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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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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Item 2.02 Results of Operations and Financial Condition.
On November 9, 2022, BiomX Inc., or the Company, issued a press release announcing its financial results for the third quarter ended September 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 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 9, 2022, 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 9, 2022 | |
| 99.2 | Investor Presentation dated November 9, 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. | |||
| November 9, 2022 | By: | /s/ Jonathan Solomon | |
| Name: | Jonathan Solomon | ||
| Title: | Chief Executive Officer | ||
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Exhibit 99.1
BiomX Reports Third Quarter 2022 Financial Results and Provides Business Update
Continued Progress Enrolling Patients in Phase 1/2 Trial of BX004 for Treatment of Lung Infections in Cystic Fibrosis; Results from Part 1 of the Trial Now Expected in Q1 2023
Announced Publication in Cell of Research Demonstrating Proof-of-Concept Assessment of Orally Administered Phage Treatment in Preclinical Model of Inflammatory Bowel Disease
Cash Runway Through at Least Mid-2024
Company Will Host a Conference Call and Webcast Today at 8:00 am ET
NESS ZIONA, Israel – November 9, 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 third quarter ended September 30, 2022.
“Despite encountering challenges early in the quarter in recruiting cystic fibrosis patients following the COVID-19 pandemic, we have recently put in place important mechanisms to accelerate screening and enrollment and are encouraged by the recent increased enrollment into BX004 that will impact both parts of the trial,” said Jonathan Solomon, Chief Executive Officer of BiomX. “Based on these latest trends, we now anticipate that enrollment for Part 1 of the study will be complete by year-end. Factoring in a modest impact from the U.S. holiday season and the time required for data analysis following each patient’s treatment period, we now expect to announce results from Part 1 of the trial in the first quarter of 2023, followed by results from Part 2 in the third quarter of 2023. We believe that we remain financially and operationally positioned to execute on our business plan with respect to our CF program, with cash runway anticipated to take us through at least mid-2024. We appreciate the continued support of our shareholders and look forward to providing our initial data from the CF program.”
Clinical Program Updates
Cystic Fibrosis (BX004)
| ● | BiomX has dosed the first patients in the Company’s Phase 1b/2a study evaluating BX004 for the treatment of chronic respiratory infections in patients with cystic fibrosis (“CF”). |
| ● | 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. |
| ● | The Phase 1b/2a trial is composed of two parts. Part 1 of the study 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 first quarter of 2023. Part 2 of the study 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 in the third quarter of 2023. |
| ● | As previously announced, BiomX has received a Therapeutics Development Award of up to $5 million from the Cystic Fibrosis Foundation (“CF Foundation”). The award is structured as an equity investment in which the CF Foundation has agreed to purchase up to $5 million of BiomX common stock across two separate tranches. The first tranche was received on December 21, 2021, with the CF Foundation making an initial equity investment of $3 million. Upon completion of all patient dosing in Part 1 of the Company’s Phase 1b/2a study of BX004, BiomX would have the right to receive the second tranche of $2 million, also as an equity investment. |
Atopic Dermatitis (BX005)
| ● | The Company is collaborating with Maruho Co. Ltd., a leading dermatology-focused pharmaceutical company in Japan, supporting a range of pre-clinical activities to move this program forward, and working on evaluating timelines for a clinical trial. |
RECENT CORPORATE HIGHLIGHTS
| ● | In August, the Company announced the publication of a scientific paper titled “Targeted suppression of human IBD-associated gut microbiota commensals by phage consortia for treatment of intestinal inflammation” in the journal, Cell. The research was conducted across several organizations, including BiomX and the Weizmann Institute of Science, and presents phage proof of concept in preclinical models of inflammatory bowel disease as well as highlights from the clinical study. The paper is available online at https://www.cell.com/cell/fulltext/S0092-8674(22)00850-9. |
Third Quarter 2022 Financial Results
| ● | Cash balance, short-term deposits and restricted cash as of September 30, 2022, were $41.5 million, compared to $63.1 million as of December 31, 2021. The decrease was primarily due to net cash used in operating activities. Based upon the Company’s strategic focus on the CF program, the existing cash and cash equivalents are expected to be sufficient to fund the current operating plan until at least the middle of 2024. |
| ● | Research and development expenses, net were $3.5 million for the three months ended September 30, 2022, compared to $6.6 million for the same period in 2021. The decrease is primarily due to a decrease in salaries and related expenses and stock-based compensation expenses driven by a reduction in personnel, as part of the corporate restructuring the Company announced in May of this year, as well as pausing the development of BX003, the product candidate for the treatment of Inflammatory Bowel Disease and Primary Sclerosing Cholangitis, pausing the development of the Company’s colorectal cancer product candidate, and the discontinuation of the Company’s product candidate for the treatment of acne, BX001. The decrease was partially offset by a decrease in grants from the Israel Innovation Authority. |
| ● | General and administrative expenses were $2.6 million for the three months ended September 30, 2022, compared to $2.8 million for the same period in 2021. The decrease is primarily due to a decrease in salaries and related expenses and stock-based compensation expenses due to a reduction in workforce. |
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| ● | Net loss for the third quarter of 2022 was $6.8 million, compared to $10 million for the same period in 2021. |
| ● | Net cash used in operating activities for the nine months ended September 30, 2022 was $21.9 million, compared to $18.5 million for the same period in 2021. |
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 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.
