Evinova China and Harbour BioMed Announce Strategic AI Collaboration to Accelerate AI-Enabled Drug Development




Evinova China and Harbour BioMed Announce Strategic AI Collaboration to Accelerate AI-Enabled Drug Development

SHANGHAI–(BUSINESS WIRE)–Yesterday, during the 8th China International Import Expo (“CIIE”), Evinova, a global health-tech company accelerating the delivery of better health outcomes by propelling the life sciences sector forward in digital health, and Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, announced a strategic collaboration in artificial intelligence (AI).

Under the terms of the collaboration, Evinova China and Harbour BioMed will jointly apply AI and digital technologies to enhance the efficiency of innovative biologics development. Building on their own strengths, the two companies aim to build an open ecosystem for AI-driven drug R&D.

Nate Zhang, General Manager of Evinova China, stated, “Evinova leverages the digital transformation insights of top global pharmaceutical companies to design our AI-powered clinical development solutions and digital strategy consulting services, so that we can accelerate the delivery of better health outcomes. To realize our mission, Evinova China needs to partner with innovative companies like Harbour BioMed, which are rooted in China while harboring global ambitions. Together, through our world-class AI technology platforms and deep therapeutic expertise, we can help take China-originated breakthrough assets from the laboratory to the world.”

Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, stated, “We are pleased to collaborate with Evinova to advance the application of AI in biotherapeutic development. Harbour BioMed has built a robust and differentiated product pipeline based on our industry-leading Harbour Mice® technology platform. Through this collaboration, we look forward to applying AI to improving clinical study efficiency and accelerating the delivery of innovative therapies to patients around the world.”

About Evinova

Evinova is a global health-tech business, accelerating the delivery of better health outcomes by propelling the life sciences sector forward in digital health, from the inside. Through our application of science-based expertise, evidence-led rigour, and human experience-driven insight, our digital solutions are deliberately designed so that everyone can reach better health outcomes together. Evinova is a separate health-tech business within the AstraZeneca Group. Please visit evinova.com or follow the company on social media @Evinova.

About Harbour BioMed

Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology. The company is building a robust and differentiated pipeline through internal R&D capabilities, strategic global collaborations in co-discovery and co-development, and selective acquisitions.

Harbour BioMed’s proprietary antibody technology platform, Harbour Mice®, generates fully human monoclonal antibodies in both the conventional two heavy and two light chain (H2L2) format and the heavy chain-only (HCAb) format. Building upon HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology enables tumor-killing effects that traditional combination therapies cannot achieve. Additionally, the HCAb-based bispecific immune cell antagonist (HBICA^TM) technology empowers the development of innovative biologics for immunological and inflammatory diseases. By integrating Harbour Mice®, HBICE®, and HBICA^TM with a single B-cell cloning platform, Harbour BioMed has built a highly efficient and distinctive antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit www.harbourbiomed.com.

Contacts

Media Contact:
Heather Bonsiero

Head of Communications and Marketing

Evinova

heather.bonsiero@evinova.com

Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples




Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples

LAKE ZURICH, Ill.–(BUSINESS WIRE)–#CommittedToLife–Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies is voluntarily recalling three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL vial. This recall is being performed to the user level in the United States.

The product is being recalled due to out-of-specification (OOS) endotoxin results of certain reserve samples from a single lot. Based upon the investigation, two additional lots were also included in the recall as a precautionary measure.

Elevated endotoxin levels can precipitate severe systemic reactions such as sepsis and septic shock. Severe responses may include inflammatory and life-threatening immune responses and death. Non-serious adverse event reports potentially associated with the OOS have been received for one lot. These non-serious adverse events included chills, change in mental status, change in respiratory status, fever, increase in body temperature, shivering and shaking. To date, no adverse event reports have been received for the second and third lots.

Famotidine Injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions:

1. Short term treatment of active duodenal ulcer.
2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.
3. Short term treatment of active benign gastric ulcer.
4. Short term treatment of gastroesophageal reflux disease (GERD).
5. Treatment of pathological hypersecretory conditions.

Fresenius Kabi is notifying its distributors and customers and is arranging for return of the recalled product. If health care facilities have any of the affected lots, they are to immediately discontinue distributing, dispensing or using the lots and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall.

Consumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. Patients should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to Fresenius Kabi Medical Affairs or Vigilance departments at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time, or send an e-mail to either productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@fresenius-kabi.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Fresenius Kabi

As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.

Contacts

Media Contact

Matt Kuhn

847-220-3033

City of Hope Appoints Leading Lung Cancer Expert Dr. Christine M. Lovly to Head National Thoracic Oncology Program




City of Hope Appoints Leading Lung Cancer Expert Dr. Christine M. Lovly to Head National Thoracic Oncology Program

• Dr. Lovly brings nearly two decades of experience in clinical care, research and academic leadership to her new role.
• Her work has advanced personalized therapies that improve outcomes and quality of life for people with lung cancer.

LOS ANGELES–(BUSINESS WIRE)–City of Hope^®, one of the largest and most advanced cancer research and treatment organizations in the United States with its National Medical Center ranked among the nation’s top cancer centers by U.S. News & World Report, today announced that internationally recognized physician-scientist Christine M. Lovly, M.D., Ph.D., F.A.S.C.O., will spearhead the development of its new national thoracic oncology program, furthering City of Hope’s mission to deliver exceptional multidisciplinary care and transformative research for patients with lung cancer. Dr. Lovly’s appointment is effective Jan. 1.

