HLSQ 8-K
Tessera Defense & Homeland Security Inc. (HLSQ)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 24, 2021
| BiomX Inc. | ||
| (Exact Name of Registrant as Specified in its Charter) |
| Delaware | 0001-38762 | 82-3364020 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) | (I.R.S. Employer Identification No.) |
| 22
Einstein St., Floor 5 Ness Ziona, Israel |
7414002 | |
| (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)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name
of each exchange on which 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, included as part of the Units | PHGE | NYSE American | ||
| Warrants included as part of the Units | 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 May 24, 2021, BiomX Inc., or the Company, issued a press release announcing its financial results for the first quarter ended March 31, 2021. 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 7.01 Regulation FD Disclosure.
The Company from time to time presents and/or distributes to the investment community at various industry and other conferences slide presentations to provide updates and summaries of its business. On May 24, 2021, the Company posted an updated corporate slide presentation in the “Investors” portion of its website at www.biomx.com. A copy of the slide presentation is furnished pursuant to Item 7.01 as Exhibit 99.2 hereto. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit | Description | |
| 99.1 | Press Release dated May 24, 2021 | |
| 99.2 | Investor Presentation dated May 24, 2021 |
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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. | ||
| May 24, 2021 | By: | /s/ Jonathan Solomon |
| Name: Jonathan Solomon | ||
| Title: Chief Executive Officer | ||
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Exhibit 99.1
BiomX Reports First Quarter 2021 Financial Results and Provides Business Updates
| - | Company announces completion of enrollment for Phase 2 cosmetic clinical study of BX001 for acne-prone skin with results from 8-week treatment period expected in Q3 2021 |
| - | BiomX continues to anticipate clinical trial readouts in up to 4 different therapeutic indications by mid-2022 |
| - | Company will host a conference call and webcast today at 8:00 am ET |
NESS ZIONA, Israel -- May 24, 2021 -- 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 business updates for the first quarter ended March 31, 2021.
“We are off to a strong start in 2021 and are well-positioned to continue making solid progress throughout our entire pipeline of novel phage therapies with the potential to make a significant impact in the microbiome space. Within the next 14 months, we will have clinical readouts in four distinct indications and remain committed to advancing our phage therapies that have the potential to restore health to the microbiome and in turn, provide safe and effective treatments to patients in need,” said Jonathon Solomon, Chief Executive Officer of BiomX. “In March, we initiated a Phase 2 cosmetic clinical study of BX001 for acne-prone skin and today we are announcing completion of enrollment for 140 patients with results at the 8- and 12-week treatment periods expected in the third and fourth quarters of 2021, respectively. Importantly, in the first quarter we also announced positive safety and tolerability results from the Phase 1a study of BX002 for Inflammatory Bowel Disease, which met its objective of delivering high concentrations of viable phage to the gastrointestinal tract. With these promising results in hand, we are advancing to a Phase 1b/2a study of BX003 for Inflammatory Bowel Disease and Primary Sclerosing Cholangitis to evaluate the reduction of target bacteria, Klebsiella pneumoniae, with data expected in the second quarter of 2022.”
Mr. Solomon added, “Based on ongoing conversations and recommendations from the cystic fibrosis Therapeutic Development Network, we are modifying our Phase 2 trial design in cystic fibrosis to a Phase 1b/2a trial design comprised of two parts. Results from Part 1 and Part 2 are expected in the first and second quarters of 2022, respectively. We are pleased that Dr. David Nichols, M.D., an experienced cystic fibrosis clinical investigator and clinician, will be assisting us with this trial as the academic principal investigator through the Therapeutic Development Network.”
