Thyroid Gland Disorders Diagnostics and Treatment Market Analysis Report 2025 | Revenue Data from 2022 to 2024, Estimates for 2025, and Projected CAGRs Through 2030 – ResearchAndMarkets.com




Thyroid Gland Disorders Diagnostics and Treatment Market Analysis Report 2025 | Revenue Data from 2022 to 2024, Estimates for 2025, and Projected CAGRs Through 2030 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Thyroid Gland Disorders: Diagnostics and Treatment Market” report has been added to ResearchAndMarkets.com’s offering.

The global market for diagnostics and treatment of thyroid gland disorders was valued at $15.5 billion in 2024 and is estimated to increase from $16.3 billion in 2025 to reach $21.0 billion by 2030, at a compound annual growth rate (CAGR) of 5.2% from 2025 through 2030.

The report analyzes trends in the global market for diagnostics and treatment of thyroid gland disorders. The report includes global revenue ($ million) for the base year 2024, estimated data for 2025, and for the forecast period of 2026 through 2030. The regions covered are North America, Europe, Asia-Pacific, and the Rest of the World (RoW. North American consists of the U.S., Canada, and Mexico. Europe includes Germany, the U.K., Italy, France, Spain and the Rest of Europe. Asia-Pacific includes China, Japan, India, South Korea and the Rest of Asia-Pacific.

This report focuses on trends and challenges that affect the market, including emerging technologies. It includes an analysis of the competitive landscape, with the rankings and market shares of the leading companies in the global market. The report has a chapter on environmental, social, and corporate governance (ESG) developments and includes company profiles that covers key financials, product portfolios and recent news.

The pharmaceutical industry is increasingly focusing on targeted and personalized therapies. There is a shift from traditional synthetic drugs to therapeutic biologic medicines, which are more efficacious, have better patient outcomes, and improve quality of life. Diagnostics include blood tests (TSH, T3, T4), imaging (ultrasound, CT, MRI), and molecular testing for early detection. Treatments include hormone replacement therapy (levothyroxine), anti-thyroid drugs, radioactive iodine therapy, targeted biologics, and minimally invasive surgeries.

Current Market Scenario

Hypothyroidism, hyperthyroidism, thyroid cancer, and autoimmune thyroid diseases affect millions of people globally, with aging populations, lifestyle factors, and iodine deficiency driving their incidence. In North America, the incidence of hypothyroidism and thyroid cancer cases is rising, while in Asia-Pacific, especially India, faces increasing congenital hypothyroidism.

Thyroid cancer is also on the rise, particularly among women in the U.S. and parts of Asia and South America. Thyroid cancer has become the fastest-growing cancer among women over the past three decades. However, disparities in thyroid disease care remain a challenge, influenced by societal and structural factors that impact access to

diagnosis and treatment.

Segmental Analysis

Hypothyroidism accounts for more than half of the market, followed by hyperthyroidism and thyroid cancer and conditions such as thyroid nodules, goiter, thyroiditis, and rare genetic disorders. The demand for synthetic levothyroxine in treating hypothyroidism, for Tepezza to treat thyroid eye disease (TED), and advanced technologies in thyroid surgery are driving the market.

By disease, hypothyroidism accounted for 51.8% of the market in 2024 due to the increasing prevalence of Hashimoto’s thyroiditis and congenital hypothyroidism. By type, treatment accounted for 63.5% of the market in 2024. By region, North America held the highest share (42.4%) in 2024 due to the presence of many leading companies and increased healthcare expenditures.

Report Includes

• 97 data tables and 62 additional tables
• An overview of the current and future global markets for thyroid gland disorder
• An analysis of the global market trends with market revenue data from 2022 to 2024, estimates for 2025, and projected CAGRs through 2030
• Estimates of the size and revenue prospects of the global market, along with a market share analysis by type, disease type, end-user industry, and region
• Facts and figures pertaining to market dynamics, technological advances, regulations, and the impact of macroeconomic factors
• Analysis of market opportunities from a Porter’s Five Forces perspective, and a value chain analysis considering the prevailing micro- and macro environmental factors
• Coverage of advances in thyroid cancer diagnosis such as genomic tests and treatments, as well as the side effects of current treatments such as radioactive iodine
• Evaluation of ESG practices in the industry, consumer attitudes towards sustainability, risks and opportunity assessment, ratings and matrices
• A patent analysis with emphasis on emerging technologies and new developments in the market
• Analysis of the industry structure, including companies’ market shares and rankings, strategic alliances, M&A activity and a venture funding outlook
• Company profiles of major players within the industry, including Amgen Inc., F. Hoffmann-La Roche Ltd., Merck KGaA, Bristol-Myers Squibb Co., and Pfizer Inc.

Key Attributes:

Key Topics Covered:

Chapter 1 Executive Summary

• Market Outlook
• Scope of Report
• Market Summary

Chapter 2 Market Overview

• Overview
• Conventional and Novel Technologies
• Diagnostics in Thyroid Gland Disorders
• Treatment of Thyroid Gland Disorders
• Porter’s Five Forces Analysis
• Potential for New Entrants (Moderate)
• Bargaining Power of Suppliers (Moderate to High)
• Bargaining Power of Buyers (Moderate to High)
• Threat of Substitutes (Low to Moderate)
• Industry Competitiveness (High)
• Macroeconomic Factors
• Aging Population
• Regulatory Environment
• Growing Incidence of Cancer
• Government Policy and Collaboration

Chapter 3 Market Dynamics

• Market Drivers
• Growing Prevalence of Thyroid Cancer
• Growing Prevalence of Thyroid Disorders
• Rising Awareness and Policy Initiatives for Thyroid Disorders
• Managing Thyroid Disorders through Personalized Medicine
• Market Restraints
• Side Effects of Treatment
• Limited Access in Low-Income Regions
• Market Opportunities
• Incorporation of AI
• Advanced Therapeutics
• Market Challenges
• Healthcare Disparities and Funding Challenges
• Requirement for Lifelong Medication

Chapter 4 Regulatory Landscape

• U.S. Approval Process
• EU Approval Process
• Asia-Pacific Approval Process
• Drug Approval and Regulations
• Levothyroxine-Based Treatments
• Anti-Thyroid Medications
• Biologic and Biosimilar Regulations
• Medical Devices and Diagnostics Regulations
• Point-of-Care and Laboratory Tests
• Wearable and Digital Health Solutions
• Future Trends and Regulatory Changes

Chapter 5 Emerging Technologies and Developments

• Overview
• Emerging Technologies in Thyroid Disorder Diagnostics
• Hybrid Feature Selection and Deep Learning Framework
• Autofluorescence Technology for Thyroid and Parathyroid Surgery
• Regenerative Medicine and Bioengineering
• Biowearable Technology
• Mobile Apps
• Recent Approvals and Launches of Drug and Device Products
• Patent Analysis
• Findings

Chapter 6 Market Segmentation Analysis

• Segmentation Breakdown
• Key Takeaways
• Market Analysis by Disease Type
• Hypothyroidism
• Hyperthyroidism
• Thyroid Cancer
• Other Diseases
• Market Analysis by Type
• Takeaways
• Diagnostics
• Treatment
• Market Analysis by End User
• Takeaways
• Treatment in Hospitals and Specialty Clinics
• Retail and Online Pharmacies
• Research and Academic Institutes
• Home Care Settings
• Geographic Breakdown
• Market Analysis by Region
• Takeaways
• North America
• Europe
• Asia-Pacific
• South America
• Middle East and Africa

Chapter 7 Competitive Intelligence

• Takeaways
• Market Shares of Leading Companies
• Developments and Strategies
• Agreements, Collaborations and Partnerships
• Acquisitions

Chapter 8 Sustainability in the Diagnostics and Treatment of Thyroid Gland Disorders Industry: ESG Perspective

• Introduction to ESG
• Initiatives by Leading Companies
• ESG Risk Ratings
• Research Viewpoint

Chapter 9 Appendix

Companies Featured

• Abbott
• Abbvie Inc.
• Amgen Inc.
• Astrazeneca
• Bristol-Myers Squibb Co.
• F. Hoffmann-La Roche Ltd.
• Fresenius Se & Co. Kgaa
• Gsk Plc.
• Lilly
• Merck Kgaa
• Novartis Ag
• Pfizer Inc.
• Sanofi
• Siemens Healthineers Ag
• Terumo Corp.

