Citius Oncology Announces $18 Million Concurrent Registered Direct Offering and Private Placement Priced At-The-Market Under Nasdaq Rules

On December 9, 2025 Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), reported that it has entered into a definitive agreement with a single healthcare-focused investor for the purchase and sale of 1,284,404 shares of its common stock at a purchase price of $1.09 per share in a registered direct offering priced at-the-market under Nasdaq rules. In addition, the Company has agreed to issue to the investor unregistered warrants to purchase up to 1,284,404 shares of common stock at an exercise price of $1.09 per share, which will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares of common stock upon exercise of the warrants and will expire five years from the date of stockholder approval.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Concurrently with the registered direct offering, in a private placement priced at-the-market under Nasdaq rules, the Company entered into a definitive agreement with the investor for the purchase and sale of 15,229,358 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 15,229,358 shares of the Company’s common stock at a purchase price of $1.09 per share and accompanying warrant. The warrants to be issued in the private placement have an exercise price of $1.09 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares of common stock upon exercise of the warrants and will expire five years from the date of stockholder approval.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offerings.

The closing of the offerings is expected to occur on or about December 10, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds from the offerings, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be approximately $18 million. The Company intends to use the net proceeds from the offerings to support the commercial launch of LYMPHIR and for working capital and general corporate purposes.

The shares of common stock (but not the shares of common stock and pre-funded warrants to be issued in the private placement and the unregistered warrants and the shares of common stock underlying the unregistered warrants) being offered in the registered direct are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-289979) that was declared effective by the Securities and Exchange Commission (the "SEC") on September 4, 2025. The offering of the shares of common stock in the registered direct is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The shares of common stock, pre-funded warrants and warrants to be issued in the private placement, as well as the unregistered warrants to be issued to the investor in the registered directed offering, are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such pre-funded warrants and warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, such securities and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Under a registration rights agreement with the investor, the Company is required to file a registration statement with the SEC covering the resale of the shares of the common stock and shares of common stock underlying the pre-funded warrants to be issued in the private placement and the shares of common stock underlying the warrants to be issued in both offerings.

The Company also has agreed to amend certain existing warrants to purchase up to an aggregate of 11,961,040 shares of the Company’s common stock that were previously issued to the investor in July 2025 and September 2025, with exercise prices of $1.32 and $1.84 per share, respectively, effective upon the closing of the offerings, such that the amended warrants will have a reduced exercise price of $1.09 per share and will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the warrants.

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.

(Press release, Citius Oncology, DEC 9, 2025, View Source [SID1234661327])

Zydus and Formycon enter into an Exclusive Partnership for the Licensing and Supply of Biosimilar to Keytruda® (Pembrolizumab), in US and Canada

On December 9, 2025 Zydus Lifesciences Limited (including its subsidiaries and affiliates), an innovation-led life-sciences company, with an international presence, reported that its wholly owned subsidiary, Zydus Lifesciences Global FZE, United Arab Emirates has entered into a strategic partnership with Formycon AG for the exclusive licensing and supply of checkpoint inhibitor FYB206, a biosimilar of Keytruda1 (Pembrolizumab) in the USA and Canada market.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of this agreement, Formycon AG will develop, register, manufacture and supply the product, while Zydus Lifesciences Global FZE, United Arab Emirates will be responsible for the commercialization of FYB206 in the defined territories. The BLA application is expected to be submitted to the USFDA in the near future and is aimed at making immunotherapy affordable and accessible to patients in need.

Commenting on this strategic partnership, Managing Director of Zydus Lifesciences Limited, Dr. Sharvil P. Patel, stated, "We are happy to collaborate with Formycon to develop and commercialize a biosimilar of Keytruda across US and Canada. This venture marks Zydus’ entry into the North American biosimilar market, debuting with an immunotherapy product. This collaboration also complements Zydus’ recent proposed acquisition of Agenus Inc.’s California, USA based manufacturing facilities, which we plan to integrate and leverage for manufacturing in the future. By combining our expertise and resources, we aim to drive significant organizational growth and deliver maximum value to patients through expanded access to affordable oncology care."

Dr. Stefan Glombitza, CEO of Formycon, stated, "FYB206, a biosimilar of Keytruda, demonstrates Formycon’s advanced expertise in developing biosimilar medicines for highly regulated countries. Partnering with Zydus, an organization recognized for its regulatory proficiency and commercial presence, enables us to deliver this important therapeutic option to the patients. This collaboration strengthens our collective commitment to expanding access to medicines."

(Press release, Zydus Cadila, DEC 9, 2025, View Source [SID1234661326])

TuHURA Biosciences, Inc. Announces $15.6 Million Registered Direct Offering

On December 9, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported that it has entered into a definitive agreement for the purchase of an aggregate of 9,462,423 shares of its common stock, Series A warrants to purchase up to an aggregate of 9,462,423 shares of its common stock and Series B warrants to purchase up to an aggregate of 9,462,423 shares of its common stock, at a purchase price of $1.65 per share and accompanying warrants in a registered direct offering. The warrants will have an exercise price of $1.95 per share and will be exercisable beginning six months after the date of issuance.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

H.C. Wainwright & Co. is acting as the exclusive lead placement agent for the offering. Rodman & Renshaw LLC is acting as co-placement agent for the offering.

