ZYUS Life Sciences Announces Closing of First Tranche of Unit Offering




ZYUS Life Sciences Announces Closing of First Tranche of Unit Offering

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

SASKATOON, Saskatchewan–(BUSINESS WIRE)–#ClinicalResearch–ZYUS Life Sciences Corporation (the “Company”) (TSX-V: ZYUS), a Canadian-based life sciences company focused on the development and commercialization of novel cannabinoid-based pharmaceutical drug candidates for pain management, is pleased to announce that it has now completed a first tranche (the “First Tranche“) of its non-brokered private placement (the “Offering“) of units of the Company (each a “Unit“) previously announced on May 1, 2025 for up to $2,000,000. Under the First Tranche of the Offering 1,212,121 Units were issued at a price of $0.66 per Unit for gross proceeds of approximately $800,000.000. The Company expects to close an additional tranche shortly.

Each Unit is priced at $0.66 and consists of one common share of the Company (a “Common Share“) and one-half of one Common Share purchase warrant (each whole Common Share purchase warrant, a “Warrant”), whereby each Warrant entitles the holder to acquire one Common Share at a price of $0.94 for a period of twenty-four months from the date of issuance, unless the term of the Warrant is accelerated pursuant to its terms. Proceeds of the Offering will be used for general corporate and working capital purposes. No finder’s fees were paid in connection with the Offering.

The Units were offered by way of private placement pursuant to exemptions from prospectus requirements under applicable securities laws. All securities issued under the First Tranche are subject to a hold period expiring September 7, 2025, in accordance with applicable securities laws and the policies of the TSX Venture Exchange (the “TSXV“). The Offering has received conditional approval from the TSXV and remains subject to final acceptance of the TSXV.

The securities described herein have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act“), or any state securities laws, and may not be offered or sold within the United States or to, or for account or benefit of, U.S. persons except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities laws or pursuant to available exemptions therefrom. This release does not constitute an offer to sell or a solicitation of an offer to buy of any securities in the United States.

About ZYUS Life Sciences Corporation

ZYUS (TSXV: ZYUS) is a life sciences company focused on the development and commercialization of novel cannabinoid-based pharmaceutical drug candidates for pain management. Through rigorous scientific exploration and clinical research, ZYUS aims to secure intellectual property protection, safeguarding its innovative therapies and bolstering shareholder value. ZYUS’ unwavering commitment extends to obtaining regulatory approval of non-opioid-based pharmaceutical solutions, in pursuit of transformational impact on patients’ lives. For additional information, visit www.zyus.com or follow us on X (formerly known as Twitter) @ZYUSCorp.

Cautionary Note Regarding Forward-Looking Statements

This news release contains “forward-looking information” within the meaning of applicable securities laws relating to the Company’s business, the Company’s ability to advance clinical research activities, obtain regulatory approval of cannabinoid-based pharmaceutical drug candidates and introduce products that act as alternatives to current pain management therapies such as opioids, receipt of TSXV final acceptance, close of the balance of the Offering and use of proceeds from the Private Placement. Any such forward-looking statements may be identified by words such as “expects”, “anticipates”, “intends”, “contemplates”, “believes”, “projects”, “plans”, “will” and similar expressions. Readers are cautioned not to place undue reliance on forward-looking statements. Statements about, among other things, the Company’s business, the Company’s ability to advance clinical research activities, obtain regulatory approval of cannabinoid-based pharmaceutical drug candidates and introduce products that act as alternatives to current pain management therapies such as opioids, obtain TSXV final acceptance, close the balance of the Offering and use of proceeds from the Private Placement are all forward-looking information. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Although such statements are based on management’s reasonable assumptions, there can be no assurance that the Company will be able to achieve these results. The Company assumes no responsibility to update or revise forward-looking information to reflect new events or circumstances or actual results unless required by applicable law.

Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this press release.

Contacts

ZYUS Media Inquiries

media@zyus.com
1-833-651-7723

ZYUS Investor Relations

investors@zyus.com

University of Delaware Study Identifies Optimal Formulation of ZIVO’s Active Ingredients for Further Testing to Mitigate Avian Influenza in Poultry




University of Delaware Study Identifies Optimal Formulation of ZIVO’s Active Ingredients for Further Testing to Mitigate Avian Influenza in Poultry

TROY, Mich.–(BUSINESS WIRE)–ZIVO Bioscience, Inc. (OTCQB: ZIVO), a pioneering biotech/agtech R&D company dedicated to developing therapeutic, medicinal and nutritional product candidates derived from proprietary algal cultures, today announced positive results from its second collaborative study with the University of Delaware evaluating the efficacy of several formulations of ZIVO’s proprietary active ingredients in mitigating the spread of Low Pathogenicity Avian Influenza (LPAI) virus among poultry.

Building upon the outcomes of the initial study, this second study aimed to assess and compare the performance of three different ZIVO formulations in both directly challenged and contact-exposed birds. The study affirmed earlier observations that ZIVO’s active ingredients may positively influence LPAI transmission dynamics, while identifying the optimal formulation for further testing.

In the first arm of the study, which involved birds receiving a direct challenge with LPAI, modest positive trends were observed in viral shedding reduction among ZIVO-treated groups compared with untreated controls. While these differences did not reach statistical significance, the findings suggest potential for ZIVO’s formulations to lessen disease severity.

The second arm focused on the transmission of the virus from infected birds to naïve birds. Notably, the formulation consisting of a blend of four distinct algal-derived materials demonstrated a slower and less efficient spread of the virus. One bird treated with this combination showed no signs of infection post-exposure, indicating potential protective effects.

Brian Ladman, PhD, Principal Investigator at the University of Delaware’s Department of Animal and Food Sciences, commented, “Any positive trend observed in these early-stage studies is very encouraging. Delaying transmission, even by a few days, can provide significant benefits to poultry producers by allowing more time to manage high risk or at-risk flocks effectively.”

