Talphera Announces First Quarter 2025 Financial Results and Provides Corporate Update
- FDA approved reduction in NEPHRO CRRT study size from 166 to 70 patients, maintaining 90% power
- Secured up to $14.8M in financing with first tranche of $4.4M completed
- Reduced net loss to $2.7M in Q1 2025 from $4.0M in Q1 2024
- Operating expenses decreased to $2.9M from $4.2M year-over-year
- Three new clinical sites activated with five more expected by mid-2025
- Continued net losses of $2.7M in Q1 2025
- Second financing tranche contingent on enrollment milestones and stock price conditions
- Cash position of $9.8M may require additional funding for operations beyond 2025
- Projected cash operating expenses of $17-19M for 2025
Insights
Talphera reports narrowed Q1 losses with study site expansion; cash runway concerns persist despite recent $4.4M financing.
Talphera's Q1 2025 results reflect a company in transition, showing both progress and persistent challenges. The $2.7M net loss from continuing operations represents a meaningful improvement from the $4.0M loss in Q1 2024, driven primarily by cost-cutting measures. The company has successfully reduced its combined R&D and SG&A expenses by
The adjusted cash position of
The FDA's approval to reduce the NEPHRO trial size from 166 to 70 patients is a significant regulatory win, potentially accelerating the development timeline and reducing costs. The company's activation of three new clinical sites with five more expected by mid-year demonstrates operational progress, though the emphasis on needing to complete enrollment by year-end highlights the urgency of their clinical program.
The recent financing structure, requiring enrollment milestones and minimum share price requirements, underscores investor caution. While management expresses confidence in completing the 70-patient study by year-end, investors should note that clinical enrollment often faces unexpected delays. The
Cash and investments at March 31, 2025, as adjusted to include the proceeds from the first tranche of the private placement financing which closed on April 2, 2025, were
Three new clinical study sites activated and screening patients thus far in 2025, with five additional sites expected by mid-year, for a total of 13
Conference call and webcast to be held Wednesday, May 14, 2025 at 4:30 pm ET
"We remain on track with new study site activation, including three institutions already activated and beginning to screen patients in 2025, and five new potentially high-enrolling sites by mid-year. The new target profile of our clinical study sites has proven beneficial as engagement with the principal investigators and activity at the sites is much higher than with the legacy sites with which we first initiated the study," stated Vince Angotti, CEO of Talphera. "We believe that the increased engagement from the new sites, including those expected to come on board in the coming months, will allow us to complete the 70-patient study by the end of the year. We expect our next enrollment update to occur when we enroll 17 patients, which is the milestone for closing the second tranche of our recent financing. Our confidence in the need for this product candidate continues to grow as we introduce more physicians to the Niyad clinical profile and NEPHRO study," continued Angotti.
First Quarter 2025 and Recent Highlights
- In March 2025, the Company announced it received approval from the
U.S. Food and Drug Administration (FDA), on its Prior Approval Supplement (PAS) requesting a reduction in the number of patients in the NEPHRO CRRT clinical study from 166 in the original study protocol to 70. With 70 patients, the primary endpoint is powered at90% . In January 2025, the agency also agreed to two other changes to broaden the clinical study inclusion criteria which allow the Company to enroll patients already on continuous renal replacement therapy (CRRT) beyond 48 hours, as well as heparin-tolerant patients at certain institutions. - In March 2025, Talphera announced the agreement for a financing of up to
$14.8 million 25% and50% enrollment and Talphera's stock price trades at a price at or above$0.73 25$4.4 million
First Quarter 2025 Financial Information
- The cash and cash equivalents balance was
$5.4 million - Combined R&D and SG&A expenses for the first quarter of 2025 totaled
$2.9 million $4.2 million $2.7 million $3.9 million - For the first quarter of 2025, the Company recognized net loss from continuing operations of
$2.7 million $4.0 million $0.1 million - Net loss attributable to common shareholders for the first quarter of 2025 was
$2.6 million $0.10 $4.0 million $0.16
2025 Expense Guidance
- Cash operating expenses, or selling, general and administrative, and research and development expenses, excluding stock-based compensation, is expected to be in the range of
$17 million $19 million
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
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
This release is intended for investors only. For additional information about Talphera, please visit www.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 (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) 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 that there will be five new potentially high-enrolling sites activated by mid-year, that the NEPHRO study enrollment rates will increase, and additional study sites will be activated allowing the study to be completed by the end of 2025; the potential of nafamostat to address unmet needs in anticoagulation of the extracorporeal circuit, and potential FDA approval of the nafamostat product candidate; Talphera's expectation that the committed capital from the private placement financing, upon completion of certain milestones and meeting certain closing conditions, should provide sufficient capital to fund the completion of the NEPHRO study, expected by the end of 2025; Talphera's expected cash operating expenses will be in the
Selected Financial Data | ||||
(in thousands, except per share data) | ||||
(unaudited) | ||||
Three Months Ended | ||||
March 31 | ||||
2025 | 2024 | |||
Statement of Operations Data | ||||
Revenue | $ 27 | $ - | ||
Operating costs and expenses: | ||||
Research and development (1) | 1,169 | 1,433 | ||
Selling, general and administrative (1) | 1,774 | 2,804 | ||
Total operating costs and expenses | 2,943 | 4,237 | ||
Loss from operations | (2,916) | (4,237) | ||
Other income, net: | ||||
Interest income and other income, net | 69 | 220 | ||
Gain on sale of future payments | - | 1,246 | ||
Gain (loss) on change in fair value of warrant liability | 181 | (1,002) | ||
Non-cash interest expense on liability related to sale of future payments | - | (181) | ||
Total other income, net | 250 | 283 | ||
Net loss from continuing operations | (2,666) | (3,954) | ||
Net income from discontinued operations | 73 | - | ||
Net loss | $ (2,593) | $ (3,954) | ||
Net loss per share attributable to stockholders: | ||||
Basic and diluted, continuing operations | $ (0.10) | $ (0.16) | ||
Basic and diluted, discontinued operations | $ 0.00 | $ - | ||
Basic and diluted loss per share | $ (0.10) | $ (0.16) | ||
Shares used in computing net loss per share of common stock, basic and diluted | 26,268 | 24,722 | ||
(1) Includes the following non-cash stock-based compensation expense: | ||||
Research and development | $ 77 | $ 107 | ||
Selling, general and administrative | 119 | 195 | ||
Total | $ 196 | $ 302 | ||
Selected Balance Sheet Data | ||||
(in thousands) | ||||
March 31, 2025 | December 31, 2024(1) | |||
(Unaudited) | (Unaudited) | |||
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 | ||
(1) | Derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2024. |
Reconciliation of Non-GAAP Financial Measures | |||
(Operating Expenses less stock-based compensation expense) | |||
Three Months Ended | |||
March 31 | |||
(unaudited) | |||
2025 | 2024 | ||
Operating expenses (GAAP): | |||
Research and development | $ 1,169 | $ 1,433 | |
Selling, general and administrative | 1,774 | 2,804 | |
Total operating expenses | 2,943 | 4,237 | |
Less stock-based compensation expense | 196 | 302 | |
Operating expenses (non-GAAP) | $ 2,747 | $ 3,935 | |
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SOURCE Talphera, Inc.
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