Samsung Bioepis and Epis NexLab Sign Research Collaboration and License Agreement with G2GBIO to Develop Novel Assets Including Long-acting Semaglutide




Samsung Bioepis and Epis NexLab Sign Research Collaboration and License Agreement with G2GBIO to Develop Novel Assets Including Long-acting Semaglutide

• Samsung Bioepis to receive exclusive license to develop and commercialize two novel assets including long-acting semaglutide using G2GBIO’s proprietary microsphere technology
• Epis NexLab, a sister company to Samsung Bioepis under Samsung Epis Holdings, also signs the agreement to collaborate in the development of the long-acting microsphere drug delivery platform

INCHEON, Korea–(BUSINESS WIRE)–#Biosimilar–Samsung Bioepis Co., Ltd. and Epis NexLab Co., Ltd., a sister company to Samsung Bioepis under Samsung Epis Holdings (KRX: 0126Z0), today announced a research collaboration and license agreement with G2GBIO, a company specializing in the development of sustained-release formulations, to develop novel assets based on G2GBIO’s proprietary microsphere technology.

Under the agreement, Samsung Bioepis will be given a full license right for the novel long-acting semaglutide asset, and an option to license another asset from G2GBIO. In addition, Samsung Bioepis will be given the first negotiation rights for the three other novel assets to be determined. Epis NexLab will be responsible for the co-development of the long-acting microsphere drug delivery platform using G2GBIO’s proprietary technology. The details of the financial terms remain confidential.

“This agreement represents an important step in expanding our drug delivery capabilities and pipeline,” said Kyung-Ah Kim, President and Chief Executive Officer, at Samsung Bioepis. “By leveraging G2GBIO’s proprietary microsphere technology and collaborating with Epis NexLab, we look forward to the development of innovative therapies and deliver meaningful treatment options to patients.”

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

Contacts

Media Contact
Yoon Kim, yoon1.kim@samsung.com
Anna Nayun Kim, nayun86.kim@samsung.com

YolTech Therapeutics Receives FDA Clearance to Initiate Phase 2/3 Study of In Vivo Gene-Editing Therapy YOLT-202 in Alpha-1 Antitrypsin Deficiency (AATD)




YolTech Therapeutics Receives FDA Clearance to Initiate Phase 2/3 Study of In Vivo Gene-Editing Therapy YOLT-202 in Alpha-1 Antitrypsin Deficiency (AATD)

SHANGHAI–(BUSINESS WIRE)–YolTech Therapeutics, a late clinical-stage biotechnology company developing in vivo gene-editing therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for YOLT-202, the company’s investigational in vivo base-editing therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD).

The FDA approval enables the initiation of an open-label, single-dose expansion Phase 2/3 clinical study to evaluate the efficacy and safety of YOLT-202 in adult patients with Alpha-1 Antitrypsin Deficiency (AATD). The study is designed as a multiregional clinical trial (MRCT) to be conducted at clinical sites in the U.S. and other countries.

YOLT-202 is currently being investigated in a first-in-human investigator-initiated trial (IIT) (NCT07193615) designed to evaluate the safety, tolerability, and preliminary efficacy of YOLT-202 in patients with AATD. As of the date of this release, two patients had been enrolled and completed dose. Following administration of YOLT-202, both patients showed rapid, robust and dose-dependent increases in AAT level as early as in Week 1. AAT levels in both patients reached above the protective threshold of 11 μM. Additionally, AAT levels increased to normal range (>20 μM) in the 45 mg dose group. These newly produced AAT proteins were both structurally corrected (M-AAT) and functional, with the proportion of corrected M-AAT increasing to >95% in the 45 mg dose group.

“The FDA clearance, together with the encouraging early clinical data, highlights the transformative potential of YOLT-202 and our in vivo base-editing platform,” stated Yuxuan Wu, M.D., Co-Founder and CEO of YolTech Therapeutics. “We are excited to advance this Phase 2/3 study and bring a potential ‘one and done’ therapy to patients with Alpha-1 Antitrypsin Deficiency.”

About YOLT-202

YOLT-202 is an in vivo gene-editing therapy that corrects PiZ mutation to PiM for the treatment of AATD. Utilizing YolTech’s proprietary adenine base editor, YOLT-202 is engineered to achieve on-target editing with minimal bystander activity. YOLT-202 has previously been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA).

About Alpha-1 Antitrypsin Deficiency (AATD)

AATD is an inherited, genetic, autosomal co-dominant disorder caused by mutations in the SERPINA1 gene, with the most frequent deficient variants coming from the Z (Glu342Lys) and S alleles (Glu264Val). The presence of Z alleles results in misfolding and polymerization of the AAT, leading to over 95% of severe AATD patients being PIZZ.

About YolTech

Built on HEPDONE™ Novel Editor Platform and non-viral LNP technologies, YolTech Therapeutics is advancing in vivo gene-editing medicines with the potential for a one-time treatment that provides lifelong benefit. The company’s expanding clinical pipeline addresses genetic, metabolic, cardiovascular, and autoimmune diseases, with early clinical results supporting the potential for durable and transformative outcomes.

