Talphera Announces Second Quarter 2025 Financial Results and Provides Corporate Update
Talphera (Nasdaq: TLPH) reported Q2 2025 financial results and provided updates on its NEPHRO clinical study. The company has enrolled 15 patients in the registrational study, which remains on track for completion by year-end. Cash position stood at $6.8 million as of June 30, 2025.
Key financial metrics include a net loss of $3.5 million ($0.10 per share) in Q2 2025, improved from $3.8 million loss in Q2 2024. Operating expenses decreased to $3.7 million from $4.3 million year-over-year. The company secured a three-tranche financing of up to $14.8 million, with the first tranche of $4.9 million closed in April 2025.
Talphera revised its 2025 cash operating expense guidance to $16-17 million, down from the previous $17-19 million range.
Talphera (Nasdaq: TLPH) ha comunicato i risultati finanziari del secondo trimestre 2025 e aggiornamenti sullo studio clinico NEPHRO. La società ha arruolato 15 pazienti nello studio registrativo, che è ancora previsto terminare entro fine anno. La posizione di cassa era di $6,8 milioni al 30 giugno 2025.
I principali indicatori finanziari mostrano una perdita netta di $3,5 milioni ($0,10 per azione) nel Q2 2025, in miglioramento rispetto alla perdita di $3,8 milioni nel Q2 2024. Le spese operative sono calate a $3,7 milioni rispetto a $4,3 milioni anno su anno. La società ha ottenuto un finanziamento in tre tranche fino a $14,8 milioni, con la prima tranche di $4,9 milioni chiusa nell'aprile 2025.
Talphera ha rivisto la guidance delle spese operative in contanti per il 2025 a $16-17 milioni, rispetto all'intervallo precedente di $17-19 milioni.
Talphera (Nasdaq: TLPH) presentó los resultados financieros del segundo trimestre de 2025 y proporcionó actualizaciones sobre su estudio clínico NEPHRO. La compañía ha inscrito a 15 pacientes en el estudio de registro, que sigue en camino de completarse antes de fin de año. La posición de efectivo era de $6,8 millones al 30 de junio de 2025.
Los indicadores financieros clave incluyen una pérdida neta de $3,5 millones ($0,10 por acción) en el T2 2025, mejorando desde una pérdida de $3,8 millones en el T2 2024. Los gastos operativos disminuyeron a $3,7 millones desde $4,3 millones interanual. La compañía aseguró un financiamiento en tres tramos de hasta $14,8 millones, con el primer tramo de $4,9 millones cerrado en abril de 2025.
Talphera revisó su previsión de gastos operativos en efectivo para 2025 a $16-17 millones, frente al rango anterior de $17-19 millones.
Talphera (Nasdaq: TLPH)는 2025년 2분기 재무 실적과 NEPHRO 임상시험에 대한 업데이트를 발표했습니다. 회사는 등록 시험에 15명의 환자를 등록했으며, 연말까지 완료될 예정입니다. 2025년 6월 30일 기준 현금잔액은 $6.8백만이었습니다.
주요 재무 지표는 2025년 2분기 순손실 $3.5백만(주당 $0.10)으로, 2024년 2분기의 $3.8백만 손실에서 개선되었습니다. 영업비용은 전년 동기 대비 $3.7백만으로 감소했고(이전 $4.3백만), 회사는 최대 $14.8백만의 3단계 트랜치 자금조달을 성사시켰으며 첫 번째 트랜치 $4.9백만은 2025년 4월에 마감되었습니다.
Talphera는 2025년 현금 영업비용 가이던스를 기존 $17-19백만에서 $16-17백만으로 하향 조정했습니다.
Talphera (Nasdaq: TLPH) a publié ses résultats financiers du deuxième trimestre 2025 et fait le point sur l'étude clinique NEPHRO. La société a recruté 15 patients dans l'étude d'enregistrement, qui reste en bonne voie pour être achevée d'ici la fin de l'année. La trésorerie s'élevait à 6,8 millions de $ au 30 juin 2025.
Les principaux indicateurs financiers montrent une perte nette de 3,5 millions de $ (0,10 $ par action) au T2 2025, en amélioration par rapport à la perte de 3,8 millions de $ au T2 2024. Les charges d'exploitation ont diminué à 3,7 millions de $ contre 4,3 millions $ en glissement annuel. La société a obtenu un financement en trois tranches pouvant atteindre 14,8 millions de $, la première tranche de 4,9 millions $ ayant été clôturée en avril 2025.
Talphera a révisé ses prévisions de dépenses opérationnelles en trésorerie pour 2025 à 16-17 millions de $, contre une fourchette précédente de 17-19 millions de $.
Talphera (Nasdaq: TLPH) veröffentlichte die Finanzergebnisse für Q2 2025 und gab Updates zur NEPHRO-Studie bekannt. Das Unternehmen hat 15 Patienten in der Zulassungsstudie eingeschlossen, die weiterhin planmäßig bis Jahresende abgeschlossen werden soll. Der Kassenbestand belief sich zum 30. Juni 2025 auf $6,8 Millionen.
Wesentliche Finanzkennzahlen umfassen einen Nettoverlust von $3,5 Millionen ($0,10 je Aktie) im Q2 2025, eine Verbesserung gegenüber dem Verlust von $3,8 Millionen im Q2 2024. Die Betriebskosten sanken von $4,3 Millionen auf $3,7 Millionen im Jahresvergleich. Das Unternehmen sicherte sich eine Dreitranchen-Finanzierung von bis zu $14,8 Millionen, wobei die erste Tranche über $4,9 Millionen im April 2025 abgeschlossen wurde.
