Disc Medicine Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants

On October 20, 2025 Disc Medicine, Inc. (NASDAQ: IRON) (Disc), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported the commencement of an underwritten offering of $220.0 million of shares of its common stock and, in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of its common stock, of which $200.0 million of shares are to be offered by Disc and $20.0 million of shares are to be offered by AI DMI LLC (the Selling Stockholder). In addition, the Selling Stockholder intends to grant the underwriters a 30-day option to purchase up to an additional $33.0 million of shares at the public offering price, less underwriting discounts and commissions. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Disc intends to use the net proceeds from the proposed offering to support the potential commercialization of bitopertin for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), to fund research and clinical development of its current or additional product candidates, and for working capital and other general corporate purposes. Disc will not receive any proceeds from the sale of shares to be offered by the Selling Stockholder.

Jefferies, Leerink Partners, Morgan Stanley and Cantor are acting as joint book-running managers for the proposed offering.

The proposed offering is being made pursuant to an automatic shelf registration statement on Form S-3 (No. 333-281359) that was previously filed with the Securities and Exchange Commission (SEC) on August 8, 2024 and a resale registration statement on Form S-3 (No. 333-269270) that was previously filed with the SEC on January 18, 2023. This proposed offering is being made only by means of a prospectus supplement and accompanying prospectuses that form a part of the registration statements. A preliminary prospectus supplement and accompanying prospectuses related to the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectuses relating to this proposed offering may also be obtained, when available, by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, (800) 808-7525 ext. 6105 or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York, 10022, or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, 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.

(Press release, Disc Medicine, OCT 20, 2025, View Source [SID1234656813])

Patient-Reported Outcomes from VERITAC-2 Clinical Trial Support Clinical Benefit of Vepdegestrant in Patients with ESR1-Mutated, ER+/HER2- Advanced or Metastatic Breast Cancer Previously Treated with Endocrine-Based Therapy

On October 20, 2025 Arvinas, Inc. (Nasdaq: ARVN), reported new patient-reported outcomes (PRO) data from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant, which are being presented in a mini oral session at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. Vepdegestrant is a novel investigational PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader which is being developed with Pfizer Inc. (NYSE: PFE) as a potential monotherapy for estrogen receptor 1 (ESR1) mutated, estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with endocrine-based therapy.

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In the VERITAC-2 clinical trial, patients with ESR1-mutated disease treated with vepdegestrant reported a statistically significant delay in deterioration of overall quality of life, pain, and multiple functioning domains compared to those who received fulvestrant. These findings complement previously reported clinical efficacy and safety data from the VERITAC-2 clinical trial, reinforcing vepdegestrant as a potential treatment option for patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy.

"These new data highlight the potential of vepdegestrant to provide significant improvements across important measures for patients with ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations in the second-line setting," said John Houston, Ph.D., Chairperson, President and Chief Executive Officer of Arvinas. "In addition to a statistically significant improvement in progression-free survival, patients receiving vepdegestrant had statistically significant and clinically meaningful benefits in patient-reported outcomes as compared to fulvestrant while being treated for their cancer. These data from the VERITAC-2 clinical trial reflect Arvinas’ goal of striving to pair scientific innovation with improved patient outcomes."

In patients with ESR1-mutated disease, vepdegestrant demonstrated a reduced risk of deterioration compared to fulvestrant which was statistically significant in several PRO domains including overall health status, pain severity, and functioning (including role, cognitive, emotional, and social functioning), and vepdegestrant consistently showed reduced risk of deterioration versus fulvestrant across all PRO domains.

We believe these data support vepdegestrant’s opportunity to be a potential best-in-class therapy for patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine therapy.

