Akari Therapeutics Announces Launch of CEO Corner Platform




Akari Therapeutics Announces Launch of CEO Corner Platform

CEO Corner segments to provide added perspective to press releases, corporate developments and pipeline progress

Provides interested parties with the ability to ask questions and submit topics for future videos

Access the Akari CEO Corner here

BOSTON and LONDON, Oct. 22, 2025 (GLOBE NEWSWIRE) — Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs), today announced the launch of its CEO Corner featuring Abizer Gaslightwala, President and CEO of Akari. The CEO Corner platform is intended to provide additional and in-depth perspective to press releases, corporate developments and development pipeline progress.

“CEO Corner gives us a platform to share more than headlines,” said Abizer Gaslightwala, Chief Executive Officer of Akari Therapeutics. “It’s a way to provide interested parties additional insight on how we’re advancing antibody drug conjugates to tackle cancers with high unmet need. By sharing a more comprehensive look into our vision and progress, we hope to give stakeholders a clearer view of the impact we’re striving to make for patients and the value we aim to create for shareholders.”

The CEO Corner is now accessible on the Company’s website here.

About Akari Therapeutics

Akari Therapeutics is an oncology biotechnology company developing next-generation spliceosome payload antibody drug conjugates (ADCs). Utilizing its innovative ADC discovery platform, the Company has the ability to generate ADC candidates and optimize them based on the desired application to any target of interest. Akari’s lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and with a proprietary linker, delivers its novel PH1 payload directly into the tumor. Unlike current ADCs that use tubulin inhibitors and DNA damaging agents as their payloads, PH1 is a novel payload that is a spliceosome modulator designed to disrupt RNA splicing within cancer cells. This splicing modulation has been shown in preclinical animal models to induce cancer cell death while activating immune cells to drive robust and durable activity. In preclinical studies, AKTX-101 has shown to have significant activity and prolonged survival, relative to ADCs with traditional payloads. Additionally, AKTX-101 has the potential to be synergistic with checkpoint inhibitors and has demonstrated prolonged survival as both a single agent and in combination with checkpoint inhibitors, as compared to appropriate controls. The Company is generating validating data on its novel payload PH1 to continue advancing its lead asset, as well as other undisclosed targets with this novel payload.

For more information about the Company, please visit www.akaritx.com and connect on X and LinkedIn.

Investor Relations Contact

JTC Team, LLC
Jenene Thomas
908-824-0775
AKTX@jtcir.com   

HCW Biologics Inc. (NASDAQ: HCWB) Participates in Virtual Investor “What This Means” Segment




HCW Biologics Inc. (NASDAQ: HCWB) Participates in Virtual Investor “What This Means” Segment

Watch the “What This Means” video here

Featuring the Company’s pembrolizumab-based immune checkpoint inhibitor

MIRAMAR, Fla., Oct. 22, 2025 (GLOBE NEWSWIRE) — HCW Biologics Inc. (the “Company” or “HCW Biologics”), (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, today announced that Peter Rhode, PhD, Chief Scientific Officer and Vice President of Clinical Operations of HCW Biologics, participated in a Virtual Investor “What This Means” segment.

Dr. Rhode’s presentation features the Company’s lead product candidate, known as HCW11-040, which is the Company’s franchise immunotherapeutic for internal clinical development as a second-generation immune checkpoint inhibitor. HCW11-040 is a multi-functional fusion protein constructed using the Company’s novel drug discovery and development platform, called the TRBC platform. This compound is a unique combination of pembrolizumab, commonly known as Keytruda^® (a registered trademark of Merck Sharp & Dohme LLC), along with interleukin-7, interleukin-15, and TGF-β receptor components (TGF-β traps). The Company has discovered through preclinical testing that this unique combination exhibits the ability to expand the exhausted T cells or TPEX cells without causing side effects. TPEX cells are located in the lymph nodes near the cancer site and these cells have been implicated as the primary responders to immune checkpoint inhibitor therapy. TPEX cells have stem cell-like properties and can change into effector T cells for providing anti-tumor effects. To improve the activity of immune checkpoint inhibitors, the Company added cytokine components that further expand and activate these TPEX cells.   The efficacy of immune checkpoint inhibitors can be further improved by equipping them with other moieties such as TGF-β traps that neutralize immunosuppressive factors, particularly one called TGF-β.

At the upcoming 40^th annual meeting of the Society for Immunotherapy of Cancer (“SITC”), the Company will be presenting extensive data for HCW11-040 in a poster presentation entitled, “A novel tetra-specific pembrolizumab-based immunotherapeutic,” that will be available at SITC on November 8, 2025.

The Virtual Investor “What This Means” segment featuring HCW Biologics is now available here.

About HCW Biologics:

