BiomX Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business and Program Updates
BiomX (NYSE: PHGE) announced its Q4 and full year 2024 financial results, highlighting key developments in its phage therapy programs. The company secured $12 million in financing in February 2025 to support its Phase 2b study of BX004. Key financial metrics include:
- Cash balance of $18.0 million as of December 31, 2024
- R&D expenses increased to $24.7 million in 2024
- Net loss decreased to $17.7 million in 2024
- Operating cash burn of $37 million in 2024
Clinical Updates:
- BX211 Phase 2 topline results for diabetic foot osteomyelitis expected by end of March 2025
- BX004 Phase 2b topline results for cystic fibrosis anticipated in Q1 2026
- Received $36.8 million in non-dilutive funding from DHA for BX211 trial
BiomX (NYSE: PHGE) ha annunciato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando sviluppi chiave nei suoi programmi di terapia con fagi. L'azienda ha ottenuto 12 milioni di dollari di finanziamento a febbraio 2025 per sostenere il suo studio di Fase 2b su BX004. Principali metriche finanziarie includono:
- Saldo di cassa di 18,0 milioni di dollari al 31 dicembre 2024
- Le spese per R&S sono aumentate a 24,7 milioni di dollari nel 2024
- La perdita netta è diminuita a 17,7 milioni di dollari nel 2024
- Consumo di cassa operativo di 37 milioni di dollari nel 2024
Aggiornamenti clinici:
- I risultati preliminari della Fase 2 di BX211 per l'osteomielite del piede diabetico sono attesi entro la fine di marzo 2025
- I risultati preliminari della Fase 2b di BX004 per la fibrosi cistica sono previsti nel primo trimestre del 2026
- Ricevuti 36,8 milioni di dollari in finanziamenti non diluitivi da DHA per la sperimentazione di BX211
BiomX (NYSE: PHGE) anunció sus resultados financieros del cuarto trimestre y del año completo 2024, destacando desarrollos clave en sus programas de terapia con fagos. La compañía aseguró 12 millones de dólares en financiamiento en febrero de 2025 para apoyar su estudio de Fase 2b de BX004. Métricas financieras clave incluyen:
- Saldo de efectivo de 18,0 millones de dólares al 31 de diciembre de 2024
- Los gastos de I+D aumentaron a 24,7 millones de dólares en 2024
- La pérdida neta disminuyó a 17,7 millones de dólares en 2024
- Quema de efectivo operativo de 37 millones de dólares en 2024
Actualizaciones clínicas:
- Se esperan los resultados preliminares de la Fase 2 de BX211 para la osteomielitis del pie diabético a finales de marzo de 2025
- Se anticipan los resultados preliminares de la Fase 2b de BX004 para la fibrosis quística en el primer trimestre de 2026
- Recibidos 36,8 millones de dólares en financiamiento no dilutivo de DHA para el ensayo de BX211
BiomX (NYSE: PHGE)는 2024년 4분기 및 전체 연도 재무 결과를 발표하며 파지 요법 프로그램의 주요 발전을 강조했습니다. 이 회사는 BX004의 2b상 연구를 지원하기 위해 2025년 2월에 1,200만 달러의 자금을 확보했습니다. 주요 재무 지표는 다음과 같습니다:
- 2024년 12월 31일 기준 현금 잔고 1,800만 달러
- 2024년 R&D 비용 2,470만 달러로 증가
- 2024년 순손실 1,770만 달러로 감소
- 2024년 운영 현금 소모 3,700만 달러
임상 업데이트:
- BX211의 당뇨병성 발 뼈염에 대한 2상 초기 결과는 2025년 3월 말까지 예상됩니다
- BX004의 2b상 초기 결과는 2026년 1분기에 예상됩니다
- BX211 시험을 위해 DHA로부터 3,680만 달러의 비희석 자금을 받았습니다
BiomX (NYSE: PHGE) a annoncé ses résultats financiers du quatrième trimestre et de l'année 2024, mettant en avant des développements clés dans ses programmes de thérapie par phages. L'entreprise a sécurisé 12 millions de dollars de financement en février 2025 pour soutenir son étude de Phase 2b sur BX004. Métriques financières clés comprennent :
- Solde de trésorerie de 18,0 millions de dollars au 31 décembre 2024
- Les dépenses en R&D ont augmenté à 24,7 millions de dollars en 2024
- La perte nette a diminué à 17,7 millions de dollars en 2024
- Brûlage de trésorerie opérationnelle de 37 millions de dollars en 2024
Mises à jour cliniques:
- Les résultats préliminaires de la Phase 2 de BX211 pour l'ostéomyélite du pied diabétique sont attendus d'ici la fin mars 2025
- Les résultats préliminaires de la Phase 2b de BX004 pour la fibrose kystique sont anticipés au premier trimestre 2026
- 36,8 millions de dollars de financement non dilutif reçus de la DHA pour l'essai BX211
BiomX (NYSE: PHGE) hat seine finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 bekannt gegeben und dabei wichtige Entwicklungen in seinen Phagentherapie-Programmen hervorgehoben. Das Unternehmen sicherte sich im Februar 2025 12 Millionen Dollar an Finanzmitteln zur Unterstützung seiner Phase 2b-Studie zu BX004. Wichtige Finanzkennzahlen umfassen:
- Barguthaben von 18,0 Millionen Dollar zum 31. Dezember 2024
- F&E-Ausgaben stiegen 2024 auf 24,7 Millionen Dollar
- Nettoverlust verringerte sich 2024 auf 17,7 Millionen Dollar
- Operativer Cash-Burn von 37 Millionen Dollar im Jahr 2024
Klinische Updates:
- Die vorläufigen Ergebnisse der Phase 2 von BX211 für diabetische Fußosteomyelitis werden bis Ende März 2025 erwartet
- Die vorläufigen Ergebnisse der Phase 2b von BX004 für Mukoviszidose werden im ersten Quartal 2026 erwartet
- Erhielt 36,8 Millionen Dollar an nicht verwässerndem Kapital von DHA für die BX211-Studie
- Secured $12 million financing in February 2025
- Received $36.8 million in non-dilutive funding from DHA
- Net loss decreased from $26.2M to $17.7M year-over-year
- Cash runway extended into Q1 2026
- R&D expenses increased 48% to $24.7M in 2024
- Operating cash burn increased 74% to $37M in 2024
- Recorded $8M in combined impairment charges
- Encountered manufacturing delays in BX004 program
- G&A expenses increased 36% to $11.8M
Insights
BiomX's financial position shows mixed signals with the recent
Despite reporting a reduced net loss of
The non-dilutive funding of
BiomX's phage therapy pipeline is approaching critical inflection points that could validate their platform technology. BX211 for diabetic foot osteomyelitis (DFO) associated with S. aureus will yield Phase 2 topline results by end of March 2025, representing the company's most immediate catalyst. This program's design was informed by compassionate use cases, suggesting real-world validation of the approach before formal clinical testing.
The BX004 program targeting Pseudomonas aeruginosa infections in cystic fibrosis (CF) patients has overcome manufacturing scale-up challenges that emerged in Q4 2024. The company's initiative to analyze real-world evidence on the relationship between P. aeruginosa reduction and clinical outcomes ahead of regulatory discussions demonstrates strategic preparation for potential commercialization pathways.
Phage therapy represents a novel approach to combat antibiotic-resistant infections - a critical unmet need in both indications. For CF patients particularly, chronic P. aeruginosa infection significantly impacts pulmonary function and mortality rates. The company's dual-program approach diversifies risk while targeting conditions where conventional antibiotics often fail. The resolution of manufacturing challenges is reassuring, though previous delays highlight execution risks inherent in novel biological manufacturing. The upcoming BX211 results will provide critical validation for the entire platform technology.
- In February 2025, BiomX announced a series of financings with total gross proceeds of approximately
$12 million to support completion of Phase 2b study of BX004; topline results anticipated in Q1 2026 - Topline Phase 2 results for BX211 in diabetic foot osteomyelitis (DFO) expected by end of March 2025
- Initiated exploration and analysis of real-world evidence in people with Cystic Fibrosis (CF) on the relationship between Pseudomonas aeruginosa reduction and clinical outcomes, ahead of expected regulatory discussions in second half of 2025
NESS ZIONA, Israel, March 25, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE, the “Company” or “BiomX”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced financial results for the fourth quarter and full year ended December 31, 2024, and provided program and business updates.
“BiomX is in the process of finalizing the analysis of topline results from the Phase 2 trial of BX211 in DFO, with readout expected by the end of the quarter,” said Jonathan Solomon, Chief Executive Officer of BiomX. “In the first quarter of 2025, we also completed a financing round that generated
Clinical Program Updates
BX211 – phage for the treatment of DFO associated with Staphylococcus aureus (S. aureus)
- BiomX expects to report initial topline results from the Phase 2 trial evaluating BX211 for the treatment of DFO by the end of March 2025. The safety, tolerability, and efficacy of BX211 are being evaluated in a randomized, double-blind, placebo-controlled, multi-center Phase 2 study for individuals with DFO associated with S. aureus. The topline results will evaluate healing of the wound associated with osteomyelitis at Week 13. The Phase 2 study design was guided in part by experience with numerous compassionate cases using phage therapy for the treatment of DFO and osteomyelitis.
