Talphera Announces Third Quarter 2025 Financial Results and Provides Corporate Update

Closed $17 million first tranche financing led by a strategic investment from CorMedix, Inc.

Cash and investments at September 30, 2025 were $21.3 million; combined with conditional future tranches of previous financings, expect sufficient cash through a potential PMA approval of Niyad in late 2026

5 of the 9 target profile clinical sites are now activated; completion of NEPHRO study expected in H1 2026

Conference call and webcast to be held Wednesday, November 12, 2025 at 4:30 pm ET

SAN MATEO, Calif.,Nov. 12, 2025/PRNewswire/ -- Talphera, Inc. (Nasdaq:TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced third quarter 2025 financial results and provided a corporate update.

"The financing closed in September, led by a strategic investment from CorMedix, combined with future conditional tranches, is expected to provide us sufficient capital through at least a Niyad PMA approval anticipated in 2026. Their investment, along with investment from existing and new financial investors, further validates the attractiveness of the Niyad market opportunity," stated Vince Angotti CEO of Talphera. "In addition, we're excited about the high quality and skilled execution of the NEPHRO study sites. Importantly, we have received consistent feedback from the principal investigators conveying eagerness for nafamostat to be available as their preferred alternative to current CRRT anticoagulants. The positive enrollment momentum in the NEPHRO clinical study has continued and we look forward to the recently activated sites and the remaining four planned sites to further accelerate the enrollment rate to complete the study in the first half of 2026."

Third Quarter 2025 and Recent Highlights

Third Quarter 2025 Financial Information

2025 Expense Guidance

Conference Call and Webcast Information

Talphera will hold a conference call and webcast at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss the results and provide an update on the Company's business.

Investors who wish to participate in the conference call may do so by dialing 1-800-836-8184 for North American callers, or 1-646-357-8785 (toll applies) for international callers outside of Canada. The conference ID is 08207. The webcast can be accessedhereor by visiting the Investors section of the Company's website atwww.talphera.comand clicking on the webcast link posted within Investors/News & Events/Upcoming Events section. The webcast will include a slide presentation and a replay will be available on the Talphera website for 90 days following the event.

About Talphera, Inc.

Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad® is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA).

This release is intended for investors only. For additional information about Talphera, please visitwww.talphera.com.

About Niyad and Nafamostat

Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad® is a lyophilized formulation of nafamostat and is currently being studied under an IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. Talphera's registrational study of Niyad® is named the NEPHRO CRRT (NafamostatEfficacy inPhase 3RegistrationalContinuousRenalReplacementTherapy) study. An ICD-10 procedural code, XY0YX37, has been issued for the extracorporeal introduction of nafamostat. The ICD-10 code is a specific/billable code that can be used to indicate a procedure. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that may be investigated and developed for the treatment of acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC), acute pancreatitis or as an anti-viral treatment, amongst other potential targets.

About the NEPHRO CRRT Study

The NEPHRO CRRT Study, which has received central IRB approval, is designed as a prospective, double-blinded trial to be conducted at up to 14 U.S. hospital intensive care units. The study will enroll and evaluate 70 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk for bleeding. The primary endpoint of the study is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours. Key secondary endpoints include the mean post-filter activated clotting time over 72 hours, filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours.

Forward-looking statements

This press release contains forward-looking statements based upon Talphera's current expectations and assumptions. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believe," "expect," "anticipate," "may," "if," "intends," "plans," "potential," "projected," "will," or the negative of these words or other comparable terminology, and include: Talphera's expectation of study completion in H1 2026, that the current cash balance, combined with conditional future tranches from previous financings, will be sufficient cash through a potential PMA approval of Niyad in late 2026; that there will be four new target profile sites activated during the fourth quarter of 2025; that recently activated sites and the remaining four planned sites are expected to further accelerate the enrollment rate to complete the study enrollment in the first half of 2026; that the NEPHRO study enrollment rates will continue, and additional study sites will be activated on a timely basis allowing the study to be completed by H1 2026; the potential of nafamostat to address unmet needs in anticoagulation of the extracorporeal circuit, and potential FDA approval of the nafamostat product candidate; and Talphera's expected cash operating expenses will be in the $14 million to $15 million range for 2025. Talphera's discussion of its strategy, plans and intentions also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to Talphera's product development activities, including that clinical studies may not be fully enrolled or completed and/or confirm any safety, efficacy or other potential developmental product characteristics described or assumed in this press release; (ii) Talphera's developmental product candidates may not be beneficial to patients or healthcare providers or be successfully commercialized; (iii) risks relating to Talphera's ability to obtain regulatory approvals for its developmental product candidates; (iv) risks related to the ability of Talphera and its business partners to implement development plans, commercial launch plans, forecasts and other business expectations; and (v) risks related to Talphera's liquidity and its ability to maintain capital resources sufficient to conduct its clinical studies. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption "Risk Factors" and elsewhere in Talphera's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in Talphera's most recent annual, quarterly or current report as filed or furnished with the SEC. Talphera's SEC reports are available atwww.talphera.comunder the "Investors" tab. Except to the extent required by law, Talphera undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.