For more information about this report visit https://www.researchandmarkets.com/r/86598m

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ImmunityBio, Inc. Announces Execution of $80 Million Equity Financing from Multiple Institutional Investors




ImmunityBio, Inc. Announces Execution of $80 Million Equity Financing from Multiple Institutional Investors

CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced that it has executed financing to provide further working capital and support its ongoing business operations. The Company entered into a securities purchase agreement for a registered direct offering with two institutional investors, providing for the issuance of common stock of ImmunityBio as well as warrants for the purchase of additional shares of common stock of ImmunityBio that is expected to result in gross proceeds at closing of approximately $80 million before deducting placement agent fees and other offering-related expenses, subject to customary closing conditions. If fully exercised, the warrants could result in additional gross proceeds of up to approximately $96 million.

Piper Sandler & Co. is acting as the exclusive placement agent for the registered direct offering.

The securities to be sold by the Company are offered under its automatic shelf registration statement on Form S-3 (Registration No. 333-278770). A final prospectus supplement, which contains additional information relating to the offering, will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement may be obtained for free by contacting Piper Sandler & Co., 350 North 5th Street, Suite 1300, Minneapolis, MN 55402, Attention: Prospectus Department, or by telephone at (800) 747-3924, or by email at prospectus@psc.com.

Before investing in this offering, interested parties should read the prospectus supplement, the accompanying prospectus and the other documents that are incorporated by reference in such prospectus supplement and the accompanying prospectus in their entirety.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About ImmunityBio, Inc.

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 natural killer 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 Private Securities Litigation Reform Act of 1995, such as statements regarding the timing and size of the proposed offering, the potential exercise of the warrants being offered and resulting additional proceeds to the Company, the anticipated closing of the equity financing described herein and use of proceeds to be received from such financing, the application of the Company’s science and platforms to treat cancers or develop cancer vaccines, immunotherapies and cell therapies that reduce or eliminate the need for standard high-dose chemotherapy. 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,” “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) whether the equity financing transaction described herein will close on the timeline anticipated, if at all, (ii) those related to the regulatory submission, filing and review process and the timing thereof, (iii) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (iv) whether clinical trials will result in registrational pathways, (v) whether clinical trial data will be accepted by regulatory agencies, (vi) 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, (vii) potential delays in product availability, regulatory approvals, and reimbursement decisions, (viii) ImmunityBio’s ability to retain and hire key personnel, (ix) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (x) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xi) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xii) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xiii) ImmunityBio’s ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies. 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 May 12, 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
+1 415-290-8045

Sarah.Singleton@ImmunityBio.com

ImmunityBio Reports 60% Increase in Revenue in Q2 2025, with Year-to-Date Sales of $43 Million and 246% Unit Growth Since J-Code with Regulatory Updates




ImmunityBio Reports 60% Increase in Revenue in Q2 2025, with Year-to-Date Sales of $43 Million and 246% Unit Growth Since J-Code with Regulatory Updates

CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced preliminary financial results for the fiscal quarter ended June 30, 2025, and clinical progress across its pipeline.

Key Highlights

• Q2 2025 Revenue Growth with Continued Strong Sales Momentum: $26.4 million, up 60% from Q1 2025, with year-to-date sales of ~$43 million.
• ANKTIVA^® Unit Growth Since J-Code: 246% unit sales volume growth in 1H 2025 compared to 2H 2024.
• Cash Position: $153.7 million in cash, cash equivalents and marketable securities as of June 30, 2025.
• NSCLC: Initiated randomized clinical trial (RCT) ResQ201A with N-803 + tislelizumab in 2^nd line lung cancer; US sites initiated, submitted clinical trial applications in EU, UK; Canada and Asia filings planned.
• Lymphopenia: FDA supportive of new data; reaffirmed RMAT/EAP; collaborative discussion outlining regulatory endpoints, trial design and registrational pathways to full approval for the treatment of lymphopenia with randomized trial design in progress.
• Full Enrollment Reached in the Randomized NCI Cancer Prevention Clinical Trial Using ANKTIVA + Adenovirus Vaccine in 186 Patients with Lynch Syndrome.
• United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) marketing authorization application of ANKTIVA approved.
• Papillary NMIBC: Discussion with FDA regarding filing status of supplemental BLA. ImmunityBio performing ongoing evaluation of next steps to address the Refuse to File decision by the FDA, following June Type A meeting with the Agency. New updated data on Papillary disease provided to the FDA and discussions with Agency to continue. Separately, ImmunityBio has applied to the National Comprehensive Cancer Network (NCCN) to seek expansion of the BCG-unresponsive NMIBC guidelines to include papillary-only disease.

Financial Overview

In the second quarter of 2025, ImmunityBio reported $26.4 million in revenue, representing a 60% increase from $16.5 million in the first quarter of 2025. This growth reflects continued commercial traction of ANKTIVA + BCG in BCG-unresponsive non-muscle invasive bladder cancer with CIS with or without Papillary tumors. The 1H 2025 sales of $42.9 million represents a 246% increase in unit volume during the first two quarters of 2025 since the J-code approval versus the last two quarters of 2024. The Company ended the quarter with $153.7 million in cash, cash equivalents and marketable securities as of June 30, 2025.

Non-Muscle Invasive Bladder Cancer (Papillary NMIBC)

ImmunityBio conducted a Type A meeting with the FDA in June to discuss its program targeting papillary-only NMIBC and the Agency’s response to the supplemental BLA filing. Contrary to the advice the FDA gave the Company in January 2025 to submit the supplemental BLA, the FDA responded with a Refuse-to-File (RTF) notice in May on the basis of requiring a randomized controlled trial (RCT) against chemotherapy. At the June meeting, ImmunityBio provided new data regarding the updated results since the initial BLA filing of papillary only data as well as real-world data of chemotherapy just published in this indication. In the papillary only NMIBC new data based on 26 of the 100 subjects in Cohort A and 80 subjects in Cohort B (Papillary Alone) of our QUILT-3.032 trial, demonstrated long-term (36-month) progression free survival and bladder sparing with ANKTIVA + BCG. ImmunityBio presented the newly published real-world data which demonstrates that compared to chemotherapy, ANKTIVA + BCG led to improved outcomes of progression free survival and cystectomy avoidance at 36-months. To our knowledge, the results to date of ANKTIVA + BCG represent the longest duration of follow-up with the longest duration of bladder sparing in these subjects. The Company indicated at the meeting that it would seek a new meeting request with this new data and withdraw the prior supplemental BLA filing; however, the Company is re-evaluating this approach in consultation with its regulatory counsel and may seek to amend the initial filing with the new data rather than withdrawing it, with a commitment to initiate a randomized controlled trial of chemotherapy free ANKTIVA + BCG versus chemotherapy in the papillary alone indication.

Separately, ImmunityBio has applied to the National Comprehensive Cancer Network (NCCN) to seek expansion of the BCG-unresponsive NMIBC guidelines to include papillary-only disease, in addition to the currently recognized CIS with or without papillary disease. The NCCN is expected to review the submission at its August 2025 meeting.

Non-Small Cell Lung Cancer (NSCLC)

ImmunityBio has launched ResQ201A, a randomized controlled trial, in the United States, evaluating its IL-15 superagonist N-803 in combination with tislelizumab, a PD-1 checkpoint inhibitor from BeOne Medicines in patients with 2^nd line lung cancer who were progressing on checkpoint inhibitors. The Company has also submitted clinical trial applications for ResQ201A in the European Union and the United Kingdom, with Canada expected to be submitted in early Q3 2025, and with plans underway to submit in Asia.