Dr. Lovly will be division chief of thoracic medical oncology, professor in the Department of Medical Oncology & Therapeutics Research at City of Hope National Medical Center and will hold the Dr. Norman and Melinda Payson Professorship in Medical Oncology.

She brings nearly two decades of experience in clinical care, translational research and academic leadership. She joins City of Hope at a critical time in the fight against lung cancer, as rates of the disease continue to rise — especially among women, younger people and nonsmokers.

Her pioneering work has shaped the modern landscape of lung cancer care, leading to more effective therapies tailored to the genetic makeup of individual tumors. Dr. Lovly is a leading authority on the molecular dynamics of targeted therapy response and resistance, especially in lung cancer subtypes characterized by EGFR and ALK alterations.

“Dr. Christine Lovly is a widely recognized expert whose groundbreaking research and unwavering commitment to patient-centered care make her an extraordinary addition to City of Hope. Her expertise in precision medicine and translational science will be instrumental in shaping our national thoracic oncology program and accelerating progress for patients with lung cancer across the country,” said Marcel van den Brink, M.D., Ph.D., president, City of Hope Los Angeles and City of Hope National Medical Center, and Deana and Steve Campbell Chief Physician Executive Distinguished Chair in Honor of Alexandra Levine, M.D.

Dr. Lovly will be responsible for advancing multidisciplinary clinical care, building and mentoring a world-class faculty, expanding translational and clinical research, and fostering strategic partnerships to further solidify City of Hope as a national leader in lung cancer innovation and patient outcomes. Dr. Lovly’s arrival marks an exciting chapter for City of Hope. Her collaborative, innovative approach will further elevate City of Hope’s lung cancer program and strengthen its systemwide commitment to excellence.

Her research portfolio includes ongoing projects focused on biomarkers, drug development and residual disease. She integrates data science into her research, helping create predictive algorithms to uncover potent drug interactions with the potential to improve efficacy and lessen side effects. This body of work resulted in Dr. Lovly receiving the 2025 William J. Darby Award “for translational research that has changed the practice of medicine worldwide.”

Today the LUNGevity Foundation presented Dr. Lovly with the Face of Hope Award, which is given to individuals who recognize the needs of those living with lung cancer and is actively making a difference on their behalf. Past recipients include Richard Pazdur, M.D., director of the U.S. Food and Drug Administration’s Oncology Center of Excellence, and Robert Winn, M.D., president of the Association of American Cancer Institutes.

“I believe the future of lung cancer care lies in precision medicine and team-based collaboration, and City of Hope is the ideal place to bring that vision to life,” Dr. Lovly said. “I look forward to working alongside world-class clinicians and researchers to build a program that truly serves patients and their families.”

Dr. Lovly comes to City of Hope from Vanderbilt University Medical Center, where she was a tenured faculty member and held a joint appointment at the Veterans Affairs Medical Center. She is an elected member of the American Society for Clinical Investigation and serves on numerous editorial boards, including Cancer Discovery, Clinical Cancer Research and JCO Precision Oncology. Dr. Lovly holds leadership roles in multiple national and international organizations, including as a current member of the American Association for Cancer Research (AACR) Board of Directors.

Dr. Lovly contributes to the scientific leadership boards of LUNGevity Foundation, GO2 Foundation for Lung Cancer Research and Lung Cancer Research Foundation. Additionally, she plays a key role in shaping national standards of care through her service on the National Comprehensive Cancer Network (NCCN) guidelines panel for non-small cell lung cancer.

About City of Hope

City of Hope’s mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the United States, and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked among the nation’s top cancer centers by U.S. News & World Report at its core, City of Hope’s uniquely integrated model spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHope™. For more information about City of Hope, follow us on Facebook, X, YouTube, Instagram and LinkedIn.

Contacts

Zen Logsdon

626-409-9367

zlogsdon@coh.org

FillPoint Health Forms Collaborative Partnership with Noble, an Aptar Pharma Company, to Enhance Patient Experience and Drive Treatment Adherence




FillPoint Health Forms Collaborative Partnership with Noble, an Aptar Pharma Company, to Enhance Patient Experience and Drive Treatment Adherence

DUBLIN, Ohio–(BUSINESS WIRE)–FillPoint Health, a Lyceum Health company and URAC/ACHC-accredited specialty pharmacy and MSO, announced today a strategic partnership with Noble, an Aptar Pharma company and global leader in drug delivery training and onboarding solutions. This collaboration aims to enhance the patient experience through provider engagement and pharmaceutical partnerships, ensuring proper device use, improved adherence, and better clinical outcomes.

Under this partnership, FillPoint Health and Noble will jointly develop and implement education and support programs that integrate Noble’s industry-leading training devices, patient onboarding tools, and education platforms into FillPoint’s provider-driven specialty pharmacy model. The collaboration will focus on bridging the gap between pharmaceutical manufacturers, healthcare providers, and patients, creating a consistent, high-touch experience from prescription to administration.

“Our partnership with Noble represents a critical step in advancing how specialty therapies are delivered and supported at the point of care,” said Michael Baldzicki, Chief Revenue Officer of FillPoint Health. “By combining Noble’s proven patient training expertise with FillPoint’s provider-centric pharmacy model, we can help patients start therapy with confidence, use their medications correctly, and stay adherent over time—ultimately improving outcomes and satisfaction.”

The collaboration aligns with FillPoint Health’s broader mission of empowering providers and patients through technology, education, and integrated care models. As part of Lyceum Health’s network, FillPoint Health partners with pharmaceutical manufacturers and specialty providers to deliver fair market value (FMV)-based services, risk-of-loss pharmacy models, and real-world data insights that enhance access, quality, and efficiency in specialty care.