Stay informed with the latest from YolTech Therapeutics:

LinkedIn: linkedin.com/company/yoltech-therapeutics
Website: www.yoltx.com

Contacts

company name: YolTech Therapeutics

media contact: Ally Yu

email address: xiaolingyu@yoltx.com

ImmunityBio Achieves Milestone with Large-Scale NK Cell Production and Cryopreservation from Over 60 Healthy and Cancer Donors




ImmunityBio Achieves Milestone with Large-Scale NK Cell Production and Cryopreservation from Over 60 Healthy and Cancer Donors

• Methods developed and validated to establish the “World Bank of NK Cells” from healthy donors and cancer patients
• Single apheresis yields up to 5 billion (5×10⁹) highly pure activated memory cytokine-enhanced NK cells (M-ceNK), providing up to 8-10 doses of M-ceNK product per patient
• Manufacturing and cryo-banking process established with finished dosage form of M-ceNK cells available within 12 days from apheresis
• M-ceNK cells successfully cryopreserved with demonstration of retained cytotoxicity against multiple tumor cell lines
• Methods now established in readiness for manufacturing in AI-driven automated robotic systems (NANT Leonardo)
• Combination of M-ceNK with ANKTIVA® successfully completed in Phase 1 safety study (QUILT 3.076)

CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced the successful completion of manufacturing engineering programs, NK2022 and NK2023, establishing a safe, reproducible, and scalable leukapheresis-to-manufacturing pathway for its autologous memory cytokine-enhanced natural killer (M-ceNK) cell therapy platform.

In addition, a Phase I program (QUILT-3.076; NCT04898543) combining M-ceNK with ANKTIVA® (nogapendekin alfa inbakicept-pmln) was completed in patients with relapsed or refractory tumors demonstrating safety following infusion of the M-ceNK drug product. Collectively, these programs enrolled 74 subjects, including both healthy donors and patients with cancer, and generated the foundational process development and robotic automation datasets required to support first-in-human clinical translation.

Manufacturing Validation

The NK2022 (Cancer and Healthy Volunteers) and NK2023 (Healthy Volunteers) programs (N=64) evaluated the safety of large-volume, non-mobilized leukapheresis and the reproducibility of downstream NK cell enrichment and cytokine-driven memory programming across two distinct donor populations.

Across both programs, 64 subjects successfully completed apheresis collection across healthy and cancer subjects without procedure-related serious adverse events (SAEs). Collected cells were stored and used for process development and validation.

Among the 64 completed apheresis subjects, 10 cancer subjects received their collected cells following ImmunityBio’s NK cell enrichment process. A total of 23 doses were administered to patients demonstrating successful repeat dosing and cryo-banking of M-ceNK cells. No SAEs were reported in the 10 cancer subjects during their treatment cycles.

Post-collection immune profiling demonstrated preserved NK cell activity and phenotype in healthy donors and in cancer patients, including those with prior exposure to systemic therapy. Critically, NK cells derived from cancer patients demonstrated cytotoxic activity equivalent to that of healthy donor-derived NK cells against NK-resistant cell lines representing multiple histologies, including breast, Merkel cell, ovarian, chordoma, medulloblastoma, glioblastoma, adenocarcinoma, and lymphoma.

“These data demonstrate that potent NK cell therapy can be manufactured at scale and administered safely, potentially offering a reliable autologous source of potent NK cells,” said Patrick Soon-Shiong, MD, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “The ability to generate up to 5 billion highly pure NK cells from a single apheresis collection, yielding up to 8-10 therapeutic doses within 12 days, opens the possibility of creating the ‘World Bank of Natural Killer Cells’, with NK cells able to be universally donated to any patient without HLA matching.”

QUILT-3.076 Safety Phase I Trial of M-ceNK Cells

Manufacturing feasibility data from NK2022 and NK2023 directly enabled ImmunityBio’s Phase 1 dose-escalation trial (QUILT-3.076; NCT04898543) evaluating autologous M-ceNK cells in combination with nogapendekin alfa inbakicept-pmln (ANKTIVA^®) in patients with relapsed or refractory solid tumors. 10 patients were enrolled in the treatment cohort and received weekly intravenous M-ceNK infusions (0.25 to 0.75×10⁹ cells per dose, up to 10 doses) combined with subcutaneous ANKTIVA^® administered every two weeks.

• Patient infusions to date: N=10. All infusion performed in an outpatient setting
• Cancer types (2^nd line & greater): Breast (N=4), Colon (N=1), Duodenum (N=1), Renal (N=1), Pancreatic (N=1), Rectal (N=1), Osteosarcoma (N=1)
• Range of M-ceNK infusions (2 to 5 bags infused) with NAI subcutaneously
• Safety: Zero (0%) TRAE Grade 4 or 5. Zero (0%) cytokine storm

The combination of autologous M-ceNK cells with ANKTIVA^® is mechanistically designed to leverage the IL-15 superagonist activity of ANKTIVA^® to sustain in vivo M-ceNK proliferation and persistence following adoptive transfer.

M-ceNK Antitumor Activity in Neuroendocrine Tumors: NCI-Led Preclinical and In Vivo Efficacy Data

Additional translational evidence supporting the M-ceNK platform was presented by K Fousek et al., National Cancer Institute (NCI) at the AACR IO Annual Meeting, 2026.

The AACR IO 2026 presentation reported the first in vivo efficacy data for the M-ceNK platform. In two SCLC xenograft models, M-ceNK cells combined with ANKTIVA produced statistically significant tumor volume reductions (p<0.01 and p<0.001, respectively), with confirmed in vivo persistence of functional M-ceNK cells. M-ceNK treatment also significantly increased MHC-Class I expression on residual tumor cells (p<0.0001), suggesting a potential dual mechanism: direct NK cell mediated tumor killing followed by conversion of residual tumors to a state potentially responsive to immune checkpoint inhibitors.

