Full Press Release Details
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
CAMBRIDGE, MA and NESS ZIONA, Israel - April 3, 2024 -
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."
Clinical Program Updates
Cystic Fibrosis (BX004)
Diabetic Foot Osteomyelitis
Atopic Dermatitis ("AD")
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
Conference Call Dial-In Information:
| Participant Dial-In Number: | + 1 877-407-0724 |
| Participant International Dial-In | +1 201-389-0898 |
| Webcast: | Link |
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.
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
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.
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.
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.
LifeSci Advisors, LLC
LifeSci Advisors, LLC
Corporate Project Manager
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 |
CONSOLIDATED STATEMENTS OF OPERATIONS
(USD in thousands, except share and per share data)