HLSQ 8-K
Tessera Defense & Homeland Security Inc. (HLSQ)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
CURRENT REPORT
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Securities registered pursuant to Section 12(b) of the Act:
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| , and one Warrant entitling the holder to receive one half share of Common Stock | American | |||
| American | ||||
| , at an exercise price of $11.50 per share | 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).
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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 November 15, 2021, BiomX Inc., or the Company, issued a press release announcing its financial results for the third quarter ended September 30, 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 November 15, 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 November 15, 2021 | |
| 99.2 | Investor Presentation dated November 15, 2021 | |
| 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. | |||
| November 15, 2021 | By: | /s/ Jonathan Solomon | |
| Name: | Jonathan Solomon | ||
| Title: | Chief Executive Officer | ||
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Exhibit 99.1
BiomX Reports Third Quarter 2021 Financial Results and Provides Business Update
Announces Strategic Focus on Cystic Fibrosis
and Atopic Dermatitis Programs Based on
Potential Proof-of-Concept Clinical Data Readouts in 2022
Cash Runway Now Extended to End of 2023, Well Beyond Key 2022 Data Readouts
FDA Clears BiomX to Begin Phase 1b/2a Trial in Cystic Fibrosis; Trial to Start Imminently
Company Will Host a Conference Call and Webcast Today at 8:00 am ET
BRANFORD, Conn. and NESS ZIONA, Israel – November 15, 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, reported today financial results and provided a business update for the third quarter ended September 30, 2021.
“In planning for the years ahead, BiomX has made the decision to prioritize the development of our cystic fibrosis and atopic dermatitis product candidates, as each has the potential to generate proof-of-concept clinical data readouts in 2022. BiomX will also discontinue development of its acne program,” said Jonathan Solomon, Chief Executive Officer of BiomX. “We believe that by focusing on the efficient use of BiomX’s capital on selected programs that can generate clinically meaningful, proof-of-concept data, will best position our company to drive value creation for shareholders. With this decision, we intend to also postpone our development efforts temporarily in inflammatory bowel disease and colorectal cancer until 2023.
“Importantly, our new strategic focus will have a positive impact on our balance sheet. This new focus may allow us to extend our cash runway by up to 6 months, until at least the end of 2023, and additional tranches that may become available to us under our venture debt facility upon satisfaction of certain specified milestones may further extend our cash runway to the first half of 2024.” We therefore believe that we remain well-positioned financially through our expected clinical data readouts in cystic fibrosis and atopic dermatitis.”
RECENT CORPORATE HIGHLIGHTS
| · | In October 2021, BiomX reported topline results of the cosmetic Phase 2 acne study showing statistically significant improvement from baseline observed in the appearance of acne-prone skin but with no meaningful difference demonstrated for BX001 relative to vehicle. |
| · | In October 2021, BiomX entered into an agreement with Maruho Co. Ltd., Japan’s largest dermatology-focused pharmaceutical company, for a right of first offer to license BiomX’s atopic dermatitis product candidate, BX005, in Japan. The right of first offer will commence following the availability of results from the Phase 1/2 study of BX005 expected in 2022. Maruho also entered into a binding agreement for an equity investment in BiomX, intended primarily to support the Phase 1/2 study, of $3 million at a premium to the market share price. |
| · | In September 2021, BiomX was cleared by the U.S. Food and Drug Administration (FDA) to initiate a Phase 1b/2a trial of BX004 in cystic fibrosis patients with chronic respiratory infections caused by Pseudomonas aeruginosa. |
| · | In August 2021, the Company announced that it entered into a debt financing agreement of up to $30 million with Hercules Capital, Inc. (NYSE:HTGC). In July 2021, BiomX announced it raised $15 million in a registered direct offering of common stock and warrants. |
Clinical Program Updates
Cystic Fibrosis (“CF”) (BX004)
| · | BX004 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. |
| · | In September 2021, BX004 was cleared by the FDA to initiate a Phase 1b/2a trial in CF patients with chronic respiratory infections caused by Pseudomonas aeruginosa. |
