On December 31, 2024 OS Therapies, Inc. (NYSE-A: OSTX) ("OS Therapies" or the "Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, reported the closing of a private placement financing, raising approximately $6 million in gross proceeds for the Company, before deducting offering-related expenses (Press release, OS Therapies, DEC 31, 2024, View Source [SID1234649372]). The Company intends to use the proceeds from the private placement for working capital, primarily focused on the clinical and regulatory milestones to support commercialization of the Company’s lead therapeutic candidate OST-HER2 in the recurrent, resected metastatic osteosarcoma in the United States in 2025, and for general corporate purposes. The US FDA has granted OST-HER2 rare pediatric disease, fast track and orphan drug designations for osteosarcoma.

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"The Company expects the capital raised in this financing to allow it to operate into 2026, by which time the Company believes it will have delivered the necessary clinical data and other Biologics License Authorization-enabling requirements to be granted authorization by the US Food & Drug Administration to begin commercialization of OST-HER2 for the prevention of recurrent, resected metastatic osteosarcoma in the United States," said Paul Romness, MHP, Chairman & CEO of OS Therapies. "If we are successful in achieving this mission, not only will we change the lives of families afflicted by this devastating childhood cancer, the Company would also be granted a priority review voucher (PRV), currently valued at approximately $150 million, that would further capitalize the Company to allow it expand the clinical development of OST-HER2 into other HER2 positive cancers such as breast cancer and/or colorectal cancer."

The US FDA granted OST-HER2 rare pediatric disease designation for osteosarcoma in 2021. The US FDA rare pediatric disease PRV program aims to incentivize drug development for rare pediatric diseases. Under this voucher program, a sponsor who receives an approval for a drug or biological product for a rare pediatric disease qualifies for a voucher that can be redeemed to receive priority review for a different product. The sponsor may also transfer or sell the voucher to another sponsor. OS Therapies intends to sell the PRV it would earn upon receiving approval of OST-HER2 for recurrent, resected metastatic osteosarcoma. The most recent publicly disclosed sale price of a PRV was on November 27th, 2024 when PTC Therapeutics announced selling its PRV to Kebilidi for $150M. With emerging scarcity in the PRV market, the Company expects the value of PRVs to increase going forward. The maximum sale price of a PRV was in 2015 when AbbVie bought a priority review voucher from United Therapeutics for $350 million.

The most recent continuing resolution (CR) negotiations in the US House of Representatives failed to reauthorize the PRV program for pediatric cancers such as osteosarcoma. Despite this, as a result of OS Therapies’ having been granted OST-HER2’s rare pediatric disease designation prior to December 20, 2024 in addition to the Company’s aim to receive an approval for OST-HER2 in the rare pediatric disease osteosarcoma in 2025, prior to the September 30, 2026 deadline, OS Therapies remains eligible to receive the PRV upon approval of OST-HER2 in recurrent, resected metastatic osteosarcoma.

The Company sold 1.5 million units at a price of $4.00 per unit, with each unit consisting of one share of Series A Senior Convertible Preferred Stock (the "Preferred Stock") convertible into one share of common stock and one warrant to purchase one share of common stock. The conversion price of the Preferred Stock into shares of common stock is $4.00 and the exercise price of the warrants is $4.40 per share.

Brookline Capital Markets, a division of Arcadia Securities, LLC, served as placement agent and Ceros Financial Services, Inc. was engaged as a selected dealer to the placement agent.

The securities sold in the private placement, as well as the common stock into which the securities are convertible or exercisable into, have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities laws and 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. The Company has agreed to file a registration statement with the Securities and Exchange Commission (the SEC") registering the resale of the shares of common stock underlying the securities issued in this private placement (the "Resale Shares").

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities being offered 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 jurisdiction. Any offering of the Resale Shares under the resale registration statement will only be made by means of a prospectus.

