[Filing Information](index=1&type=section&id=Filing%20Information) [Company Details](index=1&type=section&id=Company%20Details) BiomX Inc. is a Delaware-incorporated company with its principal executive offices in Ness Ziona, Israel. It is registered under Commission file number 001-38762 - BiomX Inc. is incorporated in Delaware with its principal executive offices located at 22 Einstein St., 5th Floor, Ness Ziona, Israel[3](index=3&type=chunk) [Securities Information](index=1&type=section&id=Securities%20Information) The company's securities, including Units, Common Stock, and Warrants, are registered and traded on the NYSE American under the symbols PHGE.U, PHGE, and PHGE.WS, respectively | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Units | PHGE.U | NYSE American | | Common stock | PHGE | NYSE American | | Warrants | PHGE.WS | NYSE American | [Filer Status](index=1&type=section&id=Filer%20Status) BiomX Inc. is classified as a non-accelerated filer, a smaller reporting company, and an emerging growth company. It has elected not to use the extended transition period for new accounting standards and is not a shell company | Filer Status | Selection | | :------------------------ | :-------- | | Large accelerated filer | ☐ | | Accelerated filer | ☐ | | Non-accelerated filer | ☒ | | Smaller reporting company | ☒ | | Emerging growth company | ☒ | - The registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards[5](index=5&type=chunk) - The registrant is not a shell company[5](index=5&type=chunk) [Shares Outstanding](index=1&type=section&id=Shares%20Outstanding) As of May 20, 2021, BiomX Inc. had 24,326,719 shares of common stock issued and outstanding - As of May 20, 2021, **24,326,719 shares** of common stock, par value $0.0001 per share, were issued and outstanding[5](index=5&type=chunk) [Cautionary Statement Regarding Forward-Looking Information](index=4&type=section&id=CAUTIONARY%20STATEMENT%20REGARDING%20FORWARD-LOOKING%20INFORMATION) [Nature of Forward-Looking Statements](index=4&type=section&id=Nature%20of%20Forward-Looking%20Statements) This report contains forward-looking statements, identified by words like 'anticipate,' 'expect,' or 'will,' pertaining to operations, financial position, business strategy, and clinical development. These statements are not guarantees of performance and are subject to various risks and uncertainties - This quarterly report includes 'forward-looking statements' concerning operations, cash flows, financial position, business strategy, clinical and pre-clinical development programs, and the potential impact of COVID-19[9](index=9&type=chunk) - These statements are not guarantees of performance and are subject to risks, uncertainties, and other important factors that could cause actual results to differ materially[9](index=9&type=chunk) [Key Risk Factors](index=4&type=section&id=Key%20Risk%20Factors) Significant risks include the ability to generate revenue and secure financing, unpredictable costs of phage technology development, the ongoing impact of COVID-19, regulatory challenges for product candidates, market acceptance, manufacturing delays, competition, intellectual property protection, and geopolitical instability in Israel - Key risks include the ability to generate revenues and raise sufficient financing, unpredictable timing and cost of phage technology development, and the continued impact of COVID-19 on operations and capital raising[10](index=10&type=chunk) - Other risks involve FDA classification of product candidates (e.g., BX001), obtaining regulatory approvals, market acceptance, ability to obtain high titers for phage cocktails, availability of raw materials, and the safety and efficacy of product candidates[10](index=10&type=chunk) - Additional factors include competition, unfavorable pricing regulations, intellectual property protection, reliance on third-party collaborators, business growth management, attracting key employees, compliance with laws, potential security breaches, and political instability in Israel[12](index=12&type=chunk) [Part I. Financial Information](index=6&type=section&id=Part%20I.