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Kensana Health Lands $120 million from GEM, Fuelling a Global Plant Based Medicine Revolution

NEW YORK, Sept. 19, 2025 (GLOBE NEWSWIRE) — Kensana Health Inc. (“Kensana”) today announced it has entered into a share subscription facility of up to $120 million with GEM Global Yield LLC SCS (“GEM”), a Luxembourg–based alternative investment group. Under the agreement, GEM will provide Kensana up to $120 million for a 36–month period following a public listing of Kensana’s ordinary shares (“Investment Period”).

According to the agreement’s terms, Kensana will not be obligated to draw down the full $120 million but can do so in part or in whole at its discretion. Kensana can also set a threshold price as the lowest price at which Kensana may issue shares to GEM under a given drawdown. Kensana will control both the timing and amount of all drawdowns and will issue common shares to GEM on each drawn down from the facility. GEM shall pay 90% of the average daily closing price during the pricing period, which is a 30–day period after Kensana delivers a draw–down notice to GEM. During the lifetime of the investment facility, GEM will not, directly or indirectly, effect any short sale of Kensana’s common shares. GEM is a long–only investor and will not engage in shorting, hedging, or the use of derivatives or synthetic instruments against Kensana’s common shares or the issuance of any warrants.

Ken Clement, founder of Kensana, commented: “It has been determined that 90% of the world’s drugs are synthetically copied from naturally occurring plant compounds. (Bade, et al., 2010. European Journal of Medicinal Chemistry) According to the WHO, up to 80% of the world’s population believes that traditional herbal medicines are safer and have fewer side effects than traditional synthetic pharmaceuticals. Kensana plans to transform modern medicine by integrating its proprietary Artificial Intelligence (AI)–enhanced technology to harness naturally occurring compounds for drug development. Since the COVID pandemic, global markets have had an insatiable appetite for everything natural which positions Kensana and its phytopharmaceutical platform to become a global leader in plant–based medicine. Kensana has already demonstrated this capability through the development of its first FDA drug candidate, KV23A, which has shown incredible efficacy in white label trials outlined in numerous peer–reviewed medical journals. The share subscription facility with GEM demonstrates investor confidence in Kensana’s prospects, as well as GEM’s strategic understanding and vision for emerging markets and industries. This facility will be a very effective financial instrument that will complement our other fundraising efforts ahead of our anticipated NASDAQ listing in 2026.”

About Kensana

Kensana, is a Canadian Phytopharmaceutical company that has created a proprietary Generation 4 AI–enhanced phytobioreactor platform (EMOB) which enables the company to assume leadership in a new industry: Phytopharmaceuticals. The EMOB platform allows Kensana to standardize and convert an abundance of naturally occurring plant and compounds into U.S. FDA registered pharmaceuticals with global respectability. Kensana’s first patented formula is entering an international FDA–registerable Phase 3 clinical trial. Uniquely risk–mitigated, the KV23a formula has already successfully proven safety and efficacy via therapeutic applications in a clinical setting. KV23a is Kensana’s first targeted FDA– registered product within a global chronic wound market worth $300 Billion USD. The Patented Chronic Wound Formula, KV23a, has Proven Medical Efficacy which has been demonstrated in Published peer reviewed medical journals validating KV23a and its efficacy while demonstrating no toxicity issues. Phytopharmaceuticals largely work by targeting specific receptors, interrupting disease pathways and disrupting pathogenic life cycles. The Kensana Platform, EMOB, has the ability to produce proprietary therapies as well as re–engineer synthetic drugs originally derived from natural plant compounds.

Kensana Health has a uniquely risk–mitigated business model and is currently entering a Series C Investment Round. For more information, please visit the website at www.kensana.health or contact Randy Uens at [email protected].

About GEM

GEM is a $3.4 billion, Luxembourg–based alternative investment group with offices in Paris, New York, and Nassau (Bahamas). GEM manages a diverse set of investment vehicles focused on emerging markets and has completed over 590 transactions in over 75 countries. Each investment vehicle has a different degree of operational control, risk–adjusted return, and liquidity profile. Its family of funds and investment vehicles provide GEM and its partners with exposure to Small–Mid Cap Management Buyouts, Private Investments in Public Equities and select venture investments. For more information: www.gemny.com


GLOBENEWSWIRE (Distribution ID 9532205)

Minovia Therapeutics Receives FDA Fast Track Designation for MNV-201 in Myelodysplastic Syndrome

HAIFA, Israel, Sept. 18, 2025 (GLOBE NEWSWIRE) — Minovia Therapeutics Ltd. (“Minovia” or the “Company”), a clinical–stage biotechnology company developing novel therapies to treat mitochondrial diseases and combat age–related decline, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the Company’s lead investigational compound, MNV–201 for Myelodysplastic Syndrome (MDS), a serious age–related hematopoietic disease. This designation is in addition to the existing FDA Fast Track and Rare Pediatric Disease Designations for MNV–201 in the treatment of Pearson Syndrome, an ultra–rare and life–threatening mitochondrial disorder affecting children and for which the Company is currently conducting a Phase 2 clinical trial.

“The Fast Track Designation in MDS is further validation of the urgency and potential for our science, which targets the mitochondria, a critical multi–functional organelle. FDA designations such as the FTD help us to decrease the potential time to market and provide additional benefits across the FDA process that, we expect, will prove both medically and financially valuable,” said Minovia Co–founder and CEO, Natalie Yivgi–Ohana, Ph.D.

FDA’s Fast Track Designation is designed to accelerate the development and review of therapies for serious or life–threatening conditions with unmet medical need. The designation provides Minovia with the opportunity for increased FDA interactions, potential eligibility for priority review, and the opportunity for a rolling submission of a future Biologics License Application (BLA) for MNV–201.  

The Company also recently announced entry into a definitive business combination agreement (the “Business Combination Agreement”) with Launch One Acquisition Corp. (Nasdaq: LPAA, “Launch One”), a publicly traded special purpose acquisition company. Following the expected closing of the transaction contemplated by this Business Combination Agreement (the “Business Combination”), projected for late 2025, the combined company will operate as Minovia Therapeutics and trade on Nasdaq under a new ticker symbol.

About MDS

MDS is defined by ineffective hematopoiesis resulting in blood cytopenia, and clonal instability with a risk of evolution to Acute Myeloid Leukemia (AML). Patients with MDS collectively have a high symptom burden and are also at risk of death from complications of cytopenia and AML. The goals of therapy for patients with MDS are to improve cytopenia, reduce disease–associated symptoms and the risk of disease progression and death, thereby improving both quality of life and lifespan. The median age at diagnosis of MDS is ~70 years, but surprisingly some of the Pearson Syndrome patients develop MDS in a much higher prevalence relative to the disease population. About 15% of the MDS patients will present with Sideroblastic Anemia, the most common symptom in Pearson Syndrome. Minovia developed novel blood biomarkers to measure mitochondrial health and has been able to demonstrate for the first time that MDS is presumably an age–related mitochondrial disease. As such, Minovia is currently conducting a Phase Ib study of MNV–201 in low–risk MDS patients. Six out of the nine expected patients in the study have been dosed so far.

About MNV–201

MNV–201 is a first–in–class cell therapy that uses Minovia’s proprietary Mitochondrial Augmentation Technology (MAT) to add healthy, energy–producing mitochondria into a patient’s own stem cells — aiming to restore organ function and improve health. In early–stage clinical studies, MAT has demonstrated a strong safety profile and signs of multi–system benefit in patients with Pearson Syndrome, including improvements in growth, muscle function, hematologic stability, and improved quality of life.

About Minovia Therapeutics

Minovia Therapeutics, chaired by John Cox, is a clinical–state biotechnology company working on treatments to replace dead or defective mitochondria with new healthy mitochondria, helping people with mitochondrial diseases and fighting aging. Minovia’s main treatment, MNV–201, is already being tested for Pearson Syndrome and Myelodysplastic Syndrome. Minovia is also developing ways to help people live longer, healthier lives. Based in Haifa, Israel, where it operates a GMP facility for mitochondrial drug substance and drug product manufacturing for clinical trials related to its therapy, Minovia is planning to expand operations to the U.S. For more information, visit www.minoviatx.com.

About Launch One Acquisition Corp.

Launch One Acquisition Corp. is a company set up to merge with and take public an exciting business in healthcare or technology. Listed on Nasdaq under the ticker LPAA, Launch One is led by experienced leaders who want to support game–changing solutions. For more information, contact Jurgen van de Vyver at [email protected].

