OS Therapies Reports Full Year 2024 Financial Results and Provides Business Update
OS Therapies (NYSE-A: OSTX) reported its full-year 2024 financial results and business updates. The company completed the treatment phase of its Phase 2b clinical trial for OST-HER2 in osteosarcoma and successfully executed a $6 million IPO, along with a $6 million private placement.
Key financial metrics show a net operating loss of $10.886 million in 2024, compared to $7.916 million in 2023, with a net loss per share of $0.88 on 12.377 million weighted average shares outstanding. The increased loss was primarily attributed to IPO expenses.
The company expects to present full data from the OST-HER2 Phase 2b osteosarcoma trial in June 2025, with plans to begin a rolling BLA submission thereafter. OS Therapies aims to secure regulatory approval by year-end 2025, which would trigger a Priority Review Voucher (PRV). The company projects its current cash position will sustain operations into 2026.
OS Therapies (NYSE-A: OSTX) ha riportato i risultati finanziari e gli aggiornamenti aziendali per l'intero anno 2024. L'azienda ha completato la fase di trattamento del suo trial clinico di fase 2b per OST-HER2 nell'osteosarcoma e ha eseguito con successo un'IPO da 6 milioni di dollari, insieme a un collocamento privato di 6 milioni di dollari.
I principali indicatori finanziari mostrano una perdita operativa netta di 10,886 milioni di dollari nel 2024, rispetto ai 7,916 milioni di dollari del 2023, con una perdita netta per azione di 0,88 dollari su 12,377 milioni di azioni in circolazione ponderate. L'aumento della perdita è stato principalmente attribuito alle spese dell'IPO.
L'azienda prevede di presentare i dati completi del trial osteosarcoma di fase 2b OST-HER2 a giugno 2025, con piani per iniziare una presentazione BLA rolling successivamente. OS Therapies mira a ottenere l'approvazione normativa entro la fine del 2025, il che attiverebbe un Voucher di Revisione Prioritaria (PRV). L'azienda prevede che la sua attuale posizione di cassa sosterrà le operazioni fino al 2026.
OS Therapies (NYSE-A: OSTX) informó sobre sus resultados financieros y actualizaciones comerciales del año completo 2024. La compañía completó la fase de tratamiento de su ensayo clínico de fase 2b para OST-HER2 en osteosarcoma y ejecutó con éxito una OPI de 6 millones de dólares, junto con una colocación privada de 6 millones de dólares.
Los principales indicadores financieros muestran una pérdida operativa neta de 10,886 millones de dólares en 2024, en comparación con 7,916 millones de dólares en 2023, con una pérdida neta por acción de 0,88 dólares sobre 12,377 millones de acciones en circulación ponderadas. La mayor pérdida se atribuyó principalmente a los gastos de la OPI.
La compañía espera presentar los datos completos del ensayo de osteosarcoma de fase 2b OST-HER2 en junio de 2025, con planes de comenzar una presentación BLA en curso posteriormente. OS Therapies tiene como objetivo asegurar la aprobación regulatoria para finales de 2025, lo que activaría un Voucher de Revisión Prioritaria (PRV). La empresa proyecta que su posición de efectivo actual sostendrá las operaciones hasta 2026.
OS Therapies (NYSE-A: OSTX)는 2024년 전체 재무 결과 및 비즈니스 업데이트를 보고했습니다. 이 회사는 OST-HER2의 골육종에 대한 2b상 임상 시험의 치료 단계를 완료했으며, 600만 달러의 IPO를 성공적으로 실행하고 600만 달러의 사모 배정을 진행했습니다.
주요 재무 지표는 2024년에 1,088만 6천 달러의 순 운영 손실을 기록했으며, 이는 2023년의 791만 6천 달러와 비교됩니다. 가중 평균 발행 주식 1,237만 7천 주에 대해 주당 순손실은 0.88달러입니다. 손실 증가의 주된 원인은 IPO 비용이었습니다.
회사는 2025년 6월 OST-HER2 2b상 골육종 임상 시험의 전체 데이터를 발표할 예정이며, 이후 Rolling BLA 제출을 시작할 계획입니다. OS Therapies는 2025년 말까지 규제 승인을 확보하는 것을 목표로 하며, 이는 우선 심사 바우처(PRV)를 유발할 것입니다. 이 회사는 현재의 현금 위치가 2026년까지 운영을 지속할 것이라고 예상하고 있습니다.
OS Therapies (NYSE-A: OSTX) a publié ses résultats financiers et ses mises à jour commerciales pour l'année complète 2024. L'entreprise a achevé la phase de traitement de son essai clinique de phase 2b pour OST-HER2 dans l'ostéosarcome et a réussi à exécuter une introduction en bourse (IPO) de 6 millions de dollars, ainsi qu'un placement privé de 6 millions de dollars.