HCW Biologics Inc. (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases promoted by chronic inflammation, especially age-related and senescence-associated diseases. The Company’s immunotherapeutics represent a new class of drug that it believes have the potential to fundamentally change the treatment of cancer and many other diseases and conditions that are promoted by chronic inflammation — and in doing so, improve patients’ quality of life and potentially extend longevity. Chronic inflammation, including inflammaging, is believed to be a significant contributing factor to senescence-associated diseases and conditions that diminish healthspan, including many types of cancer, autoimmune diseases, and neurodegenerative diseases, as well as many indications that impact quality-of-life that are not life-threatening. The Company’s lead product candidate, HCW9302, was developed using the Company’s legacy TOBI™ (Tissue factOr-Based fusIon) platform. The Company has created another drug discovery technology, the TRBC platform, which is not based on Tissue Factor. The TRBC platform has the capability to construct immunotherapeutics that not only activate and target immune responses but are also equipped with receptors that specifically target cancerous or infected cells. This platform is a versatile scaffold that enables the creation of multiple classes of immunotherapeutic compounds: Class I: Multi-Functional Immune Cell Stimulators; Class II: Second-Generation Immune Checkpoint Inhibitors; Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers. These novel immunotherapeutics can be used to treat a wide range of disease indications, including oncology, autoimmune diseases, and improving quality of life conditions. The Company has constructed over 50 molecules using the TRBC platform, including HCW11-002, HCW11-006, HCW11-018 and HCW11-040. Further preclinical evaluation studies are currently being conducted for these molecules the Company has selected based on promising preclinical data. The Company has two licensing programs in which it has licensed exclusive rights for some of its proprietary molecules. See the Company Pipeline at https://hcwbiologics.com/pipeline/

Forward Looking Statements:

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include, the actual success and potency of pembrolizumab-based TRBC fusion molecules; whether pembrolizumab-based TRBC fusion molecules will exhibit potent anti-pancreatic cancer activities and continue to outperform pembrolizumab both in vitro and in humanized mouse models; or whether pembrolizumab-based TRBC fusion molecules are effective in treatment of solid tumors and pancreatic cancers. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled “Risk Factors” in the annual report on Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 28, 2025, the latest Form 10-Q filed with the SEC on August 18, 2025 and in other filings filed from time to time with the SEC.  

Company Contact:

Dr. Peter Rhode
Chief Scientific Officer and Vice President of Clinical Operations
HCW Biologics Inc.
PeterRhode@HCWBiologics.com

Aeroflow Health Wins 2025 HME Provider of the Year Award




Aeroflow Health Wins 2025 HME Provider of the Year Award

Aeroflow Health’s innovative approach to patient access, technology integration and partnership development sets a new standard for the home medical equipment industry

ASHEVILLE, N.C. and CLEVELAND, Oct. 22, 2025 (GLOBE NEWSWIRE) — Aeroflow Health, a pioneering healthcare company that leverages cutting-edge technology to support the delivery of medical products and services, was named the 2025 HME Provider of the Year as part of the HME Excellence Awards at the HME News Business Summit in Cleveland, Ohio, on Tuesday. This marks the second time Aeroflow Health has earned this prestigious honor, having previously won the award in 2017.

“We are deeply honored to receive the HME Provider of the Year award for the second time,” said Casey Hite, CEO of Aeroflow Health. “This recognition reflects our entire team’s dedication to transforming how patients access and experience healthcare. From our earliest days bootstrapping the company, a singular mission has driven us: putting patients first through innovation, empowerment and genuine care. This award validates that doing right by patients isn’t just good ethics, it’s the foundation of sustainable growth. I’m incredibly proud of what we’ve built together and grateful to HME News for recognizing our approach to patient-centered care.”

Since its founding in 2001, Aeroflow Health has evolved into a dynamic, patient-centric healthcare solutions provider, delivering integrated solutions that extend far beyond traditional equipment delivery. The company has grown from 50 employees to more than 1,100 healthcare professionals across 35 states, serving over 1 million patients annually and generating $600 million in revenue while maintaining partnerships with more than 1,000 insurance plans.

Aeroflow Health’s integrated approach combines medical equipment with comprehensive support services across its maternal health, sleep apnea, diabetes management and urology divisions. Patients receive access to virtual consultations with certified specialists, educational classes, mental health resources, free care guides and supportive online communities. Same-day appointment scheduling is available through the company’s online portal, ensuring patients can connect with clinical support when they need it most.

The company’s proprietary technology platform provides instant insurance coverage verification and creates a personalized shopping experience that displays products and services covered by each patient’s specific insurance plan. The platform also features multilingual support through a translator phone line, ensuring accessibility for patients regardless of their primary language.

Aeroflow Health serves as a steadfast healthcare partner, connecting health plans, providers and patients to build communities committed to enhancing the best possible care. The company seamlessly integrates technology to provide a range of equipment and services that are accessible and covered through insurance, working with providers to ensure patients receive maximum coverage for the lowest price possible.

Through partnerships with more than 1,000 insurance plans, Aeroflow Health has established a strong track record of providing reliable products and exceptional customer satisfaction. The company maintains a dedicated team to support insurance providers and offers co-branding options for marketing materials with health plan partners. Aeroflow Health can provide references from other insurance providers upon request to showcase successful partnerships.

The company processes 3 million orders annually through its Don Hite Fulfillment Center in Asheville, demonstrating operational excellence at scale while maintaining the compassionate patient care and outstanding dedication to customer service that has become the company’s hallmark. The majority of Aeroflow Health’s patients come as referrals from friends, family, providers and insurance partners, reflecting the trust the company has built within the healthcare community.

The judges for the 2025 HME Provider of the Year award were Miriam Lieber, president of Lieber Consulting, LLC and Jonathan Sadock, managing partner and CEO of Paragon Ventures.

Miriam Lieber said: “What distinguishes Aeroflow is their ability to maintain an innovative, entrepreneurial spirit even as they’ve grown into a large organization,” she said. “They have never lost sight of their roots or their core mission. Concurrently, their dedication to community service remains unwavering. Whether supporting hurricane relief efforts, partnering with Habitat for Humanity, or addressing countless other community needs, Aeroflow consistently demonstrates how corporate success and social responsibility go hand-in-hand.”

