On July 10, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care reported updated results from its ongoing Phase 2 study of Bria-IMT in combination with check point inhibitor in patients with advanced metastatic breast cancer (MBC) (Press release, BriaCell Therapeutics, JUL 10, 2025, View Source [SID1234654347]).

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BriaCell is pleased to report the sustained complete resolution of temporal lobe brain metastasis and continued orbital (behind the eye) tumor reduction after > 18 months of treatment in the Phase 2 study. The metastatic tumor initially caused proptosis –a visibly bulging of the eye. As previously reported, the heavily pre-treated MBC patient had demonstrated a complete resolution of a temporal lobe brain metastasis and a significant response in a right orbital metastasis at 8 months, then at 11 months. The patient has now maintained both responses for more than 18 months, with no evidence of brain tumor recurrence and ongoing tumor shrinkage in the orbital lesion.

This patient had failed eight prior treatment regimens, including an antibody-drug conjugate (ADC), before initiating therapy with Bria-IMT plus checkpoint inhibition. She has now completed 29 treatment cycles and has been on BriaCell’s Phase 2 study for over 21 months. Serial imaging at 8, 11, and now 20 months have confirmed no detectable disease in the right temporal lobe, along with continued response in the orbital lesion. Additionally, the patient’s tumor markers have remained markedly reduced from baseline, further supporting the sustained radiologic response.

"These encouraging results continue to suggest that our novel Bria-IMT regimen may provide durable immunotherapeutic benefit in late-stage breast cancer patients with brain metastases who have exhausted other options," stated Dr. William V. Williams, BriaCell’s President & CEO. "The long-term response observed in this patient reinforces the potential of Bria-IMT to improve outcomes while maintaining a favorable tolerability profile."

On July 10, 2025 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, reported that quemliclustat, an investigational small molecule CD73 inhibitor, was granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of pancreatic cancer (Press release, Arcus Biosciences, JUL 10, 2025, View Source [SID1234654336]).

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"The orphan drug designation indicates the importance of developing new treatment options for rare diseases like pancreatic cancer, which has the highest mortality rate of all major cancers, and which has seen few treatment advancements over the past 30 years," said Richard Markus, M.D., Ph.D., chief medical officer at Arcus Biosciences. "We expect the Phase 3 PRISM-1 study to be fully enrolled this year and, if positive, intend to quickly bring this new first-line treatment option to patients, with the goal of prolonging survival for those with metastatic pancreatic cancer."

Orphan drug designation is intended to support the development and evaluation of new treatments for rare diseases affecting fewer than 200,000 people in the United States. Orphan drug designation qualifies sponsors for incentives including tax credits for qualified clinical trials, exemption from user fees including New Drug Application (NDA), and a potential seven years of market exclusivity after approval.

In January 2024, Arcus presented results from the Phase 1 ARC-8 study, which showed no new safety signals and median overall survival (OS) of 15.7 months in a pooled analysis of all patients treated with the 100mg quemliclustat-based regimens. The median OS exceeded the historical benchmark data for chemotherapy alone, including for patients with liver metastasis, which account for more than half of all pancreatic cancers. Based on the ARC-8 results, the company initiated PRISM-1, a registrational Phase 3 study to evaluate quemliclustat plus gemcitabine/nab-paclitaxel chemotherapy versus gemcitabine/nab-paclitaxel chemotherapy alone in approximately 610 patients with pancreatic ductal adenocarcinoma (PDAC) that have not been previously treated in the metastatic setting. The study is expected to be fully enrolled this year.

Quemliclustat is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established.

About the Phase 3 PRISM-1 Trial

PRISM-1 is a global, randomized, double-blind, placebo-controlled, multi-center Phase 3 study that will enroll approximately 610 patients with treatment-naïve metastatic PDAC. Participants will be randomized 2:1 between quemliclustat plus gemcitabine/nab-paclitaxel chemotherapy and gemcitabine/nab-paclitaxel chemotherapy plus placebo arms. The primary endpoint is overall survival (OS), and secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and safety.