| · | The Phase 1b/2a trial is composed of two parts and is expected to start imminently. Part 1 of the trial will evaluate the safety, pharmacokinetics and microbiologic/clinical activity of BX004 in eight CF patients in a single ascending dose and multiple dose design, with results expected in the second quarter of 2022. Part 2 of the trial will evaluate the safety and efficacy of BX004 in 24 CF patients randomized to a treatment or placebo cohort in a 2:1 ratio. Results from Part 2 are expected by the third quarter of 2022. |
Atopic Dermatitis (“AD”) (BX005)
| · | BX005 is designed to shift the skin microbiome composition of AD patients to its “pre-flare” state by reducing Staphylococcus aureus burden, potentially resulting in clinical improvement. |
| · | BX005 is currently in the final stages of GMP production. Due to delays in communications with the FDA attributable to COVID-related matters, the Company now expects results from its Phase 1/2 proof-of-concept trial evaluating the safety and efficacy of BX005 in the third quarter of 2022 instead of the first half of 2022. |
Inflammatory Bowel Disease (“IBD”) and Colorectal Cancer Programs
| · | Consistent with the new strategic focus on CF and AD programs and the efficient deployment of BiomX capital, the Company plans to temporarily pause its development efforts in IBD and colorectal cancer until early 2023, as neither program would otherwise be expected to yield proof-of-concept data in patients through the end of 2022. |
Acne-Prone Skin (BX001)
| · | Based upon the topline results of the cosmetic Phase 2 acne trial previously announced in October 2021, the Company has now determined that it is discontinuing this program to focus resources on the CF and AD programs. |
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Third Quarter 2021 Financial Results
| · | Cash balance and short-term deposits as of September 30, 2021, were $68.3 million, compared to $57.1 million as of December 31, 2020. The increase was primarily due to net cash provided by financing activities partially offset with net cash used in operating activities. During the third quarter, the Company completed a $15 million registered direct equity financing and debt financing agreement of up to $30 million. Based upon the BiomX’s new strategic focus on its cystic fibrosis and atopic dermatitis programs, the Company now expects its existing cash, cash equivalents and short-term deposits to be sufficient to fund the Company’s current operating plan until the end of 2023. Additional tranches that will become available to the Company under its venture debt facility upon satisfaction of certain specified milestones can further extend the Company’s cash runway to the first half of 2024. |
| · | Research and development (R&D) expenses, net were $6.6 million for the three months ended September 30, 2021, compared to $6.1 million for the same period in 2020. The increase was primarily due to increased expenses related to conducting pre-clinical and clinical trials of our product candidates and an increase in stock-based compensation and salaries and related expenses, mainly due to the growth in the number of employees in R&D and clinical activities. |
| · | General and administrative expenses were $2.8 million for the three months ended September 30, 2021, compared to $2.4 million for the same period in 2020. The increase was primarily due to increases in stock-based compensation and salaries and related expenses, mainly due to the growth in the number of employees, due to an increase in expenses associated with operating as a public company, such as directors’ and officers’ insurance and due to expenses resulted from moving into new premises. |
| · | Net loss for the third quarter of 2021 was $10.0 million, compared to $8.8 million for the same period in 2020. |
| · | Net cash used in operating activities for the nine months ended September 30, 2021 was $18.5 million, compared to $17.3 million for 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 third quarter 2021 ended September 30, 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 BiomX
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, such as cystic fibrosis, atopic dermatitis, inflammatory bowel disease, primary sclerosing cholangitis, and colorectal cancer. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against these targets.
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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 its expectations regarding the sufficiency of cash, cash equivalents and short-term deposits to fund the Company’s current operating plan until at least the end of 2023, or even later, the ability of its products to address unmet medical needs, the potential to receive up to $15 million in additional loan tranches if certain milestones are met, the design, aim, expected timing and results of its preclinical and clinical trials and studies, including resumption of certain development programs, as well as 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 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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BIOMX INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
USD in thousands, except share and per share data
