Apnimed Reports Second Quarter 2026 Financial Results and Provides Corporate Update
FDA NDA acceptance for Oxnimbi plus large financing and asset monetization leave Apnimed better funded as it prepares for a potential U.S. launch.
Rhea-AI Summary
Apnimed (APMD) reported second quarter 2026 results and major corporate milestones tied to its OSA candidate AD109 (proposed name Oxnimbi).
The FDA accepted the NDA for Oxnimbi for adults with obstructive sleep apnea and assigned a PDUFA target action date of February 28, 2027. Oxnimbi has completed two Phase 3 trials (SynAIRgy and LunAIRo), and Apnimed is advancing commercial readiness for a potential U.S. launch if approved. During the quarter the company expanded its leadership team, completed an upsized IPO of 13.8 million shares at $16.00 for $220.8 million in gross proceeds, and secured a senior secured credit facility of up to $150 million.
Apnimed also monetized its interest in Shionogi-Apnimed Sleep Science for $100 million upfront plus potential milestones and royalties, ended June 30, 2026 with $172.8 million in cash and equivalents, and turned to net income of $125.9 million versus a $69.5 million net loss a year earlier, driven largely by a $85.4 million gain on sale of an equity method investment and a $57.1 million gain on reversal of a deposit liability. Common stock began trading on the Nasdaq Global Select Market on July 31, 2026 under ticker APMD.
Positive
- FDA accepted NDA for Oxnimbi with a PDUFA target action date of February 28, 2027
- Upsized IPO of 13,800,000 shares at $16.00 per share raised $220.8 million in gross proceeds
- Senior secured credit facility provides up to $150 million in additional funding capacity
- Strategic monetization of Shionogi-Apnimed Sleep Science generated $100 million upfront plus potential milestones and royalties
- Cash and cash equivalents were $172.8 million at June 30, 2026, before IPO proceeds
- Q2 2026 net income was $125.9 million versus a $69.5 million net loss in Q2 2025, aided by $137.8 million in other income
- Research and development expenses fell 38% year over year to $9.9 million in Q2 2026, reflecting completion of Phase 3 trials
Negative
- Q2 2026 related-party revenue declined to $12.1 million from $17.1 million in Q2 2025
- Q2 2026 general and administrative expenses increased to $12.7 million, up more than 100% from $5.4 million a year earlier
- Loss from operations widened to $(11.7) million in Q2 2026 from $(5.9) million in Q2 2025, before other income
- New debt and revenue interest liabilities totaled about $50.3 million at June 30, 2026, up from none at December 31, 2025
News Explained
The completed IPO issued
Key Figures
- PDUFA target action date
- February 28, 2027
- AD109/Oxnimbi NDA review
- IPO gross proceeds
- $220.8 million
- Upsized initial public offering
- Senior secured credit facility
- Up to $150 million
- HealthCare Royalty Partners financing
- Strategic monetization proceeds
- $100 million
- Upfront proceeds from Shionogi-Apnimed Sleep Science interest
- Cash and cash equivalents
- $172.8 million
- June 30, 2026
- Research and development expenses
- $9.9 million
- Three months ended June 30, 2026
- Net income
- $125.9 million
- Quarter ended June 30, 2026
Historical Context
-
Upsized IPO closed with 13.8 million shares sold for $220.8 million gross proceeds.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
fda regulatory
nda regulatory
pdufa regulatory
osa medical
antimuscarinic medical
phase 3 medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- 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., Sept. 08, 2026 (GLOBE NEWSWIRE) -- 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
Research and development expenses were
General and administrative expenses were
Other income (expenses) was
Net income was
About AD109 / Oxnimbi
AD109 is Apnimed’s investigational drug candidate, with a proposed proprietary name of Oxnimbi. The proposed name remains subject to final FDA review and acceptance and may change. Oxnimbi is designed to be the first potential pharmacological treatment to improve oxygenation during sleep and target the neuromuscular root cause of upper airway collapse in people with OSA. It is a potentially first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor. Oxnimbi is intended to be a once-daily oral pill taken at bedtime that is designed to lower the complexity of treating OSA. Oxnimbi, if approved, may offer an oral solution to help improve oxygenation and health for people living with OSA. Oxnimbi has completed two Phase 3 clinical trials for the treatment of mild, moderate and severe OSA. Apnimed's NDA for Oxnimbi is under review by the FDA and was assigned a PDUFA goal date of February 28, 2027. There can be no assurances that Oxnimbi will be approved by the FDA by the PDUFA target action date, or at all.