RECENT HIGHLIGHTS AND KEY UPCOMING MILESTONES
Acne-Prone Skin (BX001)
| · | In March 2021, BiomX dosed the first subject in a Phase 2 cosmetic clinical study of BX001 and today announced completion of enrollment for this study. BX001 is a topical gel that includes a combination of naturally occurring phage that specifically target Cutibacterium acnes. The study will evaluate reduction in Cutibacterium acnes burden as well as improvement in the appearance of acne-prone skin in 140 subjects with mild-to-moderate acne vulgaris. The trial is a 12-week randomized, single center, double-blind, placebo-controlled study, and is on track for results to be reported following the 8- and 12-week treatment periods in the third and fourth quarters of 2021, respectively. |
Inflammatory Bowel Disease (“IBD”) and Primary Sclerosing Cholangitis (“PSC”) (BX003)
| · | In February 2021, BiomX announced positive Phase 1a pharmacokinetic data of BX002 designed to target Klebsiella pneumoniae, a bacteria linked to the pathogenesis of IBD and PSC. The results showed that orally administered BX002 was safe, well-tolerated and met its key objective of delivering viable phage at high concentrations of approximately 1010 plaque forming units to the gastrointestinal tract as measured in all stool samples of treated subjects. |
| · | Based on the promising results from the Phase 1a trial of BX002, BiomX plans to initiate a Phase 1b/2a study to evaluate the safety, tolerability, and efficacy of BX003 amongst 60 subjects. Results are expected in the second quarter of 2022. The goal of this study is to demonstrate reduction of target bacteria Klebsiella pneumoniae, as measured in stool of target bacteria carriers. BiomX previously consolidated its IBD and PSC programs to develop one product candidate, BX003, with a broad host range for both indications. |
| · | BiomX is hosting a Key Opinion Leader (“KOL”) webinar on May 26th at 8:00 am ET with a focus on BX003, the Company’s microbiome-based therapeutic, for IBD. The event will feature KOL, Ryan Balfour Sartor, M.D., who will discuss the IBD treatment landscape as well as the unmet medical need for these patients. Dr. Sartor will be joined by BiomX management, who will provide updates on the BX003 program for IBD and PSC. |
Cystic Fibrosis (“CF”) (BX004)
| · | In March 2021, BiomX announced the selection of phage cocktail candidate, BX004, for chronic respiratory infections caused by Pseudomonas aeruginosa, a main contributor to morbidity and mortality in patients with CF. |
| · | BiomX is updating its Phase 2 proof-of-concept study design and timelines to a Phase 1b/2a trial comprised of two parts in CF patients with chronic respiratory infections caused by Pseudomonas aeruginosa. Part 1 results are expected in the first quarter of 2022 and will evaluate the safety, pharmacokinetics and microbiologic/clinical activity of BX004 in eight CF patients in a single ascending dose and multiple ascending dose design. Part 2 of the Phase 1b/2a trial will evaluate the safety and efficacy of BX004 in 21 CF patients randomized to a treatment or placebo cohort in a 2:1 ratio. Results from Part 2 are expected by the second quarter of 2022. |
Atopic Dermatitis (BX005)
| · | In March 2021, BiomX announced the selection of a phage cocktail candidate, BX005, aimed to target Staphylococcus aureus, a bacterium associated with the development and exacerbation of inflammation in patients with atopic dermatitis. When patients experience flares, this bacterium increases in abundance and becomes the dominant bacteria. By reducing Staphylococcus aureus burden, BX005 is designed to shift the skin microbiome composition to its “pre-flare” state to potentially result in clinical improvement. |
| · | Results from a Phase 2 proof-of-concept trial evaluating the safety and efficacy of BX005 in atopic dermatitis patients are expected in the first half of 2022. |
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Colorectal Cancer
| · | BiomX is exploring phage-mediated delivery of therapeutic payloads for the treatment of colorectal cancer, such as immune-stimulating proteins, GM-CSF and IL-15, to target Fusobacterium nucleatum bacteria, which are present within a majority of colorectal tumors. |
| · | BiomX is on track to report results from preclinical in vivo studies evaluating the use of phage therapy for colorectal cancer in combination with checkpoint inhibitors in the second and third quarters of 2021. |
First Quarter 2021 Financial Results
| · | Cash balance and short-term deposits as of March 31, 2021, were $53.6 million, compared to $57.1 million as of December 31, 2020. The decrease was primarily due to net cash used in operating activities. Existing cash, cash equivalents and short-term deposits are expected to be sufficient to fund the Company’s current operating plan and capital expenditure requirements until at least mid-2022. |
| · | Research and development (R&D) expenses, net were $5.8 million for the three months ended March 31, 2021, compared to $3.5 million for the same period in 2020. The increase was primarily due to the growth in the number of employees, resulting in additional stock-based compensation, salaries and related expenses, and due to clinical activities and expenses related to conducting pre-clinical and clinical trials of our product candidates. |
| · | General and administrative expenses were $2.5 million for the three months ended March 31, 2021, compared to $2.1 million for the same period in 2020. The increase was primarily due to an increase in stock-based compensation, salaries and related expenses and an increase in expenses associated with operating as a public company, such as directors’ and officers’ insurance. |
| · | Net loss for the first quarter of 2021 was $8.4 million, compared to $5.9 million for the same period in 2020. |
| · | Net cash used in operating activities for the first quarter of 2021 was $6.4 million, compared to $6.9 million the same period in 2020. |
Conference Call 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 first quarter 2021 ended March 31, 2021. 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.
About Phage Therapy
Bacteriophage, or phage, are viruses that target bacteria and are considered inert to mammalian cells. Phage are designed to target and kill specific bacterial species or strains without disrupting other bacteria or the healthy microbiota. BiomX’s phage-based product candidates derive from its proprietary BOLT (“BacteriOphage Lead to Treatment”) R&D platform that enables the company to rapidly develop, manufacture and formulate rationally-designed phage combinations (“cocktails”) of naturally-occurring or synthetic phage to target pathogenic bacteria. The phage cocktails contain multiple phage with complementary functions optimized through in vitro and in vivo testing.