This recognition underscores Aeroflow Health’s trajectory of sustained growth and industry leadership. Guided by core values of empathy, clarity and integrity, the company’s approach emphasizes removing barriers to patient access, streamlining insurance verification processes and providing educational resources that empower patients to make informed healthcare decisions.

Jonathan Sadock said: “Aeroflow’s outreach and use of innovative digital platforms simplifies patient access to essential products and services.” He continued, “Moreover, its content marketing and communications strategy meets patients where they are, creating high engagement and satisfaction while empowering patients with knowledge and advocacy tools and fostering improved health literacy. Aeroflow Health’s commitment to strong customer, referral and payer service, while bridging care gaps and leveraging technology for personalized support, all contributed to Aeroflow Health being selected as Provider of the Year 2025.”

HME News has hosted the HME Excellence Awards since 2002, recognizing outstanding achievement in patient care, customer service, employee engagement, community involvement, and financial performance in the home medical equipment industry.

About Aeroflow Health
Aeroflow Health is a leading provider of durable medical equipment and health services, headquartered in Asheville, North Carolina. Committed to improving quality of life through innovative solutions, Aeroflow Health partners with healthcare providers and communities to offer comprehensive medical equipment and supplies, ensuring patients receive the care they need when they need it most. For additional information, please visit www.aeroflowhealth.com.

Media Contact:
FischTank PR
aeroflow@fischtankpr.com

Wake-Up Call: Aeroflow Sleep Survey Reveals a Growing Gap in Sleep Health Education and the Rise of DIY Sleep Trends




Wake-Up Call: Aeroflow Sleep Survey Reveals a Growing Gap in Sleep Health Education and the Rise of DIY Sleep Trends

New survey of 1,884 adults finds 81% struggle with sleep while 60% try unvetted online trends without medical consultation

ASHEVILLE, N.C., Oct. 22, 2025 (GLOBE NEWSWIRE) — Aeroflow Sleep, a national durable medical equipment (DME) provider specializing in CPAP supplies, today announced the results of a proprietary survey highlighting a significant disconnect in sleep health. The survey of 1,884 U.S. adults found that while a majority of Americans (81%) struggle with sleep, many are turning to unvetted online trends instead of seeking professional medical advice.

The findings underscore the need for accessible, doctor-led education to ensure patients receive proper care and avoid the potential downfalls of self-guided medical decisions.

Key Survey Results: A Public Health Concern

The survey uncovered a widespread struggle with sleep across the U.S. adult population:

• A total of 81.64% of respondents reported having trouble sleeping.
• A total of 58.78% are getting less than the recommended seven hours of sleep per night.
• A total of 63.82% of respondents feel their sleep negatively impacts their day-to-day activities and ability to complete tasks; and nearly 3 of 4 respondents (72.82%) feel it negatively impacts their mental health at least sometimes.

The Rise of DIY Sleep Trends and a Lack of Oversight

The data shows a clear and concerning trend of individuals relying on unverified online sources for sleep help as opposed to turning to medical professionals:

• A total of 69.82% of respondents have heard of online sleep trends like “mouth taping” and “magnesium mocktails.”
• Of those who had heard of the trends, 58% have tried one. A striking 60% of those who tried a trend did so without consulting a healthcare provider.
• The data reveals that a total of 32% of respondents are using melatonin and 22% are using magnesium supplements. This reliance on over-the-counter aids, combined with the low rate of physician consultation, points to the potential downfalls of self-guided health practices.

“The prevalence of self-guided approaches and adoption of unvetted online sleep trends without consulting a physician is concerning. It also emphasizes a potentially high prevalence of undiagnosed sleep disturbances,” said Dr. Carleara Weiss, PhD, Sleep Science Advisor at Aeroflow Sleep. “These findings demonstrate a clear need for healthcare professionals to be more proactive in discussing sleep with their patients and for individuals to seek out evidence-based guidance before making changes to their health routine. Without professional oversight, these self-guided approaches could have unforeseen consequences.”

The “Sleep Health Gap”

A significant disconnect exists between patient need and healthcare provider engagement. The data reveals several layers to this gap, including age and gender disparities:

• Overall, 64.6% of survey respondents have spoken to a doctor about their sleep. However, an overwhelming 80% of all respondents wish their doctors provided more sleep-related resources.
• A notable “gender flip” in healthcare-seeking behavior identified women ages 18-29 as more proactive in consulting a doctor (51.3%) than their male counterparts (42.1%). A dramatic reversal occurs later in life, with the survey finding men aged 45-60 far more likely to consult a doctor (60.6%) than women in the same age group (40.9%).
• The data also revealed a concerning trend among senior women. A full 55% of women aged 60 and older reported seeking no help for their sleep problems, medical or otherwise, compared to only 33% of men in the same age group.

“The differing behaviors we see in how people approach their sleep health, such as the proactive nature of young women and the engagement of middle-aged men, highlights a unique opportunity for tailored patient education,” said Dr. Christopher Allen, a Sleep Medicine Physician and Scientific Advisor at Aeroflow Sleep. “The data shows us that a one-size-fits-all approach to sleep health can fall short. We must encourage all individuals to recognize the signs of a sleep disorder and seek a professional medical diagnosis.”

“Our mission at Aeroflow Sleep is to empower individuals to sleep well and live better,” said Joey Sasvari, Director of Aeroflow Sleep. “These results motivate us to expand our initiatives for improving sleep health resources and access nationwide, ensuring sleep health is a top priority for patients and providers alike.”

For more details on the survey findings and to access educational resources, please click here.