“These findings resulting from rigorous testing at the University of Delaware reinforce our commitment to developing sustainable, non-antibiotic solutions for the poultry industry. The insights gained from this study show encouraging trends and identifying a superior formulation will be instrumental in guiding our future research and product optimization efforts. Given the potential impact ZIVO’s product can have on mitigating avian influenza, a widespread issue in the nation’s large poultry industry, we submitted a funding request to the State of Michigan for $5.5 million to further our research. Additionally, we are applying for a portion of the previously announced $100 million Avian Influenza Poultry Innovation Grand Challenge from the USDA,” said John Payne, Chairman and CEO of ZIVO Bioscience.

ZIVO Bioscience remains dedicated to advancing its pipeline of algal-derived compounds aimed at enhancing poultry health and productivity. The company plans to continue its collaboration with the University of Delaware to further explore and refine these interventions, including a larger scale project focused on a single formulation in order to determine the reproducibility of the observations from the first two studies.

About ZIVO Bioscience

ZIVO Bioscience, Inc. is a research and development company with an intellectual property portfolio comprised of proprietary algal and bacterial strains, biologically active molecules and complexes, production techniques, cultivation techniques and patented or patent-pending inventions for applications in human and animal health. Please visit www.zivobioscience.com for more information.

Forward Looking Statements

Except for any historical information, the matters discussed in this press release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including with respect to the Company’s product candidate’s potential to generate revenues and the expected timeframe for results of future studies. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. Although ZIVO believes there is a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. Our actual future results may be materially different from what we expect due to factors largely outside our control, including risks that our strategic partnerships may not facilitate the commercialization or market acceptance of our products; risks that we will be unable to increase production sufficient to meet demand; risks that our products may not be ready for commercialization in a timely manner or at all; risks that our products will not perform as expected based on results of our preclinical and clinical trials; our ability to raise additional funds; uncertainties inherent in the development process of our products; changes in regulatory requirements or decisions of regulatory authorities; the size and growth potential of the markets for our products; the results of clinical trials; our ability to protect our intellectual property rights; and other risks, uncertainties and assumptions, including those described under the heading “Risk Factors” in our filings with the Securities and Exchange Commission. These forward–looking statements speak only as of the date of this news release and ZIVO undertakes no obligation to revise or update any forward–looking statements for any reason, even if new information becomes available.

Contacts

ZIVO Bioscience
Keith Marchiando, Chief Financial Officer

(248) 452-9866 x130

kmarchiando@zivobioscience.com

Alliance Advisors IR
Tirth T. Patel

(212) 201-6614

tpatel@allianceadvisors.com

Sangamo Therapeutics Announces First Quarter 2025 Earnings Call




Sangamo Therapeutics Announces First Quarter 2025 Earnings Call

RICHMOND, Calif.–(BUSINESS WIRE)–Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the company has scheduled the release of its first quarter 2025 financial results after the markets close on Monday, May 12, 2025.

The company will hold a conference call at 4:30 p.m. Eastern on Monday, May 12, which will remain open to the public. During the conference call, the company will review its financial results and provide business updates.

Participants should register for, and access, the call using this link. While not required, it is recommended to join 10 minutes prior to the event start. Once registered, participants will be given the option to either dial into the call with the number and unique passcode provided, or to use the dial-out option to connect their phone instantly. The link to access the live webcast can also be found on the Sangamo Therapeutics website in the Investors and Media section under Events.

A replay will be available following the conference call, accessible under Events.

About Sangamo Therapeutics

Sangamo Therapeutics is a genomic medicine company dedicated to translating ground-breaking science into medicines that transform the lives of patients and families afflicted with serious neurological diseases who do not have adequate or any treatment options. Sangamo believes that its zinc finger epigenetic regulators are ideally suited to potentially address devastating neurological disorders and that its capsid discovery platform can expand delivery beyond currently available intrathecal delivery capsids, including in the central nervous system. Sangamo’s pipeline also includes multiple partnered programs and programs with opportunities for partnership and investment. To learn more, visit www.sangamo.com and connect with us on LinkedIn and X.

Contacts

Investor Relations
Louise Wilkie

ir@sangamo.com

Media Inquiries
Melinda Hutcheon

media@sangamo.com

Baxter Declares Quarterly Dividend




Baxter Declares Quarterly Dividend

DEERFIELD, Ill.–(BUSINESS WIRE)–Baxter International Inc. (NYSE:BAX), a global medtech leader, today announced that its Board of Directors has declared a quarterly cash dividend of $0.17 per share of common stock. The dividend is payable on July 1, 2025, to stockholders of record as of May 30, 2025. The indicated annual dividend rate is $0.68 per share of common stock.

About Baxter

Every day, millions of patients, caregivers and healthcare providers rely on Baxter’s leading portfolio of diagnostic, critical care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For more than 90 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, digital health solutions and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on X, LinkedIn and Facebook.

This release includes forward-looking statements concerning the company’s capital allocation, which currently includes the issuance of quarterly dividends. These forward-looking statements are based on assumptions about many factors (including Baxter’s ability to achieve its short- and long-term financial goals), and it is possible that Baxter’s annual dividend payout rate may differ, possibly materially, from the anticipated annual indicative dividend described herein or may be suspended for a period of time. For information about some of the risks and important factors that could affect Baxter’s future results, financial condition and liquidity, see Baxter’s most recent filings on Forms 10-K and 10-Q and other SEC filings, all of which are available on Baxter’s website. Baxter does not undertake to update its forward-looking statements unless otherwise required by the federal securities laws.

Baxter is a registered trademark of Baxter International Inc.

