On September 10, 2025 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, reported the closing of its previously announced registered direct offering and concurrent private placement of an aggregate of 5,142,858 shares of common stock and unregistered warrants to purchase up to an aggregate of 5,142,858 shares of common stock (Press release, Citius Oncology, SEP 10, 2025, View Source [SID1234655928]). The combined effective offering price for each share of common stock and accompanying warrant was $1.75. The warrants have an exercise price of $1.84 per share, will be exercisable six months from the date of issuance, and will expire on the five and one-half year anniversary from the date of issuance.

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The gross proceeds to the Company from the registered direct offering and concurrent private placement were approximately $9.0 million before deducting placement agent fees and other offering expenses payable by the Company.

Maxim Group LLC acted as the sole placement agent in connection with the offering.

The shares of common stock described above were offered pursuant to a registration statement on Form S-3 (File No. 333-289979), which was filed with the U.S. Securities and Exchange Commission ("SEC") on September 2, 2025, and was declared effective by the SEC on September 4, 2025. The offering of shares of common stock was made only by means of a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement relating to the shares of common stock has been filed with the SEC. Electronic copies of the prospectus relating to this offering, may also be obtained from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, New York 10022, Attention: Syndicate Department, by telephone at (212) 895-3745 or by email at [email protected]. The warrants issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws.

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

On September 10, 2025 Aktis Oncology, Inc., a clinical-stage oncology company focused on unlocking the breakthrough potential of targeted radiopharmaceuticals for patient populations not addressed by existing platform technologies, reported that Matthew Roden, PhD, President and Chief Executive Officer, and other members of the Aktis Oncology leadership team, will participate in the following September investor conferences (Press release, Aktis Oncology, SEP 10, 2025, View Source [SID1234655929]):

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Oppenheimer 3rd Annual Targeted Radiopharmaceutical Therapies in Oncology Summit

Date:

Thursday, September 11, 2025

Location:

New York, N.Y.

Bank of America Healthcare Trailblazers Private Company Conference

Date:

Wednesday, September 17, 2025

Location:

Everett, Mass.

On September 10, 2025 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported that the U.S. Food and Drug Administration (FDA) has accepted Corcept’s New Drug Application (NDA) for relacorilant as a treatment for patients with platinum-resistant ovarian cancer (Press release, Corcept Therapeutics, SEP 10, 2025, https://ir.corcept.com/news-releases/news-release-details/fda-files-corcepts-new-drug-application-relacorilant-treatment-0 [SID1234655914]). The FDA has assigned a PDUFA date of July 11, 2026 for the application.

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Corcept’s NDA is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials. In these trials, patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel monotherapy, with no need for biomarker selection. Relacorilant was well-tolerated, consistent with its known safety profile. Importantly, relacorilant conferred its benefit without increasing the safety burden of the patients who received it. The type, frequency and severity of adverse events in the combination arms were similar to those in the nab-paclitaxel monotherapy arms.

"The FDA’s acceptance of our NDA brings us closer to offering a much-needed treatment option to patients with this dire disease," said Joseph Belanoff, M.D., Corcept’s Chief Executive Officer. "Relacorilant has the potential to redefine how platinum-resistant ovarian cancer is treated."

About Relacorilant

Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept is developing relacorilant in ovarian cancer and a variety of other serious disorders, including endogenous hypercortisolism and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 30, 2025 for relacorilant as a treatment for patients with hypercortisolism.

About Cortisol’s Role in Oncology

Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenes in the cells to which it binds. Cortisol also suppresses the body’s immune response, which weakens its ability to fight all diseases, including cancer.

About Platinum-Resistant Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

On September 10, 2025 PanTher Therapeutics ("PanTher" or the "Company"), a clinical-stage company redefining cancer treatment with therapeutics administered continuously and exclusively at the tumor site, reported that it has concluded dosing in the first cohort of its Phase 1b clinical trial of PTM-101 in pancreatic ductal adenocarcinoma (PDAC) (Press release, PanTher Therapeutics, SEP 10, 2025, View Source [SID1234655930]). The rapid completion of this middle-dose cohort reflects vigorous engagement of the clinical oncology community with this new approach to cancer treatment.

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The ongoing dose escalation and expansion study builds on findings from PanTher’s first-in-human trial that confirmed the safety of PTM-101 at 100 mg and reported promising tumor shrinkage. In the current U.S. Phase 1b trial, patients are being treated at escalating dose levels of 200 mg and 400 mg. Completion of the full cohort at the 200 mg dose level without evidence of toxicities further demonstrates PTM-101’s safety — even at a dose higher than what is typically used for IV infusion — and confirms its ability to be administered with well-established laparoscopic procedures. The Safety Committee has cleared advancement to the final anticipated cohort, and dosing at the 400 mg dose level has now begun, with the first patient treated.