%20Financial%20Information) [Item 1. Financial Statements](index=13&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for BiomX Inc., including balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed notes explaining significant accounting policies, commitments, and recent events [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheets show a slight decrease in total assets and stockholders' equity from December 31, 2020, to March 31, 2021, primarily driven by a net loss, despite an increase in cash and cash equivalents | Metric (USD in thousands) | March 31, 2021 | December 31, 2020 | Change | | :------------------------ | :------------- | :---------------- | :----- | | Cash and cash equivalents | 39,411 | 36,477 | +2,934 | | Short-term deposits | 13,205 | 19,851 | -6,646 | | Total current assets | 56,535 | 60,667 | -4,132 | | Total assets | 67,062 | 70,363 | -3,301 | | Total current liabilities | 7,798 | 7,161 | +637 | | Total liabilities | 13,108 | 12,894 | +214 | | Total stockholders' equity| 53,954 | 57,469 | -3,515 | [Condensed Consolidated Statements of Operations](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2021, the company reported an increased net loss of $8.4 million, up from $5.9 million in the prior year, primarily due to higher R&D and general and administrative expenses | Metric (USD in thousands) | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | Change (YoY) | | :------------------------ | :-------------------------------- | :-------------------------------- | :----------- | | R&D expenses, net | 5,794 | 3,529 | +2,265 | | General and administrative expenses | 2,497 | 2,058 | +439 | | Operating loss | 8,670 | 5,966 | +2,704 | | Net loss | 8,402 | 5,901 | +2,501 | | Basic and diluted loss per share | 0.35 | 0.26 | +0.09 | [Condensed Consolidated Statements of Stockholders' Equity](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased from $57.469 million at January 1, 2021, to $53.954 million at March 31, 2021, mainly due to a net loss of $8.402 million, partially offset by proceeds from common stock issuance and stock-based compensation | Metric (USD in thousands) | January 1, 2021 | March 31, 2021 | Change | | :------------------------ | :-------------- | :------------- | :----- | | Total Stockholders' Equity| 57,469 | 53,954 | -3,515 | | Net loss | N/A | (8,402) | N/A |\ | Issuance of Common Stock under Open Market Sales Agreement | N/A | 4,334 | N/A | | Stock-based compensation expenses | N/A | 530 | N/A | [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the three months ended March 31, 2021, net cash used in operating activities decreased to $6.352 million from $6.850 million in the prior year. Investing activities provided $5.168 million, primarily from short-term deposit liquidations, while financing activities provided $4.357 million, mainly from common stock issuance | Metric (USD in thousands) | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | Change (YoY) | | :------------------------ | :-------------------------------- | :-------------------------------- | :----------- | | Net cash used in operating activities | (6,352) | (6,850) | +498 | | Net cash provided by (used in) investing activities | 5,168 | (329) | +5,497 | | Net cash provided by financing activities | 4,357 | 31 | +4,326 | | Net increase (decrease) in cash and cash equivalents and restricted cash | 3,173 | (7,148) | +10,321 | [Notes to Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed explanations for the condensed consolidated financial statements, covering general company information, significant accounting policies, subsidiary acquisition details, commitments, contingent considerations, stockholders' equity, loss per share calculations, and subsequent events [NOTE 1 – GENERAL](index=13&type=section&id=NOTE%201%20%E2%80%93%20GENERAL) BiomX Inc. was incorporated in 2017 as a blank check company, later renamed in 2019 after acquiring BiomX Israel Ltd. The company has not generated revenue and expects continued losses, funding operations through future debt/equity issuances and grants - BiomX Inc. was formed in 2017 as a blank check company, renamed in October 2019 after a reverse merger with BiomX Israel Ltd., and its shares began trading on NYSE American and Tel-Aviv Stock Exchange[41](index=41&type=chunk)[42](index=42&type=chunk)[43](index=43&type=chunk) - The company has not generated revenue from operations to date and expects to incur additional losses, planning to fund future operations through debt/equity issuances and grants from the Israel Innovation Authority (IIA)[44](index=44&type=chunk)[45](index=45&type=chunk) | Metric (USD in thousands) | March 31, 2021 | | :------------------------ | :------------- | | Cash and cash equivalents and restricted cash | 40,387 | | Short-term deposits | 13,205 | [NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES](index=14&type=section&id=NOTE%202%20%E2%80%93%20SIGNIFICANT%20ACCOUNTING%20POLICIES) The financial statements are unaudited and prepared in accordance with U.S. GAAP, relying on management estimates. The company consolidates its subsidiaries and has adopted certain accounting standards, with no significant impact expected from recent ASUs. It also details fair value measurements and derivative activities for hedging currency exposure - The unaudited condensed consolidated