SCLC is an aggressive neuroendocrine carcinoma with limited treatment options. Tissue microarray analysis demonstrated that 62% of neuroendocrine tumors lack MHC-Class I expression, rendering them resistant to T cell-based immunotherapies but vulnerable to NK cell mediated killing, identifying a substantial patient population with unmet therapeutic need. Low MHC class I surface expression limits T cell-mediated and immune checkpoint blockade (ICB)-dependent tumor killing, a contributing mechanism of ICB resistance, while simultaneously creating susceptibility to NK cell-mediated cytotoxicity via the missing-self recognition mechanism. M-ceNK cells generated from healthy donor peripheral blood mononuclear cells expressed high levels of activating receptors, low levels of inhibitory receptors, and produced elevated interferon-gamma (IFN-γ) and granzyme B upon stimulation, consistent with an enhanced cytotoxic effector phenotype. In standardized cytotoxicity assays, M-ceNK cells demonstrated potent killing activity against the majority of tumor cell lines evaluated, with the greatest cytotoxic activity observed against neuroendocrine tumor models, including five SCLC lines, four pulmonary carcinoid lines, and a large cell neuroendocrine carcinoma line, supporting the potential breadth of clinical applicability across neuroendocrine malignancies.

About ANKTIVA^® (nogapendekin alfa inbakicept-pmln)

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 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 driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

About ImmunityBio

ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield^™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist, ANKTIVA^® (nogapendekin alfa inbakicept). Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com 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 Private Securities Litigation Reform Act of 1995. All statements in this press release that are not historical facts are forward-looking statements, including, without limitation, statements regarding: the potential clinical utility, safety, and therapeutic benefit of memory cytokine-enhanced natural killer (M-ceNK) cell therapies; the potential of ImmunityBio’s NK cell manufacturing and cryopreservation processes to enable scalable, reproducible, and rapid production of NK cell therapies; the ability to generate multiple therapeutic doses from a single leukapheresis collection; the potential to establish a “world bank” of NK cells or otherwise enable broad patient access to NK cell therapies; the readiness and potential advantages of automated or AI-driven robotic manufacturing systems; the expected development pathway, clinical evaluation, and future studies of the M-ceNK platform; the potential clinical benefits of combining M-ceNK cells with ANKTIVA® (nogapendekin alfa inbakicept-pmln); the potential mechanisms of action of M-ceNK cells and ANKTIVA®, including NK cell activation, proliferation, and persistence; the potential applicability of the platform across multiple tumor types; the significance of preclinical or early clinical findings; and ImmunityBio’s plans to advance clinical development, present additional data, pursue regulatory discussions, and explore future regulatory approvals.

Forward-looking statements are based on current expectations, estimates, projections, and assumptions of management and involve known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to differ materially from those expressed or implied by these forward-looking statements. Such risks and uncertainties include, but are not limited to: uncertainties regarding the translation of preclinical findings or early clinical observations into meaningful clinical outcomes; risks related to the development, manufacture, and scale-up of cell therapy products; the possibility that manufacturing processes may not perform as expected at larger scale or in commercial settings; the ability to successfully automate or implement AI-driven manufacturing systems; the ability to establish or maintain reliable supply, cryopreservation, and distribution capabilities for cellular therapies; risks associated with clinical trial design, enrollment, conduct, and outcomes; the possibility that additional data may not confirm initial safety or activity observations; the risk that regulatory authorities may require additional studies, data, or manufacturing validation; uncertainties regarding regulatory review, approvals, timelines, and inspections of the relevant manufacturing facilities; ImmunityBio’s ability to successfully advance clinical programs and obtain regulatory approvals in the United States or other jurisdictions; competition from other therapeutic approaches; changes in regulatory requirements or standards; and ImmunityBio’s ability to obtain sufficient funding and resources to support its development programs and manufacturing efforts.

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 February 23, 2026 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

ImmunityBio 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

AOM Infusion Selected as a Limited Distribution Specialty Pharmacy for QIVIGY®, A New Immune Globulin Therapy




AOM Infusion Selected as a Limited Distribution Specialty Pharmacy for QIVIGY®, A New Immune Globulin Therapy

ARLINGTON, Texas–(BUSINESS WIRE)–AOM Infusion (“AOM”), a leading specialty infusion pharmacy and provider, today announced it has joined Kedrion Biopharma’s limited distribution network for QIVIGY^®, a new 10% immune globulin (Ig) liquid indicated for treatment of adults with Primary Humoral Immunodeficiency (PI).

The addition of QIVIGY expands AOM’s immune globulin portfolio and strengthens its ability to help patients and providers access innovative therapies for complex immune disorders. This announcement builds on AOM’s recent collaboration with Kedrion for YIMMUGO®, a 10% immune globulin liquid also indicated for the treatment of PI.

QIVIGY is a ready-to-use, sterile, non-pyrogenic liquid solution of human immune globulin (IgG) for IV administration. It supplies a broad spectrum of antibodies against bacterial and viral agents to support patients with Primary Immunodeficiency Disorders (PID).

Kedrion selected AOM as a distribution partner for its deep expertise in immune globulin therapy, national reach, and patient-centered clinical model. AOM’s recognition as one of the first specialty providers in the nation to earn the Distinction in Ig Therapy from the ACHC and IgNS further demonstrates its commitment to clinical excellence, patient safety, and outcomes-driven care.

“We’re proud to make QIVIGY available nationwide, offering a reliable new option for patients in need of IVIG therapy,” said Bob Rossilli, Chief Commercial Officer of Kedrion. “Through our long-standing relationship with AOM Infusion, we aim to reach patients where they are and ensure access to the therapies they need most. By combining our expertise and resources, we can bring QIVIGY to more communities and help support patients and families.”

“This partnership with Kedrion reflects our shared commitment to improving access to life-enhancing therapies for patients with complex immune disorders,” says Karmen Stowe, Vice President of Trade Relations & Supply Chain. “By expanding our Ig portfolio with QIVIGY, we are strengthening our ability to support providers with reliable therapy options and helping patients receive high-quality infusion care that best supports their lives.”