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||
| Note | 2021 | 2020 | 2021 | 2020 | ||||||||||||||
| Research and development (“R&D”) expenses, net | 6,608 | 6,056 | 16,102 | 13,302 | ||||||||||||||
| Amortization of intangible assets | 380 | 380 | 1,139 | 1,139 | ||||||||||||||
| General and administrative expenses | 2,845 | 2,394 | 8,436 | 6,749 | ||||||||||||||
| Operating loss | 9,833 | 8,830 | 25,677 | 21,190 | ||||||||||||||
| Financial expenses (income), net | 188 | 5 | 76 | (248 | ) | |||||||||||||
| Loss before tax | 10,021 | 8,835 | 25,753 | 20,942 | ||||||||||||||
| Tax expenses | 10 | - | 16 | - | ||||||||||||||
| Net Loss | 10,031 | 8,835 | 25,769 | 20,942 | ||||||||||||||
| Basic and diluted loss per share of Common Stock | 6 | 0.37 | 0.38 | 1.03 | 0.91 | |||||||||||||
| Weighted average number of shares of Common Stock outstanding, basic and diluted | 27,077,903 | 23,150,253 | 25,120,037 | 23,013,790 | ||||||||||||||
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BIOMX INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)
USD in thousands
| As of | ||||||||||
| Note | September 30, 2021 | December 31, 2020 | ||||||||
| ASSETS | ||||||||||
| Current assets | ||||||||||
| Cash and cash equivalents | 67,346 | 36,477 | ||||||||
| Restricted cash | 985 | 763 | ||||||||
| Short-term deposits | - | 19,851 | ||||||||
| Other current assets | 1,467 | 3,576 | ||||||||
| Total current assets | 69,798 | 60,667 | ||||||||
| Property and equipment, net | 5,863 | 2,228 | ||||||||
| Intangible assets, net | 1,899 | 3,038 | ||||||||
| Operating lease right-of-use assets | 4,239 | 4,430 | ||||||||
| Total non-current assets | 12,001 | 9,696 | ||||||||
| 81,799 | 70,363 | |||||||||
| As of | ||||||||||
| Note | September 30, 2021 | December 31, 2020 | ||||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||
| Current liabilities | ||||||||||
| Trade account payables | 1,879 | 2,320 | ||||||||
| Other account payables | 6,321 | 3,978 | ||||||||
| Current portion of operating lease liabilities | 799 | 863 | ||||||||
| Total current liabilities | 8,999 | 7,161 | ||||||||
| Non-current liabilities | ||||||||||
| Long-term debt | 4 | 14,225 | - | |||||||
| Operating lease liabilities, net of current portion | 4,728 | 5,032 | ||||||||
| Other liabilities | 420 | 701 | ||||||||
| Total non-current liabilities | 19,373 | 5,733 | ||||||||
| Commitments and Collaborations | 3 | |||||||||
| Stockholders’ equity | 5 | |||||||||
| Preferred Stock, $0.0001 par value; Authorized - 1,000,000 shares as of September 30, 2021 and December 31, 2020. No shares issued and outstanding as of September 30, 2021 and December 31, 2020. | - | - | ||||||||
| Common Stock, $0.0001 par value; Authorized - 60,000,000 shares as of September 30, 2021 and December 31, 2020. Issued – 28,206,229 shares as of September 30, 2021 and 23,270,337 shares as of December 31, 2020. Outstanding – 28,200,529 shares as of September 30, 2021 and 23,264,637 shares as of December 31, 2020. | 3 | 2 | ||||||||
| Additional paid in capital | 151,451 | 129,725 | ||||||||
| Accumulated deficit | (98,027 | ) | (72,258 | ) | ||||||
| Total stockholders’ equity | 53,427 | 57,469 | ||||||||
| 81,799 | 70,363 | |||||||||
BiomX, Inc.
Anat Primovich
Corporate Project Manager
+972506977228
[email protected]
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 expectations regarding the sufficiency of cash, cash equivalents and short - term deposits to fund the our current operating plan until at least the end of 2023 , or even later, the ability of our products to address unmet medical needs, the potential to receive up to $ 15 million in additional loan tranches if certain milestones are met, the design, aim, expected timing and results of our preclinical and clinical trials and studies, including resumption of certain development programs, as well as its pipeline and the potential of its product candidates, our ability to quickly generate clinical proof of concept in patients and the advantages of our BOLT platform as well as our leadership position in phage technology 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, recruitment 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 • Maruho ROFO 3 for rights in Japan to atopic dermatitis product candidate • Biomarker discovery collaborations in IBD • Janssen (J&J) • Boehringer Ingelheim Partnerships Pipeline Financing and investors • Publicly traded ( NYSE:PHGE ) • Equity raised: $143M • Secured debt of up to $30M • Expected cash runway until at least end of 2023 1. Phase 1 / 2 results in cystic fibrosis,, Phase 1 / 2 results in atopic dermatitis 2. Inflammatory Bowel Disease (IBD) , Primary Sclerosing Cholangitis (PSC) 3. Right Of First Offer Only clinical stage phage company focusing on chronic indications • Focusing on cystic fibrosis & atopic dermatitis. Both expected to produce POC data in 2022 1 • Additional programs in IBD / PSC 2 & Cancer to resume in 2023
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
