Enveric Biosciences Announces Pricing of $5 Million Public Offering




Enveric Biosciences Announces Pricing of $5 Million Public Offering

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, today announced the pricing of a public offering of an aggregate of 1,666,666 shares of its common stock (or common stock equivalents in lieu thereof), Series A warrants to purchase up to 1,666,666 shares of common stock and Series B warrants to purchase up to 1,666,666 shares of common stock, at a combined public offering price of $3.00 per share (or per common stock equivalent in lieu thereof) and accompanying warrants. The warrants will have an exercise price of $3.00 per share and will be exercisable immediately. The Series A warrants will expire five years from the date of issuance and the Series B warrants will expire eighteen months from the date of issuance. The closing of the offering is expected to occur on or about February 3, 2025, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be approximately $5 million. The Company intends to use the net proceeds from this offering for product development, working capital and general corporate purposes.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-284277), which was declared effective by the Securities and Exchange Commission (the “SEC”) on January 30, 2025. The offering is being made only by means of a prospectus forming part of the effective registration statement relating to the offering. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, 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.

About Enveric Biosciences

Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders. Leveraging its unique discovery and development platform, the Psybrary™, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric seeks to develop a robust intellectual property portfolio of novel drug candidates. Enveric’s lead molecule, EB-003, is a potential first-in-class neuroplastogen designed to promote neuroplasticity, without inducing hallucinations, in patients suffering from difficult-to-address mental health disorders. Enveric is focused on advancing EB-003 towards clinical trials for the treatment of neuropsychiatric disorders while out-licensing all other novel, patented Psybrary™ drug candidates to third-party licensees advancing non-competitive market strategies for patient care. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit www.enveric.com.

Forward-Looking Statements

This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans,” “expects” or “does not expect,” “proposes,” “budgets,” “explores,” “schedules,” “seeks,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management, including, but not limited to, statements regarding the completion of the offering, the satisfaction of customary closing conditions related to the offering and the anticipated use of proceeds therefrom. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: successfully outlicense patented Psybrary™ drug candidates to third-party licensees; negotiate and finalize definitive agreements based on any of its out-licensing term sheets and for licensees to perform pursuant to the terms thereof; finalize and submit its IND filing to the U.S. Food and Drug Administration; carry out successful clinical programs; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric’s products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively.

Contacts

Investor Relations

Tiberend Strategic Advisors, Inc.

David Irish

(231) 632-0002

dirish@tiberend.com

Media Relations

Tiberend Strategic Advisors, Inc.

Casey McDonald

(646) 577-8520

cmcdonald@tiberend.com

Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain




Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain

— JOURNAVX is the first and only approved non-opioid oral pain signal inhibitor and the first new class of pain medicine approved in more than 20 years —

— JOURNAVX is an effective and well-tolerated medicine without evidence of addictive potential indicated for use across all types of moderate-to-severe acute pain —

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved JOURNAVX™ (suzetrigine), an oral, non-opioid, highly selective NaV1.8 pain signal inhibitor for the treatment of adults with moderate-to-severe acute pain. JOURNAVX is an effective, well-tolerated medicine without evidence of addictive potential indicated for use across all types of moderate-to-severe acute pain.

“Today’s approval is a historic milestone for the 80 million people in America who are prescribed a medicine for moderate-to-severe acute pain each year,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “With the approval of JOURNAVX, a non-opioid, pain signal inhibitor and the first new class of pain medicine approved in more than 20 years, we have the opportunity to change the paradigm of acute pain management and establish a new standard of care.”

“This is an incredible day for patients and physicians alike who now have an approved non-opioid treatment that delivers effective acute pain relief and a favorable safety profile without addictive potential,” said Jessica Oswald, M.D., M.P.H., Associate Physician in Emergency Medicine and Pain Medicine in San Diego and Vertex Acute Pain Steering Committee Member. “I believe JOURNAVX could redefine the management of pain and become a foundational treatment option for people with all types of moderate-to-severe acute pain, where options aside from opioids have been so desperately needed.”

As part of Vertex’s ongoing commitment to patients, the company has established patient support programs to help ensure that qualified patients can access JOURNAVX. For more information visit JOURNAVX.com.

About Acute Pain

Acute pain is a serious and potentially disabling condition often caused by surgery, accident or injury. Over 80 million Americans are prescribed medicine to treat their moderate-to-severe acute pain every year. Of these, about 40 million are prescribed an opioid. Nearly 10% of acute pain patients treated initially with an opioid will go on to have prolonged opioid use, and about 85,000 patients will develop opioid use disorder annually. Poorly controlled acute pain can lead to reduced quality of life, development of chronic pain, and increased burden on the health care system and society.

About JOURNAVX™ (suzetrigine)

JOURNAVX (suzetrigine) is a first-in-class, oral, non-opioid, highly selective pain signal inhibitor that is selective for NaV1.8 relative to other NaV channels. NaV1.8 is a voltage-gated sodium channel that is selectively expressed in peripheral pain-sensing neurons (nociceptors), where its role is to transmit pain signals (action potentials). Because JOURNAVX blocks pain signals only found in the periphery, not in the brain, JOURNAVX provides effective relief of pain without the limitations of currently available therapies, including the addictive potential of opioids.

The U.S. Food and Drug Administration approved twice-daily JOURNAVX for the treatment of adults with moderate-to-severe acute pain. Vertex has established a wholesale acquisition cost for JOURNAVX in the United States of $15.50 per 50mg pill.

Vertex is also evaluating suzetrigine in peripheral neuropathic pain (PNP). The company’s Phase 3 pivotal program for suzetrigine in patients with painful diabetic peripheral neuropathy is ongoing, and Vertex plans to advance its pivotal program evaluating suzetrigine in patients with painful lumbosacral radiculopathy pending discussions with regulators.

INDICATION and IMPORTANT SAFETY INFORMATION FOR JOURNAVX^™ (suzetrigine)

INDICATION AND USAGE

JOURNAVX is a prescription medicine used to treat adults with moderate-to-severe short term (acute) pain.