Additional Information and Where to Find It

In connection with the Business Combination and the Business Combination Agreement, among Launch One, Minovia and Mito US One Ltd., a newly formed Israeli company limited by shares (“Pubco”), and certain other parties named therein. Launch One and Minovia intend to file relevant materials with the U.S. Securities and Exchange Commission (“SEC”), including a Registration Statement on Form F–4 of Pubco (the “Registration Statement”), which will include a proxy statement/prospectus of Launch One, and will file other documents regarding the proposed Business Combination with the SEC. This communication is not intended to be, and is not, a substitute for the proxy statement/prospectus or any other document that Launch One has filed or may file with the SEC in connection with the proposed Business Combination. The Registration Statement has not been filed or declared effective by the SEC. Following such filing and upon such declaration of effectiveness, the definitive proxy statement/prospectus contained within the Registration Statement and other relevant materials for the proposed Business Combination will be mailed or made available to stockholders of Launch One as of a record date to be established for voting on the proposed Business Combination.

Before making any voting or investment decision, investors and stockholders of Launch One are urged to carefully read, when they become available, the entire Registration Statement, the proxy statement/prospectus, and any other relevant documents filed with the SEC, as well as any amendments or supplements to these documents, and the documents incorporated by reference therein, because they will contain important information about Launch One, Minovia, Pubco and the proposed Business Combination . Launch One’s investors and stockholders and other interested persons will also be able to obtain copies of the Registration Statement, the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus, other documents filed with the SEC that will be incorporated by reference therein, and all other relevant documents filed with the SEC by Launch One and/or Pubco in connection with the Business Combination, without charge, once available, at the SEC’s website at www.sec.gov, or by directing a request to Launch One or Minovia at the addresses set forth below.

Participants In the Solicitation

Launch One, Minovia, Pubco and their respective directors, executive officers, other members of management and employees may be deemed participants in the solicitation of proxies from Launch One’s stockholders with respect to the Business Combination. Investors and security holders may obtain more detailed information regarding the names, and interests in the Business Combination, of Launch One’s directors and officers in Pubco's and Launch One’s filings with the SEC, including, when filed with the SEC, the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus, amendments and supplements thereto, and other documents filed with the SEC. Such information with respect to Minovia’s directors and executive officers will also be included in the proxy statement/prospectus. You may obtain free copies of these documents as described above under the heading “Additional Information and Where to Find It.”

Non–Solicitation

This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the potential transaction and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of Launch One, Pubco, or Minovia, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.

Forward–Looking Statements

This press release includes certain statements that may be considered forward–looking statements within the meaning of the federal securities laws. Forward–looking statements include, without limitation, statements about future events or Minovia’s, Launch One's, or Pubco's future financial or operating performance. For example, statements regarding the development and regulatory approval of MNV–201, the implications of Fast Track Designation, RPD and PRVs and the timing of future clinical trials or potential applications are forward–looking statements. In some cases, you can identify forward–looking statements by terminology such as “may,” “should,” “could,” “might,” “plan,” “possible,” “project,” “strive,” “budget,” “forecast,” “expect,” “intend,” “will,” “estimate,” “anticipate,” “believe,” “predict,” “potential” or “continue,” or the negatives of these terms or variations of them or similar terminology.

These forward–looking statements regarding future events and the future results of Minovia or Launch One are based on current expectations, estimates, forecasts, and projections about the industry in which Minovia or Launch One operates, as well as the beliefs and assumptions of Minovia’s and Launch One's management. These forward–looking statements are only predictions and are subject to, without limitation, (i) known and unknown risks, including the risks and uncertainties indicated from time to time in the final prospectus of Launch One relating to its initial public offering filed with the SEC, including those under “Risk Factors” therein, and other documents filed or to be filed with the SEC by Launch One or Pubco; (ii) uncertainties; (iii) assumptions; and (v) other factors beyond Minovia’s or Launch One's control that are difficult to predict because they relate to events and depend on circumstances that will occur in the future. They are neither statements of historical fact nor promises or guarantees of future performance. Therefore, Minovia’s actual results may differ materially and adversely from those expressed or implied in any forward–looking statements and Minovia and Launch One therefore caution against relying on any of these forward–looking statements.

These forward–looking statements are based upon estimates and assumptions that, while considered reasonable by Minovia and its management, as the case may be, are inherently uncertain and are inherently subject to risks, variability and contingencies, many of which are beyond Minovia’s or Launch One's control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the occurrence of any event, change or other circumstances that could give rise to the termination of the Business Combination Agreement and any subsequent definitive agreements with respect to the Business Combination; (ii) the outcome of any legal proceedings that may be instituted against Launch One, Minovia, Pubco, or others following the announcement of the Business Combination and any definitive agreements with respect thereto; (iii) the inability to complete the Business Combination due to the failure to obtain consents and approvals of the shareholders of Launch One and Minovia, to obtain financing to complete the Business Combination or to satisfy other conditions to closing, or delays in obtaining, adverse conditions contained in, or the inability to obtain necessary regulatory approvals required to complete the transactions contemplated by the Business Combination Agreement; (iv) changes to the proposed structure of the Business Combination that may be required or appropriate as a result of applicable laws or regulations or as a condition to obtaining regulatory approval of the Business Combination; (v) projections, estimates and forecasts of revenue and other financial and performance metrics, projections of market opportunity and expectations, and the estimated implied enterprise value of Minovia; (vi) Minovia’s ability to scale and grow its business, and the advantages and expected growth of Minovia; (vii) Minovia’s ability to source and retain talent, and the cash position of Minovia following closing of the Business Combination; (viii) the ability to meet stock exchange listing standards in connection with, and following, the consummation of the Business Combination; (ix) the risk that the Business Combination disrupts current plans and operations of Minovia as a result of the announcement and consummation of the Business Combination; (x) the ability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, competition, the ability of Minovia to grow and manage growth profitably, maintain key relationships and retain its management and key employees; (xi) costs related to the Business Combination; (xii) changes in applicable laws, regulations, political and economic developments; (xiii) the possibility that Minovia may be adversely affected by other economic, business and/or competitive factors; (xiv) Minovia’s estimates of expenses and profitability; (xv) the failure to realize estimated shareholder redemptions, purchase price and other adjustments; and (xvi) other risks and uncertainties set forth in the filings by Launch One and Minovia with the SEC. There may be additional risks that neither Launch One nor Minovia presently know or that Launch One and Minovia currently believe are immaterial that could also cause actual results to differ from those contained in the forward–looking statements. Any forward–looking statements made by or on behalf of Launch One or Minovia speak only as of the date they are made. Neither Launch One nor Minovia undertakes any obligation to update any forward–looking statements to reflect any changes in their respective expectations with regard thereto or any changes in events, conditions or circumstances on which any such statements are based.  

Contact

Minovia Therapeutics Ltd.
Natalie Yivgi Ohana, Co–Founder and CEO
+972–74–7039954
[email protected]

Launch One Acquisition Corp.
Jurgen van de Vyver
[email protected]
+1–510–692–9600

Investor Relations
Dave Gentry, CEO
RedChip Companies
+1–407–644–4256
[email protected]

Investor Relations
Jules Abraham
Managing Director, Communications
CORE IR
1–212–655–0924
[email protected]


GLOBENEWSWIRE (Distribution ID 9531105)

Entera Bio Presents Positive Effects of EB613 on Both Trabecular and Cortical Bone in Postmenopausal Women with Osteoporosis at ASBMR 2025

EB613 Demonstrates Significant Effects on Both Trabecular and Cortical Bone Compartments After Just 6 Months of Treatment in Phase 2 Study; Cortical Improvements Comparable to Injectable Teriparatide and Abaloparatide

Company Plans to Initiate Global Registrational Phase 3 Study Following July 2025 FDA Concurrence

Entera also Presented Promising Pharmacokinetic Data for Next–Gen EB613 Single Tablet Candidate as Potential Future Franchise Extension

JERUSALEM, Sept. 08, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and proteins replacement therapies, today announced data selected for presentation at the American Society for Bone and Mineral Research (“ASBMR”) 2025 Annual Meeting in Seattle, Washington, for its lead program EB613 which is in late stage clinical development for post–menopausal women with osteoporosis. It is estimated that 50 percent of women and 20 percent of men over the age of 50 are at risk of a fragility fractures and less than 30% of patients are adequately treated with available medications.

“The data presented at ASBMR this year marks important progress for our EB613 program,” said Miranda Toledano, Chief Executive Officer of Entera. “Available injectable anabolic treatments, while efficacious and recommended across medical guidelines, are only accessible to a minority of patients globally. Our EB613 program is being developed to address the treatment chasm in osteoporosis care with a viable anabolic treatment in tablet format for patients to adequately protect their bones.”