“We’re excited to partner with FillPoint Health to further our shared vision of improving patient engagement and outcomes,” said Craig Baker, President, Noble – Aptar Pharma. “Together, we will leverage our complementary strengths to ensure patients are fully supported in their treatment journey, from training to adherence.”

The partnership will initially focus on key therapeutic areas—including cardiology, dermatology, neurology, and rare diseases—with plans to expand into additional specialty categories and manufacturer collaborations throughout 2026.

About FillPoint Health, A Lyceum Health Company

FillPoint Health is a URAC- and ACHC-accredited specialty pharmacy and MSO focused on enhancing specialty patient care through integrated provider, payer, and pharmaceutical partnerships. FillPoint operates as part of Lyceum Health, a group of companies that includes RxNexus, a digital patient-access platform, and NewPoint-Rx, a physician-dispense division enabling compliant, FMV-based, in-office dispensing. For more info, please visit fillpointhealth.com and lyceumhealth.com.

About Noble, An Aptar Pharma Company

Noble is an Aptar Pharma company and part of AptarGroup, Inc., a global leader in drug and consumer product dosing, dispensing and protection technologies. Noble is a global leader in the development of patient-centric onboarding and drug delivery training solutions designed to improve the patient experience and drive adherence. Noble partners with pharmaceutical and biotechnology companies worldwide to create innovative, user-friendly training and support programs that empower patients to start and stay on therapy. For more information, please visit gonoble.com and www.aptar.com.

Contacts

Media Contacts:
FillPoint Health, A Lyceum Health Company:

info@fillpointhealth.com
www.lyceumhealth.com

Noble, An Aptar Pharma Company:

Ciara Jackson

Aptar Pharma

ciara.jackson@aptar.com
+49 151 1951 6502

Schrödinger to Present at Jefferies London Healthcare Conference




Schrödinger to Present at Jefferies London Healthcare Conference

NEW YORK–(BUSINESS WIRE)–Schrödinger, Inc. (Nasdaq: SDGR) today announced that management will participate in a fireside chat at the Jefferies London Healthcare Conference. The live presentation will take place on Wednesday, November 19, at 4:00 p.m. GMT (11:00 a.m. ET).

The live webcast can be accessed in the “Investors” section of Schrödinger’s website and will be archived for approximately 90 days following the event.

About Schrödinger

Schrödinger is transforming molecular discovery with its computational platform, which enables the discovery of novel, highly optimized molecules for drug development and materials design. Schrödinger’s software platform is built on more than 30 years of R&D investment and is licensed by biotechnology, pharmaceutical and industrial companies, and academic institutions around the world. Schrödinger also leverages the platform to advance a portfolio of collaborative and internal programs. Founded in 1990, Schrödinger has approximately 800 employees operating from 15 locations globally. To learn more, visit www.schrodinger.com, follow us on LinkedIn and Instagram, or visit our blog, Extrapolations.com.

Contacts

Matthew Luchini (Investors)

Schrödinger, Inc.

matthew.luchini@schrodinger.com
917-719-0636

Allie Nicodemo (Media)

Schrödinger, Inc.

allie.nicodemo@schrodinger.com
617-356-2325

MaaT Pharma Presents Updated Preclinical Data at SITC Annual Meeting Demonstrating Immune Activation and Anti-Tumor Activity of MaaT034




MaaT Pharma Presents Updated Preclinical Data at SITC Annual Meeting Demonstrating Immune Activation and Anti-Tumor Activity of MaaT034

LYON, France–(BUSINESS WIRE)–$MAAT #ASH–Regulatory News:

MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced the presentation of updated preclinical data for MaaT034, its next generation drug candidate to be evaluated to improve patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors at the 40^th  Society for Immunotherapy Cancer Annual Meeting in National Harbor, MD held  from November 5 to 9, 2025.  The SITC Annual Meeting is one of the world’s leading scientific and medical conferences focused on cancer immunotherapy. The dataset demonstrates compelling anti-tumor efficacy results and immune activation in germ-free mouse models. New analyses of multi-omic data from these models amplify the results previously presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2025.

MaaT034, the first-in-class co-cultured full ecosystem product, is designed to optimize intestinal microbiome functions and improve patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors (ICIs). MaaT034 is part of the Company’s MET-C platform, which leverages AI-driven co-culture technology to create donor-independent synthetic microbiome ecosystems at industrial scale, targeting specific disease indications.

To guide further development of MaaT034 in immuno-oncology, and in addition to its preclinical program, MaaT Pharma is also participating in two exploratory, investigator-sponsored clinical trials evaluating its donor-derived drug candidates (MaaT013 and MaaT033), respectively in metastatic melanoma and in non-small cell lung cancer (NSCLC).

Key findings from the presentation at SITC include:

• Metagenomic analysis shows that MaaT034 successfully engrafts in the gut of germ-free mice and reproduces the microbial functions of native-based microbiome ecosystems.
• MaaT034 improves dendritic cell (DC)-mediated T cell activation and potentiates anti-tumor effects mediated by anti-PD-1 checkpoint blockade in vitro.
• 70% of MaaT034 microbial species engraft in mice, ensuring an enduring presence of beneficial bacteria in the gut environment. In human FMT studies, the level of engraftment is significantly associated with positive clinical outcomes across multiple indications, as shown by a recent comprehensive meta-analysis¹.
• MaaT034 increases the production of key microbial-derived metabolites such as short-chain fatty acids, secondary bile acids, and tryptophan metabolites in germ-free mice. This translates into an improved gastrointestinal physiology as evidenced by gut mucosal restoration.
• MaaT034 optimizes anti-PD1 mediated activity in tumor-bearing, germ-free mice. While anti-PD1 alone reduced tumor growth by 10%, the combination of anti-PD1 and MaaT034 resulted in a 83.7% tumor growth reduction (compared to a 24.2% reduction when using a single strain of Akkermansia muciniphila² bacteria). These results demonstrate that improved tumor control is achieved with anti-PD1 in combination with MaaT034, as compared to PD-1 alone or in combination with a reference single bacterial strain.