It is not known if JOURNAVX is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Patients should not take JOURNAVX if they take certain medicines that are strong inhibitors of an enzyme called CYP3A. Patients should ask their healthcare providers if they are not sure.

Before taking JOURNAVX, patients should tell their healthcare provider about all of their medical conditions, including if they: have liver problems. People with liver problems may have an increased risk of getting side effects from taking JOURNAVX; are pregnant or plan to become pregnant as it is not known if JOURNAVX will harm an unborn baby. Patients and their healthcare providers should decide if they will take JOURNAVX while they are pregnant, are breastfeeding, or are planning to breastfeed, as it is not known if JOURNAVX passes into breast milk. Patients and their healthcare providers should decide if they will take JOURNAVX while they are breastfeeding.

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking JOURNAVX with certain other medicines may affect the way JOURNAVX and the other medicines work and may increase patients’ risk of side effects. Patients should ask their healthcare provider or pharmacist for a list of these medicines if they are not sure.

Patients should especially tell their healthcare provider if they take hormonal birth control medicine (contraceptives) containing progestins other than levonorgestrel or norethindrone. If they take one of these contraceptives (progestins other than levonorgestrel or norethindrone), they may not work as well during treatment with JOURNAVX. Patients should also use nonhormonal contraceptives such as condoms or use other forms of hormonal birth control during treatment with JOURNAVX and for 28 days after they stop taking JOURNAVX. Medicines that are substrates of the CYP3A enzyme may become less effective during treatment with JOURNAVX. Their healthcare provider may need to adjust the dose of patients’ medicine when starting or stopping JOURNAVX. Patients should know the medicines they take and keep a list of them to show their healthcare provider and pharmacist when they get a new medicine. Patients should not take food or drink containing grapefruit while taking JOURNAVX.

JOURNAVX can cause side effects: The most common side effects for patients treated with JOURNAVX include itching, muscle spasms, increased blood level of creatine phosphokinase, and rash. JOURNAVX may temporarily reduce the chance of females becoming pregnant while on treatment. Patients should talk to their healthcare provider if they have concerns about becoming pregnant. If patients are using contraceptives, continue to use contraceptives during treatment with JOURNAVX. Patients should tell their healthcare provider if they have any side effect that bothers them or that does not go away. These are not all of the possible side effects of JOURNAVX. Patients should call their healthcare provider for medical advice about side effects. Patients may report side effects to the FDA at 1-800-FDA-1088.

Please click here for the full Prescribing Information, including Patient Information, for JOURNAVX.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple serious diseases and conditions — cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain — and continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1.

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry’s top places to work, including 15 consecutive years on Science magazine’s Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex’s history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube and X.

Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements made by Reshma Kewalramani, M.D., and Jessica Oswald, M.D., M.P.H., in this press release and statements regarding the expectations for the potential benefits of JOURNAVX, expectations that JOURNAVX provides pain relief without the limitations of currently available therapies, including the addictive potential of opioids, expectations for the eligible patient population, plans for and status of our clinical trials evaluating suzetrigine in diabetic peripheral neuropathy, and plans to advance the pivotal program evaluating suzetrigine in patients with painful lumbosacral radiculopathy pending discussions with regulators. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company’s beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company’s development programs may not support registration or further development of its compounds due to safety, efficacy or other reasons, and other risks listed under the heading “Risk Factors” in Vertex’s annual report and in subsequent filings filed with the Securities and Exchange Commission and available through the company’s website at www.vrtx.com and www.sec.gov. You should not place undue reliance on these statements. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

Contacts

Vertex Pharmaceuticals Incorporated
Investors:
InvestorInfo@vrtx.com
Susie Lisa, CFA: +1 617-341-6108

or

Miroslava Minkova: +1 617-341-6135

Media:
mediainfo@vrtx.com
or

International: +44 20 3204 5275

or

U.S.: 617-341-6992

or

Heather Nichols: +1 617-839-3607

KORU Medical Systems Announces Phase III Clinical Trial Collaboration for a New Drug Indication in Nephrology




KORU Medical Systems Announces Phase III Clinical Trial Collaboration for a New Drug Indication in Nephrology

MAHWAH, N.J.–(BUSINESS WIRE)–KORU Medical Systems (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced a collaboration with a global pharmaceutical manufacturer on a Phase III clinical trial for an expanded indication of a commercialized drug therapy. The expanded indication is intended to treat a rare renal disorder in a population of approximately 30,000 patients with a projected 300,000 annual infusions.

This announcement highlights an additional collaboration between KORU Medical and its partners in the development of novel therapies and enhanced drug delivery experiences for patients living with rare conditions. The Phase III trial aims to assess the safety, efficacy, and performance of the drug to treat patients with complications from kidney transplants.

“We continue to see growth in the overall large volume subcutaneous market with multiple new drugs entering clinical trials and several others receiving regulatory approval. With over 2 million infusions administered on the KORU Freedom Infusion System every year, KORU continues to be a leading collaboration partner for large volume subcutaneous drug therapies in both the home and infusion clinic settings,” said Linda Tharby, President and CEO of KORU Medical. “Assuming successful completion and results from this Phase III clinical trial, this drug’s expanded indication will give us access to a new patient base and enable the delivery of a therapy to improve the lives of those with rare renal disorder.”

About KORU Medical Systems

KORU Medical Systems develops, manufactures, and commercializes innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world. The FREEDOM Syringe Infusion System (the “Freedom System”) currently includes the FREEDOM60® and FreedomEdge® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HIgH-Flo Subcutaneous Safety Needle Sets™. The Freedom System, which received its first FDA clearance in 1994, is used for self-administration in the home by the patient and/or delivery in an ambulatory infusion center by a healthcare professional. Through its Novel Therapies business, KORU Medical provides products for use by biopharmaceutical companies in feasibility/clinical trials during the drug development process and, as needed, is capable of customizing the Freedom System for clinical and commercial use across multiple drug categories. For more information, please visit www.korumedical.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, including but not limited to the success of the Phase III trial, success of the regulatory clearance, number of potential infusions available to the Freedom Infusion System. Actual results may differ materially from these statements due to potential risks and uncertainties such as those risks and uncertainties included under the captions “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 which is on file with the SEC and available on our website at www.korumedical.com/investors and on the SEC website at www.sec.gov. All information provided in this release and in the attachments is as of January 30, 2025. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. We undertake no duty to update this information unless required by law.

