Foot Ulcer

Acquisition creates leading phage therapy company with an advanced pipeline that includes two Phase 2 assets, BX004 for the treatment of chronic pulmonary infections in cystic fibrosis (“CF”) patients and BX211for the treatment of diabetic foot osteomyelitis (“DFO”) Financing of $50 million will be used to advance the two lead product candidates through Phase 2 clinical readouts in 2025 CAMBRIDGE, Mass. and NESS ZIONA, Israel, March 18, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (together with its subsidiaries and/or associates, “BiomX”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the closing of its previously announced (March 6, 2024) acquisition (the “Acquisition”) of Adaptive Phage Therapeutics, Inc. (“APT”), a U.S.-based privately-held, clinical-stage biotechnology company pioneering the development of phage-based therapies to combat bacterial infections, and its previously announced $50 million private placement to certain institutional accredited investors, which was led by affiliates of Deerfield Management Company and the AMR Action Fund, and additional investors including the Cystic Fibrosis Foundation, OrbiMed and Nantahala Capital. “We are very pleased to announce the closing of the APT acquisition, which creates a leading phage company and an advanced pipeline that includes two Phase 2 assets each aimed at treating serious infections with unmet medical need,” said Jonathan Solomon, Chief Executive Officer of BiomX. “We also appreciate the continued support of leading institutional healthcare investors. Through this financing, we expect to have sufficient capital to reach multiple data readouts in CF and DFO over the next 12-24 months.” RBC Capital Markets and Laidlaw & Company (UK) Ltd. acted as placement agents for the private placement. Haynes and Boone, LLP served as legal counsel to BiomX. Cooley LLP served as legal counsel to APT. McDermott Will & Emery LLP served as legal counsel to Deerfield Management. Wilmer Cutler Pickering Hale and Dorr LLP served as legal counsel to the placement agents. About the Acquisition and the Private Placement The Acquisition was structured as a stock-for-stock transaction whereby all outstanding equity interests of APT were exchanged in a merger for 9,164,968 shares of BiomX common stock, 40,470 shares of Series X Preferred Stock convertible into 40,470,000 shares of BiomX common stock and warrants (“Merger Warrants”) exercisable for 2,166,497 shares of BiomX common stock. Upon the consummation of the Acquisition, a successor-in-interest of APT became a wholly-owned subsidiary of BiomX. The Merger Warrants will be exercisable at any time after the date of the receipt of BiomX stockholder approval at an exercise price of $5.00 per share and will expire on January 28, 2027. Concurrently with the consummation of the Acquisition, BiomX consummated its private placement financing with existing and new investors to raise $50 million, in which the investors purchased (i) an aggregate of 216,417 shares of Series X Preferred Stock and (ii) warrants (“Private Placement Warrants”) to purchase up to an aggregate of 108,208,500 shares of BiomX common stock, at a combined purchase price of $231.10 per share of Series X Preferred Stock and an accompanying Private Placement Warrant to purchase 500 shares of BiomX common stock. The Private Placement Warrants will be exercisable any time after the date of the receipt of BiomX stockholder approval, at an exercise price of $0.2311 per share, and will expire on the 24-month anniversary of the initial exercisability date. Subject to BiomX stockholder approval, each share of Series X Preferred Stock issued in the Acquisition and the private placement initially will be convertible into 1,000 shares of BiomX common stock, and subject to certain beneficial ownership limitations set by each holder not to exceed 19.99%. In connection with the execution of the definitive merger agreement, certain stockholders of BiomX (including its directors and officers), together holding on as converted basis over 50% of the outstanding shares of common stock of BiomX, have agreed to vote their shares in favor of the conversion of the Series X Preferred Stock. The securities sold in the private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws. BiomX has agreed to registration statement (the “Resale Registration Statement”) with the Securities and Exchange Commission (the “SEC”) registering the resale of (i) the shares of BiomX common stock issued pursuant to the Acquisition, (ii) the shares of BiomX common stock issuable upon conversion of the Series X Preferred Stock purchased in the private placement, (iii) the shares of common stock issuable upon exercise of all warrants issued in connection with the Acquisition and the private placement, (iv) the Series X Preferred Stock issued pursuant to the Acquisition and purchased in the private placement and (v) all warrants issued in connection with the Acquisition and the private placement (collectively, the ”Resale Securities”). Additional details regarding the private placement are contained in BiomX’s Current Report on Form 8-K filed with the SEC on March 6, 2024. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of securities of BiomX in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. Any offering of the Resale Securities under the Resale Registration Statement will only be by means of a prospectus. Additional details are available in an updated corporate presentation that can be found online at About BX004 BiomX is developing BX004, a fixed multi-phage cocktail, for the treatment of CF patients with chronic pulmonary infections caused by P. aeruginosa, a main contributor to morbidity and mortality in patients with CF. In November 2023, BiomX announced positive topline results from Part 2 of the Phase 1b/2a study where BX004 demonstrated improvement in pulmonary function associated with a reduction in P. aeruginosa burden compared to placebo in a predefined subgroup of patients with reduced lung function1. BiomX expects to initiate a randomized, double blind, placebo-controlled, multi-center Phase 2b study in CF patients with chronic P. aeruginosa pulmonary infections in the fourth quarter of 2024. The study is designed to enroll approximately 60 patients randomized at a 2:1 ratio to BX004 or placebo. Treatment is expected to be administered via inhalation twice daily for a duration of 8 weeks. The study is designed to monitor the safety and tolerability of BX004 and is designed to demonstrate improvement in microbiological reduction of P. aeruginosa burden and evaluation of effects on clinical parameters such as lung function measured by FEV1 and patient reported outcomes. Study results are expected in the third quarter 2025. The U.S. Food and Drug Administration (“FDA”) has granted BX004 Fast Track designation and Orphan Drug Designation. 1 Predefined subgroup of patients with baseline ppFEV1<70% About BX211 BX211 is a personalized phage treatment developed by APT for the treatment of DFO associated with S. aureus. The personalized phage treatment tailors a specific phage selected from a proprietary phage-bank according to the specific strain of S. aureus biopsied and isolated from each patient. DFO is a bacterial infection of the bone that usually develops from an infected foot ulcer and is a leading cause of amputation in patients with diabetes. The ongoing randomized, double-blind, placebo-controlled, multi-center Phase 2 study investigating the safety, tolerability, and efficacy of BX211 for subjects with DFO associated with S. aureus is expected to enroll approximately 45 subjects randomized at a 2:1 ratio to BX211 or placebo. BX211 or placebo is designed to be administered weekly, by topical and IV route at Week 1 and by the topical route only at each of Weeks 2-12. Over the 12-week treatment period, all subjects are expected to continue to be treated in accordance with standard of care which will include antibiotic treatment as appropriate. A first readout of study topline results is expected at Week 13 evaluating healing of the wound associated with osteomyelitis, followed by a second readout at Week 52 evaluating amputation rates and resolution of osteomyelitis based on X-ray, clinical assessments, and established biomarkers (ESR and CRP). These readouts are expected in the first quarter of 2025 and the first quarter of 2026, respectively. About BiomX BiomX is a clinical-stage 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. For more information, please visit , 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 concerning BiomX, APT, the private placement, the Acquisition and other matters. These forward-looking statements include, but are not limited to: future expectations, plans and prospects for BiomX following the consummation of the Acquisition; the use of proceeds from the private placement and the sufficiency of BiomX cash resources; stockholder approval of the conversion of the Series X Preferred Stock and the exercise of the warrants; the milestones of BiomX; the projected cash runway of BiomX; the status and plans for clinical trials, including the timing of data; future product development; the potential market for phage therapies; and the potential commercial opportunity of BX004 and BX211. 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 the safety, tolerability and efficacy of BX004 and its potential ability to treat CF patients, as well as the potential to advance the BX004 program to a larger, pivotal Phase 2b/3 trial, if such trial is initiated, including, among other things, timing, design, enrollment, regulatory approvals and funding of such trial, 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. 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 BiomX’s control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements, as a result of various important factors, including risks and uncertainties related to the ability to recognize the anticipated benefits of the Acquisition; the outcome of any legal proceedings that may be instituted against BiomX in connection with the Acquisition and related transactions; the ability to obtain or maintain the listing of the common stock of BiomX on the NYSE American; costs related to the Acquisition; changes in applicable laws or regulations; the possibility that BiomX may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and development, such as: adverse results in BiomX’s drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials, BiomX’s ability to enroll patients in its clinical trials, and the risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the FDA and other regulatory authorities; investigational review boards at clinical trial sites and publication review bodies with respect to our development candidates; our ability to obtain, maintain and enforce intellectual property rights for our platform and development candidates; our potential dependence on collaboration partners; competition; uncertainties as to the sufficiency of BiomX’s cash resources to fund its planned activities for the periods anticipated and BiomX’s ability to manage unplanned cash requirements; and general economic and market conditions. 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 29, 2023, and additional disclosures BiomX makes in its other filings with the SEC, which are available on the SEC’s website at 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. BiomX Contacts: Investor Relations: LifeSci Advisors, LLC Managing Director John Fraunces (917) 355-2395 jfraunces@lifesciadvisors.com, or LifeSci Advisors, LLC Brian Mullen (203) 461-1175 bmullen@lifesciadvisors.com BiomX, Inc. Anat Primovich Corporate Project Manager +972 (50) 697-7228 anatp@biomx.com Source: BiomX Inc.