- In October 2024, BiomX received a milestone payment from the U.S. Defense Health Agency (DHA), approved to support the BX211 Phase 2 trial in DFO. To date, total non-dilutive funding received for this study has reached
$36.8 million .
BX004 – fixed phage cocktail for the treatment of cystic fibrosis (CF) in patients with chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa)
- Trial remains on track to report topline results in the first quarter of 2026. During the fourth quarter of 2024, BiomX encountered manufacturing delays relating to scaling up of materials for the larger phase 2 trial. These challenges have since been resolved, supporting continued progress in the program.
- Discussions with the U.S. Food and Drug Administration (FDA) and other regulatory authorities are expected during the second half of 2025, during which the Company intends to present its analyses of real-world evidence and will seek to obtain endorsement that supports potential future regulatory filings.
Business Update
BiomX entered into a securities purchase agreement with investors in February 2025 in connection with a registered direct offering, concurrent private placement of the Company’s securities, and simultaneous exercise of certain existing common stock purchase warrants. Aggregate gross proceeds were approximately
Full Year 2024 Financial Results
Cash balance and restricted cash as of December 31, 2024 were
Research and development expenses, net were
General and administrative expenses were
Goodwill impairment was
IPR&D impairment was
Long-lived assets impairment was
Net loss for 2024 was
Net cash used in operating activities for the year ended December 31, 2024 was
Conference Call and Webcast
BiomX intends to host a conference call and a live audio webcast at a later date to discuss its fourth quarter and full year 2024 financial results, in conjunction with its expected announcement of initial topline results from its Phase 2 trial for subjects with DFO.
About BX004
BiomX is developing BX004, a fixed multi-phage cocktail, for the treatment of CF patients with chronic pulmonary infections caused by P. aeruginosa, a main contributor to morbidity and mortality in patients with CF. In November 2023, BiomX announced positive topline results from Part 2 of the Phase 1b/2a trial where BX004 demonstrated improvement in pulmonary function associated with a reduction in P. aeruginosa burden compared to placebo in a predefined subgroup of patients with reduced lung function (baseline FEV1<
About BX211
BX211 is a phage treatment for the treatment of DFO associated with S. aureus. DFO is a bacterial infection of the bone that usually develops from an infected foot ulcer and is a leading cause of amputation in patients with diabetes. The ongoing randomized, double-blind, placebo-controlled, multi-center Phase 2 trial investigating the safety, tolerability, and efficacy of BX211 for subjects with DFO associated with S. aureus has finished enrollment of patients, randomized at a 2:1 ratio of BX211 to placebo. BX211 or placebo is designed to be administered weekly, by topical and IV route at Week 1 and by the topical route only at each of Weeks 2-12. Over the 12-week treatment period, all subjects are expected to continue to be treated in accordance with standard of care which will include antibiotic treatment as appropriate. A first readout of study topline results is expected at Week 13 evaluating healing of the wound associated with osteomyelitis. This readout is expected in the first quarter of 2025.
About BiomX
BiomX is a clinical-stage company leading the development of natural and engineered phage cocktails and personalized phage treatments designed to target and destroy harmful bacteria for the treatment of chronic diseases with substantial unmet needs. BiomX discovers and validates proprietary bacterial targets and applies its BOLT (“BacteriOphage Lead to Treatment”) platform to customize phage compositions against these targets. For more information, please visit www.biomx.com, the content of which does not form a part of this press release.
