On July 1, 2025 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported the initiation of patient recruitment into the Phase 2 study evaluating the efficacy of opaganib3 in combination with darolutamide4 in men with metastatic castrate-resistant prostate cancer (mCRPC), sponsored by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group Ltd (Press release, RedHill Biopharma, JUL 1, 2025, View Source [SID1234654196]). (ANZUP) in Australia, and supported by Bayer (ETR: BAYN) and Ramsay Hospital Research Foundation. The Company also announced the study will recruit people across at least 10 sites across Australia and New Zealand.

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Led by Professor Lisa Horvath, from Sydney’s Chris O’Brien Lifehouse, and ANZUP, the innovative 60-participant placebo-controlled randomized study is designed to test the potentially enhancing effect of opaganib in overcoming resistance to standard of care androgen receptor pathway inhibition (ARPI) treatment.

The unique study will utilize a companion lipid biomarker test (PCPro5) to select mCRPC patients who have poor prognosis to standard of care treatment, and who may benefit from an opaganib + darolutamide combination approach to treatment. The study’s primary endpoint is improved 12-month radiographic progression-free survival (rPFS). Several secondary and exploratory endpoints will also be evaluated.

Cancer cells can block apoptosis (programmed cell death), an important cell-level process designed to help the body get rid of unneeded or abnormal/unhealthy cells, which are critical in fighting the spread of cancer. Prior research shows that opaganib enhances androgen receptor signaling inhibitor efficacy in vitro6, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS), and may potentially provide the key to overcoming darolutamide resistance in men with mCRPC.

Prostate cancer is the second most diagnosed cancer in the world with around 1.5 million new cases per year, causing almost 400,000 deaths every year, while millions more people are living with prostate cancer resulting in a significant burden of disease.7 The global prostate cancer market was worth approximately $12 billion in 2023.8

About the Study
The study is a double-blind, placebo-controlled randomized Phase 2 trial, adding opaganib to darolutamide in people with mCRPC and poor prognosis (as defined by plasma lipid signature, PCPro). The target population of the study is people with mCRPC who have had no treatment with newer, potent AR signaling inhibitors including darolutamide, enzalutamide, apalutamide, or abiraterone. 200 people with prostate cancer who are identified as potentially eligible will have a 5-ml plasma sample taken for PCPro testing. Those who are PCPro-positive (estimated 40% of patients) and agree to enter the study will be randomized on a 1:1 ratio to either the darolutamide 600mg bid + placebo (n=30) arm or the darolutamide 600 mg bid + opaganib 500 mg bid (n=30) arm. The study is registered on clinicaltrials.gov (NCT04207255).

About Prostate Cancer
Prostate cancer is the second most diagnosed cancer in the world with around 1.5 million new cases annually – causing around 400,000 deaths, with millions more people living with prostate cancer, resulting in a significant burden of disease. Globally, the number of cases of prostate cancer increased by almost 120% from 1990 to 20199.

When prostate cancer spreads outside of the prostate to other parts of the body (such as the lymph nodes or bones) it is classified as advanced or metastatic prostate cancer10. Five-year survival rates for prostate cancer diagnosed at Stage 1 is 100%; this drops to just 28% for people with Stage 4 (advanced) disease.

About Androgen Receptor Pathway Inhibitors (ARPI)
ARPI is a key therapeutic strategy in treating prostate cancer, particularly castration-resistant prostate cancer. These treatments work by blocking the activity of male hormones such as testosterone (androgens), which are implicated in the growth of prostate cancer cells. By disrupting the AR signaling pathway, these therapies aim to slow tumor progression and improve patient outcomes. Key therapeutic options include darolutamide, enzalutamide, (Xtandi, Pfizer / Astellas) and apalutamide (Erleada, Johnson and Johnson).

About Opaganib (ABC294640)
Opaganib, a first-of-its-kind proprietary investigational host-directed and potentially broad-acting orally administered drug with anticancer, anti-inflammatory and antiviral activity, targeting multiple potential indications, including several cancers, diabetes and obesity-related disorders, gastrointestinal acute radiation syndrome (GI-ARS), chemical exposure indications, COVID-19, Ebola and other viruses as part of pandemic preparedness.

Opaganib’s host-directed action is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).

Several U.S. government countermeasures and pandemic preparedness programs have selected opaganib for evaluation for multiple indications, including Acute Radiation Syndrome (ARS), Ebola virus disease and others. Funding bodies include the Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. government Department of Health & Human Services’ National Institutes of Health and the Administration for Strategic Preparedness and Response’s (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA).

Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and Ebola. Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study.

Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was published in Microorganisms.