“With MaaT034, we are entering a new phase in our drug platform development, one that leverages our deep experience in the development of complex microbiome therapies and cutting-edge computational analysis to build a next-generation drug candidate capable of enhancing patient response to immunotherapy,” said Sheri Simmons, PhD, Acting Chief Scientific Officer, MaaT Pharma. “These findings strongly support advancing our donor-independent, synthetic microbiome therapy and we look forward to bringing MaaT034 into clinical development.”

Details of poster presentation:

• Abstract number: 1150
• Title: MaaT034, a new co-cultured microbiome ecosystem therapy candidate, potentiates anti-PD1 mediated antitumoral activity in germ-free mice
• Presentation Day: Saturday, Nov. 8, 2025
• Primary Category: Microbiome and Other Environmental Factors

Upcoming investor and medical conferences participation

• November 19-21, 2025 – Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) annual meeting in Geneva, Switzerland
• November 25, 2025 – Investir Day event in Paris, France
• December 6-9, 2025 – 67^th American Society of Hematology (ASH) annual meeting in Orlando, Fl, USA

—

About MaaT034

MaaT034, currently in preclinical development, is a next-generation donor-independent full ecosystem synthetic microbiome therapy, dedicated to improving patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors. Developed using the Company’s co-culturing proprietary MET-C platform, MaaT034 is optimized for large-scale production in oncology. Previous presented preclinical data showed that MaaT034 produced key metabolites, recognized as promoting gut barrier restoration and modulating immune responses, such as Short-Chain Fatty Acids (SCFA), secondary bile acids, and tryptophan derivatives. These data support the role of MaaT034 in gut barrier repair and in T cell reactivation either in combination with anti-PD1 or with anti-PD-L1.  By enhancing gut barrier repair and modulating immune responses, MaaT034 is expected to complement the action of these immunotherapeutic agents, potentially improving their efficacy in treating solid tumors cancer.

About MaaT Pharma

MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021.

Forward-looking Statements

All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim”, “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

¹ Ianiro, G., Punčochář, M., Karcher, N. et al. Variability of strain engraftment and predictability of microbiome composition after fecal microbiota transplantation across different diseases. Nat Med 28, 1913–1923 (2022). https://doi.org/10.1038/s41591-022-01964-3
² Akkermansia muciniphila is a commensal bacterium naturally present in large quantities in the gut microbiota of healthy people.

Contacts

MaaT Pharma – Investor Relations
Guilhaume DEBROAS, Ph.D.

Head of Investor Relations

+33 6 16 48 92 50

invest@maat-pharma.com

MaaT Pharma – Media Relations
Pauline RICHAUD

Senior PR & Corporate Communications Manager

+33 6 14 06 45 92

media@maat-pharma.com

Catalytic Agency – U.S. Media Relations
Heather Shea

Media relations for MaaT Pharma

+1 617-286-2013

heather.shea@catalyticagency.com

Galderma Receives U.S. FDA Approval for Restylane® Lyft™ for the Enhancement of the Chin Profile




Galderma Receives U.S. FDA Approval for Restylane® Lyft™ for the Enhancement of the Chin Profile

• This approval is based on results showing the safety and effectiveness of Restylane Lyft in enhancing the chin profile, with high patient satisfaction and long-lasting results^1,2
• Restylane Lyft is the only hyaluronic acid (HA) injectable approved to treat the midface, facial folds and wrinkles, back of hands and the chin, with consistent results observed across diverse patient types^1,2
• Galderma’s Restylane portfolio, including Restylane Lyft, is supported by decades of clinical evidence and real patient experiences with over 77 million treatments delivered worldwide^3,4

ZUG, Switzerland–(BUSINESS WIRE)–Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Restylane Lyft with Lidocaine for augmentation of the chin region to improve the chin profile in patients over the age of 21 with mild-to-moderate chin retrusion.² Restylane Lyft is a versatile HA injectable with over 20 years of worldwide safety data, which is also approved to treat the midface, facial folds and wrinkles (such as nasolabial folds) and back of hands.^2,3,4

The Restylane portfolio offers a versatile range of HA injectables, from soft and flexible to firm gel formulations, empowering practitioners to deliver personalized aesthetic outcomes.^5-8 Restylane Lyft, developed with NASHA^® technology, has a firmer gel with minimal modification, closely resembling the skin’s natural HA.^9,10 With its high G-prime (a measure of firmness), Restylane Lyft is specifically designed to provide structure and support, enabling it to enhance the chin for a balanced profile.^2,5,11

The approval is based on results from a pivotal clinical trial, confirming the clinical performance and safety of Restylane Lyft for chin enhancement.^1,2 The primary endpoint of the study was met, demonstrating its safety and effectiveness in improving chin projection three months after initial injection, with improvement sustained in the majority of patients through 12 months.¹ Additional results showed:¹

• Global aesthetic improvement, as assessed by both patients and investigators, remained consistently high throughout the study. At Month 3, 99.1% of investigators and 94.5% of subjects reported visible improvement. These results were maintained at Month 12, with 95.4% of investigators and 89.0% of patients continuing to report positive outcomes
• At the end of the study (Month 12), a high proportion of patients agreed or strongly agreed that Restylane Lyft delivered natural-looking chin projection, improved the appearance of the lower face, and provided a smooth transition from chin to jawline, with satisfaction rates up to 86.3%
• Restylane Lyft was well tolerated, with no unexpected or serious adverse events related to the product reported during the study, reinforcing its favorable safety profile

Regulatory applications for Restylane Lyft for use on the chin will continue to be submitted and assessed by additional authorities globally. Galderma is working to bring this expanded indication to as many countries as possible.