For more information about QIVIGY, visit: https://www.qivigy.com/hcp.

For more information about AOM Infusion, visit: https://aominfusionrx.com/.

About AOM Infusion

AOM Infusion is a nationally licensed infusion pharmacy with more than 30 years of experience delivering specialty infusion care to patients with complex, chronic conditions. The company provides therapy for more than 80 disease states and is recognized for its clinical excellence and growth, including being named to the Inc. 5000 list and becoming one of the first infusion therapy providers to earn the Immunoglobulin (Ig) Distinction from ACHC and IgNS. AOM Infusion continues to expand its therapy solutions and invest in innovative platforms to deliver high-quality, patient-centered care nationwide.

About Kedrion Biopharma

Kedrion Biopharma collects and fractionates blood plasma to produce and distribute plasma-derived therapies for rare, ultra-rare, and debilitating conditions like Coagulation and Neurological Disorders, Immunodeficiencies, and Rh sensitization. Kedrion employs approximately 5,200 people worldwide, and its industrial network includes 68 plasma collection centers in the United States and 8 in the Czech Republic, and 7 production facilities across 5 countries. Kedrion is committed to creating a world where science and care know no bounds, partnering with the medical-scientific community, institutions, patient advocacy groups, and research bodies to foster innovation and improve care.

INDICATION

QIVIGY (immune globulin intravenous, human-kthm) is a 10% immune globulin (Ig) liquid indicated for the treatment of adults with primary humoral immunodeficiency.

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE

See full prescribing information for complete boxed warning.

• Thrombosis may occur with immune globulin products, including QIVIGY.

• Renal dysfunction, acute renal failure, osmotic nephrosis may occur with immune globulin intravenous (IGIV) products in predisposed patients. Such events require immediate medical intervention, if not recognized or managed appropriately, may result in persistent or significant disability or incapacity or lead to fatal outcome.

• For patients at risk of thrombosis, renal dysfunction or failure, administer QIVIGY at the minimum dose available and the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

WARNINGS AND PRECAUTIONS

• Severe hypersensitivity reactions, including anaphylaxis, may occur. In case of hypersensitivity, discontinue QIVIGY infusion and manage as appropriate.
• Hyperproteinemia, hyperviscosity, and hyponatremia may occur in patients receiving IGIV treatment, including QIVIGY.
• Aseptic meningitis syndrome may occur in patients receiving IGIV treatment, especially with high doses or rapid infusion.
• Hemolysis can develop subsequent to IGIV treatment. Monitor patients for hemolysis.
• Transfusion-related acute lung injury: Monitor patients for pulmonary adverse reactions.
• Transmissible infectious agents: QIVIGY is made from human plasma and may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
• Interference with laboratory tests: After infusion of Ig, transitory rise of passively transferred antibodies may yield positive serological results, with potential for misleading interpretation.

ADVERSE REACTIONS

The most common adverse reactions occurring in ≥5% of patients treated were headache, fatigue, infusion-related reaction, Coombs direct test positive, nausea, sinusitis, dizziness, and diarrhea.

For more information about QIVIGY, please see the full prescribing information.

Contacts

AOM Media Contact
Kyra Barker

CONNECTIVE Agency

kb@connectiveagency.com

TIXiMED Announces Expansion of Program-Related Investment from the Helmsley Charitable Trust




TIXiMED Announces Expansion of Program-Related Investment from the Helmsley Charitable Trust

Expanded Charitable Funding will Support Phase 1 Multiple Ascending Dose Trial and Long-Term Toxicology Studies for TIX100, a Novel Oral Therapy Targeting Beta Cell Health in Type 1 Diabetes

BIRMINGHAM, Ala.–(BUSINESS WIRE)–TIXiMED, Inc., a clinical-stage pharmaceutical company developing innovative therapies for diabetes based on the breakthrough discovery of the role of TXNIP in disease progression, today announced the expansion of a program-related investment (PRI) made by The Leona M. and Harry B. Helmsley Charitable Trust in furtherance of their charitable purpose. The expanded PRI, in the form of a loan, provides TIXiMED with an additional $2.2 million to support the company’s multiple ascending dose (MAD) Phase 1b clinical trial and long-term toxicology studies for TIX100, its investigational oral therapy designed to promote beta cell survival and function in individuals with Type 1 Diabetes (T1D).

The Helmsley Charitable Trust’s original $2.65 million PRI, in December 2024, enabled TIXiMED to successfully complete its Phase 1a single ascending dose (SAD) study, which demonstrated that TIX100 was safe and well-tolerated in healthy subjects, while also providing an early, promising metabolic signal. The additional $2.2M in PRI funds announced today will enable a Phase 1b MAD clinical trial and long-term toxicology studies, thereby advancing the research closer to Phase 2 trials of TIX100 in patients with T1D. TIX100 targets thioredoxin-interacting protein (TXNIP), a key driver of beta cell dysfunction and death, promising a disease-modifying approach beyond traditional insulin management.

“We are deeply appreciative of the ongoing interest and support from the Helmsley Charitable Trust as we advance our TIX100 program,” said Stephen Daly, Chief Executive Officer of TIXiMED. “This additional funding, bringing Helmsley’s total commitment to $4.85 million, allows us to conduct the MAD trial and to complete the necessary long-term toxicology studies. These critical steps will position the program for future clinical evaluation in people facing type 1 diabetes, bringing us closer to delivering a transformative oral therapy that addresses an underlying cause of beta cell loss.”