Contacts

Media Contact

Steve Brett, (224) 948-5353

media@baxter.com

Investor Contact

Clare Trachtman, (224) 948-3020

ImmunityBio Requests an Urgent Meeting With FDA to Address the Change in the Agency’s Unambiguous Guidance on Jan 2025 to Submit a sBLA for NMIBC BCG Unresponsive Papillary Disease, Following an Inconsistent Refusal to File Letter on May 2, 2025




ImmunityBio Requests an Urgent Meeting With FDA to Address the Change in the Agency’s Unambiguous Guidance on Jan 2025 to Submit a sBLA for NMIBC BCG Unresponsive Papillary Disease, Following an Inconsistent Refusal to File Letter on May 2, 2025

CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced that the Company received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for the supplemental biologics license application (sBLA) for use of ANKTIVA plus Bacillus Calmette-Guerin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) for the indication of papillary disease. This RTF letter was received despite reaching unanimous guidance and encouragement at the in-person January 2025 meeting from the leadership of the Agency, including from CBER, CDER and OCE to submit this sBLA. At this meeting all key decision makers were specifically asked and unanimously confirmed that ImmunityBio should submit the sBLA as soon as possible based on the data in the single-arm trial. Relying on this unanimous guidance the Company submitted the sBLA in March 2025. The Company has already requested an urgent meeting to resolve the inconsistencies between the directives provided at the January Meeting and receipt of the RTF letter.

ANKTIVA was approved by the FDA in 2024 with BCG for the treatment of BCG unresponsive NMIBC with Papillary tumors with CIS (Cohort A). In the same clinical trial (QUILT-3.032) long term results of patients with Papillary tumors without CIS (Cohort B), was submitted as a sBLA. The RTF letter referenced herein does not impact this prior approval of CIS +/- Papillary in BCG unresponsive patients.

The Agency leaders present at the January meeting unambiguously invited the Company to expeditiously submit an sBLA for the NMIBC papillary indication based on the strength of the clinical response and long-term duration of follow-up data of the Papillary without CIS cohort of the QUILT 3.032 study. Data was also presented of the long term follow-up Phase 1 results which demonstrated Complete Response and Disease Free Survival in both CIS and Papillary disease, with patients in on-going cystectomy free state at 10 years. In addition disease-specific overall survival rate of 99% at 12 months and 96% at 36 months, in the BCG unresponsive patients with Papillary disease without CIS was discussed. To our knowledge, this is the most durable data to date in the Papillary setting for bladder preservation.

In March 2025, the Company completed its submission to the FDA of the sBLA for the use of ANKTIVA plus BCG in BCG-unresponsive NMIBC in the papillary indication. On May 2, 2025, and notwithstanding the FDA’s invitation to submit the sBLA articulated by its leadership at the January Meeting, the FDA delivered an RTF letter. The Company together with its consultants who attended the January 2025 meeting were shocked by this inconsistent response and have requested an urgent meeting with the Agency to resolve this issue.

“Our commitment to NMIBC patients in the papillary indication and our belief in ANKTIVA’s potential based on the strength of the clinical response and long duration of 5-year follow-up remains unchanged, despite our receipt of a refusal to file letter regarding our supplemental BLA,” said Dr. Patrick Soon-Shiong, the Company’s Founder, Executive Chairman and Global Chief Scientific and Medical Officer. “We are fully determined to work with the FDA as quickly as possible, including having already requested a Type A meeting, to explore the best path forward. We would also welcome an FDA Advisory Committee meeting as part of the regulatory process going forward. We presented our data at the recent 2025 American Urological Association (AUA) meeting and ANKTIVA+BCG was considered best in class and best in disease by the thought leaders in attendance, when compared to all the therapies currently approved or in development. Patients with BCG Unresponsive Papillary disease, face a life changing and life-threatening prospect of a total radical cystectomy, as well as the danger of the disease progressing from non-muscle invasive to muscle invasion with consequent progression and mortality. With the data presented of 99% disease specific survival at 12 months and over 82% patients not requiring bladder removal, it is essential that these patients be provided this treatment option, especially with the safety profile of ANKTIVA+BCG and the already approved indication of Papillary disease with CIS. The Company presented these data to the Agency in person in January and the Agency leaders present unanimously encouraged the company to expeditiously submit a supplemental BLA for this indication.”

Dr. Soon-Shiong further stated: “The Agency must explain the confounding inconsistency of approving ANKTIVA+BCG for patients with Papillary with CIS disease, while refusing to file the sBLA for patients with Papillary without CIS disease—even though both groups were part of the same trial, in the same high-risk population of BCG-unresponsive non-muscle invasive bladder cancer. In both cases, patients received the same surgical procedure for the Papillary component, the same therapy at the same dose, with the same excellent tolerability and meaningful clinical benefit: over 82% bladder-sparing and over 96% disease-specific survival at 36 months, as shown in Figure 1. On behalf of patients facing a potential loss of a vital organ and high risk of progression of disease, I urge the Agency to reconsider and act now.”

“I actively participated in the January 2025 meeting at which the leadership of the Agency present at that meeting unanimously supported and encouraged ImmunityBio to submit results from the single arm trial, QUILT 3.032 as a supplemental BLA because of the high-risk of progression and metastasis these patients with BCG unresponsiveness face. The consensus was reached by all present, including me, because of the lack of satisfactory alternatives in this desperately ill population at high-risk of losing their bladder – a life threatening and life changing procedure. Thus, I was startled to learn the ImmunityBio had received a ‘Refuse to File’ letter which is in my opinion rife with regulatory inaccuracies. I recommend that the company seek a rapid meeting with the Agency to resolve this issue and minimize the delay and threat to well-being of patients who could benefit significantly from avoiding a cystectomy,” said Dr. Rachel Sherman, former FDA Principal Deputy Commissioner, who pioneered single arm trials at the height of the HIV epidemic, and was responsible for developing the expedited pathways at the Agency to address life threatening and serious diseases on behalf of the American public during her 30 year career at the agency. “Furthermore, it is incomprehensible to me that the FDA refuses to file a supplemental BLA, stating the study is not sufficient to support a regulatory review, when it has already approved a product based on that very same study in essentially the same indication and population. As stated above, these patients are suffering from a disease with a high risk of morbidity and mortality in the very short term – no delay should be tolerated,” added Dr. Sherman.

