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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):
September 26, 2024
BiomX Inc. |
(Exact Name of Registrant as Specified in its Charter) |
Delaware |
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001-38762 |
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82-3364020 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(I.R.S. Employer
Identification No.) |
708 Quince Orchard Rd, Suit 205
Gaithersburg, MD |
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20878 |
(Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s telephone number, including
area code: (844) 972-0500
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 |
|
PHGE.U |
|
NYSE American |
Common Stock, $0.0001 par value |
|
PHGE |
|
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 7.01 Regulation FD Disclosure.
BiomX Inc., or 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 September 26, 2024, 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 99.1 hereto. The
Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
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.
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BIOMX INC. |
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|
|
September 26, 2024 |
By: |
/s/ Jonathan Solomon |
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Name: |
Jonathan Solomon |
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|
Title: |
Chief Executive Officer |
2
Exhibit
99.1
R e v ol u tioni z i n g the T r e a tme n t of I n f e c t i o n s A s s oci a t e d wit h C hr onic D iseas e Th r oug h P ha g e Th e r a p y INVE S T O R P R ES E N T A T I ON SEP T EM BE R 2 0 24 N Y S E Ameri c a n : P HGE 1
SAFE H A RBOR STATEMENT A b ou t t h i s Pr e sent a t i on The information contained in this presentation has been prepared by BiomX Inc. and its subsidiaries (collectively, the “Company” or “BiomX”) and contains information pertaining to the business and operations of the Company. The information contained in this presentation is current only as of the date on its cover. For any time after the cover date of this presentation, the information, including information concerning our business, financial condition, results of operations and prospects, may have changed. The delivery of this presentation shall not, under any circumstances, create any implication that there have been no changes in our affairs after the date of this presentation. We have not authorized any person to give any information or to make any representations about us in connection with this presentation that is not contained herein. If any information has been or is given or any representations have been or are made to you outside of this presentation, such information or representations should not be relied upon as having been authorized by us. Fo r w a r d - L o o k i ng S t a t e m e n t s 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. For example, when we discuss future potential clinical trials, including their design, objectives, costs, endpoints, potential benefits and timing, the potential outcomes of discussions that we may have with the U.S. Food and Drug Administration and foreign regulatory agencies, potential commercial opportunities, our financial needs to fund future clinical trials and our ability to protect our intellectual property assets in the future we are making forward - looking statements. In addition, past and current pre - clinical and clinical results, as well as compassionate use, are not indicative and do not guarantee future success of BiomX clinical trials. 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. N o O ff e r or Sol i c i t a t i on This presentation is for informational purposes only. Nothing in this presentation constitutes an offer to buy or sell or a solicitation of an offer to buy or sell investments, loans, securities, partnership interests, commodities or any other financial instruments. This presentation and any oral statements made in connection with this presentation do not constitute and may not be used for or in connection with, an offer or solicitation by anyone in any state or jurisdiction in which such an offer or solicitation is not authorized or permitted, or to any person to whom it is unlawful to make such offer or solicitation. Tr a d e m a r k s a nd Se rv i c e M a r k s The trademarks and service marks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of such products. FDA This presentation concerns certain products that are under clinical investigation and which have not yet been cleared for marketing by the U.S. Food and Drug Administration. These products are currently limited by federal law to investigational use, and no representation is made as to the safety or effectiveness of these products for the purposes for which they are being investigated. 