In the oral presentation titled “Effects of EB613 Tablets [Oral PTH(1–34)] on Trabecular and Cortical Bone Using 3D–DXA: Results from Phase 2 Study,” Rachel B. Wagman, MD presented data using 3D–DXA modelling in a post–hoc analysis of EB613 Phase 2 results to look at the treatment’s impact on trabecular and cortical bone. After 6 months of treatment, EB613 2.5 mg demonstrated significant increases in both trabecular and cortical bone parameters as compared with placebo. Mechanistically, the findings suggest that bone strengthening, and fracture resistance may occur rapidly with EB613.

“The improvements across multiple parameters, including integral volumetric BMD, cortical thickness, and cortical surface BMD, suggest that there is an early strengthening effect with EB613 and a deterioration with placebo,” said Dr. Wagman. “We look forward to studying the safety and efficacy of EB613 in Phase 3.”

  • Increases in integral volumetric BMD of the TH and FN by 1.7% (p<0.08) and 2.6% (p<0.03), respectively
  • Increases in FN trabecular volumetric BMD by 4.4% vs. placebo (p<0.03) and increases in TH trabecular volumetric BMD by 2.8% (p=0.05 vs. baseline, NS compared with placebo)
  • Increases in cortical thickness at the TH and FN by 1.3% (p=0.04) and 1.7% (p=0.056), respectively Improvements in cortical surface BMD at the TH and FN by 1.5% and 2.1%, respectively (both p<0.05)

In a poster presentation titled “Advancing Oral Anabolic Treatments for Osteoporosis: Pre–Clinical Data for Next–Gen EB613 Tablet Utilizing N–Tab™ Proprietary Technology,” Entera presented preclinical data for its Next–Gen EB613 candidate. In a cross–over pharmacokinetic study in minipigs, a single 1.5 mg Next–Gen EB613 tablet demonstrated comparable PK to the current formulation of EB613, with identical AUClast and Tmax values (1.2 min*ng/ml and 20 min, respectively), and comparable Cmax. A Phase 1 clinical trial of Next–Gen EB613 is planned to begin in late 2025.

About EB613

Substantial evidence supports the efficacy of anabolic treatments over anti–resorptive drugs for lowering fracture risk in osteoporosis patients. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. EB613 (oral PTH (1–34)), is being developed as the first oral, once–daily anabolic tablet treatment for osteoporosis. EB613 completed a phase 2, 6–month, 161–patient, placebo–controlled study that met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid dose–proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD.

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and its pipeline of first–in–class oral peptide programs targeting PTH(1–34), GLP–1 and GLP–2. The Company’s most advanced product candidate, EB613 (oral PTH(1–34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis. A placebo–controlled, dose–ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity and metabolic syndromes; and first oral GLP–2 peptide as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, and Facebook.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera's forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA's interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera's product candidates; Entera's reliance on third parties to conduct its clinical trials; Entera's ability to establish and maintain development and commercialization collaborations; Entera's operation as a development stage company with limited operating history; Entera's competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera's ability to continue as a going concern absent access to sources of liquidity; Entera's ability to obtain and maintain regulatory approval for any of its product candidates; Entera's ability to comply with Nasdaq's minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera's intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward–Looking Statements,” “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera's most recent Annual Report on Form 10–K filed with the SEC, as well as Entera's subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.


GLOBENEWSWIRE (Distribution ID 9524990)

Entera Bio to Unveil Clinical and Non-Clinical Data Across 3 Oral Peptide Programs at Upcoming September Conferences

  • Osteoporosis Program: Phase 2 analysis exploring the dual actions of oral PTH(1–34) tablet treatment, EB613 on trabecular and cortical bone, and Next–Gen EB613 PK/PD data slated for oral and poster presentations at ASBMR
  • Short Bowel Syndome and Rare GI Disorders: PK/PD of oral GLP–2 tablet candidate poster presentation at ESPEN
  • Corporate Overview at H.C. Wainwright Investor Conference

JERUSALEM, Aug. 28, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and proteins replacement therapies, today announced that the Company will present data across three key programs during September 2025. Details on the presentations are available below:

American Society for Bone and Mineral Research (ASBMR) 2025 Annual Meeting:
Oral Presentation – Dr. Rachel B. Wagman

  • Title: Effects of EB613 Tablets [Oral PTH(1–34)] on Trabecular and Cortical Bone Using 3D–DXA: Results from Phase 2 Study (1014)
  • Time: Friday, September 5, 2025, 11:45 AM
  • Location: General Session Room, 6BC (6th Floor, Seattle Convention Center)

EB613 is being developed as the first, once–daily oral anabolic (bone forming) tablet treatment for postmenopausal women with osteoporosis. A placebo–controlled Phase 2 study in 161 post–menopausal women produced a rapid onset of action with increases in BMD at both cortical bone (femoral neck and hip region) and cancellous bone (spine). Based on a July 2025 alignment with FDA, Entera is planning a global Phase 3 registration study of EB613 in women with osteoporosis.

Poster Presentation – Next–Gen EB613

  • Title: Advancing Oral Anabolic Treatments for Osteoporosis: Pre–Clinical Data for Next–Gen EB613 Tablet Utilizing N–Tab™ Proprietary Technology (581)
  • Time: Sunday, September 7, 2025, 2:00 PM – 3:30 PM
  • Location: Discovery Hall, Hall 4B (4th Floor, Seattle Convention Center)

47th European Society for Clinical Nutrition & Metabolism (ESPEN) Congress

Poster Presentation – GLP–2 Short Bowel Syndrome:

  • Title: A First–in–Class Oral GLP–2 Analog for Treatment of Short Bowel Syndrome
  • Time: Saturday, September 13, 2025, 3:30 PM – 4:00 PM
  • Location: Forum Hall Foyer 3, Prague, Czech Republic

The oral GLP–2 tablet program combines a proprietary long acting GLP–2 agonist developed by OPKO Health with Entera's proprietary N–Tab™ technology for patients suffering from short bowel syndrome and additional disorders involving gastrointestinal mucosal inflammation and nutrient malabsorption. Currently, the only approved GLP–2 agonist requires daily subcutaneous injections.

H.C. Wainwright Conference

Entera’s Chief Executive Officer Miranda Toledano will present at the H.C. Wainwright 27th Annual Global Investment Conference. The virtual presentation will be available on Friday, September 5, 2025 at 7:00 AM ET at:

https://journey.ct.events/view/0f59c59b–da4e–4dc2–a865–4f1883eca26f

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and a pipeline of first–in–class oral peptide programs targeting PTH(1–34), GLP–1 and GLP–2. The Company’s most advanced product candidate, EB613 (oral PTH(1–34)teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 with alignment from FDA on the use of BMD as its primary endpoint. The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this presentation are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this presentation regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera’s and OPKO’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, whether by Entera, OPKO or their respective collaboration and laboratory partners; impacts to research and development or clinical activities that Entera or OPKO may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing our product candidates; the parties’ reliance on third parties to conduct clinical trials; Entera’s and OPKO’s expectations regarding licensing, business transactions, including OPKO’s development efforts should Entera opt–out, and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s and OPKO’s intellectual property positions and their ability to protect their respective intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of each of Entera’s and OPKO’s most recent Annual Reports on Form 10–K filed with the SEC, as well as the companies’ respective subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera and OPKO will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera or OPKO, as applicable. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera and OPKO caution investors not to rely on the forward–looking statements made in this press release. The information in this press release is provided only as of the date of this press release, and neither Entera nor OPKO undertakes any obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.


GLOBENEWSWIRE (Distribution ID 9519749)

Sarborg Limited Closes $10 Million Seed Round to Expand Proprietary Agentic Approach

  • Funding supports next–generation AI agent development and proprietary Intellectual Property, focused initially on pharmaceutical drug–repurposing
  • Initial clients reporting commercial success, revolutionizing indication selection of lead programs
  • Early commercial success and key partnerships signal strong market traction and scalability potential into multiple commercial verticals

WILMINGTON, Del., Aug. 27, 2025 (GLOBE NEWSWIRE) — Sarborg Limited (“Sarborg” or the “Company”), a technology–driven company that integrates mathematical algorithm–led approaches with complementary cybernetics to optimize decision–making processes, is pleased to announce the successful closing of its $10 million Seed funding round, led by third–party investor, Corvus Capital.

Sarborg has achieved significant commercial and technical milestones from its development plan, since its inception in 2024. The issuance of $10 million of Convertible Promissory Notes highlights investor confidence in Sarborg’s novel approach and rapid development delivering commercial milestones.

Looking forward, the proceeds of the fundraising will enable Sarborg to scale its AI–driven drug development and deploy agents across expanded client portfolios, while diversifying its client and equity partnership base. Sarborg will continue to deepen its intellectual property portfolio and look to broaden its agentic approach to fields beyond pharmaceuticals.