Dr. Ben Williams, Program Officer for the Type 1 Diabetes Program at the Helmsley Charitable Trust, added, “TIXiMED continues to make progress developing TIX100 as a potential first-in-class disease-modifying therapy for T1D. Our support of TIXiMED with TIX100 aligns with our mission to support innovative approaches that could meaningfully improve lives for people with T1D.”

Dr. Anath Shalev, Founder and Chief Scientific Officer of TIXiMED, added, “This continued support from the Helmsley Charitable Trust allows us to advance TIX100 as a potential first-in-class, oral, disease-modifying therapy for type 1 diabetes. Building on the positive safety and early metabolic signals from our SAD study, advancing to the MAD phase and long-term toxicology will bring us one step closer to meaningful impact for patients.”

About TIXiMED, Inc.

TIXiMED is a clinical stage pharmaceutical company dedicated to developing and commercializing a first-of-its kind oral therapy for type 1 diabetes based on TXNIP inhibition. TIXiMED is the exclusive license holder for the patent surrounding TIX100, a novel, small molecule TXNIP inhibitor, and its derivatives, that has been shown to protect against models of type 1 and type 2 diabetes as well as metabolic dysfunction–associated steatotic liver disease. Visit www.tiximed.com for more information.

Contacts

Stephen Daly

Chief Executive Officer

steve@tiximed.com

Aptar Pharma and COVIRIX Medical Partner to Develop Inhalable Antiviral Treatments




Aptar Pharma and COVIRIX Medical Partner to Develop Inhalable Antiviral Treatments

CRYSTAL LAKE, Ill.–(BUSINESS WIRE)–Aptar Pharma, a global leader in drug delivery, dosing, protection technologies and services, today announced a technical collaboration with COVIRIX Medical Pty Ltd (“COVIRIX Medical”), an Australian biopharma company under a Letter of Intent.

The collaboration will focus on a feasibility study to adapt Aptar Pharma’s proprietary dry powder inhalation (DPI) platform for the delivery of COVIRIX Medical’s antiviral compound. If successful, the project intends to explore development of an integrated finished product for potential use against several pandemic‑potential respiratory viruses including – but not limited to – Covid-19, seasonal influenza, avian influenza and RSV.

COVIRIX Medical reports that its antiviral portfolio has demonstrated positive virology results against key pandemic‑potential viruses. The company is advancing its patented broad‑spectrum antiviral compounds toward inhaled delivery to directly target the respiratory tract, aiming for high local efficacy while minimizing systemic side effects.

“Covirix’s portfolio of antivirals addresses several global challenges, and Aptar Pharma is proud to actively support and accelerate the development of a product that has the potential to help patients worldwide,” said Jonathan Mulpas, Aptar Pharma’s Director of Business Development, Pulmonary Category. “Our specialized services were created precisely for this purpose – to guide customers through complex regulatory pathways and advance their programs efficiently, backed by more than three decades of deep experience in respiratory drug delivery.”

Dr. Kumud Dhital, Director and CEO of COVIRIX Medical, added, “This collaboration provides access to critical delivery technology and commercial relationships. It accelerates our path to market for a much-needed antiviral solution, creating a win-win for both companies and global public health.”

Aptar Pharma’s advanced Dry Powder Inhaler (DPI) technology, Orbital™, is a novel, easy to use device that delivers high payload powder drug formulations directly to the lungs. A single use or reusable, adaptable, hand-held dry powder inhaler, Orbital provides many advantages over powder capsule drug delivery methods for a growing range of molecules.

This collaboration will also leverage Aptar Pharma’s range of services, including formulation development via Nanopharm, an Aptar Pharma company, to facilitate and accelerate the development of the finished drug product.

The collaboration described above is focused on feasibility work and does not guarantee the development or commercialization of any product.

About Aptar Pharma

Aptar Pharma is part of AptarGroup, Inc. a global leader in drug delivery, dosing and protection technologies, and consumer product dispensing. Aptar partners with the world’s top healthcare and consumer brands to deliver medicines and create exceptional user experiences. Serving diverse markets, from pharmaceutical to beauty to food and beverage, Aptar combines market expertise with proprietary design, engineering and science to develop innovative solutions that help improve lives worldwide. Headquartered in Crystal Lake, Illinois, Aptar employs 14,000 dedicated people across 20 countries. Learn more at http://www.aptar.com.

About COVIRIX Medical

COVIRIX Medical is an Australian biotechnology company focused on repurposing and developing antiviral therapeutics for pandemic and epidemic respiratory diseases. For further information, visit www.covirix.com.

Contacts

Media Contacts:

Ciara Jackson

Aptar Pharma

ciara.jackson@aptar.com

Richard Li

COVIRIX Medical

richard@covirix.com

Compass Pathways to Present at Stifel 2026 Virtual CNS Forum on March 18, 2026




Compass Pathways to Present at Stifel 2026 Virtual CNS Forum on March 18, 2026

LONDON & NEW YORK–(BUSINESS WIRE)–$CMPS #Biotech–Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will attend the Stifel 2026 Virtual CNS Forum, from March 17-18, 2026, and will participate in a fireside chat on March 18, 2026, at 10:30am ET.

A live audio webcast of this event will be accessible from the “Events” page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event.

About Compass Pathways

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).

Compass is headquartered in London, UK, with offices in New York in the US. We envision a world where mental health means not just the absence of illness but the ability to thrive.