About the QUILT-3.032 Study

QUILT-3.032 (NCT03022825) is a Phase II/III, open-label, single-arm, multicenter study of intravesical BCG plus ANKTIVA or ANKTIVA only in patients with BCG unresponsive high grade non-muscle invasive bladder cancer (NMIBC). All participants receive BCG plus ANKTIVA (Cohorts A and B) or ANKTIVA only (Cohort C) via a urinary catheter in the bladder for 6 consecutive weeks (initial induction treatment period). After the first disease assessment, eligible patients receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36. The study duration is 60 months.

Cohort A (N=100) includes patients with histologically confirmed BCG-unresponsive NMIBC CIS with or without papillary disease. The primary endpoint is biopsy-confirmed complete response (CR) rate at any time. Secondary endpoints include duration of CR, progression-free survival (PFS), time to cystectomy, safety and overall survival. FDA Approved this indication in 2024 in which eligibility included patients with Papillary disease.

Cohort B (N=80) enrolled participants with histologically confirmed BCG-unresponsive high-grade Papillary disease without CIS. The primary endpoint is a response of a disease-free rate at 12 months. Secondary endpoints include disease-free survival DFS and disease-specific survival, PFS, time to cystectomy, safety and overall survival.

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 receptor 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 with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with CIS with or without papillary tumors. For more information, visit ImmunityBio.com (Founder’s Vision) and Anktiva.com.

About ImmunityBio

ImmunityBio is a vertically integrated biotechnology company developing next-generation therapies and vaccines 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.

References:

https://pmc.ncbi.nlm.nih.gov/articles/PMC10813486/

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, the company’s submission of the sBLA for use of ANKTIVA plus BCG in BCG-unresponsive NMIBC for the indication of papillary disease and potential results therefrom, the FDA’s delivery of a refusal to file letter regarding the aforementioned sBLA submission, potential next steps, decisions and timeline related and requirements thereof, potential Type A meeting with the FDA regarding the sBLA and timing thereof and results therefrom, potential Advisory Committee meeting with the FDA regarding the sBLA and timing thereof and results therefrom, clinical trial data and potential results to be drawn therefrom, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, potential future uses and applications of ANKTIVA and use in cancer vaccines and across multiple tumor types, 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 commercial launch execution, success and timing, (ii) risks and uncertainties regarding market access initiatives and timing, (iii) whether the FDA will accept the Company’s request for a Type A meeting and/or Advisory Committee Meeting, (iv) whether the FDA will permit the resubmission of the sBLA and the requirements thereof, (v) uncertainties regarding the timeline of the FDA’s review of these submissions even if accepted for review and filing, (vi) whether the FDA will ultimately approve the sBLA, or other submissions in a timely matter, or at all, of which there can be no assurance, (vii) risks and uncertainties regarding limited resources at the FDA and potential delays associated therewith, (viii) whether clinical trials will result in registrational pathways and the risks and uncertainties regarding the regulatory submission, filing, review and approval process, (ix) whether clinical trial data will be accepted by regulatory agencies, (x) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (xi) potential delays in product availability and regulatory approvals, (xii) ImmunityBio’s ability to retain and hire key personnel, (xiii) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xiv) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xv) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xvi) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xvii) 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 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

Media Contact:
Jen Hodson

Jen@nant.com

Henry Schein Reports First Quarter 2025 Financial Results




Henry Schein Reports First Quarter 2025 Financial Results

• First-quarter 2025 GAAP diluted EPS of $0.88, growth of 22% compared to the first quarter of 2024
• First-quarter 2025 non-GAAP diluted EPS of $1.15, growth of 4.5% compared to the first quarter of 2024
• Maintains guidance for 2025 non-GAAP diluted EPS of $4.80 to $4.94, mid-single digit 2025 Adjusted EBITDA growth, and sales growth of 2% to 4%
• Repurchased $161 million of common stock, or approximately 2.3 million shares
  
  

MELVILLE, N.Y.–(BUSINESS WIRE)–Henry Schein, Inc. (Nasdaq: HSIC), the world’s largest provider of health care solutions to office-based dental and medical practitioners, today reported financial results for the first quarter ended March 29, 2025.

“We are pleased with our first quarter financial results as well as the momentum we are seeing heading into the second quarter and remain confident in the fundamentals of our business,” said Stanley M. Bergman, Chairman of the Board and Chief Executive Officer of Henry Schein.

“We are advancing our BOLD+1 Strategic Plan, which has been refreshed for 2025 to 2027, with our team focused on growing the distribution business through increasing operational efficiency and enhancing customer experience, growing our dental and medical specialty businesses and corporate brand products, and further developing our digital footprint and digital solutions. We remain committed to our long-term financial goal of high-single-digit to low-double-digit earnings growth by continuing to successfully execute against this strategy,” Mr. Bergman added.