Les principaux indicateurs financiers montrent une perte opérationnelle nette de 10,886 millions de dollars en 2024, contre 7,916 millions de dollars en 2023, avec une perte nette par action de 0,88 dollar sur 12,377 millions d'actions en circulation pondérées. L'augmentation de la perte a été principalement attribuée aux frais d'IPO.
L'entreprise prévoit de présenter les données complètes de l'essai OST-HER2 de phase 2b sur l'ostéosarcome en juin 2025, avec des plans pour commencer une soumission BLA continue par la suite. OS Therapies vise à obtenir une approbation réglementaire d'ici la fin de 2025, ce qui déclencherait un Voucher de Révision Prioritaire (PRV). L'entreprise prévoit que sa position de trésorerie actuelle soutiendra les opérations jusqu'en 2026.
OS Therapies (NYSE-A: OSTX) hat seine Finanzzahlen und Geschäftsupdates für das gesamte Jahr 2024 veröffentlicht. Das Unternehmen hat die Behandlungsphase seiner Phase-2b-Studie für OST-HER2 bei Osteosarkomen abgeschlossen und erfolgreich einen Börsengang (IPO) über 6 Millionen Dollar sowie eine private Platzierung über 6 Millionen Dollar durchgeführt.
Die wichtigsten Finanzkennzahlen zeigen einen nettooperativen Verlust von 10,886 Millionen Dollar im Jahr 2024, verglichen mit 7,916 Millionen Dollar im Jahr 2023, mit einem Nettoverlust pro Aktie von 0,88 Dollar bei 12,377 Millionen gewichteten durchschnittlichen ausstehenden Aktien. Der Anstieg des Verlusts wurde hauptsächlich den Kosten des IPO zugeschrieben.
Das Unternehmen erwartet, die vollständigen Daten aus der OST-HER2 Phase-2b-Studie zu Osteosarkomen im Juni 2025 zu präsentieren, mit dem Plan, danach eine kontinuierliche BLA-Einreichung zu beginnen. OS Therapies strebt an, bis Ende 2025 eine behördliche Genehmigung zu erhalten, was einen Priority Review Voucher (PRV) auslösen würde. Das Unternehmen prognostiziert, dass seine aktuelle Liquiditätsposition die Betriebe bis 2026 aufrechterhalten wird.
- Completed Phase 2b clinical trial treatment phase for OST-HER2
- Secured $12 million in combined funding through IPO and private placement
- Cash runway extended into 2026 due to reduced projected spending
- Expected significant reduction in cash burn starting Q2 2025
- Potential non-dilutive funding through Priority Review Voucher in 2025
- Net operating loss increased to $10.886 million in 2024 from $7.916 million in 2023
- Net loss per share of $0.88 in 2024
- Significant operating losses from 2021 to 2024 due to clinical trial costs
Insights
OS Therapies' financial results and update reveal a strategic clinical-to-commercial transition with several positive developments despite widening losses. The company's net operating loss increased to $10.886 million in 2024 from $7.916 million in 2023, primarily due to IPO expenses. However, management has reduced the burn rate with cash runway now extending into 2026.
The completion of their OST-HER2 Phase 2b clinical trial's treatment phase represents significant progress toward regulatory submission. Their rolling BLA submission strategy positions them for potential year-end 2025 approval, which would trigger a Priority Review Voucher (PRV) - a sellable asset potentially worth $100-200 million based on recent transactions.
The company successfully raised $12 million in 2024 through their IPO and private placement while converting outstanding debt to equity, substantially strengthening their balance sheet. Their acquisition of Ayala's Lm-based assets expands their pipeline with Phase 2 lung cancer and Phase 1 prostate cancer programs, providing clinical diversification beyond their lead osteosarcoma indication.
The improved loss per share ($0.88 vs $1.46) despite larger absolute losses reflects the expanded share count post-financing. The projected reduction in cash burn starting Q2 2025 suggests improved operational efficiency now that major trial costs are behind them, creating a more sustainable runway through their critical regulatory milestones.
