Applied Therapeutics Reports Fourth Quarter and Year-end 2024 Financial Results
Applied Therapeutics (NASDAQ: APLT) reported its Q4 and full-year 2024 financial results, highlighting key leadership appointments and program developments. The company ended 2024 with $79.4 million in cash, up from $49.9 million in 2023.
Financial metrics show a net loss of $105.6 million ($0.76 per share) for 2024, compared to $119.8 million ($1.42 per share) in 2023. R&D expenses decreased to $48.7 million from $53.9 million, while G&A expenses increased to $56.0 million from $20.6 million.
The company is evaluating its response to the FDA's Complete Response Letter for govorestat in Classic Galactosemia treatment and continues developing the drug for SORD Deficiency. Recent appointments include John H. Johnson as Executive Chairman, Les Funtleyder as Interim CEO, Todd F. Baumgartner as Chief Regulatory Officer, and Reena Thomas Colacot as VP of Quality.
Applied Therapeutics (NASDAQ: APLT) ha comunicato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando nomine chiave nella leadership e sviluppi nei programmi. L'azienda ha chiuso il 2024 con 79,4 milioni di dollari in liquidità, in aumento rispetto ai 49,9 milioni del 2023.
I dati finanziari mostrano una perdita netta di 105,6 milioni di dollari (0,76 dollari per azione) per il 2024, rispetto a 119,8 milioni (1,42 dollari per azione) nel 2023. Le spese in R&S sono diminuite a 48,7 milioni di dollari dai 53,9 milioni precedenti, mentre le spese generali e amministrative sono aumentate a 56,0 milioni di dollari rispetto ai 20,6 milioni.
L'azienda sta valutando la propria risposta alla Lettera di Risposta Completa della FDA riguardante govorestat per il trattamento della Galattosemia Classica e prosegue nello sviluppo del farmaco per la Deficienza di SORD. Tra le nomine recenti figurano John H. Johnson come Presidente Esecutivo, Les Funtleyder come Amministratore Delegato ad interim, Todd F. Baumgartner come Chief Regulatory Officer e Reena Thomas Colacot come VP della Qualità.
Applied Therapeutics (NASDAQ: APLT) informó sus resultados financieros del cuarto trimestre y del año completo 2024, destacando nombramientos clave en la dirección y avances en sus programas. La compañía cerró 2024 con 79,4 millones de dólares en efectivo, frente a 49,9 millones en 2023.
Los indicadores financieros muestran una pérdida neta de 105,6 millones de dólares (0,76 dólares por acción) en 2024, comparado con 119,8 millones (1,42 dólares por acción) en 2023. Los gastos en I+D disminuyeron a 48,7 millones de dólares desde 53,9 millones, mientras que los gastos generales y administrativos aumentaron a 56,0 millones de dólares desde 20,6 millones.
La empresa está evaluando su respuesta a la Carta de Respuesta Completa de la FDA sobre govorestat para el tratamiento de la Galactosemia Clásica y continúa desarrollando el medicamento para la Deficiencia de SORD. Los nombramientos recientes incluyen a John H. Johnson como Presidente Ejecutivo, Les Funtleyder como CEO interino, Todd F. Baumgartner como Director Regulatorio y Reena Thomas Colacot como VP de Calidad.
Applied Therapeutics (NASDAQ: APLT)는 2024년 4분기 및 연간 재무 결과를 발표하며 주요 리더십 임명과 프로그램 개발 사항을 강조했습니다. 회사는 2024년 말에 7,940만 달러의 현금을 보유하여 2023년 4,990만 달러에서 증가했습니다.
재무 지표에 따르면 2024년 순손실은 1억 560만 달러(주당 0.76달러)로, 2023년의 1억 1,980만 달러(주당 1.42달러)보다 감소했습니다. 연구개발 비용은 5,390만 달러에서 4,870만 달러로 줄었고, 일반관리비는 2,060만 달러에서 5,600만 달러로 증가했습니다.
회사는 FDA의 클래식 갈락토스혈증 치료제 govorestat에 대한 완전 반응 서한에 대한 대응을 검토 중이며, SORD 결핍증 치료제 개발도 계속 진행하고 있습니다. 최근 임명된 인사로는 John H. Johnson이 집행 의장, Les Funtleyder가 임시 CEO, Todd F. Baumgartner가 최고 규제 책임자, Reena Thomas Colacot가 품질 부사장으로 임명되었습니다.
