Talphera Announces Third Quarter 2024 Financial Results and Provides Corporate Update
Talphera (TLPH) reported Q3 2024 financial results, highlighting progress in its NEPHRO CRRT study with five active sites screening patients and two additional sites expected to begin in Q4. The company ended Q3 with $11.1 million in cash and investments. Financial results showed a net loss of $3.4 million ($0.13 per share), compared to $1.4 million loss in Q3 2023. Combined R&D and SG&A expenses increased to $3.7 million from $3.4 million year-over-year, primarily due to NEPHRO study costs. The study will enroll 166 patients across up to 14 U.S. clinical sites, with the primary endpoint measured at 24 hours.
Talphera (TLPH) ha riportato i risultati finanziari del terzo trimestre 2024, evidenziando progressi nel suo studio NEPHRO CRRT con cinque siti attivi che stanno selezionando pazienti e due siti aggiuntivi che dovrebbero iniziare nel quarto trimestre. L'azienda ha chiuso il terzo trimestre con 11,1 milioni di dollari in contante e investimenti. I risultati finanziari hanno mostrato una perdita netta di 3,4 milioni di dollari (0,13 dollari per azione), rispetto a una perdita di 1,4 milioni nel terzo trimestre del 2023. Le spese combinate per R&S e SG&A sono aumentate a 3,7 milioni di dollari da 3,4 milioni rispetto all'anno precedente, principalmente a causa dei costi dello studio NEPHRO. Lo studio prevede l'arruolamento di 166 pazienti in fino a 14 siti clinici negli Stati Uniti, con l'endpoint primario misurato a 24 ore.
Talphera (TLPH) informó los resultados financieros del tercer trimestre de 2024, destacando el progreso en su estudio NEPHRO CRRT con cinco sitios activos que están seleccionando pacientes y dos sitios adicionales que se espera que comiencen en el cuarto trimestre. La compañía finalizó el tercer trimestre con 11.1 millones de dólares en efectivo e inversiones. Los resultados financieros mostraron una pérdida neta de 3.4 millones de dólares (0.13 dólares por acción), en comparación con una pérdida de 1.4 millones en el tercer trimestre de 2023. Los gastos combinados de I+D y SG&A aumentaron a 3.7 millones de dólares desde 3.4 millones interanualmente, principalmente debido a los costos del estudio NEPHRO. El estudio se inscribirá a 166 pacientes en hasta 14 sitios clínicos en EE. UU., con el punto final primario medido a las 24 horas.
탈페라 (TLPH)는 2024년 3분기 재무 결과를 발표하며 5개의 활성 사이트에서 환자를 스크리닝하고 4분기에는 2개의 추가 사이트가 시작될 예정인 NEPHRO CRRT 연구의 진행 상황을 강조했습니다. 회사는 3분기를 1, 110만 달러의 현금 및 투자로 마감했습니다. 재무 결과는 340만 달러의 순손실을 기록했으며(주당 0.13달러), 이는 2023년 3분기 140만 달러 손실에 비해 증가한 수치입니다. 연구 및 SG&A 예산 합계는 NEPHRO 연구 비용으로 인해 전년 대비 340만 달러에서 370만 달러로 증가했습니다. 이 연구는 미국의 최대 14개 임상 사이트에서 166명의 환자를 등록할 예정이며, 주요 끝점은 24시간 후에 측정됩니다.
Talphera (TLPH) a publié ses résultats financiers du troisième trimestre 2024, mettant en évidence les progrès de son étude NEPHRO CRRT, avec cinq sites actifs en cours de sélection des patients et deux sites supplémentaires devant commencer au quatrième trimestre. La société a terminé le troisième trimestre avec 11,1 millions de dollars en espèces et investissements. Les résultats financiers ont montré une perte nette de 3,4 millions de dollars (0,13 dollars par action), contre une perte de 1,4 million de dollars au troisième trimestre 2023. Les dépenses combinées de R&D et de SG&A ont augmenté à 3,7 millions de dollars contre 3,4 millions l'année précédente, principalement en raison des coûts liés à l'étude NEPHRO. L'étude comprendra 166 patients dans jusqu'à 14 sites cliniques aux États-Unis, avec le critère principal mesuré à 24 heures.
Talphera (TLPH) hat die finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht und deutet auf Fortschritte in seiner NEPHRO CRRT-Studie hin, bei der fünf aktive Standorte Patienten auswählen und zwei weitere Standorte im vierten Quartal erwartet werden. Das Unternehmen schloss das dritte Quartal mit 11,1 Millionen Dollar in bar und Investitionen. Die finanziellen Ergebnisse zeigten einen Nettoverlust von 3,4 Millionen Dollar (0,13 Dollar pro Aktie), im Vergleich zu einem Verlust von 1,4 Millionen Dollar im dritten Quartal 2023. Die kombinierten F&E- und SG&A-Ausgaben stiegen von 3,4 Millionen Dollar auf 3,7 Millionen Dollar im Jahresvergleich, hauptsächlich aufgrund der Kosten der NEPHRO-Studie. Die Studie wird 166 Patienten an bis zu 14 klinischen Standorten in den USA einschließen, wobei der primäre Endpunkt nach 24 Stunden gemessen wird.