Safe Harbor
This press release contains express or implied “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. For example, when BiomX refers to its anticipated timing for reporting results for its clinical assets as well as the design thereof, expected discussions with the FDA and results thereof, the potential of its candidates to address the substantial unmet needs of patients with intractable infections, and the estimates of the sufficiency of its cash, cash equivalents and short-term deposits, it is using forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on BiomX management’s current beliefs, expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of BiomX’s control. These risks and uncertainties include, but are not limited to, changes in applicable laws or regulations; the possibility that BiomX may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and development, such as: adverse results in BiomX’s drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials, BiomX’s ability to enroll patients in its clinical trials, and the risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the FDA and other regulatory authorities; investigational review boards at clinical trial sites and publication review bodies with respect to our development candidates; BiomX’s ability to obtain, maintain and enforce intellectual property rights for its platform and development candidates; its potential dependence on collaboration partners; competition; uncertainties as to the sufficiency of BiomX’s cash resources to fund its planned activities for the periods anticipated and BiomX’s ability to manage unplanned cash requirements; and general economic and market conditions. Therefore, investors should not rely on any of these forward-looking statements and should review the risks and uncertainties described under the caption “Risk Factors” in BiomX’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on April 4, 2024, and additional disclosures BiomX makes in its other filings with the SEC, which are available on the SEC’s website at www.sec.gov. Forward-looking statements are made as of the date of this press release, and except as provided by law BiomX expressly disclaims any obligation or undertaking to update forward-looking statements.
Contacts:
BiomX, Inc.
Ben Cohen
Head Corporate Communications
benc@biomx.com
BIOMX INC. | |||||||||||
CONSOLIDATED BALANCE SHEETS | |||||||||||
(USD in thousands, except share and per share data) | |||||||||||
As of December 31, | |||||||||||
2024 | 2023 | ||||||||||
ASSETS | |||||||||||
Current assets | |||||||||||
Cash and cash equivalents | 16,856 | 14,907 | |||||||||
Restricted cash | 958 | 957 | |||||||||
Other current assets | 2,706 | 1,768 | |||||||||
Total current assets | 20,520 | 17,632 | |||||||||
Non-current assets | |||||||||||
Non-current restricted cash | 161 | - | |||||||||
Operating lease right-of-use assets | 5,457 | 3,495 | |||||||||
Property and equipment, net | 5,045 | 3,902 | |||||||||
In-process research and development (“IPR&D”) asset | 12,050 | - | |||||||||
Total non-current assets | 22,713 | 7,397 | |||||||||
43,233 | 25,029 |
As of December 31, | ||||||||||
2024 | 2023 | |||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||
Current liabilities | ||||||||||
Trade account payables | 1,882 | 1,381 | ||||||||
Current portion of lease liabilities | 1,130 | 666 | ||||||||
Other account payables | 5,255 | 3,344 | ||||||||
Current portion of long-term debt | - | 5,785 | ||||||||
Total current liabilities | 8,267 | 11,176 | ||||||||
Non-current liabilities | ||||||||||
Contract liability | - | 1,976 | ||||||||
Long-term debt, net of current portion | - | 5,402 | ||||||||
Operating lease liabilities, net of current portion | 8,454 | 3,239 | ||||||||
Other liabilities | 77 | 155 | ||||||||
Private Placement Warrants | 2,287 | - | ||||||||
Total non-current liabilities | 10,818 | 10,772 | ||||||||
Commitments and Contingencies | ||||||||||
Stockholders’ equity | ||||||||||
Preferred Stock, | 18,645 | - | ||||||||
Common stock, | 6 | 3 | ||||||||
Additional paid in capital | 186,194 | 166,048 | ||||||||
Accumulated deficit | (180,697 | ) | (162,970 | ) | ||||||
Total Stockholders’ equity | 24,148 | 3,081 | ||||||||
43,233 | 25,029 |
(*) | All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split effective August 26, 2024. |
BIOMX INC. | |||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||
(USD in thousands, except share and per share data) | |||||
Year ended December 31, | |||||
2024 | 2023 | ||||
Research and development (“R&D”) expenses, net | 24,663 | 16,698 | |||
General and administrative expenses | 11,776 | 8,650 | |||
Goodwill impairment | 801 | - | |||
IPR&D impairment | 3,237 | - | |||
Long-lived assets impairment | 4,046 | - | |||
Operating loss | 44,523 | 25,348 | |||
Other income | (2,143 | ) | (357 | ) | |
Interest expenses | 873 | 2,404 | |||
Finance expense (income), net | 919 | (1,249 | ) | ||
Income from change in fair value of Private Placement Warrants | (26,458 | ) | - | ||
Loss before tax | 17,714 | 26,146 | |||
Tax expenses | 13 | 23 | |||
Net Loss | 17,727 | 26,169 | |||
Basic loss per share of Common Stock | 1.47 | 5.1 | |||
Diluted loss per share of Common Stock | 3.36 | 5.1 | |||
Weighted average number of shares used in computing basic loss per share of Common Stock (*) | 12,019,401 | 5,133,093 | |||
Weighted average number of shares used in computing diluted loss per share of Common Stock (*) | 13,138,106 | 5,133,093 |
(*) | All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split effective August 26, 2024. |