financial statements are prepared under U.S. GAAP, involve management estimates, and consolidate the company's subsidiaries[48](index=48&type=chunk)[50](index=50&type=chunk)[51](index=51&type=chunk) - The company uses foreign exchange contracts (options and forwards) to hedge currency exposure, with approximately **$5.219 million** in outstanding contracts as of March 31, 2021, compared to none as of March 31, 2020[55](index=55&type=chunk) | Fair Value Hierarchy (USD in thousands) | Level 1 | Level 2 | Level 3 | Fair Value | | :-------------------------------------- | :------ | :------ | :------ | :--------- | | **March 31, 2021** | | | | | | Assets: Money market funds | 30,000 | - | - | 30,000 | | Liabilities: Contingent considerations | - | - | 572 | 572 | | **December 31, 2020** | | | | | | Assets: Money market funds | 30,000 | - | - | 30,000 | | Liabilities: Contingent considerations | - | - | 701 | 701 | [NOTE 3 – ACQUISITION OF SUBSIDIARY](index=16&type=section&id=NOTE%203%20%E2%80%93%20ACQUISITION%20OF%20SUBSIDIARY) In November 2017, BiomX Israel acquired RondinX Ltd. for $4.5 million, including shares, warrants, and contingent consideration tied to future clinical, regulatory, and commercial milestones. The contingent consideration is accounted for at fair value (Level 3) - BiomX Israel acquired RondinX Ltd. in November 2017 for **$4.5 million**, which included the issuance of Preferred A Shares, warrants, and contingent consideration[62](index=62&type=chunk) - Contingent consideration is based on achieving future clinical, developmental, regulatory, commercial, and strategic milestones, potentially requiring the issuance of **567,729 shares** of Common Stock and/or cash payments up to **$32 million**[62](index=62&type=chunk) | Metric (USD in thousands) | March 31, 2021 | December 31, 2020 | | :------------------------ | :------------- | :---------------- | | Contingent consideration liability | 79 | 83 | [NOTE 4 – COMMITMENTS AND CONTINGENT CONSIDERATIONS](index=18&type=section&id=NOTE%204%20%E2%80%93%20COMMITMENTS%20AND%20CONTINGENT%20CONSIDERATIONS) The company has received and been approved for grants from the Israel Innovation Authority (IIA) for R&D programs, totaling $2.691 million received through March 31, 2021, with a contingent obligation of $3.338 million. Repayment is contingent on successful R&D and sales generation. BiomX Israel also has a research collaboration agreement with Boehringer Ingelheim for IBD biomarker discovery, with $300,000 received as of March 31, 2021 - The IIA approved new applications in March 2021 for a total budget of approximately **$5.874 million**, with a **30%** funding commitment[68](index=68&type=chunk) - Repayment of IIA grants is contingent on successful R&D programs and generating sales; no liability was recorded as of March 31, 2021, as no sales have been generated[69](index=69&type=chunk) | IIA Grant Information (USD in thousands) | Through March 31, 2021 | | :--------------------------------------- | :--------------------- | | Total grants approved | 6,212 | | Aggregate amount received | 2,691 | | Contingent obligation | 3,338 | - BiomX Israel entered a research collaboration with Boehringer Ingelheim for IBD biomarker discovery, eligible to receive **$439,000** in fees, with **$300,000** received as of March 31, 2021[74](index=74&type=chunk) [NOTE 5 – STOCKHOLDERS EQUITY](index=19&type=section&id=NOTE%205%20%E2%80%93%20STOCKHOLDERS%20EQUITY) The company has an "At-the-market Sales Agreement" (ATM Agreement) with Jefferies LLC, under which it sold 601,674 shares for $4.334 million net proceeds during Q1 2021. The 2019 incentive plan allows for automatic annual increases in available shares, with 985,530 options granted in March 2021. Warrants to Yeda Research and Development Company Limited were exercised on a cashless basis, resulting in 362,383 common shares issued, and other warrants were cancelled - Under the ATM Agreement, the company sold **601,674 shares** of Common Stock for approximately **$4.334 million** net proceeds during the three months ended March 31, 2021[75](index=75&type=chunk) - The 2019 incentive plan automatically increases available shares annually; on March 30, 2021, **985,530 options** were granted to employees, consultants, and directors at an exercise price of **$7.02 per share**, with a four-year vesting period[77](index=77&type=chunk)[78](index=78&type=chunk) - On March 10, 2021, Yeda exercised **362,444 warrants** on a cashless basis, resulting in the issuance of **362,383 shares** of Common Stock, while other warrants were cancelled[83](index=83&type=chunk) | Stock-based Compensation Expenses (USD in thousands) | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :------------------------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development