Every 8-K that Talphera, Inc. (TLPH) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow TLPH and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full TLPH filings page.
Talphera, Inc. reported second quarter 2026 results and development progress for Niyad, its nafamostat-based anticoagulant for continuous renal replacement therapy (CRRT). The NEPHRO CRRT registrational study reached 75% enrollment, with all target clinical sites activated and completion expected this year. The 2026 KDIGO guideline for acute kidney injury and acute kidney disease cites nafamostat as an acceptable regional anticoagulant during CRRT, and updated market research estimates about 200,000 U.S. CRRT procedures in 2027, a 21% increase over prior estimates.
For the quarter ended June 30, 2026, Talphera recorded no revenue and a net loss attributable to common shareholders of $4.3 million, or $0.06 per share, compared with a net loss of $3.5 million, or $0.10 per share, a year earlier. Combined research and development and selling, general and administrative expenses were $3.9 million, up from $3.7 million, primarily due to higher Niyad development costs. Cash, cash equivalents and investments totaled $17.1 million as of June 30, 2026, versus $20.4 million at December 31, 2025. Total stockholders’ equity was $14.4 million at June 30, 2026.
Talphera, Inc. held its 2026 Annual Meeting of Stockholders on June 22, 2026, where shareholders voted on directors, auditor ratification, executive pay and equity plans. Three Class III directors — Marina Bozilenko, Joseph Todisco and Mark Wan — were elected to serve until the 2029 Annual Meeting.
Shareholders ratified BPM LLP as independent auditor for the year ending December 31, 2026 and approved, on an advisory basis, the compensation of named executive officers. They also approved amended and restated versions of Talphera’s 2020 Equity Incentive Plan and 2011 Employee Stock Purchase Plan, which provide the main stock-based compensation frameworks for employees and executives.
Talphera, Inc. reported first quarter 2026 results, highlighting continued progress in its NEPHRO CRRT Phase 3 study of Niyad, a nafamostat-based anticoagulant for Continuous Renal Replacement Therapy in intensive care settings.
For the three months ended March 31, 2026, revenue was $0 compared with $27,000 a year earlier, while operating expenses rose to $3.9 million from $2.9 million, reflecting higher research and development and selling, general and administrative costs. A $1.2 million gain from the change in fair value of warrant liability and higher interest income helped reduce the net loss to $2.6 million from $2.6 million in the prior-year period, with basic and diluted net loss per share improving to $0.04 from $0.10 as the share count increased.
Cash, cash equivalents and investments totaled $21.1 million as of March 31, 2026, slightly above $20.4 million at year-end 2025, supporting ongoing clinical development. Talphera reaffirmed its expectation that the NEPHRO CRRT study will complete later in 2026 and emphasized the potential for nafamostat to address an unmet need as a regional anticoagulant alternative to heparin and citrate in CRRT.
Talphera, Inc. reported fourth quarter and full year 2025 results and updated progress on its NEPHRO CRRT registrational study for Niyad, a nafamostat-based anticoagulant. For Q4 2025, the company recorded no revenue and a net loss of $3.8 million, compared with a net loss of $1.9 million a year earlier. For full year 2025, revenue was $28,000 and net loss was $14.3 million versus a net loss of $13.0 million in 2024, while total operating expenses declined to about $13.5 million from $15.3 million. Cash, cash equivalents and investments were $20.4 million at December 31, 2025, up from $8.9 million a year earlier, supported in part by closing a $4.1 million financing tranche linked to 50% enrollment in the NEPHRO CRRT study. The trial has enrolled 35 of 70 planned patients, with all 12 active sites able to recruit, and completion is expected in 2026. Talphera guided 2026 cash operating expenses to $17–18 million and scheduled a virtual investor and analyst day to discuss its business and clinical progress.
Talphera, Inc. completed the third closing of a previously arranged private placement, raising approximately $4.1 million in gross proceeds from institutional investors and a member of management.
