Phase 3 Data for Incyte’s Retifanlimab (Zynyz®) in Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) Published in The Lancet




Phase 3 Data for Incyte’s Retifanlimab (Zynyz®) in Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) Published in The Lancet

• POD1UM-303/InterAACT 2 is the first and largest global Phase 3 trial evaluating a PD-1 inhibitor in combination with chemotherapy for the treatment of patients with advanced SCAC not previously treated with systemic chemotherapy

• The trial met its primary endpoint; treatment with retifanlimab in combination with platinum-based chemotherapy (carboplatin-paclitaxel) resulted in clinically meaningful improvements in progression-free survival and overall survival

• In May 2025, the U.S. Food and Drug Administration (FDA) approved Zynyz^® (retifanlimab-dlwr) in combination with carboplatin and paclitaxel and as a single agent for the treatment of advanced SCAC; submissions to other global regulatory agencies are also under review

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte (Nasdaq:INCY) today announced that primary results from the Phase 3 POD1UM-303/InterAACT 2 trial of retifanlimab (Zynyz^®), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination with carboplatin and paclitaxel (platinum-based chemotherapy) in adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal cancer (SCAC) who have not been previously treated with systemic chemotherapy, were published in The Lancet.¹

“The publication of the POD1UM-303/InterAACT 2 trial in The Lancet is a testament to the strength of the data generated for retifanlimab in patients with inoperable locally recurrent or metastatic SCAC, a disease which until recently had seen limited innovation for decades,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “SCAC can be a devastating disease, and patients often have a poor prognosis. These data supported the U.S. Food and Drug Administration (FDA) approval of Zynyz^® (retifanlimab-dlwr) in May 2025, providing U.S. patients the first and only first-line treatment for inoperable locally recurrent or metastatic SCAC.”

The POD1UM-303/InterAACT2 trial results, which were also featured at a Presidential Symposium on Practice-Changing Trials at the European Society for Medical Oncology (ESMO) in 2024, showed that the study met its primary endpoint by demonstrating a statistically significant improvement in progression-free survival (PFS) in patients with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy, as assessed by blinded independent central review (BICR) using RECIST v1.1.² Adding retifanlimab to carboplatin and paclitaxel resulted in a clinically meaningful 37% reduction in the risk of progression or death (Hazard Ratio [HR]: 0.63; 95% Confidence Interval [CI] (0.47, 0.84); P=0.0006).² Patients in the retifanlimab and chemotherapy combination group achieved a median PFS of 9.3 months compared to 7.4 months for patients in the placebo combination group.²

New data published today in The Lancet show that in patients treated with retifanlimab plus chemotherapy:¹

• A consistent benefit in PFS in favor of retifanlimab plus chemotherapy was observed for all pre-defined subgroups with sufficient patients for comparison.
• A clinically meaningful 6-month difference in overall survival (OS) was observed at the interim analysis (29.2 months in the retifanlimab plus carboplatin and paclitaxel group vs 23.0 months in the placebo plus carboplatin and paclitaxel group). Interim OS results were not statistically significant, and patients continue to be followed for the final key secondary OS analysis.
• The overall response rate (ORR) to treatment was improved by the addition of retifanlimab to the chemotherapy (55.8% in the retifanlimab plus carboplatin and paclitaxel group vs 44.2% in the placebo plus carboplatin and paclitaxel group) and the median duration of response was approximately doubled (14 months in the retifanlimab plus carboplatin and paclitaxel group vs 7.2 months in the placebo plus carboplatin and paclitaxel group) when compared to placebo.

As reported in The Lancet, no new safety signals were observed in POD1UM-303/InterAACT2, and safety was consistent with chemotherapy plus checkpoint inhibitor regimens. Serious and Grade 3 or worse adverse events were more frequent in the retifanlimab plus carboplatin and paclitaxel group compared with placebo plus carboplatin and paclitaxel group (47.4% vs 38.8% and 83.1% vs 75.0%, respectively). The most common Grade ≥3 adverse events were neutropenia (35.1% for retifanlimab plus carboplatin and paclitaxel vs 29.6% for placebo plus carboplatin and paclitaxel) and anemia (19.5% vs 20.4%). Despite the higher rate of serious, Grade 3 or worse, and fatal adverse events with retifanlimab plus carboplatin and paclitaxel than placebo plus carboplatin–paclitaxel, these toxicities were manageable with standard measures and carboplatin and paclitaxel delivery was not compromised.

The publication, entitled “Retifanlimab with carboplatin and paclitaxel for locally recurrent or metastatic squamous cell carcinoma of the anal canal (POD1UM-303/InterAACT-2): a global, phase 3 randomised controlled trial,” can be found online here.

“The incidence of SCAC is increasing by approximately 3% annually, driven mainly by endemic human papillomavirus (HPV infection). With no approved treatments available for advanced cases until recently, it is crucial to develop effective therapies for this orphan disease,” said Sheela Rao, M.D., Consultant Medical Oncologist, The Royal Marsden National Health Service Foundation Trust.

In May 2025, the FDA approved Zynyz^® (retifanlimab-dlwr) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic SCAC. In addition, the FDA granted approval for Zynyz as a single agent for the treatment of adult patients with locally recurrent or with metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. Incyte has also submitted a Type II variation Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for retifanlimab in advanced SCAC and in March 2025 submitted and received acceptance of a Japanese New Drug Application (J-NDA) by the Pharmaceuticals and Medical Devices Agency (PMDA) for retifanlimab in advanced SCAC.