expenses, net | 331 | 192 | | General and administrative | 199 | 145 | | **Total** | **530** | **337** | [NOTE 6 – BASIC AND DILUTED LOSS PER SHARE](index=22&type=section&id=NOTE%206%20%E2%80%93%20BASIC%20AND%20DILUTED%20LOSS%20PER%20SHARE) The basic and diluted loss per share for the three months ended March 31, 2021, was $0.35, compared to $0.26 for the same period in 2020, reflecting the increased net loss | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :----- | :-------------------------------- | :-------------------------------- | | Net loss | 8,402 | 5,901 | | Net loss per share | 0.35 | 0.26 | | Weighted average number of shares of Common Stock | 23,944,573 | 22,897,723 | [NOTE 7 – SUBSEQUENT EVENTS](index=22&type=section&id=NOTE%207%20%E2%80%93%20SUBSEQUENT%20EVENTS) Subsequent to March 31, 2021, BiomX Israel received additional funds from IIA approved programs ($992,000 in April 2021 and $625,000 in May 2021). The company also issued an additional 79,679 shares of Common Stock under the ATM Agreement for $503,000 net proceeds between April 1 and May 20, 2021 - In April and May 2021, BiomX Israel received an additional **$992,000** and **$625,000**, respectively, from IIA approved programs[93](index=93&type=chunk) - From April 1, 2021, to May 20, 2021, the company issued **79,679 shares** of Common Stock under the ATM Agreement, generating **$503,000** in net proceeds[93](index=93&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and operational results, including an overview of its clinical-stage development, updates on product candidates, the impact of COVID-19, detailed analysis of consolidated results, liquidity, capital resources, and future outlook [General Business Overview](index=23&type=section&id=General%20Business%20Overview) BiomX is a clinical-stage microbiome product discovery company developing phage technologies to target harmful bacteria in skin conditions (acne) and chronic diseases (IBD, CF, AD, PSC, CRC). The proprietary BOLT platform enables agile development of natural or engineered phage cocktails, pursuing both personalized and broad-population approaches - BiomX is a clinical-stage company developing natural and engineered phage technologies to target bacteria in acne-prone skin and chronic diseases like IBD, CF, AD, PSC, and CRC[96](index=96&type=chunk) - The company utilizes its proprietary BacteriOphage Lead to Treatment (BOLT) platform for agile and efficient development of phage cocktails, supporting both personalized and optimized fixed-cocktail approaches[98](index=98&type=chunk)[99](index=99&type=chunk)[100](index=100&type=chunk) - Since inception in 2015, the company has focused on R&D, capital raising, and intellectual property, and has not generated revenue from product sales, expecting expenses to increase as product candidates advance[97](index=97&type=chunk) [Clinical and Pre-Clinical Developments](index=24&type=section&id=Clinical%20and%20Pre-Clinical%20Developments) BiomX provided updates on its clinical and pre-clinical programs: BX001 (acne) completed Phase 2 enrollment with results expected in Q3/Q4 2021; BX002 (IBD/PSC) showed positive Phase 1a safety and tolerability, leading to a consolidated BX003 program for both indications with Phase 1b/2a results expected in Q2 2022; BX004 (CF) selected its phage cocktail, with Phase 1b/2a results expected in Q1/Q2 2022; BX005 (Atopic Dermatitis) selected its phage cocktail, with Phase 2 results expected in H1 2022; and the CRC program expects preclinical animal study results in Q2/Q3 2021 [BX001 (Acne)](index=24&type=section&id=BX001%20(Acne)) The Phase 2 cosmetic clinical study for BX001, targeting C. acnes for acne-prone skin, completed enrollment of 140 patients. Results from the 8-week time point are expected in Q3 2021, and full 12-week analysis in Q4 2021 - Enrollment for the Phase 2 cosmetic clinical study of BX001 (topical gel for acne-prone skin) was completed with **140 patients**[101](index=101&type=chunk) - Key endpoints for the BX001 study are safety, tolerability, and efficacy, with **8-week** results anticipated in Q3 2021 and full **12-week** analysis in Q4 2021[101](index=101&type=chunk) [BX002/BX003 (IBD and PSC)](index=24&type=section&id=BX002%2FBX003%20(IBD%20and%20PSC)) Positive Phase 1a results for BX002 (IBD/PSC) demonstrated safety, tolerability, and successful delivery of high concentrations of viable phage to the GI tract. The IBD and PSC programs have been consolidated into a single product candidate, BX003, targeting K. pneumoniae, with Phase 1b/2a study results expected in Q2 2022 - Phase 1a study of BX002 for IBD and PSC showed positive safety and tolerability, with no