2 I NVE S TOR PR E S E NTAT I ON
3 AT - A - GLANCE Com pa ny Therapeu tic F o cus P i pel i ne Highlig h t s Unmet nee d Part ne r s Key Invest o rs Clinical stage biotech harnessing the therapeutic potential of phage therapy • Respiratory – Cystic Fibrosis (CF), Non - Cystic Fibrosis Bronchiectasis (NCFB) • D ia b e t ic F oo t Os t eo my eli t is ( D F O) • BX004 for CF – Positive results in P1b/2a study. P2b results expected in Q3 2025 • BX211 for DFO – Ongoing P2 study, results expected Q1 2025 Treatment of underlying persistent infections in chronic diseases that become harder t o tr e at as a n t ibio t ic - re s is t ant pa t ho ge n s emerge
4 OUR SCIENCE PHAGE T H ERAP I ES
Phage : N a ture’s tool to ta r get ba c teria Each phage binds only to specific bacterial strains 1 S P EC I FIC KIL L I N G MEC H A N ISM O R THOG ON A L TO A N TI B IOT I C S Lysin proteins burst bacterial cell wall from within 2 Phage can breakdown biofilm (a polysaccharide mesh secreted by bacteria) 3 B R EA K DO WN B IOF ILM Phage components multiply and assemble within bacterial cell 4 AMPLIFY 100s of compassionate use cases with no significant side effects to date 5 S A FE TY P R O FIL E 1. K o r t r i g h t et a l . (2 0 1 9 ), C ell H o s t & M i c r o b e 5
6 Ph a ge therapy picking up mo m entum >50 compassionate cases utilizing BiomX phage Lung i nfe c t i o n P ro s t h e t i c Joint Infection Osteomyelitis LVAD infection 1 Wound infection O the r Ph a g e B y Indi c a t io n Se p t . 2023 A ug. 2023 F e b . 2019 1. 2. LVAD - Left Ventricular Assist Devices Jean - Paul Pirnay et al. Nature Microbiology, Volume 9,, June 2024, 1434 – 1453 100 cases o f c o mpassi o n at e ph ag e t r e at m e n t ( B e lg ian c o n sort iu m ) 2 • 3 5 ho sp it als, 29 c it ies • Clinical imp r ov e m e nt r e port e d in 77% o f cases
Pe e r co mpa ny, po sit ive P2 Part 1 da t a , Aug . 2023 • 3 9 pat ient s • U r in ary t ra c k i n fe c t io n s 7 Accumulating clinical efficacy and safety data for phage therapy in t h e industr y 1 1 2 B io mX posit ive P1 b/2a Part 1 da t a , F e b. 2023 • 9 pa t ient s • Cyst ic F ib ros is Pe e r co mpa ny, po sit ive P 1 b/ 2 a da t a , M ar. 2023 • 3 2 pa t ient s • Cyst ic F ib ros is 3 4 B io mX posit ive P1 b/2a P art 2 d a t a, N ov. 2 0 23 • 3 4 pat ient s • Cyst ic F ib ros is 5 Expe c ted in 202 4 - 25 fr o m va rio u s phage companies: Eff ica c y da t a fr o m > 170 pa t ients in N CF B , DF O, PJI a n d B acte r e mia 2 1. 2. Press releases of BiomX and other companies developing phage therapies NCFB - Non - Cystic Fibrosis Bronchiectasis, DFO – Diabetic Foot Osteomyelitis, PJI – Prosthetic Joint Infections
Pipeline Partners Expected r eadout Phase II Phase I Preclinical Indication Program Ph 2 b to pli ne e xp ected Q3 2025 C yst i c Fib r osis BX004 (1) Non - Cystic Fibrosis Br on c hiec t asis (NCFB) BX004 Ph2 to pli ne e xp ected Q1 2025 and Q1 2026 Diabetic Fo o t Oste om yel i tis BX211 1. Granted Orphan Drug Designation and Fast Track by the FDA BiomX harnesses its proprietary platform to develop novel phage therapies to treat underlying persistent infections in chronic diseases that become harder to treat as antibiotic - resistant pathogens emerge 8
B X0 0 4 C Y S TI C F I B R OSIS and NC F B 9