About Squamous Cell Carcinoma of the Anal Canal (SCAC)

SCAC is the most common type of anal cancer, making up 85% of cases.³ It is a rare disease for which the incidence is increasing approximately 3% per year.⁴ About 90% of cases are associated with human papillomavirus (HPV) infection—the number one risk factor for anal cancer.⁵ HIV is an important amplifier of anal cancer, as people with HIV are 25 to 35 times more likely to develop it.^6,7 Anal cancer shares many of the same symptoms as non-cancerous conditions, such as hemorrhoids—including pain, itching, a lump or mass and changes in bowel movements—and as a result can go undetected leading to the majority of patients presenting with locally advanced disease.^8,9 More information about SCAC is available by visiting www.analcancer.com.

About POD1UM

The POD1UM (PD1 Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-303, POD1UM-202 and several other Phase 1, 2 and 3 studies for patients with solid tumors, including a registration-directed trial evaluating retifanlimab in combination with platinum-based chemotherapy for patients with non-small cell lung cancer.

About POD1UM-303/InterAACT 2

POD1UM-303/InterAACT 2 (NCT04472429) is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study evaluating retifanlimab or placebo in combination with platinum-based chemotherapy (carboplatin and paclitaxel) in adult patients with inoperable locally recurrent or metastatic SCAC who have not been previously treated with systemic chemotherapy.

During the blinded portion of the study, patients, including those with well-controlled HIV infection, were randomized 1:1 to receive retifanlimab 500 mg intravenously or placebo during each 28-day cycle for up to 6 months in combination with standard therapy of carboplatin and paclitaxel, followed by retifanlimab or placebo monotherapy for up to 1-year total treatment in the absence of disease progression or unacceptable toxicity. Crossover to retifanlimab monotherapy was allowed for patients assigned to placebo upon verification of progression by blinded independent central review (BICR).

The primary endpoint was progression-free survival (PFS) as determined by BICR using RECIST v1.1. The key secondary endpoint was overall survival (OS). Other secondary endpoints include objective response rate (ORR), duration of response (DOR), disease control rate (DCR) by BICR, safety and pharmacokinetics.

For more information about the study, please visit https://clinicaltrials.gov/study/NCT04472429.

About Zynyz^® (retifanlimab-dlwr)

Zynyz^® (retifanlimab-dlwr) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), indicated in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) and as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy in the U.S.

Zynyz is also indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Zynyz is marketed by Incyte in the United States. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.

Zynyz is a registered trademark of Incyte.

Important Safety Information

What is the most important information I should know about Zynyz?

Zynyz is a medicine that may treat certain types of cancers by working with your immune system. Zynyz can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your doctor right away if you develop any new or worsening signs or symptoms, including:

Lung problems: cough, shortness of breath, chest pain

Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; severe stomach-area (abdomen) pain or tenderness

Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); bleeding or bruising more easily than normal

Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, loss of appetite

Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in your mouth or nose, throat, or genital area; fever or flu-like symptoms; swollen lymph nodes

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Zynyz. Call or see your doctor right away for any new or worsening signs or symptoms, which may include:

• chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
• confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• persistent or severe muscle pain or weakness, muscle cramps
• low red blood cells, bruising

Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain.

Rejection of a transplanted organ or tissue. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host disease, in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Zynyz. Your doctor will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your doctor will check you for these problems during your treatment. Your doctor may treat you with corticosteroid or hormone replacement medicines and may also need to delay or completely stop treatment if you have severe side effects.

Before you receive Zynyz, tell your doctor about all of your medical conditions, including if you:

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant or tissue transplant, including corneal transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant. Zynyz can harm your unborn baby

Females who are able to become pregnant:

• Your doctor should do a pregnancy test before you start treatment.
• You should use an effective method of birth control during your treatment and for 4 months after your last dose. Talk to your doctor about birth control methods that you can use during this time.
• Tell your doctor right away if you become pregnant or think you may be pregnant during treatment.
• are breastfeeding or plan to breastfeed. It is not known if Zynyz passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Zynyz when given with the chemotherapy medicines carboplatin and paclitaxel in people with SCAC include tiredness, numbness, pain, tingling, or burning in your hands or feet; nausea; hair loss; diarrhea; muscle and bone pain; constipation; bleeding; rash; vomiting; decreased appetite; itching; stomach-area pain.

The most common side effects of Zynyz when used alone in people with SCAC include tiredness, muscle and bone pain, diarrhea, infection, rectal or genital-area pain, bleeding, urinary tract infection (UTI), rash, nausea, loss of appetite, constipation, stomach-area pain, shortness of breath, fever, vomiting, cough, itching, low levels of thyroid hormone, headache, decreased weight.

The most common side effects of Zynyz when used alone in people with MCC include tiredness, muscle and bone pain, itching, diarrhea, rash, fever, nausea.

These are not all the possible side effects of Zynyz. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-3463.

General information about the safe and effective use of Zynyz

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about Zynyz, talk with your doctor. You can ask your doctor for information about Zynyz that is written for health professionals.

Please see the full Prescribing Information, including the Medication Guide, for Zynyz.

You may also report side effects to the FDA http://www.fda.gov/medwatch or to Incyte Corporation at 1-855-463-3463.

About Incyte

A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.

For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.

Incyte Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether and when Zynyz might provide a successful treatment option for patients with SCAC, contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on Incyte‘s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by FDA or other regulatory authorities; Incyte‘s dependence on its relationships with its collaboration partners; the efficacy or safety of Incyte‘s products and the products of Incyte‘s collaboration partners; the acceptance of Incyte‘s products and the products of Incyte‘s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte‘s reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended March 31, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements.

