Innate Pharma Announces Its Participation in the 25th Edition of the European Midcap Event




Innate Pharma Announces Its Participation in the 25th Edition of the European Midcap Event

MARSEILLE, France–(BUSINESS WIRE)–#ANKET–Regulatory News:

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that Frédéric Lombard, Chief financial Officer of the Company, will participate in the 25^th edition of the European Midcap Event being held from September 30 to October 1, 2025 in Paris, France.

The European Midcap Event is a key gathering that brings together institutional investors and listed companies to foster strategic meetings and financing opportunities. This flagship event provides a unique platform to engage with the European financial community.

About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through three therapeutic approaches: multi-specific NK Cell Engagers via its ANKET^® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC) and monoclonal antibodies (mAbs).

Innate’s portfolio includes several ANKET^® drug candidates to address multiple tumor types as well as IPH4502, a differentiated ADC in development in solid tumors. In addition, anti-KIR3DL2 mAb lacutamab is developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, and anti-NKG2A mAb monalizumab is developed with AstraZeneca in non-small cell lung cancer.

Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients.

Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.

Information about Innate Pharma shares

Disclaimer on forward-looking information and risk factors

This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “intend,” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release.

In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Contacts

For additional information, please contact:
Innate Pharma
Stéphanie Cornen

stephanie.cornen@innate-pharma.fr

Investor Relations
investors@innate-pharma.fr

Medias
communication@innate-pharma.fr

Curatis: Double-Digit Growth in Core Business and Development Milestone Achieved for C-PTBE-01




Curatis: Double-Digit Growth in Core Business and Development Milestone Achieved for C-PTBE-01

LIESTAL, Switzerland–(BUSINESS WIRE)–Curatis Holding AG (SIX:CURN) reports revenues of CHF 5.2m for H1 2025, a like for like yoy growth of 14% vs 6 months of revenues of Curatis AG in 2024. In addition, Curatis was able to sign a significant partnership with Phoenix Labs, Ireland, adding 4 products that generated approximately CHF 5m of revenues in 2024. The loss for the period amounted to CHF -1.2m, mainly driven by increased development expenses for C-PTBE-01 (corticorelin). Cash flow amounted to CHF -1.0m. As planned, Curatis held a Type B meeting with the US Food and Drug Administration (FDA) on 9 September 2025.

Business development and finances

Product sales in the first half of the year amounted to CHF 5.0m and services revenues to CHF 0.2m. Curatis AG was able to increase the sales of its distribution business from CHF 4.6m (H1 2024) to CHF 5.2m (H1 2025) in the entire 6 months due to strong organic growth of the existing portfolio and new products, which corresponds to a growth of 14%. The loss for the period amounted to CHF -1.2m, driven mainly by significant investments in C-PTBE-01 in preparation for the planned Phase 3 clinical trial.

Curatis has a cash position of CHF 2.0m despite increased development expenses.

For a more detailed discussion of the half-year figures, please refer to the half-year report and the associated management report, which are available on the Curatis website www.curatis.com.

Corticorelin / C-PTBE-01

Curatis’ lead product candidate, C-PTBE-01 (corticorelin), is being developed to treat peritumoral brain edema (PTBE). PTBE occurs in association with many primary and metastatic (secondary) brain tumors, often in connection with metastases caused by lung cancer, breast cancer, melanoma and colorectal cancer. PTBE results in impairment of brain function due to the accumulation of extracellular fluid around the tumor and can cause symptoms such as headaches, vomiting and neurological dysfunction such as paralysis, speech disorders, visual problems and altered mental status. Standard of care treatment for PTBE is the use of corticosteroids which frequently have serious side effects such as severe myopathy, impaired glucose metabolism, muscle wasting, abnormal weight gain, osteoporosis, gastritis, gastrointestinal bleeding, hypertension and personality changes. Additionally, corticosteroids can also counteract certain cancer therapies such as chemotherapy or emerging immunotherapies that rely on adequate T-cell functionality which is impaired by corticosteroids.

Corticorelin (hCRH), a 41 amino acid endogenous polypeptide, has demonstrated preclinically (in vivo) the ability to positively impact the blood-brain barrier after a disruption due to the underlying malignant tumor. In two clinical studies in patients with PTBE, corticorelin, demonstrated the potential to substantially reduce, or in some cases completely replace steroid use, which may reduce or avoid the severe glucocorticoid-related side effects and subsequently improve quality of life. In the US alone, more than 150,000 patients suffer from PTBE. Corticorelin is an investigational drug not approved for therapeutic use in the United States or outside the United States.

Curatis met with the FDA on 9 September 2025 to achieve alignment on the design of a pivotal Phase 3 clinical trial for corticorelin as well as on key non-clinical and manufacturing aspects. The outcome of the meeting was positive. Further details will be published once the minutes of the FDA meeting are available. In Q3 of 2025, Curatis Holding AG began the process of partnering C-PTBE-01 (corticorelin) with global pharmaceutical companies active in oncology.