Phases of P. aeruginosa infection in CF 3 Chronic pulmonary infections and the inflammatory response are a primary cause of death in CF patients Ant i bio t ic s Ant i bio t ic s Ant i bio t ic s Ant i bio t ic s Ant i bio t ic s Initial Intermittent Chroni c Cl o nal s ele c t i on Biofilm formation Genotype/phenotypic adaptation Infa nc y Ch i ldhood Adolescence / Adulthood Limit of de te c t i on P. aeruginosa density in sputum Lack of antibiotic efficacy driven by: 1. P. aeruginosa strains with multidrug res i sta n ce ( M DR ) 2. Formation of biofilm => making infection harder to treat 1. CF Foundation estimates across 94 countries ( https://www.cff.org/intro - cf/about - cystic - fibrosis ) 2. CFF Annual Data Report 2019, ECFS patient registry report, 2020 3. Ni c o l e M . B o u v i e r et al ., 2016 CF causes severe damage to the lungs, digestive system and other organs with > 80% of deaths from respiratory failure. 105K individuals are estimated to live with CF worldwide, with 33k in the US alone 1 After prolonged and repeated antibiotic courses, increased resistance to antibiotics has lowered efficacy, creating a large unmet need for CF patients suffering from chronic Pseudomonas aeruginosa (PsA) infections - Estimated at 17,000 patients in the US and Western Europe 2 10
Pseudo m onas aeruginosa (PsA) ba c teria a r e ass o ciated with decreased lung function (FEV1) in CF patients P s A c o loni za t io n asso cia ted wit h lo w er FEV 1 1 P s A c o loni za t io n asso cia ted wit h lo w er FEV 1 2 Era d ic a t e d – Cl e a r e d e a rl y / f irs t t ime PsA w h e n t r e a t e d with t h e a n t i b io t ic e r a d ic a t ion t r e a t m e n t C h ro n ic – D id n ot c l ea r e a rl y / f irs t t ime PsA i n f e c t ion w h e n t r e a t e d with t h e a n t i b io t ic e r a d ic a t ion treatment PsA bacteria and biofilm lead to persistent inflammation c a u s ing t iss u e dam a g e a n d e v e n t u a l l y n e c ros is of l u n g t iss u e 1. 2. Isabel Gascon Casaredi et al., Journal of Cystic Fibrosis 22 (2023) 98 – 102 Bjarnsholt et al., Trends in Microbiology 2013 Maya - Add image of biofilm formation by PsA in the lungs Check biofilm pathogenicity A rrows s how a gg r e g a te s of Ps A ( r e d ) wi t h in bio fi l m pa t c h e s s u rro u nded by in f l a mm a t ory c e l l s ( B l u e ) 11
P r o d u ct – Pro priet ary phage co ck t ai l targe t ing P s A Patient population – CF patients with chronic PsA lung infections D el i v e ry – N e bulized Key features – Potentially effective on antibiotic resistant strains, enables breakdown of biofilm Po t e n t i a l i m p a c t : • Suppression/eradication of PsA (CFU in sputum) • Im p roved lung f unc t io n (F E V 1) • F ew e r e x acerba t i o ns, ho spi t al izatio ns • Increased efficacy of antibiotic treatment • R ed uced o ral, inhaled and IV an t ibio t ic t rea t men t s 12 BX004 – BiomX’s proprietary phage cocktail has the potential to treat CF patie n ts wi t h chronic PsA lu n g inf e ctio n s BX004 N e b u li z er
Multicentered, double blind, placebo controlled study to asses safety, reduction of PsA burden and improvement in clinical outcomes 13 PH A SE 1 B / 2 A STUDY – Study desig n 1 • Saf e t y and t o l er ab i li t y • D ecr e as e i n PsA b urd en • F E V1 ( fo r c ed e x p i r at or y vo l ume) • C F Q - R ( C F Q ues t i on n ai r e - Revi s e d ) and C RISS Key Endp o ints: T o t a l en r o llme n t : 4 3 C F p at i en ts wi t h chronic PsA infections S t a n d a rd of ca re antibiotic, no r e st ri ctio n o n C F TR modulators Intervention: N e bulize d do se BX004 Part 1 7 days - Single a sc e nd i ng do se f o llo w ed by mu ltiple do ses 2 Treated – 7 subjects Control – 2 subjects Part 2 10 days o f same do se, tw ice daily Treated – 23 subjects Control – 11 subjects 1. S t u d y d es i g n i n f o r m ed b y i n p ut f r o m t h e C F F o u n d a t i o n 2. 7 days duration (3 ascending, 4 multiple dosing)