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. 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 future updates on its CF and Atopic Dermatitis programs, its expectations regarding the timing of the completion of enrollment and 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 and financial and operational position, 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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BIOMX INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(USD in thousands, except share and per share data)
(unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||
| Note | 2022 | 2021 | 2022 | 2021 | ||||||||||||||
| Research and development expenses, net | 3,536 | 6,608 | 13,049 | 16,102 | ||||||||||||||
| Amortization of intangible assets | 380 | 380 | 1,139 | 1,139 | ||||||||||||||
| General and administrative expenses | 2,633 | 2,845 | 7,471 | 8,436 | ||||||||||||||
| Operating loss | 6,549 | 9,833 | 21,659 | 25,677 | ||||||||||||||
| Other income | (52 | ) | - | (52 | ) | - | ||||||||||||
| Interest expenses | 555 | 172 | 1,504 | 172 | ||||||||||||||
| Financial expenses (income), net | (280 | ) | 16 | (706 | ) | (96 | ) | |||||||||||
| Loss before tax | 6,772 | 10,021 | 22,405 | 25,753 | ||||||||||||||
| Tax expenses | 8 | 10 | 26 | 16 | ||||||||||||||
| Net loss | 6,780 | 10,031 | 22,431 | 25,769 | ||||||||||||||
| Basic and diluted loss per share of Common Stock | 6 | 0.23 | 0.37 | 0.75 | 1.03 | |||||||||||||
| Weighted average number of shares of Common Stock outstanding, basic and diluted | 29,907,812 | 27,077,903 | 29,812,542 | 25,120,037 | ||||||||||||||
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BIOMX INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(USD in thousands, except share and per share data)
(unaudited)
| As of | ||||||||||
| Note | September 30, 2022 | December 31, 2021 | ||||||||
| ASSETS | ||||||||||
| Current assets | ||||||||||
| Cash and cash equivalents | 37,067 | 62,099 | ||||||||
| Restricted cash | 960 | 996 | ||||||||
| Short-term deposits | 3,500 | - | ||||||||
| Other current assets | 1,003 | 3,543 | ||||||||
| Total current assets | 42,530 | 66,638 | ||||||||
| Property and equipment, net | 5,034 | 5,694 | ||||||||
| Intangible assets, net | 382 | 1,519 | ||||||||
| Operating lease right-of-use assets | 3,955 | 4,139 | ||||||||
| Total non-current assets | 9,371 | 11,352 | ||||||||
| 51,901 | 77,990 | |||||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||
| Current liabilities | ||||||||||
| Trade accounts payable | 1,781 | 2,795 | ||||||||
| Other accounts payable | 2,023 | 5,453 | ||||||||
| Contract liability | - | 1,976 | ||||||||
| Current portion of operating lease liabilities | 687 | 819 | ||||||||
| Current portion of long-term debt | 4 | 2,989 | - | |||||||
| Total current liabilities | 7,480 | 11,043 | ||||||||
| Non-current liabilities | ||||||||||
| Contract liability | 1,976 | - | ||||||||
| Long-term debt, net of current portion | 4 | 11,799 | 14,410 | |||||||
| Operating lease liabilities, net of current portion | 3,882 | 4,787 | ||||||||
| Other liabilities | 206 | 215 | ||||||||
| Total non-current liabilities | 17,863 | 19,412 | ||||||||
| Commitments and Contingencies | 3 | |||||||||
| Stockholders’ equity | 5 | |||||||||
| Preferred Stock, $0.0001 par value; Authorized - 1,000,000 shares as of September 30, 2022 and December 31, 2021. No shares issued and outstanding as of September 30, 2022 and December 31, 2021. | - | - | ||||||||
| Common Stock, $0.0001 par value; Authorized - 120,000,000 shares as of September 30, 2022 and 60,000,000 shares as of December 31, 2021. Issued – 29,982,282 shares as of September 30, 2022 and 29,753,238 shares as of December 31, 2021. Outstanding – 29,976,582 shares as of September 30, 2022 and 29,747,538 shares as of December 31, 2021. | 2 | 2 | ||||||||
| Additional paid in capital | 157,471 | 156,017 | ||||||||
| Accumulated deficit | (130,915 | ) | (108,484 | ) | ||||||
| Total stockholders’ equity | 26,558 | 47,535 | ||||||||
| 51,901 | 77,990 | |||||||||
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BiomX Contacts
Investor Relations:
LifeSci Advisors, LLC
John Mullaly
(617)-698-9253
[email protected]
BiomX, Inc.