On December 31, 2024 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported the initiation of an investigator-initiated trial (IIT) in China for KJ-C2219, an allogeneic CAR T-cell therapy, targeting CD19/CD20 (Press release, Carsgen Therapeutics, DEC 31, 2024, View Source [SID1234649370]). The trial will evaluate KJ-C2219 for the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL).

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KJ-C2219 is developed based on CARsgen’s THANK-u Plus platform and is designed for the treatment of hematologic malignancies and autoimmune diseases.

About THANK-u Plus

CARsgen has developed the THANK-u Plus platform as an enhanced version of its proprietary THANK-uCAR allogeneic CAR-T technology to address the potential impact of NKG2A expression levels on therapeutic efficacy. THANK-u Plus demonstrates sustained expansion regardless of varying NKG2A expression levels on NK cells and exhibits significantly improved expansion compared to THANK-uCAR. Preclinical studies show that THANK-u Plus delivers superior antitumor efficacy in the presence of NK cells compared to THANK-uCAR. Allogeneic BCMA or dual-targeting CD19/CD20 CAR-T cells developed using this platform exhibit robust antitumor activity in the presence of NK cells, indicating that THANK-u Plus has broad potential for developing diverse allogeneic CAR-T therapies.

On December 31, 2024 Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, reported a regulatory update on paxalisib for the treatment of glioblastoma (GBM) following its Type C clinical meeting with the United States Food and Drug Administration (FDA) (Press release, Kazia Therapeutics, DEC 31, 2024, View Source [SID1234649369]).

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In July 2024, the Company reported topline results from the GBM-AGILE study in which newly diagnosed unmethylated (NDU) patients with glioblastoma treated with paxalisib showed a clinically meaningful improvement in a prespecified secondary analysis for overall survival (OS) compared to standard of care. Based on these results and the totality of data from all completed paxalisib clinical studies, Kazia requested a meeting with the FDA to discuss potential clinical and regulatory paths forward.

Following discussions with the FDA and feedback from Kazia’s recent Type C meeting, the FDA’s current position is that data on OS would generally not be appropriate for accelerated approval, but could be considered to support a traditional/standard approval. The Agency further commented that the secondary endpoint OS data from the GBM-AGILE study are supportive and informative for designing and executing a pivotal registrational study in pursuit of a standard approval. Importantly, the Company aligned with the FDA on key aspects of the design of a proposed registrational/pivotal phase 3 study, including patient population, primary endpoint, and the comparator arm to be used.

"We appreciate the extensive and thoughtful feedback from the FDA, which provides us with added clarity with respect to paxalisib’s potential registration pathway for the treatment of patients with NDU glioblastoma" commented Dr. John Friend, Kazia’s CEO "We believe data from the GBM-AGILE trial, including the prespecified secondary endpoint, which demonstrated a 3.8-month OS improvement, provides evidence supporting a clinically meaningful efficacy signal that merits further testing paxalisib in this patient population in a larger, pivotal study".

"As we evaluate our next steps in NDU glioblastoma, paxalisib continues to be tested in a number of other key indications, including pediatric brain cancer and brain metastases. We have received Orphan Drug and Rare Pediatric Disease Designations for both DIPG and AT/RT, which could make us eligible to receive pediatric review vouchers at the time of product approval. We recently presented very exciting data at the San Antonio Breast Cancer meeting highlighting synergistic activity between a novel combination of paxalisib and immunotherapy, and we believe paxalisib shows potential to be evaluated in breast cancers where iPI3K pathway mutations are known to drive tumor growth. The Kazia team, in conjunction with the Board of Directors, is continuing to evaluate several options, and we expect to provide an outline for our path forward to maximize shareholder value by the end of January 2025."