Pipeline: 2 Phase 2 readouts expected by end of 2022 1 1 H 22 2H21 1H23 2H22 1H24 2H23 Phase 1b/2a part 1 results Phase 1b/2a initiation Phase 1 b/ 2 a part 2 results Manufacturing Phase 2/3 1 initiation CF Phase 2/3 ongoing Phase 1/2 initiation Manufacturing Phase 1/2 results CMC scale up Manufacturing Atopic Dermatitis Phase 2 initiation Hold In vivo studies Hold In vivo results Cocktail optimization CRC Manufacturing Hold CMC Hold Manufacturing Phase 1b/2a results Manufacturing IBD/PSC 2 Cash and equivalents as of Sep 30 th , 2021 were $68.3M million; Cash runway expected at least until end of 2023, with additional venture debt tranches – mid - 24 1. Phase 1b/2a results in cystic fibrosis, Phase 2 results in atopic dermatitis, 2. As the IBD and PSC programs share the same bacterial target, Klebsiella pneumoniae, we currently anticipate that the BX003 ph age cocktail will be developed for both indications. Accordingly, the Phase 1 study is expected to support progress of both indications. 7 Programs postponed for ~12 months
Our platform allows clinical POC within 12 - 18 months 8 Target Bacteria Target Validation Phage Synthetic Engineering (optional) Cocktail Optimization Discovery & Characterizati on Manufacturin g & Formulation Phage Therapy 3 Clinical testing 1. Strong safety profile of naturally occurring phage supported by regulatory feedback allows proceeding to Phase 1/2 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 bacteria, rec ruitment 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 add res s multiple characteristics such as bacterial host range, emergence of resistance and other factors. In some cases, we may alternatively develop personalized pha ge 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 cock tai l or personalized cocktails Clinical 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
Cystic Fibrosis Upcoming milestone: Phase 1b/2a part 1 data expected in 2Q 2022
Recurring infections leading to antibiotic resistance are a main cause of death in CF 10 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. aeruginosa 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 $8.5B 2
Selected cases of compassionate use of phage therapy targeting P. aeruginosa 11 2 CF patients, Georgia 1,2 • 5 yr old & 7 yr old • Nebulized phage • Combined with antibiotics • 9 courses with 4 - 6 week intervals • Reduction in sputum bacterial burden (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 • Nebulized 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 FEV1% changed in a range between 0 to 8.9% Results demonstrate the potential of phage therapy to decrease bacterial burden and improve FEV1
12 BX 004 is active on antibiotic resistant P. aeruginosa strains and penetrates biofilm in vitro BX004 displays enhanced biofilm penetration compared to antibiotics ** ** Bacterial count Colony forming units / well ** BX004 penetrates biofilm in vitro 1 BX004 Control Biofilm was grown from P. aeruginosa for 24 hours and then treated with BX004 for 6 hours (control - untreated wells). Treatment with antibiotics not shown Crystal violet – Used for biomass staining of biofilm. Staining substantially reduced following treatment with BX004 **p - value <0.001 1. Internal data. A P. aeruginosa strain sensitive to antibiotics was grown to form biofilm 2. Imipenem 200 micrograms/ml (X100 MIC), (β - lactam antibiotic with activity against P. aeruginosa)
13 Phase 1 b/ 2 a study targeting P. aeruginosa with first readout expected in 2 Q 2022 Phase 1b/2a – Part 1 Objectives • Safety, PK and microbiologic/clinical activity • Endpoints • Safety and tolerability • Decrease in P. aeruginosa burden • Sputum pharmacokinetics • FEV1 (forced expiratory volume) • CFQ - R (CF Questionnaire - Revised) and CRISS Study Population • CF patients with chronic P. aeruginosa infection 8 Subjects • 6 receive nebulized BX004 • 2 receive nebulized placebo • 6 days duration of treatment Key Design Features • Single ascending dose followed by multiple doses Phase 1b/2a – Part 2 Objectives • Safety and efficacy Endpoints • Safety and tolerability • Decrease in P. aeruginosa burden • FEV1 (forced expiratory volume) • CFQ - R (CF Questionnaire - Revised) and CRISS Study Population • CF patients with chronic P. aeruginosa infection 24 subjects • Nebulized BX004 phage therapy or placebo • 2:1 randomization • 10 days duration of treatment Data expected 2Q 2022 Data expected 3Q 2022
Upcoming milestone: Phase 2 data expected in 3Q 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 15
16 BX005 eradicates S. aureus ( in vitro assay with 3 strains) Time (hours) Bacterial growth (measured by optical density) BX005 phage cocktail shows broad host range targeting of S. aureus in vitro In vitro, BX005 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 BX005 Source: Internal data 1. Panel of 120 strains isolated from skin of subjects from the US and Europe