Applied Therapeutics (NASDAQ : APLT) a publié ses résultats financiers du quatrième trimestre et de l'année complète 2024, mettant en avant des nominations clés à la direction et des avancées dans ses programmes. La société a terminé 2024 avec 79,4 millions de dollars en liquidités, en hausse par rapport à 49,9 millions en 2023.
Les indicateurs financiers montrent une perte nette de 105,6 millions de dollars (0,76 dollar par action) pour 2024, contre 119,8 millions (1,42 dollar par action) en 2023. Les dépenses en R&D ont diminué à 48,7 millions de dollars contre 53,9 millions, tandis que les frais généraux et administratifs ont augmenté à 56,0 millions de dollars contre 20,6 millions.
L'entreprise évalue sa réponse à la lettre de réponse complète de la FDA concernant govorestat pour le traitement de la galactosémie classique et poursuit le développement du médicament pour la déficience en SORD. Parmi les nominations récentes figurent John H. Johnson en tant que président exécutif, Les Funtleyder en tant que PDG par intérim, Todd F. Baumgartner en tant que directeur réglementaire et Reena Thomas Colacot en tant que vice-présidente de la qualité.
Applied Therapeutics (NASDAQ: APLT) meldete seine Finanzergebnisse für das vierte Quartal und das Gesamtjahr 2024 und hob dabei wichtige Führungspositionen und Programmfortschritte hervor. Das Unternehmen schloss das Jahr 2024 mit 79,4 Millionen US-Dollar an liquiden Mitteln ab, gegenüber 49,9 Millionen US-Dollar im Jahr 2023.
Die Finanzkennzahlen zeigen für 2024 einen Nettoverlust von 105,6 Millionen US-Dollar (0,76 US-Dollar je Aktie), verglichen mit 119,8 Millionen US-Dollar (1,42 US-Dollar je Aktie) im Jahr 2023. Die F&E-Ausgaben sanken von 53,9 Millionen auf 48,7 Millionen US-Dollar, während die Verwaltungs- und Vertriebskosten von 20,6 Millionen auf 56,0 Millionen US-Dollar anstiegen.
Das Unternehmen prüft seine Reaktion auf den vollständigen Antwortbrief der FDA bezüglich govorestat zur Behandlung der klassischen Galaktosämie und entwickelt das Medikament weiterhin für die SORD-Mangelkrankheit. Zu den jüngsten Ernennungen zählen John H. Johnson als Executive Chairman, Les Funtleyder als Interim-CEO, Todd F. Baumgartner als Chief Regulatory Officer und Reena Thomas Colacot als VP für Qualität.
- Cash position improved to $79.4M from $49.9M year-over-year
- Reduced net loss per share to $0.76 from $1.42 year-over-year
- R&D expenses decreased by $5.2M to $48.7M
- Received FDA Complete Response Letter for govorestat NDA
- Net loss of $105.6M for 2024
- G&A expenses increased significantly by $35.4M to $56.0M
- Uncertainty in regulatory pathway for both Classic Galactosemia and SORD Deficiency programs
Insights
Applied Therapeutics' Q4 and full-year 2024 results present concerning financial trends despite some positive elements. While cash reserves increased to
The company's net loss improved marginally to
Most critically, the FDA's Complete Response Letter for govorestat in Classic Galactosemia represents a substantial regulatory setback for their lead program. The company's vague language about "evaluating" responses and "examining" development pathways indicates significant uncertainty in their regulatory strategy.
The appointment of industry veterans to leadership positions—particularly in regulatory affairs—suggests an acknowledgment of these challenges, but comes with additional expenses. R&D costs decreased
These results reflect a company in transition facing serious headwinds with its lead programs while dramatically increasing administrative spending—a concerning combination for investors tracking this rare disease-focused biotech.
- Appointed John H. Johnson as Executive Chairman; Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer; and Reena Thomas Colacot as Vice President and Head of Quality
NEW YORK, April 14, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT) (the “Company”), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today reported financial results for the fourth quarter and full year ended December 31, 2024.
“We remain focused on preparing for potential regulatory interactions regarding govorestat in both Classic Galactosemia and Sorbitol Dehydrogenase (“SORD”) Deficiency,” said Les Funtleyder, Interim CEO and CFO of Applied Therapeutics. “As we continue to optimize our strategy for our late-stage programs, we have also made key senior appointments across regulatory, medical and quality affairs functions to bolster our capabilities. We are confident in the promise of govorestat across indications and remain committed to our mission of addressing the unmet needs of patients with rare diseases.”
