BiomX Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>BiomX Inc. has filed its 2023 10-K report detailing its operations and financial status.</b>

AI Summary

BiomX Inc. (PHGE) filed a Annual Report (10-K) with the SEC on April 4, 2024. BiomX Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The company is incorporated in Delaware and its principal executive offices are located in Ness Ziona, Israel. BiomX Inc. is registered under the SIC code 2836 for Biological Products (No Diagnostic Substances). The company's common stock and units trade on the NYSE American under the symbols PHGE and PHGE.U, respectively. BiomX Inc. is not a well-known seasoned issuer and is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act for shorter periods.

Why It Matters

For investors and stakeholders tracking BiomX Inc., this filing contains several important signals. This filing provides a comprehensive overview of BiomX Inc.'s business, financial condition, and risk factors for the fiscal year 2023, crucial for investors to assess the company's performance and outlook. The 10-K report includes details on the company's stock, warrants, and trading information, which are essential for understanding its market presence and investor relations.

Risk Assessment

Risk Level: medium — BiomX Inc. shows moderate risk based on this filing. The company's financial health and future prospects are subject to the inherent risks of the biotechnology sector, including regulatory hurdles and clinical trial outcomes, which are not detailed in this initial filing but are typical for such companies.

Analyst Insight

Review the full 10-K filing for detailed financial statements, risk factors, and management discussion to understand BiomX Inc.'s operational performance and strategic direction.

Key Numbers

• 2023 — Fiscal Year End (Report period)
• 123 — Public Document Count (Filing metadata)
• 001-38762 — SEC File Number (Filing metadata)
• 24821575 — Film Number (Filing metadata)
• 0001-38762 — Commission File Number (Filing metadata)
• 82-3364020 — IRS Employer Identification No. (Filing metadata)
• +972 723942377 — Business Phone (Contact information)
• 11.50 — Warrant Exercise Price (Warrant details)

Key Players & Entities

• BiomX Inc. (company) — Registrant name
• 2023 (date) — Fiscal year end
• December 31 (date) — Fiscal year end
• Delaware (jurisdiction) — State of incorporation
• Ness Ziona, Israel (location) — Address of principal executive offices
• 2836 (sic_code) — Standard Industrial Classification
• PHGE.U (ticker) — Trading Symbol
• PHGE (ticker) — Trading Symbol

FAQ

Industry Context

BiomX Inc. operates in the biotechnology sector, focusing on the development of bacteriophage-based therapies.

Regulatory Implications

The company is subject to SEC regulations for public filings, including the requirement to submit annual reports on Form 10-K.

What Investors Should Do

1. Thoroughly review the financial statements and management's discussion and analysis in the 10-K.
2. Analyze the risk factors section for potential challenges and uncertainties facing BiomX Inc.
3. Investigate any disclosed legal proceedings or regulatory matters.

Year-Over-Year Comparison

This is the initial filing analyzed, so no comparison to a previous filing is available.

Key Financial Figures

• $0.0001 — onsisting of one share of common stock, $0.0001 par value, and one warrant exercisable
• $11.50 — 0001 par value, at an exercise price of $11.50 per share. Indicate by check mark if t
• $0.36 — t trading day of the fiscal quarter) of $0.36 per share. The number of shares outsta

