APMD

EX-99.1

2 apmd-ex99_1.htm

EX-99.1

EX-99.1

EX-99.1

Apnimed Reports Second Quarter 2026 Financial Results and Provides Corporate Update

• U.S. Food and Drug Administration (“FDA”) Accepted the NDA for AD109, with a proposed proprietary name Oxnimbi™, and assigned a PDUFA target action date of February 28, 2027

• If approved, Oxnimbi has the potential to become the first oral pharmacologic therapy designed to address the neuromuscular root cause of upper airway collapse for the millions of people living with OSA

• Strengthened the Company’s leadership team with several key appointments

• Completed its upsized initial public offering for gross proceeds of $220.8 million and its common stock began trading on the Nasdaq Global Select Market

CAMBRIDGE, Mass., September 8, 2026 – Apnimed, Inc. (Nasdaq: APMD) (“Apnimed”), a late stage clinical pharmaceutical company dedicated to the discovery, development and commercialization of novel oral therapies that address the neurobiology of sleep-related breathing diseases, today announced its financial results for the second quarter ended June 30, 2026, and provided a corporate update.

“This was a highly productive quarter for Apnimed as we continued to execute against our strategy, highlighted by the FDA’s acceptance of our NDA for AD109 (proposed proprietary name Oxnimbi), with a PDUFA target action date of February 28, 2027,” said Kevin Lind, Chief Executive Officer of Apnimed. “Over the past several months, we have significantly strengthened our financial position, including through the successful completion of our IPO, providing us with additional resources as we prepare for the potential commercialization of Oxnimbi, pending approval. With this strengthened financial position, we are advancing our commercial readiness activities and building the capabilities needed to support a potential U.S. launch. With an estimated 80 million people in the U.S. living with OSA, many of whom remain untreated, we believe Oxnimbi has the potential to address the scale of unmet need in OSA and, if approved, represents a significant commercial opportunity for Apnimed.”

Recent Highlights and Upcoming Milestones

• Announced the FDA accepted for review the New Drug Application (“NDA”) for AD109 (proposed proprietary name Oxnimbi) for the treatment of adults with obstructive sleep apnea (“OSA”). The FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of February 28, 2027.

• Presented a broad body of data and research at both ATS 2026 and SLEEP 2026, including pooled analyses of the SynAIRgy and LunAIRo Phase 3 trials of Oxnimbi, reflecting one of the largest clinical development programs conducted for an OSA pharmacotherapy, as well as research highlighting the significant unmet need in OSA.

• Simultaneously published two peer-reviewed articles on Oxnimbi, including results from the Phase 3 SynAIRgy trial in the American Journal of Respiratory and Critical Care Medicine and a companion mechanistic review article in the American Journal of Respiratory Cell and Molecular Biology.

• Strengthened the Company’s leadership team with the appointments of Kevin Lind as Chief Executive Officer, Michael Kelly as Chief Financial Officer and Steven Spector as Chief Legal Officer and Head of Corporate Affairs as part of a planned leadership transition.

• Completed two financing transactions to support commercial readiness and the potential U.S. launch of Oxnimbi, if approved by the FDA, including an upsized initial public offering for gross proceeds of $220.8 million and a senior secured credit facility for up to $150 million with funds managed by HealthCare Royalty Partners.

• Completed the strategic monetization of the Company’s interest in Shionogi-Apnimed Sleep Science, generating $100 million in upfront proceeds, with the potential for additional milestone and royalty payments, while allowing the Company to further focus its resources on Oxnimbi.

• Apnimed’s common stock began trading on the Nasdaq Global Select Market under the ticker symbol “APMD” on July 31, 2026.

• Apnimed was included in a preliminary list of additions to the Russell 2000® Index, to be effective on September 21, 2026.

Upcoming Investor Events

Cantor Global Healthcare Conference 2026, September 9-11, 2026, New York, NY

• Apnimed fireside chat on Thursday, September 10, 2026.

Second Quarter Financial Results

Apnimed reported cash and cash equivalents of approximately $172.8 million at June 30, 2026. Subsequently, the Company completed its upsized initial public offering of 13,800,000 shares of its common stock, including 1,800,000 shares issued pursuant to the full exercise of the underwriters’ overallotment option, at a price to the public of $16.00 per share for gross proceeds of $220.8 million, less underwriting discounts and commissions.

Research and development expenses were $9.9 million for the three months ended June 30, 2026, a decrease of $6.1 million, or 38%, compared