Recent Highlights
- Appointed John H. Johnson as Executive Chairman and Les Funtleyder as Interim Chief Executive Officer. In December 2024, the Company appointed John H. Johnson as Executive Chairman of its Board of Directors. Mr. Johnson is a biopharmaceutical industry veteran with 40 years of transformational leadership experience at global healthcare organizations, including Johnson & Johnson, Eli Lilly & Company, ImClone, and Pfizer, Inc. In connection with Mr. Johnson’s appointment, the Company appointed Les Funtleyder, Chief Financial Officer of the Company, as Interim Chief Executive Officer.
- Appointed Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer and Reena Thomas Colacot as Vice President and Head of Quality. In March 2025, the Company appointed Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer to lead the Company’s global regulatory strategy. Dr. Baumgartner joins the Company with over 35 years of experience in senior regulatory, clinical development, and medical affairs roles. In January 2025, the Company appointed Reena Thomas Colacot as Vice President and Head of Quality, where she is responsible for overseeing all quality matters, including Good Manufacturing Practices, Good Laboratory Practices, and Good Clinical Practices. Ms. Colacot brings over 25 years of quality leadership experience across the biopharmaceutical and medical device industries.
- Continued Review of Govorestat Development Programs for Classic Galactosemia and SORD Deficiency. As previously disclosed, the Company received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) for the New Drug Application (“NDA”) submitted for govorestat for the treatment of Classic Galactosemia. The Company continues to evaluate its response to the CRL, including any meeting request to discuss appropriate next steps with the FDA regarding the path forward for govorestat for the treatment of Classic Galactosemia. The Company also continues to closely examine the ongoing govorestat development program for the potential treatment of SORD Deficiency and will continue to work with the FDA on the data needed to support an appropriate regulatory pathway, including ongoing work to provide the FDA with support for the potential use of the accelerated approval pathway for SORD Deficiency.
Financial Results
- Cash and cash equivalents totaled
$79.4 million as of December 31, 2024, compared with$49.9 million at December 31, 2023. - Research and development expenses for the year ended December 31, 2024, were
$48.7 million , compared to$53.9 million for the year ended December 31, 2023. The decrease of approximately$5.2 million was primarily related to a decrease in clinical, pre-clinical and drug manufacturing and formulation costs, offset by an overall increase in regulatory, personnel and stock-based compensation expenses. - General and administrative expenses were
$56.0 million for the year ended December 31, 2024, compared to$20.6 million for the year ended December 31, 2023. The increase of approximately$35.4 million was primarily related to an increase in commercial, legal and professional, data storage, personnel and stock-based compensation expense, offset by an overall decrease in insurance expense. - Net loss for the year ended December 31, 2024, was
$105.6 million , or$0.76 per basic and diluted common share, compared to a net loss of$119.8 million , or$1.42 per basic and diluted common share, for the year ended December 31, 2023.
About Applied Therapeutics
Applied Therapeutics is a clinical-stage biopharmaceutical company committed to the development of novel drug candidates against validated molecular targets in rare diseases. The Company’s lead drug candidate, govorestat, is a novel central nervous system penetrant Aldose Reductase Inhibitor (“ARI”) for the treatment of CNS rare metabolic diseases, including Classic Galactosemia, Sorbitol Dehydrogenase (“SORD”) Deficiency and PMM2-congenital disorder glycosylation (“CDG”).
To learn more, please visit www.appliedtherapeutics.com and follow the company on X at @Applied_Tx.
Forward-Looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding the strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “plan,” “intend,” “predicts” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are forward-looking statements. These include, without limitation, statements regarding the (i) likelihood that the Company’s ongoing NDA submissions will be approved and the timing of any decision and (ii) statements related to the scheduling or timing of any potential FDA meetings, interactions or submissions. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved.