Opaganib has received several orphan-drug designations from the FDA in oncology and other diseases and has undergone studies in advanced cholangiocarcinoma (Phase 2a) and prostate cancer. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.

Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.

About ANZUP
ANZUP is the leading cancer-cooperative clinical trials group that brings together all of the professional disciplines and groups involved in researching and treating urogenital cancers and conduct high quality cancer research. ANZUP’s mission is to improve the lives of people affected by bladder, kidney, testicular, penile and prostate cancers towards our vision of living life without fear of cancer. ANZUP identifies gaps in evidence and areas of clinical need, collaborates with the best clinicians and researchers in genitourinary cancer and communicates frequently and effectively with the broader community along the way. ANZUP receives valuable infrastructure support from the Australian Government through Cancer Australia.

About Chris O’Brien Lifehouse and Ramsay Hospital Research Foundation
Chris O’Brien Lifehouse is a world-class not-for-profit, comprehensive cancer hospital based in Sydney, Australia. From screening to prevention, diagnosis, treatment and wellness, Chris O’Brien Lifehouse treats all types of cancer, specializing in those that are complex and rare, offering patients every service and therapy they need under one roof.

Ramsay Hospital Research Foundation was established in 2017 to enhance healthcare delivery and improve patient outcomes in Australia, guided by a mission to provide better outcomes for its patients, to investigate the diseases and illnesses which affect them and to progress the learning and development of those who care for them.

On July 1, 2025 Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on the development of innovative medicines in the field of immunotherapy, reported the pricing of its underwritten public offering of $100 million of shares of its common stock. Nektar is selling 4,255,320 shares of common stock in the offering (Press release, Nektar Therapeutics, JUL 1, 2025, View Source [SID1234654195]). The shares of common stock are being sold at a public offering price of $23.50 per share. The gross proceeds to Nektar from the offering are expected to be approximately $100 million, before deducting underwriting discounts and commissions and estimated offering expenses. In addition, Nektar has granted the underwriters a 30-day option to purchase up to an additional 638,298 shares of its common stock at the public offering price per share, less underwriting discounts and commissions. All of the securities being sold in this offering are being offered by Nektar. The offering is expected to close on July 2, 2025, subject to the satisfaction of customary conditions.

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Nektar intends to use the net proceeds from the offering for general corporate purposes, which may include research and development, clinical development and manufacturing costs to support the advancement of its drug candidates, as well as other general corporate purposes.

Jefferies and Piper Sandler are acting as joint bookrunning managers for the offering. BTIG, LLC is acting as passive bookrunner for the offering. H.C. Wainwright & Co. is acting as co-manager for the offering.

The securities described above are being offered pursuant to a shelf registration statement on Form S-3 (No. 333-286222) that was filed with the U.S. Securities and Exchange Commission (the "SEC") on March 28, 2025 and declared effective on April 1, 2025. This offering is being made only by means of a prospectus supplement and an accompanying prospectus that form a part of the registration statement.

A final prospectus supplement related to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and an accompanying prospectus related to the offering may also be obtained, when available, from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by e-mail at [email protected].

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

On July 1, 2025 IGM Biosciences, Inc. (Nasdaq: IGMS), a biotechnology company that has focused on developing engineered IgM-based therapeutic antibodies, reported that it has entered into a definitive merger agreement (the "Merger Agreement") with Concentra Biosciences, LLC ("Concentra"), whereby Concentra will acquire IGM Biosciences for $1.247 in cash per share of IGM Biosciences common stock ("Common Stock"), plus one non-tradeable contingent value right ("CVR"), which represents the right to receive: (i) 100% of the closing net cash of IGM Biosciences in excess of $82.0 million; and (ii) 80% of any net proceeds received within one year following closing from any disposition of certain of IGM Biosciences’ product candidates and intellectual property that occurs within one year following closing, each pursuant to a contingent value rights agreement (the "CVR Agreement") (Press release, IGM Biosciences, JUL 1, 2025, View Source [SID1234654193]).

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The IGM Biosciences Board of Directors has unanimously determined that the acquisition by Concentra is in the best interests of all IGM Biosciences stockholders and has approved the Merger Agreement and related transactions.

Pursuant and subject to the terms of the Merger Agreement, Concentra will commence a tender offer (the "Offer") by July 16, 2025 to acquire all outstanding shares of Common Stock. Closing of the Offer is subject to certain conditions, including the tender of voting Common Stock representing at least a majority of the total number of outstanding shares of voting Common Stock, the availability of at least $82.0 million of cash (net of transaction costs and other liabilities at closing), and other customary closing conditions. The merger transaction is expected to close in August 2025.