Also presented at ESMO (Free ESMO Whitepaper) 2025 were results from the TACTIVE-N Phase 2 clinical trial (NCT05549505), which evaluated neoadjuvant vepdegestrant in postmenopausal women with ER+/HER2– localized breast cancer. The results presented showed that neoadjuvant vepdegestrant demonstrated biological and clinical activity in this treatment-naïve, predominantly ESR1 wild-type population of postmenopausal women with ER+/HER2- localized breast cancer.

Additional detail on Arvinas and Pfizer’s presentations at ESMO (Free ESMO Whitepaper) 2025:

Title: Patient-reported outcomes (PROs) with vepdegestrant (VEP) vs fulvestrant (FUL) in patients (pts) with estrogen receptor (ER) 1 gene mutated (ESR1m) ER+/human epidermal growth factor receptor 2 (HER2)− advanced breast cancer (aBC) in the phase 3 VERITAC-2 trial
Presenting Author: Dr. Mario Campone
Presentation Number: 489 MO
Presentation Type: Mini oral session
Session: Breast cancer, metastatic
Date: October 20, 2025
Time: 11:25-11:30 AM CEST

Title: TACTIVE-N: phase 2 study of neoadjuvant vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, or anastrozole in postmenopausal ER+/human epidermal growth factor receptor 2 (HER2)- localized breast cancer (BC)
Presenting Author: Dr. Peter A. Fasching
Presentation Number: 293MO
Presentation Type: Mini oral session
Session: Breast cancer, early stage
Date: Sunday, October 19, 2025
Time: 10:45-10:50 AM CEST

About the VERITAC-2 Clinical Trial

The Phase 3 VERITAC-2 clinical trial (NCT05654623) is a global, randomized trial evaluating the efficacy and safety of vepdegestrant (ARV-471) as a monotherapy compared to fulvestrant in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with a CDK4/6 inhibitor plus endocrine therapy. The trial enrolled 624 patients, 270 of whom had ESR1m positive disease, at 213 sites in 25 countries.

Patients were randomized 1:1 to receive either vepdegestrant once daily, orally on a 28-day continuous dosing schedule, or fulvestrant, administered intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each 28-day cycle starting from Day 1 of Cycle 2. In the trial, 43% of patients (n=270) had ESR1 mutations detected. The primary endpoint was progression-free survival (PFS) in the ESR1-mutation and intent-to-treat populations as determined by blinded independent central review. Overall survival is the key secondary endpoint.

About Vepdegestrant

Vepdegestrant is an investigational, orally bioavailable PROteolysis TArgeting Chimera (PROTAC) estrogen receptor degrader. Vepdegestrant is being developed as a potential monotherapy for estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting.

In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits. In September 2025, Arvinas and Pfizer announced their plan to jointly select a third party for the out-licensing and commercialization of vepdegestrant.

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for vepdegestrant for its use as a monotherapy in the treatment of adults with ER+/HER2- ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. Vepdegestrant has also been granted Fast Track designation by the FDA, underscoring the significant unmet need in this patient population and the potential for vepdegestrant to offer a meaningful new treatment option.

(Press release, Arvinas, OCT 20, 2025, View Source [SID1234656811])

RUTI® in combination with BCG Therapy Show Encouraging Outcomes in Bladder Cancer

On October 20, 2025 Archivel Farma reported the outcome of RUTIVAC study in Bladder Cancer.

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The RUTI vaccine, developed and produced in-house by Archivel Farma, was tested in a phase I trial involving 40 patients with high-risk non-muscle-invasive bladder cancer at Hospital Universitari Germans Trias i Pujol. Administered prior to standard BCG therapy, RUTI enhanced the immune response, reducing tumor recurrence and progression, and improving patient survival over five years.

The vaccine generated stronger CD4⁺ and CD8⁺ T-cell responses and increased cytokine production, without promoting immunosuppressive T-regulatory cells. Importantly, RUTI was well tolerated with only mild injection-site reactions.
These promising results, published in European Urology, suggest that RUTI could enhance the current standard of care for bladder cancer, paving the way for larger trials to confirm its clinical benefits. Read in View Source

Archivel Farma has been both, sponsor and RUTI supplier for this study. We extend our sincere thanks and congratulations to our partners, IrsiCaixa and the Germans Trias i Pujol Research Institute (IGTP), for their dedication and excellent work.

