Directors, Daphne Karydas as President and Chief Financial Officer, Weston Miller, MD, as Chief Medical Officer, Nina Hunter, PhD, as Chief Development Officer and Shiva G. Fritsch as Chief Corporate Affairs Officer. SERP-01 is an investigational in vivo base editing therapy designed to correct the most severe disease-causing SERPINA1 E342K (PiZZ) point mutation at its source, restoring production of functional M-AAT while reducing the toxic Z isoform of alpha-1 antitrypsin (Z-AAT), with the potential to address both the liver and lung manifestations of AATD with a single intravenous administration. The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for a Phase 2/3 clinical trial of SERP-01 in PiZZ AATD patients. Serapha intends to initiate this trial in late 2026 or early 2027. The FDA has also granted SERP-01 orphan drug designation and Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of PiZZ AATD. Positive proof-of-concept data from an ongoing investigator-initiated trial (IIT), conducted through a collaboration between clinical sites in China and Germany, were presented at the European Respiratory Society (ERS) Congress earlier this month. As presented, the data showed dose-dependent increases in AAT levels above the protective threshold that were sustained through the data cutoff, substantial reductions in disease-causing Z-AAT protein, and direct correction of the target mutation at its source following a single treatment, with no bystander or off-target editing detected by the assays employed. “What stands out is the precision of the editing profile and restoration of circulating AAT levels, which we believe give SERP-01 best-in-class potential,” continued Mr. Mills. "The emerging data from the ongoing IIT are extremely compelling and a major driver of my conviction in joining Serapha,” said Daphne Karydas, President and Chief Financial Officer of Serapha. “That, combined with the unique opportunity to build alongside Ken and this leadership team of proven operators, is why I’m thrilled to join Serapha at this stage. With the support of world-class investors, we have the team and the runway to move SERP-01 through the clinic with the speed and rigor patients with AATD deserve.” Serapha continues to expect its previously announced merger with Boundless Bio, Inc. (Nasdaq: BOLD) (“Boundless Bio”) to close in the fourth quarter of 2026, subject to the satisfaction of customary closing conditions, including approval by the stockholders of each company. In support of the proposed merger, Serapha has secured commitments for pre-closing private investments of approximately $230 million from a syndicate of investors co-led by RTW Investments and RA Capital Management, with participation from Janus Henderson Investors, Decheng Capital, Vivo Capital, Casdin Capital, LifeSci Venture Partners, Logos Capital, Balyasny Asset Management, and Eventide Asset Management. Of that amount, approximately $138 million has already been funded in a Series A financing and approximately $92 million is expected to be funded substantially concurrently with the closing of the merger. Following the closing, the combined company plans to operate under the name Serapha Bio and is expected to trade on Nasdaq under the ticker symbol “AATD,” subject to Nasdaq approval. Newly Appointed Senior Leadership Team: Kenneth T. Mills brings more than two decades of executive leadership in the biotechnology industry. He most recently served as President, Chief Executive Officer and director of Tagworks Pharmaceuticals B.V., a precision oncology company. Previously, Mr. Mills spent 15 years as the founding President and Chief Executive Officer of REGENXBIO, leading its 2015 IPO and building it into a leading gene therapy company with end-to-end research, clinical and manufacturing capabilities; he continues to serve as Chairman of its Board of Directors. He holds an SB in chemistry from the Massachusetts Institute of Technology. Daphne Karydas brings more than two decades of financial leadership across biopharmaceutical operations, capital markets and healthcare investment banking. She most recently served as President and Chief Financial Officer of Flare Therapeutics, and previously held CFO and senior strategy roles at Syndax Pharmaceuticals and Allergan plc. Ms. Krydas serves on the boards of COMPASS Pathways, Mineralys Therapeutics and Epikast. She earned her MBA from Harvard Business School and a BA and MS in chemical engineering from MIT. Weston Miller, MD, brings more than two decades of clinical development experience in genomic medicines for patients with rare, severe genetic disorders. He most recently served as Chief Medical Officer of Epicrispr Biotechnologies, and previously led clinical investigation at Graphite Bio and held medical director roles at Astellas Gene Therapies and Sangamo Therapeutics. Earlier in his career, Dr. Miller served as an associate professor of pediatrics at the University of Minnesota. He earned his MD from Louisiana State University School of Medicine and a BS in chemistry from Stanford University. Nina Hunter, PhD, has close to two decades of regulatory and drug development leadership spanning industry and government. She most recently spent six years as SVP, Global Regulatory Strategy and Quality at REGENXBIO, overseeing regulatory strategy and policy and regulatory affairs from early research through BLA submission and FDA review, with additional responsibility for Quality functions. Dr. Hunter previously spent 12 years at the FDA, rising to Director of the Office of Clinical Policy and Programs. She earned her PhD in Genetics from Harvard Medical School and an AB in Biochemistry from Bowdoin College. Shiva G. Fritsch brings more than two decades of experience guiding the growth and strategic evolution of biopharmaceutical companies. She most recently spent nine years as Chief Communications and People Officer at REGENXBIO, building its people, communications and patient advocacy functions. Ms. Fritsch previously held leadership roles at Novavax, the Howard Hughes Medical Institute and Human Genome Sciences. She earned her MBA from the University of Maryland's Robert H. Smith School of Business and a BA in Biology and Neurobiology from Bryn Mawr College. About Serapha Bio Forward-Looking Statements These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including the risk that the proposed merger or the pre-closing financings may not be completed on the anticipated terms or timing or at all; the failure to obtain the required approvals of the stockholders of Boundless Bio and Serapha; the failure to satisfy the other conditions to the closing of the proposed merger, including the effectiveness of the registration statement on Form S-4 to be filed with the SEC and approval of the Nasdaq listing application; the risk that the anticipated ownership percentages of the combined company or the amount of the cash dividend to pre-merger Boundless Bio stockholders may change based on adjustments at or prior to closing; risks related to the ability to attract and retain key personnel, including the newly appointed executive officers; the fact that the investigator-initiated trial is being conducted by third parties outside of Serapha’s control, is early stage, involves a limited number of patients, is not designed to support regulatory approval and may not be predictive of the results of Serapha’s planned clinical trials; the uncertainties inherent in clinical development and the regulatory approval process, including the risk that the FDA’s clearance of the IND and its grant of orphan drug and RMAT designations do not ensure or accelerate approval; the combined company’s ability to successfully develop and, if approved, commercialize SERP-01; the combined company’s reliance on third parties in connection with manufacturing, research and clinical and preclinical testing; Serapha’s reliance on intellectual property rights licensed from YolTech Therapeutics and other risks related to the protection of intellectual property; the combined company’s need for substantial additional funding; and other risks described in Boundless Bio’s filings with the SEC, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in the registration statement on Form S-4 and the proxy statement/prospectus to be filed in connection with the proposed merger. Should one or more of these risks or uncertainties materialize, or should any of the parties’ assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. You should not place undue reliance on these forward-looking statements. Forward-looking statements speak only as of the date of this release, and neither Serapha nor Boundless Bio undertakes any obligation to update them except as required by law. No Offer or Solicitation Important Additional Information and Where to Find It Participants in the Solicitation Investors and Media:
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