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BiomX Announces Third Quarter 2024 Financial Results and Provides Business and Program Updates

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BiomX announced Q3 2024 financial results and clinical program updates. Patient enrollment for BX211 Phase 2 trial in Diabetic Foot Osteomyelitis is complete, with topline results expected in Q1 2025. The BX004 Phase 2b study in Cystic Fibrosis faced manufacturing delays, now resolved, with results expected in H1 2026. Cash balance was $24.7M as of September 30, 2024. R&D expenses increased to $7.3M from $5.6M year-over-year. The company reported net income of $9.6M compared to a net loss of $7.9M in Q3 2023, mainly due to changes in warrant fair value. Cash runway extends into Q4 2025.

BiomX ha annunciato i risultati finanziari del terzo trimestre 2024 e aggiornamenti sul programma clinico. L'arruolamento dei pazienti per il trial di fase 2 BX211 nell'Osteomielite Diabetica è completato, con i risultati iniziali attesi per il primo trimestre del 2025. Lo studio BX004 fase 2b sulla Fibrosi Cistica ha affrontato ritardi nella produzione, ora risolti, con risultati attesi nella prima metà del 2026. Il saldo di cassa era di 24,7 milioni di dollari al 30 settembre 2024. Le spese di ricerca e sviluppo sono aumentate a 7,3 milioni di dollari rispetto ai 5,6 milioni dell'anno precedente. L'azienda ha riportato un utile netto di 9,6 milioni di dollari rispetto a una perdita netta di 7,9 milioni di dollari nel terzo trimestre 2023, principalmente a causa delle variazioni nel valore equo delle opzioni. La liquidità prevista si estende fino al quarto trimestre del 2025.

BiomX anunció los resultados financieros del tercer trimestre de 2024 y actualizaciones del programa clínico. La inscripción de pacientes para el ensayo de fase 2 BX211 en Osteomielitis Diabética se ha completado, y se esperan los resultados iniciales para el primer trimestre de 2025. El estudio BX004 fase 2b en Fibrosis Quística enfrentó retrasos en la producción, que ya se han resuelto, con resultados esperados en la primera mitad de 2026. El saldo de efectivo era de 24,7 millones de dólares al 30 de septiembre de 2024. Los gastos de investigación y desarrollo aumentaron a 7,3 millones de dólares desde 5,6 millones del año anterior. La compañía reportó ingresos netos de 9,6 millones de dólares en comparación con una pérdida neta de 7,9 millones de dólares en el tercer trimestre de 2023, principalmente debido a cambios en el valor razonable de las opciones. La liquidez se extiende hasta el cuarto trimestre de 2025.

BiomX는 2024년 3분기 재무 결과 및 임상 프로그램 업데이트를 발표했습니다. 당뇨발 골수염에 대한 BX211 2상 시험의 환자 등록이 완료되었으며, 주요 결과는 2025년 1분기에 예상됩니다. 낭포성 섬유증에 대한 BX004 2b상 연구는 제조 지연이 있었으나 현재 해결되었으며, 결과는 2026년 상반기에 예상됩니다. 2024년 9월 30일 기준 현금 잔고는 2,470만 달러였습니다. 연구 개발 비용은 전년 대비 560만 달러에서 730만 달러로 증가했습니다. 회사는 2023년 3분기 790만 달러의 순손실에 비해 960만 달러의 순이익을 보고했으며, 이는 주의 공정 가치 변동으로 인한 것입니다. 현금 보유 기간은 2025년 4분기까지 연장됩니다.

BiomX a annoncé les résultats financiers du troisième trimestre 2024 et des mises à jour sur le programme clinique. L'inscription des patients pour l'essai BX211 Phase 2 dans l'ostéomyélite diabétique est complète, avec des résultats préliminaires attendus au premier trimestre 2025. L'étude BX004 Phase 2b sur la mucoviscidose a rencontré des retards de production, désormais résolus, avec des résultats attendus dans la première moitié de 2026. Le solde de trésorerie s'élevait à 24,7 millions de dollars au 30 septembre 2024. Les dépenses de recherche et développement ont augmenté de 5,6 millions à 7,3 millions de dollars d'une année sur l'autre. L'entreprise a enregistré un bénéfice net de 9,6 millions de dollars par rapport à une perte nette de 7,9 millions de dollars au troisième trimestre 2023, principalement en raison des variations de la juste valeur des bons de souscription. La durée de trésorerie s'étend jusqu'au quatrième trimestre 2025.