Diabetes is now an epidemic, with 38.4 million people in America living with the condition and well over a quarter of the country (97.6 million) classified as having prediabetes. And like most public health crises, it isn’t affecting all communities evenly. Black, Native American, and Hispanic individuals experience diabetes at more than double the rate of White people due to a variety of systemic inequities and cultural factors. In some geographic areas, like Texas, the stark disparities are claiming thousands of limbs — and thousands of lives — due to complications from untreated foot ulcers that lead to lower extremity amputations and a resulting five-year mortality risk of nearly 60%. As The New York Times explained in a recent feature, Texas has one of the highest rates in the nation for diabetes-related amputations, accounting for approximately 52 per 100,000 hospital admissions. In places like San Antonio, which has a large Mexican American population, providers estimate that nearly half of adults over 40 are likely to have diabetes, contributing to the region’s excessive mortality rate tied to the condition. A large number of these people are uninsured or on Medicaid, are most comfortable communicating in languages other than English, and may have additional comorbidities on top of complex socioeconomic barriers. As a result, the highest-needs communities are incurring enormous costs to the healthcare system while still falling through the cracks. To change the trajectory of outcomes for people at risk of major complications from diabetes, health plans need to find innovative, proactive, and culturally sensitive ways to work with these groups. It starts with small, sustainable changes including building trustworthy relationships, communicating in the member’s preferred language and channel, and offering empathy and education to people living with diabetes. Building trust to encourage human engagement and therapy adherence Many communities of color have historical reasons to mistrust the modern healthcare system, leading to lower levels of engagement and delays in addressing clinical concerns. And as The New York Times notes, many people (especially men) face additional stigmas against the “weakness” of seeking out care for seemingly minor concerns, likely contributing to the fact that men in San Antonio are three times more likely than women to experience an amputation related to complex diabetes. Breaking through these misconceptions is key to connecting people living with diabetes with care and fostering relationships that encourage ongoing adherence to medications, self-monitoring, and collaboration with providers and health plans. Since it’s no secret that many members avoid picking up the phone when their health plan calls, Medicaid plans should consider getting creative about leveraging partners that are already trusted within the community. This could mean working with local religious organizations on blood sugar testing or foot check events; sponsoring a farmers market with classes about healthy swaps for traditional dishes; collaborating with social media influencers on the importance of preventive care; or working with providers, diabetes device manufacturers, and lifestyle coaching services to give members an easier on-ramp into managing their long-term health. Creating a trusted presence that shows understanding of the community and dedication to its well-being will be the first step toward building relationships and reducing social barriers to diabetes care. Communicating in a clear, culturally sensitive manner Converting awareness into actionable relationships depends on clearing communication hurdles, such as reaching patients via their preferred channels and in their preferred language. In areas like Texas, where close to 30% of residents speak Spanish at home, English-only communications are likely to be ineffective for a large number of people. Something as simple as making materials available in Spanish, as well as English, could have an outsized impact on care, as one Medicaid health plan serving multiple regions of Texas, including El Paso, quickly found out. After introducing Spanish language text messages, it took less than a year for hundreds of members to proactively reach out to clinical staff in their preferred language looking for support and insights specific to managing complications from diabetes. For another plan serving a highly culturally diverse population in the Northeast that speaks more than 20 primary languages, a language line offering a wide array of interpreters helped ensure that members could communicate freely with outreach staff from a diabetes remote monitoring device partner. The health plan prioritized collecting data on preferred languages up front to ensure that the right interpreter would be available to assist with building trust and improving engagement to boost outcomes over time. Educating with empathy to foster long-term relationships Once members are aware of the need for diabetes-centered care and open to engaging in the process, plans must provide actionable education, coaching, and services to prevent complications. Whether coming directly from a plan or from a partner, these interactions must be tailored to the needs of each individual and acknowledge the fact that not all members have the capacity or resources to stay on track with their care. In addition to using population health analytics to identify targeted socioeconomic vulnerabilities, plans can employ motivational interviewing techniques to establish a member’s baseline abilities to access and adhere to care. Working