Outlook

The Curatis Group anticipates growth in its product and service revenues for 2025 compared to 2024. This growth is expected to be primarily driven by new products, notably four recently contracted products from Phoenix Labs in pain management and urology. These products generated approximately CHF 5 million in sales in 2024. Curatis Group’s objective remains to achieve a break even result in 2026 regardless of whether a partner for C-PTBE-01 can be secured. This would be achieved through substantially increased revenues and lower costs compared to 2025.

About Curatis

Curatis Holding AG is a publicly listed company (CURN.SW) specializing in the late stage development and commercialization of drugs for rare diseases and specialty care. Curatis has a sales portfolio of more than 40 products and a pipeline of orphan and specialty drugs. More information can be found on the website www.curatis.com.

Disclaimer:

The information contained in this media release and in any link to our website indicated herein is not for use within any country or jurisdiction or by any persons where such use would constitute a violation of law. If this applies to you, you are not authorized to access or use any such information.

This media release contains “forward-looking statements” that are based on our current expectations, assumptions, estimates and projections about us and our industry. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate or imply future results, performance or achievements, and may contain the words “may”, “will”, “should”, “continue”, “believe”, “anticipate”, “expect”, “estimate”, “intend”, “project”, “plan”, “will likely continue”, “will likely result”, or words or phrases with similar meaning. Undue reliance should not be placed on such statements because, by their nature, forward-looking statements involve risks and uncertainties, including, without limitation, economic, competitive, governmental and technological factors outside of the control of Curatis Group, that may cause Curatis’ business, strategy or actual results to differ materially from the forward-looking statements (or from past results). For any factors that could cause actual results to differ materially from the forward-looking statements contained in this media release, please see the risk factors included in our listing prospectus in connection with the Business Combination. Curatis Group undertakes no obligation to publicly update or revise any of these forward-looking statements, whether to reflect new information, future events or circumstances or otherwise. It should further be noted that past performance is not a guide to future performance. Persons requiring advice should consult an independent adviser.

The information contained in this media release is not an offer to sell or a solicitation of offers to purchase or subscribe for securities. This media release is not a prospectus within the meaning of the Swiss Financial Services Act nor a prospectus under any other applicable laws.

Some financial information in this media release has been rounded and, as a result, the figures shown as totals in this media release may vary slightly from the exact arithmetic aggregation of the figures that precede them.

Contacts

Patrick Ramsauer

CFO

Phone: +41 61 927 8777

ir@curatis.com

A Pharmacy-First Approach to Innovation: Pete Pharma and FABRX Announce Partnership




A Pharmacy-First Approach to Innovation: Pete Pharma and FABRX Announce Partnership

PHOENIX–(BUSINESS WIRE)–Pete Pharma announced today a groundbreaking partnership with FABRX, the global pioneer of pharmaceutical 3D printing, to introduce this innovative technology to the U.S. compounding pharmacy market.

FABRX, founded over a decade ago, has successfully deployed pharmaceutical 3D printing across hospitals, universities, and clinical research centers worldwide. Pete Pharma will leverage this deep foundation of scientific validation to bring the technology into a commercially viable, pharmacy-ready solution for the first time in the United States.

“Compounding pharmacies have been eager for meaningful innovation that improves efficiency, enhances compliance, and expands their ability to personalize care for patients,” said Dan Siddall, Founder of Pete Pharma. “By combining FABRX’s proven scientific expertise with Pete Pharma’s commercialization strategy, we’re making pharmaceutical 3D printing not just possible, but practical and scalable across the U.S. market.”

The introduction of pharmaceutical 3D printing offers compounding pharmacies the ability to:

• Improve workflow efficiency by automating labor-intensive processes
• Enable greater personalization of medications, particularly in areas such as pediatrics, lifestyle therapeutics, HRT, and metabolic care
• Enhance quality and compliance through in-line quality control and digital traceability

In addition to bringing FABRX’s validated technology to the U.S., Pete Pharma will launch the platform through a first-of-its-kind business model that transforms how pharmacies access innovation. This model is designed to be:

• Pharmacy-First: the first-of-its-kind model is built around the needs of the pharmacies, ensuring that success is not measured just by the delivery of technology, but by the value and outcomes created through the compounded products themselves
• Scalable: accessible to independent pharmacies nationwide
• Efficient: reducing the burden of labor and consumable waste
• Forward-looking: addressing regulatory requirements head-on while reshaping the conventional distribution model in compounding

“This is more than a technology launch; it’s the beginning of a new era for compounding pharmacies,” added Dan Siddall. “We’re building a model that makes advanced pharmaceutical technology available in a way that works for the realities of the compounding industry.”