BiomX hat die finanziellen Ergebnisse für das dritte Quartal 2024 und Aktualisierungen des klinischen Programms angekündigt. Die Patienteneinschreibung für die BX211 Phase 2 Studie bei diabetischer Fußosteomyelitis ist abgeschlossen, und die Ergebnisse werden im ersten Quartal 2025 erwartet. Die BX004 Phase 2b Studie zur zystischen Fibrose hatte Verzögerungen in der Herstellung, die nun behoben sind, und Ergebnisse werden in der ersten Hälfte von 2026 erwartet. Der Kassenbestand betrug am 30. September 2024 24,7 Millionen Dollar. Die F&E-Ausgaben erhöhten sich von 5,6 Millionen auf 7,3 Millionen Dollar im Jahresvergleich. Das Unternehmen meldete einen Nettogewinn von 9,6 Millionen Dollar im Vergleich zu einem Nettoverlust von 7,9 Millionen Dollar im dritten Quartal 2023, hauptsächlich bedingt durch Änderungen im fairen Wert von Optionsscheinen. Die Liquidität reicht bis in das vierte Quartal 2025.

Positive
  • Received $36.8M in non-dilutive funding from DHA for BX211 trial
  • Net income improved to $9.6M from -$7.9M YoY
  • Positive Phase 1b/2a BX004 trial results showing 14.3% patient conversion to P. aeruginosa negative
  • Cash runway extended into Q4 2025
Negative
  • Manufacturing delays in BX004 program pushing results to H1 2026
  • R&D expenses increased 30% YoY to $7.3M
  • G&A expenses increased 45% YoY to $3.2M
  • Cash balance decreased to $24.7M from $30.7M since December 2023
  • Net cash used in operations doubled to $30.7M vs $15.0M YoY

Insights

The Q3 2024 results reveal concerning financial metrics with increased operating expenses. R&D costs rose to $7.3M from $5.6M YoY, while G&A expenses increased to $3.2M from $2.2M. The cash burn accelerated significantly, with net cash used in operations reaching $30.7M for the nine months, double the $15.0M from 2023. Despite showing a net income of $9.6M, this was primarily due to warrant valuation changes rather than operational improvements. The cash runway extends into Q4 2025, but with a small market cap of $13.6M and increased spending, additional financing may be needed before clinical milestones are reached.

The clinical pipeline faces mixed developments. The BX211 DFO program maintains its timeline for Q1 2025 readout and has secured substantial non-dilutive funding ($36.8M total from DHA), demonstrating strong government support. However, the CF program BX004 delay to H1 2026 due to manufacturing issues is concerning. While Phase 1b/2a data showed promising signals with 14.3% of patients achieving bacterial clearance and 5.66% FEV1 improvement in a specific subgroup, the extended timeline could impact competitive positioning in the CF market. The manufacturing resolution provides some reassurance, but execution risks remain elevated.

BX211 Phase 2 for treatment of Diabetic Foot Osteomyelitis (DFO) patient enrollment completed and on track to report topline results in Q1 2025

BX004 Phase 2b study in Cystic Fibrosis (CF) is now expected to report topline results in H1 2026 following resolved manufacturing delays

Company to host conference call and webcast today at 8:00AM ET

NESS ZIONA, Israel, Nov. 14, 2024 (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 announces financial results for its third quarter ended September 30, 2024, and provides program and business updates.

“We continue to be encouraged by the progress in diabetic foot osteomyelitis (DFO), having achieved an important milestone by completing patient enrollment for the BX211 program. We remain on track to share topline (through Week 13) Phase 2 results of BX211 in the first quarter of 2025,” said Jonathan Solomon, BiomX’s Chief Executive Officer. “BX211 is a novel phage treatment for DFO and holds the potential to prevent amputations associated with intractable infections that have penetrated the bone in patients with diabetic foot ulcers. In October 2024, we received additional non-dilutive funding from the US Defense Health Agency (“DHA”) to continue advancing the DFO program and are grateful for the continued support provided by the DHA. During the last quarter, our CF program experienced manufacturing delays, which have been resolved, and we now expect to report topline results for BX004 in our Phase 2b study in the first half of 2026. Results from our Phase 1b/2a study for the BX004 program in CF continue to receive positive feedback at major scientific conferences, including those attended during the past quarter, and we remain confident about the future of this program and its potential to address the significant unmet medical need of CF patients.”