Contacts

Investor Contact:
Louisa Smith

investor@korumedical.com

Biote Announces CEO Retirement and Succession Plan




Biote Announces CEO Retirement and Succession Plan

Terry Weber Retiring as CEO and Director and Transitioning to Strategic Advisor to Company’s Board of Directors

Health Care Veteran Bret Christensen to Succeed Terry Weber as CEO and Director

IRVING, Texas–(BUSINESS WIRE)–biote Corp. (NASDAQ: BTMD) (“Biote” or the “Company”), a leading solutions provider in preventive health care through the delivery of personalized hormone optimization and therapeutic wellness, today announced that Terry Weber is retiring as Chief Executive Officer and stepping down from the Company’s Board of Directors, effective as of February 1, 2025. She will be transitioning to Strategic Advisor to the Company’s Board of Directors. Concurrently, Mr. Bret Christensen has been named Chief Executive Officer and Director, effective February 1, 2025.

“On behalf of the Board, I want to thank Terry for her many contributions to Biote’s success over the past six years. Under Terry’s leadership, Biote has grown to become one of the nation’s leading educators in hormone optimization, with over 7,000 Biote-certified practitioners advancing patient health and well-being throughout the country,” said Marc Beer, Executive Chairman of the Board of Directors. “Terry’s passionate commitment to women’s health has been invaluable in enabling Biote to redefine the concept of healthy aging, and we believe her strategic vision has positioned Biote for continued growth in the years ahead.”

Ms. Weber commented, “It has been my profound honor to grow Biote over the past six years while building Biote’s best-in-class practitioner network and advancing the cause of women’s health. I am proud of Biote’s continued efforts to initiate essential conversations that I believe will enhance health care industry practices and policies long-term. I look forward to collaborating with Bret and the Board as Biote further expands access to transformative healthcare solutions.”

Mr. Christensen is a distinguished executive with over two decades of leadership experience in women’s health and the broader health care sector. Throughout his career, Mr. Christensen has consistently worked to advance health care offerings into industry standards, demonstrating an outstanding ability to launch innovative solutions, penetrate markets and effectively scale businesses.

“On behalf of the Board of Directors, I am delighted to welcome Bret to Biote,” Mr. Beer said. “In his prior commercial and general management leadership roles at Hologic (NASDAQ: HOLX), Myriad Genetics (NASDAQ: MYGN) and Insulet (NASDAQ: PODD), Bret helped revolutionize treatments in women’s health care, oncology and diabetes, generating profitable growth and achieving significant commercial success of numerous products. With his deep expertise spanning the diagnostic, therapeutic and medical device health care sectors, we believe Bret is exceptionally qualified to lead Biote’s next level of growth and help drive value creation for Biote stakeholders.”

Mr. Christensen said, “I am excited to join Biote at this pivotal time as the Company continues to build on its success in hormone optimization while capturing the complementary growth opportunity in therapeutic wellness. With an unparalleled technology, training and education platform, I believe Biote is uniquely positioned to deliver impactful wellness services and products to an expanding universe of practitioners and patients and achieve accelerated growth.”

About Biote

Biote is transforming healthy aging through innovative, personalized hormone optimization and therapeutic wellness solutions delivered by Biote-certified medical providers. Biote trains practitioners to identify and treat early indicators of aging conditions, an underserved global market, providing affordable symptom relief for patients and driving clinic success for practitioners.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Some of the forward-looking statements can be identified by the use of forward-looking words. Statements that are not historical in nature, including the words “may,” “can,” “should,” “will,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “hope,” “believe,” “seek,” “target,” “continue,” “could,” “might,” “ongoing,” “potential,” “predict,” “would” and other similar expressions, are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual results or developments to differ materially from those expressed or implied by such forward-looking statements, including but not limited to: the success of our dietary supplements to attain significant market acceptance among clinics, practitioners and their patients; our customers’ reliance on certain third parties to support the manufacturing of bio-identical hormones for prescribers; our and our customers’ sensitivity to regulatory, economic, environmental and competitive conditions in certain geographic regions; our ability to increase the use by practitioners and clinics of the Biote Method at the rate that we anticipate or at all; our ability to grow our business; the significant competition we face in our industry; the impact of strategic acquisitions and the implementation of our growth strategies; our limited operating history; our ability to protect our intellectual property; the heavy regulatory oversight in our industry; changes in applicable laws or regulations; the inability to profitably expand in existing markets and into new markets; the possibility that we may be adversely impacted by other economic, business and/or competitive factors, including the impact of hurricane and other natural disasters; and future exchange and interest rates. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and other risks and uncertainties described in the “Risk Factors” section of the Biote’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2024, filed with the Securities and Exchange Commission on November 12, 2024, and other documents filed by Biote from time to time with the Securities and Exchange Commission. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Biote assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Biote does not give any assurance that it will achieve its expectations.

Contacts

Investor Relations:

Eric Prouty

AdvisIRy Partners

eric.prouty@advisiry.com

Media:
biote@theblissgrp.com

Walgreens Boots Alliance Suspends Quarterly Dividend as Company Continues Disciplined Execution Against Strategic Priorities




Walgreens Boots Alliance Suspends Quarterly Dividend as Company Continues Disciplined Execution Against Strategic Priorities

DEERFIELD, Ill.–(BUSINESS WIRE)–Walgreens Boots Alliance, Inc. (Nasdaq: WBA) today announced that its board of directors is suspending the company’s cash dividend historically paid to stockholders on a quarterly basis, as management continues to evaluate and refine its capital allocation policy consistent with the company’s broader long-term turnaround efforts.