First Quarter 2025 Financial Results

• Total net sales for the quarter were $3.2 billion:
  • Constant currency total net sales increased 1.4% compared with the first quarter of 2024. Excluding the impact of personal protective equipment (PPE) and COVID test kits, constant currency sales growth was 2.0%.
  • As-reported total net sales decreased 0.1% due to a stronger U.S. dollar versus the first quarter of last year.
• Global Distribution and Value-Added Services sales for the quarter increased 0.8% in constant currencies compared with the first quarter of 2024, and increased 1.5% excluding the impact of PPE and COVID test kits. As-reported sales decreased 0.7%. The main components include:
  • Global Dental Distribution merchandise sales for the quarter increased 0.4% in constant currencies compared with the first quarter of 2024, and increased 0.9% excluding the impact of PPE and COVID test kits. Monthly sales growth accelerated throughout the quarter after a slow start in January primarily as a result of weather-related events in the U.S. As-reported sales decreased 2.1%.
  • Global Dental Distribution equipment sales for the quarter decreased 2.4% in constant currencies compared with the first quarter of 2024. Sales growth was impacted by a deferral of sales from the fourth quarter of 2023 to the first quarter of 2024, resulting in a more difficult year-over-year comparison. Adjusting for this, global dental equipment sales growth in constant currencies was approximately flat to prior year. As-reported sales decreased 4.5%.
  • Global Medical Distribution sales for the quarter increased 3.0% in constant currencies compared with the first quarter of 2024, and increased 4.4% excluding the impact of PPE and COVID test kits, reflecting increased patient traffic to physician offices, strong growth in our home solutions business and growth from acquisitions. As-reported sales increased 2.9%.
• Global Specialty Products sales for the quarter increased 4.3% in constant currencies compared with the first quarter of 2024, reflecting continued growth in implant and biomaterial sales and acquisition growth. As-reported sales increased 2.0%.
• Global Technology sales for the quarter increased 3.4% in constant currencies compared with the first quarter of 2024. Strong sales growth in practice management systems, including Dentrix Ascend and Dentally cloud-based solutions, as well as in revenue cycle management products, was partially offset by lower sales of certain legacy products that are being sunset. As-reported sales increased 2.9%.

First-quarter sales growth is detailed in Exhibit A¹.

• GAAP net income² for the quarter was $110 million, or $0.88 per diluted share⁴, and compares with first-quarter 2024 GAAP net income of $93 million, or $0.72 per diluted share.
• Non-GAAP net income² for the quarter was $143 million, or $1.15 per diluted share⁴, and compares with first-quarter 2024 non-GAAP net income of $143 million, or $1.10 per diluted share.
• Adjusted EBITDA³ for the quarter was $259 million and compares with first-quarter 2024 Adjusted EBITDA of $255 million.
  

Restructuring Plan

During the first quarter of 2025, the Company recorded $25 million in restructuring costs and expects to achieve annual run-rate savings at the high end of its $75 million to $100 million goal by the end of 2025.

Share Repurchases

During the first quarter of 2025, the Company repurchased approximately 2.3 million shares of its common stock at an average price of $71.58 per share, for a total of $161 million. The impact of these share repurchases on first-quarter diluted EPS was immaterial.

At the end of the quarter, Henry Schein had $718 million authorized and available for future stock repurchases.

2025 Financial Guidance

Henry Schein today maintained its financial guidance for 2025. Guidance is for current continuing operations as well as acquisitions that have closed and does not include the impact of restructuring and integration expenses, amortization expense of acquired intangible assets, the insurance claim recovery associated with the cybersecurity incident and costs associated with shareholder advisory matters. This guidance also assumes that foreign currency exchange rates remain generally consistent with current levels and that additional tariffs will not be introduced.

• 2025 non-GAAP diluted EPS attributable to Henry Schein, Inc. is unchanged and is expected to be $4.80 to $4.94, reflecting growth of 1% to 4% compared with 2024 non-GAAP diluted EPS of $4.74.
• 2025 total sales growth is unchanged and is expected to be approximately 2% to 4% over 2024.
• 2025 Adjusted EBITDA³ growth is unchanged and is expected to increase mid-single digits compared with 2024.

Adjustments to 2025 GAAP Net Income and Diluted EPS

The Company is providing guidance for 2025 diluted EPS on a non-GAAP basis and for 2025 Adjusted EBITDA, as noted above. The Company is not providing a reconciliation of its 2025 non-GAAP diluted EPS guidance to its projected 2025 diluted EPS prepared on a GAAP basis, or its 2025 Adjusted EBITDA guidance to net income prepared on a GAAP basis. This is because the Company is unable to provide without unreasonable effort an estimate of restructuring costs related to an ongoing initiative to drive operating efficiencies, including the corresponding tax effect, which will be included in the Company’s 2025 diluted EPS and net income, prepared on a GAAP basis. The inability to provide this reconciliation is due to the uncertainty and inherent difficulty of predicting the occurrence, magnitude, financial impact and timing of related costs.

Management does not believe these items are representative of the Company’s underlying business performance. For the same reasons, the Company is unable to address the probable significance of the unavailable information, which could be material to future results.

First-Quarter 2025 Conference Call Webcast

The Company will hold a conference call to discuss first-quarter 2025 financial results today, beginning at 8:00 a.m. Eastern time. Individual investors are invited to listen to the conference call through Henry Schein’s website by visiting https://investor.henryschein.com/webcasts. In addition, a replay will be available beginning shortly after the call has ended for a period of one week.

The Company will be posting slides that provide a summary of its first-quarter 2025 financial results on its website at https://www.henryschein.com/us-en/Corporate/investor-presentations.aspx.

About Henry Schein, Inc.

Henry Schein, Inc. (Nasdaq: HSIC) is a solutions company for health care professionals powered by a network of people and technology. With approximately 25,000 Team Schein Members worldwide, the Company’s network of trusted advisors provides more than 1 million customers globally with more than 300 valued solutions that help improve operational success and clinical outcomes. Our Business, Clinical, Technology and Supply Chain solutions help office-based dental and medical practitioners work more efficiently so they can provide quality care more effectively. These solutions also support dental laboratories, government and institutional health care clinics, as well as other alternate care sites.

Henry Schein operates through a centralized and automated distribution network, with a selection of more than 300,000 branded products and Henry Schein corporate brand products in our main distribution centers.

