PresentationGood morning, everyone, and welcome to the Talphera Virtual Analyst and Investor event. [Operator Instructions]. As a reminder, this call is being recorded, and a replay will be made available on the Talphera website following the conclusion of the event. I'd now like to turn the call over to Vince Angotti, Chief Executive Officer at Talphera. Please go ahead.Vincent AngottiCEO & Director Thank you, Tara. And good morning, everyone, and thank you for joining our event today. I'm excited to be jo ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-35068 TALPHERA, INC. (Exact name of registrant as specified in its charter) Delaware 41-2193603 (State or other jurisdiction of incorporation or ...

Talphera (NasdaqGM:TLPH) Q4 2025 Earnings call March 23, 2026 11:00 AM ET Company ParticipantsJames Molloy - Managing Director, Equity ResearchJoao Teixeira - Associate Professor in Division of NephrologyShakil Aslam - Chief Medical OfficerSharon McMahon - Associate Professor of MedicineVincent Angotti - CEOConference Call ParticipantsEd Arce - Managing Director, Senior Research AnalystNazibur Rahman - VP and Biopharmaceuticals Equity Research AnalystYuan Zhi - Senior Equity Research AnalystModeratorGood mo ...

Talphera (NasdaqGM:TLPH) Q4 2025 Earnings call March 23, 2026 11:00 AM ET Company ParticipantsJoao Teixeira - Associate Professor in Division of NephrologyShakil Aslam - Chief Medical OfficerSharon McMahon - Associate Professor of MedicineVincent Angotti - CEOConference Call ParticipantsEd Arce - Managing Director and Senior Research AnalystJim Molloy - Managing Director and Biotechnology and Specialty Pharmaceuticals Equity Research AnalystNazibur Rahman - VP and Biopharmaceuticals Equity Research AnalystY ...

Talphera (NasdaqGM:TLPH) Q4 2025 Earnings call March 23, 2026 11:00 AM ET Speaker4Good morning, everyone, and welcome to the Talphera Virtual Analyst and Investor Event. At this time, all attendees are in a listen-only mode. A question and answer session will follow the formal presentations. As a reminder, this call is being recorded, and a replay will be made available on the Talphera website following the conclusion of the event. I'd now like to turn the call over to Vince Angotti, Chief Executive Officer ...

Talphera Announces Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update Exhibit 99.1 ● Reached the 35-patient enrollment milestone or 50% enrollment in the NEPHRO CRRT study. ● All 12 clinical sites are now able to enroll patients and are expected to support increased enrollment rates for the remainder of the NEPHRO CRRT clinical study. Fourth Quarter 2025 Financial Information 2026 Guidance Previously announced achievement of 50% enrollment of the NEPHRO CRRT clinical study in ...

Talphera Announces Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update Accessibility StatementSkip Navigation Previously announced achievement of 50% enrollment of the NEPHRO CRRT clinical study in March 2026 and closed the associated financing tranche of $4.1 million All 12 clinical study sites now able to enroll patients to support an expected study completion in 2026 Cash and investments of $20.4 million at December 31, 2025 Fourth Quarter 2025 and Recent Highlights Fourth Q ...

Core Insights - Talphera, Inc. will host a virtual investor and analyst event on March 23, 2026, to discuss Niyad® for continuous renal replacement therapy (CRRT) [1] - The event will feature principal investigators from the NEPHRO CRRT study, which evaluates Niyad's efficacy [1][2] Company Overview - Talphera, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative therapies for medically supervised settings [9] - The lead product candidate, Niyad, is a lyophilized formulation of nafamostat, which has received Breakthrough Device Designation from the FDA [9] Product and Study Details - Nafamostat is a broad-spectrum serine protease inhibitor with anticoagulant, anti-inflammatory, and potential antiviral properties, used in CRRT for over 30 years in Japan and South Korea [2] - Niyad aims to serve as a regional anticoagulant for patients who cannot tolerate heparin or are at risk of bleeding, addressing limitations of current anticoagulants [2] - The NEPHRO CRRT study is a prospective, double-blinded trial enrolling 70 adult patients in U.S. ICUs, focusing on the mean post-filter activated clotting time as the primary endpoint [7] Expert Involvement - Blaithin McMahon, PhD, and Joao Teixeira, MD, are principal investigators with extensive backgrounds in nephrology and critical care, contributing to the study's credibility [4][5]

Financial Data and Key Metrics Changes - The cash balance as of September 30, 2025, was $21.3 million, which is expected to be sufficient for operations through the anticipated Nifamostat PMA approval next year [17] - Cash operating expenses for Q3 2025 totaled $3.4 million, a decrease from $3.7 million in Q3 2024, primarily due to reductions in personnel and other SG&A expenses [17][18] - The revised expected cash operating expense guidance for 2025 is now in the range of $14-$15 million, down from the previous range of $16-$17 million [18] Business Line Data and Key Metrics Changes - The nephrostudy enrollment rate has shown improvement, with a focus on medical ICUs and nephrologists as principal investigators, leading to a robust enrollment from existing sites [5][10] - The study size was reduced from 166 to 70 patients to accelerate completion, with the goal of achieving 35 patients or 50% enrollment [5][10] Market Data and Key Metrics Changes - The company is positioned to become the only FDA-approved regional anticoagulant for use during continuous renal replacement therapy (CRRT) if Nifamostat is approved [8][14] - There is a clear market need for an FDA-approved regional anticoagulant due to the disadvantages of currently used products like heparin and citrate [15] Company Strategy and Development Direction - The company is focused on completing the nephrostudy and preparing for the launch of Nifamostat, with a potential FDA approval expected in late 2026 [3][31] - Recent investments have validated the Nifamostat opportunity, and the company is restructuring its clinical study approach to enhance enrollment rates [4][5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the low clinical, regulatory, and commercial risks associated with the Nifamostat program, citing its established use in Japan and South Korea [14][15] - The anticipated completion of the nephrostudy has been pushed to the first half of 2026 due to delays in activating new clinical sites, but management remains optimistic about the quality and enrollment potential of these sites [12][18] Other Important Information - The company completed a $17 million financing round, which included a strategic investment from CorMedix, providing them with a 60-day exclusive negotiation period for a potential acquisition [3][4] - The company is also advancing a compassionate use IDE for specific patients with contraindications to currently available anticoagulants [13] Q&A Session Summary Question: Are the new target sites enrolling patients faster? - Management indicated that the new target sites are enrolling at a similar rate as before, and additional sites are needed to achieve accelerated enrollment [20][23] Question: Has federal government volatility affected clinical studies? - Management has not received feedback indicating that federal government issues have impacted the sites, although one site experienced delays due to personnel cuts [24][26] Question: What is the expected timeline for the Veterans Affairs Medical Center site? - The Veterans Affairs Medical Center site is expected to begin enrollment before the end of the year, despite earlier delays [27]

