Bio-Path Holdings Reports Full Year 2024 Financial Results
Bio-Path Holdings (BPTH) reported financial results for FY2024, highlighting progress in obesity and oncology programs. The company posted a net loss of $9.9 million ($4.12 per share), compared to $16.1 million loss in 2023. Year-end cash position stood at $1.2 million.
Key developments include promising pre-clinical results for BP1001-A in treating obesity in Type 2 diabetes patients, showing enhanced insulin sensitivity in cell models. The company expanded its patent portfolio with new patents in the US and New Zealand, now holding 7 US patents and 61 foreign patents across 26 countries.
Research and development expenses decreased to $7.3 million from $11.6 million in 2023, while general and administrative expenses increased to $4.7 million from $4.2 million. The Phase 1/1b trial of BP1002 for refractory/relapsed AML has advanced to the fourth dose cohort of 90 mg/m2.
Bio-Path Holdings (BPTH) ha riportato i risultati finanziari per l'anno fiscale 2024, evidenziando progressi nei programmi per l'obesità e l'oncologia. L'azienda ha registrato una perdita netta di 9,9 milioni di dollari (4,12 dollari per azione), rispetto a una perdita di 16,1 milioni di dollari nel 2023. La posizione di cassa a fine anno si è attestata a 1,2 milioni di dollari.
Sviluppi chiave includono risultati preclinici promettenti per BP1001-A nel trattamento dell'obesità nei pazienti con diabete di tipo 2, mostrando una sensibilità all'insulina migliorata in modelli cellulari. L'azienda ha ampliato il proprio portafoglio brevetti con nuovi brevetti negli Stati Uniti e in Nuova Zelanda, ora detenendo 7 brevetti statunitensi e 61 brevetti esteri in 26 paesi.
Le spese per ricerca e sviluppo sono diminuite a 7,3 milioni di dollari rispetto a 11,6 milioni di dollari nel 2023, mentre le spese generali e amministrative sono aumentate a 4,7 milioni di dollari rispetto a 4,2 milioni di dollari. La fase 1/1b della sperimentazione di BP1002 per AML refrattario/recidivante è avanzata al quarto coorte di dosaggio di 90 mg/m2.
Bio-Path Holdings (BPTH) reportó resultados financieros para el año fiscal 2024, destacando avances en programas de obesidad y oncología. La compañía registró una pérdida neta de 9,9 millones de dólares (4,12 dólares por acción), en comparación con una pérdida de 16,1 millones de dólares en 2023. La posición de efectivo al final del año fue de 1,2 millones de dólares.
Los desarrollos clave incluyen resultados preclínicos prometedores para BP1001-A en el tratamiento de la obesidad en pacientes con diabetes tipo 2, mostrando una sensibilidad a la insulina mejorada en modelos celulares. La compañía amplió su cartera de patentes con nuevos patentes en EE. UU. y Nueva Zelanda, ahora posee 7 patentes estadounidenses y 61 patentes extranjeras en 26 países.
Los gastos de investigación y desarrollo disminuyeron a 7,3 millones de dólares desde 11,6 millones de dólares en 2023, mientras que los gastos generales y administrativos aumentaron a 4,7 millones de dólares desde 4,2 millones de dólares. El ensayo de fase 1/1b de BP1002 para AML refractario/recidivante ha avanzado al cuarto cohorte de dosis de 90 mg/m2.
Bio-Path Holdings (BPTH)는 2024 회계연도 재무 결과를 보고하며 비만 및 종양학 프로그램에서의 진행 상황을 강조했습니다. 이 회사는 990만 달러의 순손실을 기록했으며 (주당 4.12 달러), 2023년의 1610만 달러 손실과 비교됩니다. 연말 현금 보유액은 120만 달러로 나타났습니다.
주요 개발 사항으로는 제2형 당뇨병 환자의 비만 치료를 위한 BP1001-A의 유망한 전임상 결과가 있으며, 세포 모델에서 인슐린 감수성이 향상된 것으로 나타났습니다. 이 회사는 미국과 뉴질랜드에서 새로운 특허를 추가하여 현재 7개의 미국 특허와 26개국에 걸쳐 61개의 외국 특허를 보유하고 있습니다.