- First patient enrolled in NEPHRO CRRT study in August 2024
- Five clinical sites actively screening with multiple patients completing the study
- Two additional large-volume clinical sites expected to join in Q4 2024
- Net loss increased to $3.4 million from $1.4 million year-over-year
- R&D and SG&A expenses increased to $3.7 million from $3.4 million year-over-year
- Cash position of $11.1 million may require additional funding for operations
Insights
The Q3 2024 results reveal concerning financial metrics. With
The NEPHRO CRRT study progress, while showing momentum with five active sites and two more coming online, suggests significant ongoing costs. With 166 patients targeted and only "multiple patients" completed so far, the study completion timeline and associated costs create substantial financial uncertainty. The lack of specific guidance on study completion timing raises additional concerns about potential cash needs in 2025.
The NEPHRO CRRT study design shows promise with its focused 72-hour duration and clear primary endpoint measured at 24 hours, which could accelerate completion once enrollment gains momentum. The strategic expansion to high-volume sites and validation from the American Society of Nephrology's Kidney Week indicates strong clinical interest in nafamostat as a regional anticoagulant alternative to heparin.
However, the vague language around enrollment numbers ("multiple patients") and lack of specific completion timeline guidance suggests potential challenges in patient recruitment. The planned expansion to 14 sites from the current seven could help accelerate enrollment, but also indicates the study may be progressing slower than initially anticipated.
Five sites actively screening with multiple patients having completed the study; two additional institutions expected to begin screening in the fourth quarter totaling seven active sites
Cash and investments at September 30, 2024 of
Conference call and webcast to be held Wednesday, November 13, 2024 at 4:30 pm ET
"Our NEPHRO CRRT study has gained momentum, with activated study sites now screening patients and two additional sites to begin screening in the fourth quarter. We're actively engaged with new high-volume sites we expect to further contribute to enrollment rates in the first half of 2025. While we are not providing specific guidance on the study completion date, with execution of our plan to improve enrollment rates and activation of additional study sites, we anticipate the study to be completed next year," stated Vince Angotti, Talphera Chief Executive Officer. "As a reminder, this is not a prolonged study as the primary endpoint is measured at 24 hours with a patient completing the study at 72 hours," continued Angotti.
Dr. Shakil Aslam, Talphera Chief Medical Officer, added, "I remain convinced that nafamostat, if approved, will provide the first FDA-approved regional anticoagulant for CRRT, potentially avoiding the risks of systemic anticoagulation that occurs with heparin. After engagement and discussion with numerous clinicians and the NEPHRO investigators, we have identified opportunities to further improve patient screening and enrollment for a timely completion of the study."
Third quarter 2024 and recent highlights
- The first patient was enrolled in the NEPHRO CRRT study in August 2024.
- Five clinical sites have been activated and are screening patients, with multiple patients now having completed the study. Two additional large-volume clinical sites are expected to be screening patients in the fourth quarter. The NEPHRO CRRT study will enroll 166 patients undergoing continuous renal replacement therapy (CRRT) at up to 14 clinical sites across
the United States . The primary endpoint of the study is the mean post-filter activated clotting time for circuits infused with nafamostat compared to placebo over the first 24 hours. - In October, we met with several physicians, nurses and NEPHRO CRRT study principal investigators at the American Society of Nephrology's Kidney Week 2024 in
San Diego , confirming dissatisfaction with the current anticoagulants and validating the target product profile of nafamostat and its potential as a much-needed alternative anticoagulant for CRRT.