Clinical Program Updates

BX211 personalized phage for the treatment of DFO associated with Staphylococcus aureus

  • Patient enrollment for BX211 Phase 2 trial in DFO was completed. The safety, tolerability, and efficacy of BX211 is currently being evaluated in a randomized, double-blind, placebo-controlled, multi-center Phase 2 trial for subjects with DFO. Initial topline results of the Phase 2 trial (Week 13) are expected in the first quarter of 2025. 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, the Company received additional funding from the DHA to advance the BX211 trial in DFO. To date, total non-dilutive funding received towards this trial has totaled $36.8 million.

BX004 – fixed phage cocktail for the treatment of CF in patients with chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa)

  • In the third quarter, BiomX presented positive safety and efficacy data from the Phase 1b/2a trial of BX004 at the North American Cystic Fibrosis conference and European Respiratory Society’s annual meeting.
  • Key highlights from Part 2 of the Phase 1b/2a study included:

    • Study drug was safe and well-tolerated, with no related SAEs (serious adverse events) or related APEs (acute pulmonary exacerbations) to study drug.
    • In the BX004 arm, 3 out of 21 (14.3%) patients converted to sputum culture negative for P. aeruginosa (PsA) after 10 days of treatment (including 2 patients after 4 days) compared to 0 out of 10 (0%) in the placebo arm, in subjects with quantitative sputum PsA CFU at baseline. Lung function, as measured by forced expiratory volume in 1 second (FEV1), increased in subjects receiving the cocktail (+5.66%) compared to placebo (-3.23%), in the subgroup on continuous inhaled antibiotics (same antibiotic with no cycling or alternating regimen), on elexacaftor / tezacaftor / ivacaftor (ETI) and with lower lung function (FEV1 <70%).

Business Updates

  • In August 2024, the Company effected a 1-for-10 reverse stock split of its issued share capital combining and converting every ten issued and outstanding shares of Common Stock into one issued and outstanding new share of Common Stock. The Reverse Stock Split has not changed the par value of the Common Stock or the authorized number of shares of Common Stock or preferred stock.
  • In October 2024, the Company also announced a mandatory separation of its units that traded under the ticker symbol “PHGE.U”, each of which consisted of one share of Common Stock and one warrant to purchase one-half of a share of Common Stock (the “Units”). Each warrant (a “Warrant”) entitled the holder to purchase one-half of a share of Common stock at a price of $115 per share. The Units were mandatorily separated and no longer trade on the NYSE American. In the separation, Unit holders received the number of shares of Common Stock and Warrants underlying such Units. The Warrants expired on October 28, 2024.

Third Quarter 2024 Financial Results

Cash balance, short-term deposits and restricted cash as of September 30, 2024, were $24.7 million, compared to $30.7 million as of December 31, 2023. The decrease was primarily due to net cash used in operating activities and the repayment in April 2024, of the Company’s prior debt facility, which was partially offset by the Company’s private placement financing of $50 million in March 2024. BiomX estimates its cash, cash equivalents and short-term deposits are sufficient to fund its operations into the fourth quarter of 2025.

Research and development expenses, net were $7.3 million for the third quarter of 2024, compared to $5.6 million for the third quarter of 2023. 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 grants BiomX received.

General and administrative expenses were $3.2 million for the third quarter of 2024, compared to $2.2 million for the third quarter of 2023. The increase is primarily attributed to a full quarter consolidation of expenses following APT’s acquisition, incorporating the combined workforce, increased professional services, and additional subcontractor expenses.

The Company recognized goodwill impairment expenses of $801 thousand in the third quarter of 2024, resulting from the fair value assessment of goodwill related to the 2024 APT acquisition. No comparable goodwill impairment expenses were recorded in the same period of 2023.

Net income was $9.6 million for the third quarter of 2024, compared to a net loss of $7.9 million for the third quarter of 2023. The increase is mainly due to the change in the fair value of the warrants issued as part of the March 2024 financing.

Net cash used in operating activities for the nine months ended September 30, 2024, was $30.7 million, compared to $15.0 million for the same period in 2023.

Conference Call and Webcast Details

BiomX will host a conference call and webcast on November 14, 2024, at 8:00 a.m. ET to discuss its third quarter 2024 financial results and to provide a corporate update.

Participant Dial-In Number:

+1 877-407-0724

Participant International Dial-In

+1 201-389-0898

Webcast Link

Link

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 half 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 personalized phage treatment for the treatment of DFO associated with S. aureus. The personalized phage treatment tailors a specific phage selected from a proprietary phage-bank according to the specific strain of S. aureus biopsied and isolated from each patient. 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 for a randomized at a 2:1 ratio to BX211 or 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, followed by a second readout at Week 52 evaluating amputation rates and resolution of osteomyelitis based on X-ray, clinical assessments, and established biomarkers (ESR and CRP). These readouts are expected in the first quarter of 2025 and the first quarter of 2026, respectively.