Contacts

Enquiries
Media: Dana Sultan-Rothman, media@compasspathways.com
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

Personalis Announces New Publication Advancing Neoadjuvant Treatment Monitoring in Breast Cancer with NeXT Personal®




Personalis Announces New Publication Advancing Neoadjuvant Treatment Monitoring in Breast Cancer with NeXT Personal®

FREMONT, Calif.–(BUSINESS WIRE)–Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced the publication of the PREDICT-DNA study in the Journal of Clinical Oncology. The article, “The Pathologic Response Evaluation and Detection In Circulating Tumor-DNA (PREDICT-DNA) study: Ultrasensitive ctDNA Assessment of Breast Cancer Minimal Residual Disease,” showed that ultrasensitive molecular residual disease (MRD) testing with NeXT Personal can perform better than current standard approaches in predicting patient outcomes following neoadjuvant therapy (NAT).

The prospective study followed 227 patients with Triple-Negative (TNBC) and HER2+ breast cancer across more than 24 leading US cancer centers. The results demonstrate the ability of NeXT Personal to provide a more precise risk-stratification for patients who have received NAT.

A key finding of the study was the necessity of the ultrasensitive range for accurately tracking patient response to neoadjuvant therapy. Of note, 55% of all ctDNA detections following NAT occurred at levels below 100 parts per million, detections that could be missed with less sensitive tests.

“Many breast cancer patients receive neoadjuvant therapy as standard of care, prior to surgery. The results of this study suggest that an ultrasensitive ctDNA assay like NeXT Personal could help patients better understand their response to neoadjuvant therapy, with the potential to help inform the need for additional therapy,” said Richard Chen, MD, Chief Medical Officer and Executive Vice President, R&D at Personalis. “The publication of this data is important as we look to expand reimbursement and improve the tools used in neoadjuvant monitoring.”

Key study highlights include:

• High Prognostic Power: Detectable ctDNA post-NAT was associated with a 4 to 9 times higher likelihood of relapse.
• Superior to Traditional Metrics: In multivariate analyses, ctDNA status was the most significant independent prognostic signal, performing better than nodal status, tumor grade, and pathologic complete response (pCR) status. In addition, ctDNA detection post-NAT was a stronger predictor of recurrence than pCR status.
• Identification of Low Risk: Patients who were ctDNA-negative post-NAT showed excellent outcomes, regardless of pCR status.
• Post-Surgical Relapse Prediction: Patients with detectable ctDNA up to 12 months post-surgery were more than 100 times more likely to experience disease recurrence.

“We partnered with Personalis because their technology offers a level of sensitivity down to 1 to 3 parts per million that allows for a higher cancer detection rate,” said Dr. Ben Park, MD, PhD, Director of the Vanderbilt-Ingram Cancer Center. “The PREDICT-DNA results show that if a patient clears their ctDNA, their outcomes are excellent even if residual disease is found at surgery. Conversely, detectable ctDNA signals a very high risk. These insights allow us to more precisely risk-stratify breast cancer patients in future trials and clinical practice.”

The findings reinforce the NeXT Personal test’s ability to detect ctDNA at ultrasensitive levels, providing a window for earlier clinical intervention that other approaches may miss. The NeXT Personal test achieves ultrasensitive detection of small traces of ctDNA from a patient’s blood sample using a personalized approach that tracks up to ~1,800 tumor-specific variants unique to each patient’s tumor.

About Personalis, Inc.

At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and X (Twitter).

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts, including statements relating to the attributes, advantages, sensitivity, and clinical relevance (including prognostic power, risk-stratification capabilities and superiority to traditional metrics) of the NeXT Personal test and the potential impact or expected benefits of the PREDICT-DNA study. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to Personalis’ ability to demonstrate attributes, advantages or clinical validity or utility of the NeXT Personal test, including the NeXT Personal MRD assay remaining unique in its ability to detect traces of cancer in the ultrasensitive range; future clinical data differing from the clinical data previously presented or expected results; the ability of Personalis to expand reimbursement for, or the rate of adoption and use of, the NeXT Personal test; changes in health care policy, which could increase Personalis’ costs, decrease Personalis’ revenue, and impact sales of and reimbursement for Personalis’ tests; the impact of competition and macroeconomic factors on Personalis’ business; the partnering and/or collaboration arrangements that Personalis has entered into or may enter into in the future, which may not be successful, or may terminate, which could adversely impact Personalis’ business or affect its ability to develop and commercialize its services and products; having a limited number of suppliers; and customer concentration. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Personalis’ Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (SEC) on February 26, 2026. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.

Contacts

Investor Relations:
Caroline Corner

investors@personalis.com
415-202-5678

Media Contact:
Patrick Schmidt

pr@personalis.com
630-290-2787

Combat Medical Raises £2.6 Million Series A to Advance Treatment of BCG Unresponsive Bladder Cancer




Combat Medical Raises £2.6 Million Series A to Advance Treatment of BCG Unresponsive Bladder Cancer

• Investment led by T&J Meyer Family Foundation, joined by Varia Ventures, NW Angel Fund and other non-institutional investors
• Financing advances Combat’s HIVEC^® HEAT FDA registration trial to change standard of care in BCG unresponsive NMIBC
• Future financings to progress patented hyperthermic technology aimed at improving chemotherapy therapeutic efficacy, tolerability and treatment outcomes for advanced bladder and peritoneal cancers

LONDON–(BUSINESS WIRE)–Combat Medical (Combat), a medical device company optimising the delivery and efficacy of cancer therapeutics, today announced it has raised £2.6 million in the first close of a Series A financing to advance its hyperthermic intravesical chemotherapy treatment, HIVEC^®, through phase 3 clinical trials and toward FDA registration. The round was led by T&J Meyer Family Foundation, and included investment from Varia Ventures, NW Angel Fund and non-institutional family offices and individuals.