Contacts

Media
media@incyte.com

Investors
ir@incyte.com

Quince Therapeutics Announces Pricing of Up to $22 Million Private Placement of Securities




Quince Therapeutics Announces Pricing of Up to $22 Million Private Placement of Securities

Financing to provide $11.5 million in upfront proceeds with up to an additional $10.4 million of proceeds assuming exercise in full of the warrants

Financing priced at a premium to last close

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–$QNCX #biotech–Quince Therapeutics, Inc. (Nasdaq: QNCX) (“Quince” or the “Company”), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, today announced that it has entered into a securities purchase agreement with certain institutional and accredited investors to purchase shares of its common stock (or pre-funded warrants in lieu thereof), and accompanying common warrants (“Warrants”) that is expected to result in approximately $11.5 million in upfront proceeds and potential additional proceeds of up to $10.4 million if the accompanying common warrants are exercised in full for cash, before deducting placement agent fees and other private placement expenses.

The private placement is being led by healthcare-focused institutional investor Nantahala Capital with participation from existing Quince stockholders including ADAR1 Capital Management, along with members of Quince’s senior management.

Quince intends to use the net proceeds of this offering for working capital and general corporate purposes, including funding the ongoing enrollment of the Company’s pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A–T; NCT06193200/IEDAT-04-2022) clinical trial in Ataxia-Telangiectasia (A-T), research and development expenses, general and administrative expenses and capital expenditures. The net upfront proceeds from the private placement, combined with Quince’s current cash, cash equivalents, and short-term investments are expected to fund the Company’s operations into the second quarter of 2026, or the second half of 2026 if the Warrants are exercised in full for cash.

At the closing, the Company will issue to the investors an aggregate of 8,671,928 shares of common stock (or pre-funded warrants in lieu thereof), along with accompanying Warrants to purchase an aggregate of 8,671,928 shares of common stock (or pre-funded warrants in lieu thereof), at a combined purchase price of $1.325 per share (or $1.324 per pre-funded warrant) and accompanying Warrant (representing a 10% premium over the $1.20 closing price per share of the Company’s common stock). The accompanying Warrants have an exercise price of $1.20 per share and will become exercisable immediately. The Warrants will expire five years from the date of issuance. The private placement is expected to close during the week of June 16, 2025, subject to the satisfaction of customary closing conditions.

Citizens Capital Markets is acting as the lead placement agent for the private placement. Maxim Group LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, are acting as co-placement agents for the private placement.

The securities to be issued in connection with the private placement described above are being offered in a private placement and have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state or other applicable jurisdictions’ securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

This news release does not constitute an offer to sell or the solicitation of an offer to buy 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 Quince Therapeutics

Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases. For more information on the company and its latest news, visit www.quincetx.com.

Forward-looking Statements

Statements made in this news release that are not statements of historical or current facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this news release regarding the expected closing of the private placement; the receipt of additional gross proceeds if the accompanying common warrants are exercised in full; the achievement of positive clinical trial results and approval of the eDSP by the FDA; the company’s intended use of the proceeds from the private placement; the company’s expectation that the net proceeds from the closing of the private placement, combined with its current cash, cash equivalents and marketable securities, will fund its operating and capital expenditures into the second quarter of 2026, or the second half of 2026, assuming all warrants are exercised for cash; and the company’s strategy, future operations, future financial position, projected expenses, expected timing and results of clinical trials, prospects, plans and objectives of management constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks and uncertainties related to: cost, timing, progress and results of the pivotal Phase 3 NEAT clinical trial in A-T indication and potential future trials in other indications; the company’s ability to obtain FDA approval and successfully commercialize its product candidate; the satisfaction of customary closing conditions related to the proposed private placement and the impact of general economic, industry or political conditions in the United States or internationally, the current or evolving effects of macroeconomic conditions, on Quince’s business operations and activities. There can be no assurance that the company will be able to complete the proposed private placement on acceptable terms, or at all. Quince’s actual results, performance, or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including the risks discussed under the heading “Risk Factors” discussed under the caption “Item 1A. Risk Factors” in Part I of Quince’s most recent Annual Report on Form 10-K or any updates discussed under the caption “Item 1A. Risk Factors” in Part II of its Quarterly Reports on Form 10-Q and in the company’s other filings with the SEC. Quince undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as required by law.

Contacts

Media & Investor Contact:
Stacy Roughan

Quince Therapeutics, Inc.

Vice President, Corporate Communications & Investor Relations

ir@quincetx.com

BeOne Medicines to Host Investor R&D Day Webcast on June 26, 2025




BeOne Medicines to Host Investor R&D Day Webcast on June 26, 2025

SAN CARLOS, Calif.–(BUSINESS WIRE)–$ONC #BeOne–BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that it will host an Investor R&D Day in New York City and via webcast on June 26, 2025 at 8:30 am ET. John V. Oyler, Co-Founder, Chairman, and CEO of BeOne, along with the Company’s leadership team and distinguished key opinion leaders, will provide an update on BeOne’s extensive global innovation pipeline and platforms, including new assets, targets and clinical data, and will share insights on the Company’s vision, differentiated capabilities, and value creation drivers.

Live webcast of this event can be accessed from the investors section of the Company’s website at http://ir.beonemedicines.com/, https://hkexir. beonemedicines.com/, https://sseir. beonemedicines.com/. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the Company’s website.