Lymphopenia

The Company also met with the Division of Non-Malignant Hematology at the FDA in June to present updated data from its lymphopenia program. The Division was supportive of the findings including the underlying science of stimulating lymphocytes with ANKTIVA and expressed a desire to support an efficient path to approval, noting that additional time will be required to finalize the appropriate development plan. Expanded Access Program (EAP) authorization has been activated for the indication for all solid tumors in patients who have failed first-line treatment on chemotherapy, radiotherapy or immunotherapy and exhibit low Absolute Lymphocyte Counts (ALC < 1,000/μL).

Disclaimer Regarding Financial Overview

The information and amounts presented above, including under the caption “Financial Overview,” reflects the Company’s preliminary estimates based solely upon information available to it as of the date of this press release, and the amounts reported are not a comprehensive statement of its financial results or position as of June 30, 2025. Any actual amount that the Company reports in its Quarterly Report on Form 10-Q for the period ended June 30, 2025 will be subject to its financial closing procedures and any final adjustments that may be made prior to the time its financial results for the period ended June 30, 2025 are finalized. As a result, these preliminary estimates may differ materially from the actual results that will be reflected in the Company’s condensed consolidated financial statements for the quarter when they are completed and publicly disclosed.

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 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.

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. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.

ANKTIVA was approved by the FDA in 2024 and by UK MHRA in 2025 for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit Anktiva.com.

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 natural killer 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 Private Securities Litigation Reform Act of 1995, such as statements regarding discussions and meetings with the U.S. FDA, including with respect to the previously reported RTF letter received by the Company and potential implications thereof, potential next steps, decisions and timeline related to the Company’s regulatory submissions and strategy, financial results anticipated to be reported in future SEC filings, clinical trial data and potential results and implications to be drawn therefrom, the expectation that the EAP described herein will enable patients to have access to ANKTIVA for the indication described, the RMAT designation as previously reported and potential results therefrom and regulatory submissions in connection therewith, the belief that ALC levels and NLR levels obtained from a CBC are predictors of clinical benefit and outcomes relating to overall survival, clinical trial and expanded access program enrollment, timing, data and potential results to be drawn therefrom, anticipated components of ImmunityBio’s Cancer BioShield^TM platform, anticipated review timeline for the Company’s NCCN guidelines submission in NMIBC papillary only and potential implications 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, (ii) whether the RMAT designation will lead to an accelerated review or approval, of which there can be no assurance, (iii) risks and uncertainties regarding commercial launch execution, success and timing, (iv) risks and uncertainties regarding participation and enrollment and potential results from the expanded access clinical investigation program described herein, (v) whether clinical trials will result in registrational pathways and the risks, (vi) whether clinical trial data will be accepted by regulatory agencies, (vii) 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, (viii) potential delays in product availability and regulatory approvals, (ix) ImmunityBio’s ability to retain and hire key personnel, (x) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xi) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xii) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xiii) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, (xiv) whether the NCCN will review and/or approve the Company’s submission described herein on the anticipated timeline or at all, and (xv) ImmunityBio’s ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies. 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 May 12, 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.

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

Gilead Receives Positive CHMP Opinions Under Accelerated Review From European Medicines Agency for Twice-Yearly Lenacapavir for HIV Prevention




Gilead Receives Positive CHMP Opinions Under Accelerated Review From European Medicines Agency for Twice-Yearly Lenacapavir for HIV Prevention

– If Approved, Lenacapavir Would Be the First and Only Twice-Yearly HIV PrEP Option in the European Union –

– Positive Opinion Also Received for EMA’s EU-M4all Procedure, Designed to Facilitate Availability in Low- and Lower-Middle-Income Countries –

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion under accelerated review recommending lenacapavir—the company’s injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk. The final European Commission (EC) decision is expected later this year, and, if approved, lenacapavir will be marketed in the European Union (EU) under the trade name Yeytuo^®.

The marketing authorization application (MAA) recommendation will now be reviewed by the EC as it evaluates lenacapavir as a potential new preventative strategy against HIV in all 27 EU Member States, as well as Norway, Iceland and Liechtenstein. Additionally, if approved, lenacapavir will be granted one additional year of market exclusivity in the EU as a result of the new indication.

The CHMP also adopted a positive EU-Medicines for all (EU-M4all) opinion, which enables a streamlined assessment for World Health Organization (WHO) prequalification and will facilitate national regulatory evaluations in low- and lower-middle-income countries (LLMICs).

“This milestone reflects our commitment to reimagine HIV prevention in Europe and around the world,” said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences. “Lenacapavir for PrEP has the potential to become a critical tool for public health, helping to expand prevention options for people who face the highest barriers to care.”

Despite ongoing advances in HIV prevention, persistent social and economic factors including stigma and discrimination continue to cause disparities in PrEP use. In 2023, a total of 24,731 new HIV diagnoses were reported across 30 EU/European Economic Area countries—an increase of 11.8% compared with 2022.

“These positive opinions from the CHMP are an important step toward a new HIV prevention option that could help meet the diverse needs of people across Europe and aim at helping end new HIV infections by the EU target of 2030,” said Jean-Michel Molina, MD, PhD, Université Paris Cité, Professor of Infectious Diseases and Head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals. “The opinions reflect the strength of the clinical evidence and the potential of long-acting innovations like lenacapavir to address real-world barriers to the use of PrEP. Expanding the range of PrEP options, in Europe and in countries around the world, is essential to making HIV prevention more accessible for people who need it most.”

The positive opinions were supported by data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead. In the PURPOSE 1 trial (NCT04994509), data at the primary analysis showed that administration of twice-yearly subcutaneous lenacapavir led to zero HIV infections among 2,134 participants, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada^® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) in cisgender women in sub-Saharan Africa. In the PURPOSE 2 trial (NCT04925752), there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous lenacapavir group, demonstrating 99.9% of participants did not acquire HIV infection and superiority of prevention of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people. In both trials, lenacapavir demonstrated superiority of prevention of HIV infections when compared with background HIV incidence (bHIV) and was generally well-tolerated, with no significant or new safety concerns identified. Data from both trials were published in The New England Journal of Medicine and, based in part on the trial results, in December 2024 the journal Science named lenacapavir its 2024 “Breakthrough of the Year.”

Continued Global Regulatory Filings for Lenacapavir for HIV Prevention, Milestone Partnerships and Global Guidance

Gilead is executing a global access strategy informed by health advocates and organizations that prioritizes speed and enables the most efficient paths for regulatory review, approval of and access to twice-yearly lenacapavir for PrEP.

More information about Gilead’s recently announced strategic partnership agreement with The Global Fund to Fight AIDS, Tuberculosis and Malaria, as well as updates on Gilead’s access strategies in countries and regions around the world: See Gilead press release

More information about the WHO’s recently announced guidelines for the use of lenacapavir for PrEP: See Gilead company statement

Lenacapavir for PrEP is not approved by any regulatory authority outside of the United States.

There is currently no cure for HIV or AIDS.

About the PURPOSE Program

Gilead’s landmark PURPOSE program is the most comprehensive and diverse HIV prevention trial program ever conducted. The program comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity.

The PURPOSE trials are evaluating the safety and efficacy of an investigational, twice-yearly injectable medicine, lenacapavir, to reduce the chance of getting HIV. The Phase 2 and 3 program, consisting of PURPOSE 1-5, is assessing the potential of lenacapavir to help a diverse range of people around the world who could benefit from PrEP.

More information about the PURPOSE program, including individual trial descriptions, populations and locations, can be found at www.purposestudies.com.

About Lenacapavir

Lenacapavir is approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals. Lenacapavir is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents (≥35kg) who are at risk of HIV acquisition.

The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes.

Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science named lenacapavir its 2024 “Breakthrough of the Year.”

U.S. Indication for Yeztugo^®

Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo.

U.S. Important Safety Information for Yeztugo

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION

• Individuals must be tested for HIV-1 infection prior to initiating Yeztugo, and with each subsequent injection of Yeztugo, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of Yeztugo by individuals with undiagnosed HIV-1 infection. Do not initiate Yeztugo unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving Yeztugo must transition to a complete HIV-1 treatment regimen.