The partnership between Pete Pharma and FABRX positions both organizations to set the standard for innovation in compounding, creating a future where pharmacies can operate more efficiently while delivering better, more effective therapies for patients.

About Pete Pharma

Pete Pharma is a U.S.-based innovator focused on transforming the compounding industry through advanced technologies, proprietary base formulations, and commercialization strategies. With a pharmacy-first approach, Pete Pharma partners directly with compounding pharmacies to deliver scalable solutions that improve efficiency, compliance, and patient outcomes.

About FABRX

FABRX, founded in 2014, is a global leader in pharmaceutical 3D printing technology. Spun out of University College London, FABRX has spent over a decade pioneering research and clinical applications of 3D printing in hospitals, universities, and research centers worldwide. Its M3DIMAKER platform is the first pharmaceutical 3D printer designed specifically for personalized medicines.

Contacts

Dan Siddall

Dan@petepharma.com
(720) 891-3770

Evolus Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




Evolus Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

NEWPORT BEACH, Calif.–(BUSINESS WIRE)–Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today reported the grant of non-qualified stock options to purchase an aggregate of 8,744 shares of Evolus common stock and an aggregate of 15,000 restricted stock units (RSUs) of the company’s common stock to 6 newly hired non-executive employees of the company, and 143,403 shares of Evolus common stock and 104,603 RSUs of the company’s common stock to Tatjana Mitchell, the company’s new Chief Financial Officer. The awards were approved by the compensation committee of the company’s board of directors under the Evolus 2023 Inducement Incentive Plan as an inducement material to the new employees entering into employment with Evolus in accordance with Nasdaq Listing Rule 5635(c)(4), with the non-executive employee awards and Ms. Mitchell’s awards having a grant date and vesting commencement date of September 7, 2025 and September 8, 2025, respectively.

The non-executive employee stock options have an exercise price of $7.66 per share, the closing price of the company’s common stock on September 5, 2025. The non-executive employee stock options have a 10-year term and vest over 4 years, with 25% of the number of shares subject to the option vesting on each annual anniversary of the vesting commencement date. The non-executive employee RSUs vest 25% on each annual anniversary of the vesting commencement date.

Ms. Mitchell’s stock options have an exercise price of $7.61 per share, the closing price of the company’s common stock on September 8, 2025, and such stock options have a 10-year term and vest over 4 years, with 25% of the number of shares subject to the option vesting on each annual anniversary of the vesting commencement date. Ms. Mitchell’s RSUs vest 50% on the third anniversary of the vesting commencement date and 50% on the fourth anniversary of the vesting commencement date.

The awards are subject to the terms and conditions of the 2023 Inducement Incentive Plan and the terms and conditions of the stock option agreement or RSU agreement, as applicable, covering the grant, including requirements to remain continuously employed on each vesting date.

About Evolus, Inc.

Evolus (NASDAQ: EOLS) is a global performance beauty company redefining the aesthetic injectable market for the next generation of beauty consumers through its unique, customer-centric business model and innovative digital platform. Our mission is to become a global leader in aesthetics anchored by our flagship products: Jeuveau® (prabotulinumtoxinA-xvfs), the first and only neurotoxin dedicated exclusively to aesthetics, and Evolysse™, a collection of unique injectable hyaluronic acid (HA) gels. Visit us at www.evolus.com, and follow us on LinkedIn, X, Instagram or Facebook.

Jeuveau^® is a registered trademark and Evolysse^™ is a trademark of Evolus, Inc.

Contacts

Evolus Contacts:
Investors:
Nareg Sagherian

Vice President, Head of Global Investor Relations and Corporate Communications

Tel: 248-202-9267

Email: ir@evolus.com

Media:

Email: media@evolus.com

Hercules Pharmaceuticals Appoints Elie Bahou as Executive Vice President, Chief Pharmacy Strategy Officer




Hercules Pharmaceuticals Appoints Elie Bahou as Executive Vice President, Chief Pharmacy Strategy Officer

Veteran pharmacy leader to advance Hercules’ strategy with operational excellence and AI-driven innovation

PORT WASHINGTON, N.Y.–(BUSINESS WIRE)–Hercules Pharmaceuticals, a national leader in pharmaceutical distribution and provider-aligned GPO services, today announced the appointment of Elie Bahou, PharmD, MBA, as Executive Vice President, Chief Pharmacy Strategy Officer.

Bahou brings decades of executive leadership across pharmacy services, distribution, and PBM strategy. Most recently, as Senior Vice President and System Chief Pharmacy Officer at Providence St. Joseph Health, he directed one of the nation’s largest integrated pharmacy enterprises, advancing payer-provider collaborations, strengthening supply chain resiliency, and designing innovative models to expand patient access. Earlier in his career, Bahou held leadership roles with Cardinal Health, where he developed deep expertise in pharmaceutical distribution, and with OptumRx, where he helped shape payer and PBM strategies that informed his provider-focused approach to pharmacy services.