IMPORTANT SAFETY INFORMATION

Restylane Lyft with Lidocaine is indicated for deep implantation into the facial tissue for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds, for cheek augmentation and for the correction of age-related midface contour deficiencies in patients over the age of 21. Restylane Lyft with Lidocaine is also indicated for injection into the dorsal hand to correct volume loss in patients over the age of 21. Restylane Lyft with Lidocaine is also indicated for injection into the mid-to-deep dermis (subcutaneous and/or supraperiosteal) for augmentation of the chin region to improve the chin profile in patients over the age of 21 with mild-to-moderate chin retrusion.

Restylane Lyft with Lidocaine contains traces of gram-positive bacterial protein and is contraindicated for patients with allergies to such material or for patients with severe allergies that have required in-hospital treatment. This product should not be used by people with bleeding disorders, with hypersensitivity to amide-type local anesthetics, such as lidocaine, or by women who are pregnant or breastfeeding.

The most common side effects reported in the clinical study to support approval of augmentation of the chin region included bruising, nodules, exfoliation, hemorrhage, edema, papules and redness. Patients also reported pain, tenderness, swelling, itching, and lumps/bumps.

Delayed-onset inflammation near the site of dermal filler injections is one of the known adverse events associated with dermal fillers, and cases have been reported to occur at the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, superficial necrosis, and scarring at the injection site. Do not implant into blood vessels. Use with caution in patients recently treated with anticoagulant or platelet inhibitors to avoid bleeding and bruising.

Restylane Lyft with Lidocaine is only available through a licensed practitioner. Complete Instructions for Use are available here.

About the Restylane portfolio

Restylane hyaluronic acid (HA) injectables are designed differently to go beyond volumizing for natural-looking results.^1,12-14 Our HA is exceptionally pure and our innovative manufacturing process preserves its biocompatibility while creating individual products designed for a specific purpose.^9,10,15 Restylane’s unique technologies, NASHA HD^™, NASHA and OBT^™/XpresHAn^™ are meaningfully designed to mimic the diverse range of facial structures and skin layers.^12-14 With the highest G’ and highest flexibility, Restylane can provide structural support, natural expressions and a healthy glow.^7,13,15-18 Trusted for almost three decades, our HA gels work in sync with your skin for 100% natural looking results.^12,19,20

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References

1. Galderma. Data on file. MA-60800. 43USCH2208 R Lyft Chin US Clinical Study Report.
2. Restylane^® Lyft. Instructions for Use. Available online. Galderma Laboratories, L.P., 2025.
3. Galderma. Data on file. MA-57232 [Updated]. 77 Million treated.
4. Galderma. Data on file. MA-55607. Restylane^® 27 years data publications analysis.
5. Galderma Data on file. MA-56724. X-strain and G’ including Shaype.
6. Nikolis A, Humphrey S, Rivers JK, et al. Effectiveness and Safety of a New Hyaluronic Acid Injectable for Augmentation and Correction of Chin Retrusion. J Drugs Dermatol. 2024;23(4):255–261.
7. Öhrlund Å, Winlöf P, Bromée T, et al. Differentiation of NASHA and OBT Hyaluronic Acid Gels According to Strength, Flexibility, and Associated Clinical Significance. J Drugs Dermatol. 2024;23(1):1332–1336.
8. Belmontesi M, De Angelis F, Di Gregorio C, et al. Injectable Non-Animal Stabilized Hyaluronic Acid as a Skin Quality Booster: An Expert Panel Consensus. J Drugs Dermatol. 2018;17(1):83–88.
9. Edsman K, Nord LI, Öhrlund Å, et al. Gel Properties of Hyaluronic Acid Dermal Fillers. Dermatol Surg. 2012;38:1170–1179.
10. Galderma. Data on file. MA-58650. Degree of modification of HA fillers.
11. Data on file. MA-34483. Study Report. Galderma Laboratories, L.P., 2021.
12. Di Gregorio C, Avelar L, Lam S, et al. 25+ years of experience with the Restylane portfolio of injectable HA fillers for facial aesthetic treatment. E-poster presented at AMWC; March 27-29, 2024; Monaco.
13. Nikolis A, Enright KM, Lazarova D, et al. The role of clinical examination in midface volume correction using hyaluronic acid fillers: should patients be stratified by skin thickness? Aesthet Surg J Open Forum. 2020; 2(1):1–12.
14. Galderma. Data on file. Subject satisfaction (GAIS) – NASHA and OBT Fillers. 2021.
15. Kablik J, Monheit GD, Yu LP, et al. Comparative physical properties of HA dermal fillers. Dermatol Surg. 2009; 35, 302–312.
16. Bromée T, Öhrlund Å, Winlöf P, et al. A new hyaluronic acid injectable, HASHA, sets new G-prime standards. Abstract presented at AMWC 2025; Mar 27-29, 2025; Monaco.
17. Narins RS, Brandt FS, Dayan SH, et al. Persistence of nasolabial fold correction with a HA dermal filler with retreatment: results of an 18-month extension study. Dermatol Surg. 2011;37: 644-650.
18. Talarico S, Meski AP, Buratini L. et al. High patient satisfaction of a HA filler producing enduring full-facial volume restoration: an 18-month open multicenter study. Dermatol Surg. 2015;41: 1361–1369.
19. Solish N, Bertucci V, Percec I, et al. Dynamics of HA fillers formulated to maintain natural facial expression. J Cosmet Dermatol. 2019;18(3): 738-746.
20. Philipp‐Dormston WG, Schuster B, and Podda M. Perceived naturalness of facial expression after HA filler injection in nasolabial folds and lower face. J Cosmet Dermatol. 2020;19(7): 1600-1606.