Contraindications

• Yeztugo is contraindicated in individuals with unknown or positive HIV-1 status.

Warnings and precautions

• Comprehensive risk management:
  • Use Yeztugo to reduce the risk of HIV-1 acquisition as part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs).
  • HIV-1 acquisition risk includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or present STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network. Counsel individuals on the use of other prevention methods to help reduce their risk.
  • Use Yeztugo only in individuals confirmed to be HIV-1 negative. Evaluate for current or recent signs or symptoms consistent with HIV-1 infection. Confirm HIV-1 negative status prior to initiating, prior to each subsequent injection, and as clinically appropriate.
• Potential risk of resistance:
  • There is a potential risk of developing resistance to Yeztugo if an individual acquires HIV-1 before or when receiving Yeztugo, or following discontinuation. HIV- 1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection taking only Yeztugo, because Yeztugo alone is not a complete regimen for HIV-1 treatment.
  • To minimize this risk, it is essential to test before each injection and additionally as clinically appropriate. Individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen.
  • Alternative forms of PrEP should be considered after discontinuation of Yeztugo for those who are at continuing risk of HIV-1 acquisition and should be initiated within 28 weeks of the last Yeztugo injection.
• Long-acting properties and potential associated risks:
  • Residual concentrations of Yeztugo may remain in systemic circulation for up to 12 months or longer after the last injection.
  • Select individuals who agree to the required injection dosing schedule because nonadherence or missed doses could lead to HIV-1 acquisition and development of resistance.
• Serious injection site reactions: Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer. Only administer Yeztugo subcutaneously.

Adverse reactions

• Most common adverse reactions (≥5%) in Yeztugo clinical trials were injection site reactions, headache, and nausea.

Drug interactions

• Strong or moderate CYP3A inducers may significantly decrease Yeztugo concentrations. Dosage modifications are recommended when initiating these inducers.
• It is not recommended to use Yeztugo with combined P-gp, UGT1A1, and strong CYP3A inhibitors.
• Coadministration of Yeztugo with sensitive substrates of CYP3A or P-gp may increase their concentrations and result in the increased risk of their adverse events. Yeztugo may increase the exposure of drugs primarily metabolized by CYP3A initiated within 9 months after the last injection of Yeztugo.

Dosage and administration

• HIV screening: Test for HIV-1 infection prior to initiating, prior to each subsequent injection, and as clinically appropriate using an approved or cleared test for the diagnosis of acute or primary HIV-1 infection.
• Dosage: Initiation dosing (injections and tablets) followed by once-every-6-months continuation injection dosing. Tablets may be taken with or without food.
  • Initiation: Day 1: 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally.
  • Continuation: 927 mg by subcutaneous injection every 6 months (26 weeks) from date of last injection ±2 weeks.
• Anticipated delayed injections: If scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, Yeztugo tablets may be taken on an interim basis (for up to 6 months) until injections resume. Dosage is 300 mg orally (1 x 300-mg tablet) once every 7 days. Resume continuation injections within 7 days of the last oral dose.
• Missed injections: If more than 28 weeks have elapsed since the last injection and Yeztugo tablets have not been taken, restart with initiation dosing if clinically appropriate.
• Dosage modifications of Yeztugo are recommended when initiating with strong or moderate CYP3A inducers. Consult the full Prescribing Information for recommendations.

About Gilead HIV

For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Yeztugo (lenacapavir) (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; Gilead’s ability to effectively manage the access strategy relating to lenacapavir, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

U.S. full Prescribing Information for Truvada and Yeztugo, including Boxed Warning, are available at www.gilead.com.

Truvada, Truvada for PrEP, Yeztugo, Yeytuo, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).

Contacts

Ashleigh Koss, Media

public_affairs@gilead.com

Jacquie Ross, Investors

investor_relations@gilead.com

Genentech Provides Update on Astegolimab in Chronic Obstructive Pulmonary Disease




Genentech Provides Update on Astegolimab in Chronic Obstructive Pulmonary Disease

– The pivotal Phase IIb ALIENTO study met the primary endpoint of a statistically significant reduction in the annualized exacerbation rate (AER) at 52 weeks when astegolimab was given every two weeks –

– The Phase III ARNASA study did not meet the primary endpoint of a statistically significant reduction in the AER at 52 weeks –

– The safety profile of astegolimab was consistent with previously reported data, with no new safety signals identified –

– Analysis of the ALIENTO and ARNASA data will be discussed with regulatory authorities and shared at an upcoming medical meeting –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today topline results from the pivotal Phase IIb ALIENTO (n=1,301) and the Phase III ARNASA (n=1,375) trials investigating astegolimab compared to placebo, on top of standard of care maintenance therapy in people with moderate to very severe chronic obstructive pulmonary disease (COPD). The studies included a broad population: both former and current smokers, regardless of blood eosinophil count, who have a history of frequent exacerbations.

The pivotal Phase IIb ALIENTO study met its primary endpoint and showed that astegolimab reduced the annualized exacerbation rate (AER) by a statistically significant 15.4% at 52 weeks, when given every two weeks. However, the Phase III ARNASA study did not meet its primary endpoint of a statistically significant reduction in the AER, demonstrating a numerical 14.5% reduction at 52 weeks when astegolimab was given every two weeks. The results were generally consistent across secondary endpoints in both studies. The total number of exacerbations was lower than prospectively anticipated in both trials. The safety profile of astegolimab was consistent with previously reported data, with no new safety signals identified.

“While COPD remains the third leading cause of death worldwide, patients and families have limited treatment options for managing this debilitating and complex disease,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “This was the first set of studies in an ‘all-comers’ COPD population, and we will discuss these data with regulatory authorities to evaluate next steps for astegolimab.”

Detailed results from ALIENTO and ARNASA will be shared at an upcoming medical meeting.

About the ALIENTO and ARNASA studies

Astegolimab is an investigational, fully human anti-ST2 monoclonal antibody designed to bind with high affinity to the ST2 receptor, thereby blocking the signaling of IL-33. The astegolimab COPD pivotal program consists of two registrational studies, the Phase IIb ALIENTO (NCT05037929) and Phase III ARNASA (NCT05595642) studies. Both ALIENTO and ARNASA are double-blinded, placebo-controlled, multi-center studies that evaluate the efficacy and safety of astegolimab administered every two or every four weeks in patients with COPD on top of standard of care maintenance therapy. Patients in the studies included former and current smokers, regardless of blood eosinophil count, who have a history of frequent exacerbations. The primary analysis is based on the initial phase of the study, which consisted of 1,301 patients for ALIENTO and 1,375 patients for ARNASA. The primary endpoint is the reduction in the annualized rate of moderate and severe COPD exacerbations (AER) over the 52-week treatment period. AER is the total number of exacerbations (a sudden worsening in airway function and respiratory symptoms) occurring over the relevant treatment period, divided by the total number of patient years. Standard of care maintenance therapy for both studies was one of the following combinations – inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA); long-acting muscarinic antagonist (LAMA) plus LABA; ICS plus LAMA plus LABA.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contacts

Media Contact:

Lindsey Mathias, (650) 467-6800

Advocacy Contact:

Del Conyers, (571) 684-1616

Investor Contacts:

Loren Kalm, (650) 225-3217

Bruno Eschli, +41 61 68-75284

Cloudbreak Pharma Inc. Announces Positive Phase 2 Results for CBT-004 in Patients with Vascularized Pinguecula




Cloudbreak Pharma Inc. Announces Positive Phase 2 Results for CBT-004 in Patients with Vascularized Pinguecula

Novel preservative-free CBT-004 eye drop formulation demonstrates statistically significant improvements in conjunctival hyperemia and patient-reported symptoms with excellent safety profile

IRVINE, Calif.–(BUSINESS WIRE)–#clinicaltrials–Cloudbreak Pharma Inc. a clinical-stage ophthalmology company developing innovative therapies for ocular surface diseases, today announced positive topline results from its Phase 2 clinical trial evaluating CBT-004 ophthalmic solution in patients with vascularized pinguecula and associated conjunctival hyperemia.