In his new role, Bahou will oversee enterprise-wide pharmacy strategy, uniting clinical insight with operational execution to enhance provider partnerships, accelerate manufacturer collaboration, and scale Hercules’ leadership position through operational excellence and AI-driven innovation. His efforts will support the creation of a smarter, more reliable healthcare supply chain for providers and partners nationwide.

“Elie is one of the most respected pharmacy leaders in the country, with a proven ability to lead large-scale pharmacy enterprises while keeping patients at the center,” said Sara Amani, CEO of Hercules Pharmaceuticals. “He brings the strategic perspective and operational expertise to help drive Hercules’ next phase of growth and impact.”

“Hercules is uniquely positioned to redefine how pharmacy services connect patients, providers, and manufacturers,” said Elie Bahou. “I am honored to join a team committed to delivering innovative solutions that ensure affordable, reliable access to high-value medicines nationwide.”

Hercules is addressing one of the most urgent challenges in U.S. healthcare: drug shortages and systemic supply chain vulnerabilities. By diversifying sourcing channels and expanding manufacturer partnerships, the company helps providers reduce concentration risk, secure consistent access to essential therapies, and safeguard patient care against disruption. In parallel, Hercules delivers financial strength to health systems, specialty pharmacies, community practices, and retail by improving cash flow and reducing dependence on a limited number of large distributors. Through this model, Hercules strengthens provider resilience while ensuring patients receive the medicines they need, when they need them.

Contacts

Media Contact:

press@herculesrx.com
1-800-815-5800

FORE Biotherapeutics Presents Phase 1/2a Plixorafenib Data Demonstrating Prolonged Duration of Effect in BRAF Altered Thyroid Cancers at American Thyroid Association® 2025 Annual Meeting




FORE Biotherapeutics Presents Phase 1/2a Plixorafenib Data Demonstrating Prolonged Duration of Effect in BRAF Altered Thyroid Cancers at American Thyroid Association® 2025 Annual Meeting

Plixorafenib demonstrated mPFS of 64 months and a clinical benefit rate of 85.7% in patients with MAPKi-naïve BRAF V600-mutated papillary thyroid cancer, a potential future development indication for plixorafenib

Global registrational FORTE Phase 2 study is evaluating BRAF alterations, including in thyroid cancers

PHILADELPHIA–(BUSINESS WIRE)–FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, today presented new plixorafenib results from the previously completed Phase 1/2a clinical trial that demonstrate treatment with plixorafenib in patients with BRAF-altered papillary thyroid cancer (PTC) and anaplastic thyroid cancer (ATC) resulted in durable disease control that appears very favorable compared with historical data with standard treatment options. The data also demonstrate an encouraging safety profile consistent with previously reported results following treatment with plixorafenib. The data are being presented at the American Thyroid Association^® (ATA) 2025 Annual Meeting, taking place September 10-14, 2025 in Scottsdale.

“These results presented at ATA 2025 demonstrate durable clinical benefit in both V600 mutated and BRAF fusion thyroid tumors, and durable disease control in patients with stable disease. These new findings continue to support the strong clinical profile of plixorafenib as well as the potential to benefit patients with BRAF-altered thyroid cancers,” said Eric J. Sherman, M.D., Head and Neck Cancer Medical Oncologist at the Memorial Sloan Kettering Cancer Center, and Principal Investigator for the ongoing FORTE Phase 2 plixorafenib study. “Patients with differentiated thyroid cancer, including papillary thyroid cancers which account for about 80% of all thyroid cancers, are in dire need of new treatment options. BRAF V600E alterations occur in approximately 60% of papillary thyroid cancers, underscoring the need for development of a targeted therapy such as plixorafenib that addresses the mechanistic drivers of these tumors along with the compelling clinical efficacy and safety profile demonstrated by treatment with plixorafenib.”

“We are excited to share these data that show additional evidence of strong and durable clinical activity of plixorafenib, in both BRAF V600 mutant and BRAF fusion thyroid cancers,” said Stacie Peacock Shepherd, M.D., Ph.D., Chief Medical Officer of Fore. “The data also demonstrate a high duration of response in MAPKi-naïve patients, highlighting the unique mechanism of action of plixorafenib that avoids paradoxical MAPK pathway activation and delivers differentiated results as a single therapeutic agent in BRAF altered cancers. We continue to advance our ongoing registrational FORTE basket study, which includes BRAF V600 altered thyroid cancers, as we aim to generate further data to inform treatment and help patients with BRAF driven tumors.”