About Quemliclustat

Quemliclustat is an investigational, potent and selective small molecule CD73 inhibitor that is being co-developed in collaboration with Gilead Sciences. CD73 is the primary enzymatic producer of immunosuppressive adenosine in the tumor microenvironment, and high CD73 expression is associated with significantly poorer prognosis in several tumor types. Quemliclustat has been shown to block the production of adenosine. Once the immunosuppressive effects of adenosine are removed, activation of antitumor immune cells may be restored, resulting in cancer cell death.

About Pancreatic Cancer

According to the American Cancer Society, approximately 67,440 Americans will be diagnosed with pancreatic cancer in the U.S. in 2025, and pancreatic cancer has the highest mortality rate of all major cancers. Approximately 50% of people with PDAC are diagnosed in the metastatic setting, which is associated with a five-year survival rate of only 3%. Pancreatic cancer occurs in the pancreas, an organ located behind the stomach that helps with digestion and controlling blood sugar. The majority (over 90%) of pancreatic cancers are adenocarcinomas, a type of cancer that forms in tissues that line certain internal organs and release fluids like those that help with digestion. There have been limited advancements for treating pancreatic cancer, and chemotherapy has been the standard of care for more than 30 years.

On July 10, 2025 IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, reported that it has commenced its previously disclosed rights offering (the "Rights Offering") (Press release, IceCure Medical, JUL 10, 2025, View Source [SID1234654335]).

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Pursuant to the Rights Offering, the Company is distributing to all holders of record of the Company’s ordinary shares, no par value per share ("Ordinary Shares") as of 5:00 p.m., Eastern Time, on July 9, 2025 (the "Record Date"), at no charge, non-transferable subscription rights (the "Subscription Rights") to purchase up to an aggregate of 10,000,000 units ("Units") at a subscription price of $1.00 per whole Unit.

Each holder of the Company’s Ordinary Shares will receive one Subscription Right for every Ordinary Share owned on the Record Date. Each Subscription Right will entitle its holder to purchase 0.1703 of a Unit, each comprised of one Ordinary Share and a warrant to purchase one Ordinary Share (the "Warrant") at a subscription price of $1.00 per Unit or, in lieu of such Unit, one Unit, each comprised of one pre-funded warrant to purchase one Ordinary Share and one Warrant, at a subscription price of $0.9999 per Unit . No fractional Subscription Rights are being distributed and no fractional Units will be issued upon the exercise of any Subscription Rights in the Rights Offering. Shareholders must exercise Subscription Rights for at least one whole Unit to participate in the Rights Offering. The Subscription Rights will expire if they are not exercised by 5:00 p.m., Eastern Time, on July 28, 2025, the expected expiration date of the Rights Offering. The Company may extend the period for exercising the Subscription Rights. Subscription Rights which are not exercised by the expiration date of the Rights Offering will expire and will have no value.

Assuming the Rights Offering is fully subscribed, the Company expects to receive aggregate gross proceeds of $10 million. Holders who fully exercise their basic Subscription Rights will be entitled to subscribe for additional Units that remain unsubscribed as a result of any unexercised basic Subscription Rights. If over-subscription privilege requests exceed the remaining Units available, the remaining Units will be allocated pro-rata among holders who over-subscribe based on the number of Ordinary Shares held by all holders exercising the privilege. Epoch Partner Investments Limited ("Epoch"), the Company’s largest shareholder, has committed to participate in the Rights Offering and exercise its Subscription Right in full and any over-subscription privilege to purchase Units not subscribed for by other shareholders with an aggregate subscription price of up to $5 million. Li Haixiang, the sole director of Epoch, is a member of the board of directors of the Company. As previously announced by the Company on May 21, 2025, Epoch granted IceCure a $2 million unsecured loan on May 17, 2025 bearing interest of 4.05% (the "Bridge Loan"). The Bridge Loan will be repaid after 12 months or upon the completion of the Rights Offering, whichever is earlier. The Company intends to use the proceeds of the Rights Offering, including proceeds directly raised from Epoch’s participation in the Rights Offering, to repay the principal and any accrued interest from the Bridge Loan and for general corporate and working capital purposes.