Such risks and uncertainties include, without limitation, (i) our plans to develop, market and commercialize our product candidates, (ii) the initiation, timing, progress and results of our current and future preclinical studies and clinical trials and our research and development programs, (iii) our ability to take advantage of expedited regulatory pathways for any of our product candidates, (iv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing, (v) our ability to successfully acquire or license additional product candidates on reasonable terms and advance product candidates into, and successfully complete, clinical studies, (vi) our ability to maintain and establish collaborations or obtain additional funding, (vii) our ability to obtain and timing of regulatory approval of our current and future product candidates, (viii) the anticipated indications for our product candidates, if approved, (ix) our expectations regarding the potential market size and the rate and degree of market acceptance of such product candidates, (x) our ability to fund our working capital requirements and expectations regarding the sufficiency of our capital resources, (xi) the implementation of our business model and strategic plans for our business and product candidates, (xii) our intellectual property position and the duration of our patent rights, (xiii) developments or disputes concerning our intellectual property or other proprietary rights, (xiv) our expectations regarding government and third-party payor coverage and reimbursement, (xv) our ability to compete in the markets we serve, (xvi) the impact of government laws and regulations and liabilities thereunder, (xvii) developments relating to our competitors and our industry, (xviii) our ability to achieve the anticipated benefits from the agreements entered into in connection with our partnership with Advanz Pharma and (xiv) other factors that may impact our financial results. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. Factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including those described in the “Risk Factors” section contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
Contacts
Investors:
Maeve Conneighton / Andrew Vulis
(212) 600-1902
appliedtherapeutics@argotpartners.com
Media:
media@appliedtherapeutics.com
| Applied Therapeutics, Inc. Condensed Balance Sheets (in thousands, except share and per share data) (Unaudited) | ||||||||
| As of | As of | |||||||
| December 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 79,398 | $ | 49,898 | ||||
| Current portion of security deposits | — | 254 | ||||||
| Prepaid expenses and other current assets | 4,248 | 4,234 | ||||||
| Total current assets | 83,646 | 54,386 | ||||||
| Noncurrent portion of security deposits | 253 | — | ||||||
| Operating lease right-of-use asset | 2,792 | 447 | ||||||
| TOTAL ASSETS | $ | 86,691 | $ | 54,833 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIT) | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current portion of operating lease liabilities | $ | 406 | $ | 429 | ||||
| Accounts payable | 4,433 | 1,742 | ||||||
| Accrued expenses and other current liabilities | 16,143 | 15,286 | ||||||
| Warrant liabilities | 6,314 | 53,725 | ||||||
| Total current liabilities | 27,296 | 71,182 | ||||||
| NONCURRENT LIABILITIES: | ||||||||
| Noncurrent portion of operating lease liabilities | 2,389 | 38 | ||||||
| Clinical holdback - long-term portion | — | 759 | ||||||
| Total noncurrent liabilities | 2,389 | 797 | ||||||
| Total liabilities | 29,685 | 71,979 | ||||||
| Commitments and Contingencies (Note 15) | ||||||||
| STOCKHOLDERS’ EQUITY/(DEFICIT): | ||||||||
| Common stock, | 35 | 8 | ||||||
| Preferred stock, par value | — | — | ||||||
| Additional paid-in capital | 631,181 | 451,432 | ||||||
| Accumulated deficit | (574,210 | ) | (468,586 | ) | ||||
| Total stockholders' equity/(deficit) | 57,006 | (17,146 | ) | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIT) | $ | 86,691 | $ | 54,833 | ||||
| Applied Therapeutics, Inc. Condensed Statements of Operations (in thousands, except share and per share data) (Unaudited) | ||||||||
| Year Ended | ||||||||
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| REVENUE: | ||||||||
| License revenue | $ | — | $ | 9,219 | ||||
| Research and development services revenue | 455 | 774 | ||||||
| Total revenue | 455 | 9,993 | ||||||
| COSTS AND EXPENSES: | ||||||||
| Research and development | 48,744 | 53,905 | ||||||
| General and administrative | 56,010 | 20,623 | ||||||
| Total costs and expenses | 104,754 | 74,528 | ||||||
| LOSS FROM OPERATIONS | (104,299 | ) | (64,535 | ) | ||||
| OTHER INCOME (EXPENSE), NET: | ||||||||
| Interest income | 3,534 | 1,372 | ||||||
| Change in fair value of warrant liabilities | (4,782 | ) | (56,573 | ) | ||||
| Other expense | (77 | ) | (27 | ) | ||||
| Total other expense, net | (1,325 | ) | (55,228 | ) | ||||
| Net loss | $ | (105,624 | ) | $ | (119,763 | ) | ||
| Net loss per share attributable to common stockholders—basic and diluted | $ | (0.76 | ) | $ | (1.42 | ) | ||
| Weighted-average common stock outstanding—basic and diluted | 139,534,746 | 84,244,494 | ||||||
FAQ
What were Applied Therapeutics (APLT) financial results for 2024?
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