(Press release, Archivel Farma, OCT 20, 2025, View Source [SID1234656810])

AIM ImmunoTech to Attend the 2025 Maxim Growth Summit

On October 20, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company"), reported it will participate at the 2025 Maxim Growth Summit, taking place October 22-23, 2025 in New York, NY. This prestigious event brings together industry leaders, innovators, and premier institutions to explore the latest trends and advancements across several industries.

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As part of the conference, members of management will be available to participate in in-person one-on-one meetings with qualified members of the investor community who are registered to attend the conference. To view the Company’s Maxim Growth Summit presentation slide deck, please visit the Presentations page on aimimmuno.com.

For more information and a complete agenda of the Maxim Growth Summit, please visit www.maximgrp.com/2025-growth-summit.

(Press release, AIM ImmunoTech, OCT 20, 2025, View Source [SID1234656809])

Imugene’s PD1-Vaxx colorectal cancer trial to feature at ESMO 2025 Congress

On October 20, 2025 Imugene Limited (ASX:IMU), a clinical-stage immuno-oncology company, reported that an abstract for the Neo-POLEM Phase II trial has been accepted for e-poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, being held in Berlin, Germany, 17–21 October 2025.

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The accepted abstract, titled "Phase II trial of neoadjuvant PD-1 vaccine PD1-Vaxx in operable MSI-high colorectal cancer", will be presented by Dr Tony Dhillon, Consultant Medical Oncologist at the Royal Surrey NHS Foundation Trust, United Kingdom.

The ESMO (Free ESMO Whitepaper) Congress is Europe’s largest and most influential oncology meeting, attracting over 30,000 clinicians, researchers, patient advocates, and industry participants from around the world.

Imugene Managing Director and Chief Executive Officer Leslie Chong said: "We are delighted to see PD1-Vaxx recognised with presentation at the ESMO (Free ESMO Whitepaper) Congress, highlighting its growing international clinical footprint. The Neo-POLEM study marks an important expansion of our PD1-Vaxx program into early-stage colorectal cancer, an area where improved treatment options remain urgently needed."

Upon its release, the poster will be available on Imugene’s website at
View Source

About the Neo-POLEM study
Neo-POLEM is a collaborative investigator-initiated Phase II clinical trial coordinated by the Southampton Clinical Trials Unit (UK) in partnership with the Australasian Gastro- Intestinal Trials Group (AGITG) and funded by Imugene Limited.

The trial is designed to determine whether PD1-Vaxx, Imugene’s novel PD-1-targeting B- cell vaccine, can elicit major pathological responses in microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) early-stage colorectal cancer.

MSI-H colorectal tumours are characterised by high tumour mutation burden and immune infiltration, features that predict responsiveness to immunotherapy. PD10-Vaxx aims to induce a polyclonal B-cell antibody response against PD-1, potentially offering efficacy comparable to or greater than monoclonal antibody checkpoint inhibitors (nivolumab, pembrolizumab, ipilimumab) while improving safety and accessibility.

The single-arm Bayesian optimal design trial will enrol 44 patients with operable MSI-high or dMMR stage II–III colon cancer across 6–10 sites in the UK and Australia. Participants receive three PD1-Vaxx vaccinations over six weeks prior to surgical resection, followed by investigator-selected adjuvant therapy. The primary endpoint is major pathological response (MPR), defined as ≤ 10% viable tumour cells at resection. Secondary endpoints include safety, complete response rate, objective response rate, disease-free and overall survival, and surgical outcomes.

Recruitment commenced in May 2025, with the study now open at multiple Australian sites and UK site activation underway.

(Press release, Imugene, OCT 20, 2025, View Source [SID1234656780])