Infant, Newborn, Diseases

REDWOOD CITY, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) in mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), today announced that the first patient has been dosed in Jasper’s Phase 1b/2a (SPOTLIGHT) clinical study of subcutaneous briquilimab for the treatment of CIndU. The SPOTLIGHT study is evaluating a single administration, at two different dose levels, of subcutaneous briquilimab in adult patients with cold urticaria (ColdU) or symptomatic dermographism (SD). “We are excited to announce dosing of the first patient in the SPOTLIGHT study in patients with CIndU, our second clinical program evaluating briquilimab in a mast cell-mediated disease,” said Edwin Tucker, Chief Medical Officer of Jasper. “As with our BEACON study in CSU, we expect the SPOTLIGHT study to establish proof of concept for the depletion of mast cells by briquilimab in CIndU and help us to determine doses and dosing regimens for future registrational studies. We plan to provide enrollment updates as we progress through the study and anticipate reporting preliminary data in the second half of 2024.” The SPOTLIGHT study is expected to enroll approximately 15 patients across 2 dose cohorts. The primary endpoints are safety and tolerability of briquilimab with secondary endpoints focused on efficacy measures and pharmacokinetics. The study is being conducted at four sites in the EU. Jasper anticipates reporting preliminary data from the SPOTLIGHT study in the second half of 2024. “c-Kit inhibitors are a promising class of monoclonal therapeutics with demonstrated efficacy in mast cell driven diseases,” said Marcus Maurer, M.D., Professor of Dermatology and Allergy at Charité – Universitätsmedizin in Berlin. “As a potent and differentiated c-Kit inhibitor, I believe briquilimab has the potential to serve as an important treatment option for patients suffering from CIndU, and I look forward to enrolling patients into the SPOTLIGHT study and additionally into the BEACON study for CSU.” About Briquilimab Briquilimab (formerly JSP191) is a targeted aglycosylated monoclonal antibody that blocks stem cell factor from binding to the cell-surface receptor c-Kit, also known as CD117, thereby inhibiting signaling through the receptor. This inhibition disrupts the critical survival signal, leading to the depletion of the mast cells via apoptosis which removes the underlying source of the inflammatory response in mast cell driven diseases such as chronic urticaria. Jasper is currently conducting clinical studies of briquilimab as a treatment in patients with CSU or with CIndU. Briquilimab is also currently in clinical studies as a treatment for patients with LR-MDS and as a conditioning agent for cell therapies for rare diseases. To date, briquilimab has a demonstrated efficacy and safety pro more than 145 dosed participants and healthy volunteers, with clinical outcomes as a conditioning agent in severe combined immunodeficiency (SCID), AML, MDS, FA, and sickle cell disease (SCD). About Jasper Jasper is a clinical-stage biotechnology company developing briquilimab, a monoclonal antibody targeting c-Kit (CD117) as a therapeutic for chronic mast and stem cell diseases such as chronic urticaria and lower to intermediate risk MDS and as a conditioning agent for stem cell transplants for rare diseases such as SCD, FA and SCID. To date, briquilimab has a demonstrated efficacy and safety pro more than 145 dosed participants and healthy volunteers, with clinical outcomes as a conditioning agent in SCID, AML, MDS, FA, and SCD. For more information, please visit us at . Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding briquilimab’s potential, including with respect to its potential in mast cell driven diseases such as CSU and CIndU and its potential to serve as an important treatment option for patients suffering from CIndU; Jasper’s expectations regarding its Phase 1b/2a SPOTLIGHT study of subcutaneous briquilimab in CIndU, including the expected enrollment, cohorts and site locations, the expected timing for reporting preliminary data, the expectation that the SPOTLIGHT or BEACON studies will establish proof of concept or help Jasper determine doses and dosing regimens for future registrational studies; and Jasper’s expectations regarding its BEACON study in CSU, including the expectation that Jasper will enroll additional patients in the BEACON study for CSU. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Many actual events and circumstances are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that prior study results may not be replicated; the risk that Jasper’s product candidates may not be beneficial to patients or successfully commercialized; patients’ willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper’s business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jasper’s business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics; the risk that Jasper will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; and other risks and uncertainties indicated from time to time in Jasper’s filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or Jasper’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jasper’s assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements. Contacts: Joyce Allaire (investors) LifeSci Advisors 617-435-6602 jallaire@lifesciadvisors.com Alex Gray (investors) Jasper Therapeutics 650-549-1454 agray@jaspertherapeutics.com Lauren Walker (media) Real Chemistry 646-564-2156 lbarbiero@realchemistry.com

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.