Successful Launch and Strong Commercial Validation

Sarborg has quickly capitalized on early revenue–generation, with the successful execution of an initial services agreement with a NASDAQ–listed Pharmaceutical Company, validating its core technologies and a repurposing strategy based on their lead–program drug–signature model.

Sarborg has delivered personalized dashboards to clients, a critical tool designed to provide key personnel with real–time access to data related to deliverables, research and development oversight, and drug discovery. Furthermore, Sarborg has built a proprietary portfolio of over 800 disease signatures, each uniquely mapped using its proprietary data–driven approach and now focusing on an agentic–approach to repurposing without human intervention.

Proceeds from the fundraising will be strategically deployed to:

  • Advance Sarborg’s proprietary AI agents focused on drug repurposing, target identification, and clinical trial optimization.
  • Develop novel pharmaceutical IP, transforming underused molecules into novel IP through solid–form engineering and formulation expertise.
  • Grow Sarborg’s internal pipeline of pharmaceutical assets for monetization via outlicensing or royalty–based deal structures.
  • Expand the client base and revenue–generating service business to fund ongoing innovation and reduce dilution in future rounds.

Following the demand for its seed financing, the Company expects to shortly launch a follow–on Series A financing round to enable Sarborg to scale globally and solidify its position as a category leader in AI–driven agentic innovation, combining new equity, tokenized securities and crypto–based blockchain technologies across multiple verticals.

About Sarborg Limited

Sarborg is a technology–driven company that integrates proprietary AI–agents and mathematical algorithm–based approaches with complementary cybernetics and extensive neural networks, to optimize decision–making processes. Its current principal vertical is focused on evaluating drug repurposing matching unique drug and disease signatures for pharmaceutical companies, leveraging machine learning and algorithmic strategies to enhance asset portfolio management and improve the probability of success in clinical trials. The Company is planning its expansion into further analytic areas beyond pharmaceuticals.

The company is composed of a seasoned and highly experienced team in cybernetics and signature development, drug development, medical affairs and commercialization, regulatory affairs, IP and manufacturing. Since its inception in 2024, Sarborg has applied its suite of AI agents, cybernetic algorithms, and machine learning capabilities across various sectors, enabling a highly efficient decision–making process throughout its portfolio.

Investors & Media:
[email protected]
www.sarborg.com


GLOBENEWSWIRE (Distribution ID 9519004)

Minovia Therapeutics Announces $350,000 Grant from Countdown for a Cure Foundation to Develop Mitochondria Blood-Based Biomarkers

HAIFA, Israel, Aug. 27, 2025 (GLOBE NEWSWIRE) — Minovia Therapeutics Ltd. (“Minovia” or the “Company”), a clinical–stage biotechnology company developing novel therapies to treat mitochondrial diseases and combat age–related decline, announces that it has been chosen to receive a $350,000 grant from Countdown for a Cure for a research proposal related to the development of novel mitochondrial blood–based biomarkers.

Minovia Chief Scientific Officer Dr. Noa Sher, commented, “We are grateful to the Countdown for a Cure Foundation, whose funds are expected to be instrumental in our advancing development of blood–based functional mitochondrial biomarkers. These biomarkers will enable identification of patients who may benefit from our mitochondrial augmentation technology, or MAT, proprietary platform, as well as patient follow–up after MAT treatment. Given how critical mitochondria are to human health, we envision a world in which assessment of mitochondrial biomarkers is available in routine checkups for individuals of all age groups. We look forward to optimizing this technology.”

In addition to the novel MAT–based mitochondrial therapies under development, Minovia has set dual goals of developing biomarkers to quantify mitochondrial content, quality and function and of using these biomarkers to determine mitochondrial scores in healthy individuals relative to mitochondrial disease patients. For this reason, Minovia opened a clinical trial in Sheba Medical Center to collect blood samples from both healthy volunteers and patients suffering from mitochondrial diseases. The Countdown for a Cure grant will fund clinical operations for blood sample collection from approximately 30 patients with primary mitochondrial diseases, and 140 samples from healthy controls. The samples collected will be analyzed in Minovia’s labs with its newly developed biomarkers, and a “MitoScore” will be determined for each sample. In addition, the Countdown for a Cure funding will support the development of new biomarkers using novel research tools.

Mitochondrial dysfunction is known to occur in rare genetic mitochondrial diseases, as well as in chronic and age–related diseases. There is a profound unmet need for treatment of these devastating diseases, as there are currently no approved therapies for mitochondrial dysfunction and no functional tests to diagnose and quantify mitochondrial dysfunction in individuals of all ages.

The Company also recently announced entry into a definitive business combination agreement (the “Business Combination Agreement”) with Launch One Acquisition Corp. (Nasdaq: LPAA, “Launch One”), a publicly traded special purpose acquisition company. Following the expected closing of the transaction contemplated by this Business Combination Agreement (the “Business Combination”), projected for late 2025, the combined company will operate as Minovia Therapeutics and trade on Nasdaq under a new ticker symbol.

About Minovia Therapeutics

Minovia Therapeutics, chaired by John Cox, is a clinical–state biotechnology company working on treatments to replace dead or defective mitochondria with new healthy mitochondria, helping people with mitochondrial diseases and fighting aging. Its main drug product, MNV–201, is already being tested for Pearson Syndrome and Myelodysplastic Syndrome. Minovia is also developing ways to help people live longer, healthier lives. Based in Haifa, Israel, where it operates a GMP facility for mitochondrial drug substance and drug product manufacturing for clinical trials related to its therapy, Minovia is planning to expand to the U.S. For more information, visit www.minoviatx.com.

About Countdown for a Cure

Countdown For A Cure (CFAC) is a non–profit organization dedicated to advancing mitochondrial research and medicine, improving the lives of those affected by diseases linked to mitochondrial dysfunction. Founded in 2024 by Mitzi and Jeff Solomon, who experienced mitochondrial dysfunction and its impact on their family firsthand, CFAC partners with leading research institutions and patient advocacy groups to fund cutting–edge science and provide critical support to families. Mitzi and Jeff are driven by an unwavering commitment to supporting families, accelerating research, and uniting a community determined to make a tangible difference in the lives of those affected by mitochondrial disease and all diseases connected to mitochondrial dysfunction.

About Launch One Acquisition Corp.

Launch One Acquisition Corp. is a company set up to merge with and take public an exciting business in healthcare or technology. Listed on Nasdaq under the ticker LPAA, Launch One is led by experienced leaders who want to support game–changing solutions. For more information, contact Jurgen van de Vyver at [email protected].

Additional Information and Where to Find It

In connection with the Business Combination and the Business Combination Agreement, among Launch One, Minovia and Mito US One Ltd., a newly formed Israeli company limited by shares (“Pubco”), and certain other parties named therein. Launch One and Minovia intend to file relevant materials with the U.S. Securities and Exchange Commission (“SEC”), including a Registration Statement on Form F–4 of Pubco (the “Registration Statement”), which will include a proxy statement/prospectus of Launch One, and will file other documents regarding the proposed Business Combination with the SEC. This communication is not intended to be, and is not, a substitute for the proxy statement/prospectus or any other document that Launch One has filed or may file with the SEC in connection with the proposed Business Combination. The Registration Statement has not been filed or declared effective by the SEC. Following such filing and upon such declaration of effectiveness, the definitive proxy statement/prospectus contained within the Registration Statement and other relevant materials for the proposed Business Combination will be mailed or made available to stockholders of Launch One as of a record date to be established for voting on the proposed Business Combination.

Before making any voting or investment decision, investors and stockholders of Launch One are urged to carefully read, when they become available, the entire Registration Statement, the proxy statement/prospectus, and any other relevant documents filed with the SEC, as well as any amendments or supplements to these documents, and the documents incorporated by reference therein, because they will contain important information about Launch One, Minovia, Pubco and the proposed Business Combination. Launch One’s investors and stockholders and other interested persons will also be able to obtain copies of the Registration Statement, the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus, other documents filed with the SEC that will be incorporated by reference therein, and all other relevant documents filed with the SEC by Launch One and/or Pubco in connection with the Business Combination, without charge, once available, at the SEC’s website at www.sec.gov, or by directing a request to Launch One or Minovia at the addresses set forth below.

Participants In the Solicitation

Launch One, Minovia, Pubco and their respective directors, executive officers, other members of management and employees may be deemed participants in the solicitation of proxies from Launch One’s stockholders with respect to the Business Combination. Investors and security holders may obtain more detailed information regarding the names, and interests in the Business Combination, of Launch One’s directors and officers in Pubco's and Launch One’s filings with the SEC, including, when filed with the SEC, the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus, amendments and supplements thereto, and other documents filed with the SEC. Such information with respect to Minovia’s directors and executive officers will also be included in the proxy statement/prospectus. You may obtain free copies of these documents as described above under the heading “Additional Information and Where to Find It.”