Financial Performance - Total assets increased to $30,742,000 as of September 30, 2025, compared to $18,236,000 as of December 31, 2024, representing a growth of 68.5%[15] - Revenue for the three months ended September 30, 2025, was $1,000, compared to $0 for the same period in 2024, indicating a significant increase[19] - Net loss for the three months ended September 30, 2025, was $4,436,000, compared to a net loss of $3,353,000 for the same period in 2024, reflecting a 32.3% increase in losses[19] - Basic and diluted loss per share for continuing operations was $0.11 for the three months ended September 30, 2025, compared to $0.13 for the same period in 2024[19] - For the nine months ended September 30, 2025, the net loss was $10,518 thousand, an improvement from a net loss of $11,134 thousand in the same period of 2024[25] - The net loss for the three months ended September 30, 2025, was $4.4 million, compared to $3.4 million for the same period in 2024, representing a 29.4% increase in net loss[99] - For the nine months ended September 30, 2025, the net loss was $10.5 million, compared to $11.1 million for the same period in 2024, indicating a 5.4% decrease in net loss[99] Equity and Liabilities - Total stockholders' equity increased to $19,177,000 as of September 30, 2025, from $8,001,000 as of December 31, 2024, marking a 139.5% increase[15] - Total liabilities increased to $11,565,000 as of September 30, 2025, compared to $10,235,000 as of December 31, 2024, an increase of 13.0%[15] - The company has incurred recurring operating losses and negative cash flows since inception, raising substantial doubt about its ability to continue as a going concern[31] Cash Flow and Investments - Cash and cash equivalents decreased to $3,457,000 as of September 30, 2025, from $8,863,000 as of December 31, 2024, a decline of 61.0%[15] - Net cash used in operating activities for the nine months ended September 30, 2025, was $8,928 thousand, compared to $10,429 thousand in the prior year, indicating a reduction in cash outflow[25] - The company reported a significant increase in cash and cash equivalents, ending the period with $3,457 thousand, down from $11,117 thousand at the end of the previous year[25] - The company incurred $17,815 thousand in cash used for investing activities, a substantial increase from $4,979 thousand in the prior year[25] - The net cash provided by financing activities was $21,337 thousand for the nine months ended September 30, 2025, compared to $12,044 thousand in the same period of 2024[25] Research and Development - Research and development expenses for the nine months ended September 30, 2025, totaled $4,472,000, down 16.9% from $5,395,000 for the same period in 2024[19] - Research and development expenses for the three months ended September 30, 2025, decreased by $0.3 million (12%) compared to the same period in 2024, primarily due to a reduction in employee compensation and related expenses[108] - For the nine months ended September 30, 2025, research and development expenses decreased by $0.9 million (17%) compared to the same period in 2024, mainly due to a reduction in headcount and related costs[108] Capital Raising and Financing - The company plans to seek additional capital through various means, including public or private equity offerings and potential collaborations[32] - In September 2025, the company raised approximately $17.0 million from a private placement of common stock and pre-funded warrants[122] - The first closing of the April 2025 Private Placement raised approximately $4.9 million by issuing 3,405,118 shares at $0.586 per share and pre-funded warrants at $0.585 per warrant[68] - The company may seek additional capital through public or private equity offerings, debt securities, or strategic partnerships[118] - The company expects to need additional capital to fund planned operations for at least the next twelve months[143] Legal and Regulatory Matters - The company has faced multiple lawsuits related to alleged misstatements, with the Ninth Circuit affirming the dismissal of a securities class action on August 20, 2025[55][56] - The FDA and other regulatory agencies strictly regulate promotional claims, and improper promotion of off-label uses could lead to significant liabilities[200] Market and Competitive Environment - The company anticipates intense competition in the biotechnology and pharmaceutical industries, which may affect its market position[192] - Future sales of DSUVIA to the Department of Defense (DoD) are unpredictable and may not meet expectations due to various government-related factors[168] Operational Challenges - The company may experience delays in clinical trials, which could increase costs and jeopardize regulatory approval and commercialization of its product candidates[171] - The process for obtaining FDA approval is time-consuming and may involve unexpected delays and costs, impacting the company's financial condition[186] - The company has limited financial and managerial resources, which may lead to missed opportunities for more profitable product candidates[184] Future Outlook - The company expects to incur significant losses in 2025 and may require additional capital to fund operations before the twelve-month anniversary of the filing date of the Quarterly Report[117] - The company has not yet generated significant product revenue and does not anticipate significant near-term revenues from its product candidates, which may impact its ability to achieve profitability[164]