Welcome to our dedicated page for Talphera SEC filings (Ticker: tlph), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
acelrx pharmaceuticals inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. the company’s product candidates, dsuvia™ (known as arx-04 outside of the united states) and zalviso®, are designed to deliver sufentanil, a strong opioid analgesic, via a non-invasive, sublingual formulation in medical supervised settings. dsuvia is designed to deliver sublingual tablets containing 30 mcg sufentanil via a disposable, pre-filled, single-dose applicator. the phase 3 clinical program has completed and assessed the investigational product in the treatment of moderate-to-severe acute pain in patients who had undergone surgery or who presented to an emergency room with trauma or injury. in clinical studies, dsuvia demonstrated reductions in pain intensity as early as 15-to-30 minutes after the start of dosing and the most common adverse events included nausea, headache, dizziness, and vTalphera, Inc. is advancing nafamostat-based product candidates and is funded through recent equity financings. The company reports 200,000,000 shares authorized and 20,522,655 shares issued and outstanding as of June 30, 2025, up from 17,029,469 at December 31, 2024. Its lead developmental product, Niyad, a lyophilized formulation of nafamostat, is being studied under an IDE and has received FDA Breakthrough Device Designation for regional anticoagulation in continuous renal replacement therapy; nafamostat is approved in Japan and South Korea for related uses. Talphera also acquired LTX-608, a nafamostat IV formulation for potential ARDS, DIC, acute pancreatitis or antiviral use. A securities appeal remains pending after dismissal of plaintiffs’ case; briefing completed January 21, 2025 and oral argument occurred June 12, 2025. The company completed a private placement that included 4,999,316 pre-funded warrants exercisable at $0.001 and other financing activity disclosed.
Talphera, Inc. (TLPH) furnished a press release on August 14, 2025 announcing its financial results for the three months ended June 30, 2025 and providing a corporate update. The Form 8-K states the press release is included as Exhibit 99.1 and clarifies the information is being "furnished" rather than "filed," so it is not subject to Section 18 liability under the Exchange Act and is not incorporated by reference into other filings except by specific reference. No financial figures or operational details are included in the 8-K itself; readers are directed to the referenced press release for the substantive results.