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About BiomX
BiomX is a clinical-stage microbiome company developing both natural and engineered phage cocktails designed to target and destroy bacteria that affect the appearance of skin, as well as target bacteria in the treatment of chronic diseases, such as inflammatory bowel disease, primary sclerosing cholangitis, cystic fibrosis, atopic dermatitis and colorectal cancer. 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.
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 potential markets opportunities, the capabilities of the BOLT platform, the design, aim, expected timing, and interim and final results of its preclinical and clinical trials and studies, the sufficiency of its existing cash, cash equivalents and short-term deposits, its pipeline and the potential of its product candidates, 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 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 31, 2021 and additional disclosures BiomX makes in its 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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BIOMX INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
USD in thousands, except share and per share data
Three months ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Research and development expenses, net | 5,794 | 3,529 | ||||||
| Amortization of intangible assets | 379 | 379 | ||||||
| General and administrative expenses | 2,497 | 2,058 | ||||||
| Operating loss | 8,670 | 5,966 | ||||||
| Finance income, net | (271 | ) | (65 | ) | ||||
| Loss before taxes | 8,399 | 5,901 | ||||||
| Tax expenses | 3 | - | ||||||
| Net loss | 8,402 | 5,901 | ||||||
| Basic and diluted loss per share of Common Stock | 0.35 | 0.26 | ||||||
| Weighted average number of shares of Common Stock outstanding, basic and diluted | 23,944,573 | 22,897,723 | ||||||
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BIOMX INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)
USD in thousands
| As of March 31, 2021 | As of December 31, 2020 | |||||||
| Current assets | ||||||||
| Cash and cash equivalents | 39,411 | 36,477 | ||||||
| Restricted cash | 976 | 763 | ||||||
| Short-term deposits | 13,205 | 19,851 | ||||||
| Other current assets | 2,943 | 3,576 | ||||||
| Total current assets | 56,535 | 60,667 | ||||||
| Property and equipment, net | 3,531 | 2,228 | ||||||
| Intangible assets, net | 2,658 | 3,038 | ||||||
| Operating lease right-of-use assets | 4,338 | 4,430 | ||||||
| Total non-current assets | 10,527 | 9,696 | ||||||
| 67,062 | 70,363 | |||||||
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| As of March 31, 2021 | As of December 31, 2020 | |||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Trade account payables | 2,685 | 2,320 | ||||||
| Other account payables | 4,350 | 3,978 | ||||||
| Current portion of operating lease liabilities | 763 | 863 | ||||||
| Total current liabilities | 7,798 | 7,161 | ||||||
| Non-current liabilities | ||||||||
| Operating lease liabilities, net of current portion | 4,738 | 5,032 | ||||||
| Contingent considerations | 572 | 701 | ||||||
| Total non-current liabilities | 5,310 | 5,733 | ||||||
| Stockholders’ equity | ||||||||
| Preferred stock, $0.0001 par value; Authorized – 1,000,000 shares as of March 31, 2021 and December 31, 2020. No shares issued and outstanding as of March 31, 2021 and December 31, 2020 | - | - | ||||||
| Common stock, $0.0001 par value; Authorized -60,000,000 shares as of March 31, 2021 and December 31, 2020. Issued - 24,247,040 shares as of March 31, 2021 and 23,270,337 shares as of December 31, 2020. Outstanding - 24,241,340 shares as of March 31, 2021 and 23,264,637 shares as of December 31, 2020. | 2 | 2 | ||||||
| Additional paid in capital | 134,612 | 129,725 | ||||||
| Accumulated deficit | (80,660 | ) | (72,258 | ) | ||||
| Total stockholders’ equity | 53,954 | 57,469 | ||||||
| 67,062 | 70,363 | |||||||
Media:
Courtney Solberg, Solebury Trout
(917) 698-9253
Source: BiomX Inc.
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Exhibit 99.2
© 2020 BiomX LTD. All rights reserved Company Introduction
Safe Harbor Statement 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 historical matters . 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 . When we discuss our ability to quickly generate clinical proof of concept in patients and the advantages of our BOLT platform, our leadership position in phage technology and timing of, among other things, clinical trials initiations, conclusion and receipt of results and meeting milestones relating to our development plan as well as commercialization plans, we are making forward - looking statements . 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 our control . Actual results and outcomes may differ materially from those indicated in the forward - looking statements . Therefore, you should not rely on any of these forward - looking statements . You should review additional disclosures we make in our filings with the Securities and Exchange Commission (the “SEC”), which are available on the SEC’s website at www . sec . gov . Except as required by law, we are under no duty to (and expressly disclaim any such obligation to) update or revise any of the forward - looking statements, whether as a result of new information, future events or otherwise . 2
We develop disease modifying therapies based on natural or engineered phage cocktails as precision medicines to target and specifically destroy harmful bacteria What we do 3 Our R&D platform enables generation of clinical proof of concept in patients within 12 - 18 months from project initiation * * In certain indications the length of clinical validation may be longer depending on indication, identity of target bacteria , r ecruitment rate, cohort size and other factors.