About Aeroflow Sleep:
Aeroflow Sleep is a national DME provider dedicated to helping patients sleep well and live better. The company offers a wide range of CPAP equipment and supplies through insurance, making it easier for individuals to receive the high-quality care and resources they need to navigate their sleep health journey. To learn more about Aeroflow Sleep, visit aeroflowsleep.com.

Media Contact:
FischTank PR
aeroflow@fischtankpr.com

ADARx Pharmaceuticals Announces First Patient Dosed in Phase 3 STOP-HAE Clinical Trial and Orphan Drug Designation for ADX-324, a Long-Acting siRNA in Development for the Prophylactic Treatment of Hereditary Angioedema (HAE)




ADARx Pharmaceuticals Announces First Patient Dosed in Phase 3 STOP-HAE Clinical Trial and Orphan Drug Designation for ADX-324, a Long-Acting siRNA in Development for the Prophylactic Treatment of Hereditary Angioedema (HAE)

– Next-generation siRNA therapeutic candidate with the potential for twice-yearly dosing –

SAN DIEGO, Oct. 22, 2025 (GLOBE NEWSWIRE) — ADARx Pharmaceuticals, Inc. (ADARx), a late-stage clinical biotechnology company developing next-generation RNA therapeutics, today announced that the first patient has been dosed in its Phase 3 STOP-HAE clinical trial evaluating ADX-324 in patients with hereditary angioedema (HAE). Additionally, ADARx announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ADX-324 for the treatment of patients with HAE.

“Despite advances in prophylactic therapy, most HAE patients remain at risk of breakthrough attacks and do not achieve sustained, long-term attack-free control. In addition, the currently approved prophylaxis treatments require monthly or more frequent injections. We believe the FDA’s Orphan Drug Designation for ADX-324 underscores the continued need for additional treatment options and highlights the potential of ADX-324 to provide extended attack-free periods with substantially reduced dosing frequency,” said Zhen Li, President and Chief Executive Officer of ADARx. “Dosing the first patient in our ADX-324 Phase 3 clinical trial is a significant milestone for ADARx and we look forward to advancing this program for the HAE community.”

The Phase 3 STOP-HAE clinical trial of ADX-324 is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of ADX-324 in preventing HAE attacks in adults with Type I and Type II HAE. The trial will also assess safety, pharmacokinetics (PK), pharmacodynamics (PD), and patient reported health-related quality of life (HRQoL). Approximately 90 patients will be enrolled and randomized to receive either ADX-324 300 mg every 6 months, ADX-324 240 mg every 3 months, or placebo during the study. Patients completing the trial will be eligible to enroll in a long-term-open-label extension study.

Enrollment for this Phase 3 program follows positive Phase 1/2 data demonstrating that ADX-324 achieved significant and durable suppression of prekallikrein (PKK) protein levels with a favorable safety profile.

For more information about the clinical trial, visit https://stophae.com.

About HAE and ADX-324

HAE is a rare genetic disorder characterized by recurrent, unpredictable attacks of swelling that can be painful, disabling, and life-threatening. These attacks result from dysregulation of the kallikrein-kinin system (KKS), which regulates blood pressure, inflammation, coagulation and pain. PKK is a critical protein in the plasma kallikrein pathway that activates a second protein called kallikrein, which, if present, produces bradykinin, a potent vasodilator. A dysfunctional KKS leads to excessive release of bradykinin which causes the swelling attacks in HAE.

ADX-324 is an investigational siRNA therapy designed to inhibit PKK generation at the mRNA level and reduce the production of plasma PKK, thereby averting bradykinin generation and potentially preventing HAE attacks. Compared to currently approved prophylactic treatments, ADX-324 is expected to decrease PKK to a greater degree, offering the potential for greater and more durable control of kallikrein activity, which is expected to result in a higher proportion of patients remaining attack-free with a less frequent dosing regimen.

About ADARx Pharmaceuticals 

ADARx Pharmaceuticals is a late-stage clinical biotechnology company dedicated to transforming cutting-edge science into next-generation RNA medicines across a broad range of therapeutic areas. We have developed proprietary technology to control the expression of specific disease drivers with highly selective RNA targeted therapies with the goal of delivering life-changing treatments for patients with urgent unmet medical needs. ADARx is focused on advancing and expanding a deep pipeline of highly potent, durable and selective RNA-targeted therapeutic candidates, developing product candidates for the treatment of complement-mediated, genetic, cardiovascular, thrombotic, central nervous system and metabolic (obesity) diseases. In addition to our wholly-owned programs, we have entered into a collaboration and license option agreement with AbbVie to develop siRNA therapeutics across multiple disease areas, including neuroscience, immunology and oncology. Follow ADARx on LinkedIn.

CONTACT: Contacts

Investors: ir@adarx.com 

Media: teri@redhousecomms.com 

SELLAS Life Sciences to Participate in the J.P. Morgan U.S. Opportunities Forum




SELLAS Life Sciences to Participate in the J.P. Morgan U.S. Opportunities Forum

Company to conduct 1×1 meetings with investors on Wednesday, November 12th

NEW YORK, Oct. 22, 2025 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that Dr. Angelos Stergiou, President and Chief Executive Officer of SELLAS, will participate in the J.P. Morgan U.S. Opportunities Forum, which is being held on Wednesday, November 12, at the Kimpton EPIC Hotel in Miami, Florida.

J.P. Morgan U.S. Opportunities Forum Details:

Format: 1×1 investor meetings

Date: Wednesday, November 12, 2025

Location: Kimpton EPIC Hotel, Miami, FL

Registration Link: Click Here or please contact your J.P. Morgan representative

About SELLAS Life Sciences Group, Inc.

SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (tambiciclib) – potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. For more information on SELLAS, please visit www.sellaslifesciences.com.

Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the GPS clinical development program, including the REGAL study and the timing of future milestones related thereto. These forward-looking statements are based on current plans, objectives, estimates, expectations, and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 20, 2025 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations, or other circumstances that exist after the date as of which the forward-looking statements were made.

Investor Contact
John Fraunces
Managing Director
LifeSci Advisors, LLC
jfraunces@lifesciadvisors.com

Alvotech Announces Changes in Global Business Development and Commercial Operations Team




Alvotech Announces Changes in Global Business Development and Commercial Operations Team

REYKJAVIK, Iceland, Oct. 22, 2025 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced changes to its global business development and commercial operations team. Anil Okay, Chief Commercial Officer, is stepping down to serve as Chief Executive Officer of Adalvo. Trisha Durant has joined Alvotech as Senior Vice President, Global Business Development and Commercial Operation, ex-North America. Harshika Sarbajna is Senior Vice President Commercial, North America. Agne Pasko is Vice President Head of Business Development.

“I want to thank Anil for his dedication and success in leading the expansion of Alvotech’s commercial partnerships and operations. It is good to know that Adalvo, a company I founded and has been dear to my heart, is now in very capable hands,” said Róbert Wessman, chairman and CEO of Alvotech. “I’m confident that with Trisha joining the team to manage commercial operations outside of North America, Harshika in charge of North American partnerships and Agne leading business development globally, we have a stellar leadership team for continuing commercial success of Alvotech.”

Trisha Durant has 18 years of experience in the pharmaceutical industry, with an exemplary track record in strategy development, execution, forging strategic alliances, driving revenue growth and structuring high-impact commercial teams. She joins Alvotech from Biocon, where she served most recently as Head of Europe, leading commercial expansion. Prior to this, Trisha was at McKesson for 10 years, in a range of global roles and in Ernst & Young’s Global Tax Advisory practice for 6 years. Trisha is based in the United Kingdom.

Harshika Sarbajna joined Alvotech’s commercial team in 2022, from Sandoz where she led biosimilars and specialty products in the U.S. Prior to that she was the Global Head of Marketing and Strategy for Sandoz, within the anti-infectives and biosimilars businesses, based in Munich, Germany. In a career spanning over 18 years, she has also led strategy and strategic partnerships for Dr. Reddy’s and worked as a management consultant at Parthenon for the U.S., Middle East and Asia. Harshika is based in the United States.

Agne Pasko joined Alvotech in 2019, and has held several senior roles in Commercial Operations, Supply Chain and Business Development, driving revenue growth, new partnerships and portfolio expansion. Prior to joining Alvotech she managed development and marketing for 3P Pharmaceuticals, Northway Biotech and Stem Cell RC. Agne is based in Spain.

About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram and YouTube.

Alvotech Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial operating performance of Alvotech and may include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, and market launches. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential”, “aim” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (2) the ability to maintain stock exchange listing standards; (3) changes in applicable laws or regulations; (4) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (5) Alvotech’s estimates of expenses and profitability; (6) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (7) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (10) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (11) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (12) Alvotech’s ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (13) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements; (14) Alvotech’s ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (15) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (16) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (17) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, conflicts in Ukraine, the Middle East and other global geopolitical tension, on the Company’s business, financial position, strategy and anticipated milestones; and (18) other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication.

ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS
Benedikt Stefansson, VP
alvotech.ir@alvotech.com

Alvotech Announces Changes in Global Business Development and Commercial Operations Team




Alvotech Announces Changes in Global Business Development and Commercial Operations Team

REYKJAVIK, ICELAND (OCTOBER 21, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced changes to its global business development and commercial operations team. Anil Okay, Chief Commercial Officer, is stepping down to serve as Chief Executive Officer of Adalvo. Trisha Durant has joined Alvotech as Senior Vice President, Global Business Development and Commercial Operation, ex-North America. Harshika Sarbajna is Senior Vice President Commercial, North America. Agne Pasko is Vice President Head of Business Development.

“I want to thank Anil for his dedication and success in leading the expansion of Alvotech’s commercial partnerships and operations. It is good to know that Adalvo, a company I founded and has been dear to my heart, is now in very capable hands,” said Róbert Wessman, chairman and CEO of Alvotech. “I’m confident that with Trisha joining the team to manage commercial operations outside of North America, Harshika in charge of North American partnerships and Agne leading business development globally, we have a stellar leadership team for continuing commercial success of Alvotech.”

Trisha Durant has 18 years of experience in the pharmaceutical industry, with an exemplary track record in strategy development, execution, forging strategic alliances, driving revenue growth and structuring high-impact commercial teams. She joins Alvotech from Biocon, where she served most recently as Head of Europe, leading commercial expansion. Prior to this, Trisha was at McKesson for 10 years, in a range of global roles and in Ernst & Young’s Global Tax Advisory practice for 6 years. Trisha is based in the United Kingdom.

Harshika Sarbajna joined Alvotech’s commercial team in 2022, from Sandoz where she led biosimilars and specialty products in the U.S. Prior to that she was the Global Head of Marketing and Strategy for Sandoz, within the anti-infectives and biosimilars businesses, based in Munich, Germany. In a career spanning over 18 years, she has also led strategy and strategic partnerships for Dr. Reddy’s and worked as a management consultant at Parthenon for the U.S., Middle East and Asia. Harshika is based in the United States.