Filing Documents

• ea0202988-10k_biomx.htm (10-K) — 1603KB
• ea020298801ex4-1_biomx.htm (EX-4.1) — 31KB
• ea020298801ex10-3_biomx.htm (EX-10.3) — 76KB
• ea020298801ex10-22_biomx.htm (EX-10.22) — 81KB
• ea020298801ex10-23_biomx.htm (EX-10.23) — 14KB
• ea020298801ex10-24_biomx.htm (EX-10.24) — 76KB
• ea020298801ex10-25_biomx.htm (EX-10.25) — 14KB
• ea020298801ex10-28_biomx.htm (EX-10.28) — 255KB
• ea020298801ex10-29_biomx.htm (EX-10.29) — 49KB
• ea020298801ex10-30_biomx.htm (EX-10.30) — 51KB
• ea020298801ex10-31_biomx.htm (EX-10.31) — 39KB
• ea020298801ex10-32_biomx.htm (EX-10.32) — 40KB
• ea020298801ex10-33_biomx.htm (EX-10.33) — 18KB
• ea020298801ex10-34_biomx.htm (EX-10.34) — 162KB
• ea020298801ex21-1_biomx.htm (EX-21.1) — 2KB
• ea020298801ex23-1_biomx.htm (EX-23.1) — 2KB
• ea020298801ex31-1_biomx.htm (EX-31.1) — 16KB
• ea020298801ex31-2_biomx.htm (EX-31.2) — 16KB
• ea020298801ex32-1_biomx.htm (EX-32.1) — 9KB
• ea020298801ex97-1_biomx.htm (EX-97.1) — 39KB
• ea020298801ex99-1_biomx.htm (EX-99.1) — 7KB
• image_001.jpg (GRAPHIC) — 38KB
• logo_001.jpg (GRAPHIC) — 5KB
• ex10-24_001.jpg (GRAPHIC) — 4KB
• ex10-24_002.jpg (GRAPHIC) — 2KB
• ex10-24_004.jpg (GRAPHIC) — 1KB
• ex10-24_005.jpg (GRAPHIC) — 2KB
• ex10-24_006.jpg (GRAPHIC) — 8KB
• ex10-25_001.jpg (GRAPHIC) — 5KB
• ex10-25_002.jpg (GRAPHIC) — 3KB
• 0001213900-24-030053.txt (&nbsp;) — 8757KB
• phge-20231231_cal.xml (EX-101.CAL) — 55KB
• phge-20231231_def.xml (EX-101.DEF) — 360KB
• phge-20231231_lab.xml (EX-101.LAB) — 631KB
• phge-20231231_pre.xml (EX-101.PRE) — 355KB
• phge-20231231.xsd (EX-101.SCH) — 85KB
• ea0202988-10k_biomx_htm.xml (XML) — 667KB

RISK FACTORS

ITEM 1A. RISK FACTORS 28

UNRESOLVED STAFF COMMENTS

ITEM 1B. UNRESOLVED STAFF COMMENTS 70

CYBERSECURITY

ITEM 1C. CYBERSECURITY 70

PROPERTIES

ITEM 2. PROPERTIES 70

LEGAL PROCEEDINGS

ITEM 3. LEGAL PROCEEDINGS 70

MINE SAFETY DISCLOSURES

ITEM 4. MINE SAFETY DISCLOSURES 70 part II

MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 71

[RESERVED]

ITEM 6. [RESERVED] 71

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 72

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 83

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 83

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 83

CONTROLS AND PROCEDURES

ITEM 9A. CONTROLS AND PROCEDURES 83

OTHER INFORMATION

ITEM 9B. OTHER INFORMATION 84

DISCLOSURE REGARDING FOREIGN JURISDICIONS THAT PREVENT INSPECTIONS

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICIONS THAT PREVENT INSPECTIONS 84 part III

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 85

EXECUTIVE COMPENSATION

ITEM 11. EXECUTIVE COMPENSATION 90

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 95

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 97

PRINCIPAL ACCOUNTANT FEES AND SERVICES

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 98 part IV

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 100

FORM 10-K SUMMARY

ITEM 16. FORM 10-K SUMMARY 101 i On March 15, 2024, BiomX Inc. acquired Adaptive Phage Therapeutics, Inc., a Delaware corporation, or APT, and such acquisition, the Acquisition, pursuant to an agreement and plan of merger, or the Merger Agreement, by and among BiomX Inc., APT, BTX Merger Sub I, Inc., a Delaware corporation, and BTX Merger Sub II, LLC, a Delaware limited liability company. References in this Annual Report on Form 10-K , or the Annual Report to the "Company," "BiomX," "we," "us" or "our" mean BiomX Inc. and its consolidated subsidiaries, including APT, unless otherwise expressly stated or the context indicates otherwise, provided, however, that all financial information included in this Annual Report, including financial information as of and for the years ended December 31, 2023 and December 31, 2022 and other information as of a date before March 15, 2024, unless noted specifically, does not include APT. References in this Annual Report to BiomX Ltd. mean BiomX Ltd., our wholly owned Israeli subsidiary. The description of the Company herein describes the post Acquisition Company and reflects the integration of APT's business. As further described elsewhere in this Annual Report, on October 28, 2019, Chardan Healthcare Acquisition Corp., a special purpose acquisition company, combined with BiomX Ltd. in the Business Combination (as defined below) and changed its name to BiomX Inc. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING This Annual Report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended or the Exchange Act. The statements contained in this Annual Report that are not purely historical are forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not histo