The funding will be used to further fund the ongoing pivotal FDA registration trial, HIVEC HEAT, to investigate the effectiveness of the Company’s HIVEC treatment of BCG unresponsive non-muscle-invasive bladder cancer (NMIBC). The primary objective is to generate phase 3 clinical data to evidence Combat’s patented HIVEC treatment as an effective, safe and tolerable alternative to the current standard of care, which is radical cystectomy.

Combat will use future financings to complete FDA registration, growing operations to scale, expanding its existing clinical programmes for advanced bladder cancer (HIVEC) and peritoneal cancer (HIPEC), with a focus on US market entry.

Edward Bruce-White, Chief Executive Officer of Combat Medical, commented: “Our installed base of over 350 systems and the completion of over 100,000 HIVEC treatments to date demonstrates efficacy and use as a safe and well-tolerated, bladder-sparing alternative to radical cystectomy in BCG-unresponsive, high-risk NMIBC. Setting a new standard for patient care, it also provides clinicians and payers with advanced, affordable options that can easily be built into current treatment pathways. We are proud to have our investors on board as we progress through to FDA approval.”

Balint Nemeth, T&J Meyer Family Foundation, added: “Combat Medical is leading the development and clinical use of device assisted therapies with potential to disrupt current treatment standards. With systems in wide clinical use and already impacting patient outcomes, we are excited to support the company as HIVEC progresses through clinical trials.”

Contacts

Media contacts:
Sarah Jeffery

Zyme Communications

Tel: +44 (0) 7771 730919

Email: sarah.jeffery@zymecommunications.com

Innoviva Specialty Therapeutics Earns Strong Performance Rating in Access to Medicine Foundation’s 2026 Antimicrobial Resistance Benchmark Report




Innoviva Specialty Therapeutics Earns Strong Performance Rating in Access to Medicine Foundation’s 2026 Antimicrobial Resistance Benchmark Report

Report Highlights the Company’s Collaboration with GARDP to Develop NUZOLVENCE^® (zoliflodacin) for Oral Suspension for the Treatment of Uncomplicated Urogenital Gonorrhea in Adults and Pediatric Patients

WALTHAM, Mass.–(BUSINESS WIRE)–Innoviva Specialty Therapeutics, a subsidiary of Innoviva Inc., today announced that its infectious disease therapeutic portfolio earned a strong performance rating of 80% in the 2026 Antimicrobial Resistance (AMR) Benchmark Report published by the Access to Medicine Foundation. The score represents the highest rating in the small- and medium-sized enterprise (SME) category, achieved by only one other company in this year’s report. The AMR Benchmark evaluates pharmaceutical companies’ efforts to combat antimicrobial resistance and expand global access to effective treatments.

“We are honored to be recognized in this important global assessment of the antibiotic treatment landscape, particularly at a time when there is a growing need for new therapies as antibiotic resistance continues to rise across many regions, challenging our ability to treat life-threatening infections effectively,” said David Altarac, M.D., Chief Medical Officer of Innoviva Specialty Therapeutics. “Addressing this urgent public health crisis is central to our mission, and we remain committed to developing innovative therapies that target high-priority and difficult-to-treat pathogens.”

The Foundation’s recognition highlights Innoviva Specialty Therapeutics’ commitment to advancing therapies for serious and life-threatening infections, including those caused by priority pathogens, classified by the World Health Organization (WHO), as well as for its innovation and best practices in research and development. The report cites the Company’s recently U.S. FDA-approved first-in-class single-dose oral therapy, NUZOLVENCE^® (zoliflodacin) for oral suspension in adults and adolescents, which treats susceptible strains of Neisseria gonorrhoeae, including those resistant to cephalosporins, and meets three of four WHO innovation criteria. The report notes that the Company’s work in this area demonstrates Best Practice for its innovative candidate and stands out for its integration of access and stewardship considerations within its development plan, which was created in partnership with the Global Antibiotics Research and Development Partnership (GARDP).

Innoviva was evaluated in the SME category based on its performance in the R&D Technical Area. This assessment examines the strength and innovation of the Company’s pipeline, including alignment with WHO criteria, demonstrated clinical value, and relevance to critical gaps in the global antimicrobial R&D landscape. It also considers whether late-stage (Phase II/III) projects are supported by comprehensive access and stewardship plans.

The 2026 AMR Benchmark report will be formally presented at a high-level launch event in London, underscoring the growing global urgency to combat antimicrobial resistance and accelerate coordinated action across governments, industry, and healthcare systems. Co-hosted by the Access to Medicine Foundation and the Fleming Initiative, the event will convene approximately 100 global health leaders for a focused discussion on recent progress, persistent challenges, and practical steps to accelerate industry action against drug resistance.

Since its establishment in 2023, Innoviva Specialty Therapeutics has built a comprehensive portfolio of hospital-focused therapies addressing urgent, challenging, and unmet medical needs. The portfolio includes a novel vasopressor for patients with septic or other distributive shock, as well as four FDA-approved antimicrobial agents, including NUZOLVENCE^® (zoliflodacin) for oral suspension. The Company remains focused on expanding its infectious disease portfolio and collaborating with global partners to help address one of the most pressing public health challenges of our time.

About NUZOLVENCE^® (zoliflodacin) for oral suspension

NUZOLVENCE is a first-in-class, single-dose, oral antibiotic FDA-approved for the treatment of uncomplicated urogenital gonorrhea, including strains resistant to current first-line therapies.

NUZOLVENCE is a spiropyrimidinetrione bacterial type II topoisomerase inhibitor indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg. The NUZOLVENCE mechanism of action is distinct from that of currently approved antibiotics and has demonstrated activity against drug-resistant Neisseria gonorrhoeae.