Non–Solicitation

This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the potential transaction and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of Launch One, Pubco, or Minovia, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.

Forward–Looking Statements

This press release includes certain statements that may be considered forward–looking statements within the meaning of the federal securities laws. Forward–looking statements include, without limitation, statements about future events or Minovia’s, Launch One's, or Pubco's future financial or operating performance. For example, statements regarding the development and regulatory approval of MNV–201, the implications of Fast Track Designation, RPD and PRVs and the timing of future clinical trials or potential applications are forward–looking statements. In some cases, you can identify forward–looking statements by terminology such as “may,” “should,” “could,” “might,” “plan,” “possible,” “project,” “strive,” “budget,” “forecast,” “expect,” “intend,” “will,” “estimate,” “anticipate,” “believe,” “predict,” “potential” or “continue,” or the negatives of these terms or variations of them or similar terminology.

These forward–looking statements regarding future events and the future results of Minovia or Launch One are based on current expectations, estimates, forecasts, and projections about the industry in which Minovia or Launch One operates, as well as the beliefs and assumptions of Minovia’s and Launch One's management. These forward–looking statements are only predictions and are subject to, without limitation, (i) known and unknown risks, including the risks and uncertainties indicated from time to time in the final prospectus of Launch One relating to its initial public offering filed with the SEC, including those under “Risk Factors” therein, and other documents filed or to be filed with the SEC by Launch One or Pubco; (ii) uncertainties; (iii) assumptions; and (v) other factors beyond Minovia’s or Launch One's control that are difficult to predict because they relate to events and depend on circumstances that will occur in the future. They are neither statements of historical fact nor promises or guarantees of future performance. Therefore, Minovia’s actual results may differ materially and adversely from those expressed or implied in any forward–looking statements and Minovia and Launch One therefore caution against relying on any of these forward–looking statements.

These forward–looking statements are based upon estimates and assumptions that, while considered reasonable by Minovia and its management, as the case may be, are inherently uncertain and are inherently subject to risks, variability and contingencies, many of which are beyond Minovia’s or Launch One's control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the occurrence of any event, change or other circumstances that could give rise to the termination of the Business Combination Agreement and any subsequent definitive agreements with respect to the Business Combination; (ii) the outcome of any legal proceedings that may be instituted against Launch One, Minovia, Pubco, or others following the announcement of the Business Combination and any definitive agreements with respect thereto; (iii) the inability to complete the Business Combination due to the failure to obtain consents and approvals of the shareholders of Launch One and Minovia, to obtain financing to complete the Business Combination or to satisfy other conditions to closing, or delays in obtaining, adverse conditions contained in, or the inability to obtain necessary regulatory approvals required to complete the transactions contemplated by the Business Combination Agreement; (iv) changes to the proposed structure of the Business Combination that may be required or appropriate as a result of applicable laws or regulations or as a condition to obtaining regulatory approval of the Business Combination; (v) projections, estimates and forecasts of revenue and other financial and performance metrics, projections of market opportunity and expectations, and the estimated implied enterprise value of Minovia; (vi) Minovia’s ability to scale and grow its business, and the advantages and expected growth of Minovia; (vii) Minovia’s ability to source and retain talent, and the cash position of Minovia following closing of the Business Combination; (viii) the ability to meet stock exchange listing standards in connection with, and following, the consummation of the Business Combination; (ix) the risk that the Business Combination disrupts current plans and operations of Minovia as a result of the announcement and consummation of the Business Combination; (x) the ability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, competition, the ability of Minovia to grow and manage growth profitably, maintain key relationships and retain its management and key employees; (xi) costs related to the Business Combination; (xii) changes in applicable laws, regulations, political and economic developments; (xiii) the possibility that Minovia may be adversely affected by other economic, business and/or competitive factors; (xiv) Minovia’s estimates of expenses and profitability; (xv) the failure to realize estimated shareholder redemptions, purchase price and other adjustments; and (xvi) other risks and uncertainties set forth in the filings by Launch One and Minovia with the SEC. There may be additional risks that neither Launch One nor Minovia presently know or that Launch One and Minovia currently believe are immaterial that could also cause actual results to differ from those contained in the forward–looking statements. Any forward–looking statements made by or on behalf of Launch One or Minovia speak only as of the date they are made. Neither Launch One nor Minovia undertakes any obligation to update any forward–looking statements to reflect any changes in their respective expectations with regard thereto or any changes in events, conditions or circumstances on which any such statements are based.

Contacts:

Minovia Therapeutics Ltd.
Natalie Yivgi Ohana, Co–Founder and CEO
+972–74–7039954
[email protected]

Launch One Acquisition Corp.
Jurgen van de Vyver
[email protected]
+1–510–692–9600

Investor Relations
Dave Gentry, CEO
RedChip Companies
+1–407–644–4256
[email protected]

Investor Relations
Jules Abraham
Managing Director, Communications
CORE IR
1–212–655–0924
[email protected]


GLOBENEWSWIRE (Distribution ID 9518763)

Entera Bio Announces Second Quarter 2025 Financial Results and Business Updates

  • FDA provides pivotal agreement on EB613 Phase 3 design, confirming Bone Mineral Density (BMD) as primary endpoint and clearing streamlined pathway for first oral anabolic osteoporosis treatment
  • Significant regulatory and pipeline advancements achieved including FDA waiver of additional safety studies and next–gen EB613 expected to enter Phase 1 in November 2025
  • Strong momentum across OPKO collaboration with obesity program showing promising preclinical data; and EB612 oral PTH directed hypoparathyroidism program candidate validation
  • Strong balance sheet provides runway through mid–Q3 2026, including dedicated OPKO collaboration funding

JERUSALEM, Aug. 08, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptide and protein replacement therapies, today reported financial results and key business updates for the quarter ended June 30, 2025.

“Last week's FDA agreement on using BMD as the primary endpoint for EB613's Phase 3 program represents a pivotal milestone in our journey to bring the first oral anabolic osteoporosis tablet treatment to market,” said Miranda Toledano, Chief Executive Officer of Entera. “This unprecedented regulatory alignment validates both the strength of our clinical data and our strategic vision that began taking shape in July 2022. The concurrence opens the door to addressing a massive unmet need – with less than 25% of the world's 200 million osteoporotic women having access to safe, effective, and affordable treatment options, and no new therapies approved in this space since 2019. Beyond EB613, throughout Q2, we continued building momentum across our entire pipeline, including presenting promising pharmacokinetic data for our oral GLP–1/glucagon dual agonist program with OPKO. With our strengthened cash position of $18.9 million, including dedicated OPKO collaboration funding, we are well–positioned to execute on multiple value–creating milestones across 2025 and beyond.”

Key Recent Highlights

EB613: First Oral PTH(1–34) Anabolic Treatment for Osteoporosis

  • FDA Agreement that BMD Primary Endpoint Would Support NDA: In a July Type A meeting, FDA provided written concurrence on our Phase 3 study design – a single multinational, randomized, double–blind, placebo–controlled, 24–month study in women with postmenopausal osteoporosis, where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures is evaluated as the key secondary endpoint. As a 505(b)(2) application, the submission will rely on FDA's previous findings of effectiveness and safety for the Reference Listed Drug Forteo®, where the correlation between BMD and fracture has been well–established. The study is designed and powered to demonstrate a statistically significant increase in total hip BMD, coupled with a positive trend on vertebral fracture reduction as key secondary endpoint to provide substantial evidence of effectiveness. This FDA decision is independent of the Agency's qualification of the SABRE BMD Initiative which is still expected within 2025.
  • Regulatory Burden Significantly Reduced: In May and June, Entera received written agreements from FDA that dedicated oral carcinogenicity studies and comprehensive nonclinical developmental and reproductive toxicity (DART) studies are not warranted given the totality of evidence generated fromForteo® literature and nonclinical studies conducted with EB613.
  • Strong Clinical Data Gains Scientific Recognition: In April, Dr. Rachel B Wagman presented early effects of EB613 on trabecular and cortical bone using 3D–DXA at the 2025 WCO–IOF–ESCEO Congress. Additionally, 3D Shaper Phase 2 data was selected for oral presentation at ASBMR 2025 in September.
  • Next–Generation EB613 Advancing: “Advancing Oral Anabolic Treatments for Osteoporosis: Pre–Clinical Data for Next Gen EB613 Tablet Utilizing N–Tab™ Proprietary Technology” was selected for poster presentation at ASBMR 2025. Next Gen EB613 is being developed with a new generation of Entera's N–TAB™ platform and is expected to enter the clinic in a Phase 1 Safety and PK Study in November 2025.
  • Strategic Regulatory Engagement: In June, CEO Miranda Toledano participated in the Boston “CEO Forums: An FDA Listening Tour to Engage Pharma and Bio CEOs” and presented a one–minute brief on osteoporosis and potential regulatory reform to spur innovation.