Unique position as leader in phage technology 4 Technology • BOLT phage therapy platform – Rapid path from discovery to clinic • Scalable in - house manufacturing – can support annually over 50 different phage at a clinical grade • Acne collaboration with leading global cosmetic company • Biomarker discovery collaborations in IBD • Janssen (J&J) • Boehringer Ingelheim Partnerships Pipeline Financing and investors • Approximately $ 60 M raised in 2 private rounds • October 2019 public listing ( NYSE:PHGE ) and raising an additional $ 60 M 1. Inflammatory Bowel Disease (IBD) , Primary Sclerosing Cholangitis (PSC). 2. Phase 2 results in acne, Phase 1b/2a results in cystic fibrosis, Phase 2 results in atopic dermatitis, Phase 1b/2a results in IBD/PSC Only clinical stage phage company focusing on chronic indications • P ositive P hase 1 data for topical delivery of BX 001 in subjects with acne prone skin • Positive Phase 1 a data of pharmacokinetic study for IBD/PSC 1 evaluating oral delivery • 4 Phase 2 readouts expected by mid 2022 2
Phage: Nature’s precision tool to target bacteria Each phage binds only to specific bacterial strains Phage have an amplifying lifecycle Locate Inject Infect Multiply Assemble Eradicate Seek 1 2 3 4 5 6 7 5 Source: Kortright et al. (2019), Cell Host & Microbe
Oncology • Colorectal Cancer – F. nucleatum • Gastric Cancer – H. pylori Other • Acne – C. acnes • Liver Disease - E. faecalis Multiple potential applications of phage therapy 6 Immune mediated • Inflammatory Bowel Disease (IBD) – K. pneumoniae • Primary Sclerosing Cholangitis (PSC) - K. pneumoniae • Atopic Dermatitis – S. aureus Infectious diseases • Cystic Fibrosis - P. aeruginosa • Carbapenem Resistance - K. pneumoniae
Phage discovery Preclinical Phase I Phase II Phase III Product Candidates Acne • BX001 1 (Cosmetic route) IBD/PSC • BX003 2 Cystic fibrosis • BX004 Atopic dermatitis • BX005 Colorectal cancer Pipeline • Positive Phase 1 a results ( 1 Q 2021 ) • Phase 1 b/ 2 a results expected 2 Q 2022 • Positive Phase 1 results (1Q 2020) • Phase 2 results exp. 3Q and 4Q 2021 7 • Animal model results expected 2 Q - 3 Q 2021 • Phase 1b/2a part 1 results expected 1Q 2022, part 2 expected 2Q 2022 (1) BX001 is intended to be developed and commercialized as a cosmetic (2) In November 2020, BiomX announced the consolidation of its IBD and PSC programs to develop one broad host range product candidate for both IBD and PSC, designated BX003 (replacing a previous phage product candidate for IBD named BX002) • Phase 2 results expected in 1 H 2022
Our platform allows clinical POC within 12 - 18 months 8 Target Bacteria Target Validation Phage Synthetic Engineering (optional) Cocktail Optimization Discovery & Characterization Manufacturing & Formulation Phage Therapy 3 Clinical testing 1). Strong safety profile of naturally occurring phage supported by regulatory feedback allows proceeding to Phase 2 studies without preclinical safety studies or Phase 1 studies in healthy volunteers. 2). In certain indications the length of clinical validation may be longer depending on indication, identity of target bacter ia, recruitment rate, cohort size and other factors. 3) Usually, we would develop an optimized phage therapy, which is comprised of several phage (a phage cocktail) optimized to address multiple characteristics such as bacteri al host range, emergence of resistance and other factors. In some cases, we may alternatively develop personalized phage cocktails tailored to target specific strain/s of a given patient. We may complete a clinical POC by treating multiple patients with either an optimized phage cocktail or personalized cocktails C linical POC in patients enabled within 12 - 18 months 1,2 Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Traditional pharma drug development Phage therapy Discovery CMC Tox Phase 1 Phase 1/2 Phase 2 Phage cocktail
Inflammatory Bowel Disease (IBD), Primary Sclerosing Cholangitis (PSC) Upcoming milestone: Phase 1b/2a data expected in 2Q 2022
10 Pro - inflammatory Klebsiella strains affect IBD pathology Inflammatory induction is seen in GF mice* Higher abundance of Klebsiella strains in IBD patients IFN - g IFN - g G F + 7 o ther m ix G F + t arget s train TH 1 % r elative Abundance Abundance of Klebsiella strains Activity of bacterial target confirmed by BiomX IBD • Identifying potential disease causing pro - inflammatory Klebsiella strains Disease s tate Induce i nflammation Source: Atarashi et al. ( 2017 ), Science * TH 1 – A lineage of CD 4 + effector T cell secreting IFNg and TNF. In IBD, TH 1 cells accumulate in the intestinal tract of IBD patients and are directly associated with disease Klebsiella strains CD – Crohn’s disease UC – Ulcerative colitis GF – Germ Free