with an interpreter or on their own, outreach staff should ask open-ended questions about the member’s challenges, intrinsic motivations, and goals. These questions may reveal whether a member is feeling overwhelmed by their many health issues and is in need of extensive assistance or if they are frustrated by a specific barrier that can be easily addressed with an existing plan benefit. During these interactions, no matter how long they take, outreach staff should strive to make members feel like their top priority via active listening, empathy, and a collaborative approach to problem solving. In Texas and elsewhere in the country, meeting members where they are in their healthcare journey is essential for keeping lines of communication open and creating the right conditions for people to proactively seek out diabetes care. By employing culturally sensitive care and communications techniques and prioritizing the individuality of their members, health plans can effectively break down barriers and connect all people with the tools they need to live healthier, longer lives free of the complications of unmanaged diabetes. Flickr user moodboardphotography

SARASOTA, Fla., March 14, 2024 /PRNewswire/ -- Omeza®, a regenerative skincare company that develops marine-based therapies for the treatment of chronic wounds, today presented positive interim data from a diabetic foot ulcer (DFU) clinical trial showing that Omeza® OCM™ plus offloading of weight on the affected foot achieved a 91 percent area reduction (PAR) rate in DFUs within twelve weeks, and a 63 percent PAR within four weeks. PAR is considered a surrogate endpoint of complete wound healing, with a PAR of 50 percent at four weeks in diabetic wound patients considered a strong predictor of subsequent complete healing.1 The interim data are being presented at the Cellular, Acellular, and Matrix-Like Products Wound Care Summit (CAMPs) March 13-14 in Miami, and the completed data set demonstrating even stronger results is being submitted for publication in a peer-reviewed wound journal. "Diabetic foot ulcers are one of the leading causes of mortality, morbidity, and lower extremity amputations in patients with diabetes, and the medical community continuously strives to identify novel therapies to prevent or reduce these complications and their significant burden to patients, families, and the healthcare system at large," said Dr. Richard Simman, Professor of Plastic Surgery at the University of Toledo College of Medicine, Jobst Vascular Institute at ProMedica Health System in Toledo, Ohio. Promedica conducted the DFU clinical trial. "In evaluating Omeza®'s platform, the first twelve patients treated in the study demonstrated significant healing—and in some cases, complete closure—of their diabetic wounds in twelve weeks or less, which is a notable achievement, given the resistance to standard treatments that DFUs often display," said Simman, principal investigator at the Promedica clinical trial site. In the study, patients with DFUs were treated with OCM™, a drug/device containing cold water fish peptides and other pharmaceutical-grade components that create an absorbable matrix which conforms to the wound bed and supports the synthesis of new tissue. Patients also received standard of care, which included offloading—no weight-bearing by the foot—to support healing. By week four of treatment, the average PAR was 63 percent, with two patients achieving complete wound closure. By week twelve, the average PAR was 91 percent, with two additional patients achieving complete closure of their DFUs. Both of these cases were of ≥1 year duration prior to treatment with OCM™ and off-loading. No adverse events related to treatment were reported during the study. "We continue to be encouraged by the high rates of wound closure experienced by patients in our three studies that are currently underway, and we look forward to obtaining further confirmation of OCM's™ ability to treat advanced wounds from day one, as well as to transition chronic wounds from a stalled state to a healing state more quickly and completely than other products on the market," said Desmond Bell, DPM, Chief Medical Officer at Omeza®. "All of the components in our platform are natural, pharmaceutical-grade ingredients that are known to be safe and have been shown to harness an individual's innate immune processes to activate healing at the site of the wound," Bell said. "Our ongoing in vivo and in vitro studies will further elucidate the mechanisms of action that underlie the exciting results we're accumulating in clinical trials and the real-world setting." Reference: 1 (22)02154-1/fulltext About OMEZA Omeza is a commercial-stage regenerative skin and wound-care company that develops marine-based products comprising essential omega fatty acids and hydrolyzed fish collagen infused with cod liver oil. Founded in 2014, the company currently markets Omeza Complete Matrix (OCM™) designed to reduce inflammation, increase tissue proliferation, and support skin remodeling in adults with a range of chronic, non-healing wounds. Omeza is currently conducting three clinical trials in patients with diabetic ulcers, chronic venous leg ulcers, and multiple other etiologies to evaluate the effects of Omeza Combination Therapy versus standard of care on wound healing, pain reduction, quality of life, and additional secondary endpoints. The company is headquartered in Sarasota, Florida, and has research, manufacturing, and analytical facilities located throughout Florida. Media Contact: Bernadette Cupit [email protected] 908-334-4554 SOURCE Omeza LLC