serious adverse events, and successfully delivered high concentrations of viable phage (approximately **10 PFU**) to the gastrointestinal tract[102](index=102&type=chunk) - The IBD and PSC programs were consolidated into a single product candidate, BX003, targeting Klebsiella pneumoniae, with Phase 1b/2a study results expected in Q2 2022[103](index=103&type=chunk)[102](index=102&type=chunk) [BX004 (Cystic Fibrosis)](index=24&type=section&id=BX004%20(Cystic%20Fibrosis)) The phage cocktail for BX004, targeting Pseudomonas aeruginosa for chronic respiratory infections in CF patients, has been selected. The Phase 2 study design is being updated to a Phase 1b/2a trial, with Part 1 results (safety, PK, microbiologic/clinical activity) expected in Q1 2022 and Part 2 results (safety and efficacy) by Q2 2022 - The phage cocktail for BX004, targeting Pseudomonas aeruginosa in Cystic Fibrosis patients, has been selected[104](index=104&type=chunk) - The BX004 program is advancing to a Phase 1b/2a trial in CF patients, with Part 1 results expected in Q1 2022 and Part 2 results by Q2 2022[104](index=104&type=chunk) [BX005 (Atopic Dermatitis)](index=25&type=section&id=BX005%20(Atopic%20Dermatitis)) The phage cocktail for BX005, targeting Staphylococcus aureus to reduce inflammation in atopic dermatitis, has been selected. Results from a Phase 2 proof-of-concept trial evaluating safety and efficacy are expected in the first half of 2022 - The phage cocktail for BX005, targeting Staphylococcus aureus for atopic dermatitis, has been selected[106](index=106&type=chunk) - Results from a Phase 2 proof-of-concept trial for BX005 are expected in the first half of 2022, evaluating safety and efficacy in atopic dermatitis patients[106](index=106&type=chunk) [Colorectal Cancer (CRC) Program](index=25&type=section&id=Colorectal%20Cancer%20(CRC)%20Program) For the CRC program, BiomX is exploring phage-mediated delivery of therapeutic payloads to Fusobacterium nucleatum bacteria in colorectal cancer tumors. Preclinical results from animal studies evaluating phage therapy with checkpoint inhibitors are expected in Q2 and Q3 2021 - The CRC program is investigating phage-mediated delivery of therapeutic payloads to Fusobacterium nucleatum in colorectal cancer tumors[107](index=107&type=chunk) - Preclinical results from animal studies combining phage therapy with checkpoint inhibitors are anticipated in Q2 and Q3 2021[107](index=107&type=chunk) [Impact of COVID-19](index=25&type=section&id=Impact%20of%20COVID-19) While COVID-19 has not materially impacted results of operations as of May 20, 2021, uncertainty remains regarding its future effects on R&D activities and clinical trial enrollment. The company has implemented safety measures and updated clinical milestone guidance due to pandemic-related challenges - As of May 20, 2021, COVID-19 has not had a material impact on the company's results of operations[110](index=110&type=chunk) - Uncertainty persists regarding the potential future impact of COVID-19 on R&D activities and clinical trial enrollment, leading to updated guidance on the timing of certain clinical milestones[110](index=110&type=chunk) - The company has implemented mandatory and recommended measures to safeguard employees and clinical trial participants, including social distancing and remote work[110](index=110&type=chunk) [Consolidated Results of Operations (Three Months Ended March 31, 2021 and 2020)](index=26&type=section&id=Consolidated%20Results%20of%20Operations%20(Three%20Months%20Ended%20March%2031%2C%202021%20and%202020)) The company experienced a significant increase in operating loss and net loss for Q1 2021 compared to Q1 2020, driven by higher R&D and general and administrative expenses. Financial income also saw a substantial increase [R&D Expenses, Net](index=26&type=section&id=R%26D%20Expenses%2C%20Net) R&D expenses, net, increased by $2.2 million (61%) to $5.8 million for Q1 2021, primarily due to higher stock-based compensation, salaries, and expenses related to preclinical and clinical trials, reflecting growth in R&D employees and activities | Metric (USD in thousands) | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | Change (YoY) | | :------------------------ | :-------------------------------- | :-------------------------------- | :----------- | | R&D expenses, net | 5,794 | 3,529 | +2,265 (61%) | - The increase in R&D expenses is primarily attributed to higher stock-based compensation, salaries, and expenses for preclinical and clinical trials, driven by growth in R&D employee count and activities[112](index=112&type=chunk) [General and Administrative Expenses](index=26&type=section&id=General%20and%20Administrative%20Expenses) General and administrative