A FORTUNE 500 Company and a member of the S&P 500® index, Henry Schein is headquartered in Melville, N.Y., and has operations or affiliates in 33 countries and territories. The Company’s sales reached $12.7 billion in 2024, and have grown at a compound annual rate of approximately 11.2 percent since Henry Schein became a public company in 1995.

For more information, visit Henry Schein at www.henryschein.com, Facebook.com/HenrySchein, Instagram.com/HenrySchein, and @HenrySchein on X.

Cautionary Note Regarding Forward-Looking Statements and Use of Non-GAAP Financial Information

In accordance with the “Safe Harbor” provisions of the Private Securities Litigation Reform Act of 1995, we provide the following cautionary remarks regarding important factors that, among others, could cause future results to differ materially from the forward-looking statements, expectations and assumptions expressed or implied herein. All forward-looking statements made by us are subject to risks and uncertainties and are not guarantees of future performance. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance and achievements or industry results to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.

These statements include total sales growth, EPS and Adjusted EBITDA guidance and are generally identified by the use of such terms as “may,” “could,” “expect,” “intend,” “believe,” “plan,” “estimate,” “forecast,” “project,” “anticipate,” “to be,” “to make” or other comparable terms. A fuller discussion of our operations, financial condition and status of litigation matters, including factors that may affect our business and future prospects, is contained in documents we have filed with the United States Securities and Exchange Commission, or SEC, including our Annual Report on Form 10-K, and will be contained in all subsequent periodic filings we make with the SEC. These documents identify in detail important risk factors that could cause our actual performance to differ materially from current expectations.

Risk factors and uncertainties that could cause actual results to differ materially from current and historical results include, but are not limited to: our dependence on third parties for the manufacture and supply of our products and where we manufacture products, our dependence on third parties for raw materials or purchased components; risks relating to the achievement of our strategic growth objectives; risks related to the Strategic Partnership Agreement with KKR Hawaii Aggregator L.P. entered into in January 2025; our ability to develop or acquire and maintain and protect new products (particularly technology products) and services and utilize new technologies that achieve market acceptance with acceptable margins; transitional challenges associated with acquisitions, dispositions and joint ventures, including the failure to achieve anticipated synergies/benefits, as well as significant demands on our operations, information systems, legal, regulatory, compliance, financial and human resources functions in connection with acquisitions, dispositions and joint ventures; certain provisions in our governing documents that may discourage third-party acquisitions of us; adverse changes in supplier rebates or other purchasing incentives; risks related to the sale of corporate brand products; risks related to activist investors; security risks associated with our information systems and technology products and services, such as cyberattacks or other privacy or data security breaches (including the October 2023 incident); effects of a highly competitive (including, without limitation, competition from third-party online commerce sites) and consolidating market; changes in the health care industry; risks from expansion of customer purchasing power and multi-tiered costing structures; increases in shipping costs for our products or other service issues with our third-party shippers, and increases in fuel and energy costs; changes in laws and policies governing manufacturing, development and investment in territories and countries where we do business; general global and domestic macro-economic and political conditions, including inflation, deflation, recession, unemployment (and corresponding increase in under-insured populations), consumer confidence, sovereign debt levels, ongoing wars, fluctuations in energy pricing and the value of the U.S. dollar as compared to foreign currencies, changes to other economic indicators and international trade agreements; the threat or outbreak of war, terrorism or public unrest (including, without limitation, the war in Ukraine, the Israel-Gaza war and other unrest and threats in the Middle East and the possibility of a wider European or global conflict); changes to laws and policies governing foreign trade, tariffs and sanctions, including the current imposition of additional new tariffs by the U.S. on numerous countries, retaliatory tariffs and potential for additional retaliatory tariffs; greater restrictions on imports and exports; supply chain disruption; geopolitical wars; failure to comply with existing and future regulatory requirements, including relating to health care; risks associated with the EU Medical Device Regulation; failure to comply with laws and regulations relating to health care fraud or other laws and regulations; failure to comply with laws and regulations relating to the collection, storage and processing of sensitive personal information or standards in electronic health records or transmissions; changes in tax legislation, changes in tax rates and availability of certain tax deductions; risks related to product liability, intellectual property and other claims; risks associated with customs policies or legislative import restrictions; risks associated with disease outbreaks, epidemics, pandemics (such as the COVID-19 pandemic), or similar wide-spread public health concerns and other natural or man-made disasters; risks associated with our global operations; litigation risks; new or unanticipated litigation developments and the status of litigation matters; our dependence on our senior management, employee hiring and retention, increases in labor costs or health care costs, and our relationships with customers, suppliers and manufacturers; and disruptions in financial markets. The order in which these factors appear should not be construed to indicate their relative importance or priority.

We caution that these factors may not be exhaustive and that many of these factors are beyond our ability to control or predict. Accordingly, any forward-looking statements contained herein should not be relied upon as a prediction of actual results. We undertake no duty and have no obligation to update forward-looking statements except as required by law.

Included within the press release are non-GAAP financial measures that supplement the Company’s Consolidated Statements of Income prepared under generally accepted accounting principles (GAAP). These non-GAAP financial measures adjust the Company’s actual results prepared under GAAP to exclude certain items. In the schedule attached to the press release, the non-GAAP measures have been reconciled to and should be considered together with the Consolidated Statements of Income. Management believes that non-GAAP financial measures provide investors with useful supplemental information about the financial performance of our business, enable comparison of financial results between periods where certain items may vary independent of business performance and allow for greater transparency with respect to key metrics used by management in operating our business. The impact of certain items that are excluded include integration and restructuring costs, and amortization of acquisition-related assets, because the amount and timing of such charges are significantly impacted by the timing, size, number and nature of the acquisitions we consummate and occur on an unpredictable basis. These non-GAAP financial measures are presented solely for informational and comparative purposes and should not be regarded as a replacement for corresponding, similarly captioned, GAAP measures.