About BeOne Medicines

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statements

This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeOne’s plans, commitments, aspirations and goals related to BeOne’s medicines and drug candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors which are discussed in the section entitled “Risk Factors” in BeiGene’s most recent periodic report filed with the U.S. Securities and Exchange Commission (“SEC”) as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the SEC. All information in this presentation is as of the date presented, and BeiGene undertakes no duty to update such information unless required by law.

Contacts

Investors:
Liza Heapes

+1 857-302-5663

ir@beonemed.com

Media:
Kyle Blankenship

+1 667-351-5176

media@beonemed.com

Clinical and Pre-Clinical Data on the Novel Barriolide, EP395 (glasmacinal), Published in Three Articles in Pulmonary Pharmacology and Therapeutics




Clinical and Pre-Clinical Data on the Novel Barriolide, EP395 (glasmacinal), Published in Three Articles in Pulmonary Pharmacology and Therapeutics

REYKJAVIK, Iceland–(BUSINESS WIRE)–EpiEndo Pharmaceuticals (‘EpiEndo’ or the ‘Company’), a clinical-stage biopharmaceutical company developing a new class of oral anti-inflammatory drugs which enhance the host defence response to inhaled pathogens, has had three articles published in peer-reviewed journal, Pulmonary Pharmacology and Therapeutics.

These publications describe the potential for EpiEndo’s lead asset EP395, also known as ‘glasmacinal’, to be of therapeutic benefit in the treatment of COPD and support its continued clinical development. The article “Effect of EP395, a novel anti-inflammatory macrolide, in an inhaled lipopolysaccharide challenge model in healthy volunteers: a randomised controlled trial” reports that EP395 enhances the host defence response to inhaled LPS whilst reducing pro-inflammatory mediators. The paper was co-authored with investigators from Fraunhofer Institute for Toxicology and Experimental Medicine who conducted the study.

The second article, “Effects of EP395, a novel macrolide, on acute neutrophilic airway inflammation” describes preclinical data that demonstrate EP395 has comparable inhibitory effects on acute neutrophilic airway inflammation to azithromycin, which is used chronically off-label for its immunomodulatory properties to reduce COPD exacerbations.

Finally, “A novel macrolide, EP395, with reduced antibacterial activity and an enhancing effect on respiratory epithelial barrier” reports that EP395 has negligible antibiotic activity and enhances the barrier function of the respiratory epithelium.

Maria Bech, CEO of EpiEndo Pharmaceticals commented:

“It is great to see the publication of this clinical and pre-clinical research in a peer-reviewed journal, highlighting the efficacy we are seeing with glasmacinal in neutrophilic inflammation.

“The anti-inflammatory effects of glasmacinal are comparable to those seen with azithromycin preclinically, but without anti-microbial activity. The clinical LPS study shows that EP395 enhances the host defence response to inhaled challenge, supporting our hypothesis that glasmacinal could be effective in reducing exacerbations in COPD but without developing anti-microbial resistance.

“We continue to develop glasmacinal as a potential new oral treatment option for COPD patients, aiming to bring additional therapeutic options to patients with chronic respiratory diseases.”

Professor Clive Page, Emeritus Professor of Pharmacology, King’s College London and Chairman of EpiEndo Pharmaceutical’s Scientific Advisory Board added:

“These exciting new data demonstrate glasmacinal’s effect on neutrophilic inflammation both in a clinical study and in established non-clinical models of airways disease. These novel findings, coupled with data presented at ERS in 2024 on EP395’s anti-inflammatory effect on eosinophilic inflammation (caused by allergens), demonstrate the broad anti-inflammatory activity of this drug that has the potential to provide a novel, groundbreaking approach to treat patients with COPD, irrespective of their type of inflammation.”

About EpiEndo Pharmaceuticals (www.epiendo.com)

EpiEndo is a clinical-stage biopharmaceutical company with a unique approach to chronic respiratory diseases that focuses on the role of epithelial function in various inflammatory disorders.

EpiEndo’s new class of orally available macrolides, with reduced antimicrobial resistance (AMR) potential, known as ‘Barriolides™’, show promise as first-in-class therapeutics for chronic respiratory diseases as well as other inflammatory indications. EpiEndo’s lead asset, glasmacinal, was the first Barriolide™ to enter clinical trials, for chronic obstructive pulmonary disease (COPD).

Glasmacinal aims to be a first on-market oral treatment which is anti-inflammatory and enhances the host defense response to inhaled pathogens such as viruses, bacteria & pollution.​ Therefore, glasmacinal has the potential to become an impactful treatment in reducing exacerbations in patients with COPD.

According to the WHO, COPD is the third leading cause of death globally, and the global economic burden of COPD is projected to cost $4.8 trillion by 2030.

Contacts

EpiEndo Pharmaceuticals:
Maria Bech, CEO

+354 454 0090

Vigo Consulting (media relations):

Rozi Morris

+44 20 7390 0230

epiendo@vigoconsulting.com

3D Investment Partners: Leading Proxy Advisory Firm Glass Lewis Recommends Toho Holdings Shareholders Vote “AGAINST” the Reappointment of CEO Hiromi Edahiro at the Company’s June 2025 AGM




3D Investment Partners: Leading Proxy Advisory Firm Glass Lewis Recommends Toho Holdings Shareholders Vote “AGAINST” the Reappointment of CEO Hiromi Edahiro at the Company’s June 2025 AGM

Glass Lewis Highlights “Relevant and Substantiated Concerns Regarding Toho Holdings’ Governance Practices,” Especially the Company’s Response to the Nihon University Incident