14 • S t udy drug was w e l l - t o le r at e d • In Part 1, Mean PsA CFU/g 1 reduction at Day 15: - 1.42 log10 CFU/g (BX004) compared to - 0 . 28 lo g 10 C F U/ g (p lac e bo ) • Culture conversion: Part 2, in the BX004 arm, 3 of 21 (14.3%) patients converted to sputum culture negative for PsA after 10 days of treatment compared to 0 out of 10 (0%) in the placebo arm 2 . In Part 1, 1 of 7 (14.3%) treated patients also had converted based on physician report • Part 2: BX004 showed signals of improvement in pulmonary function vs. placebo : Relative FEV1 3 improvement (5.67%) and CF Questionnaire - Revised respiratory 3 (8.87 points) at Day 17 (1 week after EOT 3 ) in subgroup of patients with reduced lung function 4 • Part 2: In full population, BX004 vs. placebo PsA levels were more variable. In a prespecified subgroup of patients on SOC 3 inhaled antibiotics on continuous regimen, BX004 vs. placebo showed bacterial reduction of 2.8 log10 CFU/g at EOT 3 , exceeding Part 1 results Phase 1b/ 2a – Resu l t highli g hts (P a rts 1 and 2) 1. CFU – Colony forming units 2. In patients that had quantitative CFU levels at study baseline 3. FEV1 (or ppFEV1) – percent predicted forced expiratory volume in 1 second, CF Questionnaire - Revised Respiratory – a PRO (Patient reported outcome) for respiratory parameters in CF aptients, EOT – End of treatment, SOC – standard of care 4. Predefined group with Baseline FEV1<70%
15 PART 1 BX004 demonstrated greater reduction in PsA levels comp a red to placebo Placebo BX004 2 7 n - 0 . 2 8 ( 0 .1 3 ) - 1. 4 2 (1. 03 ) Mean redu c tion (SD) Log 10 CFU/g - 0.3 7 , - 0. 1 8 - 3. 27 , - 0.37 M a x, Min 1. CFU – Colony forming units
In the BX004 arm 3 out of 21 (14.3%) patients converted to sputum culture negative for P. aeruginosa after 10 days of treatment (2 already after 4 days) 2 . In the placebo arm 0 out of 10 (0%) 2 16 PART 2 BX004 showed greater conversion (bacterial culture turned negative) in treatment over placebo B a se li n e Ps A 1 in s p utum (CF U / g) Durati o n o f PsA i n f e cti o n (y e ars) Patient 2.40x10 3 18 1 5.60x10 7 13 2 1.09x10 7 35 3* *Subject had negative sputum culture for P. aeruginosa at D4, D10, D28, D38, and at follow - up standard of care clinic visits (D63, D150, and D175) In addition, in Part 1 of the study, one subject in the BX004 arm (1/7: 14.3%) who was persistently positive for PsA for at least 13 years had a 3.3 log reduction at D15 later converted to sputum negative 1. PsA – Pseudomonas aeruginosa, CFU/g – Colony forming units per gram 2. In patients that had quantitative CFU levels at study baseline Pa t ien t s which wer e co nver t ed :
PART 2 BX004 shows meaningful clinical improvement after 10 days of treatment in multiple clinical readouts C l in ical i mprovement s were o bse r ved o n bo t h obje c t ive & pat i e nt r e port ed outcomes Cli n ical r e ado uts in pat ient s wit h r e du c e d bas e line lung f u n c t io n (p r e defin e d g roup, ppFEV1 of < 70%) Difference Placebo ( N= 8) 2 BX004 (N=12) 2 3.29 - 4. 8 6 ( 3.3 9) - 1 . 57 ( 2. 64) D10 5.67 - 4. 2 1 ( 2. 7 8 ) 1 . 46 ( 2.33 ) D17 2.19 - 1 . 12 ( 3. 96) 1 .0 7 ( 2.32 ) D28 5.3 - 0. 62 ( 3. 6 5 ) 4.68 ( 3.28 ) D38 Difference Placebo (N=8) 3 BX004 (N=12) 3 8.87 - 6. 3 5 ( 3. 4 5 ) 2. 52 ( 2. 61) D17 7.07 - 5 . 56 (4. 0 5) 1 . 51 (5 . 1) D38 ppFEV1 change from Baseline: Mean(SE) CFQR respiratory change from Baseline: Mean(SE) Treatment 5 . 67 % Follow u p ppF EV 1 BX004 Placebo Treatment Follow u p CFQR 1 (respiratory) 8 . 8 7 BX004 Placebo # #: p=0.07 1. PRO (Patient reported outcome) - CF Questionnaire - Revised for respiratory parameter 2. 2. BX004: D38 N=7, Placebo: D28 N=7, D38 N=6 3. 3. BX004: D17 and D38 N=11, Placebo: D17 and D38 N=7 17
International, multicenter, double blind, placebo controlled study to assess reduction of PsA burden and improvement in clinical outcome 18 PH A SE 2B STUDY – Study design • Decrease in PsA burden (incl. Culture conversion/eradication) • F E V1 ( fo r c ed e x p i r at or y vo l ume) • C F Q - R ( C F Q ues t i on n ai r e - Revi s e d ) and C RISS • Saf e t y and t o l er ab i li t y Key Endp o ints: T o t a l en r o llme n t : O b j e c ti ve: ~6 0 C F p at i en ts wi t h chronic PsA infec ti o n s S t a n d a rd o f care antibiotic, no r e st ri ctio n o n C F TR modulators Intervention: N e bulize d do se BX004 Part 2b 2 mo nt hs of same d o se, t w ice daily Treated (n=40) Control (n=20) Ra n do mi z ed 2 :1 Topline r esu l ts ex pe cted in Q3 2 0 25 *Subject to discussions with FDA, and further consultation. Number of subjects under the study stated is an objective and actual numbers may vary