17 BX005 has the potential to be an efficacious and safe topical treatment for long - term use • Atopic dermatitis, a rapidly growing market 1 : • > $ 5 billion in 2020 • Expected to surpass $ 15 billion in 2027 • Over 35 % of atopic dermatitis patients are children • Parents are seeking efficacious topical treatments with a better safety profile • Calcineurin inhibitors and recently approved topical JAK inhibitor carry a black box warning for cancer risks in the US • Corticosteroids – limited for short term use. Long - term use has been associated with skin atrophy, starch marks, and corticosteroid addiction • Based on clinical experience of using natural phage topically 3 , BX 005 is expected to have fewer side effects and a safer profile compared to existing treatments 1. Atopic dermatitis Market forecast, trend analysis & competition tracking, Fact Mr. report 2. Atopic dermatitis: Global drug forecast and market analysis to 2027, GlobalData report 3. Based on safety data from BiomX’s clinical studies using a topical phage cocktail for acne - prone skin Children are the largest atopic dermatitis patient group Atopic dermatitis patients by age group (US) 2 Age 0 - 19 37% Age 20 - 39 32% Age 40 - 59 20% Age >60 11 % Age 0 - 19 37 % Age 20 - 39 32% Age 40 - 59 20% Age >60 11 %
18 Phase 1b/2a atopic dermatitis study targeting S. aureus Study design - A double - blind, randomized, multicenter, vehicle - controlled study • Objectives • Safety, efficacy and pharmacodynamics • Endpoints • Safety and tolerability • Decrease in target bacteria • Clinical improvement (e.g. change in EASI / IGA / SCORAD scores) • Study Population • Adults with moderate - to - severe atopic dermatitis • S. aureus colonized • Approximately 48 subjects • BX005 or placebo (vehicle) administered topically twice daily • 8 - week duration of treatment wk: week; F/U: Follow - Up Data expected 3Q 2022 BX005/Placebo Applications Sampling First application Last application Topical administration Baseline 8 wks 4 weeks 8 weeks Screening 12 wks Post - dosing safety F/U
Inflammatory Bowel Disease (IBD), Primary Sclerosing Cholangitis (PSC) Upcoming milestone: Phase 1b/2a data expected in 2H 2023
20 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 GF + 7 other mix GF + target strain TH1 % relative Abundance Abundance of Klebsiella strains Activity of bacterial target confirmed by BiomX IBD • Identifying potential disease causing pro - inflammatory Klebsiella strains Disease state Induce inflammation Source: Atarashi et al. (2017), Science * TH1 – A lineage of CD4+ effector T cell secreting IFNg and TNF. In IBD, TH1 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
21 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 22 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 *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
23 BX002: Phase 1a pharmacokinetic results demonstrate delivery of high levels of viable phage to the gut 1 1. Study conducted with BX002, a phage therapy candidate for oral administration targeting K. pneumoniae. In November 2020, Biom X announced the consolidation of its IBD and PSC programs to develop one broad host range product candidate for both indication s, designated BX003. 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 1a 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 • BX002 was safe and well tolerated • Viable phage delivered is ~1,000 times higher compared to bacterial burden of K. pneumoniae in IBD patients
Stool test Phage treatment Identify presence of K. pneumoniae using companion diagnostic 24 In November 2020, BiomX announced the consolidation of its IBD and PSC programs to develop one broad host range product candidate for both indications, designated BX003. Phase 1b/2a 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 • BX003 or placebo • 30 subjects per cohort Data expected 2H 2023 Patient A Target bacteria Phase 1b/2a study results expected in 2H 2023
Colorectal Cancer Upcoming milestone: Proof of concept in animal models by 2H 2023
26 + = 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 colorectal cancer (CRC) patients do not respond to immunotherapy
27 Bacteria residing inside tumors offer a novel targeted intervention to “uncloak” t umors to “hot” Numerous observations of bacteria residing inside tumors F. nucleatum Tumo r x30 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
28 Engineered phage are designed to deliver payloads 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 Source: Internal data 29 CT - 26 2x10 5 /mouse (SC) 1 FN 14 (IV) 12 Phage treatment (IV) 15 Day: 18 CT - 26 2x10 5 /mouse (SC) 1 18 FN14 (IV) 12 Phage treatment (IV) 23 15 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 – engineered phage treatment resulted in RNA expression of IL - 15 payload in tumors and elevation of CD8+ cells in draining lymph nodes Impact of engineered phage + anti - PD1 in CRC mouse model Engineered Payloads: IL - 15 H 2 2023 * P. value < 0.05 7 Phages in 1g tumor FN14 FN14+Phages Phages only RNA expression of IL - 15 payload in tumors Phages in 1 g tumor CT (IL - 15 payload) CD8 T cells in dLN + % of total cells Bacteria + native phage Bacteria + vehicle Bacteria + engineered phage
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