Agne Pasko joined Alvotech in 2019, and has held several senior roles in Commercial Operations, Supply Chain and Business Development, driving revenue growth, new partnerships and portfolio expansion. Prior to joining Alvotech she managed development and marketing for 3P Pharmaceuticals, Northway Biotech and Stem Cell RC. Agne is based in Spain.

About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram and YouTube.

Alvotech Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial operating performance of Alvotech and may include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, and market launches. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential”, “aim” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (2) the ability to maintain stock exchange listing standards; (3) changes in applicable laws or regulations; (4) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (5) Alvotech’s estimates of expenses and profitability; (6) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (7) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (10) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (11) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (12) Alvotech’s ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (13) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements; (14) Alvotech’s ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (15) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (16) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (17) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, conflicts in Ukraine, the Middle East and other global geopolitical tension, on the Company’s business, financial position, strategy and anticipated milestones; and (18) other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication.

ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS
Benedikt Stefansson, VP
alvotech.ir@alvotech.com

Attachments

• Trisha Durant
• Harshika Sarbajna
• Agne Pasko

smartbax announces a €4.7 M Pre-Series A round to advance novel antibiotic compound through preclinical stage




smartbax announces a €4.7 M Pre-Series A round to advance novel antibiotic compound through preclinical stage

• Lead antibacterial compound against a novel target in Gram-negative bacteria validated in infection models
• Progressing a platform of small-molecule enzymatic activators that induce self-digestion of bacteria as novel mode of action against multi-drug resistant Gram-negative and Gram-positive bacteria
• Funding round led by Anobis Asset and Bayern Kapital; second closing remains open

Munich, Germany, Oct. 22, 2025 (GLOBE NEWSWIRE) — smartbax, a biotech company developing next-generation antibiotics against multi-drug resistant bacteria, today announced the successful first closing of its €4.7 M Pre-Series A financing round. The round was led by new investors Anobis Asset and Bayern Kapital, with participation from UnternehmerTUM Funding for Innovators as well as existing investors HTGF – High-Tech Gründerfonds and Boehringer Ingelheim Venture Fund (BIVF). A second closing of the round remains open to investors.

smartbax will use the funds to progress its proprietary pipeline of small-molecule antibiotics designed to overcome bacterial resistance with innovative approaches and novel mechanisms of action. The lead candidate is an inhibitor that blocks a previously unexplored step in the synthesis of lipopolysaccharides (LPS), key structural components of the outer membrane in Gram-negative bacteria. This new inhibitor has already demonstrated in vivo proof of concept, including activity against multi-drug resistant strains, shows potential as an orally available drug, and will now be advanced through preclinical development.

In parallel, smartbax is advancing its platform of small-molecule activators of bacterial hydrolases. Rather than inhibiting bacterial functions like traditional antibiotics, these compounds stimulate hydrolase activity, causing bacteria to digest themselves from within. This innovative mode of action has not been exploited in commercial antibiotics to date and offers a promising strategy to overcome established resistance mechanisms. smartbax has identified two activator classes, effective against different targets in Gram-positive and Gram-negative bacteria, both of which display encouraging drug-like properties, are able to eliminate biofilms and show no development of resistance. The company will further develop these candidates toward lead selection and in vivo proof of concept using the current funds.

“Small-molecule antibiotics remain one of the most effective tools in combating the rapidly growing threat of antimicrobial resistance. smartbax is currently the only German biotech dedicated exclusively to developing these crucial tools, and we are proud to advance complementary approaches with both a classical inhibitor against a novel target and enzyme activators with a truly novel mode of action in the antibiotic realm,” said Dr. Robert Macsics, CEO of smartbax. “Our programs focus on WHO priority pathogens and aim to provide new treatment options for critically ill patients who currently have limited alternatives. We are delighted to have assembled such a strong consortium of investors who share our commitment to addressing this urgent public health threat.”

Martin Falk, managing director at Anobis Asset, said: “Antibiotic resistance is one of the most urgent medical challenges of our time, and there is a clear need for new therapeutic approaches. In Germany alone, nearly 10,000 people die each year as a direct consequence of infections with multi-drug resistant bacteria; many more are hospitalized and often face lengthy recovery times. We are proud to support a team focused on developing solutions that could help patients and protect public health worldwide.”

Monika Steger, Managing Partner at Bayern Kapital, commented: “Rising bacterial resistance to antibiotics poses an enormous burden on global healthcare. smartbax is tackling this problem with two novel drug approaches that are already showing great potential at their current stage. At the same time, the market for new antibiotics is opening up a highly attractive growth area with great economic opportunities. Our investment in smartbax is therefore a promising investment in the local biotech ecosystem and the resilience of our healthcare system.”

Inga vom Holtz, Director Investments at UnternehmerTUM Funding for Innovators, added: “smartbax has grown from academic research into a biotech company with a clear focus on antibiotic innovation. We are pleased to join this financing round and to support a team that is advancing both classical inhibitors and entirely new antibacterial mechanisms with enzyme activators, and we are proud that such innovation has its origins at the Technical University Munich.”

About smartbax

smartbax is developing a new generation of antibiotics to address the increasing spread of multi-drug resistant bacteria. Their team of experts is advancing a complementary pipeline of small molecules against novel bacterial targets and with innovative modes of action to prevent resistance. Their lead program is a new inhibitor of lipopolysaccharide synthesis in Gram-negative bacteria. Moreover, the company specializes in the tailored activation of enzymatic pathways that trigger bacterial self-digestion, as this approach is particularly promising in the context of difficult-to-treat biofilms. Two activators are in development, targeting both Gram-positive bacteria and Gram-negative bacteria individually.

