8-K
BiomX Inc. (PHGE)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the SecuritiesExchange Act of 1934
Date of Report (Date of earliest event reported): August 10, 2022
| BiomX Inc. | ||
|---|---|---|
| (Exact Name of Registrant as Specified in its Charter) | ||
| Delaware | 001-38762 | 82-3364020 |
| --- | --- | --- |
| (State or other jurisdiction<br><br>of incorporation) | (Commission File Number) | (I.R.S. Employer<br><br>Identification No.) |
| 22 Einstein St., Floor 4Ness Ziona, Israel | 7414003 | |
| --- | --- | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s telephone number, including area code:
+972 723942377
| n/a |
|---|
| (Former name or former address, if changed since last report) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange onwhich registered |
|---|---|---|
| Units, each consisting of one share of Common Stock, $0.0001 par value, and one Warrant entitling the holder to receive one half share of Common Stock | PHGE.U | NYSE American |
| Shares of Common Stock, $0.0001 par value | PHGE | NYSE American |
| Warrants, each exercisable for one-half of a share of common stock, $0.0001 par value, at an exercise price of $11.50 per share | PHGE.WS | NYSE American |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 2.02 Results of Operations and Financial Condition.
On August 10, 2022, BiomX Inc., or the Company, issued a press release announcing its financial results for the second quarter ended June 30, 2022. A copy of the press release issued in connection with the announcement is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit | Description |
|---|---|
| 99.1 | Press Release dated August 10, 2022 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL documents) |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| BIOMX INC. | |||
|---|---|---|---|
| August 10, 2022 | By: | /s/ Jonathan Solomon | |
| Name: | Jonathan Solomon | ||
| Title: | Chief Executive Officer |
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Exhibit 99.1
BiomXReports Second Quarter 2022 Financial Results and Provides Business Update
EnrollmentContinues in Phase 1/2 Trial of BX004 for Treatment of Lung Infections in Cystic Fibrosis (“CF”); resultsfrom Part 1 expected by the end of Q3 2022
Enteredinto Second Collaboration with Boehringer Ingelheim to Discover Microbiome Markers for Inflammatory Bowel Disease
AnnouncedPublications in the Journals Cell and Bioinformatics
CashRunway Through Multiple Data Readouts and Extended to at Least Mid-2024
CompanyWill Host a Conference Call and Webcast Today at 8:00 am ET
BRANFORD,Conn. and NESS ZIONA, Israel – Aug 10, 2022 – BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today reported financial results, and provided a business update for the second quarter ended June 30, 2022.
“It has been an eventful quarter for the Company. We enrolled our first patients in our BX004 cystic fibrosis program, expanded our partnering activities, published important research, and successfully restructured our operations to further extend our cash runway,” said Jonathan Solomon, Chief Executive Officer of BiomX. “With the ongoing enrollment of patients in our CF study, we are one step closer towards reaching an important milestone in the BX004 program. Sites have been opening according to plan and, provided that the pace of enrollment for the study will continue as expected, we continue to anticipate a data readout from the first part of the study by the end of the third quarter of 2022. Our recent KOL event also highlighted the unmet medical need that exists today for so many CF patients who require innovative new therapeutic approaches to help combat these persistent and difficult-to-treat lung infections.
“As we enter the second half of 2022, BiomX also remains well positioned financially, with our cash runway now expected to take us through at least mid-2024. Over this period, we expect to reach potential milestones intended to help drive significant shareholder value, and I look forward to sharing additional updates later this year.”