11 Source: Nakamoto et al. (2019), Nature Microbiology *TH17 – A lineage of CD4+ effector T cell secreting IL17A +, promoting inflammation and fibrosis within the liver PSC • Klebsiella identified as possible driver of “leaky gut” Discovery approach Klebsiella pneumoniae (KP) is a specific gut pathobiont of PSC that is an intestinal barrier disrupter and is pro - inflammatory ( “ leaky gut ” ) KP isolated from mice ’ s lymph nodes colonized with patient samples Th17* is induced in livers of GF mice inoculated with fecal samples from PSC patients GF mice Humanized microbiota mice Analysis of immune response Fecal samples from PSC patients Healthy PSC patients Colitis patients Klebsiella pneumoniae plays a gating role SPF – Specific - pathogen - free HC – Healthy Controls PSC/UC – PSC and ulcerative colitis
Phage cocktail composition drives activity 12 Source: Internal data 1 st - generation phage cocktail (in - vivo) 2 nd - generation phage cocktail (in - vivo) reduces bacterial load Control 2 nd - gen cocktail Application of phage Fecal bacterial load Mucosa * *P< 0.05 ; **P < 0.001 ** Phage cocktail Control 0 2 4 6 8 10 10 0 10 2 10 4 10 6 10 8 10 10 Day from inoculation C F U / g r s t o o l *P < 0.01 LOD 1 st - gen cocktail Control Application of phage Fecal bacterial load * Adding 2 phage with new MOA Phage cocktails are optimized to prevent appearance of resistant bacteria by targeting multiple bacterial receptors and defense mechanisms
13 BX 002 : Phase 1 a pharmacokinetic results demonstrate delivery of high levels of viable phage to the gut 1 (1) Study conducted with BX 002 , a phage therapy candidate for oral administration targeting K. pneumoniae . In November 2020 , BiomX announced the consolidation of its IBD and PSC programs to develop one broad host range product candidate for both indication s, designated BX 003 . ( 2 ) PFU – Plaque forming units. ( 3 ) Value is based on median levels of K. Pneumoniae measured in clinical stool samples collected by BiomX from IBD patients. Time (days) Results - Median levels of viable phage detected in stool prior and following oral delivery of phage Baseline Treatment Follow up Median PFU 2 levels measured in stool (per day) ~ 10 3 Median levels 3 of target bacteria in IBD patients (~ 10 7 ) Phase 1 a study design 3 - day multiple - dose study (placebo - controlled) • Objectives • Safety and pharmacokinetics • Endpoints • Safety and tolerability • Detection of viable phage in stool • Study Population: Healthy volunteers • 18 subjects • Oral delivery • 14 phage treatment + 4 placebo • BX 002 was safe and well tolerated • Viable phage delivered is ~ 1,000 times higher compared to bacterial burden of K. pneumoniae in IBD patients
Stool t est Phage treatment Identify presence of K. pneumoniae using companion diagnostic 14 In November 2020 , BiomX announced the consolidation of its IBD and PSC programs to develop one broad host range product candidate for both in dic ations, designated BX 003 . Phase 1 b/ 2 a study design Proof - of - Principle 4 - week dosing study (placebo - controlled) • Objectives • Safety and efficacy • Endpoints • Safety and tolerability • Reduction of K. pneumoniae (efficacy) • Stool microbiome evaluation • Study Population: Target bacteria carriers (Healthy volunteers or IBD/PSC patients ) • 60 subjects total • Oral delivery • BX 003 or placebo • 30 subjects per cohort Data expected 2 Q 2022 Patient A Target bacteria Phase 1b/2a study results expected in 2Q 2022
Cystic Fibrosis Upcoming milestone: Phase 1 b/ 2 a part 1 data expected in 1 Q 2022
Recurring infections leading to antibiotic resistance are a main cause of death in CF 16 1. CF Foundation, Bomberg et al., 2008 2. Vertex 10 K filing 2020 , internal estimates Phases of P. aeruginosa infection in CF 1 Antibiotics Antibiotics Antibiotics Antibiotics Antibiotics Initial Intermittent Chronic Clonal selection Biofilm formation Genotype/phenotypic adaptation Infancy Childhood Adolescence / Adulthood Limit of detection P . a eruginosa density in sputum Repeated antibiotic courses lead to nonmucoid and mucoid multidrug - resistance (MDR) of P. aeruginosa strains • CF patients regularly use multiple therapies – CFTR modulators, anti - infectives, mucolytic agents, bronchodilators and other • Worldwide CF therapeutic market in 2020 was approximately $ 8.5 B
