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BiomX Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business and Program Updates

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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

Positive
  • 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
Negative
  • 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 $12 million financing in February 2025 providing critical runway extension into Q1 2026 - just enough to cover their next major clinical milestone for BX004. The cash balance of $18 million as of December 31, 2024 (pre-February financing) represents a modest improvement from $15.9 million year-over-year, but operational cash burn accelerated significantly with $37 million used in 2024 versus $21.3 million in 2023.

Despite reporting a reduced net loss of $17.7 million (down from $26.2 million), this improvement appears primarily driven by non-operational factors related to warrant valuation changes rather than improved fundamentals. The $8 million in combined impairment charges ($0.8 million goodwill, $3.2 million IPR&D, $4 million long-lived assets) following the APT acquisition raises questions about capital allocation and integration efficiency.

The non-dilutive funding of $36.8 million for BX211 from the Defense Health Agency represents an important validation, though R&D expenses still increased substantially to $24.7 million from $16.7 million. For a company with $15.7 million market cap, the February financing likely came with significant dilution, though necessary to fund operations through critical upcoming clinical readouts.

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 $12 million in gross proceeds. We believe that these resources will enable readout of BX004 Phase 2b topline results, which are anticipated in the first quarter of 2026. In addition, the funds will support the analysis of real-world evidence to assess the relationship between Pseudomonas aeruginosa reduction and clinical outcomes in individuals with cystic fibrosis ahead of regulatory discussions expected in the second half of this year.”

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 $12 million, before deducting placement agent fees and other offering expenses. Following these offerings, the Company expects to have sufficient funding to reach substantial inflection points, including topline results of its Phase 2b study of BX004 in the first quarter of 2026.

Full Year 2024 Financial Results

Cash balance and restricted cash as of December 31, 2024 were $18.0 million, compared to $15.9 million as of December 31, 2023. The increase was primarily due to funds raised in the Company’s March 2024 financing, partly offset by net cash used in operating activities. The December 31, 2024 cash balance does not reflect the additional $12 million in gross proceeds raised in the Company’s February 2025 financing round. BiomX estimates its cash, cash equivalents and short-term deposits are sufficient to fund its operations into the first quarter of 2026.

Research and development expenses, net were $24.7 million for the year ended December 31, 2024, compared to $16.7 million for the prior year. The increase was primarily due to the following factors: preparations for the Phase 2b clinical trial of the Company’s CF product candidate, BX004; an increase in expenses relating to the Phase 2 clinical trial of the Company’s DFO product candidate, BX211; and an increase in rent and related expenses following the March acquisition of Adaptive Phage Therapeutics (APT). This increase was partly offset by higher governmental grants BiomX received.

General and administrative expenses were $11.8 million for the year ended December 31, 2024, compared to $8.7 million for the prior year. The increase is primarily attributed to a consolidation of expenses following APT’s acquisition, incorporating the combined workforce, increased professional services, and additional subcontractor expenses.

Goodwill impairment was $0.8 million for the year ended December 31, 2024, following an impairment of the Company’s goodwill resulting from the APT acquisition. The Company had no goodwill impairment in the year ended December 31, 2023.

IPR&D impairment was $3.2 million for the year ended December 31, 2024, following the Company’s quantitative assessment for in process research and development (IPR&D) impairment. The Company had no IPR&D impairment in the year ended December 31, 2023.

Long-lived assets impairment was $4.0 million for the year ended December 31, 2024, after evaluating the right-of-use asset and related leasehold improvements following the Company’s decision to cease the use of the property in Gaithersburg, Maryland and make it available for sublease. The Company had no long-lived assets impairment in the year ended December 31, 2023.

Net loss for 2024 was $17.7 million, compared to $26.2 million for the prior year. The decrease is mainly due to the change in the fair value of the warrants issued as part of the Company’s March 2024 financing.

Net cash used in operating activities for the year ended December 31, 2024 was $37 million, compared to $21.3 million for the same period in 2023. 

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<70%). BiomX expects to initiate a randomized, double blind, placebo-controlled, multi-center Phase 2b trial in CF patients with chronic P. aeruginosa pulmonary infections. The trial is designed to enroll approximately 60 patients randomized at a 2:1 ratio to BX004 or placebo. Treatment is expected to be administered via inhalation twice daily for a duration of 8 weeks. The trial is designed to monitor the safety and tolerability of BX004 and is designed to demonstrate improvement in microbiological reduction of P. aeruginosa burden and evaluation of effects on clinical parameters such as lung function measured by FEV1 and patient reported outcomes. Pending progress of the trial, topline results are expected in the first quarter of 2026. The U.S. Food and Drug Administration (“FDA”) has granted BX004 Fast Track designation and Orphan Drug Designation.

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, $0.0001 par value; Authorized - 1,000,000 shares as of December 31, 2024 and December 31, 2023. Issued and outstanding – 147,735 as of December 31, 2024. No shares issued and outstanding as of December 31, 2023. 18,645  - 
Common stock, $0.0001 par value (“Common Stock”); Authorized - 750,000,000 shares as of December 31, 2024 and 120,000,000 shares as of December 31, 2023. Issued and outstanding – 18,176,661 and 4,723,380 as of December 31, 2024 and December 31, 2024, respectively. (*) 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.

FAQ

What are the expected milestone dates for BiomX (PHGE) clinical trials in 2025-2026?

BX211 Phase 2 results expected by March 2025, and BX004 Phase 2b topline results anticipated in Q1 2026.

How much funding did BiomX (PHGE) secure in February 2025?

BiomX secured approximately $12 million in gross proceeds through a registered direct offering and concurrent private placement.

What was BiomX's (PHGE) cash position at the end of 2024?

Cash balance was $18.0 million as of December 31, 2024, compared to $15.9 million at the end of 2023.

How much non-dilutive funding has BiomX (PHGE) received for the BX211 DFO trial?

Total non-dilutive funding received from the U.S. Defense Health Agency for the BX211 trial reached $36.8 million.

What was BiomX's (PHGE) net loss for the full year 2024?

Net loss for 2024 was $17.7 million, down from $26.2 million in the previous year.
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