Anat Primovich
Corporate Project Manager
+972 (50) 697-7228
[email protected]
Source: BiomX Inc.
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Exhibit 99.2
© 2020 BiomX LTD. All rights reserved Company Introduction
Safe Harbor Statement 2 This presentation contains certain “forward - looking statements” within the meaning of the “safe harbor” provisions of the U . S . Private Securities Litigation Reform Act of 1995 . Forward - looking statements can be identified by words such as : “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that predict or indicate future events or trends or that are not statements of 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 middle of 2024 , the ability of our products to address unmet medical needs, the design, aim, expected timing and results of our preclinical and clinical trials and studies, including resumption of certain development programs, including whether we will be able to obtain funding for such programs, as well as our pipeline and the potential of our 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 .
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 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 • Therapeutics Development Award from the Cystic Fibrosis Foundation. • Biomarker discovery collaborations in IBD: Janssen (J&J) & Boehringer Ingelheim • Maruho ROFO 2 for rights in Japan to atopic dermatitis product candidate Partnerships Pipeline Financing and investors • Publicly traded ( NYSE:PHGE ) • Equity raised: $146M • Grants received: $6.3M • Current debt facility: $15M • Expected cash runway until at least middle of 2024 1. Inflammatory Bowel Disease (IBD) , Primary Sclerosing Cholangitis (PSC) 2. Right Of First Offer 4 ၬ Broad platform based on computational and synthetic biology capabilities • Focusing on cystic fibrosis; Expected to produce clinical data in 1Q23 • Additional programs in atopic dermatitis, IBD / PSC 1 & Cancer
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 Source: Kortright et al. ( 2019 ), Cell Host & Microbe 5
Oncology • Colorectal Cancer – F. nucleatum • Gastric Cancer – H. pylori Other • Acne – C. acnes • Liver Disease - E. faecalis Multiple potential applications of phage therapy 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 6
Phage discovery Preclinical Phase I Phase II Phase III Product Candidates Cystic fibrosis • BX004 Atopic dermatitis • BX005 Pipeline 7
platform allows clinical POC within 12 - 18 Our months 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 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, 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 bacterial 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 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 Discov ery CMC Tox Phase 1 Phase 2 Phage therapy Phage Ph cocktail ase 1/2 8
Cystic Fibrosis Upcoming milestone: Phase 1b/2a part 1 data expected in 1Q 2023 Program is supported by Cystic Fibrosis Foundation
Recurring infections leading to antibiotic resistance are a main cause of death in CF 1. CF Foundation, Bomberg et al., 2008 2. Vertex 10K filing 2020, internal estimates Phases of P. aeruginosa infection in CF 1 Antibiotics Antibiotics Antibiotics Antibiotics Initial Intermittent Chronic Antibiotics 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 10
25 CF patients already treated with phage under compassionate use • Indication - P. aeruginosa AMR lung infections • Location – 8 Yale University, 2 Georgia, 1 San - Diego • Administration – 10 nebulized, 1 IV phage 11 CF patients treated for P. aeruginosa 1 - 4 1. Kutateladze et al., 2008 2. Kvachadze et al., 2011 3. Law et al., 2019 4. Stanley et al., 2020 5. Dedrick et al. 2022 Yale cases: • 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 s 0.76 log reduction) • Outcome - FEV1% changed in a range of 0 to 8.9% Results demonstrate the safety of phage therapy and potential to decrease bacterial burden and improve clinical outcome 14 CF patients treated for Mycobacterium (20 patient total) 5 • Indication - Non - tuberculous Mycobacterium infections. Lung infections in all CF patients • Location – San Diego (UCSD) • Administration – 20 IV, certain patient also nebulized/topical/ other 11 UCSD cases: • eIND path for all patients • IV phage (+ additional for certain patients) • Twice daily for ~6 months (though a favorable outcome required improvement within 8 weeks) • Outcome - Favorable clinical or microbiological responses in 11/20 patients (for 5 patients infection was resolved)
BX004 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) 12
Phase 1b/2a study targeting P. aeruginosa with first readout expected in 3Q 2022 Phase 1b/2a – Part 1 Phase 1b/2a – Part 2 13 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 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 Data expected 1Q 2023 Data expected 3Q 2023
Atopic Dermatitis Upcoming milestone: TBD
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
BX005 eradicates S. aureus ( in vitro assay with 3 strains) 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 16 0.2 0.4 0.6 0.8 0 5 10 Time (hours) 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
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 , BX005 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 Age 40 - 59 20% Age 0 - 19 17 37% Age 20 - 39 3 2 3 % 2% Age 40 - 59 20% A A g e g e > 6 > 0 6 0 11 % 1 %
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 BX005/Placebo Applications Sampling First application Topical administration Baseline 8 wks 4 weeks 8 weeks Screening 12 wks Last application Post - dosing safety F/U 18
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