19 B X004 is a pro m ising c a ndidate for treating NC F B N o n Cyst ic Fibro sis B ro nc h ie c t a sis (N CFB ) is a c h ron ic pro g r e ssi ve in flammat o ry lung disease wit h > 1 milli o n di ag n o sed pa t ient s (US , 5 EU an d Japan) 1 Ch ara c t e riz e d by p e rman e n t dilat atio n of th e b r on c hi c a used by m ulti pl e e t iolo g ies but wit h similar sympt o ms N o F D A ap pro v e d t r e at m e n t s. Insmed r e c e n t ly an n o unc e d po si t ive r e sults wit h brenso c at ib ( r ev e rsib le in h ib it o r o f dip e p t id yl pept id ase 1) fo r t r e at m e n t of N CFB NCFB pa t ients infect ed w it h P s A pres ent w o rse clinical symp t o ms co mpa red to no n - infect ed pa t ients More frequent inpatient and outpatient encounters in NCFB patients positive for PsA 2 • P s A – P s e ud o m o n as A e ru g i n o s a, IP: In P a t i e n t • Based on 19,254 NCFB patient registries in the US between 2006 - 2020, IQVIA’s PharMetrics Plus database Inpatient encounters within 1 year Outpatient encounters within 1 year 1.. Weycker, Chron Respir Dis. 2017, Quint, European Respiratory Journal, 2016, Ringshausen, European Respiratory Journal, 2019, Henkle, Chest, 2018, Asakura, American Journal of Respiratory and Critical Care Medicine 2024, Insmed Commercial Presentation June 4th, 2024 2. F r a n k l i n et . a l , J M E , A p r 2 0 24 - P s A p o s it ive ( N =1 ,1 80) - P s A n ega t ive ( N =1 8,07 4 ) - P s A p o s it ive ( N =1 ,1 80) - P s A n ega t ive ( N =1 8,07 4 )
BX211 Diab e ti c F o o t O s t e o m y elitis (DFO) 20
• Hospitalization and off - loading (removing all pressure from foot, reducing patient mobility) • Debridement and/or antibiotic therapy, typically 4 - 6 weeks of IV/oral antibiotics High unmet need in D F O T r u o n g 2 0 22; G iu r a to , 2 0 17 DFO is a bacterial infection of the bone in patients with diabetes that is caused by bacteria spreading from adjacent infected soft tissue 1. Sup e r f i c i al ulcer 2. U l c er d e e p e n s e x t e n d i ng t h r ough s ubcu t i s , and b ecomes i n f ect ed 3. D F O – U l c er and i n f ect i on fu r t h e r p e n etrate and r each b on e , d i s p l ay i ng d es t r uc t i on of p e r i os t eum St ap h y l oco c c us aureus i s t he mos t c ommon b act eria p r es e n t i n D F O Infection r ea c h e s bon e S tanda r d o f car e 30 - 4 0 % of DFO c as es r esult i n a m p uta t i on 21
Biofilm and antibiotic resistance among key drivers of treatment failure Key d rivers o f t rea t ment f a ilure: • Biofilm - S. aureus inhabiting biofilms are 10 to 1,000 - fold more resistant to antibiotics, compared to planktonic cells • Poor blood supply limits effective concentration of IV/oral antibiotics • An t ib io t ic r e sis t an c e • S . a u r e u s pr e s e nt in ~ 50% of DFO c as e s • While other organisms are often present, S. aureus is considered the main pathogenic species, due to its rapid do ublin g t ime an d ars e n al of v irul e n c e facto rs S. au r e us f o rms biofilm pat c h es in d iab e tic f o o t ulc e rs Con f o c a l l a s e r s c a nn ing m i c ros c opy of s o f t t iss u e f rom pa ti e n t wi t h di a be t ic f oot u l c e r in fe c te d by S. a u r e u s S. a u r e u s ba c te ri a ( g r e e n ) B a c te ri a l bio fi l m s , EPS ( blu e ) Host c e ll n u c l e i ( r e d ) Eleftheriadou, 2010 Lesens 2011 Neut 2011 Oates 2012 Kavanagh 2018 Sharma 2023 22
23 Multiple compassionate treatments of DFO patients demonstrate potential for phage treatment Fish 2017, Fish 2018, Suh 2022, Onallah 2023 11 Osteomyelitis cases (not DFO, various bacteria) Treatment Bacteria No. o f c ases IV, 11 days A.baumanii and K. pneumonia 1 IV 2 weeks or direct application, 7 - 12 days P. aeruginosa 5* Direct application, 7 - 10 days P. aeruginosa and S. epidermidis 2 Direct application, 7 days E.faecalis 1 Direct application, 9 days S.agalactiae and S aureus 1 IV S.aureus 1* Outcome - at least 8 reported as clinical recovery 12 DFO c a se s ( S. a u r e u s ) 9 pa t ient s • S in g le ph ag e agai n st S a u r e us • T o pi c al app licatio n or in j e c t io n to bo n e , su r round in g t iss ue • 3 - 7 w e e kly appli c ations • Olympia, Wash in g t o n 3 pat ient s • Admin is trat io n – D ir e c t appl icati o n • 6 - 45 days of app licatio n • Je rusale m , Isra e l O u t co me (in 11 o u t o f 12 pa t ients) o Clearance of soft tissue infection and DFO o Wound h e alin g o Pre ve n t e d amputa t io n