Contacts

For further information:

Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com
+41 76 315 26 50

Richard Harbinson

Corporate Communications Director

richard.harbinson@galderma.com
+41 76 210 60 62

Céline Buguet

Franchises and R&D Communications Director

celine.buguet@galderma.com
+41 76 249 90 87

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

emil.ivanov@galderma.com
+41 21 642 78 12

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com
+41 21 642 76 43

Innate Pharma Announces Conference Call and Webcast for Third Quarter 2025 Results and Business Updates




Innate Pharma Announces Conference Call and Webcast for Third Quarter 2025 Results and Business Updates

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

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the Company will hold a conference call on Thursday, November 13, 2025, at 2 p.m. CET / 8 a.m. ET, to give an update on business progress during the third quarter of 2025.

Participants during the call will be:

• Jonathan Dickinson, Chief Executive Officer
• Sonia Quaratino, Executive Vice President, Chief Medical Officer
• Yannis Morel, Executive Vice President, Chief Operating Officer
• Stéphanie Cornen, Vice President, Investor Relation, Communication and Commercial Strategy
• Frédéric Lombard, Senior Vice President, Chief Financial Officer

Details for the Virtual Event

The live webcast will be available at the following link: https://events.q4inc.com/attendee/424851735

Analysts may also join via telephone, click here to register.

This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event.

About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Leveraging its antibody-engineering expertise, the company has developed innovative therapeutic approaches, including monoclonal antibodies (mAbs), Antibody Drug Conjugates (ADC) and multi-specific NK Cell Engagers through its proprietary ANKET^® (Antibody-based NK cell Engager Therapeutics) platform.

Innate’s portfolio includes lacutamab, an anti-KIR3DL2 mAb developed in advanced forms of cutaneous T cell lymphomas and peripheral T cell lymphomas, IPH4502, a differentiated Nectin‑4 ADC in development in solid tumors, and monalizumab, an anti-NKG2A antibody developed in collaboration 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 renowned research institutions, working together 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,” “expect” “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

Radiant Biotherapeutics to Present New Data from Lead Oncology Program at SITC 2025 Annual Meeting




Radiant Biotherapeutics to Present New Data from Lead Oncology Program at SITC 2025 Annual Meeting

• RBT-101, Radiant’s lead oncology program and 4-1BB agonist, demonstrated robust, durable and complete tumor regression without liver toxicity in MC38 colorectal mouse tumor model
• Poster presentation scheduled on Friday, November 7, 2025

TORONTO–(BUSINESS WIRE)–Radiant Biotherapeutics, a biotechnology company committed to advancing a breakthrough antibody approach, the Multabody™, for a broad range of therapeutic areas, including cancer and infectious diseases, announced new data at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting demonstrating its lead oncology candidate, RBT-101, exhibited robust, durable and complete tumor regression while avoiding liver toxicity, in a MC38 colorectal mouse tumor model.

Radiant’s proprietary Multabody™ technology uniquely harnesses natural mechanisms to effectively engage multiple disease targets with unmatched strength, precise tunability, and exceptional breadth. 4-1BB is a clinically validated immune checkpoint target that elicits potent anti-tumor immunity and enhanced T cell responses but has eluded safe and effective therapeutic targeting by traditional 4-1BB agonists due to systemic and Fc-mediated liver toxicity. Radiant has leveraged its Multabody™ platform to develop RBT-101, a multivalent 4-1BB agonist that does not rely on traditional antibody methods to enhance potency, binding strength or durability.

Key Highlights from SITC 2025 Poster Presentation:

• RBT-101 achieved sustained complete tumor regression in MC38 colorectal mouse tumor model
• RBT-101 demonstrated long-lived anti-tumor immunological memory; no detectable tumor growth was observed in mice that were re-challenged with MC38 tumor cells after previous successful treatment
• RBT-101 demonstrated no signs of liver toxicity, in contrast to benchmark 4-1BB agonist urelumab

“Our data to be presented at SITC demonstrates that RBT-101 achieves what first-generation 4-1BB agonists could not – delivering robust anti-tumor activity without liver toxicity,” said Jo Hulme, Ph.D., CSO of Radiant. “This validates our Multabody platform’s potential to address a broad range of therapeutic targets while avoiding the inherent limitations of conventional antibody-based approaches, as RBT-101 drove potent, tunable and safe agonism of 4-1BB that more closely mimicked natural ligand biology. We look forward to the continued development of Multabodies as promising therapeutics in oncology and other disease areas.”

The poster, titled “Multabodies: A next-generation approach for cancer immunotherapy and 4-1BB agonist therapy,” will be presented onsite on Friday, November 7, 2025, and will also be available on the SITC virtual meeting platform beginning November 7 at 9 a.m. ET.