The results presented at ATA 2025 are from 21 patients with thyroid cancer, 16 with PTC and 5 with ATC, treated with plixorafenib in a previously completed Phase 1/2a study that treated a total of 113 patients with advanced, unresectable solid tumors that were intolerant to standard therapy or had no standard therapy available. All 21 patients with thyroid cancer received prior radiation therapy, nearly all underwent prior surgery, and the majority had received prior systemic anticancer therapies. The safety profile of treatment with plixorafenib in patients with ATC or PTC was consistent with previously reported results from the Phase 1/2a study.

Treatment with plixorafenib with and without cobicistat in MAPK-inhibitor naïve patients with a BRAF V600 mutation demonstrated an encouraging clinical benefit with a differentiated duration of response and support plixorafenib’s paradox breaker mechanism of action in BRAF-altered tumors, including a median progression free survival (mPFS) of 63.9 months and a clinical benefit rate (CBR: response or stable disease ≥ 24 weeks) of 85.7% (6 of 7 patients). Four MAPK-inhibitor naïve PTC patients remained on treatment for over 5 years, including one partial response (PR) of 59.2 months (treatment duration=7.6 years) and a second PR of 30.9 months (treatment duration=8.3 years). In four ATC patients with a BRAF V600 mutation, all of whom were MAPK-inhibitor naïve, the mPFS was 16.1 months, with one confirmed PR lasting 17.8 months and two patients reaching stable disease. In the three PTC patients that received prior MAPK inhibition therapy as well as at least one prior BRAF inhibition therapy, all three patients reached stable disease, with a CBR of 33.3%. Clinical benefit was also observed in patients with BRAF fusion PTC, with one of three patients achieving a PR lasting 12.9 months (treatment duration=25 months, continued post-study completion), and one patient with ATC having stable disease.

The results presented at ATA 2025 demonstrate a differentiated and durable clinical benefit in BRAF altered anaplastic and papillary thyroid cancers, compared to historical results of approved and investigational therapies, including BRAF, MEK, and pan-RAF inhibitors. Plixorafenib’s novel mechanism of action does not induce paradoxical activation of the MAPK pathway, thereby not requiring combination with a MEK inhibitor and potentially improving upon safety, efficacy, and durability compared with treatments containing prior generation RAF inhibitors.

FORE is advancing the registration-intended FORTE Master Protocol, a global Phase 2 clinical trial which includes four sub-protocol baskets evaluating plixorafenib in distinct patient populations. The three monotherapy indications currently under evaluation are BRAF V600 progressive or recurrent primary CNS tumors, rare BRAF V600 mutated advanced solid tumors, including ATC, and solid tumors with BRAF fusions, including PTC and ATC. BRAF v600E alterations occur in 45% of ATC and approximately 60% of PTC, representing a differentiated potential future development opportunity for plixorafenib.

Poster Presentation Details:

Title: Clinical Activity and Safety of Novel BRAF Inhibitor (BRAFi) Plixorafenib (FORE8394; PLX8394) in Advanced Thyroid Cancers (TC) Harboring BRAF Alterations

Lead Author & Presenter: Eric J. Sherman, M.D., Memorial Sloan Kettering Cancer Center

Poster Session: Clinical Thyroid Diseases & Cancer

Date and Time: Friday, September 12, 2025, 3:00 – 4:00 p.m. MT

Poster Number: 300

About FORE Biotherapeutics

Fore is a registration stage targeted oncology company dedicated to developing innovative treatments that provide better outcomes for patients with the hardest-to-treat cancers. The Company’s lead asset plixorafenib (FORE8394; formerly PLX8394) is a V600 and non-V600 BRAF inhibitor rationally designed with a first-in-class mechanism to address treatment gaps from 1^st and 2^nd generation BRAF inhibitors. Plixorafenib has demonstrated single-agent efficacy signals across a variety of tumor types with a favorable safety profile in a Phase 1/2a clinical trial of over 100 patients and is currently enrolling patients in FORTE, a global registrational basket trial to support three distinct indications. For more information, please visit www.fore.bio or follow us on X and LinkedIn.

Contacts

Investors and Media:
Argot Partners

212.600.1902 | ForeBio@argotpartners.com

Mandos Health to Present New Analyses in Niemann-Pick Disease Type C at the 2025 American Neurological Association Annual Meeting




Mandos Health to Present New Analyses in Niemann-Pick Disease Type C at the 2025 American Neurological Association Annual Meeting

THOUSAND OAKS, Calif.–(BUSINESS WIRE)–Mandos Health^® by Beren Therapeutics Public Benefit Corporation (P.B.C.) announced today that new analyses detailing the clinical and biological effects of its investigational drug, adrabetadex, in Niemann-Pick Disease Type C (NPC) will be presented at the 150^th annual meeting of the American Neurological Association (ANA) September 13–16 in Baltimore, Maryland.