Key Phase 2 Results

Primary Endpoint Achieved: Both investigated concentrations of CBT-004 demonstrated statistically significant improvements in conjunctival hyperemia compared to vehicle at Day 28, as assessed by an independent reading center using digital imaging.

Rapid Onset and Sustained Efficacy: Significant improvements were observed as early as Day 7 with the highest investigated concentration CBT-004 , with benefits persisting through the 28-day treatment period.

Significant Symptom Relief: Both CBT-004 concentrations showed statistically significant improvements in five common patient-reported symptoms including burning/stinging, itching, foreign body sensation, eye discomfort, and pain compared to vehicle.

Excellent Safety Profile: No treatment-related adverse events were observed. Most adverse events were mild to moderate. No clinically meaningful changes in visual acuity or intraocular pressure were reported.

Addressing a Significant Unmet Medical Need

Vascularized pinguecula affects millions of Americans and represents a substantial unmet medical need in ophthalmology. This common, benign conjunctival growth can become problematic when it develops abnormal blood vessels and inflammation, which can lead to persistent redness, irritation, pain, and foreign body sensation. Current management options are limited, with many patients relying on off-label corticosteroids or surgical excision, both of which carry significant limitations and potential complications.

Study Design and Results

The multicenter, randomized, double-masked, vehicle-controlled Phase 2 study enrolled 88 adult patients with vascularized pinguecula and associated conjunctival hyperemia. Participants were randomized to receive one of two concentrations of CBT-004, or vehicle. The primary endpoint was the change from baseline in conjunctival hyperemia at Day 28, as measured by an independent reading center using standardized digital imaging protocols.

Expert Commentary

“There is a significant unmet need for patients suffering from symptomatic pinguecula, as current therapies are largely off-label and may carry safety concerns with long-term use,” said Dr. John Hovanesian, Clinical Professor of Ophthalmology and recognized key opinion leader in anterior segment disease. “The results from this trial are exciting, as they demonstrate that a targeted, non- steroidal therapy can meaningfully improve both the clinical signs and symptoms that impact patients’ quality of life.”

“As a principal investigator in this study, I was impressed by the consistency and magnitude of improvement in both objective redness and patient-reported discomfort with CBT-004,” commented Dr. Sherif El-Harazi, Medical Director at Global Research Management. “The safety profile was excellent, and I believe this therapy could represent a meaningful advance for our patients with vascularized pinguecula.”

About CBT-004

CBT-004 is a novel, preservative-free topical ophthalmic solution containing a potent and selective inhibitor of vascular endothelial growth factor (VEGF) receptors and platelet-derived growth factor (PDGF) receptors. The formulation is specifically designed to reduce abnormal blood vessel growth and inflammation associated with vascularized pinguecula while minimizing potential ocular surface toxicity through its preservative- free composition.

Next Steps and Regulatory Strategy

Based on these positive Phase 2 results, Cloudbreak Pharma Inc. plans to advance CBT-004 into Phase 3 development and initiate discussions with the U.S. Food and Drug Administration (FDA) to establish the regulatory pathway toward potential approval. The company anticipates providing updates on Phase 3 study design and timing in the coming months.

Market Opportunity

The vascularized pinguecula market represents a significant commercial opportunity with limited therapeutic options. The prevalence of pinguecula increases with age and UV exposure, affecting a substantial portion of the aging population. With no FDA-approved treatments specifically indicated for this condition, CBT-004 has the potential to become a category-defining therapy in this underserved market.

About Cloudbreak Pharma Inc.

Cloudbreak Pharma Inc. is a clinical-stage ophthalmology company dedicated to developing innovative therapies for ocular surface diseases with high unmet medical need. The company’s pipeline focuses on novel treatments targeting inflammation, vascularization, and other pathological processes affecting the ocular surface. Cloudbreak is committed to improving outcomes for patients with challenging eye conditions through scientifically-driven therapeutic development.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the potential therapeutic benefits of CBT-004, the company’s clinical development plans, regulatory strategy, and market opportunity. These forward-looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause actual results to differ include, but are not limited to, the uncertainty of clinical trial results, regulatory approval processes, competitive developments, and other risks detailed in the company’s filings. The company undertakes no obligation to update these forward-looking statements except as required by law.

Please note that the information contained in this press release may not be complete. For further details about Cloudbreak Pharma Inc., and our drug candidates, please refer to our company’s website (at www.cloudbreakpharma.com).

Contacts

Contact Information:
Cloudbreak Pharma Inc.

Email: media@cloudbreakpharma.com
Web: www.cloudbreakpharma.com

Sarepta Therapeutics Provides Statement on ELEVIDYS




Sarepta Therapeutics Provides Statement on ELEVIDYS

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement:

Shortly after 2:30 p.m. ET today, Sarepta received an informal request from the U.S. Food and Drug Administration (FDA) to voluntarily halt shipment of ELEVIDYS (delandistrogene moxeparvovec), our gene therapy for Duchenne muscular dystrophy (Duchenne), in the U.S. We first heard of this potential request earlier in the day at the same time the public and our patient communities did, through media reports.

At Sarepta, patient safety and well-being are always our top priority. We are committed to upholding the highest safety standards for all of our therapies. This guides every decision we make, as evidenced by our conservative decision to pause shipments of ELEVIDYS for non-ambulant patients while we work with the FDA to update the label and evaluate the use of an enhanced immunosuppression regimen to mitigate the risk of acute liver failure.

Based on our comprehensive scientific interpretation of the data, which shows no new or changed safety signals in the ambulant patient population, we will continue to ship ELEVIDYS to the ambulant population. We look forward to continued discussions and sharing of information with FDA in order to advance our shared purpose of protecting patient safety and informed access to care.

We recognize that the death of any patient is heartbreaking, including the recent death of a 51-year-old non-ambulant Limb-Girdle Muscular Dystrophy (LGMD) patient. We also want to clarify that this tragic event occurred in a Phase 1 clinical trial for an investigational gene therapy called SRP-9004. SRP-9004 is a clinical stage therapy that is intended to treat a different disease (LGMD Type 2D), is administered using a different dose, and is manufactured using a different process. The LGMD study participant who passed away was not treated with ELEVIDYS, and the dosing for the SRP-9004 trial had concluded at the time of his death.

Additionally, in a timely manner, Sarepta reported this ALF event as a life-threatening case to FDA on June 20, 2025, and further followed up with notification to FDA of the death on July 3, 2025, in accordance with applicable law and our commitment to full regulatory transparency.

ELEVIDYS is the only approved gene therapy for individuals devastated by Duchenne, a rare, progressive and ultimately fatal disease. We are committed to working closely with the FDA to ensure that all decisions are grounded in science and the best interests of patients, considering the compelling need of these families to access disease-modifying therapy.

About ELEVIDYS (delandistrogene moxeparvovec-rokl)

ELEVIDYS (delandistrogene moxeparvovec-rokl) is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene that codes for the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle.

ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age.

• For patients who are ambulatory and have a confirmed mutation in the DMD gene
• For patients who are non-ambulatory and have a confirmed mutation in the DMD gene.

The DMD indication in non-ambulatory patients is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin in skeletal muscle. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION: ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene.

WARNINGS AND PRECAUTIONS:

Infusion-related Reactions:

• Infusion-related reactions, including hypersensitivity reactions and anaphylaxis, have occurred during or up to several hours following ELEVIDYS administration. Closely monitor patients during administration and for at least 3 hours after the end of infusion. If symptoms of infusion-related reactions occur, slow, or stop the infusion and give appropriate treatment. Once symptoms resolve, the infusion may be restarted at a lower rate.
• ELEVIDYS should be administered in a setting where treatment for infusion-related reactions is immediately available.
• Discontinue infusion for anaphylaxis.