This change in capital allocation is aimed at strengthening WBA’s balance sheet by reducing debt over time and improving free cash flow, as the company works toward achieving a retail pharmacy-led turnaround underpinned by a sustainable economic model. The company’s cash needs over the next several years, including with respect to litigation and debt refinancing, were important considerations as part of the decision to suspend the dividend.

WBA leadership remains focused on successfully executing against its strategic priorities and maintaining financial discipline, which it believes will deliver sustained value creation over the long term.

About Walgreens Boots Alliance

Walgreens Boots Alliance (Nasdaq: WBA) is an integrated healthcare, pharmacy and retail leader serving millions of customers and patients every day, with a 175-year heritage of caring for communities.

A trusted, global innovator in retail pharmacy with approximately 12,500 locations across the U.S., Europe and Latin America, WBA plays a critical role in the healthcare ecosystem. Through dispensing medicines, improving access to pharmacy and health services, providing high quality health and beauty products and offering anytime, anywhere convenience across its digital platforms, WBA is shaping the future of healthcare in the thousands of communities it serves and beyond.

WBA employs approximately 312,000 people, with a presence in eight countries and consumer brands including: Walgreens, Boots, Duane Reade, the No7 Beauty Company and Benavides. The Company is proud of its contributions to healthy communities, a healthy planet, an inclusive workplace and a sustainable marketplace. In fiscal 2024, WBA scored 100% on the Disability Equality Index for disability inclusion.

More Company information is available at www.walgreensbootsalliance.com.

Cautionary Note Regarding Forward-Looking Statements: All statements in this press release that are not historical, including statements regarding WBA’s broader turnaround efforts and refining its capital allocation, generating positive cash flows and strengthening WBA’s balance sheet, the ability of WBA to pay dividends in the future, achieving a sustainable economic model, executing against strategic priorities and delivering sustained value creation over the long term, are forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions, known or unknown, that could cause actual results to vary materially from those indicated or anticipated. These risks, assumptions and uncertainties include those described in Item 1A (Risk Factors) of our Form 10-K for the fiscal year ended August 31, 2024, and in other documents that we file or furnish with the Securities and Exchange Commission. If one or more of these risks or uncertainties materializes, or if underlying assumptions prove incorrect, actual results may vary materially from those indicated or anticipated by such forward-looking statements. All forward-looking statements we make or that are made on our behalf are qualified by these cautionary statements. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. We do not undertake, and expressly disclaim, any duty or obligation to update publicly any forward-looking statement after the date of this release, whether as a result of new information, future events, changes in assumptions or otherwise.

WBA-DIV

Contacts

WBA Media Relations
USA / Jim Cohn

+1 224 813 9057

WBA Investor Relations
Eric Wasserstrom

+1 847 315 2922

Guardant Health to Report Fourth Quarter and Full Year 2024 Financial Results on February 20, 2025




Guardant Health to Report Fourth Quarter and Full Year 2024 Financial Results on February 20, 2025

PALO ALTO, Calif.–(BUSINESS WIRE)–Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced it will report financial results for the fourth quarter and full year 2024 after market close on Thursday, February 20, 2025. Company management will webcast a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.

Live audio of the webcast will be available on the “Investors” section of the company website at: www.guardanthealth.com. The webcast will be archived and available for replay after the event.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Contacts

Investor Contact:
Zarak Khurshid

investors@guardanthealth.com

Media Contact:
Melissa Marasco

press@guardanthealth.com
+1 650-647-3711

FDA Grants Priority Review to Merck’s Application for WELIREG® (belzutifan) for the Treatment of Patients With Advanced Pheochromocytoma and Paraganglioma (PPGL)




FDA Grants Priority Review to Merck’s Application for WELIREG® (belzutifan) for the Treatment of Patients With Advanced Pheochromocytoma and Paraganglioma (PPGL)

Acceptance based on objective response rate data from the Phase 2 LITESPARK-015 trial evaluating WELIREG in certain patients with advanced PPGL

If approved, WELIREG would be the only available therapy in the U.S. for eligible patients with advanced PPGL

RAHWAY, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) seeking approval of WELIREG^® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and pediatric patients (12 years and older) with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma (PPGL). The sNDA is based on objective response rate (ORR) and duration of response (DOR) data from the Phase 2 LITESPARK-015 trial, which will be presented at an upcoming medical meeting. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of May 26, 2025.

“Pheochromocytoma and paraganglioma are rare tumors that form in and around the adrenal glands, and currently, there are no approved therapies available in the U.S. for patients with this rare disease,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “Today’s U.S. filing acceptance demonstrates our commitment to advancing novel therapies, such as WELIREG, to help treat patients with certain rare oncologic diseases. We look forward to working with the FDA to potentially provide this critical option to these patients who urgently need new innovative therapies.”

WELIREG is the first and only HIF-2α inhibitor therapy approved in the U.S. for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors (pNETs) not requiring immediate surgery, based on results from the Phase 2 LITESPARK-004 trial. WELIREG is also approved for certain adult patients with VHL disease-associated tumors in China and 16 additional countries around the world.

WELIREG is also approved in the U.S. and Canada for the treatment of adult patients with advanced RCC following a PD-1/PD-L1 inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI), based on results from the Phase 3 LITESPARK-005 trial.

Merck is investigating WELIREG in rare oncologic diseases, RCC and other tumor types through a broad clinical development program, including in Phase 2 and 3 trials evaluating WELIREG as monotherapy and in combination with other medicines.

About LITESPARK-015

LITESPARK-015 is an open-label, single-arm, multi-cohort Phase 2 trial (NCT04924075) evaluating the efficacy and safety of WELIREG monotherapy in patients with advanced PPGL (Cohort A1), pNETs (Cohort A2), VHL disease-associated tumors (Cohort B1), advanced gastrointestinal stromal tumors (Cohort C), or advanced solid tumors with HIF-2α-related genetic alterations (Cohort D). The primary endpoint is ORR per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by blinded independent central review (BICR). Secondary endpoints include DOR, time to response, disease control, progression-free survival, overall survival and safety. The trial enrolled an estimated 322 patients who received WELIREG 120 mg orally once daily.