The first abstract, recognized by ANA as an “Abstract of Distinction,” reports improved overall survival in adrabetadex-treated participants with neurological onset before 6 years of age compared to matched external controls. The second abstract provides biomarker data supporting the potential of adrabetadex as a disease-modifying therapy if approved. NPC is a rare and progressive neurodegenerative disorder characterized by impaired cholesterol trafficking, severe neurological deficits, and ultimately, premature mortality.

“This is one of the most rigorously conducted investigations comparing treated participants to matched external controls in Niemann-Pick Disease Type C (NPC),” said Dr. Elizabeth Berry-Kravis, Professor of Pediatrics, Director of RUSH Pediatric Neurosciences F.A.S.T. Center for Translational Research at Rush University Medical Center and lead study author. “For those of us who have witnessed the relentless and heart-breaking progression of this condition, we are encouraged by the potential for adrabetadex to meaningfully alter the disease course, extend survival and improve outcomes for patients with NPC and their families.”

Both analyses will be featured in poster presentations during the ANA meeting:

About Niemann-Pick Disease Type C (NPC)

NPC is a rare, autosomal-recessive, severe, neurodegenerative disorder caused by pathologic variants in the NPC1 (~95% of cases) or NPC2 genes, leading to impaired cholesterol trafficking resulting in progressive neurological decline and premature death. Earlier neurological onset is associated with more rapid progression and poorer prognosis, with mean survival of ~5.6 years for early infantile onset (age of neurological onset <2 years) and ~13.4 years for late infantile onset (2 to <6 years). Individuals with early and late infantile-onset NPC typically present with manifestations affecting multiple organs, but the most severe and debilitating effects occur in the brain.

About Adrabetadex (VTS-270)

Adrabetadex (VTS-270) is a proprietary mixture of 2-hydroxypropyl-β-cyclodextrin isomers under investigation as a treatment for NPC. By reestablishing intracellular cholesterol trafficking, adrabetadex directly addresses the core pathology of NPC.

Adrabetadex has not been approved by the FDA or any other health authority at this time.

About Mandos LLC

Mandos LLC is a wholly-owned subsidiary of Beren Therapeutics Public Benefit Corporation (P.B.C.), a biotechnology company creating the potential for possibilities for individuals living with Niemann-Pick Disease Type C (NPC), a condition characterized by defects in cholesterol trafficking. The company’s experienced team of scientists are focused on evaluating adrabetadex, a derivatized cyclodextrin, as a potential treatment that can target the underlying pathology of NPC. Since 2021, Mandos Health has supported the NPC community by providing access to adrabetadex* through its Expanded Access Program (EAP). The company will continue working closely with patients, families, researchers, regulators, and others on a path to bring forth this potentially transformative therapy for NPC and other cholesterol-trafficking diseases. For more information, please visit https://mandoshealth.com/about-us.

About Rush University Medical Center

Rush University System for Health (RUSH) is an academic health system whose mission is to improve the health of the individuals and diverse communities it serves through the integration of outstanding patient care, education, research and community partnerships. RUSH comprises Rush University Medical Center, Rush University, Rush Copley Medical Center, and Rush Oak Park Hospital, as well as numerous outpatient care facilities. Rush University, with more than 2,500 students, is a health sciences university that comprises Rush Medical College, the College of Nursing, the College of Health Sciences, and the Graduate College.

*Adrabetadex is an investigational drug that has not been approved by the U.S. Food and Drug Administration and has not been found safe and effective to treat NPC or any other condition.

Contacts

Amanda Eckel

BGB Group

Aeckel@bgbgroup.com

Orano Med Achieves Key Milestone in French ATEF Facility Construction, an Essential Asset for Large-Scale Production of Innovative Lead-212-based Therapies




Orano Med Achieves Key Milestone in French ATEF Facility Construction, an Essential Asset for Large-Scale Production of Innovative Lead-212-based Therapies

BESSINES-SUR-GARTEMPE, France–(BUSINESS WIRE)–Orano Med:

• ATEF (Advanced Thorium Extraction Facility) plant is now watertight, marking a major step toward the completion of civil engineering work.
• Construction is progressing according to schedule, with start-up planned for 2027.
• A site visit brought together institutional partners, local authorities, and economic stakeholders to celebrate this achievement.
• ATEF will be the world’s first industrial facility dedicated to the production of thorium-228, the precursor of lead-212 used in innovative targeted alpha therapies against cancer.

Orano Med, a subsidiary of the Orano group specializing in the development of targeted alpha therapies in oncology, announced today that the Advanced Thorium Extraction Facility (ATEF) in Bessines-sur-Gartempe, near Limoges, France, has now reached the dry-in phase, with sealing works completed. This marks a major milestone since the groundbreaking in November 2024.