Acute Serious Liver Injury:

• Acute serious liver injury has been observed with ELEVIDYS, and administration may result in elevations of liver enzymes (such as GGT, GLDH, ALT, AST) or total bilirubin, typically seen within 8 weeks.
• Patients with preexisting liver impairment, chronic hepatic condition, or acute liver disease (e.g., acute hepatic viral infection) may be at higher risk of acute serious liver injury. Postpone ELEVIDYS administration in patients with acute liver disease until resolved or controlled.
• Prior to ELEVIDYS administration, perform liver enzyme test and monitor liver function (clinical exam, GGT, and total bilirubin) weekly for the first 3 months following ELEVIDYS infusion. Continue monitoring if clinically indicated, until results are unremarkable (normal clinical exam, GGT, and total bilirubin levels return to near baseline levels).
• Systemic corticosteroid treatment is recommended for patients before and after ELEVIDYS infusion. Adjust corticosteroid regimen when indicated. If acute serious liver injury is suspected, consultation with a specialist is recommended.

Immune-mediated Myositis:

• In clinical trials, immune-mediated myositis has been observed approximately 1 month following ELEVIDYS infusion in patients with deletion mutations involving exon 8 and/or exon 9 in the DMD gene. Symptoms of severe muscle weakness, including dysphagia, dyspnea, and hypophonia, were observed.
• Limited data are available for ELEVIDYS treatment in patients with mutations in the DMD gene in exons 1 to 17 and/or exons 59 to 71. Patients with deletions in these regions may be at risk for a severe immune-mediated myositis reaction.
• Advise patients to contact a physician immediately if they experience any unexplained increased muscle pain, tenderness, or weakness, including dysphagia, dyspnea, or hypophonia, as these may be symptoms of myositis. Consider additional immunomodulatory treatment (immunosuppressants [e.g., calcineurin-inhibitor] in addition to corticosteroids) based on patient’s clinical presentation and medical history if these symptoms occur.

Myocarditis:

• Acute serious myocarditis and troponin-I elevations have been observed following ELEVIDYS infusion in clinical trials.
• If a patient experiences myocarditis, those with pre-existing left ventricle ejection fraction (LVEF) impairment may be at higher risk of adverse outcomes. Monitor troponin-I before ELEVIDYS infusion and weekly for the first month following infusion and continue monitoring if clinically indicated. More frequent monitoring may be warranted in the presence of cardiac symptoms, such as chest pain or shortness of breath.
• Advise patients to contact a physician immediately if they experience cardiac symptoms.

Preexisting Immunity against AAVrh74:

• In AAV-vector based gene therapies, preexisting anti-AAV antibodies may impede transgene expression at desired therapeutic levels. Following treatment with ELEVIDYS, all patients developed anti-AAVrh74 antibodies.
• Perform baseline testing for presence of anti-AAVrh74 total binding antibodies prior to ELEVIDYS administration.
• ELEVIDYS administration is not recommended in patients with elevated anti-AAVrh74 total binding antibody titers greater than or equal to 1:400.

Adverse Reactions:

• The most common adverse reactions (incidence ≥5%) reported in clinical studies were vomiting, nausea, liver injury, pyrexia, and thrombocytopenia.

Report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782).

For further information, please see the full Prescribing Information.

About Sarepta Therapeutics
Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. For more information, please visit www.sarepta.com or follow us on LinkedIn, X, Instagram and Facebook.

Forward-Looking Statements
This statement contains “forward-looking statements.” Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believe,” “anticipate,” “plan,” “expect,” “will,” “may,” “intend,” “prepare,” “look,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, research and development programs, clinical trials, ELEVIDYS, and expected plans, including our plan to continue to ship ELEVIDYS to the ambulant population and continued discussions and sharing of information with FDA in order to advance our shared purpose of protecting patient safety and informed access to care.

Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; our products or product candidates may cause undesirable side effects that result in significant negative consequences following any marketing approval; different methodologies, assumptions and applications we use to assess particular safety or efficacy parameters may yield different statistical results, and even if we believe the data collected from clinical trials are positive, these data may not be sufficient to support approval by the FDA or other global regulatory authorities; success in clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful, and the results of future research may not be consistent with past positive results or with advisory committee recommendations, or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates; we may not be able to comply with all FDA requests in a timely manner or at all; the possible impact of regulations and regulatory decisions by the FDA and other regulatory agencies on our business; and those risks identified under the heading “Risk Factors” in our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company, which you are encouraged to review.

Any of the foregoing risks could materially and adversely affect the Company’s business, results of operations and the trading price of Sarepta’s common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained herein. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law.

Internet Posting of Information
We routinely post information that may be important to investors in the ‘For Investors’ section of our website at www.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us.

Source: Sarepta Therapeutics, Inc.

Contacts

Investor Contact:
Ian Estepan

617-274-4052

iestepan@sarepta.com

Media Contacts:
Tracy Sorrentino

617-301-8566

tsorrentino@sarepta.com

Wedgewood Expands Advisory Committee with the Launch of Two New Veterinary Councils




Wedgewood Expands Advisory Committee with the Launch of Two New Veterinary Councils

SWEDESBORO, N.J.–(BUSINESS WIRE)–Wedgewood is excited to announce the expansion and evolution of its Veterinary Advisory Committee to reflect the company’s continued growth and leadership in the veterinary community. As part of this transformation, the company welcomes new members to both the Strategic Veterinary Council and the Specialists Customer Council. These additions are intended to bring fresh perspectives and ensure Wedgewood remains deeply connected to both emerging trends and frontline clinical practice.

This new structure will strengthen Wedgewood’s ability to collaborate with a broader range of veterinary professionals and ensure its offerings are shaped by those delivering care every day. The councils are designed to provide meaningful guidance across clinical, operational, and strategic areas, helping the company stay responsive to the needs of the profession and grounded in real-world insight.

The Strategic Veterinary Council includes leaders in education, operations, regulatory, and medical excellence who will advise Wedgewood on big-picture strategy and forward-looking industry trends. This group will play a critical role in helping us ensure our offerings are aligned with the evolving realities of veterinary practice. The council includes:

• Dr. Dawn Boothe – Professor Emerita and board-certified pharmacologist known for her decades-long impact in clinical pharmacology and education.
• Dr. Kelly Cairns – VP of Medical Excellence and Education at Thrive Pet Healthcare, with deep expertise in internal medicine and veterinary education.
• Brian Carlson – Director of Operations at Old Derby Animal Hospital and veterinary business consultant specializing in growth strategy.
• Dr. Matthew Edson – Founding Dean of the Shreiber School Veterinary Medicine of Rowan University and advocate for veterinary education that prepares confident, practice-ready graduates.
• Dr. Andrea Johnson – Co-founder of PetVet365, focused on reinventing practice ownership and advancing pet care delivery.
• Dr. Natalie Marks – CEO of VANE and nationally recognized speaker, columnist, and veterinary media contributor.
• Dr. Joshua Stern – Associate Dean and Professor of Cardiology at NCSU, leading groundbreaking research in companion animal genetics and cardiology.
• Dr. Dean Vicksman – Chair of the Board of Directors at EveryCat Health Foundation and long-time champion of feline health.
• Dr. Sathya Chinnadurai – Senior VP of Animal Health at Brookfield Zoo, a highly respected zoological veterinarian and researcher, best known for his leadership in animal health, welfare, and conservation medicine.

The Specialists Customer Council is composed of practicing veterinarians who will keep Wedgewood closely connected to the day-to-day challenges of specialty care. These members offer deep clinical expertise and will provide actionable feedback on how we can better serve the needs of high-demand specialty practices. Members of this council include:

• Dr. Gary Block – President of the Evidence Based Veterinary Medicine Association and co-founder of OSVS and BSVESS referral hospitals.
• Dr. Jane Brunt – Executive Director of the CATalyst Council and founder of Maryland first feline-exclusive hospital.
• Dr. Rustin Sturgeon – National Medical Director of Ophthalmology at Pathway Vet Alliance with expertise in medical excellence coaching.
• Dr. Rob Swinger – Board-certified ophthalmologist and Medical Director at Elite Veterinary Specialists.
• Dr. Noël Lucas – Founder of Blue Oasis Pet Hospital and advocate for transparency in veterinary care and mental health.
• Dr. Stephanie Correa – Founder and President of Animal Cancer Care Clinic, the largest dedicated veterinary oncology network in the U.S.