¹ See Exhibit A for details of sales growth. Internal sales growth is calculated from total net sales using constant foreign currency exchange rates and excludes sales from acquisitions.

² See Exhibit B for a reconciliation of GAAP net income and diluted EPS to non-GAAP net income and diluted EPS.

³ See Exhibit C for a reconciliation of GAAP net income to Adjusted EBITDA.

⁴ References to diluted EPS refer to diluted EPS attributable to Henry Schein, Inc.

(TABLES TO FOLLOW)

Contacts

Investors
Ronald N. South

Senior Vice President and Chief Financial Officer

ronald.south@henryschein.com
(631) 843-5500

Graham Stanley

Vice President, Investor Relations and Strategic Financial Project Officer

graham.stanley@henryschein.com
(631) 843-5500

Media

Tim Vassilakos

Executive Director, Global Corporate Communications

timothy.vassilakos@henryschein.com
(516)-510-0926

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Aurinia Pharmaceuticals to Release First Quarter 2025 Financial and Operational Results on May 12, 2025




Aurinia Pharmaceuticals to Release First Quarter 2025 Financial and Operational Results on May 12, 2025

ROCKVILLE, Md. & EDMONTON, Alberta–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that it will release first quarter 2025 financial and operational results before markets open on May 12, 2025.

Aurinia’s management team will host a conference call and webcast at 8:30 AM ET that day to review these results and provide a general business update. The link to the audio webcast is available here. To join the conference call, please dial 877-407-9170 / +1 201-493-6756. A replay of the webcast will be available on Aurinia’s website.

About Aurinia

Aurinia Pharmaceuticals is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS^® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a dual B cell activating factor (BAFF) and a proliferation inducing ligand (APRIL) inhibitor for the potential treatment of autoimmune diseases.

Contacts

Media & Investor Inquiries:
Andrea Christopher

Corporate Communications & Investor Relations

Aurinia Pharmaceuticals Inc.

achristopher@auriniapharma.com

General Investor Inquiries:
ir@auriniapharma.com

Mammoth Biosciences Announces Nomination of MB-111 as First Development Candidate and Appoints Genetic Medicines Veteran Bob D. Brown to Board of Directors




Mammoth Biosciences Announces Nomination of MB-111 as First Development Candidate and Appoints Genetic Medicines Veteran Bob D. Brown to Board of Directors

MB-111 is a potential first-in-class in vivo ultracompact CRISPR therapy for Familial Chylomicronemia Syndrome and Severe Hypertriglyceridemia

Dr. Brown brings deep expertise in nucleic acid drug development as Mammoth advances its lead program, MB-111, to IND-enabling stage and continues to build a leading company in genetic medicines

BRISBANE, Calif.–(BUSINESS WIRE)–#CRISPR—Mammoth Biosciences, Inc., a biotechnology company harnessing its proprietary next-generation CRISPR gene editing platform to create potential one-time curative therapies, today announced the nomination of its first clinical development candidate, MB-111, and the appointment of biotechnology industry veteran, Bob D. Brown, Ph.D., to its Board of Directors.

MB-111 utilizes CasPhi — an ultracompact CRISPR in vivo gene editing system that is less than half the size of first-generation, Cas9-based systems — encapsulated in a lipid nanoparticle for delivery to the liver after IV administration. MB-111 has the potential to be a first-in-class, one-time treatment for patients with very high triglycerides including familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (SHTG).

MB-111 is designed to permanently disrupt the expression of the APOC3 gene in the liver, and thus to reduce expression of ApoC-III protein. ApoC-III is a critical driver of lipid metabolism and disrupting its production has been shown to reduce plasma triglycerides in patients with pathologically elevated levels, including those with FCS and SHTG. These patients suffer from recurrent episodes of acute pancreatitis, leading to frequent hospitalizations, as well as an increased risk of cardiovascular disease. Mammoth Biosciences is on track to initiate IND-enabling studies this year.

“The nomination of our lead program as a development candidate is a major milestone for Mammoth and the gene editing field, as well as the first proof point of the therapeutic potential of our novel ultracompact CRISPR systems and gene editing technologies,” said Trevor Martin, Ph.D., co-founder and Chief Executive Officer of Mammoth Biosciences. “The preclinical data on MB-111 is compelling, and we’re excited about its potential to be a first-in-class genetic cure for debilitating diseases such as FCS and SHTG. We believe Dr. Brown’s extensive drug discovery and development experience, and track record of building leading companies in siRNA and antisense oligonucleotide therapeutics across rare and chronic diseases will be invaluable to our goal of increasing the number of patients who can derive benefit from Mammoth Biosciences’ genetic medicines.”

Dr. Bob D. Brown brings over 30 years of experience in multidisciplinary biotechnology research and drug development, including in the US and ex-US jurisdictions. Most recently, Dr. Brown served as Chief Scientific Officer and Executive Vice President of R&D at Dicerna Pharmaceuticals, an RNAi-focused therapeutics company that was acquired by Novo Nordisk. At Novo, he served as President and Head of the Dicerna Transformation Research Unit and SVP. During his time at Dicerna, he led the discovery and early clinical development of numerous genetic medicines, including nedosiran for the treatment of primary hyperoxaluria, RG6346 for the treatment of chronic hepatitis B, belcesiran for the treatment of alpha-1 antitrypsin deficiency, and several other drug candidates now in the clinical development pipelines of large pharmaceutical companies.

Prior to Dicerna, Dr. Brown held various positions at Genta, a clinical-stage antisense oligonucleotide therapeutics company, most recently as its Vice President of Research and Technology. Previously, he was a co-founder and Vice President of R&D of Oasis Biosciences, which was acquired by Gen-Probe. Dr. Brown is an inventor or co-inventor of more than 85 issued US patents, and earned a Ph.D. in molecular biology from the University of California, Berkeley and B.S. degrees in chemistry and biology from the University of Washington, Seattle.

