Talphera(TLPH) - 2025 Q2 - Quarterly Results

Company Overview and Recent Developments Second Quarter 2025 Highlights & Corporate Update Talphera announced its second quarter 2025 financial results and provided a corporate update, highlighting significant progress in the NEPHRO clinical study with accelerated patient enrollment and a strategic financing round to support ongoing operations - 15 patients have been enrolled in the NEPHRO clinical study, which remains on track for completion by the end of 2025, with a planned PMA submission in the first quarter of 2026[1][3] - Enrollment momentum has accelerated in the last six weeks due to new target profile clinical sites and study protocol changes, with new sites enrolling 90% of patients to date[2] - Talphera announced the closing of the first tranche of $4.9 million of a three-tranche financing for up to $14.8 million, led by existing investors Nantahala Capital and Rosalind Advisors[3] About Talphera, Inc. Talphera is a specialty pharmaceutical company focused on developing and commercializing innovative therapies for use in medically supervised settings, with Niyad® (nafamostat) as its lead product candidate - Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings[9] - Talphera's lead product candidate, Niyad®, is a lyophilized formulation of nafamostat, currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit[9] - Niyad® has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA)[9] Clinical Development NEPHRO CRRT Study Progress The NEPHRO clinical study is progressing well, with accelerated patient enrollment and strategic expansion of clinical sites, supporting the projected completion by year-end 2025 and a subsequent PMA submission in Q1 2026 - 15 patients have been enrolled in the NEPHRO clinical study, supporting the expected completion timeline by the end of 2025[1][3] - Enrollment momentum has increased, with new target profile clinical sites enrolling 90% of patients to date[2] - Talphera expects to add six new clinical sites by the end of the third quarter, bringing the total number of sites up to 13, including nine with the target profile[2][3] - A planned PMA submission is anticipated in the first quarter of 2026, assuming enrollment and site activation trends continue[3] About Niyad and Nafamostat Nafamostat is a broad-spectrum synthetic serine protease inhibitor with anticoagulant, anti-inflammatory, and potential anti-viral activities. Niyad® is its lyophilized formulation, currently undergoing a registrational study (NEPHRO CRRT) as an anticoagulant for extracorporeal circuits, and has received Breakthrough Device Designation - Nafamostat is a broad-spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities[11] - Niyad® is a lyophilized formulation of nafamostat, currently being studied under an IDE as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA[11] - The registrational study of Niyad® is named the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study[11] - An ICD-10 procedural code, XY0YX37, has been issued for the extracorporeal introduction of nafamostat, and LTX-608 is a proprietary nafamostat formulation for direct IV infusion with other potential therapeutic targets[11] About the NEPHRO CRRT Study Design The NEPHRO CRRT Study is a prospective, double-blinded trial designed to enroll 70 adult patients undergoing renal replacement therapy who are at risk for bleeding or cannot tolerate heparin, evaluating Niyad®'s efficacy as an anticoagulant - The NEPHRO CRRT Study is designed as a prospective, double-blinded trial to be conducted at up to 14 U.S. hospital intensive care units[12] - The study will enroll and evaluate 70 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk for bleeding[12] - The primary endpoint of the study is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours[12] - Key secondary endpoints include 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 over the first 24 hours[12] Financial Results Second Quarter 2025 Financial Information Overview Talphera reported a reduced net loss for Q2 2025 compared to Q2 2024, primarily due to lower personnel and general administrative expenses, and provided updated, reduced guidance for 2025 cash operating expenses - Cash and cash equivalents balance was $6.8 million as of June 30, 2025[7] - Net loss from continuing operations for the second quarter of 2025 was $3.5 million, compared to $3.8 million for the second quarter of 2024, largely due to reductions in personnel expense and change in fair value of warrant liability[7] - Net loss attributable to common shareholders for Q2 2025 was $3.5 million, or $0.10 per basic and diluted share, compared to $3.8 million, or $0.15 per basic and diluted share, for Q2 2024[7] 2025 Expense Guidance - Cash operating expenses (selling, general and administrative, and research and development expenses, excluding stock-based compensation) are expected to be in the range of $16 million to $17 million in 2025[5] - This 2025 guidance is a reduction from the previously provided range of $17 million to $19 million[5] Key Financial Results (Q2 2025 vs Q2 2024) Combined R&D and SG&A Expenses (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :----------------------------------- | :--------------------- | :--------------------- | :----------- | | Combined R&D and SG&A expenses | $3,700 | $4,300 | -$600 | | Excluding non-cash stock-based compensation | $3,500 | $4,000 | -$500 | | Net loss from continuing operations | $3,489 | $3,827 | -$338 | | Net loss attributable to common shareholders | $3,489 | $3,827 | -$338 | | Basic and diluted loss per share | $0.10 | $0.15 | -$0.05 | - The decrease in combined R&D and SG&A expenses in Q2 2025 was primarily due to reductions in personnel expense and other general and administrative expenses[7] - The divestment of DSUVIA represents a discontinued operation; all historical operating results for the business are reflected within discontinued operations, with no DSUVIA related expenses in Q2 2025 or Q2 2024[7] Selected Financial Data Tables The selected financial data tables provide a detailed breakdown of the company's statement of operations for the three and six months ended June 30, 2025 and 2024, balance sheet data as of June 30, 2025 and December 31, 2024, and a reconciliation of non-GAAP operating expenses Statement of Operations Data Statement of Operations Data (in thousands, except per share data) | Statement of Operations Data | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $ - | $ - | $ 27 | $ - | | Research and development | 1,500 | 1,909 | 2,669 | 3,342 | | Selling, general and administrative | 2,193 | 2,361 | 3,967 | 5,165 | | Total operating costs and expenses | 3,693 | 4,270 | 6,636 | 8,507 | | Loss from operations | (3,693) | (4,270) | (6,609) | (8,507) | | Interest income and other income, net | 83 | 201 | 152 | 421 | | Gain on sale of future payments | - | - | - | 1,246 | | Gain (loss) on change in fair value of warrant liability | 121 | 455 | 302 | (547) | | Non-cash interest expense on liability related to sale of future payments | - | (213) | - | (394) | | Total other income, net | 204 | 443 | 454 | 726 | | Net loss from continuing operations | (3,489) | (3,827) | (6,155) | (7,781) | | Net income from discontinued operations | - | - | 73 | - | | Net loss | $ (3,489) | $ (3,827) | $ (6,082) | $ (7,781) | | Basic and diluted loss per share, continuing operations | $ (0.10) | $ (0.15) | $ (0.20) | $ (0.31) | | Basic and diluted loss per share, discontinued operations | $ - | $ - | $ 0.00 | $ - | | Basic and diluted loss per share | $ (0.10) | $ (0.15) | $ (0.20) | $ (0.31) | | Shares used in computing net loss per share, basic and diluted | 34,530 | 26,202 | 30,422 | 25,462 | Non-Cash Stock-Based Compensation Expense (in thousands) | Expense Type | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $ 55 | $ 85 | $ 132 | $ 192 | | Selling, general and administrative | 111 | 138 | 230 | 333 | | Total | $ 166 | $ 223 | $ 362 | $ 525 | Selected Balance Sheet Data Selected Balance Sheet Data (in thousands) | Metric | June 30, 2025 (Unaudited) | December 31, 2024 (Unaudited) | | :----------------------------------- | :-------------------------- | :---------------------------- | | Cash, cash equivalents and investments | $ 6,791 | $ 8,863 | | Total assets | 16,515 | 18,236 | | Total liabilities | 9,888 | 10,235 | | Total stockholders' equity | 6,627 | 8,001 | Reconciliation of Non-GAAP Financial Measures Reconciliation of Non-GAAP Operating Expenses (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Operating expenses (GAAP): | | | | | | Research and development | $ 1,500 | $ 1,909 | $ 2,669 | $ 3,342 | | Selling, general and administrative | 2,193 | 2,361 | 3,967 | 5,165 | | Total operating expenses | 3,693 | 4,270 | 6,636 | 8,507 | | Less stock-based compensation expense | 166 | 223 | 362 | 525 | | Operating expenses (non-GAAP) | $ 3,527 | $ 4,047 | $ 6,274 | $ 7,982 | Additional Information Conference Call and Webcast Information Talphera will host a conference call and webcast on August 14, 2025, to discuss the financial results and provide a business update, with details provided for participation and replay access - Talphera will hold a conference call and webcast on Thursday, August 14, 2025, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time[1][6] - Investors can participate by dialing 1-800-836-8184 (North America) or 1-646-357-8785 (international), using conference ID 32530[8] - A webcast, including a slide presentation, will be accessible via www.talphera.com and a replay will be available on the Talphera website for 90 days following the event[8] Forward-looking Statements This press release contains forward-looking statements based on current expectations and assumptions, subject to risks and uncertainties that could cause actual results to differ materially, as detailed in the company's SEC filings - The press release contains forward-looking statements based upon Talphera's current expectations and assumptions, made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995[13] - These statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied, including risks related to product development, regulatory approvals, commercialization, and liquidity[13] - Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of their original date, and are advised to consult Talphera's SEC reports for full details on risks[13] Investor Contacts Contact information for Talphera's Chief Financial Officer and LifeSci Advisors is provided for investor inquiries - Talphera Investor Contact: Raffi Asadorian, CFO, 650-216-3500, investors@talphera.com[14] - LifeSci Advisors Contact: Kevin Gardner, 617-283-2856, kgardner@lifesciadvisors.com[14]