About Radiant Biotherapeutics

Radiant Biotherapeutics is a biotechnology company advancing breakthrough Multabody™ therapeutics that deliver unmatched strength, tunability, and breadth in a single molecule. The company’s proprietary platform leverages apoferritin scaffolding and sophisticated protein engineering to create antibodies with unprecedented therapeutic potential across a broad range of disease areas, including cancer and infectious diseases. The platform is compatible with standard antibody manufacturing processes, bringing flexibility, modularity and scalability. For more information, please visit radiantbio.com.

Contacts

Chris Brinzey

ICR Healthcare

Chris.Brinzey@icrhealthcare.com

Driven by Strong Demand, ImmunityBio Reports 467% Year-to-Date Unit Growth and $75 Million in Sales Year-to-Date, Up 434% from Q3 2024




Driven by Strong Demand, ImmunityBio Reports 467% Year-to-Date Unit Growth and $75 Million in Sales Year-to-Date, Up 434% from Q3 2024

• Q3 2025 Revenue and Other Income Growth with Continued Strong Sales Momentum: $33.7 million of total revenue and other income, up from $26.4 million in Q2 2025.
• Product Revenue: Up 434% in Q3 2025 versus Q3 2024, with year-to-date sales of $74.7 million.
• ANKTIVA^® Unit Growth: 467% unit sales volume growth in year-to-date 2025 compared to fiscal year 2024.
• Cash Position: $257.8 million in cash, cash equivalents, and marketable securities as of September 30, 2025, up from $153.7 million as of June 30, 2025.
• Glioblastoma: Early results from the first five recurrent glioblastoma patients treated with ANKTIVA plus the Optune Gio^® device in combination with PD-L1 CAR-NK showed 100% disease control, including three responses (two near complete) and two cases of stable disease. Lymphocyte counts increased in all five patients. Based on these findings, ImmunityBio is initiating a randomized registration trial for second line GBM patients.
• Non-Small Cell Lung Cancer (NSCLC): ImmunityBio has initiated enrollment in ResQ201A, a global, randomized Phase 3 study evaluating ANKTIVA in combination with TEVIMBRA^® (BeOne) and docetaxel versus docetaxel alone in patients with checkpoint inhibitor-resistant NSCLC.
• Non-Hodgkin Lymphoma: Early results from the Company’s QUILT.106 trial showed promising complete responses in the first two patients with late-stage Waldenstrom macroglobulinemia treated to date using its CD19 CAR-NK natural killer cell therapy.
• Papillary NMIBC: The Company shared updated QUILT-3.032 trial data showing durable 36-month progression-free survival and bladder-sparing benefits of ANKTIVA plus Bacillus Calmette-Guérin (BCG). In addition, ImmunityBio has applied to the National Comprehensive Cancer Network (NCCN) to seek expansion of the BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) guidelines to include papillary-only disease in addition to carcinoma in situ (CIS) with or without papillary tumors. The NCCN reviewed the submission at its August 2025 meeting, and the Company is awaiting their decision.
• ANKTIVA Access Update: ANKTIVA selected as preferred drug of choice for NMIBC patients with CIS, with or without papillary tumors by a large medication contracting organization with ~80 million lives under management. The Company remains committed to patients through the expansion of the recombinant BCG (rBCG) early access program (EAP) and its copay assistance program with as low as $25 copay payments for qualifying patients.

CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced its financial results for the fiscal quarter and nine months ended September 30, 2025.

In the third quarter of 2025, ImmunityBio reported $31.8 million of product revenue, representing a 434% increase from $6.0 million in the third quarter of 2024. This growth reflects continued commercial traction of ANKTIVA in combination with BCG in BCG-unresponsive NMIBC with CIS with or without papillary tumors. The first three quarters of 2025 sales totaling $74.7 million represents a 467% increase in unit volume during the first three quarters of 2025 versus the last three quarters of 2024. The Company ended the quarter with $257.8 million in cash, cash equivalents, and marketable securities as of September 30, 2025.

“We are pleased with the continued strong demand for ANKTIVA in NMIBC CIS. Unit sales grew nearly 6X year-to-date compared with full-year 2024, reflecting adoption both at leading research centers and in community urology clinics, including rural areas,” said Richard Adcock, President and CEO of ImmunityBio. “ANKTIVA’s total response rate continues to gain momentum with payors as it was recently added as the preferred drug in its indication by a large medication contracting organization covering ~80 million lives. Additionally, enrollment in the rBCG EAP nearly doubled this quarter, underscoring the urgent need to address the BCG shortage. On the clinical side of the business, our BCG-naïve study is enrolling well, and we are optimistic about the potential to expand ANKTIVA’s reach to an even broader population of bladder cancer patients in the near future.”

“We continue to achieve compelling results with the core components of our BioShield™ platform, demonstrated by sustained demand for ANKTIVA in bladder cancer and encouraging data this quarter showing its potential to reverse lymphopenia in non-small cell lung cancer,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer, of ImmunityBio. “ANKTIVA also showed strong data in achieving disease control in glioblastoma, an extremely difficult to treat cancer. We are excited about the growth opportunities for our science and its potential to address many more unmet needs.”

Third-Quarter Ended September 30, 2025 Financial Summary and Comparison to Prior Year Quarter

Product Revenue, Net

Product revenue, net increased $25.8 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024.

Research and Development Expense

Research and development (R&D) expense increased $0.8 million to $51.2 million during the three months ended September 30, 2025, as compared to $50.4 million during the three months ended September 30, 2024. The increase was due to higher manufacturing costs and higher distribution costs driven by more production and clinical trial activities, and higher license fees, partially offset by fewer sponsored research agreements.