About pheochromocytoma and paraganglioma

Pheochromocytoma and paraganglioma (PPGL) are rare adrenal tumors that can be caused by certain genetic syndromes or mutations. It is estimated that up to 2,000 new cases of PPGL are diagnosed each year in the U.S., and up to 52,800 new cases are diagnosed each year worldwide. Pheochromocytoma occur in the center of the adrenal gland, whereas paraganglioma occur in nerve tissue in the adrenal glands and near certain blood vessels and nerves. Up to 25% of PPGL cases are metastatic at diagnosis.

About WELIREG^® (belzutifan) 40 mg tablets, for oral use

Indications in the U.S.

Certain von Hippel-Lindau (VHL) disease-associated tumors

WELIREG (belzutifan) is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

Advanced Renal Cell Carcinoma (RCC)

WELIREG is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

Selected Safety Information for WELIREG

Warning: Embryo-Fetal Toxicity

Exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of WELIREG. Advise patients of these risks and the need for effective non-hormonal contraception as WELIREG can render some hormonal contraceptives ineffective.

Anemia

WELIREG can cause severe anemia that can require blood transfusion. Monitor for anemia before initiation of, and periodically throughout, treatment. Transfuse patients as clinically indicated. For patients with hemoglobin <8 g/dL, withhold WELIREG until ≥8 g/dL, then resume at the same or reduced dose or permanently discontinue WELIREG, depending on the severity of anemia. For life-threatening anemia or when urgent intervention is indicated, withhold WELIREG until hemoglobin ≥8 g/dL, then resume at a reduced dose or permanently discontinue WELIREG.

In LITESPARK-004 (N=61), decreased hemoglobin occurred in 93% of patients with VHL disease and 7% had Grade 3 events. Median time to onset of anemia was 31 days (range: 1 day to 8.4 months).

The safety of erythropoiesis-stimulating agents (ESAs) for treatment of anemia in patients with VHL disease treated with WELIREG has not been established.

In LITESPARK-005 (n=372), decreased hemoglobin occurred in 88% of patients with advanced RCC and 29% had Grade 3 events. Median time to onset of anemia was 29 days (range: 1 day to 16.6 months). Of the patients with anemia, 22% received transfusions only, 20% received ESAs only, and 12% received both transfusion and ESAs.

Hypoxia

WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization.

Monitor oxygen saturation before initiation of, and periodically throughout, treatment. For decreased oxygen saturation with exercise (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg), consider withholding WELIREG until pulse oximetry with exercise is greater than 88%, then resume at the same or a reduced dose. For decreased oxygen saturation at rest (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg) or when urgent intervention is indicated, withhold WELIREG until resolved and resume at a reduced dose or discontinue. For life-threatening or recurrent symptomatic hypoxia, permanently discontinue WELIREG. Advise patients to report signs and symptoms of hypoxia immediately to a healthcare provider.

In LITESPARK-004, hypoxia occurred in 1.6% of patients.

In LITESPARK-005, hypoxia occurred in 15% of patients and 10% had Grade 3 events. Of the patients with hypoxia, 69% were treated with oxygen therapy. Median time to onset of hypoxia was 30.5 days (range: 1 day to 21.1 months).

Embryo-Fetal Toxicity

Based on findings in animals, WELIREG can cause fetal harm when administered to a pregnant woman.

Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. WELIREG can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose.

Adverse Reactions

In LITESPARK-004, serious adverse reactions occurred in 15% of patients, including anemia, hypoxia, anaphylaxis reaction, retinal detachment, and central retinal vein occlusion (1 patient each).

WELIREG was permanently discontinued due to adverse reactions in 3.3% of patients for dizziness and opioid overdose (1.6% each).

Dosage interruptions due to an adverse reaction occurred in 39% of patients. Those which required dosage interruption in >2% of patients were fatigue, decreased hemoglobin, anemia, nausea, abdominal pain, headache, and influenza-like illness.

Dose reductions due to an adverse reaction occurred in 13% of patients. The most frequently reported adverse reaction which required dose reduction was fatigue (7%).

The most common adverse reactions (≥25%), including laboratory abnormalities, that occurred in patients who received WELIREG were decreased hemoglobin (93%), fatigue (64%), increased creatinine (64%), headache (39%), dizziness (38%), increased glucose (34%), and nausea (31%).

In LITESPARK-005, serious adverse reactions occurred in 38% of patients. The most frequently reported serious adverse reactions were hypoxia (7%), anemia (5%), pneumonia (3.5%), hemorrhage (3%), and pleural effusion (2.2%). Fatal adverse reactions occurred in 3.2% of patients who received WELIREG, including sepsis (0.5%) and hemorrhage (0.5%).

WELIREG was permanently discontinued due to adverse reactions in 6% of patients. Adverse reactions which resulted in permanent discontinuation (≥0.5%) were hypoxia (1.1%) and hemorrhage (0.5%).

Dosage interruptions due to an adverse reaction occurred in 39% of patients. Of the patients who received WELIREG, 28% were 65 to 74 years, and 10% were 75 years and over. Dose interruptions occurred in 48% of patients ≥65 years of age and in 34% of younger patients. Adverse reactions which required dosage interruption in ≥2% of patients were anemia (8%), hypoxia (5%), COVID-19 (4.3%), fatigue (3.2%), and hemorrhage (2.2%).

Dose reductions due to an adverse reaction occurred in 13% of patients. Dose reductions occurred in 18% of patients ≥65 years of age and in 10% of younger patients. The most frequently reported adverse reactions which required dose reduction (≥1.0%) were hypoxia (5%) and anemia (3.2%).

The most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (88%), fatigue (43%), musculoskeletal pain (33%), increased creatinine (34%), decreased lymphocytes (34%), increased alanine aminotransferase (32%), decreased sodium (31%), increased potassium (29%), and increased aspartate aminotransferase (27%).

Drug Interactions

Coadministration of WELIREG with inhibitors of UGT2B17 or CYP2C19 increases plasma exposure of belzutifan, which may increase the incidence and severity of adverse reactions. Monitor for anemia and hypoxia and reduce the dosage of WELIREG as recommended.