Knowing that preventing a resistance crisis tomorrow means taking action today, smartbax was founded in 2021 as a spin-off of the Technical University Munich (TUM) with the aim of making innovative research applicable in creating novel antibiotics that add true value for patients worldwide.

For more information visit our website: https://www.smartbax.de/

Media contact:
Dr. Regina Lutz, Katja Arnold
MC Services AG
smartbax@mc-services.eu

About Anobis Asset

As a Freiburg-based single family office with a background in the pharmaceutical industry, Anobis Asset is actively exploring investment opportunities across the healthcare and life sciences landscape, with a focus on innovation-driven ventures and long-term partnerships.

About Bayern Kapital

Bayern Kapital is the venture capital company of the Free State of Bavaria and, with 700 million euros under management, investments of up to 25 million euros per company, over 110 active portfolio companies and 30 years of experience in the VC business, is one of the most active, financially strongest and most experienced investors in the DACH region. Bayern Kapital invests in a consortium with private investors in Bavarian high-tech and deep-tech start-ups and scale-ups with innovative business models from all sectors, from the seed and scale-up phase through to exit.

Since its foundation in 1995, Bayern Kapital has invested over 500 million euros of its own equity capital in more than 320 start-ups and scale-ups from sectors such as life sciences, software & IT, materials & new materials, nanotechnology and environmental technology. This has created over 12,000 permanent jobs in sustainable companies in Bavaria.

Examples of numerous pioneering success stories that Bayern Kapital has supported from an early stage include Casavi, Catalym, commercetools, egym, EOS, Fazua, Immunic, Isar Aerospace, IQM, Parcellab, Proglove, Qbilon, Riskmethods, SimScale, Sirion, tado, Tubulis, Marvel Fusion, Proxima Fusion, plancq, Akhetonics and many more. bayernkapital.de 

About UnternehmerTUM Funding for Innovators

UnternehmerTUM Funding for Innovators is the pre-seed fund of UnternehmerTUM, Europe’s foremost center for innovation and business creation. It invests early – often as the first institutional investor – in deep tech founders building category-defining companies. The fund specializes in hard tech and the code that powers it, backing scalable B2B technologies with billion-euro potential and helping founders move breakthrough science from lab to market. UnternehmerTUM Funding for Innovators offers founder-friendly convertible loans and is committed to follow-on investments, ensuring its companies have the resources to scale their ambitions.

funding.unternehmertum.de 

About HTGF – High-Tech Gründerfonds 

HTGF is one of the leading and most active early-stage investors in Germany and Europe, financing startups in the fields of Deep Tech, Industrial Tech, Climate Tech, Digital Tech, Life Sciences and Chemistry. With its experienced investment team, HTGF supports startups in all phases of their development into international market leaders. HTGF invests in pre-seed and seed phases and can participate significantly in later-stage financing rounds. Since its inception in 2005, HTGF has financed around 800 startups and achieved 200 successful exits. HTGF has a fund volume of over 2 billion euros.

Fund investors in the public-private partnership include the Federal Ministry for Economic Affairs and Energy, KfW Capital as well as 45 companies and family offices.  

For more information, please visit HTGF.de or follow us on LinkedIn.   

About Boehringer Ingelheim Venture Fund

The Boehringer Ingelheim Venture Fund (BIVF), established in 2010, is dedicated to investing in groundbreaking biotechnology companies that are at the forefront of therapeutic and digital innovations, aiming to advance biomedical research. With a commitment to revolutionizing the standard of care, the BIVF fosters long-term partnerships with scientists and entrepreneurs. The BIVF’s focus is on nurturing disease-modifying therapeutic concepts and facilitating their clinical application. The BIVF prioritizes the translation of first-in-class concepts that address significant medical needs in fields such as oncology, immunology, regenerative medicine, neurodegeneration, infectious diseases, and digital health technologies. These innovative concepts often encompass novel platform technologies designed to tackle targets and diseases that were previously considered untreatable.

With a fund volume of EUR 350 million, the BIVF operates as an evergreen fund, continually reinvesting to fuel its mission. The partners of the BIVF gain from the fund’s deep expertise in drug discovery & development, translational science, and management, along with access to a network of experts within the Boehringer Ingelheim organization. Currently, the BIVF supports a diverse portfolio of over 40 companies, leveraging its extensive experience to drive progress in healthcare.

For additional information, please visit boehringer-ingelheim-venture.com/

Onco3R Therapeutics reports first pre-clinical data from its best-in-class precision oncology portfolio at the 2025 AACR-NCI-EORTC symposium




Onco3R Therapeutics reports first pre-clinical data from its best-in-class precision oncology portfolio at the 2025 AACR-NCI-EORTC symposium

• Three posters to be presented featuring pre-clinical data of potential best-in-class FGFR3 selective inhibitor, SMARCA2 selective inhibitor, and P53 Y220C reactivator
• Candidates for FGFR3 and SMARCA2 programs identified: IND enabling studies anticipated in mid-2026

Leuven, Belgium, October 22, 2025. Onco3R Therapeutics, a clinical-stage immunology and oncology biotech company dedicated to transforming patients’ lives with best-in-class medicines, today announced that it will present preclinical data from its FGFR3, SMARCA2 and P53 Y220C small molecules programs in 3 posters at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, taking place October 22-26, 2025, in Boston.