"The swift execution of this first stage of our Phase 1b study underscores the momentum of our clinical strategy and the promise of PTM-101 as a new treatment paradigm for pancreatic cancer," said Laura Indolfi, Ph.D., Chief Executive Officer and Co-founder of PanTher Therapeutics. "We are encouraged by the good safety profile observed so far and excited by the strong engagement from our clinical investigators. Medical and surgical oncologists are eager for better treatment options for their patients and have found that PTM-101 fits seamlessly into their existing neoadjuvant clinical treatments, creating an opportunity to reach patients at a critical point early in their journey."

Intravenous chemotherapy is highly inefficient at permeating solid tumors and can cause debilitating side effects. PTM-101 is an investigational thin film formulation of the chemotherapy drug paclitaxel that is designed to overcome these limitations. It delivers a sustained (~6 weeks) high dose directly to the tumor site with little to no systemic exposure.

"From a surgical perspective, PTM-101 has been straightforward to place and has integrated seamlessly into minimally invasive staging laparoscopy and mediport placement. I favor a robotic-assisted approach, which allows for enhanced handling of the delicate tissue around the pancreas," said principal investigator Danielle DePeralta, M.D., surgical director of the Pancreas Multidisciplinary Program at the Northwell Health Cancer Institute, Lake Success, NY. "Importantly, patch placement is incorporated into procedures that the patient would otherwise need prior to initiating standard systemic chemotherapy. My hope is that targeted local treatment with the patch, paired with standard chemotherapy, will make more patients with isolated pancreatic tumors candidates for surgical removal with the goal of long-term survival and cure. Because of the proximity of pancreatic tumors to major blood vessels, even minimal tumor shrinkage can make a big difference."

The dose escalation and dose expansion Phase 1b study (NCT06673017) is assessing safety, tolerability, and anti-tumor activity of PTM-101 when combined with standard of care neoadjuvant chemotherapy (FOLFIRINOX) in subjects with borderline resectable or locally advanced PDAC. Dosing of patients has taken place at three clinical sites in the United States, with The University of Texas MD Anderson Cancer Center in Houston, Texas, recently joining the list of sites participating in the trial.

PTM-101 is the lead product candidate within PanTher’s pipeline of implantable medicines designed to directly address hard-to-treat solid tumors. PanTher is additionally developing polymeric drug formulations for the treatment of a range of other solid tumor types.

About PTM-101

PanTher’s most advanced investigational product candidate, PTM-101, is an absorbable thin film formulation of paclitaxel for non-metastatic pancreatic cancer. PTM-101 is designed to deliver continuous, long-term, high-dose chemotherapy to the tumor with little to no systemic exposure. The product, laparoscopically implanted at the tumor site, easily integrates with common minimally invasive procedures used in staging pancreatic cancer. PTM-101 is currently being evaluated in a Phase 1b clinical trial (NCT06673017) with support from the Cancer Prevention & Research Institute of Texas (CPRIT) DP220066.

On September 10, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported the publication of a peer-reviewed article in Cancer Immunology Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Alligator Bioscience, SEP 10, 2025, View Source [SID1234655916]). The paper presents preclinical data on ATOR-4066, a bispecific antibody targeting CD40 and CEACAM5 developed using Alligator’s proprietary Neo-X-Prime platform and RUBY format.

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The study, titled "ATOR-4066, a Neo-X-Prime bispecific antibody targeting CD40 and CEACAM5, induces strong myeloid and T cell dependent tumor immunity and synergizes with PD-1 blockade", highlights the potential of ATOR-4066 to overcome key resistance mechanisms in the tumor microenvironment. The data demonstrates that ATOR-4066 induces localized activation of myeloid cells and T cells within the tumor, while sparing healthy peripheral tissues, resulting in potent antitumor immunity.

Key findings from the publication include:

Tumor-localized activation: ATOR-4066 selectively activated CD40 in human tumor samples.
Potential to outperform other tumor targeting therapies: ATOR-4066 mediates strong anti-tumor activity also in tumors with heterogenous CEACAM5 expression.
Turning the tumor hot: Mechanistic analyses shows that ATOR-4066 efficiently activates the immune system in the tumor resulting in tumor rejection.
Synergy with checkpoint blockade: ATOR-4066 demonstrated synergistic activity with anti-PD-1 treatment.
"Publication of these data in Cancer Immunology Research underscores the potential of our Neo-X-Prime platform and RUBY format to generate bispecific antibodies capable of reshaping the tumor microenvironment and driving durable immune responses," said Søren Bregenholt, CEO of Alligator Bioscience. "As a follow-on to mitazalimab, ATOR-4066 represents a promising new therapeutic strategy for CEACAM5-expressing tumors and provides further evidence of Alligator’s strength in developing tumor-targeted CD40 agonists."