연구 및 개발 비용은 2023년 1160만 달러에서 730만 달러로 감소했으며, 일반 및 관리 비용은 420만 달러에서 470만 달러로 증가했습니다. BP1002의 불응성/재발성 AML에 대한 1/1b 단계 시험은 90 mg/m2의 네 번째 용량 집단으로 진행되었습니다.
Bio-Path Holdings (BPTH) a publié des résultats financiers pour l'exercice 2024, mettant en avant des progrès dans les programmes d'obésité et d'oncologie. L'entreprise a enregistré une perte nette de 9,9 millions de dollars (4,12 dollars par action), contre une perte de 16,1 millions de dollars en 2023. La position de trésorerie à la fin de l'année s'élevait à 1,2 million de dollars.
Les développements clés incluent des résultats précliniques prometteurs pour BP1001-A dans le traitement de l'obésité chez les patients diabétiques de type 2, montrant une sensibilité à l'insuline améliorée dans des modèles cellulaires. L'entreprise a élargi son portefeuille de brevets avec de nouveaux brevets aux États-Unis et en Nouvelle-Zélande, détenant désormais 7 brevets américains et 61 brevets étrangers dans 26 pays.
Les dépenses de recherche et développement ont diminué à 7,3 millions de dollars contre 11,6 millions de dollars en 2023, tandis que les dépenses générales et administratives ont augmenté à 4,7 millions de dollars contre 4,2 millions de dollars. L'essai de phase 1/1b de BP1002 pour l'AML réfractaire/récidivant a avancé au quatrième groupe de dose de 90 mg/m2.
Bio-Path Holdings (BPTH) berichtete über die finanziellen Ergebnisse für das Geschäftsjahr 2024 und hob Fortschritte in den Programmen zur Bekämpfung von Fettleibigkeit und Onkologie hervor. Das Unternehmen verzeichnete einen Nettoverlust von 9,9 Millionen Dollar (4,12 Dollar pro Aktie), im Vergleich zu einem Verlust von 16,1 Millionen Dollar im Jahr 2023. Die Kassenposition zum Jahresende betrug 1,2 Millionen Dollar.
Wichtige Entwicklungen umfassen vielversprechende präklinische Ergebnisse für BP1001-A bei der Behandlung von Fettleibigkeit bei Typ-2-Diabetes-Patienten, die eine verbesserte Insulinempfindlichkeit in Zellmodellen zeigen. Das Unternehmen erweiterte sein Patentportfolio mit neuen Patenten in den USA und Neuseeland und hält nun 7 US-Patente sowie 61 ausländische Patente in 26 Ländern.
Die Forschungs- und Entwicklungskosten sanken auf 7,3 Millionen Dollar von 11,6 Millionen Dollar im Jahr 2023, während die allgemeinen und Verwaltungskosten auf 4,7 Millionen Dollar von 4,2 Millionen Dollar stiegen. Die Phase 1/1b-Studie von BP1002 für refraktäres/rezidiviertes AML hat die vierte Dosisgruppe von 90 mg/m2 erreicht.
- Net loss improved to $9.9M in 2024 from $16.1M in 2023
- R&D expenses decreased by 37% to $7.3M
- Positive pre-clinical results for BP1001-A in obesity treatment
- Expanded patent portfolio with new US and NZ patents
- Clinical trial progress with BP1002 advancing to higher dose cohort
- Increased G&A expenses to $4.7M from $4.2M
- Low cash position of $1.2M as of December 2024
- Continued net cash burn of $10.6M from operations
- May need additional capital raising to continue operations
Insights
Bio-Path's 2024 financial results show meaningful improvements in their operating efficiency with net losses decreasing 38.5% to
The company's advancement of BP1001-A for obesity treatment in diabetes patients represents a strategic expansion beyond oncology into the lucrative metabolic disease market. Recent preclinical results showing restored insulin sensitivity in multiple cell models provide early validation, though significant clinical hurdles remain before commercialization potential can be realistically assessed.