expenses rose by $0.4 million (19%) to $2.5 million for Q1 2021, mainly due to increased stock-based compensation, salaries, and costs associated with operating as a public company | Metric (USD in thousands) | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | Change (YoY) | | :------------------------ | :-------------------------------- | :-------------------------------- | :----------- | | General and administrative expenses | 2,497 | 2,058 | +439 (19%) | - The increase in G&A expenses is primarily due to higher stock-based compensation, salaries, and expenses related to operating as a public company, including directors' and officers' insurance[113](index=113&type=chunk) [Financial Income, Net](index=26&type=section&id=Financial%20Income%2C%20Net) Net financial income increased significantly by $0.2 million (328%) to $0.3 million for Q1 2021, primarily due to USD/NIS exchange rate differences and revaluation of contingent considerations, partially offset by lower interest rates | Metric (USD in thousands) | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | Change (YoY) | | :------------------------ | :-------------------------------- | :-------------------------------- | :----------- | | Financial income, net | (271) | (65) | +206 (328%) | - The substantial increase in financial income is mainly due to favorable USD/NIS exchange rate differences and the revaluation of contingent considerations, despite a decrease in interest rates on bank deposits[114](index=114&type=chunk) [Basic and Diluted Loss Per Share](index=26&type=section&id=Basic%20and%20Diluted%20Loss%20Per%20Share) Basic and diluted loss per share increased by $0.09 (35%) to $0.35 for Q1 2021, reflecting the higher net loss primarily driven by increased R&D expenses | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :----- | :-------------------------------- | :-------------------------------- | | Basic and diluted loss per share | 0.35 | 0.26 | | Weighted average number of shares of Common Stock | 23,944,573 | 22,897,723 | - The increase in loss per share is primarily due to the higher net loss, which was mainly caused by increased R&D expenses[115](index=115&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) The company believes its current cash and cash equivalents are sufficient until at least mid-2022. It anticipates needing additional funds for operations and development, planning to raise capital through equity/debt financings or collaborative agreements, including its ATM Agreement - Current liquidity (cash, cash equivalents, and short-term deposits) is expected to fund operations until at least mid-2022[116](index=116&type=chunk) - Additional funds will likely be required for future operating expenses, capital requirements, or acquisitions, to be raised through public/private equity or debt financings, collaborative agreements, or the ATM Agreement[116](index=116&type=chunk) [Cash Flows Analysis](index=27&type=section&id=Cash%20Flows%20Analysis) Net cash used in operating activities decreased to $6.4 million in Q1 2021 from $6.8 million in Q1 2020. Investing activities provided $5.2 million in Q1 2021 (vs. used $0.3 million in Q1 2020) due to short-term deposit liquidations. Financing activities provided $4.4 million in Q1 2021 (vs. $0.03 million in Q1 2020) primarily from common stock issuance under the ATM Agreement | Cash Flow Activity (USD in thousands) | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | Change (YoY) | | :------------------------------------ | :-------------------------------- | :-------------------------------- | :----------- | | Net cash used in operating activities | (6,352) | (6,850) | +498 | | Net cash provided by (used in) investing activities | 5,168 | (329) | +5,497 | | Net cash provided by financing activities | 4,357 | 31 | +4,326 | | Net increase (decrease) in cash and cash equivalents and restricted cash | 3,173 | (7,148) | +10,321 | - Operating cash outflow decreased due to a net loss offset by changes in operating assets and liabilities, including depreciation, amortization, and stock-based compensation[118](index=118&type=chunk) - Investing cash inflow was primarily from the liquidation of short-term deposits, partially offset by property and equipment purchases[120](index=120&type=chunk) - Financing cash inflow was mainly from the issuance of Common Stock under the Open Market Sales Agreement[122](index=122&type=chunk) [Outlook](index=29&type=section&id=Outlook) The company has an accumulated deficit of $80.6 million and does not expect significant revenue in the next twelve months. Existing liquidity is projected to fund operations until at least mid-2022. Future funding will be sought through equity, debt, and grants to support ongoing