“It’s an exciting time at Wedgewood as we continue to grow and deepen our partnerships across the veterinary community,” said Dr. Rae Hutchins, Chief Veterinary Officer at Wedgewood. “Expanding our Advisory Committee allows us to stay at the forefront of clinical innovation, grounded in scientific rigor, and ensures we’re responding directly to the evolving needs of veterinarians and the animals they care for.”

This momentum reflects Wedgewood’s long-standing commitment to serving the veterinary community with insight, integrity, and partnership. By continuing to work closely with leaders across the profession, the company is dedicated to building smarter, more agile solutions that elevate clinical care and support continued progress for all.

About Wedgewood:

Wedgewood is the nation’s largest and most trusted provider of compounded veterinary medications. Its next-generation home delivery platform, Blue Rabbit, streamlines patient care and marks a significant evolution in online pharmacy services. Together, Blue Rabbit and Wedgewood serve more than 70,000 veterinary professionals and more than one million animals annually. For more information visit www.Wedgewood.com.

Contacts

Jennifer Ravalli

jennifer.ravalli@wedgewood.com

TerSera Therapeutics to Present Real-World Data on Intrathecal Ziconotide (PRIALT®) Prescription Patterns at ASPN 2025




TerSera Therapeutics to Present Real-World Data on Intrathecal Ziconotide (PRIALT®) Prescription Patterns at ASPN 2025

DEERFIELD, Ill.–(BUSINESS WIRE)–TerSera Therapeutics LLC, a biopharmaceutical company with a focus in oncology, rare disease, and non-opioid pain management, announced today that its collaborative research on intrathecal ziconotide (PRIALT^®) prescribing patterns has been accepted for presentation at the 7th Annual Meeting of the American Society of Pain and Neuroscience (ASPN) taking place July 17-20, 2025, in Miami, Florida. The poster will be presented by the primary author, Tolga Suvar, M.D., Assistant Professor, Department of Anesthesiology and Pain Medicine, and Attending Physician at Rush University Pain Center in Chicago, IL. A copy of the poster is available here.

The abstract, titled “Real-world Treatment Patterns of Intrathecal Ziconotide”, highlights a retrospective, non-interventional study conducted in partnership with Pentec Health, Inc., and other clinical collaborators. The study analyzed real-world data from over 1,000 patients treated with ziconotide between 2017 and 2024, using dispensing and claims records from Pentec, a leading provider of specialty infusion pharmacy and complex in-home clinical services. Evolution of prescribing patterns was analyzed over time and compared with the recommendations for ziconotide in the Polyanalgesic Consensus Conference (PACC) guidelines.

Key findings from the study¹ include:

• Shift Toward Monotherapy Use: Use of ziconotide as monotherapy increased from 36.0% in 2017–2018 to 63.1% in 2023–2024, reflecting growing adoption of guideline-aligned prescribing of ziconotide.
• Lower Starting Doses: The proportion of patients initiated on lower ziconotide doses (<0.5 mcg/day) rose from 3.4% to 20.3% over the study period, indicating a trend toward more conservative initial dosing strategies.
• Increased Use of Patient-Controlled Analgesia (PCA): The use of basal rate with PCA nearly doubled, from 23.7% to 45.3% over the study period, suggesting increasing use of novel approaches to delivery of intrathecal medications.

“These findings underscore the importance of real-world evidence in shaping clinical practice,” said Dr. Suvar. “It is encouraging to see increased alignment with PACC guidelines and a growing emphasis on patient-tailored dosing strategies. Precision in dosing—based on the unique characteristics and pathologies of each patient—is essential for optimizing outcomes and minimizing risk.”

About PRIALT^® (Ziconotide Intrathecal Infusion)

PRIALT is a non-opioid intrathecal analgesic indicated for the management of severe chronic pain in patients for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatments. Derived from a marine snail peptide, ziconotide acts as a selective N-type calcium channel blocker, interrupting pain signal transmission in the spinal cord. Ziconotide is administered via continuous intrathecal infusion and is not associated with the risk of addiction or respiratory depression commonly seen with opioid therapies.²

IMPORTANT SAFETY INFORMATION

Contraindications

PRIALT is contraindicated in patients with:

• A known hypersensitivity to ziconotide or any of its formulation components.
• Any other concomitant treatment or medical condition that would render intrathecal administration hazardous, such as the presence of infection at the microinfusion injection site, uncontrolled bleeding diathesis, and spinal canal obstruction that impairs circulation of cerebrospinal fluid (CSF).
• A pre-existing history of psychosis.

Warnings and Precautions

Cognitive and Neuropsychiatric Adverse Reactions

Severe psychiatric symptoms and neurological impairment may occur during treatment. Monitor all patients frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. PRIALT may cause or worsen depression, with the risk of suicide in susceptible patients.

In clinical trials, 12% of patients reported hallucinations; other acute psychiatric events included paranoid reactions (3%), hostility (2%), delirium (2%), psychosis (1%), and manic reactions (0.4%).

Patients with pretreatment psychiatric disorders may be at an increased risk. Management of psychiatric complications may need to include discontinuation of PRIALT, treatment with psychotherapeutic agents and/or short-term hospitalization.

In clinical trials, cognitive adverse reactions included confusion (33%), memory impairment (22%), speech disorder (14%), aphasia (12%), thinking abnormal (8%), and amnesia (1%). Cognitive impairment may appear gradually after several weeks of treatment. Reduce the dose of PRIALT or discontinue the use of PRIALT if signs or symptoms of cognitive impairment develop, but other contributing causes must also be considered. The cognitive effects of PRIALT are generally reversible within 2 weeks after drug discontinuation. The elderly (≥65 years) are at higher risk for confusion. Concomitant use of central nervous system (CNS) depressants with PRIALT may have additive effects.

Meningitis and Other Infections

Meningitis can occur due to inadvertent contamination of the microinfusion device and other means. In clinical trials, the rate of meningitis was 3% (40 cases) in the PRIALT group using either internal or external microinfusion devices and 1% (1 case) with placebo. In patients with external microinfusion devices and catheters, meningitis occurred in 38 out of 41 patients (93%), 37 of whom received PRIALT and one who received placebo. Patients, caregivers, and healthcare providers must be particularly vigilant for the signs and symptoms of meningitis including, but not limited to, fever, headache, stiff neck, altered mental status (e.g., lethargy, confusion, disorientation), nausea or vomiting, and occasionally seizures.

Strict aseptic procedures must be used during the preparation of the PRIALT solution and refilling of the microinfusion device.

Reduced Level of Consciousness

In clinical trials, 2% of PRIALT-treated patients became unresponsive or stuporous. If reduced levels of consciousness occur, discontinue PRIALT until the event resolves, and other etiologies (e.g., meningitis) must be considered.

Elevation of Serum Creatine Kinase

In clinical trials, serum creatine kinase (CK) levels above the upper limit of normal (ULN) were reported in 40% of patients, with 11% of patients having CK levels >3 times ULN. Incidences were higher during the first 2 months of treatment. Serum CK should be monitored periodically. In the setting of new neuromuscular symptoms, evaluate patients, obtain CK measurements, and if symptoms continue and CK levels remain elevated or continue to rise, reduce the dose or discontinue the use of PRIALT.

Withdrawal From Opiates

PRIALT is not an opiate and cannot prevent or relieve the symptoms associated with the withdrawal of opiates. To avoid withdrawal syndrome when opiate withdrawal is necessary, do not abruptly reduce or withdraw opioid medications.

Driving and Operating Machinery

Use of PRIALT has been associated with cognitive impairment and decreased alertness/unresponsiveness. Caution patients against engaging in hazardous activities that require complete mental alertness or motor coordination.

Most Common Adverse Reactions

The most frequently reported adverse reactions (≥25%) in clinical trials (n=1254 PRIALT-treated patients) were dizziness, nausea, confusional state, and nystagmus. Slower titration of PRIALT may result in fewer serious adverse reactions and discontinuations for adverse reactions.