BIOPSY 24 BX211 phage treatment for DFO patients with S. aureus • Product – Phage treatment targeting S. aureus. Phage, originating from a ‘phage - bank’, are personally matched for each patient • Patient population – DFO patients with S. aureus infection • D el i very – IV + to pi c al • Trea t ment - On to p o f st andard o f c are • Key features – Is potentially effective on antibiotic resistant strains, enables breakdown of biofilm, and improves antibiotic penetration • Potential impact: (1) Prevent amputations (2) Shorten time to healing 1 CULTURE 2 M A T CH PH A G E T O S . A U R E U S ISO L A TE Pro prietary Ph ag e S us ce p t ib ili t y T e st (P S T ) pl atfo rm 3 S . aur e us bact e rial c ulture Ph ag e - ban k ‘A T M - like’ di sp e n sin g syst e m P H A G E THE RA P Y A C CES S E D A T HOSP I T A L 4
Multicenter, double blind, placebo controlled study to assess improvement of clinical outcomes 25 PH A SE 1 B / 2 A STUDY – Study design Topline results from week 26 expected in Q1 2025, and from week 52 expected in Q1 2026 En ro llme n t : O bj ectiv e : Up to 45 patients wit h D iab e t ic F oo t Ost e o m y e li t is po si t ive fo r S . a u r e us B ac k g round st an dard o f c are an t ib io t ic Intervention: IV & t o pi c al sin g le dose 1 BX211 Treatment Control Ra n do mi z ed 2 :1 D u ra tio n: 12 w e e ks o f on c e w e e kly t r e at m e n t 1 W eek 13 (r e a d o ut 1) W eek 52 (r e a d o ut 2) 12 weeks • Percent area reduction of study ulcer through Week 13 • T i me t o c om p l ete ulcer h e ali ng • T i me t o 8 5% C RP 2 r e d uc t i on Key Endp o ints: • P er c e n t age of s ubject s w i t h am p ut at i on - f r ee s urvi val at W e ek 52 • Saf e t y and t o l er ab i li t y 4 0 weeks F/ U F/ U 1. T o p ic a l f or 12 w e e k s , I V o n ly in w e e k 1 2. C - r e a c t i v e p rot e in
FI N A NCIN G A ND INVESTORS UN M ET NEED • In several chronic diseases, such as CF, NCFB, and diabetes, underlying related infections become harder to treat as resistant pathogens emerge • Accordingly, the need for new antimicrobial therapies becomes more urgent every year PHA GE TH ER A PY - PICKING UP M O M ENTU M • BiomX and peer companies have shown evidence of clinical effects with phage therapy • H un d r eds of c ases of co m p assi ona t e usa ge of p h a g e B X 2 11 • Diabetic Foot Osteomyelitis (‘DFO’) patients represent the majority of 160K lower limb amputations in diabetic patients annually in the US 3 . Potential commercial opportunity of > $ 2 b illi on w o r l dw i d e 3 • Phase 2 ongoing, readout expected in 1Q25 • Pseudomonas aeruginosa (‘PsA’) lung infections are a leading cause of morbidity and mortality In C F. P otent ial c o mm e r c ial o pp o r tuni ty o f > $ 1. 5 bi lli o n w o r l d w i d e 1 • Positive results in a Phase 1b/2a study - 14.3% of patients in the BX004 arm converted to sputum culture negative for PsA after 10 days of treatment compared to none in the placebo arm 2 • Pha se 2 b r ead o u t expect ed 3 Q 25 B X 004 • P u b li c l y t r ad ed ( N YSE A m e r i c a n : PH G E ) • $32.7 million cash and cash equivalents as of June 30, 2024 Sum m ary 1. S ee s li d e 2 8 2. In patients that had quantitative CFU levels at study baseline 3. S ee s li d e 2 9 • Key investors: 26
Thank you
28 BX004 CF addressable market of > $1.5 billion worldwide References/Comments BX004 Num b er of CF p at i e nt s wi t h chronic PsA infec t i o n s 1 ~8,000 P at i e n t p o p ul at i o n (US) Magnitude observed under tobramycin Phase 3 study was ~1.5 - 2 l o g 2 Suppression/eradication of PsA (CFU in sputum) Pote nt ial e f f ect on Ps A C F U in lungs Magnitude observed under tobramycin Phase 3 study was 8 - 12% 2 I m p rov e d lu n g fu n ction (FEV1) Pote nt ial im pa ct on lu n gs Benchmarks (cost annually per patient): Trikafta: $300K, alternating antibiotics treatment, Tobi Podhaler and Cayston solution: $80K, Arikayce for MAC: $100 - 120K 3 $100K - $1 2 0K ann ually p er pat i e n t Pote nt ial pricing in t h e US US pat i e n t p o p ul at i o n t i m es p o t e nt ial p rici n g ~$1 B ill i on in the US a l one (worldwide $1.6 b illio n ) 4 Mar k et p o t e nt ial 1. 2. 3. 4. CFF 2019 Patient Registry Annual Data Report See slide on Tobramycin study Trikafta and Arikayce – Publicly announced pricing, First Databank, Jan. 8, 2021, public pricing information. for alternating Tobi Podhaler and Cayston solution assumes 65% compliance Assumes rest of the world outside US comprises 40% of total market (Vertex annual report, publicly available pricing for Vertex drugs)