Coadministration of WELIREG with CYP3A4 substrates decreases concentrations of CYP3A4 substrates, which may reduce the efficacy of these substrates or lead to therapeutic failures. Avoid coadministration with sensitive CYP3A4 substrates. If coadministration cannot be avoided, increase the sensitive CYP3A4 substrate dosage in accordance with its Prescribing Information. Coadministration of WELIREG with hormonal contraceptives may lead to contraceptive failure or an increase in breakthrough bleeding.

Lactation

Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with WELIREG and for 1 week after the last dose.

Females and Males of Reproductive Potential

WELIREG can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to initiating treatment with WELIREG.

Use of WELIREG may reduce the efficacy of hormonal contraceptives. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose.

Based on findings in animals, WELIREG may impair fertility in males and females of reproductive potential and the reversibility of this effect is unknown.

Pediatric Use

Safety and effectiveness of WELIREG in pediatric patients under 18 years of age have not been established.

Merck’s focus on cancer

Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovation products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information, including information for the Boxed Warning about embryo-fetal toxicity, for WELIREG (belzutifan) at https://www.merck.com/product/usa/pi_circulars/w/welireg/welireg_pi.pdf and Medication Guide for WELIREG at https://www.merck.com/product/usa/pi_circulars/w/welireg/welireg_mg.pdf. 

Contacts

Media Contacts:

Julie Cunningham

(617) 519-6264

Michael McArdle

(908) 447-9453

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Steven Graziano

(732) 594-1583

Children’s Hospital Los Angeles Adds Transformative Gene Therapy and Expands to 10 Treatments, Becoming the Largest Provider of Pediatric Cell and Gene Therapies on the West Coast




Children’s Hospital Los Angeles Adds Transformative Gene Therapy and Expands to 10 Treatments, Becoming the Largest Provider of Pediatric Cell and Gene Therapies on the West Coast

Milestone expansion strengthens access to state-of-the art therapies for children, adolescents, and young adults

LOS ANGELES–(BUSINESS WIRE)–Children’s Hospital Los Angeles (CHLA), a national leader in advanced pediatric medical care and innovative cell and gene therapy research and treatment, announced today the addition of its 10^th cell and gene therapy treatment, establishing CHLA as the pediatric provider offering the most FDA-approved, state-of-the-art cell and gene therapy treatments on the West Coast. This milestone underscores CHLA’s unwavering commitment to improving outcomes for pediatric patients with debilitating and life-threatening conditions and expanding access to critical healthcare services.

CHLA’s newest gene therapy offering is Casgevy, which treats sickle cell disease and transfusion-dependent beta thalassemia, adding to the hospital’s existing portfolio of nine groundbreaking treatments. Together, these cell and gene therapies address a broad spectrum of critical health needs for children, adolescents, and young adults, providing options for patients seeking advanced care for conditions like sickle cell disease, hemophilia, thalassemia, leukemia, vision loss from inherited retinal dystrophy, spinal muscular atrophy and muscular dystrophy.

“This is a transformative time for Children’s Hospital Los Angeles and the pediatric community we serve,” says Alan S. Wayne, MD, Pediatrician-in-Chief at Children’s Hospital Los Angeles. “With the addition of this gene therapy, we are further advancing our mission to create hope and build healthier futures for patients and families by providing access to paradigm-changing therapies that offer the prospect of cure and improved quality of life.”

“These new therapies represent the next generation of medical innovation,” says Malika Maddison, Vice President of Service Line Strategy and Operations at Children’s Hospital Los Angeles. “Our ability to offer these treatments ensures that our patients have access to world-class care.”

CHLA currently offers the following FDA-approved cell and gene therapies:

• Casgevy (treats sickle cell disease and transfusion-dependent beta thalassemia)
• Elevidys (treats Duchenne muscular dystrophy)
• Hemgenix (treats hemophilia B)
• Kymriah (treats B-cell acute lymphoblastic leukemia and diffuse large B-cell lymphoma)
• Luxturna (treats inherited retinal disease)
• Lyfgenia (treats sickle cell disease)
• Omisirge (treats patients with blood cancers undergoing umbilical cord transplantation to minimize infection risks)
• Roctavian (treats hemophilia A)
• Zolgensma (treats spinal muscular atrophy)
• Zynteglo (treats transfusion-dependent beta thalassemia)

CHLA’s history in gene therapy innovation dates back to the 1990s, when researchers at CHLA and the Keck School of Medicine of USC received a grant from the National Institutes of Health to construct one of the first academic cell and gene manufacturing facilities in the nation under the FDA’s current good manufacturing practice (cGMP) standards.

In 1996, CHLA researchers in this cGMP facility developed a new pediatric stem cell gene therapy, supporting the first clinical trial and the first cures for newborns with a severe type of immunodeficiency known as ADA SCID.

Today, CHLA collaborates with USC in a state-of-the-art laboratory dedicated to advancing gene and cell therapies at both institutions. In 2022, the USC/CHLA Cell Therapy program was awarded an $8 million grant from the California Institute for Regenerative Medicine to support infrastructure to accelerate development and increase access to cell and gene therapies.

CHLA’s specialized medical expertise is vital in pediatric gene therapy research and treatment, helping to ensure the best possible outcomes for children and young adults. CHLA’s teams work together across the hospital to provide comprehensive and personalized care for each patient and family—all at one location.

To learn more about CHLA’s cell and gene therapies, please visit CHLA.org/GeneTherapy.