Forward-looking statements appear in a number of

Forward-looking statements appear in a number of places in this Annual Report including, without limitation, in the sections entitled "Management's Discussion and Analysis of Financial Conditions and Results of Operations," and "Business." The risks and uncertainties include, but are not limited to: the ability to generate revenues, and raise sufficient financing to meet working capital requirements; the integration of the operations of APT into the Company; the receipt of our stockholders' approval to certain proposals relating to the Acquisition and related private investment transaction; the unpredictable timing and cost associated with our approach to developing product candidates using phage technology; political and economic instability, including, without limitation, due to natural disasters or other catastrophic events, such as the Russian invasion of Ukraine and world sanctions on Russia, Belarus, and related parties, terrorist attacks, hurricanes, fire, floods, pollution and earthquakes; obtaining U.S. Food and Drug Administration, or FDA, acceptance of any non-U.S. clinical trials of product candidates; our ability to enroll patients in clinical trials and achieve anticipated development milestones when expected; the ability to pursue and effectively develop new product opportunities and acquisitions and to obtain value from such product opportunities and acquisitions; penalties and market withdrawal associated with any unanticipated problems with product candidates and failure to comply with labeling and other restrictions; general economic conditions, our current low stock price and other factors on our operations, the continuity of our business, including our preclinical and clinical trials, and our ability to raise additional capital; expenses associated with compliance with ongoing regulatory obligations and successful continuing regulatory review; market acceptance of our product candidates and ability to identify or discover

Forward-looking statements are subject to known

Forward-looking statements are subject to known and unknown risks and uncertainties and are based on our management's potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. While these statements are based upon information available to us as of the filing date of this Annual Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. Actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors discussed in the section of this Annual Report entitled "Risk Factors". Except as may be required by applicable law, we undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this Annual Report or to reflect the occurrence of unanticipated events. You should, however, review the factors and risks we describe in the reports we will file from time to time with the U.S. Securities and Exchange Commission or the SEC, after the date of this Annual Report. iii RISK FACTORS SUMMARY The summary below provides an overview of many of the risks the Company faces, and a more detailed discussion of risks can be found in Item 1A. "Risk Factors" below. You should carefully consider these risks and uncertainties when investing in our securities. The principal risks and uncertainties affecting our business include, but are not limited to, the following: We are a clinical-stage company with limited operating history and have incurred losses since our inception. We anticipate that we will continue to incu

BUSINESS

ITEM 1. BUSINESS Overview We are a clinical stage product discovery company developing products using both natural and engineered phage technologies designed to target and kill specific harmful bacteria associated with chronic diseases, such as cystic fibrosis, or CF and diabetic foot osteomyelitis, or DFO. Bacteriophage or phage are bacterial, species-specific, strain-limited viruses that infect, amplify and kill the target bacteria and are considered inert to mammalian cells. By utilizing proprietary combinations of naturally occurring phage and by creating novel phage using synthetic biology, we develop phage-based therapies intended to address both large-market and orphan diseases. Based on the urgency of treating the infection (whether acute or chronic), the susceptibility of the target bacteria to phage (e.g. the ability to identify a phage cocktail that would target a broad range of bacterial strains) and other considerations, we offer two phage-based product types: (1) Fixed cocktail therapy – in this approach a single product containing a fixed number of selected phages is developed to cover a wide range of bacterial strains, thus allowing treatment of broad patient populations with the same product. Fixed cocktails are developed using our proprietary BOLT platform, in which high throughput screening, directed evolution, and bioinformatic approaches are leveraged to produce an optimal phage cocktail. (2) Personalized therapy – in this approach a large library of phages is developed, of which single optimal phages are personally matched to treat specific patients. Matching optimal phages with patients is carried out using a proprietary phage susceptibility testing, or PST, where multiple considerations are analyzed simultaneously – allowing for an efficient screen of the phage library while maintaining short turnaround times. In our therapeutic programs, we focus on using phage therapy to target specific strains of pathogenic bacteria that are asso

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View this 10-K filing on SEC EDGAR