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BiomX Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Recent acquisition of Adaptive Phage Therapeutics creates leader in phage therapy with advanced, clinical-stage pipeline    

Closed concurrent $50 million financing to support BX004 and BX211 programs through key data readouts expected in 2025 

Patient recruitment on track in BX211 Phase 2 trial in Diabetic Foot Osteomyelitis (“DFO”), with topline results expected in Q1 2025

Company will host a conference call and webcast today at 8:00 am ET   

CAMBRIDGE, Mass. and NESS ZIONA, Israel, April 03, 2024 (GLOBE NEWSWIRE) — BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

“2023 marked a year of great progress for BiomX, highlighted by the positive results from our Phase 1b/2a trial which demonstrated that a short course of treatment with BX004 can result in a favorable treatment effect in Cystic Fibrosis (“CF”) patients with chronic P. aeruginosa infections. Results from this trial take us one step closer toward bringing forward a new and effective phage-based treatment option to address these deadly pulmonary infections impacting so many CF patients,” said Jonathan Solomon, Chief Executive Officer of BiomX. “As BX004 continues to advance, our recent acquisition of Adaptive Phage Therapeutics provides BiomX with a second, exciting Phase 2 asset, BX211, which has the potential to address serious infections in DFO. The concurrent $50 million financing we closed provides the capital needed to reach important clinical milestones over the next 12-24 months.”    

Business Update

Clinical Program Updates

Cystic Fibrosis (BX004)

Diabetic Foot Osteomyelitis (BX211)

Atopic Dermatitis (“AD”) (BX005)

Full Year 2023 Financial Results

Conference Call and Webcast Details
BiomX will host a conference call and webcast on April 3, 2024, at 8:00 a.m. ET to discuss its fourth quarter and full year 2023 financial results and to provide a corporate update.

Conference Call Dial-In Information:

Participant Dial-In Number: +1 877-407-0724
Participant International Dial-In +1 201-389-0898
Webcast: 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 function1.

BiomX expects to initiate a randomized, double blind, placebo-controlled, multi-center Phase 2b trial in CF patients with chronic P. aeruginosa pulmonary infections in the fourth quarter of 2024. 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. Trial results are expected in the third quarter 2025. The 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 is expected to enroll approximately 45 subjects 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 developing both natural and engineered phage cocktails and personalized phage treatments designed to target and destroy bacteria in the treatment of chronic diseases. BiomX discovers and validates proprietary bacterial targets and customizes 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 discusses the expected timing of clinical trials, key data readouts and topline results, its cash runway and sufficiently of capital to meet milestones and the potential benefits of BX004 and BX211, BiomX is making 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. In addition, past and current pre-clinical and clinical results, as well as compassionate use, are not indicative and do not guarantee future success of BiomX clinical trials. 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. Actual results and outcomes may differ materially from those indicated in the forward-looking statements, as a result of various important factors, including risks and uncertainties related to the ability to recognize the anticipated benefits of the acquisition of APT; the outcome of any legal proceedings that may be instituted against BiomX following the acquisition and related transactions; the ability to obtain or maintain the listing of the common stock of BiomX on the NYSE American following the acquisition; costs related to the acquisition; 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 March 29, 2023, 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.

BiomX Contacts

Investor Relations:
LifeSci Advisors, LLC
John Fraunces
Managing Director
(917) 355-2395
jfraunces@lifesciadvisors.com, or

Brian Mullen
LifeSci Advisors, LLC
(203) 461-1175
Bmullen@lifesciadvisors.com

BiomX, Inc.
Anat Primovich
Corporate Project Manager
+972 (50) 697-7228
anatp@biomx.com
Source: BiomX Inc.

BIOMX INC.
CONSOLIDATED BALANCE SHEETS
(USD in thousands, except share and per share data)
 
  As of December 31,  
  2023     2022  
ASSETS          
           
Current assets          
Cash and cash equivalents   14,907       31,332  
Restricted cash   957       962  
Short-term deposits         2,000  
Other current assets   1,768       2,587  
Total current assets   17,632       36,881  
               
Non-current assets              
Operating lease right-of-use assets   3,495       3,860  
Property and equipment, net   3,902       4,790  
Total non-current assets   7,397       8,650  
    25,029       45,531  
  As of December 31,  
  2023     2022  
LIABILITIES AND STOCKHOLDERS’ EQUITY          
           
Current liabilities          
Trade account payables   1,381       820  
Current portion of lease liabilities   666       687  
Other account payables   3,344       2,150  
Current portion of long-term debt   5,785       4,282  
Total current liabilities   11,176       7,939  
               
Non-current liabilities              
Contract liability   1,976       1,976  
Long-term debt, net of current portion   5,402       10,591  
Operating lease liabilities, net of current portion   3,239       3,798  
Other liabilities   155       188  
Total non-current liabilities   10,772       16,553  
               
Commitments and Contingencies (Note 10)              
               
Stockholders’ equity              
               
Preferred Stock, $0.0001 par value; Authorized – 1,000,000 shares as of December 31, 2023 and December 31, 2022. No shares issued and outstanding as of December 31, 2023 and December 31, 2022.          
Common stock, $0.0001 par value (“Common Stock”); Authorized – 120,000,000 shares as of December 31, 2023 and December 31, 2022. Issued – 45,979,930 and 29,982,282 as of December 31, 2023 and 2022, respectively. Outstanding – 45,979,930 and 29,976,582 as of December 31, 2023 and 2022, respectively.   3       2  
               
Additional paid in capital   166,048       157,838  
Accumulated deficit   (162,970 )     (136,801 )
Total Stockholders’ equity   3,081       21,039  
    25,029       45,531  
BIOMX INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(USD in thousands, except share and per share data)
 
  Year ended December 31,  
  2023     2022  
           
Research and development (“R&D”) expenses, net   16,698       16,244  
Amortization of intangible assets         1,519  
General and administrative expenses   8,650       9,456  
               
Operating loss   25,348       27,219  
               
Other income   (357 )     (134 )
Interest expenses   2,404       2,069  
Finance income, net   (1,249 )     (902 )
               
Loss before tax   26,146       28,252  
               
Tax expenses   23       65  
               
Net Loss   26,169       28,317  
               
Basic and diluted loss per share of Common Stock   0.51       0.95  
               
Weighted average number of shares of Common Stock outstanding, basic and diluted   51,330,324       29,854,003  

 


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