Believes Shareholders Should Expect “Stronger Accountability and Leadership at the Highest Levels” and Advises Shareholders to Vote Against the Reappointment of CEO Hiromi Edahiro in order to “Express Their Concerns and Dissatisfaction”

TOKYO–(BUSINESS WIRE)–3D Investment Partners Pte. Ltd., the investment manager of 3D Opportunity Master Fund (“3D” or “we”), today announced that Glass, Lewis & Co. (“Glass Lewis”), a leading independent provider of proxy research and voting recommendations for the institutional investor community, has recommended that shareholders of Toho Holdings Co., Ltd. (“Toho HD” or the “Company”) (TOKYO: 8129) vote “AGAINST” the reappointment of Representative Director, President, CEO and CFO Hiromi Edahiro (“Mr. Edahiro”) at the Company’s 77th Annual General Meeting of Shareholders (the “AGM”), scheduled to be held on June 27, 2025.

In its report, Glass Lewis recognized that 3D “raises relevant and substantiated concerns regarding Toho Holdings’ governance practices” and concluded that shareholders should vote against the reappointment of Mr. Edahiro.

In reaching its conclusion, Glass Lewis highlighted Toho HD’s fraudulent scheme related to Nihon University Hospital (the “Nihon University Incident”) and found that the incident – which was “characterized by limited disclosure and unclear accountability” – warranted “further scrutiny.”

Furthermore, Glass Lewis criticized Toho HD’s response to the Nihon University Incident particularly; they analyze that this incident suggested “gaps in the Company’s risk awareness and disclosure governance framework.” Glass Lewis noted that:

• “[T]he Company’s involvement in transactions perceived as questionable might have merited a more proactive and transparent response. From the standpoint of risk oversight and shareholder communication, an internal investigation followed by a timely explanation would likely have been more appropriate.”

• “[T]he Company’s first formal disclosure [of the Nihon University Incident] was issued only in response to 3D’s public statements ahead of this shareholder meeting. In our view, this reactive approach appears misaligned with generally accepted expectations for corporate transparency. The rationale cited—that disclosure was delayed to protect the Company’s reputation—may in fact have had the opposite effect, potentially exacerbating reputational risks.”

3D completely agrees with Glass Lewis that shareholders should expect “stronger accountability and leadership at the highest levels.” 3D strongly believes that addressing Toho HD’s serious governance and compliance failures is essential to enhance the Company’s corporate value sustainably, and that substantive change must start at the top of the organization.

3D therefore encourages Toho HD shareholders to vote AGAINST Mr. Edahiro at the Company’s upcoming AGM.

Note: The passages in quotation marks (“”) are direct quotes excerpted by 3D from Glass Lewis’ report. The portions in brackets ([ ]) have been added by 3D for additional clarity/context. Permission to use these quotes from Glass Lewis was neither explicitly sought nor obtained.

About 3D Investment Partners Pte. Ltd.

3D Investment Partners Pte. Ltd. is an independent Singapore-based Japan focused value investing fund manager founded in 2015. 3D Investment Partners Pte. Ltd. focuses on partnering with management[s] who share its investment philosophy of medium- to long-term value creation through compound capital growth and a common objective of achieving long-term returns.

Disclaimer

This press release, including annexes is provided for informational purposes only and does not constitute an offer to purchase or sell any security or investment product, nor does it constitute professional or investment advice. This press release should not be relied on by any person for any purpose and is not, and should not be construed as investment, financial, legal, tax or other advice.

3D Investment Partners Pte. Ltd. and its affiliates and related persons (“3DIP”) of either believe that the current market price of Toho HD does not reflect its intrinsic value. 3DIP acquired beneficial and/or economic interests based on its own idea that Toho HD securities have been undervalued and provide an attractive investment opportunity and may in the future beneficially own, and/or have an economic interest in, Toho HD securities. 3DIP intends to review its investments in Toho HD on a continuing basis and, depending upon various factors including, without limitation, Toho HD’s financial position and strategic direction, the outcome of any discussions with Toho HD, overall market conditions, other investment opportunities available to 3DIP, and the availability of Toho HD securities at prices that would make the purchase or sale of Toho HD securities desirable, 3DIP may, from time to time (in the open market or in private transactions), buy, sell, cover, hedge, or otherwise change the form or substance of any of its investments (including the investment in Toho HD securities) to any degree in any manner permitted by any applicable law, and expressly disclaims any obligation to notify others of any such changes.

3DIP provides no representation or warranty, either expressed or implied, in relation to the accuracy, completeness, or reliability of the information contained herein (including content or quotes from news coverage or other third-party public sources (“Third-Party Materials”)), nor is it intended to be a complete statement or summary of the securities, markets, or developments referred to herein. 3DIP expressly disclaims any responsibility or liability for any loss whatsoever arising from any use of, or reliance on, this press release or its contents as a whole or in part by any person, or otherwise whatsoever arising in connection with this press release. 3DIP hereby expressly disclaims any obligation to update or provide additional information regarding the contents of this press release or to correct any inaccuracies in the information contained in this press release.

3DIP disclaims any intention or agreement to be treated as a joint holder (kyodo hoyu sha) under the Financial Instruments and Exchange Act of Japan, a closely related party (missetsu kankei sha) under the Foreign Exchange and Foreign Trade Act with other shareholders, or receiving any power or permission to represent other shareholders in relation to the exercise of their voting rights, and has no intention to solicit, encourage, induce or require any person to cause other shareholders to represent such voting rights.