- Full data from OST-HER2 Phase 2b osteosarcoma trial, including synthetic control arm data being developed at the request of FDA to support a Breakthrough Therapy Designation request, to be presented at MIB Factor in June 2025
- Rolling BLA submission expected to begin thereafter in order to gain regulatory approval by year-end 2025, triggering issuance of a Priority Review Voucher (PRV)
“2024 was a transformative year for OS Therapies as we completed our initial public offering and finalized the treatment phase of our Phase 2b clinical trial in the prevention of recurrence in fully resected, lung metastatic osteosarcoma,” said Paul Romness, MPH, Chairman & CEO of OS Therapies. “In parallel, the Company entered into an agreement to acquire all of the listeria monocytogenes (Lm)-based assets from Ayala Pharmaceuticals, supported the development of additional data for OST-HER2 in canines and positioned the Company’s tunable antibody drug conjugate (tADC) program for partnering. The Company remains primarily focused on gaining a Biologics Licensing Authorization (BLA) for OST-HER2 in osteosarcoma that would trigger the issuance of a Priority Review Voucher (PRV) that the Company expect to then divest in order to capitalize with non-dilutive capital to allow the Company to fully exploit the OST-HER2 immunotherapeutic candidate and the rest of the Lm platform.”
“While historically, from 2021 to 2024, there were significant operating losses associated with the initiation, prosecution, and completion of the OST-HER2 clinical trial in recurrent, fully resected, metastatic osteosarcoma that used significant cash resources, going forward we expect a significantly reduced outlays beginning in the second quarter of 2025 now that one-time study costs were recognized in the first quarter of 2025,” said Chris Acevedo, Chief Financial Officer of OS Therapies. “We have reduced our burn rate substantially such that we expect cash on hand to last the Company into 2026, through our projected BLA milestone and the related issuance of a PRV by the FDA that we intend to sell.”
OS Therapies’ lead product candidate, OST-HER2, is a cancer immunotherapy biologic drug candidate comprised of HER2 bioengineered form of the Lm that mimics a listeria infection of HER2 overexpressing cancer cells and triggers a strong, immune response against cancer cells expressing HER2. This off-the-shelf immunotherapy is designed to prevent metastasis, delay recurrence, kill primary tumors expressing HER2 and increase overall survival.
Full-Year 2024 Corporate Highlights:
- Completed treatment phase for Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma, a rare pediatric indication
- Announced Phase 1 adult safety data of OST-HER2, primarily in breast cancer patients
- Formed Scientific, Commercial and Patient Advocacy advisory boards
-
Completed
$6 million -
Completed
$6 million - Developed 2 new tunable ADC therapeutic candidates
- Accepted into Johnson & Johnson – JLABS
2025 Progress to Date and Future Milestones
Progress to Date:
- Positive Phase 2b data for OST-HER2 clinical trial in recurrent, fully resected, lung metastatic osteosarcoma
- Agreement to acquire all LM-based Immuno-Oncology programs and IP assets from Ayala Pharmaceuticals, adding Phase 2 lung cancer and Phase 1 prostate cancer programs to pipeline, subject to closing conditions
- Initiated commercial-ready manufacturing of OST-HER2 in preparation for BLA submission
- Formed subsidiary OS Drug Conjugates and initiated review of strategic options for tunable Drug Conjugates (tDC) and tADC platform
- Scheduled meeting with United Kingdom’s Medicines and Healthcare products Regulatory Agency's (MHRA) Scientific Advice Meeting in the third quarter of 2025 for review of OST-HER2 immunotherapy candidate for osteosarcoma
Remaining Expected 2025 Milestones:
- Presentation of full clinical data from OST-HER2 Phase 2b osteosarcoma clinical trial, including new synthetic control and biomarker data
- End of Phase 2 Meeting with FDA for OST-HER2 osteosarcoma program, subsequent BLA submission and potential approval
- Summer 2025 Scientific Advice Meeting (SAM) with MHRA for OST-HER2 osteosarcoma program, ILAP application submission and MHRA Conditional Marketing Authorisation application & decision
-
EMA National Competent Authority Scientific Advice Meeting Request (Medicines Evaluation Board,
Netherlands ) for OST-HER2 osteosarcoma program, EMA PRIME, EMA-FDA Parallel Scientific Advice application and EMA Conditional Marketing Authorisation application & decision - USDA meeting for OST-HER2 canine osteosarcoma program, conditional approval and initiation of pivotal clinical studies in preventive and therapeutic applications of OST-HER2 in osteosarcoma
Loss from Operations:
The Company recorded a net operating loss of
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities.
About OS Therapies
OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the US Food & Drug Administration and Fast-Track and Orphan Drug designations from the US FDA and European Medicines Agency. The Company positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a Biologics Licensing Application (BLA) to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the
In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit www.ostherapies.com.
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management’s expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and grant of a priority review voucher and other risks and uncertainties described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s most recent Annual Report on Form 10-K and other subsequent documents we file with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
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OS Therapies Contact Information:
Jack Doll
410.207.7793
Irpr@ostherapies.com
https://x.com/OSTherapies
https://www.instagram.com/ostherapies/
https://www.facebook.com/OSTherapies/
https://www.linkedin.com/company/os-therapies/
Source: OS Therapies Inc.
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