RECENTCORPORATE HIGHLIGHTS
| ● | In<br> June, BiomX announced the dosing of the first two patients in the Company’s Phase 1b/2a<br> study evaluating BX004 for the treatment of chronic respiratory infections in patients with<br> cystic fibrosis. |
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| ● | Also<br> in June, BiomX announced a second partnership with Boehringer Ingelheim to discover inflammatory<br> bowel disease (“IBD”) microbiome markers. BiomX will utilize its XMarker microbiome-based<br> biomarker discovery platform with the goal of identifying biomarkers for a pathogenic bacterium<br> thought to be associated with IBD. Such biomarkers could help identify IBD patients that<br> would benefit from potential therapies targeted at the microbiome. In September 2020, Boehringer<br> Ingelheim and BiomX entered into their first collaboration, which focused on identifying<br> biomarkers associated with patient phenotypes in IBD. |
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| ● | In<br> August, the Company announced the publication of a scientific paper titled “Targeted<br> suppression of human IBD-associated gut microbiota commensals by phage consortia for treatment<br> of intestinal inflammation” in the journal, Cell. The research was conducted<br> across several organizations, including BiomX and the Weizmann Institute of Science (Rehovot,<br> Israel), and presents positive results from a proof-of-concept assessment in a preclinical<br> model of inflammatory bowel disease. The paper is available online at https://www.cell.com/cell/fulltext/S0092-8674(22)00850-9. |
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| ● | On<br> May 12^th^, the Company hosted a Key Opinion Leader Event on BX004 for Treatment<br> of Pseudomonas Aeruginosa (“PsA”) Infections in CF patients. The live webinar<br> featured presentations from Key Opinion Leaders, Dave Nichols, M.D. and Saima Aslam, M.D.,<br> who discussed phage therapy, the current treatment landscape, and the unmet medical need<br> in CF patients with chronic PsA pulmonary infections. The webinar is now available<br> on the Company’s website at https://ir.biomx.com/news-events/ir-calendar/detail/7514/kol-webinar-on-bx004-for-treatment-of-pseudomonas. |
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| ● | Also<br> in May, BiomX announced a corporate restructuring plan intended to extend the Company’s<br> capital resources at least until the middle of 2024. With this plan, the Company reduced<br> its operating costs, which included a reduction in personnel, while prioritizing the ongoing<br> CF program. |
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| ● | Also<br> in May, BiomX announced the publication of a scientific paper titled “Exodus: Sequencing-based<br> Pipeline for Quantification of Pooled Variants” in the journal, Bioinformatics.<br> The research was conducted by scientists at BiomX and is available online at https://doi.org/10.1093/bioinformatics/btac319. |
| --- | --- |
ClinicalProgram Updates
CysticFibrosis (BX004)
| ● | In<br> June, BiomX announced the dosing of the first two patients in the Company’s Phase 1b/2a<br> study evaluating BX004 for the treatment of chronic respiratory infections in patients with<br> CF. |
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| ● | BX004<br> is being developed for the treatment of chronic respiratory infections caused by Pseudomonas aeruginosa, a main contributor to morbidity and mortality in patients with CF. |
| --- | --- |
| ● | The<br> Phase 1b/2a trial is composed of two parts. Part 1 of the study will evaluate the safety,<br> pharmacokinetics, and microbiologic/clinical activity of BX004 in eight CF patients in a<br> single ascending dose and multiple dose design, with results expected by the end of the third<br> quarter of 2022. Part 2 of the study will evaluate the safety and efficacy of BX004 in 24<br> CF patients randomized to a treatment or placebo cohort in a 2:1 ratio. Results from Part<br> 2 are expected in the first quarter of 2023. |
| --- | --- |
| ● | BiomX<br> has received a Therapeutics Development Award of up to $5 million from the Cystic Fibrosis<br> Foundation (“CF Foundation”). The award is structured as an equity investment<br> in which the CF Foundation has agreed to purchase up to $5M million of BiomX common stock<br> across two separate tranches. The first tranche was received on December 21, 2021, with the<br> CF Foundation making an initial equity investment of $3 million. Upon completion of all patient<br> dosing in Part 1 of the Company’s Phase 1b/2a study of BX004, BiomX would have the<br> right to receive the second tranche of $2 million, also as an equity investment. |
| --- | --- |
AtopicDermatitis (BX005)