3DIP does not have the intention to make a proposal, directly or through other shareholders of Toho HD, to transfer or abolish the business or assets of Toho HD and/or Toho HD group companies at the general shareholders meeting of Toho HD. 3DIP does not have the intention or purpose to engage in any conduct which constricts the continuing and stable implementation of business of Toho HD and/or Toho HD group companies.

This press release may include Third-Party Materials. Permission to quote from Third-Party Materials in this press release may neither have been sought nor obtained. The content of the Third-Party Materials has not been independently verified by 3DIP and does not necessarily represent the views of 3DIP. The authors and/or publishers of the Third-Party Materials are independent of, and may have different views to 3DIP. Quoting Third-Party Materials in this press release does not imply that 3DIP endorses or concurs with any part of the content of the Third-Party Materials or that any of the authors or publishers of the Third-Party Materials endorses or concurs with any views which have been expressed by 3DIP on the relevant subject matter. The Third-Party Materials may not be representative of all relevant news coverage or views expressed by other third parties on the stated issues.

In respect of information that has been prepared by 3DIP (and not otherwise attributed to any other party) and which appears in the English language version of this press release, in the event of any inconsistency between the English language version and the Japanese language version of this press release, the meaning of the Japanese language version shall prevail unless otherwise expressly indicated.

Contacts

KRIK (PR Agent)

Koshida: +81-70-8793-3990

Sugiyama: +81-70-8793-3989

Bayer and Broad Institute Extend Research Collaboration to Develop New Cardiovascular Therapies




Bayer and Broad Institute Extend Research Collaboration to Develop New Cardiovascular Therapies

• Focus on joint discovery of novel therapeutic approaches based on findings in human genomics research related to cardiovascular diseases
• Current efforts focused on treatment options for specific forms of cardiovascular disease such as dilated cardiomyopathy
• Phase I clinical study in healthy volunteers for development of new treatment for patients with atrial fibrillation recently initiated
• Extended collaboration to further strengthen Bayer’s precision cardiology pipeline

BERLIN & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Bayer and the Broad Institute today announced that they have extended their research collaboration of 10 years by an additional five years, to further advance findings in human genomics research in cardiovascular diseases. The expanded agreement will focus on joint precision cardiology target identification, leveraging the established human cardiomyocyte platform to rapidly validate observations, and discovery of novel therapeutic approaches.

Current efforts are directed to develop potential treatment options for patients with specific forms of cardiovascular disease such as dilated cardiomyopathy (DCM), amongst others. DCM is a type of heart disease characterized by the enlargement of the heart’s chambers, which leads to a decreased ability to pump blood effectively. This condition can result in heart failure and other complications if left untreated.¹

Established in 2013, this longstanding collaboration combines the Broad Institute’s extensive expertise in genomics and biology with Bayer’s in-depth experience in small, chemically manufactured molecules and biologics drug discovery to advance drug discovery research for novel cardiovascular therapeutics. This strategic research alliance already has resulted in a number of joint publications and conference presentations, and it has paved the way for Bayer’s announcement in May 2025 regarding the initiation of a Phase I study with its investigational highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor which has a potential to help control the electrical activity of heart cells in patients with atrial fibrillation (AFib).

“We are constantly evaluating novel approaches to treat cardiovascular diseases that affect millions of people worldwide. Our shared commitment is to explore novel therapeutic targets and modalities in various cardiovascular and renal diseases to help deliver new treatment options to patients in need,” said Andrea Haegebarth, Ph.D., Global Head of Research and Early Development for Cardiovascular, Renal, and Immunology at Bayer’s Pharmaceuticals Division. “The first joint therapeutic project entered the clinic last month and we are excited to collaborate further with the esteemed scientists at the Broad Institute to identify and develop disease-modifying therapeutics treating underlying causes of cardiovascular diseases.”

“I am delighted to see Broad and Bayer continue this fruitful collaboration in cardiovascular research,” said Todd Golub, director and founding core member of the Broad Institute. “By working together, Broad and Bayer are able to make advances that neither organization could make on its own.”

Academic collaborations are integral to Bayer’s research and development strategy, aimed at delivering innovative treatment solutions to patients, particularly in areas with significant unmet medical needs, such as cardiovascular health. Bayer’s strategic focus in cardiovascular research emphasizes precision drug development, facilitating the rapid identification of the most promising targets and commercially viable programs.

Bayer with its Bayer Research & Innovation Center (BRIC) is closely located to the Broad Institute in Kendall Square, Cambridge, MA. BRIC houses a center of precision oncology research as well as an experienced team of scientists focused on research and early development for developing precision cardiovascular, renal, and immunology therapeutics. BRIC is also home to Bayer Co.Lab Cambridge which is part of a pioneering global network of life science incubators focused on disruptive innovation and scientific breakthroughs.

Financial details have not been disclosed.

About Bayer’s Commitment in Cardiovascular Diseases

Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) diseases of high unmet medical need. The strategy is to unlock the strong potential of the future CV market by transforming Bayer’s portfolio into precision cardiology, addressing the high CV disease burden, and driving the long-term growth. Bayer’s portfolio already includes several innovative products as well as compounds in various stages of preclinical and clinical development.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer

aka (2025e-0114)

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contacts

Bayer Global Media Contact:

Derin Denham, phone +1 973 610 7324
Email: derin.denham@bayer.com

Bayer U.S. Media Contact:

Elaine Colon, phone +1 732 236 1587
Email: elaine.colon@bayer.com

Mirum Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




Mirum Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

FOSTER CITY, Calif.–(BUSINESS WIRE)–Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that on June 10, 2025, the Compensation Committee of Mirum’s Board of Directors granted inducement awards consisting of non-qualified stock options to purchase 115,620 shares of common stock and 57,740 restricted stock units (“RSUs”) to 10 new employees under Mirum’s 2020 Inducement Plan. The Compensation Committee of Mirum’s Board of Directors approved the awards as an inducement material to the new employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4).