References/Comments BX211 Lower limb amputations (LLA), diabetic patients annually, US 1 160,000 Ge n eral pat i e n t p o p ul at i o n De d uc t i o n s d ue t o 2 : - 85% of a m p ut a t i o n a re d ue t o D F O - 50% p ositive for S. a ur e us - 60% n ot urge n t a m p ut a t i o n s, e nab li n g b i o p sy a n d treatment 85% X 50% X 60% = 2 5 % 40,000 ( 2 5% of 1 60 , 000) Assu m ed r e l e va n t p o p ul at i o n f or BX 2 1 1 treatment Ba sed on 50% of th e s a v e d $50K a m p ut a t i o n cos t s 3 $25,000 Pricing 40K t i m es $2 5 K $1 B ill i on Rel e va n t m a rket for BX 2 1 1, US ROW is over $1 billion, based on the following: . Annual incidence of LLA in the OECD is 3 - 4 higher than the US 4 Assu m ing OECD p rici n g is 50% of US p rici n g. >$2 B ill i on Rel e va n t m a rket for BX 2 1 1, W orl d wi d e 29 BX211 DFO addressable market of >$2B worldwide 1. (1) CDC National Diabetes Statistics Report, 2020 (2) Brooks, 2021; Giurato, 2017, Lesens, 2014 (3) Nilsson, 2018; Brooks, 2021 (4) Hughes, 2020; OECDiLibrary Diabetes care report,2017
30 JON A THA N S O L OM ON | C E O & B O A RD M E MB E R Prior to his role in BiomX, Mr. Solomon was a co - founder, president, and CEO of ProClara (formerly NeuroPhage), which is pioneering an approach to treating neurodegenerative diseases. Under his leadership, the company raised more than $100 million and launched an ongoing clinical trial related to Alzheimer’s disease. Mr. Solomon holds a B.Sc. magna cum laude in Physics and Mathematics from the Hebrew University, an M.Sc. summa cum laude in Electrical Engineering from Tel Aviv University, and an M.B.A. with honors from the Harvard Business School. M E RA V B A SS A N , P H D | C D O Dr. Bassan was most recently Vice President Head of Translational Sciences at Teva Pharmaceutical Industries, Inc., where she was responsible for early stages of clinical development via translation from animal data to human. Prior to this role, Dr. Bassan served as Vice President of Project Leadership at Teva Pharmaceutical, where she managed project leaders overseeing end - to - end drug development at pre - clinical, PI - III and post marketing stages in multiple therapeutic areas, such as pain, oncology, women‘s health, endocrinology, GI, biosimilars and other areas. Overall, Dr. Bassan has over 20 years of leadership experience with clinical and drug development teams in her various roles at Teva Pharmaceutical and other smaller biotech companies. M A R I N A WOL FS ON | CFO Marina Wolfson has served as the Senior Vice President of Finance and Operations of the Company since December 2019. Ms. Wolfson’s experience includes working with large pharmaceutical and hi - tech companies, as well as venture capital funds. Prior to joining the Company, Ms. Wolfson worked as Vice President of Finance at BioView Ltd. (TASE) from 2010 to 2019 and a senior auditor at Ernst & Young, an international auditing and business advisory firm 2007 to 2010. Ms. Wolfson is a certified public accountant in Israel and holds a B.A in Economics and Accounting (with honors) and an MBA (with honors, specializing in finance) from Ben - Gurion University. Execu t ive team
31 MIC H AE L B I L L A RD | General Manager, U.S . Mr. Michael Billard has over twenty - years of experience in biotech, pharma, and consumer product development. He served as VP, Project Execution at Adaptive Phage Therapeutic since September 2020, which was acquired by the Company in March 2024. Prior to that, he held senior leadership roles at Propella Therapeutics, Inc., Paragon Bioservices and DSM Nutritional Products (formerly Martek BioSciences) along with project management positions at MedImmune, Inc. and Baxter Healthcare Corporation. Mr. Billard earned his Master of Science in Biotechnology from Johns Hopkins University. I N B A L B E N JAMI N I - E LRAN | C H RO Ms Benjamini - Elran has over 15 years of experience in executive HR roles in global and diverse environments. At Teva Pharmaceuticals Industries Inc (NYSE:TEVA) she served in various senior roles including Director of HR of the European HQ (Netherlands) and HR manager of R&D API division. Her most recent experience was as Head of HR at Herzog, one of the largest law firms in Israel and as an independent HR consultant, advising a variety of companies in the Israeli hi - tech and biotech sectors. Ms. Benjamini - Elran holds an MBA from Bar - Ilan University and a BA in behavioral science from Ben - Gurion University. Executive team (cont’d)