Important Safety Information (ISI)

Indication and Usage

Indication

NUZOLVENCE^® is a spiropyrimidinetrione bacterial type II topoisomerase inhibitor indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg.

Usage to Reduce Development of Drug-Resistant Bacteria: To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZOLVENCE and other antibacterial drugs, NUZOLVENCE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Contraindications

• Known history of hypersensitivity to NUZOLVENCE.
• Concomitant use with moderate or strong CYP3A4 inducers because this is predicted to result in decreased plasma concentrations of zoliflodacin and may reduce the NUZOLVENCE efficacy.

Warnings and Precautions

• Embryo-Fetal Toxicity: Potential Risk for Pregnant Females
  • Based on data from animal studies, NUZOLVENCE may cause fetal harm when administered to a pregnant female at clinically relevant doses. Avoid use during pregnancy. Advise pregnant females about the potential risk to the fetus with maternal exposure to NUZOLVENCE. Obtain a pregnancy test prior to initiation in persons of reproductive potential.
• Embryo-Fetal Toxicity: Potential Risk Related to Males with Female Partners of Reproductive Potential:
  • Based on data from an animal toxicity study, the risk of early pregnancy loss may be increased in female partners of males treated with NUZOLVENCE. Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after NUZOLVENCE administration.
• Testicular Toxicity and Risks to Male Fertility:
  • Based on findings from animal studies, NUZOLVENCE may cause testicular toxicity and impair male fertility. An assessment of spermatogenesis has not been conducted in humans. Advise males that NUZOLVENCE may cause testicular toxicity and impair male fertility.
• Hypersensitivity Reactions:
  • Hypersensitivity reactions, including rash and pruritus, have been reported in patients receiving NUZOLVENCE. Before therapy with NUZOLVENCE is instituted, carefully inquire about previous hypersensitivity reactions to NUZOLVENCE. If an allergic reaction to NUZOLVENCE occurs, discontinue NUZOLVENCE and institute appropriate supportive measures.
• Clostridioides difficile Infection (CDI):
  • CDI has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
• Development of Drug-Resistant Bacteria:
  • Prescribing NUZOLVENCE in the absence of a proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions

The most common adverse reactions (≥2%) are headache, dizziness, nausea, and diarrhea. Laboratory abnormalities (neutropenia, leukopenia) were also observed.

Drug Interactions

Concomitant use with moderate or strong CYP3A4 inducers is contraindicated.

Use in Specific Populations

• Pregnancy: Based on findings from animal studies, NUZOLVENCE may cause fetal malformations or increased embryo-fetal loss when administered to a pregnant female. A postmarketing descriptive pregnancy safety study is available for NUZOLVENCE. If exposure occurs during pregnancy, pregnant females or their healthcare providers should report the pregnancy to Entasis Therapeutics at 1-800-651-3861.
• Lactation: There are no data on the presence of zoliflodacin in either human or animal milk, effects on the breastfed infant, or effects on milk production. If NUZOLVENCE is present in breast milk, intestinal flora alteration in the breastfed infant could occur.
• Females and Males of Reproductive Potential: Based on animal studies, NUZOLVENCE may cause fetal malformations when administered to a pregnant female at clinically relevant doses. Additionally, based on data from an animal study, the risk of early pregnancy loss may be increased in partners of males treated with NUZOLVENCE.
  • Pregnancy Testing: Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with NUZOLVENCE.
  • Contraception: Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after their single-dose treatment of NUZOLVENCE.
  • Infertility: Based on data from repeat-dose animal toxicity and fertility studies, NUZOLVENCE may cause testicular toxicity and impair male fertility.
• Pediatric Use: The safety and effectiveness of NUZOLVENCE in pediatric patients younger than 12 years of age or weighing less than 35 kg have not been established.
• Geriatric Use: Clinical studies of NUZOLVENCE did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.

Reporting Adverse Events

You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact:

Innoviva Specialty Therapeutics™

1-800-651-3861

medinfo@istx.com

U.S. Food and Drug Administration

1-800-FDA-1088

www.fda.gov/medwatch

Before administering, please see the Full Prescribing Information for NUZOLVENCE.

About Innoviva Specialty Therapeutics

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics’ products, through its affiliate, La Jolla Pharmaceutical Company, include GIAPREZA^® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock, and XERAVA^® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva Specialty Therapeutics’ products, through its affiliate, Entasis Therapeutics Inc., include XACDURO^® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter), and NUZOLVENCE^® (zoliflodacin), a first-in-class, single-dose, oral antibiotic FDA-approved for the treatment of uncomplicated urogenital gonorrhea, including strains resistant to current first-line therapies. Through a licensing agreement with Basilea Pharmaceutica, Ltd., Innoviva Specialty Therapeutics retains U.S. marketing rights for ZEVTERA^® (ceftobiprole), the only FDA-approved cephalosporin specifically designed to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI), adult patients with Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). For more information about Innoviva Specialty Therapeutics, please visit here.

Forward Looking Statements

This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR^®/BREO^® ELLIPTA^®, ANORO^® ELLIPTA^®, GIAPREZA^®, NUZOLVENCE^®, XERAVA^®, XACDURO^® and ZEVTERA, the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus (“COVID-19”); the timing, manner and amount of capital deployment, including potential capital returns to stockholders; and risks related to the Company’s growth strategy. Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at www.sec.gov. Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

Contacts

Media Contact:
David Patti

Corporate Communications

Innoviva Specialty Therapeutics

David.patti@inva.com

Investor Relations Contact:
Eleanor Barisser

Director of Investor Relations and Corporate Communications

Innoviva, Inc.

Eleanor.barisser@inva.com