The subscription period for the Rights Offering commenced on July 10, 2025 and will end at 5:00 p.m., Eastern Time, on July 28, 2025, unless extended by the Company (the "Subscription Period"). The Subscription Rights are non-transferable and will only be exercisable during the Subscription Period. Once holders have exercised their Rights, such exercise may not be revoked, canceled, or changed, even if holders subsequently learn information about the Company or its business, financial position, results of operations or cash flows that is material or adverse or that the holders otherwise consider to be unfavorable. The Company may cancel, modify or amend the Rights Offering at any time and for any reason prior to the expiration of the Subscription Period.

The Company has engaged Maxim Group LLC as dealer-manager for the Rights Offering. Questions about the Rights Offering or requests for copies of the final prospectus may be directed to Maxim Group LLC at 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, or via e-mail at [email protected] or telephone at +1 (212) 895-3745.

The Rights Offering is being made pursuant to the Company’s registration statement on Form F-1 (File No. 333-288062) (as amended, the "Registration Statement"), which was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on July 9, 2025. The Rights Offering is being made only by means of a prospectus, copies of which will be delivered to holders of the Company’s Ordinary Shares as of 5:00 p.m., Eastern Time, on the Record Date and can be accessed through the SEC’s website at www.sec.gov. Questions about the Rights Offering or requests for a copy of the prospectus related to the Rights Offering may be directed to the Information Agent, Broadridge Corporate Issuer Solutions, LLC, at (855) 793-5068 or via e-mail at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy any Subscription Rights, Ordinary Shares, Warrants, Units or any other securities, nor will there be any offer, solicitation or sale of any Subscription Rights, Ordinary Shares, Warrants, Units or any other securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful under the securities laws of such state or jurisdiction. This press release is not an offering and an offering can only be made by the prospectus and any prospectus supplements for the Rights Offering, which should be read carefully before making an investment decision.

The Company has not made and will not make any recommendation to shareholders regarding the exercise of Subscription Rights. The Company’s shareholders as of 5:00 p.m., Eastern Time, on the Record Date should make an independent investment decision about whether to exercise their Subscription Rights based on their own assessment of the Company’s business, financial condition, prospects for the future and the terms of the Rights Offering.

On July 10, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the Jazz Board of Directors has unanimously selected Renee Gala, Jazz’s President and Chief Operating Officer, as the President and Chief Executive Officer, effective August 11, 2025, when she will also join the Board (Press release, Jazz Pharmaceuticals, JUL 10, 2025, View Source [SID1234654334]). She will succeed co-founder, Chairperson and CEO Bruce Cozadd, who informed the Board in December 2024 of his intent to retire as CEO upon the identification of the Company’s next leader. This appointment reflects a key milestone in the Board’s long-term succession planning process and previously disclosed CEO transition.

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Ms. Gala was promoted to the role of President and COO in October 2023, after having served as Executive Vice President and Chief Financial Officer of the Company since March 2020. She brings more than 30 years of experience across finance, strategy, corporate development and commercialization. In her current role, she oversees the Company’s global business operations, which include commercial, medical, research and development, technical operations and quality, as well as corporate strategy. Ms. Gala has played a critical role in driving Jazz’s ongoing transformation, including architecting a business development strategy that has diversified the Company’s portfolio, driven total revenue growth of nearly 90%, built broad capabilities, and established a pipeline that has positioned the Company for value creation and sustainable growth.