Poster presentations to highlight new quantitative and serologic diagnostic methods for Celiac Disease detection and determination of intestinal mucosal health New tools may serve as companion diagnostics for identifying seroactive patients and for monitoring the efficacy of Latiglutenase, the Company’s Celiac Disease therapeutic program BOCA RATON, Fla., March 18, 2024 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that two abstracts have been accepted for presentation at the 2024 Digestive Disease Week Conference (DDW 2024) taking place May 18-21, 2024, in Washington, D.C. The first presentation, titled, “A Composite Mucosal Scale for Celiac Disease Encompassing both Morphology and Inflammation,” will highlight VCIEL, a new quantitative composite scale, combining the histologic scales of villus height to crypt depth ratio (Vh:Cd) and density of intraepithelial lymphocytes (IEL), designed to enhance the accuracy and precision for measuring small intestinal mucosal health of celiac disease (CeD) patients with particular benefit for histologic endpoint measurements in clinical trials. The second presentation, titled, “Dynamics of Serologic Change to Gluten in Celiac Disease Patients,” will report research involving the largest database of CeD clinical results and will explore key issues related to the diagnostics of CeD, such as the effects of resuming a gluten-containing diet on seropositivity and the correlation between two different tTG-IgA assays. “The abstracts accepted for presentation at DDW 2024 showcase significant advancements in the field of gastroenterology, particularly in the precision diagnosis and management of celiac disease through the innovative VCIEL scale that our team has developed,” stated James Sapirstein, Chairman and CEO of First Wave BioPharma. “The invitation to present our findings on the VCIEL scale for measuring mucosal health of the small intestine as well as our research on the impact of gluten reintroduction as a diagnostic intervention for serologic measurements at one of the most influential meetings on gastrointestinal disease validates the potential for our work to advance better understanding and treatment of celiac disease,” said Jack Syage, PhD, President and Chief Operating Officer of First Wave. Details on the presentations are as follows: Presentation Title: A Composite Mucosal Scale for Celiac Disease Encompassing both Morphology and Inflammation Presenters: Jack Syage, PhD. President & Chief Operating Officer, First Wave BioPharma Jennifer Sealy-Voyksner, PhD., Vice President R&D, First Wave BioPharma Session Title: Celiac Disease and Gluten Related Disorders Date and Time: May 19, 2024, from 12:30 PM to 1:30 PM EDT Presentation Title: Dynamics of Serologic Change to Gluten in Celiac Disease Patients Presenters: Jack Syage, PhD. President & Chief Operating Officer, First Wave BioPharma Jennifer Sealy-Voyksner, PhD., Vice President R&D, First Wave BioPharma Session Title: Celiac Disease and Gluten Related Disorders Date and Time: May 19, 2024, from 12:30 PM to 1:30 PM EDT About Celiac Disease Celiac disease is a chronic, hereditary autoimmune and inflammatory disease triggered by gluten consumption. Celiac disease is characterized by damage to the lining of the small intestine, causing malabsorption, gastrointestinal dysfunction and debilitating symptoms. Over the course of a lifetime, untreated or poorly managed celiac disease is often associated with deteriorating general health, multiple serious intestinal and extra-intestinal medical complications, and increased morbidity and mortality. Celiac disease is a global disease and affects approximately 1% of the population worldwide and is increasing in prevalence with improved diagnostic tools and improved awareness. About First Wave BioPharma, Inc. First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company is currently advancing a therapeutic development pipeline with multiple late-stage clinical programs built around three proprietary technologies – latiglutenase, a Phase 3-ready, potentially first-in-class, targeted, oral biotherapeutic for celiac disease; capeserod, a selective 5-HT4 receptor partial agonist being developed for gastroparesis; and adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency. First Wave BioPharma is headquartered in Boca Raton, Florida. For more information visit . Forward-Looking Statements This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether any financing or licensing transaction may be completed, completed with different terms, in an untimely manner, or not at all; whether the Company will be able to realize the expected benefits of its acquisition of ImmunogenX; the Company’s ability to integrate the assets and contemplated commercial operations acquired from ImmunogenX into the Company’s business; whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; whether the Company will be able to maintain compliance with Nasdaq’s continued listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; the effects of the First Wave Bio, Inc. acquisition, the related settlement and their effect on the Company’s business, operating results and financial prospects; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware. For more information: First Wave BioPharma, Inc. 777 Yamato Road, Suite 502 Boca Raton, FL 33431 Phone: (561) 589-7020 info@firstwavebio.com Media contact: Tiberend Strategic Advisors, Inc. David Schemelia (609) 468-9325 dschemelia@tiberend.com