Each stock option has an exercise price per share equal to $48.98 per share, Mirum’s closing trading price on June 10, 2025, and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employees’ continued service relationship with Mirum through the applicable vesting dates. The RSUs will vest over three years, with 33% of the underlying shares vesting on each anniversary of the applicable vesting commencement date, subject to the new employees’ continued service relationship with Mirum through the applicable vesting dates. The awards are subject to the terms and conditions of Mirum’s 2020 Inducement Plan and the terms and conditions of an applicable award agreement covering the grant.

About Mirum Pharmaceuticals, Inc.

Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Mirum has three approved medications: LIVMARLI® (maralixibat), CHOLBAM® (cholic acid) capsules, and CTEXLI™ (chenodiol) tablets.

LIVMARLI, an IBAT inhibitor, is approved for the treatment of two rare liver diseases affecting children and adults. It is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome in the U.S. (three months and older), in Europe (two months and older), and in other regions globally. It is also approved in the U.S. in cholestatic pruritus in PFIC patients 12 months of age and older; in Europe, it is approved for patients with PFIC three months of age and older. Mirum is also initiating the Phase 3 EXPAND study, a label expansion opportunity for LIVMARLI in additional settings of cholestatic pruritus. CHOLBAM is FDA-approved for the treatment of bile acid synthesis disorders due to single enzyme deficiencies and adjunctive treatment of peroxisomal disorders in patients who show signs or symptoms of liver disease. CTEXLI is FDA-approved for the treatment of cerebrotendinous xanthomatosis (CTX) in adults.

Mirum’s late-stage pipeline includes two investigational treatments for several rare diseases. Volixibat, an IBAT inhibitor, is being evaluated in two potentially registrational studies including the Phase 2 VISTAS study for primary sclerosing cholangitis (PSC) and Phase 2b VANTAGE study for primary biliary cholangitis (PBC). Volixibat has been granted Breakthrough Therapy Designation for the treatment of cholestatic pruritus in patients with PBC. Mirum is also planning for a Phase 2 study evaluating MRM-3379, a PDE4D inhibitor for the treatment of Fragile X syndrome, a rare genetic neurocognitive disorder.

To learn more about Mirum, visit mirumpharma.com and follow Mirum on Facebook, LinkedIn, Instagram and X.

Contacts

Investor Contact:
Andrew McKibben

ir@mirumpharma.com

Media Contact:
Erin Murphy

media@mirumpharma.com

Global Healthy Living Foundation Peer-Reviewed Research Shows Hidden Risks of the Inflation Reduction Act’s Drug Pricing Reform




Global Healthy Living Foundation Peer-Reviewed Research Shows Hidden Risks of the Inflation Reduction Act’s Drug Pricing Reform

Report reveals potential for higher patient costs, worse health outcomes despite lower “fair prices”

UPPER NYACK, N.Y.–(BUSINESS WIRE)–The Global Healthy Living Foundation (GHLF) has launched a research-backed public education campaign to raise awareness about the unintended consequences of drug pricing reforms under the Inflation Reduction Act (IRA). This initiative stems from a recent peer-reviewed paper co-authored by GHLF’s Chief Science Policy Officer, Dr. Robert Popovian, Pharm.D., MS, published in the Journal of Health Economics and Outcomes Research (JHEOR). It includes a podcast episode, an infographic, and an article aimed at informing patients, caregivers, and policymakers.

“The IRA’s “maximum fair price” (MFP) policy was designed to reduce out-of-pocket costs for Medicare patients. However, it may lead to the opposite: higher out-of-pocket costs and increased health risks for vulnerable patients,” report author Dr. Popovian says

“By suppressing the retail price, CMS is reducing the profit margins and revenue for pharmacy benefit managers (PBMs), which is good. Predictably, the PBMs will not stand pat—they can shift the drug to a higher formulary tier, where patients will pay more out-of-pocket to acquire the medicine so the PBM can protect its profit margin,” said Dr. Popovian in a recent episode of GHLF’s Healthcare Matters podcast.

The study specifically modeled outcomes for two widely used blood thinners, Eliquis and Xarelto. If PBMs reclassify these drugs to higher cost tiers to compensate for lost profit, patients could face an estimated $688 million more in out-of-pocket costs. This cost-shift could result in over 320,000 patients abandoning treatment, potentially leading to 145,000 major cardiovascular events and up to 97,000 deaths.

“This research underscores a serious gap in how drug pricing reforms are being implemented and monitored,” said Dr. Popovian. “Without proper oversight and transparency, policies that were meant to help patients could end up hurting them.”

The GHLF education campaign includes:

• A peer-reviewed paper published in JHEOR: “Could the Inflation Reduction Act Maximum Fair Price Hurt Patients?”
• A patient-friendly article: “Lower Prices, Higher Risk: How Drug Reform Could Backfire on Patients” published on GHLF’s website and supported by social media
• A special podcast episode of Healthcare Matters, co-hosted by Dr. Popovian
• A downloadable infographic explaining the findings at-a-glance

“This campaign is not about politics—it’s about patients,” said Seth Ginsberg, GHLF Co-Founder and President. “We want people to understand what’s at stake when reforms don’t account for the full complexity of our health care system.”