"The Board conducted a thorough and thoughtful search including both internal and external candidates, and we’re highly confident that Renee is exactly the right leader to build on Jazz’s momentum," said Rick Winningham, Lead Independent Director. "The Board’s priority was to find an exceptional leader who could not only operate the business but also serve as a catalyst in driving long-term growth at this important moment for the Company. Among a field of highly capable and qualified candidates, Renee was the clear standout, with a compelling set of experiences and skillsets, as well as a strong track record of driving high performance and change at Jazz through both corporate development and operational initiatives. The Board has a strong focus on Jazz’s evolution and delivering value, and we believe Renee is ideally equipped to drive and deliver Jazz’s continued success."

"I am honored to step into the CEO role and build upon Jazz’s extraordinary legacy, fueled by exceptional people, a spirit of purpose and an unwavering commitment to patients," said Ms. Gala. "With a market-leading portfolio of medicines, a promising pipeline, a strong financial position and an ongoing focus on corporate development, Jazz has immense potential—and more work to be done to realize it. I look forward to continuing the important efforts underway and working with our team to pursue new opportunities—both within our portfolio and through external innovation—to drive greater value for our patients and shareholders. I want to express my deep appreciation to Bruce for his steadfast leadership over the past two decades in building an organization defined by patient-centricity and mutual respect, a foundation that will serve us well into the future. I’m grateful for the opportunity to have partnered with Bruce over the last five years and look forward to continuing to work with him and the Board in this next chapter."

"I co-founded Jazz 22 years ago and am immensely proud of our journey. From the beginning, our mission has been to work tirelessly to transform patient lives," said Mr. Cozadd. "We have since grown into an innovative biopharma company with expanded commercial and scientific capabilities to drive the next phase of our evolution, and a value rich pipeline poised to reach even more patients than we ever thought possible. I am thrilled to be handing over the reins to Renee and am excited for her to lead Jazz into our next phase of growth. In her role as Jazz’s CFO and then as our President and COO, Renee’s leadership has been critical in Jazz’s transformation into a high-growth biopharmaceutical company fueled by a strong R&D pipeline and robust commercial operations. I am confident that she will continue to further this mission as CEO, while nurturing the culture that makes Jazz such a compelling place to spend your career."

Mr. Cozadd will continue to serve as Chairperson of the Board, providing strategic input as the Company continues to execute on its growth strategy.

About Renee Gala
Ms. Gala, who joined Jazz as CFO in 2020 and was promoted to COO in 2023, is a proven organizational leader with decades of progressive leadership experience across key areas spanning finance, strategy, corporate development, and commercial at a range of life science companies. Before joining Jazz in 2020, Ms. Gala served as the CFO of GRAIL Inc., a healthcare company focused on early cancer detection. From 2014 to 2019, she served as senior vice president and CFO of Theravance Biopharma, Inc., a biopharmaceutical company, following its spin-out from Theravance, Inc. (now Innoviva, Inc.). Ms. Gala joined Theravance in 2006 and held various roles in the finance organization before leading the company’s spin-out transaction. Prior to that, she served in various roles in global treasury, pharmaceutical sales and corporate strategy/business development at Eli Lilly and Company from 2001 to 2006. She also currently serves on the Board of Directors of DexCom, and previously served on the Board of Directors of Gossamer Bio, Corcept Therapeutics and Gyroscope Therapeutics, prior to its acquisition by Novartis. She holds a B.S. in Mathematics from Vanderbilt University and an M.B.A. from Columbia Business School.

On July 10, 2025 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported that it will host a key opinion leader (KOL) webinar to discuss pelareorep in metastatic pancreatic ductal adenocarcinoma (mPDAC) and other gastrointestinal cancers (Press release, Oncolytics Biotech, JUL 10, 2025, View Source [SID1234654333]). The webinar will take place on Tuesday, July 22, 2025, at 1:00 p.m. ET.