About Apnimed
Apnimed is 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. We believe the introduction of once-nightly oral drugs has the potential to expand diagnosis and the reach of treatment for people with OSA. We believe that people with OSA would benefit from having multiple treatment options with differing mechanisms to more fully address the heterogeneity of OSA’s disease pathophysiology. Apnimed envisions a new era where novel oral therapies simplify intervention and expand the reach of diagnosis and treatment.
Apnimed is advancing its product candidate, AD109 (proposed proprietary name Oxnimbi), which is designed to improve oxygenation in individuals living with OSA. We believe that Oxnimbi could become the catalyst for a new oral treatment paradigm for OSA that has been historically limited to devices or invasive surgeries.
Learn more at apnimed.com or follow us on X and LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). We may, in some cases, use terms such as "predicts," "forecasts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Examples of forward-looking statements contained in this press release include, without limitation, statements regarding our expectations as to commercial readiness activities, the potential approval and commercialization of Oxnimbi, the potential acceptance of Oxnimbi as the proprietary name for AD109, the clinical and therapeutic potential of Oxnimbi (including to address OSA), the size of the commercial opportunity for Oxnimbi, the occurrence and timing of the PDUFA goal date for Oxnimbi, and other statements that are not historical facts. We intend these forward- looking statements to be covered by the safe harbor provisions for forward looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act, and are making this statement for purposes of complying with those safe harbor provisions.
Forward-looking statements are based on our current expectations, estimates and projections only as of the date of this release and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the risks inherent in biopharmaceutical product development; our ability to execute on our strategy, including obtaining the requisite regulatory approvals on the expected timeline, if at all; risks related to our financial condition and the need for substantial additional funding in order to complete development activities and commercialize Oxnimbi; risks related to the competitive landscape for OSA products; our ability to attract, integrate and retain key personnel; risks related to regulatory developments and approval processes of the FDA and comparable foreign regulatory authorities; and risks related to establishing and maintaining our intellectual property protections. These and other risks and uncertainties concerning our business and operations are described more fully in the sections titled “Risk Factors” of the final prospectus related to the offering filed with the U.S. Securities and Exchange Commission (“SEC”) and in its most recent periodic report filed with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Apnimed undertakes no duty to update such information except as required under applicable law.
Media Contact:
media@apnimed.com
Investor Contact:
ir@apnimed.com
| APNIMED, INC. AND SUBSIDIARY CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (in thousands, except share and per share amounts) | ||||||||
| June 30, 2026 | December 31, 2025 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 172,804 | $ | 41,890 | ||||
| Prepaid research and development | 1,407 | 1,541 | ||||||
| Accounts receivable | 690 | 959 | ||||||
| Deferred transaction costs | 4,779 | — | ||||||
| Prepaid expenses and other current assets | 5,092 | 665 | ||||||
| Total current assets | 184,772 | 45,055 | ||||||
| PROPERTY AND EQUIPMENT, NET | 53 | 66 | ||||||
| ASSETS HELD FOR SALE | — | 26,893 | ||||||
| CONTINGENT ASSET | 9,893 | — | ||||||
| OPERATING LEASE RIGHT-OF-USE ASSET | 714 | 835 | ||||||