First PTH (1–34) Tablet Protein Replacement Therapy for Hypoparathyroidism

  • First pre–clinical PK/PD data from undisclosed collaborative research with long–acting PTH agonist as a once–daily tablet format is expected by end of year.

OPKO Health Collaboration Programs

  • First GLP–1/Glucagon Agonist (Oxyntomodulin) Peptide Tablet Candidate for Obesity: In June, a poster at ENDO2025 reported PK data from a mini–pig study of oral OPK–88006 (dual GLP–1/glucagon receptor agonist in partnership with OPKO Health, Nasdaq: “OPK”) which showed plasma levels consistent with those reported in humans for the highest subcutaneous dose of Wegovy™ (semaglutide) weekly injection, a standard of care for the treatment of obesity. The reported pharmacological data supports a once–daily tablet regimen of this first–in–class oral dual agonist. A Phase 1 study is being planned and IND filing is expected in H1 2026.
  • First GLP–2 Peptide Tablets for Short Bowel Syndrome: In June, Entera in partnership with OPKO's “First–in–Class Oral GLP–2 Analog for Treatment of Short Bowel Syndrome” abstract was selected for poster presentation at the 47th European Society for Clinical Nutrition & Metabolism (“ESPEN”) Congress.

Financial Results for the Quarter Ended June 30, 2025

Cash and cash equivalents were $18.9 million as of June 30, 2025, including $8.0 million in restricted cash designated to fund the OPKO collaboration through Phase 1 studies of oral GLP–1/glucagon candidate OPK–88006. Cash on hand is expected to support operations through mid–third quarter 2026.

Net loss was $2.7 million, or $0.06 per ordinary share, for the three months ended June 30, 2025, compared to $2.1 million, or $0.06 per ordinary share, for the three months ended June 30, 2024.

Research and development expenses were $1.5 million for the three months ended June 30, 2025, compared to $1.1 million for the three months ended June 30, 2024, an increase of $0.4 million. The increase was primarily due to regulatory activities and Phase 3 planning for EB613.

General and administrative expenses were $1.1 million for the three months ended June 30, 2025, compared to $1.1 million for the three months ended June 30, 2024.

Total operating expenses were $2.7 million for the three months ended June 30, 2025, compared to $2.2 million for the three months ended June 30, 2024.

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and a pipeline of first–in–class oral peptide programs targeting PTH(1–34), GLP–1 and GLP–2. The Company’s most advanced product candidate, EB613 (oral PTH(1–34)teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 with alignment from FDA on the use of BMD as its primary endpoint. The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this presentation are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this presentation regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this presentation. The information in this presentation is provided only as of the date of this presentation, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

 
ENTERA BIO LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
 
       
  June 30,   December 31,
  2025   2024
  (Unaudited)   (Audited)
   
Cash and cash equivalents 10,858   8,660
Accounts receivable and other current assets 438   312
Restricted cash 8,015   –
Property and equipment, net 79   57
Other assets 277   361
Total assets 19,667   9,390
 
 
Accounts payable and other current liabilities 1,844   1,176
Total non–current liabilities 567   134
Total liabilities 2,411   1,310
Total shareholders' equity 17,256   8,080
       
Total liabilities and shareholders' equity 19,667   9,390

   
ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)

(Unaudited)

  
  Three Months Ended
June 30,
  2025   2024
REVENUES –   57
COST OF REVENUES –   49
GROSS PROFIT –   9
OPERATING EXPENSES:    
Research and development 1,520   1,086
General and administrative 1,148   1,088
TOTAL OPERATING EXPENSES 2,668   2,174
OPERATING LOSS 2,668   2,165
FINANCIAL INCOME, NET (12)   (20)
NET LOSS 2,656   2,145
     
LOSS PER SHARE BASIC AND DILUTED 0.06   0.06
       
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 46,836,700   37,090,160
     


GLOBENEWSWIRE (Distribution ID 9509020)

Entera Bio Receives FDA Agreement on BMD as Primary Endpoint for EB613 Registrational, Phase 3 Study in Post-Menopausal Women with Osteoporosis

JERUSALEM, July 28, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and protein replacement therapies, announced today that in a written response to a Type A meeting request, the U.S. Food and Drug Administration (FDA) agreed with the Company’s proposal that the NDA marketing application filing for EB613 would be supported by a single multinational, randomized, double–blind, placebo–controlled, 24 month phase 3 study in women with postmenopausal osteoporosis, where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures is evaluated as the key secondary endpoint. This marks a shift from precedent placebo–controlled phase 3 studies of new osteoporosis drugs which required incidence of fracture as the primary endpoint.

“This regulatory update is a major milestone for Entera and the entire osteoporosis community,” said Miranda Toledano, CEO of Entera. “Our alignment with the FDA reflects the strength of our data and collaborative discussions. Importantly, it allows us to advance our clinical development program without having to wait for FDA’s qualification of the Study to Advance Bone Mineral Density as a Regulatory Endpoint (SABRE), which is still expected this year. We thank the FDA and the Review Team at the Division of Endocrinology for their constructive approach. We also thank the SABRE team for paving the path to innovation for osteoporosis treatment,” said Toledano.

“Osteoporosis afflicts more women than heart attack, stroke and breast cancer combined. Over 200 million women globally are estimated to have osteoporosis and remain vastly undertreated, despite efficacious injectable anabolic (bone forming) treatments. One in two women over the age of 50 will suffer a fracture due to osteoporosis. No new drug for osteoporosis has been approved by FDA since 2019; and innovation has stalled for close to a decade due to the size, duration, cost and ethical constraints associated with fracture endpoint studies. In a silent disease, patient and clinician access to novel and alternative forms of validated mechanisms of action is important. We are developing EB613 as the first oral, once–daily anabolic tablet treatment to potentially serve this unmet medical need. EB613 is intended to increase skeletal mass, improve bone microarchitecture and reduce the risk of fracture,” said Miranda Toledano, CEO of Entera.

About EB613

Substantial evidence supports the efficacy of anabolic therapies over bisphosphonates for lowering fracture risk in osteoporosis patients at high risk. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. EB613 (oral PTH (1–34), teriparatide), is being developed as the first oral, once–daily anabolic tablet treatment for osteoporosis. EB613 completed a phase 2, 6–month, 161–patient, placebo–controlled study that met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid dose–proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD. The effects of EB613 on trabecular and cortical bone using 3D–DXA showed increases with EB613 compared with placebo in a variety of indices, including integral volumetric BMD and trabecular volumetric BMD, cortical thickness, and cortical surface BMD. Mechanistically, the findings suggest that bone strengthening, and fracture resistance may occur rapidly with EB613. Furthermore, the data are consistent with those of published subcutaneous teriparatide at the 6–month time point. Further abstracts have been submitted to ASBMR and NAMS 2025 conferences.

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and its pipeline of first–in–class oral peptide programs targeting PTH(1–34), GLP–1 and GLP–2. The Company’s most advanced product candidate, EB613 (oral PTH(1–34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis. A placebo–controlled, dose–ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity and metabolic syndromes; and first oral GLP–2 peptide as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

About SABRE

The Study to Advance BMD as a Regulatory Endpoint (SABRE) initiative, which started as a public private partnership sponsored by the FNIH in 2013, has amassed the strongest evidence to date that treatment–related gains in Bone Mineral Density (BMD) reliably and quantitatively predict fracture–risk reduction. In November 2023, the SABRE team submitted a full qualification package to FDA’s Biomarker Division as part of the Drug Development Tool Biomarker Qualification Pathway to potentially qualify BMD as a surrogate endpoint to fracture; in March 2024, the FDA Biomarker Division indicated to the SABRE project team that a decision would be issued within 10 months. The single most important predictor of osteoporotic fractures in postmenopausal women without a previous fracture is BMD. Treatment guidelines in the U.S. strongly recommend pharmacologic therapy for patients with a BMD T–score of –2.5 or lower in the spine, femoral neck, total hip. SABRE final FQP meta–analysis included data from 22 randomized, placebo–controlled trials (63,000 participants across seven drug classes) and showed that treatment–related gains in total–hip BMD explain 72% of the observed fracture–risk reduction. The R2 for this correlation was 0.73—double the correlation between blood pressure and stroke (R² = 0.37), which is the well accepted basis for the value of antihypertensive therapy.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this presentation are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this presentation regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this presentation. The information in this presentation is provided only as of the date of this presentation, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.