“I’m honored to join Mammoth Biosciences at such a pivotal moment, as CRISPR technology stands ready to transform healthcare and redefine the future of medicine,” said Dr. Brown. “I look forward to working with the exceptional Mammoth Biosciences team to harness the power of their groundbreaking platform to tackle some of the most pressing medical challenges and improve patients’ lives. Drawing on my experiences in drug discovery and clinical development, I aim to help advance Mammoth Biosciences’ ultracompact CRISPR gene editing therapies—starting with MB-111—toward clinical application.”

About Mammoth Biosciences

Mammoth Biosciences is a biotechnology company focused on leveraging its proprietary ultracompact CRISPR systems to develop potential long-term curative therapies for patients with life-threatening and debilitating diseases. Founded by CRISPR pioneer and Nobel laureate Jennifer Doudna and Trevor Martin, Janice Chen, and Lucas Harrington, the company’s ultracompact systems are designed to be more specific and enable in vivo gene editing in difficult to reach tissues utilizing both nuclease applications and new editing modalities beyond double stranded breaks, including base editing, reverse transcriptase editing, and epigenetic editing. The company is building out its wholly owned pipeline of potential in vivo gene editing therapeutics and capabilities and has partnerships with leading pharmaceutical and biotechnology companies to broaden the reach of its innovative and proprietary technology platform. Mammoth Biosciences’ deep science and industry experience, along with a robust and differentiated intellectual property portfolio, have enabled the company to further its mission to transform the lives of patients and deliver on the promise of CRISPR technologies.

Contacts

Media Contact:
Mohana Ray

Email: Mammoth.PR@hdmz.com
Phone: 312-506-5210

InnoCare’s Zurletrectinib Receives Priority Review from China’s NMPA




InnoCare’s Zurletrectinib Receives Priority Review from China’s NMPA

BEIJING–(BUSINESS WIRE)–InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, announced today that its new generation pan-TRK inhibitor zurletrectinib (ICP-723) has been granted priority review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), which accepted the New Drug Application (NDA) of zurletrectinib for the treatment of patients with advanced solid tumors harboring NTRK gene fusions recently. Priority review is one of the key policies introduced by the CDE to accelerate drug approval.

In the registrational trial for patients with NTRK fusion-positive solid tumors, zurletrectinib demonstrated outstanding efficacy with a good safety profile.

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, “We are delighted that zurletrectinib has been granted priority review. Zurletrectinib has demonstrated outstanding efficacy and a favorable safety profile. We anticipate it will provide better treatment options for eligible patients with solid tumors earlier.”

Zurletrectinib is a pan-TRK inhibitor developed by InnoCare. British Journal of Cancer, part of leading science journal Nature, published a paper entitled “Zurletrectinib is a next-generation TRK inhibitor with strong intracranial activity against NTRK fusion-positive tumors with on-target resistance to first-generation agents”¹.

NTRK fusion genes occur in various types of adult and pediatric tumors. In some rare tumors, such as salivary gland carcinoma, secretory breast cancer, and infantile fibrosarcoma, the incidence of NTRK gene fusion exceeds 90%². It is estimated that there are about 6,500 new cases of NTRK fusion-positive solid tumors are diagnosed in China each year. There are significant unmet clinical needs in this area due to lack of effective treatment options.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

InnoCare Forward-looking Statements

This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management’s intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.

Contacts

Media
Chunhua Lu

86-10-66609879

chunhua.lu@innocarepharma.com

Investors
86-10-66609999

ir@innocarepharma.com

InfuSystem to Report First Quarter 2025 Financial Results on May 8, 2025




InfuSystem to Report First Quarter 2025 Financial Results on May 8, 2025

Investor Conference Call to be held 9:00 a.m. Eastern Time

ROCHESTER HILLS, Mich.–(BUSINESS WIRE)–InfuSystem Holdings, Inc. (NYSE American: INFU) (“InfuSystem” or the “Company”), a leading national health care service provider, facilitating outpatient care for durable medical equipment manufacturers and health care providers, announced today it will issue first quarter 2025 financial results on Thursday, May 8, 2025, before the market opens.

The Company will also conduct a conference call for all interested parties on Thursday, May 8, 2025 at 9:00 a.m. Eastern Time to discuss its financial results.

To participate in this call, please dial (833) 366-1127 or (412) 902-6773, or listen via a live webcast, which is available in the Investors section of the Company’s website at https://ir.infusystem.com/. A replay of the call will be available by visiting https://ir.infusystem.com/ for the next 90 days or by calling (877) 344-7529 or (412) 317-0088, replay access code 6704669 through Thursday, May 15, 2025.

About InfuSystem Holdings, Inc.

InfuSystem Holdings, Inc. (NYSE American: INFU), is a leading national health care service provider, facilitating outpatient care for durable medical equipment manufacturers and health care providers. INFU services are provided under a two-platform model. The lead platform is Patient Services, providing the last-mile solution for clinic-to-home healthcare where the continuing treatment involves complex durable medical equipment and services. The Patient Services segment is comprised of Oncology, Pain Management and Wound Therapy businesses. The second platform, Device Solutions, supports the Patient Services platform and leverages strong service orientation to win incremental business from its direct payer clients. The Device Solutions segment is comprised of direct payer rentals, pump and consumable sales, and biomedical services and repair. Headquartered in Rochester Hills, Michigan, the Company delivers local, field-based customer support and also operates Centers of Excellence in Michigan, Kansas, California, Massachusetts, Texas and Ontario, Canada.

Contacts

Joe Dorame, Joe Diaz & Robert Blum

Lytham Partners, LLC

602-889-9700