| OTHER ASSETS | 24 | 24 | ||||||
| TOTAL ASSETS | $ | 195,456 | $ | 72,873 | ||||
| LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | $ | 6,598 | $ | 1,788 | ||||
| Accrued expenses and other current liabilities | 9,184 | 11,026 | ||||||
| Operating lease liability | 265 | 250 | ||||||
| Short-term deferred revenue | 19,531 | 97,812 | ||||||
| Total current liabilities | 35,578 | 110,876 | ||||||
| LONG TERM LIABILITIES: | ||||||||
| Operating lease liability, net of current | 485 | 623 | ||||||
| Convertible notes | 39,331 | 40,646 | ||||||
| Debt | 40,267 | — | ||||||
| Revenue interest liability | 10,037 | — | ||||||
| Deposit liability | — | 57,120 | ||||||
| Deferred revenue | — | 15,244 | ||||||
| TOTAL LIABILITIES | 125,698 | 224,509 | ||||||
| COMMITMENTS AND CONTINGENCIES (NOTE 7) | ||||||||
| Convertible Preferred Stock, authorized as of June 30, 2026 and December 31, 2025, respectively; 28,522,107 shares issued and outstanding as of June 30, 2026 and December 31, 2025. Liquidation preference of December 31, 2025, respectively. | 245,939 | 221,147 | ||||||
| STOCKHOLDERS’ DEFICIT: | ||||||||
| Common stock, and 196,577 Class C) shares authorized as of June 30, 2026 and 45,627,228 (42,481,983 Class A, 2,948,668 Class B, and 196,577 Class C) shares authorized as of December 31, 2025; 4,801,823 (1,853,155 Class A, 2,752,091 Class B, and 196,577 Class C) shares issued and outstanding as of June 30, 2026 and 4,781,256 (1,832,588 Class A, 2,752,091 Class B, and 196,577 Class C) shares issued and outstanding as of December 31, 2025. | 1 | 1 | ||||||
| Additional paid-in capital | 27,508 | 24,560 | ||||||
| Accumulated deficit | (203,690 | ) | (397,344 | ) | ||||
| Total stockholders’ deficit | (176,181 | ) | (372,783 | ) | ||||
| TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT | $ | 195,456 | $ | 72,873 | ||||
| APNIMED, INC. AND SUBSIDIARY CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except share and per share amounts) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| REVENUE - RELATED PARTY | $ | 12,080 | $ | 17,110 | $ | 96,894 | $ | 20,241 | ||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Research and development | 9,900 | 15,969 | 18,004 | 39,425 | ||||||||||||
| General and administrative | 12,674 | 5,353 | 19,180 | 10,823 | ||||||||||||
| Cost of services - related party | 1,210 | 1,724 | 3,370 | 3,041 | ||||||||||||
| Total operating expenses | 23,784 | 23,046 | 40,554 | 53,289 | ||||||||||||
| INCOME (LOSS) FROM OPERATIONS | (11,704 | ) | (5,936 | ) | 56,340 | (33,048 | ) | |||||||||
| OTHER INCOME (EXPENSES): | ||||||||||||||||
| Interest income | 970 | 309 | 1,188 | 740 | ||||||||||||
| Gain on sale of equity method investment | 85,380 | — | 85,380 | — | ||||||||||||
| Gain on reversal of deposit liability | 57,120 | — | 57,120 | — | ||||||||||||
| Change in fair value of long-term debt | (1,659 | ) | — | (1,659 | ) | — | ||||||||||
| Change in fair value of revenue interest liability | (460 | ) | — | (460 | ) | — | ||||||||||
| Change in fair value of convertible notes | (796 | ) | — | 1,315 | — | |||||||||||
| Other income (expense) | (2,738 | ) | — | (2,738 | ) | — | ||||||||||
| Total other income | 137,817 | 309 | 140,146 | 740 | ||||||||||||
| NET INCOME (LOSS) FROM CONTINUING OPERATIONS BEFORE INCOME TAXES | 126,113 | (5,627 | ) | 196,486 | (32,308 | ) | ||||||||||
| Income tax expense | — | — | — | — | ||||||||||||
| NET INCOME (LOSS) FROM CONTINUING OPERATIONS | 126,113 | (5,627 | ) | 196,486 | (32,308 | ) | ||||||||||
| Loss from discontinued operations | (178 | ) | (63,847 | ) | (2,832 | ) | (65,812 | ) | ||||||||
| NET INCOME (LOSS) | $ | 125,935 | $ | (69,474 | ) | $ | 193,654 | $ | (98,120 | ) | ||||||
| Net income (loss) per share of Class A, Class B and Class C - Basic: | ||||||||||||||||
| Continuing operations | $ | 26.29 | $ | (1.18 | ) | $ | 40.97 | $ | (6.80 | ) | ||||||
| Discontinued operations | $ | (0.04 | ) | $ | (13.43 | ) | $ | (0.59 | ) | $ | (13.85 | ) | ||||