32 RUS SELL G . GR EIG, PH.D. CHAI R MAN OF TH E B OAR D OF DI R E CTOR S Russell G. Greig, Ph.D. worked at GlaxoSmithKline for three decades, most recently as President of SR One, GlaxoSmithKline’s corporate venture group. Prior to joining SR One, he served as President of GlaxoSmithKline’s Pharmaceuticals International from 2003 to 2008 as well as on the GlaxoSmithKline corporate executive team. Currently, Dr. Greig serves as Chairman of MedEye Solutions in the Netherlands, eTheRNA in Belgium and Sanifit in Spain. A L A N M O SES , M D DIRECTOR Alan Moses, M.D., was co - founder and co - director of the Clinical Investigator Training Program at Beth Israel Deaconess - Harvard Medical School - MIT. Dr. Moses served as Senior Vice President and Chief Medical Officer of the Joslin Diabetes Center in Boston. He was appointed Professor of Medicine at Harvard Medical School. Over the course of 14 years at Novo Nordisk, Dr. Moses served in multiple roles, rising to the position of Senior Vice President and Global Chief Medical Officer. ED D IE W IL L I A M S DIRECTOR Mr. Eddie Williams is a well - recognized, senior global life sciences executive with extensive boardroom and commercial operations experience. He most recently served as a Special Advisor to the Chief Executive Officer of Ascendis Pharma, Inc., and previously as their interim U.S. Chief Commercial Officer. J O N A TH A N SOL O M O N DIRECTOR Prior to his role in BiomX, Mr. Solomon was a co - founder, president, and CEO of ProClara (formerly NeuroPhage), which is pioneering an approach to treating neurodegenerative diseases. Under his leadership, the company raised more than $100 million and launched an ongoing clinical trial related to Alzheimer’s disease. Accounting Officer prior to being appointed to the CFO position in 2021. J O N A TH A N L EFF DIRECTOR Jonathan Leff is a Partner on the Therapeutics team at Deerfield and Chairman of the Deerfield Institute, and joined the Firm in 2013. He focuses on venture capital a n d s t r u c t u r e d inv e s t m e n t s in bio t e c hn olo g y a n d ph a rm a c e u t i c a ls. He is a member of the Boards of several public and private healthcare companies as well as several not - for - profit organizations, including the Spinal Muscular Atrophy Foundation and the Columbia University Medical Center. GR EG M ER R IL DIRECTOR Mr. Greg Merril is a serial life - science entrepreneur, recognized by Ernst & Young as a regional Entrepreneur of the Year winner. He has served as Chair of several international phage therapy conferences. As prior founding CEO of Immersion Medical (NASDQ: IMMR) he led the creation of the world’s first commercially successful virtual reality surgical training simulators. JESSE G O O D M A N, M D , M PH DIRECTOR Jesse Goodman, M.D., M.P.H. is Professor of Medicine at Georgetown University and Director of the Center on Medical Product Access, Safety and Stewardship wh i c h f o c u s e s on s c i e n c e a n d pol i c y t o a dd r e ss p u blic h e a l t h n ee ds inc l u ding antimicrobial resistance. He is Attending Physician in Infectious Diseases at Georgetown University, Washington DC Veterans Administration and Walter Reed Medical Centers. SU SAN B L UM DIRECTOR Ms. Blum is the Chief Financial Officer of Melinta Therapeutics, LLC. (“Melinta”), a company focused on the development and commercialization of innovative therapies for acute and life - threatening illnesses. She joined Melinta in 2016 as the company’s Controller, and then served as Vice President of Finance & Chief Board of di r ectors
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