In oncology, progression to the fourth dose cohort (90 mg/m²) in their Phase 1/1b trial of BP1002 for refractory AML patients is incrementally positive, particularly with mention of "meaningful patient response" - though specific efficacy data wasn't disclosed. Their expanded patent portfolio (now 7 US and 61 foreign patents) strengthens their intellectual property position but doesn't address the immediate capital needs that will likely necessitate dilutive financing in the near term.
Bio-Path's DNAbilize® platform shows promising versatility with their dual focus on oncology and obesity. The preliminary data for BP1001-A in metabolic disease is mechanistically interesting, as Grb2 downregulation affecting insulin signaling represents a novel approach compared to GLP-1 agonists and other established obesity treatments. The restoration of insulin sensitivity in multiple cell models (myoblast, hepatoma, and skeletal muscle) suggests potential broad-spectrum metabolic benefits, though animal models and human data will be crucial to validate this approach.
The progress in their BP1002 leukemia program to the 90 mg/m² cohort indicates acceptable safety at lower doses while suggesting dose-dependent efficacy. Targeting venetoclax-resistant AML patients is strategically sound, addressing a significant unmet need in a vulnerable population with options. However, the vague mention of "meaningful patient response" without specific metrics or patient numbers leaves significant uncertainty about the true clinical impact.
Their patent portfolio expansion strengthens their competitive position, particularly with the new STAT3 inhibition patent, which could be valuable as STAT3 is increasingly recognized as a critical oncogenic transcription factor. The company's RNAi delivery technology could potentially overcome historical challenges in nucleic acid therapeutics, but they face substantial competition from well-funded players with more advanced delivery platforms.
Reports Continued Progress Across Both Obesity and Oncology Franchises
HOUSTON, March 28, 2025 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (OTCQB:BPTH), a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer and obesity drugs, today announced its financial results for the year ended December 31, 2024 and provided an update on recent corporate developments.
“We are merely touching the tip of the iceberg in terms of realizing the potential of our DNAbilize® platform to change the treatment paradigm in both obesity and oncology,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. “Throughout the last year, we built on the body of scientific evidence in support of our powerful platform technologies’ therapeutic effects and fortified our intellectual property to protect it from potential competitors. We continue to advance our clinical studies for BP1001-A as a treatment for obesity in Type 2 diabetes patients, where we have shown restored insulin sensitivity in cell models. Beyond this, our ongoing oncology studies continue to advance, and we are reporting ever improving outcomes for the most vulnerable patients battling these life-threatening cancers.”
Recent Corporate Highlights
- Announced Pre-Clinical Results Signaling Increased Potential for BP1001-A as Treatment for Obesity in Type 2 Diabetes Patients. Scientific evidence suggests that by downregulating growth factor receptor-bound protein 2 (Grb2) expression, BP1001-A could help lower blood glucose level by affecting insulin signaling. In December 2024, Bio-Path reported results from preclinical studies of BP1001-A for obesity demonstrating enhanced insulin sensitivity in myoblast and hepatoma cells. Furthermore, in March 2025, Bio-Path reported preclinical results that BP1001-A attenuated fatty acid-induced insulin resistance and restored insulin sensitivity in muscle progenitor and skeletal muscle fiber cell models. Together these studies signal increased potential for BP1001-A as a treatment for obesity and related metabolic diseases in Type 2 diabetes patients.
- Expanded Global Patent Portfolio. In February 2025, Bio-Path announced the receipt of newly issued patents in the United States and New Zealand, and updated investors on the extent of its global intellectual property portfolio. Bio-Path received Notice of Allowance from the United States Patent and Trademark Office for U.S. Patent No. 17/339,366 titled, "P-ethoxy nucleic acids for STAT3 inhibition." The New Zealand Intellectual Property Office has granted Patent No. 741793 titled, “P-ethoxy nucleic acids for liposomal formulation.” These new patents build on earlier patents granted that protect the DNAbilize® platform technology and the Company’s novel RNAi nanoparticle drugs.