Selected cases of compassionate use of phage therapy targeting P. aeruginosa 17 2 CF patients, Georgia 1,2 • 5 yr old & 7 yr old • N ebulized phage • Combined with antibiotics • 9 courses with 4 - 6 week intervals • Reduction in sputum bacterial burden noted ( 10 7 10 4 CFU/g) 2 • Patient gained weight, clinical improvement observed 1 CF patient, San Diego, US 3 11 CF patients treated with phage targeting P. aeruginosa 1 Kutateladze et al., 2008 2 Kvachadze et al., 2011 3 Law et al., 2019 4 Stanley et al., 2020 8 CF patients, Yale University, US 4 • 26 yr old • Phage administered IV • Combined with antibiotics • No exacerbation within 100 days following the end of phage therapy • eIND path for 8 CF patients • N ebulized phage • 7 - 10 days, single or multiple rounds • Post phage therapy P. aeruginosa CFU titers decreased significantly ( 2.2 ± 0.76 log reduction) • Post phage therapy FEV 1 % changed in a range between 0 to 8.9 % Results demonstrate the potential of phage therapy to decrease bacterial burden and improve FEV 1
** ** Bacterial count Colony forming units / well 18 BX 004 is active on antibiotic resistant P. aeruginosa strains and penetrates biofilm in vitro C o n t r o l I m i p e n e m 2 0 0 g / m L P h a g e c o c k t a i l 10 6 10 7 10 8 10 9 10 10 BX 004 displays enhanced biofilm penetration compared to antibiotics ** BX 004 penetrates biofilm in vitro 1 BX 004 Control Biofilm was grown from P. aeruginosa for 24 hours and then treated with BX 004 for 6 hours (control - untreated wells). Treatment with antibiotics not shown Cr ystal v iolet – Used for biomass staining of biofilm. Staining substantially reduced following treatment with BX 004 **p - value < 0.001 1. Internal data. A P. aeruginosa strain sensitive to antibiotics was grown to form biofilm 2. Imipenem 200 micrograms/ml (X 100 MIC), (β - lactam antibiotic with activity against P. aeruginosa)
19 P hase 1 b/ 2 a study targeting P. aeruginosa with first readout in 1 Q 2022 Phase 1 b/ 2 a – Part 1 Objectives • Safety, PK and microbiologic/clinical activity • Endpoints • Safety and tolerability • Decrease in P. aeruginosa burden • Sputum pharmacokinetics • FEV 1 (forced expiratory volume) • CFQ - R (CF Questionnaire - Revised) and CRISS Study Population • CF patients with chronic P. aeruginosa infection 8 Subjects • 6 receive nebulized BX 004 • 2 receive nebulized placebo • 6 days duration of treatment Key Design Features • Single ascending dose followed by multiple doses Data expected 1 Q 2022 Phase 1 b/ 2 a – Part 2 Data expected 2 Q 2022 Objectives • Safety and efficacy Endpoints • Safety and tolerability • Decrease in P. aeruginosa burden • FEV 1 (forced expiratory volume) • CFQ - R (CF Questionnaire - Revised) and CRISS Study Population • CF patients with chronic P. aeruginosa infection 21 subjects • Nebulized BX 004 phage therapy or placebo • 2:1 randomization • 10 days duration of treatment
Upcoming milestone: Phase 2 data expected in 1 H 2022 Atopic Dermatitis
Atopic Dermatitis (AD) flares are associated with presence of S. aureus Relative abundance of staphylococcal species on skin during AD disease stages (metagenomics analysis) Control = healthy skin Baseline = routine AD disease state Flare = worsening in the clinical severity of the typical AD, without usage of skin - directed antimicrobial and anti - inflammatory treatments for seven days Post flare = 10 – 14 days after initiation of skin - directed therapies Individuals Mean relative abundance Control Baseline Flare Post - flare Byrd and Kong ( 2017 ) Sci Transl Med. 05 9 ( 397 ) S. aureus becomes the dominant bacterial species during AD flares and is correlated with SCORAD
22 Proinflammatory mechanisms Such as, protein A and superantigens (enterotoxins) which trigger inflammatory responses and cytokine release Kong, H.H. et al , ( 2012 ), Genome research . Byrd, A.L. et al , ( 2017 ) Science translational medicine S. aureus contributed to pathogenicity through multiple virulence factors Alpha - toxin forms pores in keratinocytes and proteases facilitate dissolution of the stratum corneum. Barrier disfunction S. aureus has developed several surface molecules to adhere to the human stratum corneum Adhesion