The closing of the offering is expected to occur in three tranches. The first closing of the offering is expected to occur on or about December 10, 2025, subject to satisfaction of customary closing conditions. At the first closing, the Company will issue an aggregate of 5,219,999 shares of its common stock, Series A warrants to purchase up to an aggregate of 5,219,999 shares of its common stock and Series B warrants to purchase up to an aggregate of 5,219,999 shares of its common stock. The second closing of the offering is expected to occur by no later than January 30, 2026. At the second closing, the Company will issue an aggregate of 3,030,303 shares of its common stock, Series A warrants to purchase up to an aggregate of 3,030,303 shares of its common stock and Series B warrants to purchase up to an aggregate of 3,030,303 shares of its common stock. The third closing of the offering is expected to occur by no later than February 27, 2026. At the third closing, the Company will issue an aggregate of 1,212,121 shares of its common stock, Series A warrants to purchase up to an aggregate of 1,212,121 shares of its common stock and Series B warrants to purchase up to an aggregate of 1,212,121 shares of its common stock. The Series A warrants will expire five and one-half years from the date of the first closing and the Series B warrants will expire twenty-four months from the date of the first closing.

The gross proceeds to the Company are expected to be approximately $8.6 million from the first closing of the offering, approximately $5 million from the second closing of the offering and approximately $2 million from the third closing of the offering, before deducting the placement agents’ fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering for working capital, satisfaction of the Company’s $3.4 million bridge note obligation to the Matthew Nachtrab Revocable Trust, and general corporate purposes. The bridge note obligation bears interest at a rate of 3% per month and requires repayment on the earlier of December 31, 2025 or on the date that is 30 days following the successful closing of an equity financing in which the Company receives gross cash proceeds in excess of $12,000,000.

The securities described above are being offered pursuant to a "shelf" registration statement (File No. 333-291239) filed with the Securities and Exchange Commission ("SEC") on November 3, 2025, which became effective automatically on November 22, 2025. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the securities being offered will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected] and Rodman & Renshaw LLC at 600 Lexington Avenue, 32nd Floor, New York, NY 10022, by telephone at (212) 540-4414, or by email at [email protected].

This press release shall not constitute an offer to sell or the 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 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 jurisdiction.

(Press release, TuHURA Biosciences, DEC 9, 2025, View Source [SID1234661325])

Phanes Therapeutics to Present Phase 1/2 Study Results of Spevatamig (PT886) in Combination with Chemotherapy in Frontline (1L) Treatment of Metastatic PDAC at ASCO GI 2026

On December 9, 2025 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that they will present their Phase 1/2 study results of spevatamig (PT886) in combination with chemotherapy in frontline (1L) treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium held on Jan 8-10, 2026 in San Francisco, CA. This marks the first public release of Phanes’ clinical trial data from their ongoing U.S. multi-center study with spevatamig. Details of the presentation are below:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Title: Phase 1/2 study of spevatamig (PT886) in combination with gemcitabine plus nab-paclitaxel (GnP) in frontline (1L) treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC)

Abstract #: 709

Session: Cancers of the Pancreas, Small Bowel and Hepatobiliary Tract

Date/Time: January 9th, 2026, at 11:30am-1pm (PST)

First Author: Anwaar Saeed, MD, University of Pittsburgh Medical Center

ABOUT SPEVATAMIG
Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with Merck’s anti-PD-1 therapy, pembrolizumab.

The multi-center Phase 1/2 clinical trial of spevatamig (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of spevatamig in patients with advanced gastric, gastroesophageal junction, pancreatic ductal or biliary tract adenocarcinomas. The Phase 2 study of spevatamig has begun in China.

(Press release, Phanes Therapeutics, DEC 9, 2025, View Source [SID1234661324])

D3 Bio Secures $108 Million in Series B Financing to Advance Global Clinical Programs

On December 9, 2025 D3 Bio, a global clinical-stage biotechnology company focused on the discovery and development of innovative oncology therapeutics, reported the completion of a $108 million Series B financing round.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The funding round was backed by a distinguished group of investors, including IDG Capital and SongQing Capital. Existing investors — WuXi AppTec’s Corporate Venture Fund, Temasek, HSG, MPCi, and Medicxi — also contributed to the round. The robust involvement from both new and current investors highlights widespread confidence in D3 Bio’s innovative pipeline and its global development strategy.

Proceeds from this financing will primarily support the planned global Phase III pivotal program for the company’s lead asset, elisrasib (D3S-001). These pivotal trials will assess elisrasib as both a monotherapy and in combination therapies for KRAS G12C-mutant cancers across key countries and regions, including the United States, China, and the European Union, to facilitate global regulatory submissions.

Furthermore, the funding will facilitate ongoing development of D3 Bio’s comprehensive pipeline of targeted and immuno-oncology programs, which are centred on innovative mechanisms with first-in-class or best-in-class potential.

Dr. George Chen, Founder, Chairman, and CEO of D3 Bio, stated, "The completion of our Series B financing demonstrates the strong confidence our investors place in our vision, scientific approach, business operations, and global development capabilities. This funding enables us to advance our lead program into late-stage clinical trials and further expand our pipeline of innovative therapies designed to benefit patients globally."

Dr. Antoine Yver, Member of the Board of Directors and Scientific Committee of D3 Bio, stated, "This financing demonstrates that the swift and effective pursuit of the best- or first-in-class science is meaningful to society, and validates D3 Bio’s leading innovation, scientific vision and development strategy. It also highlights the unique potential of elisrasib for individuals affected by KRAS G12C-mutant cancers."

(Press release, D3 Bio, DEC 9, 2025, View Source [SID1234661323])