Third Quarter 2024 Financial Information
- The cash, cash equivalents and investments balance was
$11.1 million as of September 30, 2024. - Combined R&D and SG&A expenses for the third quarter of 2024 totaled
$3.7 million compared to$3.4 million for the third quarter of 2023. Excluding non-cash stock-based compensation expense, these amounts were$3.5 million for the third quarter of 2024, compared to$3.0 million for the third quarter of 2023. The increase in combined R&D and SG&A expenses in the third quarter of 2024 was primarily due to an increase in costs associated with the NEPHRO study, partially offset by lower SG&A expenses. - For the third quarter of 2024, the Company recognized net loss from continuing operations of
$3.4 million $1.4 million - Net loss attributable to common shareholders for the third quarter of 2024 was
$3.4 million $0.13 $1.4 million $0.08
Conference Call and Webcast Information
Talphera will hold a conference call and webcast at 4:30 p.m. Eastern Standard Time/1:30 p.m. Pacific Standard 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 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 166 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 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 the NEPHRO study enrollment rates will increase, additional study sites will be activated allowing the study to be completed by the end of 2025, that nafamostat, if approved, will potentially avoid the risks of systemic anticoagulation, the potential of nafamostat to address unmet needs in anticoagulation of the extracorporeal circuit, the potential advantage of having Breakthrough Device Designation, and potential FDA approval of the nafamostat product candidate. Talphera's discussion of its strategy, plans and intentions also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to Talphera's product development activities, including that clinical studies may not be fully enrolled or completed and/or confirm any safety, efficacy or other potential developmental product characteristics described or assumed in this press release; (ii) Talphera's developmental product candidates may not be beneficial to patients or healthcare providers or be successfully commercialized; (iii) risks relating to Talphera's ability to obtain regulatory approvals for its developmental product candidates; (iv) risks related to the ability of Talphera and its business partners to implement development plans, commercial launch plans, forecasts and other business expectations; and (v) risks related to Talphera's liquidity and its ability to maintain capital resources sufficient to conduct its clinical studies. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption "Risk Factors" and elsewhere in Talphera's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in Talphera's most recent annual, quarterly or current report as filed or furnished with the SEC. Talphera's SEC reports are available at www.talphera.com under the "Investors" tab. Except to the extent required by law, Talphera undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
Selected Financial Data | |||||||
(in thousands, except per share data) | |||||||
(unaudited) | |||||||
Three Months Ended | Nine Months Ended | ||||||
September 30 | September 30 | ||||||
2024 | 2023 | 2024 | 2023 | ||||
Statement of Operations Data | |||||||
Revenue | $ - | $ 117 | $ - | $ 370 | |||
Operating costs and expenses: | |||||||
Research and development (1) | 2,053 | 1,178 | 5,395 | 3,777 | |||
Selling, general and administrative (1) | 1,696 | 2,248 | 6,861 | 9,199 | |||
Total operating costs and expenses | 3,749 | 3,426 | 12,256 | 12,976 | |||
Loss from operations | (3,749) | (3,309) | (12,256) | (12,606) | |||
Other income, net: | |||||||
Interest expense | - | - | - | (134) | |||
Interest income and other income, net | 155 | 187 | 576 | 1,245 | |||
Gain on sale of future payments | - | - | 1,246 | - | |||
Gain (loss) on change in fair value of warrant liability | 241 | 1,706 | (306) | 5,718 | |||
Non-cash interest expense on liability related to sale of future payments | - | - | (394) | - | |||
Total other income, net | 396 | 1,893 | 1,122 | 6,829 | |||
Net loss before income taxes | (3,353) | (1,416) | (11,134) | (5,777) | |||
Provision for income taxes | - | (2) | - | (5) | |||
Net loss from continuing operations | (3,353) | (1,418) | (11,134) | (5,782) | |||
Net income (loss) from discontinued operations | - | 61 | - | (8,098) | |||
Net loss | $ (3,353) | $ (1,357) | $ (11,134) | $ (13,880) | |||
Net (loss) income per share attributable to stockholders: | |||||||
Basic and diluted, continuing operations | $ (0.13) | $ (0.08) | $ (0.43) | $ (0.45) | |||
Basic and diluted, discontinued operations | $ - | $ 0.00 | $ - | $ (0.63) | |||
Basic and diluted loss per share | $ (0.13) | $ (0.08) | $ (0.43) | $ (1.08) | |||
Shares used in computing net loss per share of common stock, basic and diluted | 26,213 | 16,758 | 25,714 | 12,880 | |||
(1) Includes the following non-cash stock-based compensation expense: | |||||||
Research and development | $ 92 | $ 210 | $ 284 | $ 383 | |||
Selling, general and administrative | 142 | 168 | 475 | 1,016 | |||
Discontinued operations | - | - | - | 19 | |||
Total | $ 234 | $ 378 | $ 759 | $ 1,418 | |||
Selected Balance Sheet Data | |||
(in thousands) | |||
September 30, 2024 | December 31, 2023(1) | ||
(Unaudited) | (Unaudited) | ||
Cash, cash equivalents and investments | $ 11,117 | $ 9,381 | |
Total assets | 21,014 | 20,395 | |
Total liabilities | 11,373 | 6,290 | |
Total stockholders' equity | 9,641 | 14,105 | |
(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, 2023. |
Reconciliation of Non-GAAP Financial Measures | |||||||
(Operating Expenses less stock-based compensation expense) | |||||||
Three Months Ended | Nine Months Ended | ||||||
September 30 | September 30 | ||||||
2024 | 2023 | 2024 | 2023 | ||||
Operating expenses (GAAP): | |||||||
Research and development | $ 2,053 | $ 1,178 | $ 5,395 | $ 3,777 | |||
Selling, general and administrative | 1,696 | 2,248 | 6,861 | 9,199 | |||
Total operating expenses | 3,749 | 3,426 | 12,256 | 12,976 | |||
Less stock-based compensation expense | 234 | 378 | 759 | 1,399 | |||
Operating expenses (non-GAAP) | $ 3,515 | $ 3,048 | $ 11,497 | $ 11,577 | |||
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SOURCE Talphera, Inc.
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