About Children’s Hospital Los Angeles

Founded in 1901, Children’s Hospital Los Angeles is at the forefront of pediatric medicine and is the largest provider of hospital care for children in California. Children’s Hospital is home to renowned experts who work together across disciplines to deliver inclusive and compassionate care, and drive advances that set pediatric standards across the nation and around the globe. Children’s Hospital Los Angeles provides a level of care to its diverse population of children that is among the best in the world. The hospital is consistently ranked in the top 10 in the nation on U.S. News & World Report’s Honor Roll of Best Children’s Hospitals. CHLA is the top-ranked children’s hospital in California and the Pacific U.S. region for 2024-25. Children’s Hospital Los Angeles embraces its mission to create hope and build healthier futures. Children’s Hospital Los Angeles is among the top 10 children’s hospitals for National Institutes of Health funding. The Saban Research Institute of Children’s Hospital Los Angeles supports the full continuum of research, allowing physicians and scientists to translate discoveries into treatments and bring answers to families faster. The pediatric academic medical center also is home to one of the largest training programs for pediatricians in the United States. And the hospital’s commitment to building strong communities is evident in CHLA’s efforts to fight food insecurity, enhance health education and literacy, and introduce more people to careers in health care. To learn more, follow CHLA on Facebook, LinkedIn, and X, formerly known as Twitter, and visit CHLA.org/blog.

Contacts

Marlen Bugarin

Lead Public Relations Specialist

mbugarin@chla.usc.edu

Sphere Fluidics Launches Cyto-Mine Chroma and Announces Early Access Program




Sphere Fluidics Launches Cyto-Mine Chroma and Announces Early Access Program

Researchers invited to gain early access to next-generation platform to optimize functional single-cell analysis workflows across expanded applications in life science R&D

CAMBRIDGE, England–(BUSINESS WIRE)–Sphere Fluidics, a leading provider of innovative picodroplet-based microfluidics solutions for functional single cell analysis and isolation, today announced the launch of Cyto-Mine^® Chroma and the opening of its Early Access Program at SLAS2025 International Conference and Exhibition in San Diego.

Cyto-Mine Chroma represents the next generation of Sphere Fluidics’ industry-leading Cyto-Mine single-cell analysis platform. The Early Access Program provides an opportunity to be among the first to demo the Cyto-Mine Chroma for faster project timeline completion and improved outcomes across broad applications, including antibody discovery, cell line development, and emerging areas such as cell therapy. Through the program, the Company will collaborate closely with forward-thinking customers to drive innovation and inform the development of future applications and assays on the platform.

Offering enhanced capabilities, including multiplexing and greater assay flexibility, Cyto-Mine Chroma has been developed to maximize the efficiency and precision of single-cell functional analysis – enabling tens of millions of cells to be screened in a day. Leveraging a four-color laser and detector system, Cyto-Mine Chroma expands the number of parameters that can be analyzed for each cell in a single assay. This supports the upcoming launch of the Company’s first multiplexed assay kit, facilitating multiple readouts within a single experiment, optimizing the throughput and precision of cell selection. By accelerating the early selection of superior candidate cells for downstream expansion or further analysis, overall timelines are reduced from months to weeks, while reducing effort and cost.

Sphere Fluidics will be showcasing Cyto-Mine Chroma at its booth (#2744) at SLAS2025. Chief Technology Officer, Richard Hammond, will be presenting a Solutions Spotlight demonstrating the new platform’s capabilities on day two of the conference, Tuesday January 28^th, 12:00 – 12:20pm.

“The next-generation Cyto-Mine Chroma platform has been designed to transform single-cell analysis. We are excited to unveil this innovative platform and its Early Access Program at SLAS, the premier event for lab automation and screening. This launch underscores our dedication to advancing biotechnology. Collaborating closely with key industry stakeholders and researchers will allow us to ensure our microfluidic technologies meet the evolving needs of the sector, both now and in the future.” commented Dale Levitzke, CEO, Sphere Fluidics.

To learn more about Cyto-Mine Chroma, please visit https://spherefluidics.com/our-products/platform-products/cyto-mine-chroma/

Contacts

For further information please contact:
Dr Claire Cox

Sphere Fluidics Ltd.

Tel: +44 (0)7365 209 441

Email: claire.cox@spherefluidics.com

Zyme Communications
Lily Jeffery

Tel: +44 (0)7891 477 378

Email: lily.jeffery@zymecommunications.com

PureTech Founded Vedanta Biosciences Publishes Additional Phase 2 VE303 Results in Nature Medicine




PureTech Founded Vedanta Biosciences Publishes Additional Phase 2 VE303 Results in Nature Medicine

VE303 was well tolerated and decreased the odds of rCDI through multiple mechanisms

Analyses identified predictors of VE303 colonization and protection from CDI recurrence

Topline data for the ongoing Phase 3 pivotal RESTORATiVE303 study are expected in 2026

BOSTON–(BUSINESS WIRE)–PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, noted that its Founded Entity, Vedanta Biosciences, a late clinical-stage company developing defined bacterial consortia as oral therapies for gastrointestinal diseases, today announced the publication of additional results from the Phase 2 CONSORTIUM study for its lead candidate, VE303, which is being evaluated for prevention of recurrent Clostridioides difficile infection (rCDI). The new analyses were published this month in Nature Medicine and can be viewed online.

VE303 is a potential first-in-class Live Biotherapeutic Product for the prevention of rCDI, which consists of a defined consortium of eight bacterial strains. Clinical results from Vedanta’s successful Phase 2 CONSORTIUM study, published in the Journal of the American Medical Association (JAMA), demonstrated that the higher dose of VE303 studied was well tolerated and reduced the odds of CDI recurrence by more than 80% compared with placebo.

The new publication which is entitled “Multi-omic Profiling a Defined Bacterial Consortium for Treatment of Recurrent Clostridioides difficile Infection,” reports additional results from CONSORTIUM. Profiling of microbiome composition, fecal metabolites, and host immune function indicated that VE303 works through multiple mechanisms to prevent rCDI by restoring a healthy gut microbial community, decreasing inflammation, and increasing levels of protective metabolites. In addition, the work identified predictors of high or low VE303 colonization and clinical response.

Taken together, these results demonstrate that VE303 works through multiple mechanisms to reduce CDI recurrence. Results from the CONSORTIUM study informed the design and dose selection for the global, pivotal Phase 3 study, RESTORATiVE303, that is currently underway to confirm the efficacy and safety profile of VE303 in the prevention of rCDI. Topline data for this study are expected in 2026.