To celebrate this milestone, a site visit was organized, bringing together numerous institutional and local partners who have supported the project since its inception. Among those present were Andréa Brouille, mayor of Bessines-sur-Gartempe and first vice-president of the Nouvelle-Aquitaine region, and Alain Auzemery, president of the ELAN community of municipalities and vice-president of the Haute-Vienne departmental council. Representatives from these authorities, the Nouvelle-Aquitaine Development and Innovation Agency (ADI NA), the Limoges and Haute-Vienne Chamber of Commerce and Industry, and the Limousin Union of Metallurgy Industries and Trades also took part in the visit.

Both Orano Med and Orano Projets¹ teams were present to share the progress of the work and discuss the next steps. “Construction is progressing according to schedule. We have the full commitment of our partners and all the companies and stakeholders involved to bring this exciting ATEF plant to fruition,” underscored Bruno Pagnard, ATEF project manager.

Eric Pluche, director of Orano’s Bessines-sur-Gartempe site, also emphasized the significance of the new ATEF facility, both for the development embarked upon by the Bessines-sur-Gartempe industrial site and, more broadly, for the local economy, which is gaining an innovative platform that will create skilled jobs. “With the hiring of 70 new employees, Orano is demonstrating its commitment to investing in the region over the long term and helping to boost its attractiveness,” he commented.

Orano Med is developing a new generation of targeted cancer therapies, known as Targeted Alpha Therapy (TAT), using the unique properties of lead-212. The development of these promising drugs has long been hampered by the difficulty of producing them on an industrial scale. With a floor area of nearly 7,000 m² and a production capacity ten times greater than that of the Maurice Tubiana laboratory, ATEF will be the world’s first industrial-scale facility dedicated to the production of thorium-228, a key precursor for the production of lead-212.

The coming months will be devoted to completion of civil engineering work, followed by the installation and qualification of the plant equipment. The facility is scheduled to begin operations in 2027. The total investment is estimated at €250 million, including €22 million of French government funding through the France 2030 scheme under the “Industrialization and Health Capacities 2030” call for projects.

“The ATEF plant is a key component in Orano Med’s fully integrated industrial platform. This platform will cover the entire value chain of targeted alpha therapies, from precursor production to lead-212–based therapies. It will enable the large-scale production of these treatments to meet the needs of patients worldwide,” said Fabrice Darvey, Director of Industrial Operations at Orano Med.

The combined production capacities of ATEF and the Maurice Tubiana laboratory will in the short term provide the necessary supplies for clinical trials and commercial launches of the first treatments developed by Orano Med. Within ten years, this industrial platform will be able to treat up to 25,000 patients per year.

About Orano Med

Orano Med, a subsidiary of the Orano Group, is a clinical-stage biotechnology company which develops a new generation of targeted therapies against cancer using the unique properties of lead-212 (²¹²Pb), an alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha-Emitter Therapy (TAT). AlphaMedix, its most advanced asset in clinical development for GEP-NETs tumors, received Breakthrough Designation from the FDA in 2024. The company is advancing several potential treatments using ²¹²Pb combined with various targeting agents through clinical and preclinical studies. Orano Med has ²¹²Pb manufacturing facilities, laboratories, and R&D centers in France and in the US. It is expanding its GMP-manufacturing capacities for ²¹²Pb radiolabeled pharmaceuticals in North America and Europe and building a unique, independent, and fully integrated industrial platform to serve the needs of patients globally. For more information, please visit: http://www.oranomed.com

About Orano

As a recognized international leading operator in the field of nuclear materials, Orano delivers solutions to address present and future global energy and health challenges. Its expertise and mastery of cutting-edge technologies enable Orano to offer its customers high value-added products and services throughout the entire fuel cycle. Every day, the Orano group’s 17,500 employees draw on their skills, unwavering dedication to safety and constant quest for innovation, with the commitment to develop know-how in the transformation and control of nuclear materials, for the climate and for a healthy and resource-efficient world, now and tomorrow.

Orano, giving nuclear energy its full value.

Contacts

Halsin Partners

Mike Sinclair

msinclair@halsin.com

Apimeds Welcomes FDA Draft Guidance as Catalyst for Advancing Apitox Non-Opioid Pain Program




Apimeds Welcomes FDA Draft Guidance as Catalyst for Advancing Apitox Non-Opioid Pain Program

MATAWAN, N.J.–(BUSINESS WIRE)–Apimeds Pharmaceuticals US, Inc. (NYSE: APUS) today welcomed the U.S. Food and Drug Administration’s (FDA) newly released draft guidance on the development of non-opioid pain therapies, highlighting its potential to accelerate the company’s lead program, Apitox, for chronic osteoarthritis pain. The draft guidance, entitled “Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry”, can be found here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-non-opioid-analgesics-chronic-pain.