Bio-Path continues to expand its intellectual property portfolio by filing patent applications that are applicable to its technology and business strategy. Bio-Path’s patent portfolio currently includes seven issued patents in the U.S. and 61 issued patents in foreign jurisdictions, providing protection in 26 countries. The Company has three additional pending patent applications in the U.S. and five additional allowed patent applications in foreign jurisdictions.
- Provided Update from Phase 1/1b Clinical Trial of BP1002 for Treatment of Refractory/Relapsed Acute Myeloid Leukemia. In February 2025, the Company provided an update from the ongoing Phase 1/1b clinical trial evaluating BP1002 for the treatment of refractory/relapsed acute myeloid leukemia (AML), including venetoclax-resistant patients. The Company announced a meaningful patient response to treatment and that the study has progressed to the fourth, higher dose cohort of 90 mg/m2.
Financial Results for the Year Ended December 31, 2024
- The Company reported a net loss of
$9.9 million , or$4.12 per share, for the year ended December 31, 2024, compared to a net loss of$16.1 million , or$33.63 per share, for the year ended December 31, 2023.
- Research and development expense for the year ended December 31, 2024 decreased to
$7.3 million , compared to$11.6 million for the year ended December 31, 2023 primarily due to decreased manufacturing expenses related to drug product releases in 2024 compared to 2023.
- General and administrative expense for the year ended December 31, 2024 increased to
$4.7 million , compared to$4.2 million for the year ended December 31, 2023 primarily due to increased salaries and benefits expense as well as expenses related to our special shareholder meeting in 2024.
- Change in fair value of the Company’s warrant liability for the year ended December 31, 2024 resulted in a non-cash income of
$2.1 million compared to a non-cash loss of$0.3 million for the year ended December 31, 2023.
- As of December 31, 2024, the Company had cash of
$1.2 million , compared to$1.1 million as of December 31, 2023. Net cash used in operating activities for the year ended December 31, 2024 was$10.6 million compared to$11.5 million for the comparable period in 2023. Net cash provided by financing activities for the year ended December 31, 2024 was$10.7 million .
About Bio-Path Holdings, Inc.
Bio-Path is a biotechnology company developing DNAbilize®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous infusion. Bio-Path’s lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for blood cancers, and BP1001-A, a drug product modification of prexigebersen, is in a Phase 1/1b study for solid tumors. BP1001-A is also being evaluated as a treatment for obesity and related metabolic diseases in Type 2 diabetes patients. The Company’s second product, BP1002, which targets the Bcl-2 protein, is being evaluated for the treatment of blood cancers and solid tumors, including acute myeloid leukemia. In addition, an IND application is expected to be filed for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide developed by Bio-Path as a specific inhibitor of STAT3.
For more information, please visit the Company's website at www.biopathholdings.com.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws. These statements are based on management's current expectations and accordingly are subject to uncertainty and changes in circumstances. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Bio-Path’s ability to raise needed additional capital on a timely basis in order for it to continue its operations, have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies, the accuracy of such data, limited patient populations of early stage clinical studies and the possibility that results from later stage clinical trials with much larger patient populations may not be consistent with earlier stage clinical trials, the maintenance of intellectual property rights, that patents relating to existing or future patent applications will be issued or that any issued patents will provide meaningful protection of our drug candidates, the impact, risks and uncertainties related to global pandemics, including the COVID-19 pandemic, and actions taken by governmental authorities or others in connection therewith, and such other risks which are identified in Bio-Path's most recent Annual Report on Form 10-K, in any subsequent quarterly reports on Form 10-Q and in other reports that Bio-Path files with the Securities and Exchange Commission from time to time. These documents are available on request from Bio-Path Holdings or at www.sec.gov. Bio-Path disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact Information:
Investors
Will O’Connor
Stern Investor Relations, Inc.
212-362-1200
will@sternir.com
Doug Morris
Investor Relations
Bio-Path Holdings, Inc.
832-742-1369
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