Advisors

Wilson Sonsini Goodrich & Rosati, P.C. is acting as legal counsel to IGM Biosciences. Gibson, Dunn & Crutcher LLP is acting as legal counsel to Concentra.

On July 1, 2025 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported encouraging clinical findings among patients with advanced metastatic colorectal cancer ("mCRC") previously treated with leronlimab (Press release, CytoDyn, JUL 1, 2025, View Source [SID1234654192]). The final results indicate that 3/5 patients treated with leronlimab had at least a partial response, as measured by radiologic criteria, including one patient with a complete response who remains alive five years later.

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Dr. Benjamin Weinberg, Associate Professor at Georgetown University and Principal Investigator of CytoDyn’s colorectal cancer ("CRC") program, will present the Company’s clinical data at the ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025 taking place in Barcelona, Spain from July 2 to July 5, 2025.

The results, from patients treated under a compassionate use protocol, reiterate a favorable safety profile of leronlimab as well as its potential for clinical benefit in patients with mCRC. They also support the rationale for the design and therapeutic potential of CytoDyn’s ongoing Phase II trial in patients with relapsed/refractory microsatellite stable CRC. CytoDyn recently announced the dosing of the first patient in this study, and is now enrolling additional patients across multiple clinical sites.

If the observed results in the previously treated CRC patients are confirmed prospectively, the Company believes leronlimab could be used effectively to treat a wide range of solid tumor types. In addition to its potential as a "stand-alone" agent in oncology, the Company presented exciting evidence of leronlimab’s activity as a "priming" agent for cancer patients with low levels of PD-L1 who were previously unresponsive to, or ineligible for, checkpoint inhibitors at the 2025 ESMO (Free ESMO Whitepaper) Breast Cancer meeting. The data driving this working theory has shown particular promise in the treatment of patients with advanced metastatic triple-negative breast cancer ("mTNBC").

"At the 2025 ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress, Dr. Weinberg will share the data and evidence that form the basis for our belief in the potential of leronlimab as a treatment in CCR5 positive solid tumor oncology," said Dr. Jacob Lalezari, CEO of CytoDyn. "Our ongoing Phase II trial in patients with mCRC was designed to prospectively confirm these observations, and we look forward to enrolling additional patients as we pursue clinical confirmation of our working theory."

On July 1, 2025 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "Company"), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported the pricing of an underwritten public offering for gross proceeds of approximately $6 million prior to deducting underwriting commissions and offering expenses (Press release, Cellectar Biosciences, JUL 1, 2025, View Source [SID1234654191]).

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The offering is comprised of (i) 865,000 Class A Units with each Class A Unit consisting of (a) one share of common stock and (b) one common warrant to purchase one share of common stock (the "Common Warrants"), and (ii) 335,000 Class B Units with each Class B Unit consisting of (a) one pre-funded common stock purchase warrant to purchase one share of common stock ("Pre-funded Warrants") and (b) one Common Warrant. The price per Class A Unit is $5.00 and the price per Class B Unit is $4.99999 (collectively, the "Offering"). The Common Warrants will have an exercise price of $5.25 per share, will be exercisable upon issuance, and have a term expiring five years from issuance.

Ladenburg Thalmann & Co. Inc. is acting as sole bookrunning manager in connection with this Offering.

The closing of the Offering is expected to take place on or about July 2, 2025, subject to the satisfaction of customary closing conditions.

In addition, the Company has granted the underwriter a 45-day option to purchase up to 180,000 additional shares of common stock and/or 180,000 Common Warrants, solely to cover over-allotments, if any, at the public offering price, less the underwriting discounts and commissions.

The gross proceeds from the Offering to the Company, before deducting underwriting discounts and commissions and other Offering expenses and excluding any proceeds that may be received upon the exercise of the Common Warrants and the exercise of the underwriter’s option to purchase additional shares of common stock and/or Common Warrants, are expected to be approximately $6 million. The Company currently intends to use the net proceeds of the Offering for general corporate purposes, including working capital and operating expenses, and to initiate a Phase 1b clinical study of our compound CLR 121125 (CLR 125) in triple-negative breast cancer.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-288333), which was declared effective by the United States Securities and Exchange Commission ("SEC") on July 1, 2025. A preliminary prospectus relating to the securities being offered was filed with the SEC on June 30, 2025, and is available on the SEC’s website at View Source The securities are being offered only by means of a prospectus which forms part of the effective registration statement and is available on the SEC’s website located at View Source A final prospectus relating to this Offering will be filed by the Company with the SEC. Electronic copies of the preliminary prospectus and the final prospectus, when available, may also be obtained by contacting Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, New York 10019 or by email at [email protected].

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