Talphera hat seine Prognose für die liquiden betrieblichen Aufwendungen 2025 auf $16-17 Millionen gesenkt (vorher $17-19 Millionen).
- Accelerated NEPHRO study enrollment with 15 patients enrolled to date
- Secured potential financing of up to $14.8 million with first tranche of $4.9M completed
- Reduced net loss to $3.5M from $3.8M year-over-year
- Lowered operating expense guidance for 2025 to $16-17M from $17-19M
- Expanding to 13 total clinical sites by Q3 end to accelerate enrollment
- Limited cash position of $6.8M as of June 30, 2025
- Remaining financing tranches dependent on enrollment milestones and stock price conditions
- Continued operating losses and cash burn from operations
Insights
Talphera shows accelerating NEPHRO enrollment with limited cash runway, needs milestone-triggered financing for PMA submission timeline.
Talphera's Q2 results reveal encouraging operational progress against concerning financial constraints. The company has enrolled 15 patients in their NEPHRO study for nafamostat, with 90% of patients coming from new clinical sites that match their target profile. This acceleration supports management's projection to complete enrollment by year-end 2025, enabling a Q1 2026 PMA submission.
The financial picture requires careful interpretation. With
Management has prudently reduced 2025 expense guidance to
The strategic pivot to target profile clinical sites appears effective, with plans to expand from 7 to 13 total sites by Q3-end. This approach addresses previous enrollment challenges while clinician feedback suggests market demand for nafamostat as a preferred alternative to current CRRT anticoagulation products. The key investor consideration remains whether Talphera can maintain enrollment momentum to trigger the next financing tranche before cash reserves deplete.
New sites accelerate registrational study enrollment - 15 patients have been enrolled in the NEPHRO study which remains on track with completion projected by the end of the year
Cash and cash equivalents at June 30, 2025 were
Conference call and webcast to be held Thursday, August 14, 2025 at 4:30 pm ET
"We have enrolled 15 patients in the NEPHRO clinical study and based on the recent accelerated rate of enrollment, we expect to complete the study by the end of the year," stated Vince Angotti, CEO of Talphera. "In the last six weeks, we have gained enrollment momentum from the new target profile clinical sites and study protocol changes. New sites have enrolled
Second Quarter 2025 and Recent Highlights
- As announced today, the Company has enrolled 15 patients in the NEPHRO clinical study, supporting the expected completion timeline of the clinical study by the end of 2025, and a planned PMA submission in the first quarter of 2026, assuming enrollment and site activation trends continue. 13 total clinical sites are anticipated by the end of the third quarter, which include four legacy sites, three currently enrolling target profile sites, and six new target profile sites that are expected to be enrolling patients in the third quarter.
- In April 2025, Talphera announced the closing of the first tranche of
$4.9 million $14.8 million $0.73 25
Second Quarter 2025 Financial Information
- The cash and cash equivalents balance was
$6.8 million - Combined R&D and SG&A expenses for the second quarter of 2025 totaled
$3.7 million compared to$4.3 $3.5 million for the second quarter of 2025, compared to$4.0 million for the second quarter of 2024. The decrease in combined R&D and SG&A expenses in the second quarter of 2025 was primarily due to reductions in personnel expense and other general and administrative expenses. - For the second quarter of 2025, the Company recognized net loss from continuing operations of
$3.5 million $3.8 million - Net loss attributable to common shareholders for the second quarter of 2025 was
$3.5 million $0.10 $3.8 million $0.15
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
$16 million $17 million $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 six new potentially high-enrolling sites activated during the third quarter, 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 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; and Talphera's expected cash operating expenses will be in the
Selected Financial Data | |||||||
Three Months Ended | Six Months Ended | ||||||
June 30 | June 30 | ||||||
2025 | 2024 | 2025 | 2024 | ||||
Statement of Operations Data | |||||||
Revenue | $ - | $ - | $ 27 | $ - | |||
- | - | ||||||
Operating costs and expenses: | |||||||
Research and development (1) | 1,500 | 1,909 | 2,669 | 3,342 | |||
Selling, general and administrative (1) | 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) | |||
- | - | ||||||
Other income, net: | |||||||
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 | - | (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) | |||
Net loss per share attributable to stockholders: | |||||||
Basic and diluted, continuing operations | $ (0.10) | $ (0.15) | $ (0.20) | $ (0.31) | |||
Basic and diluted, 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 of common | 34,530 | 26,202 | 30,422 | 25,462 | |||
(1) Includes the following non-cash stock-based | |||||||
Research and development | $ 55 | $ 85 | $ 132 | $ 192 | |||
Selling, general and administrative | 111 | 138 | 230 | 333 | |||
Total | $ 166 | $ 223 | $ 362 | $ 525 | |||
Selected Balance Sheet Data | |||
June 30, 2025 | December 31, 2024(1) | ||
(Unaudited) | (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 | |
(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 | Six Months Ended | ||||||
June 30 | June 30 | ||||||
(unaudited) | (unaudited) | ||||||
2025 | 2024 | 2025 | 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 | 166 | 223 | 362 | 525 | |||
Operating expenses (non-GAAP) | $ 3,527 | $ 4,047 | $ 6,274 | $ 7,982 | |||
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SOURCE Talphera, Inc.
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