The full text of the announcement from Vedanta is as follows:

Vedanta Biosciences Publishes Additional Phase 2 VE303 Results in Nature Medicine

VE303 was well tolerated and decreased the odds of rCDI through multiple mechanisms

Analyses identified predictors of VE303 colonization and protection from CDI recurrence

Topline data for the ongoing Phase 3 pivotal RESTORATiVE303 study are expected in 2026

CAMBRIDGE, Mass., January 23, 2025 — Vedanta Biosciences, a late clinical-stage company developing defined bacterial consortia as oral therapies for gastrointestinal diseases, today announced the publication of additional results from the Phase 2 CONSORTIUM study for its lead candidate, VE303, which is being evaluated for prevention of recurrent Clostridioides difficile infection (rCDI). The new analyses were published this month in Nature Medicine and can be viewed online.

VE303 is a potential first-in-class Live Biotherapeutic Product for the prevention of rCDI, which consists of a defined consortium of eight bacterial strains. Clinical results from Vedanta’s successful Phase 2 CONSORTIUM study, published in the Journal of the American Medical Association (JAMA), demonstrated that the higher dose of VE303 studied was well tolerated and reduced the odds of CDI recurrence by more than 80% compared with placebo. VE303 organisms rapidly and robustly colonize the gut in a dose-dependent manner. Colonization predicted greater recurrence-free probability, establishing a direct connection between exposure and clinical response.

The publication which is entitled “Multi-omic Profiling a Defined Bacterial Consortium for Treatment of Recurrent Clostridioides difficile Infection,” reports additional results from CONSORTIUM. Profiling of microbiome composition, fecal metabolites, and host immune function indicated that VE303 works through multiple mechanisms to prevent rCDI by restoring a healthy gut microbial community, decreasing inflammation, and increasing levels of protective metabolites. In addition, the work identified predictors of high or low VE303 colonization and clinical response.

“This clinical research offers new insights into the mechanisms of action of VE303, providing a rationale for the drug’s protective effects in rCDI,” said Bernat Olle, Ph.D., Chief Executive Officer of Vedanta Biosciences. “Due to VE303’s precisely known, defined composition, we can study its mechanisms of action and PK-PD relationships in a rigorous way, taking a step towards understanding why some patients respond better than others to a microbiome restoration intervention. We believe this line of work helps fill a knowledge gap in the field, since characterization of the mechanisms of action of first-generation fecal microbiota products has been very limited.”

Highlights of the publication include:

• Abundance of specific VE303 strains, and of VE303 strains overall, was predictive of remaining recurrence-free.
• The strains that colonized well differed across individuals, suggesting that efficacy is derived from strains working together as a consortium.
• VE303 colonization and clinical benefit correlated with increased levels of short-chain fatty acids and key secondary bile acids, both of which have beneficial effects in conferring resistance to CDI.
• Faster recovery of a more diverse microbiome, which was seen in the high dose recipients of VE303, was associated with non-recurrence.
• The elimination rate of the antibiotic used for the CDI episode was a predictor of VE303 colonization. Given that clearance of residual antibiotic from stool varies significantly among individuals and can take a week or longer, treating with VE303 for 14 consecutive days following completion of standard-of-care antibiotics enabled VE303 strains to be inoculated when the intestinal environment was most permissive to colonization.
• VE303 use led to lower levels of pro-inflammatory and potentially pathogenic Gram-negative species, including Klebsiella and Citrobacter, that are linked to CDI recurrence and AMR bacterial infections.

Taken together, these results demonstrate that VE303 works through multiple mechanisms to reduce CDI recurrence. Results from the CONSORTIUM study informed the design and dose selection for the global, pivotal Phase 3 study, RESTORATiVE303, that is currently underway to confirm the efficacy and safety profile of VE303 in the prevention of rCDI. Topline data for this study are expected in 2026.

This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50120C00177.

About VE303

VE303 is a potential first-in-class Live Biotherapeutic Product for the prevention of recurrent Clostridioides difficile infection (rCDI). VE303 is an orally administered, defined bacterial consortium therapeutic candidate which consists of eight strains that were rationally selected using Vedanta’s product engine. VE303 is produced from pure, clonal bacterial cell banks, which yield a standardized drug product in powdered form and bypass the need to rely on direct sourcing of donor fecal material of inconsistent composition. Vedanta published positive results in JAMA in April 2023 from the Phase 2 CONSORTIUM trial, in which VE303 met its primary endpoint of preventing C. difficile infection recurrence at eight weeks. Vedanta is currently enrolling patients into a Phase 3 RESTORATiVE303 registrational study of VE303 for the prevention of recurrent C. difficile infection. Vedanta Biosciences received a $5.4 million research grant from the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) in 2017 and a contract of up to $81.9 million from Biomedical Advanced Research and Development Authority (BARDA) in 2020 to support clinical studies of VE303. VE303 was granted Orphan Drug Designation in 2017 by the U.S. Food and Drug Administration (FDA) for the prevention of recurrent CDI.

About Vedanta Biosciences

Vedanta Biosciences is a clinical-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s lead assets are potential first-in-class oral therapies – VE303, in a Phase 3 registrational trial for prevention of recurrent C. difficile infection, and VE202, in a Phase 2 trial for treatment of ulcerative colitis. Vedanta’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks. The product engine, supported by broad foundational intellectual property, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep pipeline through its experienced research and development team and its extensive network of scientists, clinicians and industry leaders that is being advanced both internally and through its Founded Entities. PureTech’s R&D engine has resulted in the development of 29 therapeutics and therapeutic candidates, including three that have been approved by the U.S. Food and Drug Administration. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration enabling studies. All of the underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points.

For more information, visit www.puretechhealth.com or connect with us on X (formerly Twitter) @puretechh.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to Vedanta’s development plans for its pipeline of therapeutics of defined bacterial consortia as oral therapies for gastrointestinal diseases, including VE303, the timing of topline results for ongoing clinical trials, potential benefits to patients, and Vedanta’s and our future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2023, filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

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Justin Chen

+1 609 578 7230

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