R&D and new product candidates - The company has an accumulated deficit of **$80.6 million** and anticipates continued losses without significant revenue generation in the next twelve months[125](index=125&type=chunk)[126](index=126&type=chunk) - Current liquidity (cash, cash equivalents, restricted cash of **$40.4 million**, and short-term deposits of **$13.2 million**) is estimated to fund operations until at least mid-2022[125](index=125&type=chunk) - Future funding for operations and development will rely on equity issuances (including the ATM Agreement), debt, and potential grants from the IIA or other institutions, subject to market demand and favorable terms[126](index=126&type=chunk) [Off-Balance Sheet Arrangements](index=29&type=section&id=Off-Balance%20Sheet%20Arrangements) As of March 31, 2021, the company had no off-balance sheet arrangements. It uses forward and option contracts to hedge against foreign exchange risk for NIS-denominated expenses, with approximately $5.2 million in outstanding contracts - As of March 31, 2021, the company had no off-balance sheet arrangements[127](index=127&type=chunk) - The company uses foreign exchange contracts (forward and option) to hedge NIS-denominated expenses, with approximately **$5.2 million** in outstanding contracts as of March 31, 2021[127](index=127&type=chunk)[128](index=128&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, BiomX Inc. is not required to provide disclosures under this item - As a smaller reporting company, BiomX Inc. is exempt from providing quantitative and qualitative disclosures about market risk[129](index=129&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the effectiveness of disclosure controls and procedures as of March 31, 2021, and concluded they were effective. There have been no material changes in internal control over financial reporting during the quarter [Evaluation of Disclosure Controls and Procedures](index=29&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management, with the participation of the principal executive and financial officers, concluded that the company's disclosure controls and procedures were effective as of March 31, 2021 - Management, including the CEO and CFO, evaluated the effectiveness of disclosure controls and procedures and concluded they were effective as of March 31, 2021[131](index=131&type=chunk) [Changes in Internal Control over Financial Reporting](index=29&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) There were no changes in internal control over financial reporting during the three months ended March 31, 2021, that materially affected or are reasonably likely to materially affect the company's internal control over financial reporting - No material changes in internal control over financial reporting occurred during the three months ended March 31, 2021[132](index=132&type=chunk) [Part II. Other Information](index=30&type=section&id=Part%20II.%20Other%20Information) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) On March 10, 2021, Yeda Research and Development Company Limited exercised 362,444 warrants on a cashless basis, resulting in the issuance of 362,383 shares of Common Stock, exempt from registration under Section 4(a)(2) of the Securities Act - Yeda Research and Development Company Limited exercised **362,444 warrants** on a cashless basis on March 10, 2021, receiving **362,383 shares** of Common Stock[134](index=134&type=chunk) - The issuance of these warrant shares was exempt from registration under Section 4(a)(2) of the Securities Act of 1933[134](index=134&type=chunk) [Item 6. Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents (Certificate of Incorporation, Bylaws), certifications from executive officers (Rule 13a-14, 18 U.S.C. Section 1350), and XBRL taxonomy documents - The exhibits include corporate governance documents (Amended and Restated Certificate of Incorporation, Bylaws), certifications from the Principal Executive Officer and Principal Financial Officer, and XBRL instance and taxonomy documents[135](index=135&type=chunk) [Part III. Signatures](index=31&type=section&id=Part%20III.%20Signatures) [Report Signatures](index=31&type=section&id=Report%20Signatures) The report was officially signed on May 24, 2021, by Jonathan Solomon, Chief Executive Officer, and Marina Wolfson, Senior Vice President of Finance and Operations, on behalf of BiomX Inc - The report was signed by Jonathan Solomon, CEO, and Marina Wolfson, SVP of Finance and Operations, on May 24, 2021[141](index=141&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission file number: 0001-38762 BIOMX INC. (Exact name of registrant as specified in its charter) | Delaware | 82-3364020 | | --- | --- | | (State or othe ...