GLOBENEWSWIRE (Distribution ID 9501141)

Veteran Global Health Leader, Dr. Rebecca Martin, Named President of Global Immunization at Sabin

WASHINGTON, July 21, 2025 (GLOBE NEWSWIRE) — Renowned global health expert Rebecca Martin, PhD, recognized internationally for her leadership in developing and implementing immunization programs and strengthening health systems, joins the Sabin Vaccine Institute today as President of Global Immunization, assuming the reins of the nonprofit’s efforts in vaccination innovation and extending vaccine access.

Martin most recently served as Vice President for Global Health at Emory University, and as the Director of the Emory Global Health Institute, following a 24–year career with the US Centers for Disease Control and Prevention (CDC). She is also an adjunct professor in the Department of Global Health at Emory. She brings decades of successful partnering with global, regional and country–level health leaders in infectious disease prevention, as well as in–country experience leading low– and middle–income country (LMIC) health and immunization initiatives.

Her extensive CDC career includes ten years working in Kenya, Tanzania, and Denmark, seconded to the World Health Organization African and European regions. In her four years in Nairobi, Kenya, she provided technical expertise to eight East African countries focused on vaccine–preventable disease surveillance, prevention and elimination strategies and policies, and new vaccine introductions. For several years in Dar as Salaam, Tanzania, she led surveillance and workforce development for CDC as part of the President’s Emergency Plan for AIDS Relief (PEPFAR), and supervised staff in surveillance, health management information systems (HMIS), monitoring and evaluation (M&E), and human capacity development for CDC HIV/AIDS programs.

Currently, she serves as the Vice–Chair for WHO Regional Office for Africa (AFRO) Emergency Preparedness & Response Technical Advisory Group (EPR–TAG), an independent advisory group providing strategic guidance on all matters pertaining to public health emergency preparedness and response in Africa.

“With her global, country and local–level experience, Rebecca has the first–hand expertise needed to address today’s challenging immunization landscape, and more importantly, to co–create new solutions with public and private partners to boost lagging immunization rates and prevent human suffering,” says Sabin CEO Amy Finan. “She is an outstanding addition to Sabin’s executive team and will lead Sabin’s global immunization work as we continue to respond to the needs of individual countries and help shape new global strategies with partners to increase access and uptake of vaccines.”

Martin calls her new role a “full circle” moment.  

“I am honored and excited to join the Sabin Vaccine Institute as President of Global Immunization, bringing my experience, knowledge, and commitment to Sabin's critical mission in making vaccines available to everyone, everywhere,” she says.

“I am thrilled to work with the dedicated colleagues at Sabin who are passionate about tackling vaccine–preventable diseases through collaboration with stakeholders from multiple sectors in addition to health,” she adds. “There is no moment more urgent than now to innovate and double down on our efforts to prevent illness and save lives through immunization.”

Sabin’s Global Immunization team works with local and national governments and academic, global, and philanthropic partners to put communities at the heart of solutions that tackle urgent vaccination challenges, with a renewed focus to bolster the falling coverage in childhood routine immunization and support life–course immunization. In 2023, almost 14.5 million children received no vaccinations, according to WHO, an increase of 2.7 million more children compared to 2019.

The Sabin team brings expertise across the immunization spectrum, including building global communities of practice, identifying barriers and creating solutions to improve vaccine access and delivery of current and new vaccines, and conducting epidemiological research to support immunization. Sabin’s skills are applied to multiple infectious diseases, including HPV, typhoid, cholera, rotavirus, COVID–19 and malaria. Additional work includes efforts to immunize zero–dose children and transition to hexavalent vaccines in national immunization programs.

During her tenure at Emory, Martin built and aligned multidisciplinary global health infrastructure, fostered global collaborations across health organizations, led interdisciplinary global health research and worked to build the next generation of global health leaders. She was also a member of Emory’s Woodruff Health Sciences Center leadership team.

Martin’s most recent role with the CDC was Director of the Center for Global Health, then the largest operating unit at the CDC. Her achievements include leading the CDC's global efforts across disease initiatives and through the start of the global health security agenda, including polio eradication and disease control acceleration and elimination for vaccine–preventable diseases, malaria elimination, ending HV epidemics, and strengthening health systems to detect and respond to disease threats and emergencies.

Martin received her Doctor of Philosophy from the Johns Hopkins Bloomberg School of Public Health in international health with a focus on infectious disease epidemiology. She has co–authored manuscripts and developed strategic plans, normative guidance and guidelines on immunization strategies, vaccine–preventable diseases and surveillance methods for both immunization and HIV, and for global health security.

About the Sabin Vaccine Institute 
  
The Sabin Vaccine Institute is a leading advocate for expanding vaccine access and uptake globally, advancing vaccine research and development, and amplifying vaccine knowledge and innovation. Unlocking the potential of vaccines through partnership, Sabin has built a robust ecosystem of funders, innovators, implementers, practitioners, policy makers and public stakeholders to advance its vision of a future free from preventable diseases. As a nonprofit with three decades of experience, Sabin is committed to finding solutions that last and extending the full benefits of vaccines to all people, regardless of who they are or where they live. At Sabin, we believe in the power of vaccines to change the world. For more information, visit www.sabin.org and follow us on X @SabinVaccine. 

Media Contact:
Monika Guttman
Senior Media Relations Specialist
Sabin Vaccine Institute
+1 (202) 621–1691
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/05fb30d1–3f58–4240–aafe–91d33dab3398


GLOBENEWSWIRE (Distribution ID 9497738)

علم Superhumans الجديد: نظام الذكاء الاصطناعي BioSport™ يكشف النقاب عن الإمكانات الرياضية الخفية

كالجاري، ألبرتا ونيويورك, July 16, 2025 (GLOBE NEWSWIRE) —

 في خطوة تشير إلى عصر جديد في علم السلامة والأداء الرياضي، كشفت شركة BioSport™ Health Inc، المتخصصة في بتقنيات دقيقة للرعاية الصحية، اليوم عن هيئة استشارية عالمية تابعة لها – مجموعة متنوعة من نخبة الرياضيين والعلماء والمديرين الماليين – للمساعدة في توجيه إطلاق منصتها العالمية القادمة المقرر في خريف 2025.

في عالم رياضات النخبة المحفوف بمخاطر كبيرة، قد يتوقف الفرق بين الانتصار والهزيمة على عيب بيولوجي واحد غير ظاهر. خطر خفي بوجود مشاكل في القلب. التهاب مزمن. استعداد وراثي للإصابة. فهذه التهديدات الصامتة قد أنهت مسيرات رياضية وحيوات واعدة – كانت تحدث أحيانًا على الهواء مباشرة أمام ملايين المشاهدين. ورغم عقود من التقدم في مجالات التدريب والطب الرياضي والأجهزة القابلة للارتداء، إلا أن اللاعبين الرياضيين في أمريكا وحول العالم لا يزالون يتعرضون لنفس المشاكل المتكررة: الإصابات الناتجة عن فرط الإجهاد ومضاعفات أمراض القلب ونقاط القوة أو الضعف غير المكتشفة. وغالبًا ما يُخمّن المدربون الجداول الزمنية للتعافي. فيما تعتمد اختيارات أعضاء الفرق على المقاييس السطحية للأداء. حتى الرياضيون المتميزون نادرًا ما يكونون على دراية بالطبيعة الحقيقية لأجسامهم – أو كيفية حماية هذه الموهبة البيولوجية.

تعتمد منصة BioSport™ على أسس علم الجينوم وتحليل الميكروبيوم والذكاء الاصطناعي وتعد بمعالجة بعض المشكلات الأكثر إلحاحًا وتكرارًا في الألعاب الرياضية:

  • الإصابات المرتبطة بفرط الإجهاد بما فيها؛ تمزق الرباط الصليبي الأمامي والهدم العضلي والكسور الناجمة عن الإجهاد.
  • الأحداث القلبية المفاجئة لا تزال السبب الرئيسي للوفاة بين اللاعبين الرياضيين أثناء اللعب.
  • عدم المساواة في اختيار اللاعبين بسبب مقاييس الأداء القديمة.
  • وغياب الإلمام بالإمكانات البيولوجية الحقيقية للاعب على نطاق واسع.