GHLF encourages policymakers, journalists, and patient advocates to explore these resources and consider how reforms like the IRA impact access to critical medications.

About GHLF

The Global Healthy Living Foundation is a U.S. based, 501(c)(3) nonprofit, international organization whose mission is to improve the quality of life for people with chronic illnesses by advocating for improved access to health care through education, patient-centered clinical research, support, advocacy, and economic and policy research. GHLF is also a staunch advocate for vaccines. The Global Healthy Living Foundation is the parent organization of CreakyJoints®, the international, digital community for millions of people living with arthritis and their supporters worldwide who seek education, support, activism, and patient-centered research in English, Spanish, and French. In addition to arthritis and autoimmune disorders, GHLF supports dermatology, gastroenterology, neurology, cardiology, oncology, infectious disease, rare disease, and pulmonary patients through a host of different programs and activities which draw more than 700,000 patients a month to GHLF websites and create more than 10 million impressions a month on seven social media platforms. In 2024, GHLF had more than 1 million views and listens with its patient-centered audio-visual content, found on YouTube and podcast platforms. GHLF never asks the public for donations, receiving funding instead through governments, non-governmental organizations, foundations, industry, family foundations, and GHLF Co-Founder Louis Tharp. Visit www.ghlf.org for more information.

Contacts

Louis Tharp

ltharp@ghlf.org
www.ghlf.org

Johnson & Johnson Elects Daniel Pinto, President, JPMorganChase to its Board of Directors




Johnson & Johnson Elects Daniel Pinto, President, JPMorganChase to its Board of Directors

NEW BRUNSWICK, N.J.–(BUSINESS WIRE)–Johnson & Johnson (NYSE: JNJ) announced today that Daniel Pinto, President, JPMorganChase, has been elected to its Board of Directors.

“We are thrilled to have Daniel join Johnson & Johnson’s Board of Directors,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “He is an exceptional leader with deep financial expertise and understanding of global capital markets. Daniel’s unique perspective and wealth of experience will be a tremendous asset to Johnson & Johnson as we continue to invest in and advance the next generation of healthcare innovation for patients.”

“I’ve long admired Johnson & Johnson’s continued investment in scientific innovation and its commitment to improving health outcomes for patients facing the most challenging diseases,” said Daniel Pinto. “It’s an honor to join Johnson & Johnson’s board of directors and serve alongside board members who are dedicated to improving the health and well-being of communities around the world.”

About Daniel Pinto

Mr. Pinto is a prominent business leader with more than three decades of financial expertise helming critical leadership roles within JPMorganChase, one of the world’s preeminent global financial services firms, where he currently serves as President and as a member of the Company’s Operating Committee.

Mr. Pinto has spent his career at JPMorganChase and its predecessor companies. He began as a financial analyst and foreign exchange trader at Manufacturers Hanover in 1983 in Buenos Aires. In 1992, he was appointed head of Sales for Chemical Bank and, shortly after, became head trader and Treasurer of Chemical Bank in Mexico. Daniel moved to London in 1996 to oversee local markets in Eastern Europe, the Middle East, Africa and Asia for Chase Manhattan, later taking charge of the markets side of the firm’s emerging-market business.

In early 2006, Mr. Pinto was made global head of Emerging Markets, later expanding his remit to include Global Credit Trading & Syndicate and Global Fixed Income for the Investment Bank. He was made co-CEO of the Corporate & Investment Bank in 2012 and became sole CEO in 2014.

In January 2018, he was named Co-President and Chief Operating Officer of JPMorganChase to work closely with the CEO and the Board to identify and pursue critical firmwide opportunities. He became sole President and COO in January 2022. In January 2025, he announced that he would retire from the company at the end of 2026. He retains the role of President until June 30th, 2025, and will then serve as Vice Chairman of the company through 2026.

Mr. Pinto holds a bachelor’s degree in Public Accounting and Business Administration from Universidad Nacional de Lomas de Zamora in Buenos Aires. He is a member of the Board of Directors of the Institute of International Finance.

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Contacts

Media:
media-relations@its.jnj.com

Investors:

investor-relations@its.jnj.com

Arcus Biosciences Announces New Employment Inducement Grants




Arcus Biosciences Announces New Employment Inducement Grants

HAYWARD, Calif.–(BUSINESS WIRE)–Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today announced that the Compensation Committee of the Company’s Board of Directors granted two new employees options to purchase a total of 8,400 shares of the Company’s common stock at an exercise price per share of $9.85, which was the closing price on June 9, 2025, and restricted stock units to acquire a total of 4,200 shares of the Company’s common stock. The equity awards were granted pursuant to the Company’s 2020 Inducement Plan, which was approved by the Company’s Board of Directors in January 2020 pursuant to the “inducement exception” under NYSE Listed Company Manual Rule 303A.08.

About Arcus Biosciences

Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination therapies for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has advanced multiple investigational medicines into registrational clinical trials including domvanalimab, an Fc-silent anti-TIGIT antibody being studied in combination with zimberelimab, an anti-PD-1 antibody, for upper gastrointestinal and non-small cell lung cancer, casdatifan, a HIF-2a inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com.

Inducement PR

Source: Arcus Biosciences

Contacts

Investor Inquiries:
Pia Eaves

VP of Investor Relations & Strategy

(617) 459-2006

peaves@arcusbio.com

Media Inquiries:
Holli Kolkey

VP of Corporate Communications

(650) 922-1269

hkolkey@arcusbio.com

Maryam Bassiri

AD, Corporate Communications

(510) 406-8520

mbassiri@arcusbio.com