The funding came through unregistered sales of common stock and pre-funded warrants under Section 4(a)(2) and Regulation D. Under a related registration rights agreement, Talphera agreed to file resale registration statements for the shares and warrant shares within 15 days of each closing and to use reasonable best efforts to have them declared effective, including a 90-day outside date following a full SEC review.
Talphera, Inc. reported that Nasdaq has notified the company it is out of compliance with the exchange’s minimum bid price rule, which requires a closing bid of at least $1.00 per share for 30 consecutive business days. The company’s Nasdaq Capital Market listing is not immediately affected.
Talphera has 180 calendar days, until September 7, 2026, to regain compliance by maintaining a closing bid of at least $1.00 for ten consecutive business days. If it fails to do so, it may qualify for an additional 180-day period or face potential delisting if it cannot demonstrate a viable plan to cure the deficiency.
Talphera, Inc. (TLPH) reported results of its 2025 Annual Meeting. Stockholders elected three Class II directors and ratified BPM LLP as auditor for the year ending December 31, 2025. An advisory vote approved executive compensation, and stockholders favored holding the advisory vote every year.
Equity plans were approved: the amended and restated 2020 Equity Incentive Plan and the amended and restated 2011 Employee Stock Purchase Plan. Stockholders also approved an amendment authorizing a reverse stock split at a ratio of not less than 1-for-10 and not greater than 1-for-30, at the Board’s discretion within 12 months solely if advisable to regain Nasdaq minimum bid compliance.
A total of 9,778,006 shares were represented out of 20,522,655 entitled to vote. The company noted it had already regained compliance with Nasdaq’s $1.00 minimum bid price based on 10 consecutive trading days ending October 17, 2025.
Talphera, Inc. completed an optional second and third closing of its previously disclosed private placement, generating approximately $1.6 million in aggregate gross proceeds, excluding any proceeds from future exercises of the pre-funded warrants issued at this closing.
The company reiterated existing registration rights, agreeing to file registration statements for the resale of common shares issued in the private placement and shares underlying pre-funded warrants within 15 days of the applicable closing, and to use reasonable best efforts to have them declared effective as promptly as practical, and in any event within 90 days in the event of a full SEC review.
Separately, Talphera was notified on October 20, 2025 that it regained compliance with Nasdaq’s minimum bid price requirement, after the closing bid price met or exceeded $1.00 for 10 consecutive business days ending October 17, 2025, following its earlier transfer to The Nasdaq Capital Market.
Talphera appointed Joseph Todisco as a Class III director and compensation committee member, serving until the 2026 annual meeting. In connection with his appointment, he received 6,397 restricted stock units and options to purchase 38,381 shares at an exercise price of $1.11, vesting in three equal annual installments beginning on October 14, 2025, subject to continued service. The company also intends to enter into a non‑employee director indemnification agreement with him.
The board seat was designated under a securities purchase agreement with CorMedix. While CorMedix and affiliates beneficially own at least 25% of the shares it purchased at the first closing, it may designate one Talphera director. The agreement grants CorMedix a 60‑day Right of First Negotiation following Talphera’s public announcement of achieving the primary endpoint and topline results in the NEPHRO CRRT study for Niyad, during which Talphera will not engage with other parties on a similar transaction. If no agreement is reached, for nine months from that announcement Talphera will not enter a similar deal on less favorable financial terms without CorMedix’s consent. The right ends upon a public termination of the study before the primary endpoint or on December 31, 2027.
Talphera, Inc. filed a Current Report on Form 8-K disclosing a registration rights agreement related to a private placement dated September 7, 2025. Under the agreement the company agreed to file registration statements covering resale of the common stock issued in the private placement no later than 15 days following the applicable closing date and to use reasonable best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 90 days following the applicable closing date if the SEC conducts a full review. The filing states the offering was made in a private placement under Section 4(a)(2) of the Securities Act and Regulation D, and the securities have not been registered. The form of the Registration Rights Agreement is filed as Exhibit 10.3, alongside the purchase agreement and warrant forms listed in Item 9.01.
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.