Indication

PRIALT^® (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal (IT) therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. You may also contact TerSera Therapeutics at 1-844-334- 4035 or medicalinformation@tersera.com.

Please see full Prescribing Information, including BOXED Warning.

About TerSera Therapeutics

TerSera Therapeutics is a biopharmaceutical company with a focus in oncology, rare disease, and non-opioid pain management. Founded in 2016, TerSera is building new cornerstones of care through its portfolio of unique therapeutics, amplifying their ability to deliver meaningful outcomes for patients. For additional information, please visit TerSera.com and follow us on LinkedIn.

About Pentec Health

Pentec Health is a leader in specialty pharmacy, infusion services, and DME distribution, committed to solving and simplifying complex care challenges to better meet patient and provider needs. Accredited by the Joint Commission and the American Nurses Credentialing Center, with distinctions in Specialty Care Nurse Fellowship, Pentec Health delivers exceptional results through unique solutions, technical expertise, and clinical collaboration. Our proven delivery models reduce administrative burdens and help improve patient outcomes. Pentec Health serves more than 11,000 patients living with complex medical conditions, with care provided nationwide by over 350 clinicians. For additional information, please visit PentecHealth.com.

References

1. Suvar, T., Lindley, D., Leatherman, D., Howard, K., Lucia, R., Duran, N., Murray, M., McGlothlen, G., Dagenhart, J., Cannon, J., Sayeed, S., & Lubenow, T. (2025, July). Real-world treatment patterns of intrathecal ziconotide [Poster presentation]. American Society of Pain and Neuroscience (ASPN) 2025 Annual Meeting.
2. PRIALT^® (ziconotide). Prescribing information. TerSera Therapeutics LLC.

PRIALT is a registered trademark of TerSera Therapeutics LLC.

TerSera and the TerSera logo are trademarks of TerSera Therapeutics LLC.

©2025 TerSera Therapeutics LLC. All rights reserved.

Contacts

For more information:
TerSera Therapeutics:
Mark Leonard

847-651-9682

mleonard@tersera.com

Pentec Health:
Jeremy Krick

224-483-4419

jeremy.krick@pentechealth.com

MEI Pharma Announces $100,000,000 Private Placement to Initiate Litecoin Treasury Strategy, Becoming First and Only Publicly Traded LTC Holder on a National Exchange




MEI Pharma Announces $100,000,000 Private Placement to Initiate Litecoin Treasury Strategy, Becoming First and Only Publicly Traded LTC Holder on a National Exchange

• Charlie Lee, the Founder of Litecoin and a lead investor in the PIPE, will join the Board of Directors of the Company effective upon the closing of the Private Placement
• GSR, a preeminent digital asset market maker and lead investor in the private placement, is appointed to act as the treasury’s Asset Manager
• MEI Pharma will use 100% of the net proceeds to launch its treasury strategy focused on Litecoin, becoming the first and only publicly traded LTC holder on a national exchange

SAN DIEGO–(BUSINESS WIRE)–MEI Pharma, Inc. (Nasdaq: MEIP) (the “Company” or “MEI”) today announced that it has entered into securities purchase agreements for a private investment in public equity (PIPE) for the purchase and sale of 29,239,767 shares of common stock (or pre-funded warrants in lieu thereof) at a price of $3.42 per share, for expected aggregate gross proceeds of approximately $100 million, before deducting placement agent fees and other estimated offering expenses. In connection with the closing of the transaction, MEI will appoint Charlie Lee to its Board of Directors (at which time current member Taheer Datoo will resign) and GSR as its digital asset and treasury management advisor to oversee the implementation of its Litecoin Treasury Strategy.

Charlie Lee and GSR acted as lead investors, alongside participation from the Litecoin Foundation as well as prominent crypto venture capital firms and infrastructure providers including MOZAYYX, ParaFi, Hivemind, Primitive, RLH Capital, Delta Blockchain & CoinFund, among others.

This transaction marks a significant milestone in MEI’s long-term strategic plan and establishes MEI as the first and only publicly traded company to adopt Litecoin as a treasury reserve asset. Litecoin (LTC) is a leading peer-to-peer cryptocurrency that was created by Charlie Lee in October 2011. It is often referred to as the “silver to Bitcoin’s gold” due to its similarities to Bitcoin. As one of the longest-running blockchains with 100% uptime since its inception, Litecoin has demonstrated a proven track record of growth and reliability with significant enterprise-grade use cases. By integrating Litecoin into its treasury operations, MEI gains access to a decentralized monetary asset that complements its cash management framework.

“Litecoin was designed to be fast, secure, and decentralized – and it’s exciting to see those principles now being embraced by a public company like MEI,” said Charlie Lee, Creator of Litecoin. “This milestone not only reflects growing institutional confidence in LTC but also sets the stage for broader adoption in traditional capital markets.”

“We’re thrilled to partner with MEI in building a thoughtful LTC-focused treasury strategy,” said Josh Riezman, US Chief Strategy Officer of GSR. “Our goal is to help institutions unlock the long-term potential of digital assets while managing risk and maintaining flexibility. This treasury strategy is centered around a completely fair and fully decentralized digital asset with a nearly unparalleled track record as a store of value and means of payment.”

“MEI is pleased to pioneer this innovative public company treasury strategy with GSR and Charlie Lee, the first to our knowledge in the biotech sector,” said Frederick W. Driscoll, Chairman of the Board of MEI.

The closing of the PIPE is expected to occur on or about July 22, 2025, subject to the satisfaction of customary closing conditions. The Company intends to use the funds to acquire the native cryptocurrency of the Litecoin blockchain commonly referred to as “LTC”, which will serve as the Company’s primary treasury reserve asset.

Titan Partners Group, a division of American Capital Partners, is acting as the sole placement agent in connection with the PIPE.

The offer and sale of the foregoing securities is being made in a private placement in reliance on an exemption from the registration requirement of the Securities Act of 1933, as amended (the “Securities Act”), pursuant to Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder, and applicable state securities laws. Accordingly, the securities offered in the private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirement of the Securities Act and such applicable state securities laws. Concurrently with the execution of the securities purchase agreements, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission (the “SEC”) registering the resale of the shares of common stock. Any offering of the Company’s Common Stock under the resale registration statement will only be made by means of a prospectus.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

The private placement is being conducted in accordance with applicable Nasdaq rules and was priced to satisfy the “Minimum Price” requirement (as defined in the Nasdaq rules).

About MEI Pharma

MEI Pharma, Inc. (Nasdaq: MEIP) is a pharmaceutical company with a portfolio of several drug candidates that may offer novel and differentiated therapies. The drug candidate pipeline includes voruciclib, an oral cyclin-dependent kinase 9 inhibitor. For more information, please visit www.meipharma.com. Follow us on X (formerly Twitter) @MEI_Pharma and on LinkedIn.

Forward-Looking Statements

Certain information contained in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements regarding our future actions, prospective products, future performance or results, including the success of the PIPE transaction and Litecoin strategy, the anticipated closing date of the PIPE transaction, the amount of proceeds to be received by MEI Pharma and the intended use of proceeds from the PIPE transaction, and any assumptions underlying any of the foregoing. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, risk relating to our satisfaction of closing conditions for the PIPE, maintaining our current listing on Nasdaq, our ability to retain and attract senior management and other key employees, fluctuations in the market price of LTC and any associated impairment charges that we may incur as a result of a decrease in the market price of LTC below the value at which LTC is carried on our balance sheet, changes in the accounting treatment relating to our LTC holdings, our ability to achieve profitable operations, government regulation of cryptocurrencies and online betting, changes in securities laws or regulations, customer acceptance of new products and services including our LTC treasury strategy, the demand for our products and our customers’ economic condition, the impact of competitive products and pricing, the lengthy sales cycle, our proprietary rights, general economic conditions and other risk factors detailed in our annual report and other filings with the SEC. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.

Contacts

Justin J. File

858-898-0976

investor@meipharma.com
Source: MEI Pharma, Inc.