Erik Emerson, Chief Executive Officer of Apimeds, issued the following statement:

“The FDA’s draft guidance represents a landmark moment for companies like Apimeds that are committed to developing safe, non-opioid treatments for chronic pain. The agency’s call for flexibility in the number of required trials, openness to biomarkers, and willingness to accept strong scientific justification is more than regulatory encouragement; it’s an affirmation of the value of platforms like Apitox.

The guidance opens the door to more efficient development timelines, including the possibility of a single, well-controlled chronic pain trial supported by confirmatory evidence, along with potential fast track or breakthrough designations. For Apitox, this could translate into accelerating our path to regulatory submission, and ultimately, faster relief to patients suffering from osteoarthritis pain.

The FDA’s leadership in advancing non-opioid pain therapies is an important step toward reshaping how we approach one of the world’s most urgent healthcare challenges. For Apimeds, this guidance reinforces our belief that innovative biologic treatments like Apitox can redefine the standard of care in osteoarthritis and beyond. We are committed to working closely with regulators to bring safer, more effective solutions for pain management to patients as quickly as possible.”

About Apimeds Pharmaceuticals

Apimeds Pharmaceuticals (NYSE American: APUS) is a clinical-stage biopharmaceutical company focused on developing non-opioid, biologic-based therapies for pain management. The company’s lead product candidate, Apitox, is in late-stage clinical development for osteoarthritis of the knee. For more information visit www.apimedsus.com. Information on the Apimeds’ website does not constitute a part of and is not incorporated by reference into this press release.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “anticipate”, “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and the information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Apimeds undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Apimeds will be realized or, even if substantially realized, that they will have the expected consequences to or effects on the company or its business or operations. Readers are cautioned that certain important factors may affect Apimeds’ actual results and could cause such results to differ materially from any forward-looking statements that may be made in this press release. Factors that may affect Apimeds’ results include, but are not limited to, the ability of Apimeds to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to Apimeds’ ability to advance its product candidate and successfully complete clinical trials; risks relating to its ability to hire and retain qualified personnel; and the additional risk factors described in Apimeds’ filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on April 15, 2025 (as amended on May 2, 2025).

Contacts

Media Contact:
Erik Emerson, CEO

erik@apimedsus.com

Corstasis Therapeutics Strenghtens Leadership Team with the Appointment of Dr. Amin Medjamia as VP of Medical Affairs




Corstasis Therapeutics Strenghtens Leadership Team with the Appointment of Dr. Amin Medjamia as VP of Medical Affairs

HENDERSON, Nev.–(BUSINESS WIRE)–#Biotech–Corstasis Therapeutics Inc. (www.corstasis.com), a late clinical-stage innovator of outpatient therapies for the treatment of fluid overload in patients with cardiorenal and hepatic diseases, announced today the appointment of Amin M. Medjamia M.D. as Vice President of Medical Affairs.

Dr. Medjamia is an accomplished physician and medical affairs leader with more than 20 years of experience spanning biotechnology and medical devices. At Corstasis, he will oversee clinical strategy, scientific communications, and clinical algorithm development via medical engagement as the company advances its lead program Enbumyst™ (bumetanide nasal spray).

Prior to joining Corstasis, Dr. Medjamia held senior leadership roles at Abiomed, a Johnson & Johnson MedTech company, where he directed global evidence generation for the company’s portfolio of mechanical circulatory support devices. His leadership contributed to PMA approvals, global reimbursement milestones in France and Japan, and large-scale international randomized controlled trials.

“We are honored to welcome Dr. Medjamia to Corstasis at this critical time,” said Ben Esque, CEO of Corstasis. “His passion and expertise in cardiovascular medicine and evidence strategy will strengthen our ability to develop and deliver new pathways to improve patient outcomes and reduce cost of care.”

“I am excited to join Corstasis and help advance its mission of improving outpatient options for patients suffering from fluid overload,” said Dr. Medjamia.

About Corstasis Therapeutics

Corstasis Therapeutics is a late clinical-stage biopharmaceutical company whose mission is to develop and commercialize enhanced outpatient treatment options for patients with cardiorenal and hepatic diseases, with the intent of improving outcomes and reducing overall healthcare costs. Our lead product, *Enbumyst™ bumetanide nasal spray, has been developed for the short-term treatment of edema associated with congestive heart failure, liver and kidney disease, with an anticipated PDUFA action date of September 14, 2025.

*Enbumyst™ (Bumetanide Nasal spray) is an investigational therapy that has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.

For more information, please visit www.corstasis.com.

Contacts

Corstasis Therapeutics Inc.

Ben Esque, CEO

Phone: 702-541-9222

Email: Info@corstasis.com