AcelRx Pharmaceuticals(ACRX) - 2025 Q1 - Quarterly Results

Executive Summary & Corporate Update Q1 2025 Key Highlights Talphera announced Q1 2025 financial results and corporate updates, with adjusted cash and investments of $9.8 million as of March 31, 2025, and activated three new clinical research sites - As of March 31, 2025, adjusted cash and investments (including the first tranche of private placement financing on April 2) totaled $9.8 million[1] - Three new clinical research sites have been activated and are screening patients year-to-date in 2025, with five more expected by mid-year, totaling 13[1] CEO Commentary on Clinical Progress CEO Vince Angotti reported good progress in activating new research sites, expecting to complete 70 patients by year-end, with increased site engagement boosting confidence in Niyad - The company expects to complete clinical studies for 70 patients by the end of 2025[2] - Higher engagement from new clinical research sites is accelerating patient recruitment[2] - Demand for the Niyad product candidate continues to grow, with the next recruitment update provided upon enrolling 17 patients[2] Recent Regulatory & Financing Milestones Talphera achieved significant regulatory and financing milestones in Q1 2025, including FDA approval for reduced patient numbers and broadened enrollment criteria for the NEPHRO CRRT study, and closing the first tranche of a private placement financing FDA Approvals & Study Protocol Changes The FDA approved protocol amendments for the NEPHRO CRRT clinical study, reducing patient numbers from 166 to 70 and broadening enrollment criteria to include patients on CRRT for over 48 hours and heparin-intolerant patients - FDA approved reducing the NEPHRO CRRT clinical study patient count from 166 to 70, with 90% power for the primary endpoint[3] - FDA agreed to broaden clinical study enrollment criteria, allowing recruitment of patients who have received continuous renal replacement therapy (CRRT) for over 48 hours and heparin-intolerant patients[3] Private Placement Financing Talphera secured a financing agreement up to $14.8 million, led by existing investors Nantahala Capital and Rosalind Advisors, including management, with the first tranche of $4.4 million net proceeds closed on April 2, 2025 - The company secured a financing agreement up to $14.8 million, structured in two tranches contingent on 25% and 50% patient enrollment milestones and stock price conditions[4] - The first tranche of financing closed on April 2, 2025, with net proceeds of $4.4 million[4] Financial Performance & Outlook First Quarter 2025 Financial Results Talphera significantly narrowed its net loss in Q1 2025 to $2.6 million from $4.0 million in Q1 2024, primarily due to reduced personnel and general administrative expenses, with cash and cash equivalents at $5.4 million - In Q1 2025, the company's net loss from continuing operations was $2.7 million, a reduction from $4.0 million in Q1 2024[8] - Net loss attributable to common stockholders in Q1 2025 was $2.6 million, or $0.10 per basic and diluted share, an improvement from $4.0 million (or $0.16 per share) in Q1 2024[8] - As of March 31, 2025, cash and cash equivalents balance was $5.4 million[8] Statement of Operations In Q1 2025, the company reported revenue of $27 thousand, compared to zero in Q1 2024, with combined R&D and SG&A expenses decreasing from $4.237 million in Q1 2024 to $2.943 million in Q1 2025, leading to a narrower operating loss Q1 2025 Statement of Operations Data (Summary) | Metric | Three Months Ended March 31, 2025 ($'000) | Three Months Ended March 31, 2024 ($'000) | | :--------------------------------- | :----------------------- | :----------------------- | | Revenue | $27 | $- | | R&D Expenses | $1,169 | $1,433 | | Sales, General & Administrative Expenses | $1,774 | $2,804 | | Total Operating Costs and Expenses | $2,943 | $4,237 | | Operating Loss | $(2,916) | $(4,237) | | Net Loss from Continuing Operations | $(2,666) | $(3,954) | | Net Income from Discontinued Operations | $73 | $- | | Net Loss | $(2,593) | $(3,954) | | Basic and Diluted Loss Per Share | $(0.10) | $(0.16) | Balance Sheet As of March 31, 2025, the company reported cash, cash equivalents, and investments of $5.388 million, total assets of $14.995 million, total liabilities of $9.396 million, and total stockholders' equity of $5.599 million Balance Sheet Data (Summary) | Metric | March 31, 2025 ($'000) | December 31, 2024 ($'000) | | :-------------------- | :------------- | :------------- | | Cash, Cash Equivalents and Investments | $5,388 | $8,863 | | Total Assets | $14,995 | $18,236 | | Total Liabilities | $9,396 | $10,235 | | Total Stockholders' Equity | $5,599 | $8,001 | Non-GAAP Operating Expenses Non-GAAP operating expenses, excluding stock-based compensation, were $2.747 million in Q1 2025, down from $3.935 million in Q1 2024, reflecting efforts to control operating costs Non-GAAP Operating Expense Reconciliation (Summary) | Metric | Three Months Ended March 31, 2025 ($'000) | Three Months Ended March 31, 2024 ($'000) | | :--------------------------------- | :----------------------- | :----------------------- | | R&D Expenses (GAAP) | $1,169 | $1,433 | | Sales, General & Administrative Expenses (GAAP) | $1,774 | $2,804 | | Total Operating Expenses (GAAP) | $2,943 | $4,237 | | Less: Stock-Based Compensation Expense | $196 | $302 | | Operating Expenses (Non-GAAP) | $2,747 | $3,935 | 2025 Expense Guidance Talphera projects 2025 cash operating expenses (excluding stock-based compensation) to be between $17 million and $19 million, covering costs for executing and completing the NEPHRO CRRT registration trial - Cash operating expenses (SG&A and R&D, excluding stock-based compensation) for 2025 are projected to be between $17 million and $19 million[6] - This expense guidance includes costs for executing and completing the NEPHRO CRRT registration trial by year-end[6] Product & Clinical Development About Talphera & Niyad Talphera is a specialty pharmaceutical company focused on developing and commercializing innovative therapies in medically supervised settings, with Niyad® (nafamostat) as its lead candidate for extracorporeal circuit anticoagulation, holding FDA Breakthrough Device Designation - Talphera is a specialty pharmaceutical company focused on developing and commercializing innovative therapies in medically supervised settings[10] - Niyad® is a lyophilized formulation of nafamostat, under investigation as an extracorporeal circuit anticoagulant, and has received FDA Breakthrough Device Designation[10][12] - Nafamostat is a broad-spectrum synthetic serine protease inhibitor with anticoagulant, anti-inflammatory, and potential antiviral activities[12] NEPHRO CRRT Study Details The NEPHRO CRRT study is a prospective, double-blind trial across up to 14 US hospital ICUs, evaluating 70 adult patients receiving renal replacement therapy who are heparin-intolerant or at bleeding risk, with the primary endpoint being mean post-filter activated clotting time over the initial 24 hours - The NEPHRO CRRT study is a prospective, double-blind trial to be conducted in up to 14 US hospital intensive care units[13] - The study will enroll and evaluate 70 adult patients receiving renal replacement therapy who are heparin-intolerant or at risk of bleeding[13] - The primary endpoint is the mean post-filter activated clotting time over the initial 24 hours for Niyad versus placebo[13] Corporate Information Conference Call & Webcast Details Talphera will host a conference call and webcast on May 14, 2025, at 4:30 PM ET to discuss Q1 results and provide business updates, with investor participation via phone or company website - The conference call and webcast will be held on May 14, 2025, at 4:30 PM ET[7] - North American investors can dial 1-800-836-8184, international investors 1-646-357-8785, with conference ID 58894[9] - The webcast will be accessible on the Talphera website under Investors/News & Events/Upcoming Events, with a 90-day replay available[9] Forward-Looking Statements This press release contains forward-looking statements based on Talphera's current expectations and assumptions, protected by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, involving risks related to clinical studies, regulatory approvals, and liquidity - Forward-looking statements are based on Talphera's current expectations and assumptions, protected by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995[14] - Risks and uncertainties include product development activities, clinical study results, regulatory approvals, commercialization capabilities, and company liquidity[14] - The company undertakes no obligation to publicly revise these forward-looking statements to reflect new information, events, or circumstances, unless required by law[14] Investor Contacts Investor contact information for Talphera and LifeSci Advisors is provided, including names, phone numbers, and email addresses - Talphera Investor Contact: CFO Raffi Asadorian, Phone: 650-216-3500, Email: investors@talphera.com[15] - LifeSci Advisors Contact: Kevin Gardner, Phone: 617-283-2856, Email: kgardner@lifesciadvisors.com[15]