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The webinar will feature KOLs Dirk Arnold, M.D., Ph.D. (Asklepios Tumorzentrum Hamburg), Alexander Eggermont, M.D., Ph.D. (University Medical Center Utrecht), Sanjay Goel, M.D., M.S., FASCO (Rutgers Cancer Institute of New Jersey), and Devalingam Mahalingam, M.D., Ph.D. (Northwestern University), who will join the Oncolytics management team to discuss pelareorep’s existing pancreatic clinical data in addition to its potential as an immunotherapy in mPDAC and other gastrointestinal indications.

A live question and answer session will follow a formal presentation and roundtable discussion with the KOLs. To register for the event, please click here.

About the KOLs

Dirk Arnold, M.D., Ph.D., is the Director of Asklepios Tumorzentrum Hamburg and the primary investigator of the GOBLET trial. He has also held positions as Director of the Instituto CUF de Oncologia in Lisbon, Portugal, Director of the Department of Medical Oncology at the University of Freiburg, and Director of the University Cancer Center Hamburg. His research and primary scientific interest focus on gastrointestinal cancers, immunotherapy, and drug development. Dr. Arnold completed his M.D. degree at the Universities of Ulm and Berlin in Germany and specialist instruction at Charité, Humboldt University in Berlin.

Alexander Eggermont, M.D., Ph.D., is a Professor of Clinical & Translational Immunotherapy at the University Medical Center Utrecht in the Netherlands and Board Member of the Comprehensive Cancer Center Munich of the Technical University Munich and the Ludwig Maximilians University, Munich, Germany. Previously, he was the Chief Executive Officer of Gustave Roussy Cancer Campus Grand Paris, France, from 2010 to 2019. Additionally, he was President of both the EORTC (European Organisation for Research and Treatment of Cancer) from 2003 to 2006 and the ECCO (European Cancer Organisation) from 2008 to 2010. He is an author or co-author on more than 900 peer-reviewed papers and has received a number of honors and awards, including Honorary Professor of Oncology "Joseph Maisin Chair" at the Catholic University of Louvain, Belgium, the German Cancer Aid Award in 2019, and the status of Chevalier of the Légion d’Honneur by the French Ministry of Foreign Affairs.

Sanjay Goel, M.D., M.S., FASCO, is an attending physician and a Professor of Medicine at Robert Wood Johnson Medical School. He serves as the Director of Phase I Therapeutics at Rutgers Cancer Institute. He has an interest in drug development of anti-cancer agents, and biomarkers of drug response, particularly in solid tumors and colorectal cancer. His work also includes the outcomes of health in minority patients and health disparities. Dr. Goel has been the author or co-author on over 150 research publications and owns a patent in EGFR-targeted therapy.

He has been the recipient of the Advanced Clinical Research Award (ACRA) in colorectal cancer by the Conquer Cancer Foundation (CCF), of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), and has been funded by the National Institutes of Health. He is an active ASCO (Free ASCO Whitepaper) volunteer currently serving on the ASCO (Free ASCO Whitepaper) SEP Item Writing Task Force. He has also served as the track leader of the Scientific Program Committee in the "Developmental Therapeutics and Translational Research – Immunotherapy" track of ASCO (Free ASCO Whitepaper). He has been a grant reviewer on several NIH study sections and on the ASCO (Free ASCO Whitepaper) CCF Grant Review Committee. He has been an invited speaker at several national and international conferences.

Devalingam Mahalingam, M.D., Ph.D., is a faculty member at the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (LCC). He serves as the Director of the Clinical Trials Office (CTO) and the Director of the Developmental Therapeutics (DT) program. His clinical research interests and expertise are designing and executing early phase clinical studies utilizing novel therapeutic agents, incorporating precision oncology and developing these targets within clinical studies for gastrointestinal cancers. He has worked on a number of agents (including oncolytic viruses and GSK3 beta inhibitors) from pre-clinical development to late phase studies. He earned his M.D. and Ph.D. from the National University of Ireland, Galway, clinical training at the Royal College of Physicians Ireland, and completed his fellowship at the University of Texas Health Science Center San Antonio in 2009. He has served as Principal Investigator on approximately 50 clinical trials and authored over 120 manuscripts.