BX 005 eradicates S. aureus ( in vitro assay with 3 strains) Time (hours) Bacterial growth (measured by optical density) BX 005 phage cocktail shows broad host range targeting of S. aureus in vitro Source: Internal data 1 . Panel of 120 strains isolated from skin of subjects from the US and Europe In vitro , BX 005 eradicated over 90 % of S. aureus strains 1 0 0.2 0.4 0.6 0.8 0 5 10 15 20 3 untreated S. aureus strains The same 3 strains treated with BX 005 23
24 Data expected 1 H 2022 Phase 2 study results targeting S. aureus expected in 1 H 2022 Study design • Objectives • Safety, efficacy and pharmacodynamics • Endpoints • Safety and tolerability • Decrease in target bacteria • Clinical improvement (e.g. change in EASI/IGA scores) • Study Population • Atopic dermatitis patients • S. aureus colonized • 8 0 subjects • BX 005 or placebo (vehicle) administered topically • 8 - week duration of treatment BX 005 /Placebo Applications: Sampling: First application Last application Topical administration Baseline 8 weeks 4 weeks 9 weeks 8 weeks 1 week
Acne Upcoming milestone: Phase 2 data expected in 3 Q and 4 Q 2021 (cosmetic study)
BX 001 : Phage cocktail attributes BX 001 A topical gel containing natural phage against C. acnes to modulate skin microbiome 26 * Source: Internal data, in vitro results Phage cocktails penetrate biofilm ( in vitro ) • Active against antibiotic - resistant strains* • Penetrates biofilm*
27 BX 001 /Placebo Applications: Sampling: 2 weeks 2 weeks First application Last application Once daily Baseline 4 weeks 2 weeks 5 weeks 1 week BX 001 : Phase 1 clinical trial design Phase 1 – Completed 4 - week study (placebo - controlled) • Primary endpoint • Safety & Tolerability • Exploratory endpoints • Reduction of C. acnes (efficacy) • Skin microbiome evaluation • 75 subjects • 2 doses (high and low dose) + placebo (vehicle) • 25 subjects per cohort
28 BX 001 : Phase 1 results demonstrate statistically significant reduction in C. acnes levels • Both high and low doses demonstrated excellent safety and tolerability • Findings on the high sebum subgroup support enrichment of study population in the Phase 2 study ( 1 ) Measured by qPCR. Cutibacterium acnes (or C. acnes) comprised over 98 % of Cutibacterium spp. ( 2 ) Subjects were divided into high and low sebum level groups based on median level of sebum at baseline ( 133 µg/cm 2 ) 0.22 log* difference - high dose Vs. control * p= 0.036 Cutibacterium levels qPCR Log 10 (copies/sample) * V i s i t 2 ( B a s e l i n e ) V i s i t 3 ( d a y 1 4 ) V i s i t 4 ( d a y 2 8 ) V i s i t 5 ( d a y 3 5 ) -0.4 -0.2 0.0 0.2 0.4 BMX-01-003 M e a n c h a n g e f r o m b a s e l i n e i n C u t i b a c t e r i u m q P C R L o g 1 0 ( C o p i e s / s a m p l e ) BX001 10 7 BX001 10 9 Vehicle 0.4 log* difference - high dose Vs. control * p< 0.008 Cutibacterium levels qPCR Log 10 (copies/sample) Change in level of Cutibacterium 1 – All subjects Change in level of Cutibacterium 1 – High sebum subgroup 2
BX 001 /Placebo Applications: Sampling: 12 weeks First application Last application Baseline 12 weeks 8 weeks 13 weeks 1 week 29 BX 001 phase 2 cosmetic study results expected in 2 H 2021 Phase 2 Study Design 12 - week application, Placebo - controlled • Objectives • Safety and efficacy • Endpoints • Safety and tolerability • Reduction of C. acnes (efficacy) • Skin microbiome evaluation • IGA and lesion numbers (efficacy) • 140 subjects • Phage or placebo (vehicle) • 70 subjects per cohort • 8 - week data expected 3 Q 2021 • 12 - week data expected 4 Q 2021
Colorectal Cancer Upcoming milestone: Proof of concept in animal models by 2 Q - 3 Q 2021
31 + = Immune checkpoint inhibitors Effect on tumor “ Cold ” tumor “ Hot ” tumor + = Immune checkpoint inhibitors Effect on tumor Sources: Vareki ( 2018 ), Journal for immunotherapy of Cancer; Galon et al. ( 2019 ), Nature Reviews/Drug Discovery Most c olorectal c ancer (CRC) patients do n ot respond to immunotherapy
32 Bacteria residing inside t umors offer a novel targeted intervention to “ uncloak ” t umors to “ hot ” Numerous observations of bacteria residing inside tumors F. nucleatum Tumor x 30 x 10 ISH, red= F. nucleatum Representative RNA - In - situ hybridization images showing patterns of F. nucleatum localization in human rectal cancer tissue samples F. nucleatum is found in over 80 % of colorectal cancer tumors (BiomX internal analysis and public data) BiomX internal data Li YY, Ge QX, Cao J, et al. ( 2016 ) World J Gastroenterol. Bachrach et al. ( 2016 ), Cell Host & Microbe Serna et al. ( 2020 ) Annals of Oncology Kostic et al. ( 2013 ), Cell Host & Microbe