| ● | In<br> April, the United States Food and Drug Administration (“FDA”) approved the Company’s<br> IND application for BX005, which is being developed for the treatment of moderate to severe<br> atopic dermatitis (“AD”). |
|---|---|
| ● | While<br> the recently announced restructuring is expected to result in a delay to the AD program,<br> the Company plans to support a range of activities that will continue to move this program<br> forward and will provide a more detailed update later in the year. |
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| ● | The<br> Company and Maruho Co. Ltd., a leading dermatology-focused pharmaceutical company in Japan,<br> entered into an agreement in the second half of 2021 granting Maruho a right of first offer<br> to license BX005 in Japan. |
| --- | --- |
| ● | The<br> Company is collaborating with Maruho and working on evaluating timelines for a clinical trial. |
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SecondQuarter 2022 Financial Results
| ● | Cash balance, short-term deposits and restricted cashas<br> of June 30, 2022, were $46.7 million, compared to $63.1 million as of December 31, 2021.<br> The decrease was primarily due to net cash used in operating activities. Based upon the Company’s<br> strategic focus on the CF program, the existing cash and cash equivalents are expected<br> to be sufficient to fund the current operating plan through middle of 2024. |
|---|---|
| ● | Research and development (“R&D”) expenses, netwere<br> $4.6 million for the three months ended June 30, 2022, compared to $3.8 million for the same<br> period in 2021. R&D expenses, net were $9.5 million for six months ended June 30, 2022,<br> as well as for the six months ended June 30, 2021. A decrease in Israel Innovation Authority<br> grants resulted in higher R&D expenses, net, offset by a decrease in salaries and related<br> expenses and stock-based compensation expenses due to a reduction in workforce. An additional<br> offset is due to pauses in the development of BX003, the product candidate for the treatment<br> of IBD and primary sclerosing cholangitis, and the colorectal cancer product candidate, as<br> well as due to the discontinuation of the product candidate, BX001, for the treatment of<br> acne. |
| --- | --- |
| ● | General and administrative expenseswere $2.4 million<br> for the three months ended June 30, 2022, compared to $3.1 million for the same period in<br> 2021. General and administrative expenses were $4.8 million for the six months ended June<br> 30, 2022, compared to $5.6 million for the prior year. The decrease for the six months ended<br> June 30, 2022 was primarily due to a decrease in salaries and related expenses and stock-based<br> compensation expenses due to a reduction in workforce. In addition, the decrease is due to<br> additional expenses incurred in 2021 that resulted from moving into new premises. |
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| ● | Net lossfor the second quarter of 2022 was $7.5<br> million, compared to $7.3 million for the same period in 2021. |
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| ● | Net cash used in operating activities for the<br> six months ended June 30, 2022 was $16.4 million, compared to $12.8 million for the same<br> period in 2021. |
| --- | --- |
ConferenceCall and Webcast Information
BiomX management will host a conference call and webcast today at 8:00 am ET to report financial results and business updates for the second quarter 2022. To participate in the conference, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel), or 1-201-389-0898 (International). A live and archived webcast of the call will be available on the Investors section of the Company’s website at www.biomx.com.
AboutBiomX
BiomX is a clinical-stage microbiome company developing both natural and engineered phage cocktails 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.
Additional information is available at www.biomx.com, the content of which does not form a part of this press release.
SafeHarbor
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 future updates on its CF, AD and other programs, its expectations regarding the opening of sites, pace of enrollment and timing of the results of the CF trial, the potential safety, tolerability and potential treatment effect of its product candidates, the potential to achieve the applicable clinical milestones required to receive an additional $2 million investment from CFF, and its cash runway, capitalization and financial condition, 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. 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. 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 30, 2022 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.