“First generation precision medicines are often suboptimal in the clinic due to low target coverage, off-target toxicity and emergence of resistance. At Onco3R, our vision is to design best-in-class medicines to address the unmet needs left by first generation drugs and unlock the full potential of therapeutic targets” said François Gonzalvez, PhD, CSO and co-Founder of Onco3R Therapeutics.

“We are thrilled to present the first preclinical data from our lead oncology programs FGFR3, SMARCA2 and P53 Y220C. Each program has identified best-in-class molecules which offer the potential to deliver transformational efficacy and improved tolerability for patients. Our FGFR3 and SMARCA2 candidates, G-012 and G-141 respectively, have reached the optimum potency and selectivity profile to mitigate dose-limiting toxicities while maintaining maximum target coverage. This has translated into robust anti-tumor activity in vivo. The poster presentations will highlight data supporting the advancement of these two candidates towards the clinic, as well as the discovery of unique small molecule P53 reactivators.”

 “These compelling preclinical results further validate our patient-centric drug discovery approach, which integrates deep translational science with rational, structure-based and AI-augmented drug design”, Pierre Raboisson, PhD, CEO and co-Founder of Onco3R Therapeutics said. “We look forward to advancing these two candidates and remain on track to initiate IND-enabling studies in mid-2026. The identification of these candidates, alongside the continued clinical progress of our SIK3 inhibitor O3R-5671 in autoimmune indications, reinforces Onco3R’s strong strategic position. With a robust pipeline and clear execution momentum, we are confidently advancing toward our next value-driving milestones.”

Presentation details

Title: Discovery of Best-in-Class FGFR3 small molecule inhibitors with high isoform selectivity and activity against gatekeeper mutations
Session:                                         
Session: Poster Session C                          
Session Date and Time: Saturday, October 25, 12:30-4pm
Presenting author: Sandrine Vendeville, PhD

Key findings from preclinical studies include:

• G-012 demonstrated best-in-class potency and selectivity with favorable drug-like properties.
• Based on translational modelling, the compound reached the optimal selectivity against other FGFR isoforms to mitigate off-target toxicity and maintain maximal target coverage.
• G-012 showed robust anti-proliferative activity in FGFR3-driven cancer cells and induced significant tumor regression in vivo.
• G-012 is currently advancing in 14 days toxicology studies.
• IND-enabling studies are anticipated in mid-2026.

Title: Discovery of novel SMARCA2 small molecule inhibitors with best-in-class potency and selectivity for the treatment of SMARCA4-mutant cancers
Session: Poster Session C                          
Session Date and Time: Saturday, October 25, 12:30-4pm
Presenting author: Lijs Beke, PhD

Key findings from preclinical studies include:

• G-141 combined best-in-class cellular potency and selectivity to allow optimal target coverage and unlock the full therapeutic potential of SMARCA2 inhibition.
• The compound showed synthetic lethality in SMARCA4-deficient cells and induced robust anti-tumor activity in vivo without signs of SMARCA4-related toxicity.
• G-141 showed favorable drug-like properties and is currently advancing in 14 days toxicology studies.
• IND-enabling studies are anticipated in mid-2026.

Title: Discovery of a Best-in-Class small molecule p53 Y220C reactivator: Breaking through the potency ceiling
Session: Poster Session C                          
Session Date and Time: Saturday, October 25, 12:30-4pm
Presenting author: François Gonzalvez, PhD

Key findings from preclinical studies include:

• Onco3R patient-centric drug discovery approach identified unique small molecule P53 reactivators with best-in-class cellular potency.
• Onco3R leads exhibit the optimal potency and residence time to induce deep and sustain target engagement and fully unlock the tumor suppressive function of P53 in cells.  
• This translated into robust anti-proliferative activity in P53 Y220C mutant cancer cell lines (single digit nanomolar IC50s) and tumor regression in a Y220C P53 mutant xenograft model.
• Further characterization of the lead candidates is ongoing.

About Onco3R Therapeutics
At Onco3R Therapeutics, we are driven by our purpose to transform the lives of patients with autoimmune diseases and cancer through precision-designed, best-in-class therapies. With over 150 years of combined R&D experience, our team brings deep expertise in disease biology, drug discovery & development, and translational science. We focus on clinically validated targets and select the right therapeutic modality, small or large molecules, to address the underlying disease biology with best-in-class therapies. Our mission is to develop safer, more effective medicines in oncology and immunology that truly make a difference for patients. By integrating learnings from past clinical challenges and applying cutting-edge technologies, we aim to de-risk clinical development and accelerate the delivery of innovative treatments with real-world impact. The company is based in the biotech cluster in Leuven, Belgium. For more information, visit www.onco3r.com or follow us on LinkedIn.

About O3R-5671
O3R-5671 has been developed based on more than 12 years of preclinical and clinical data on SIK inhibitors for autoimmune diseases. O3R-5671 is a highly selective SIK3 inhibitor, designed to avoid the toxicities associated with inhibiting SIK1 and SIK2. Furthermore, O3R-5671 does not inhibit other kinases and has demonstrated a highly attractive profile in an extensive safety panel. Preclinical data demonstrated that O3R-5671 inhibits the release of the inflammatory cytokines TNFα and IL-23 and promotes the release of the immunomodulatory cytokine IL-10. These data, along with data from animal models of autoimmune diseases, indicate that O3R-5671 has the potential to treat a variety of autoimmune diseases including ulcerative colitis, Crohn’s Disease, psoriasis, psoriatic arthritis and rheumatoid arthritis. O3R-5671 is currently being investigated in a first-in-human study in healthy volunteers with a SAD-MAD design.

Attachment

• AACR-EORTC-NCI Meeting 2025_final