Financial Data and Key Metrics Changes - Cash balance and short-term deposits as of December 31, 2020, were $57.1 million, down from $82.4 million as of December 31, 2019 [34] - Research and development expenses increased to $21 million in 2020 from $13.5 million in 2019, primarily due to growth in employee numbers and clinical trial manufacturing [34] - General and administrative expenses rose to $9.3 million in 2020 from $8.7 million in 2019, attributed to costs associated with operating as a public company [35] - Net loss for 2020 was $30.1 million compared to $20.6 million in 2019, with net cash used in operating activities at $24.4 million for 2020, up from $17.6 million in 2019 [36] Business Line Data and Key Metrics Changes - The company added two new programs to its pipeline in 2020: atopic dermatitis and cystic fibrosis, alongside positive Phase 1 data for its lead program in acne-prone skin [7][31] - The BOLT platform has enabled rapid development and formulation of phage therapy candidates, with four meaningful clinical data readouts expected within the next 15 months [9][12] Market Data and Key Metrics Changes - The microbiome space has seen significant momentum, with many companies researching its effects on various diseases, indicating a growing market opportunity for BiomX's unique phage therapy approach [11] Company Strategy and Development Direction - BiomX aims to become a leader in microbiome health by utilizing phage therapy to target and eliminate pathogenic bacteria while preserving beneficial bacteria [30] - The company is focused on advancing its pipeline with multiple clinical readouts expected, including Phase 2 studies in acne-prone skin, cystic fibrosis, and atopic dermatitis [10][21][27] Management's Comments on Operating Environment and Future Outlook - Management expressed pride in the company's progress despite COVID-19 challenges, highlighting the dedication of the research and development team [8] - The company anticipates a busy and productive 15 months ahead, with significant clinical data readouts expected [9][32] Other Important Information - The BOLT platform's capabilities include computational biology, microbiology, and synthetic engineering, which have been crucial for the rapid development of the company's pipeline [12][13] Q&A Session Summary Question: Inquiry about the BOLT platform and specific candidates - Management confirmed that hundreds of candidates were screened for BX004 and BX005, leading to the selection of the most promising cocktails based on their host range and clinical outcome parameters [38] Question: Data expectations from the cystic fibrosis study - The primary endpoint will focus on safety and tolerability, with exploratory endpoints assessing the reduction of bacterial burden and improvements in lung function and quality of life [40][41] Question: Insights from Phase 1a data of BX002 - Key outcomes included the ability to deliver high levels of phage to the GI tract and confidence in the therapeutic window, with phage levels significantly exceeding target bacteria levels [45][46] Question: Future plans for the colorectal cancer program - Management expressed excitement about the potential of the colorectal cancer program, emphasizing its unique approach and the possibility of partnerships for future applications [72][75]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38762 BiomX Inc. (Exact Name of Registrant as Specified in Its Charter) | Delaware | 82-3364020 | | --- | --- | | (State or ot ...

| --- | --- | --- | --- | |--------------------------------|-------|-------|-------| | | | | | | Company Overview November 2020 | | | | | | | | | Safe Harbor Statement 2 This presentation contains certain "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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38762 BiomX Inc. (Exact Name of Registrant as Specified in Its Charter) | Delaware | 82-3364020 | | --- | --- | | (State or other j ...

BiomX Inc. (NYSE:PHGE) Q2 2020 Earnings Conference Call August 13, 2020 8:00 AM ET Company Participants Marina Wolfson - VP Finance & Operations Jonathan Eitan Solomon - CEO and Board Member Dr. Sailaja Puttagunta - CMO Conference Call Participants Kristen Kluska - Cantor Fitzgerald Keay Nakae - Chardan Capital Markets Operator Hello, and welcome to the BiomX Second Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] As a reminder, this co ...

BiomX Corporate Presentation August 2020 Safe Harbor Statement 2 This presentation contains certain "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 stateme ...

BiomX Company Introduction Safe Harbor Statement 2 This presentation contains certain "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 histori ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarter ended March 31, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38762 BiomX Inc. (Exact Name of Registrant as Specified in Its Charter) | Delaware | 82-3364020 | | --- | --- | | (State or other jurisdict ...