من جهته أردف الدكتور Anmol S. Kapoor، طبيب أمراض القلب ومؤسس شركة Kapoor Wealth Partners، وهي شركة استشارات واستثمارات للجيل القادم من أبوظبي قائلاً: “رغم كل هذه التقنيات المتاحة في المساحات المحيطة بالملاعب، لا يزال اللاعبون الرياضيون يتساقطون”. “لقد عكفنا على علاج الأعراض واتباع أسلوب التخمين في الفترات اللازمة للتعافي. ما نحتاجه هو خريطة بيولوجية متكاملة – رعاية مُخصصة تعتمد على بنية جسم كل لاعب رياضي. وهذا هو ما تقدمه BioSport™.”

منصة دقيقة من أجل مستقبل الرياضة

توجد BioFit Score في صميم منصة The BioSport™، وهي ذات براءة اختراع مُعلقة وتحلل ما يزيد عن 15,000 متغير وراثي بشري إلى جانب بيانات ميكروبيوم الأمعاء لتقييم:

  • خطر الإصابة
  • القدرة على التعافي
  • الاستعدادت القلبية
  • القدرة على التحمل والطاقة الكامنة
  • مؤشرات الإجهاد الذهني
  • الحالات الهرمونية والالتهابية

تم جمع هذه المعلومات بواسطة PanOmiQ™ لدى BioAro Inc، وهي أسرع منصة MultiOmics مدعومة بالذكاء الاصطناعي في العالم ومدمجة مع أجهزة جمع البيانات (معدل ضربات القلب، والنوم، وحجم العمل) القابلة للارتداء ويتم تسليمها من خلال لوحات معلومات سهلة الاستخدام وتطبيقات الأجهزة المحمولة للاعبين.

الهدف: تمكين اللاعبين الرياضيين والمدربين والفرق الطبية من اتخاذ قرارات فورية ودقيقة فيما يتعلق بالتدريب والتغذية والراحة والمخاطرة. حيث يمكن بالاستعانة بالذكاء الاصطناعي وبيانات الأجهزة القابلة للارتداء أن يُحوّل جهاز BioSport™ هذه البيانات إلى تقارير وتوصيات فورية. والنتيجة؟ يُمكن للمدربين واللاعبين الرياضيين تعديل الحمل التدريبي ورصد العلامات التحذيرية وتحسين التغذية بناءً على الخصائص البيولوجية الفريدة لكل رياضي—وليس بناءً على معادلات عامة.

وفي هذا الصدد قال Patrick Kirkwood الرئيس التنفيذي لشركة BioSport™ Health Inc “اعتبره جهاز GPS لجسمك”. “فنحن نمنح اللاعبين الرياضيين خريطة طريق لبلوغ القمة— وتجنب الانزلاق إلى الهاوية.”

مجلس عالمي يتمتع بخبرات عريضة في مجالات الرياضة والعلوم والإستراتيجيات

ولدعم هذا الطرح الطموح، قامت BioSport™ بتعيين مجلس استشاري عالمي قوي:

  • Grant Fuhr – حارس مرمى Hall of Fame في دوري الهوكي الوطني (NHL) والمتوج بكأس ستانلي خمس مرات
  • Christina Nathalie Smith لاعبة أولمبية شابة (OLY) – رائدة الزلاجات الجماعية الأولمبية
  • Nik Lewis –لاعب Hall of Famer في دوري كرة القدم الكندي وصاحب الرقم القياسي في مهارات الاستقبال على مر العصور
  • Paul O’Donoghue – رائد أعمال في مجال الطاقة والتكنولوجيا وخبير إستراتيجي بالأعمال
  • H.E. Prof. Dr. Zahid Haque– دبلوماسي الرياضة العالمية ومناصر لمكافحة المنشطات
  • Kurt Soost – محلل مالي معتمد (CFA) – مدير استثمار مخضرم وخبير في أسواق رأس المال
  • Nick Wilson لاعب أوليمبي شاب (OLY) – رياضي أولمبي وخبير إستراتيجي يتمتع بكفاءة عالية

يقول Grant Fuhr، حارس مرمى Hall of Famer دوري الهوكي الوطني (NHL)، والذي واجه ضغوط رياضة النخبة بصورة مباشرة: “هذا النوع من المنصات يُغيّر حياة الأشخاص. “فالأمر لا يقتصر على الأداء فحسب – بل يتعلق بإدراك المخاطر قبل فوات الأوان. فهذه المنصة لم تكن متاحة لجيلنا. واللاعبين بحاجة إليها حاليًا. BioSport™ هو الابتكار الذي كنت أتمنى أن نحظى به عندما كنت لاعبًا.”

حتى مع ظهور الأجهزة القابلة للارتداء وتطبيقات التدريب ومختبرات العلوم الرياضية، لا تزال هناك نقطة عمياء رئيسية: التفرد البيولوجي.

وفقًا لبيانات الطب الرياضي الأمريكية الحديثة:

  • تشكل الإصابات الناتجة عن فرط الإجهاد أكثر من 35% من الزيارات الطبية ذات الصلة بالألعاب الرياضية.
  • يظل توقف القلب المفاجئ السبب الرئيسي للوفاة بين اللاعبين الرياضيين الشباب ولا سيما في الرياضات عالية الشدة.
  • يرتبط التخصص المبكر بشكلٍ مباشر بالإرهاق والألم المزمن الذي يحدث في أواخر مرحلة المراهقة.

يقول Patrick Kirkwood: “لا يوجد نموذج واحد يناسب الجميع في البيولوجيا البشرية”. “فقد يكون أمامنا لاعبان رياضيان متطابقان نظريًا، لكن أحدهما قد يكون عرضة للإصابة أو إجهاد القلب بيولوجيًا. وهنا تبرز أهمية هذه المنصة—فهي تضفي وضوحًا على هذه الفوضى.”

تهدف الشركة إلى إرساء معيار عالمي جديد في مجال الصحة الرياضية، ولا يقتصر الأمر على المحترفين، بل يمتد ليشمل الشباب والهواة واللاعبين الرياضيين الجامعيين أيضًا. وقد دخلت منصة BioSport™ حاليًا في مرحلة الاستخدام التجريبي لدى مجموعة مختارة من الأندية المحترفة ومراكز التدريب الأولمبية وأكاديميات الشباب. ومن المقرر إطلاقها على نطاق واسع في خريف 2025 مستهدفةً أسواق أمريكا الشمالية وأوروبا والشرق الأوسط وآسيا والمحيط الهادئ.

تشمل مميزات المنصة ما يلي:

  • مجموعات اختبار الجينوم والميكروبيوم (للاستخدام في العيادات أو المنازل)
  • لوحات بيانات مدمجة بالذكاء الاصطناعي للاعبين الرياضيين والمدربين
  • تطبيقات الأجهزة المحمولة للتعافي والتخطيط الشخصي
  • بوابات إلكترونية للأطباء وإمكانية إجراء فحص عن بُعد من متخصصي الجينوم
  • وحدات متكاملة قابلة للارتداء لمراقبة الأداء بشكل مستمر

وأضاف الدكتور Kapoor: “إن BioSport™ ليس مجرد أداة صحية، بل هو شبكة أمان للأفراد المعرضين لمخاطر صحية عالية. فنحن نبني مستقبلاً لا يُبعد فيه أحد عن المنافسة بسبب مرض يمكن الوقاية منه”.

لا يقتصر دور BioSport™ على مساعدة اللاعبين الرياضيين في مطاردة الميداليات الذهبية، بل يساعدهم أيضًا في مواصلة مسيرتهم الرياضية وأحلامهم ومستقبلهم. فالأمر يتعلق بـ Powering Superhumans™.

حول BioSport™

BioSport™ هي شركة من الجيل الجديد متخصصة في تقنيات الصحة الرياضية، يقع مقرها في كندا والولايات المتحدة وتُركز على تحسين أداء اللاعبين الرياضيين وإطالة مسيرتهم الرياضية من خلال علم الجينوم وذكاء الميكروبيوم والتخصيص المعزز بالذكاء الاصطناعي. وتدعم المنصة الحقوق الخاصة للملكية الفكرية والشراكات العالمية والرؤيةً اللازمة لوضع معيار عالمي جديد في مجال المعلومات المتعلقة بصحة الرياضيين.

سفير علامة BioSport™

Hayden Mayeur

حائز على ميداليتين في بطولة العالم وبطل كندا الحالي في بطولة الانطلاق الجماعي للرجال

جهة الاتصال الإعلامية

[email protected]
www.theBioSport.com

تتاح الصور المرافقة لهذا الإعلان على

https://www.globenewswire.com/NewsRoom/AttachmentNg/4cf136e9–2de5–4dbf–9cf1–91b3d4a6ff73

https://www.globenewswire.com/NewsRoom/AttachmentNg/d90ca089–d861–4ad1–aa94–a106e3bb5f1b


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