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BIOMXINC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(USD in thousands, except share and per share data)
(unaudited)
| Three Months Ended<br> June 30, | Six Months Ended<br> June 30, | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | 2022 | 2021 | ||||||||
| Research and development (“R&D”) expenses, net | 4,584 | 3,824 | 9,513 | 9,494 | |||||||
| Amortization of intangible assets | 379 | 380 | 759 | 759 | |||||||
| General and administrative expenses | 2,361 | 3,098 | 4,838 | 5,591 | |||||||
| Operating loss | 7,324 | 7,302 | 15,110 | 15,844 | |||||||
| Interest expenses | 488 | - | 949 | - | |||||||
| Financial expenses (income), net | (339 | ) | 31 | (426 | ) | (112 | ) | ||||
| Loss before tax | 7,473 | 7,333 | 15,633 | 15,732 | |||||||
| Tax expenses | 9 | 3 | 18 | 6 | |||||||
| Net loss | 7,482 | 7,336 | 15,651 | 15,738 | |||||||
| Basic and diluted loss per share of Common Stock | 0.25 | 0.30 | 0.53 | 0.65 | |||||||
| Weighted average number of shares of Common Stock outstanding, basic and diluted | 29,774,709 | 24,320,259 | 29,764,588 | 24,134,065 |
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BIOMXINC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(USD in thousands, except share and per share data)
(unaudited)
| December 31, <br> 2021 | |||||
| ASSETS | |||||
| Current assets | |||||
| Cash and cash equivalents | 37,745 | 62,099 | |||
| Restricted cash | 963 | 996 | |||
| Short-term deposits | 8,000 | - | |||
| Other current assets | 1,605 | 3,543 | |||
| Total current assets | 48,313 | 66,638 | |||
| Property and equipment, net | 5,252 | 5,694 | |||
| Intangible assets, net | 760 | 1,519 | |||
| Operating lease right-of-use assets | 4,057 | 4,139 | |||
| Total non-current assets | 10,069 | 11,352 | |||
| 58,382 | 77,990 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
| Current liabilities | |||||
| Trade accounts payable | 1,656 | 2,795 | |||
| Other accounts payable | 2,394 | 5,453 | |||
| Contract liability | - | 1,976 | |||
| Current portion of operating lease liabilities | 708 | 819 | |||
| Current portion of long-term debt | 1,732 | - | |||
| Total current liabilities | 6,490 | 11,043 | |||
| Non-current liabilities | |||||
| Contract liability | 1,976 | - | |||
| Long-term debt, net of current portion | 12,929 | 14,410 | |||
| Operating lease liabilities, net of current portion | 4,039 | 4,787 | |||
| Other liabilities | 209 | 215 | |||
| Total non-current liabilities | 19,153 | 19,412 | |||
| Stockholders’ equity | |||||
| Preferred Stock, 0.0001 par value; Authorized - 1,000,000 shares as of June 30, 2022 and December 31, 2021. No shares issued and outstanding as of June 30, 2022 and December 31, 2021. | - | - | |||
| Common Stock, 0.0001 par value; Authorized - 60,000,000 shares as of June 30, 2022 and December 31, 2021. Issued – 29,780,409 shares as of June 30, 2022 and 29,753,238 shares as of December 31, 2021. Outstanding – 29,774,709 shares as of June 30, 2022 and 29,747,538 shares as of December 31, 2021. | 2 | 2 | |||
| Additional paid in capital | 156,872 | 156,017 | |||
| Accumulated deficit | (124,135 | ) | (108,484 | ) | |
| Total stockholders’ equity | 32,739 | 47,535 | |||
| 58,382 | 77,990 |
All values are in US Dollars.
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BiomXContacts:
Investor Relations:
LifeSci Advisors, LLC
John Mullaly
(617)-698-9253
jmullaly@lifesciadvisors.com
BiomX, Inc.
Anat Primovich
Corporate Project Manager
+972 (50) 697-7228
anatp@biomx.com
Source: BiomX Inc.
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