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 its anticipated timing for reporting results for its clinical assets as well as the design 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, BiomX’s ability to regain compliance with the listing standards set forth in the NYSE American Company Guide by November 23, 2025; 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
benc@biomx.com

CORE IR
Peter Seltzberg 
ir-biomx@biomx.com

 
BIOMX INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(USD in thousands, except share and per share data)
(unaudited)
 
   
  As of
  September 30,
2024
  December 31,
2023
ASSETS     
      
Current assets     
      
Cash and cash equivalents  23,537   14,907
Restricted cash  1,114   957
Other current assets  3,665   1,768
Total current assets  28,316   17,632
        
Non-current assets       
Other assets  96   -
Operating lease right-of-use assets  9,700   3,495
Property and equipment, net  6,581   3,902
In-process Research and development (“IPR&D”) assets  15,287   -
Total non-current assets  31,664   7,397
   59,980   25,029


 
  As of 
  September 30,
2024

  December 31,
2023
 
        
LIABILITIES AND STOCKHOLDERS’ EQUITY       
        
Current liabilities       
Trade accounts payable  2,779  1,381 
Current portion of lease liabilities  1,096  666 
Other accounts payable  5,069  3,344 
Current portion of long-term debt  -  5,785 
Total current liabilities  8,944  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  8,651  3,239 
Other liabilities  161  155 
Private Placement Warrants  4,328  - 
Total non-current liabilities  13,140  10,772 
       
Commitments and Contingencies (Note 7)      
       
Stockholders’ equity      
       
Preferred Stock, $0.0001 par value; Authorized – 1,000,000 shares as of September 30, 2024 and December 31, 2023. Issued and outstanding- 14,774 as of September 30, 2024. No shares issued and outstanding as of December 31, 2023.  18,645  - 
Common Stock, $0.0001 par value; Authorized – 750,000,000 shares as of September 30, 2024 and 120,000,000 shares as of December 31, 2023. Issued and outstanding -18,176,602 shares as of September 30, 2024 and 4,723,320 shares as of December 31, 2023. (*)  6  3 
       
Additional paid in capital  185,429  166,048 
Accumulated deficit  (166,184) (162,970)
Total stockholders’ equity  37,896  3,081 
   59,980  25,029 


 
BIOMX INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(USD in thousands, except share and per share data)
(unaudited)
 
  Three Months Ended
September 30,
Nine Months Ended
September 30,
  2024  2023  2024  2023 
              
Research and development (“R&D”) expenses, net  7,279  5,641  18,281  14,023 
General and administrative expenses  3,248  2,154  8,756  6,053 
Goodwill impairment  801  -  801  - 
              
Operating loss  11,328  7,795  27,838  20,076 
          
Other income  (84) (89) (2,189) (270)
Interest expenses  5  574  868  1,884 
Income from change in fair value of Private Placement Warrants  (20,559) -  (24,417 - 
Finance expense (income), net  (332) (382) 1,104  (1,034)
              
Loss (income) before tax  (9,642) 7,898  3,204  20,656 
          
Tax expenses  -  8  10  22 
          
Net loss (income)  (9,642) 7,906  3,214  20,678 
          
Basic loss (earnings) per share of Common Stock (*)  (0.31) 1.30  0.32  4.29 
Diluted loss per share of Common Stock (*)  (0.31) 1.30  2.45  4.29 
          
Weighted average number of shares used in computing basic loss (earnings) per share of Common Stock  16,366,122  6,058,774  9,944,267  4,819,658 
Weighted average number of shares used in computing diluted loss per share of Common Stock  16,387,633  6,058,774  11,294,879  4,819,658 

FAQ

When will BiomX (PHGE) report BX211 Phase 2 topline results for DFO treatment?

BiomX expects to report topline results for the BX211 Phase 2 trial in Diabetic Foot Osteomyelitis in the first quarter of 2025.

What was BiomX's (PHGE) cash balance as of September 30, 2024?

BiomX reported a cash balance, short-term deposits and restricted cash of $24.7 million as of September 30, 2024.

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

BiomX has received total non-dilutive funding of $36.8 million from the US Defense Health Agency for the BX211 trial in DFO.

What were BiomX's (PHGE) R&D expenses in Q3 2024?

BiomX's research and development expenses were $7.3 million for the third quarter of 2024, compared to $5.6 million in Q3 2023.

BiomX Inc.

NYSE:PHGE

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9.35M
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Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
NESS ZIONA