Selling, General and Administrative Expense

Selling, general and administrative (SG&A) expense increased $0.4 million to $36.3 million during the three months ended September 30, 2025, as compared to $35.9 million during the three months ended September 30, 2024. The increase was due to higher costs related to headcount, partially offset by lower costs related to litigation settlements and commercial consulting activities.

Net Loss Attributable to ImmunityBio Common Stockholders

Net loss attributable to ImmunityBio common stockholders was $67.3 million during the three months ended September 30, 2025, compared to $85.7 million during the three months ended September 30, 2024. The reduction of loss was primarily driven by increased product revenue and lower related-party interest expense, partially offset by an increase in interest expense related to the revenue interest liability, and changes in the fair value of warrant liabilities, a related-party convertible note and derivative liabilities.

Nine Months Ended September 30, 2025 Financial Summary and Comparison to Prior Year Nine Months

Product Revenue, Net

Product revenue, net increased $67.8 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024.

Research and Development Expense

R&D expense decreased $0.2 million to $154.7 million during the nine months ended September 30, 2025, as compared to $154.9 million during the nine months ended September 30, 2024. The decrease was mainly due to a reduction in outside service costs, CMO fees and drug materials purchased and used in manufacturing, partially offset by an increase in clinical trial costs and by higher manufacturing costs driven by increased production activities.

Selling, General and Administrative Expense

SG&A expense decreased $15.8 million to $111.3 million during the nine months ended September 30, 2025, as compared to $127.1 million during the nine months ended September 30, 2024. The decrease was primarily driven by lower costs related to litigation settlements and commercial consulting activities, partially offset by higher stock-based compensation expense, recruiting and training expenses, salaries, benefits and commissions, and travel expenses due to growing sales and marketing activities.

Net Loss Attributable to ImmunityBio Common Stockholders

Net loss attributable to ImmunityBio common stockholders was $289.5 million during the nine months ended September 30, 2025, compared to $354.4 million during the nine months ended September 30, 2024. This reduction of loss was primarily driven by increased product revenue, lower SG&A expense described above, lower related-party interest expense, and changes in the fair value of warrant liabilities, partially offset by changes in the fair value of derivative liabilities and a related-party convertible note, an increase in interest expense related to the revenue interest liability, and lower interest and investment income.

About ANKTIVA

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating natural killer (NK) cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.

A key component in the Company’s BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

ANKTIVA is currently approved by the U.S. Food and Drug Administration (FDA) with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors.

About ImmunityBio

ImmunityBio is a vertically-integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit ImmunityBio.com (Founder’s Vision) and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s clinical development programs, commercial success of its products and product candidates, manufacturing capabilities, continued collaboration with third parties, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such forward-looking statements include statements regarding future operating results and prospects, commercialization activities, momentum and market data, including related to adoption of ANKTIVA, decisions and timelines related to the Company’s regulatory submissions and strategy, statements regarding the early results from initial GBM patients treated with ANKTIVA and the Company’s plans for initial trials in such program, early results from the NSCLC study and the implications thereof, the Company’s application to the NCCN to seek expansion of the BCG-unresponsive NMIBC guidelines and expectations related thereto, expectations related to the pricing and increased access to patients enabled by the rBCG EAP clinical trial and EAP enrollment, timing, data and potential results to be drawn therefrom, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, potential future uses and applications of ANKTIVA alone or in combination with other therapeutic agents for the prevention or reversal of lymphopenia, potential future uses and applications of ANKTIVA alone or in combination with other therapeutic agents across multiple tumor types and indications and for potential applications beyond oncology, potential regulatory pathways and the regulatory review process and timing thereof, the application of the Company’s science and platforms to treat cancers or develop cancer vaccines, immunotherapies and cell therapies that have the potential to change the paradigm in cancer care, and ImmunityBio’s approved product and investigational agents as compared to existing treatment options, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “is,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding the FDA regulatory submission, filing and review process and the timing thereof, as well as that associated with regulatory agencies outside of the U.S. such as the European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA) and other global regulatory agencies, (ii) risks and uncertainties regarding commercial launch execution, success and timing, (iii) risks and uncertainties regarding participation and enrollment and potential results from the expanded access clinical investigation programs described herein, (iv) whether clinical trials will result in registrational pathways, (v) whether clinical trial data will be accepted by regulatory agencies, (vi) whether the NCCN will review and/or approve the Company’s submission described herein on the anticipated timeline or at all, (vii) risks and uncertainties regarding market access initiatives and timing, (viii) risks and uncertainties regarding changes in personnel at the FDA and limited resources at the FDA and potential delays associated therewith, (ix) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (x) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (xi) potential delays in product availability and regulatory approvals, (xii) risks and uncertainties associated with third-party collaborations and agreements, (xiii) ImmunityBio’s ability to retain and hire key personnel, (xiv) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xv) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xvi) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xvii) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xviii) ImmunityBio’s ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for ANKTIVA, its product candidates, and other technologies in development.

More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 3, 2025, and the Company’s Form 10-Q filed with the SEC on August 5, 2025, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at www.sec.gov.

ImmunityBio cautions you not to place undue reliance on any forward looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law.

Contacts

Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1 858-746-9289

Hemanth.Ramaprakash@ImmunityBio.com

Media
Sarah Singleton
ImmunityBio, Inc.
+1 415-290-8045

Sarah.Singleton@ImmunityBio.com