| Basic net income (loss) per share | $ | 26.25 | $ | (14.61 | ) | $ | 40.38 | $ | (20.65 | ) | ||||||
| Net income (loss) per share of Class A, Class B and Class C - Diluted: | ||||||||||||||||
| Continuing operations | $ | 3.92 | $ | (1.18 | ) | $ | 6.07 | $ | (6.80 | ) | ||||||
| Discontinued operations | $ | (0.01 | ) | $ | (13.43 | ) | $ | (0.09 | ) | $ | (13.85 | ) | ||||
| Diluted net income (loss) per share | $ | 3.91 | $ | (14.61 | ) | $ | 5.98 | $ | (20.65 | ) | ||||||
| Weighted average common shares outstanding, basic | 4,797,152 | 4,754,020 | 4,795,472 | 4,751,347 | ||||||||||||
| Weighted average common shares outstanding, diluted | 32,353,048 | 4,754,020 | 32,173,441 | 4,751,347 | ||||||||||||
FAQ
What leadership changes did Apnimed implement during and around the quarter?
Apnimed strengthened its leadership team as part of a planned transition, appointing Kevin Lind as Chief Executive Officer, Michael Kelly as Chief Financial Officer, and Steven Spector as Chief Legal Officer and Head of Corporate Affairs.
How did Apnimed’s operating expenses change in the second quarter of 2026?
For the three months ended June 30, 2026, research and development expenses were $9.9 million, down $6.1 million or 38% from $16.0 million a year earlier, mainly due to lower AD109 clinical trial costs after completion of the LunAIRo and SynAIRgy trials. General and administrative expenses were $12.7 million, up $7.3 million from $5.4 million, driven by higher legal services, increased headcount-related salaries and stock-based compensation, and about $4.0 million in infrastructure spending to prepare for the expected Oxnimbi launch, if approved.
What were the main components of Apnimed’s other income in Q2 2026?
Other income for the three months ended June 30, 2026 was $137.8 million, up from $0.3 million a year earlier. This increase was primarily due to a $57.1 million gain on reversal of a deposit liability, an $85.4 million gain on sale of an equity method investment, a $0.6 million increase in interest income, and a small change in the fair value of a contingent asset, partially offset by a combined $2.9 million change in fair value of long-term debt, revenue interest liability and convertible notes, and $2.9 million of long-term debt and revenue interest liability issuance costs.
How did Apnimed’s balance sheet change between December 31, 2025 and June 30, 2026?
Total assets increased to $195.5 million at June 30, 2026 from $72.9 million at December 31, 2025, largely due to higher cash and cash equivalents and recognition of a $9.9 million contingent asset. Total liabilities decreased to $125.7 million from $224.5 million, reflecting elimination of a $57.1 million deposit liability and deferred revenue, while new long-term debt of $40.3 million and a $10.0 million revenue interest liability were added.
What is Oxnimbi and how is it intended to treat obstructive sleep apnea?
Oxnimbi (AD109) is Apnimed’s investigational once-daily oral combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor. It is designed to improve oxygenation during sleep and target the neuromuscular root cause of upper airway collapse in people with mild, moderate and severe obstructive sleep apnea. The proposed proprietary name remains subject to final FDA review and acceptance, and there is no assurance of FDA approval by the PDUFA target action date, or at all.
What capital markets milestones did Apnimed achieve after the quarter?
Apnimed’s common stock began trading on the Nasdaq Global Select Market under the ticker symbol “APMD” on July 31, 2026, and the company was included in a preliminary list of additions to the Russell 2000 Index, expected to be effective on September 21, 2026.
Which upcoming investor event will feature Apnimed’s management?
Apnimed is scheduled to participate in the Cantor Global Healthcare Conference 2026, held September 9–11, 2026 in New York, NY, with an Apnimed fireside chat on Thursday, September 10, 2026.