33 Engineered p hage are designed to deliver p ayloads to bacteria in tumors Phage are designed to carry payloads to intra - tumor bacteria Phage cocktail with a payload turns cold tumors into hot Add payload using SynBio + new gene Phage cocktail Phage cocktail + = Immune checkpoint inhibitors Effect on tumor “ Cold ” tumor “ Cold ” tumor “ Hot ” tumor + = Immune checkpoint inhibitors Effect on tumor Phage cocktail IV Payloads : IL - 15 , GM - CSF, Cytosine Deaminase
Key development milestones 34 FN14 FN14+Phages Phages only 10 0 10 1 10 2 10 3 10 4 10 5 10 6 10 7 P h a g e s i n 1 g t u m o r CT - 26 2 x 10 5 /mouse (SC) 1 FN 14 (IV) 12 Phage treatment (IV) 15 Day: 18 IL - 15 - engineered phage w.t. phage NTC , 1,000 750 250 Base pairs: IL 15 insertion into phage w.t. phage IL-15 - phage 0 1000 2000 3000 Luminescence (IL-15-Hibit) R L U Luminescence (AU) IL - 15 expression in bacteria WT phage Engineered phage CT - 26 2 x 10 5 /mouse (SC) 1 18 FN 14 (IV) 12 Phage treatment (IV) 23 15 7 10 Day: Anti PD - 1 treatment (IP) 13 Survival, Tumor growth rate 16 19 IV delivery of phage to intra - tumor bacteria ( in - vivo ) IL - 15 payload engineered into F. nucleatum phage ( in - vitro ) Impact of engineered phage + anti - PD 1 in CRC mouse model Engineered Payloads: IL - 15 , GM - CSF, Cytosine Deaminase Planned 2 Q - 3 Q 2021 Phage per 1 gram tumor Source: Internal data
35 2 H 20 1 H 20 2 H 21 1 H 21 Cash, cash equivalents and short - term deposits as of March 31 st , 2021 were $ 53.6 M million 2 H 22 1 H 22 1. Phase 2 results in acne, Phase 1 b/ 2 a results in cystic fibrosis, Phase 2 results in atopic dermatitis, Phase 1 b/ 2 a results in IBD/PSC 2. Our acne product is developed under a cosmetic regulatory path and we currently do not anticipate any additional clinical tri als beyond the Phase 2 study. 3. As the IBD and PSC programs share the same bacterial target, Klebsiella pneumoniae, we currently anticipate that the BX 003 phage cocktail will be developed for both indications. Accordingly, the Phase 1 study is expected to support progress of both indications. Key Catalysts: 4 Phase 2 readouts by mid 2022 1 Acne 2 IBD/PSC 3 Atopic Dermatitis CF Mfg. Phase 2 results Phase 2 initiation Pre - commercial Pre - commercial Phase 1 Results Phase 1 a initiation Mfg. Phase 1 a results Mfg . Phase 1 b/ 2 a results CMC Phage discovery Phase 1 b/ 2 a initiation Cocktail optimization Mfg Phase 1 b/ 2 a results –––– Phage discovery Mfg Cocktail optimization Mfg. Phase 2 results –––– CRC Initiate in vivo studies In vivo results In vivo results Mfg Cocktail optimization Phage engineering
Assaf Oron CBO Former CBO of Evogene, an agricultural biotechnology company; raised $ 85 M in NYSE listing. Executed transactions with turnover of >$ 100 M with global seed companies Marina Wolfson, CPA SVP Finance & Operations Most recently principle financial officer of Bioview (TASE:BIOV). Former senior auditor at E&Y working with large pharmaceutical and hi - tech companies, VCs and start - ups Inbal Benjamini - Elran VP Human Resource 15 years experience in executive HR roles globally. Former head of HR at Herzog law firm and HR director at Teva Europe (NYSE:TEVA) Experienced leadership team 36 Management Team Scientific Founders Prof. Timothy K. Lu Prof. Eran Elinav Prof. Rotem Sorek Jonathan Solomon CEO and Board Member Former co - founder, president, and CEO of ProClara for treating neurodegenerative diseases; raised > $ 100 M. Harvard Business School grad. Service in an elite IDF unit Sailaja Puttagunta , MD CMO Infectious disease physician (Yale graduate), Developed several antibiotics through all clinical development stages under Allergan, Pfizer, Durata and other biotechs Merav Bassan , PhD CDO Over 20 years of early and clinical drug development experience at Teva Pharmaceuticals and small biotechs . Most recently served as VP of translational sciences at Teva
Experienced leadership team 37 Board of Directors Director, Jonas Grossman Director, Gbola Amusa, MD Chairman, Russell Greig, PhD Director, Alan Moses, MD Director, Jonathan Solomon Director, Lynne Sullivan Director, Paul Sekhri
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