On December 31, 2024 Galera Therapeutics, Inc. (OTC: GRTX) reported that it has completed the acquisition of Nova Pharmaceuticals, Inc. ("Nova"), a privately held biotechnology company advancing a pan-NOS Inhibitor to treat patients with highly resistant forms of breast cancer, including metaplastic breast cancer and other refractory subsets of triple-negative breast cancer ("TNBC") (Press release, Galera Therapeutics, DEC 31, 2024, View Source [SID1234649368]).

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In support of the acquisition, a syndicate of investors led by Ikarian Capital has invested approximately $3 million to purchase Galera common stock. Galera’s new lead program is the Investigator-sponsored Phase 1/2 trial of a pan-NOS Inhibitor on top of standard-of-care nab-paclitaxel and alpelisib in metaplastic breast cancer. The Company’s cash balance at closing is anticipated to fund operations into 2026 and through data readout from its lead program in metaplastic breast cancer. A second trial is planned for this agent in TNBC in collaboration with the I-SPY 2 consortium. The Company intends to support a third trial of Avasopasem, one of its small molecule dismutase mimetics, in patients with hormone-receptor positive (HR+) advanced breast cancer who have become resistant to conventional therapy. This trial is expected to commence enrollment in the first half of 2025.

"Dismutase Mimetics and NOS inhibitors involve complementary pathways that play important roles in cancer, in the tumor microenvironment, in resistance to conventional chemoradiotherapy and in immuno-oncology," said Mel Sorensen, M.D., President & CEO of Galera. "Substantial mechanistic and preclinical rationale for both agents in solid tumors, especially in breast cancer, has been generated by the companies and their collaborators. Both product candidates are in clinical stage development, having been well-characterized in many patients both in oncologic and non-oncologic indications. Galera has decided to focus its near-term development on the hardest-to-treat subsets of advanced breast cancer."

The Company continues as Galera Therapeutics, Inc. (OTC:GRTX) and will be led by Dr. Sorensen, as President and Chief Executive Officer and Joel Sussman, as Chief Accounting Officer. A team of consultants comprising people from both Galera and Nova will manage the R&D of the company, in a capital efficient manner.

"I am excited about the ability to combine our technologies to address the unmet need of many breast cancer patients," said Par S Hyare CEO of Nova Pharmaceuticals. "This agreement allows Galera and our collaborators the opportunity to advance our product candidates to the next stage of clinical development. The investigators at Houston Methodist have presented data showing several responses in the ongoing trial and we look forward to the data readout in the next nine to fifteen months under the capable leadership of Galera’s team."

About the Proposed Transactions

Under the terms of the merger agreement and the securities purchase agreement, Galera has issued approximately 21.1 million shares of common stock plus pre-funded warrants exercisable for approximately 23 million shares of common stock, and approximately 119,318 shares of Series B non-voting (1:1000) convertible preferred stock in a private placement. At the closing, Galera stockholders will own approximately 55.2% of the common shares (assuming that the pre-funded warrants are exercised in full). The shares of Series B non-voting convertible preferred stock will be convertible into shares of common stock, subject to stockholder approval at a subsequent meeting of the Company’s stockholders. Following that approval, on an as-converted basis, the pre-acquisition Galera stockholders will own approximately 25% of the combined Company and the new investors and Nova stockholders will own approximately 75% of the combined Company (assuming that the pre-funded warrants are exercised in full).

The transaction was unanimously approved by the Board of Directors of both companies and by the stockholders of Nova.

The Board of Directors includes three current Galera board members, Mr. Larry Alleva and Mr. Kevin Lokay and Dr. Sorensen, and two additional board members selected by Nova, Mr. Michael Friedman and Dr. Nancy T. Chang. Mr. Friedman has an MBA from the University of Chicago and brings over 20 years’ experience in investment banking, in finance and in the life science industry to the Board of Galera. Dr. Chang is a PhD biochemist who has spent her career in leadership roles in academia, in large and small pharma companies and in the venture capital world and she has extensive experience in biopharma boards.

Stifel, Nicolaus & Company served as the financial advisor to Galera. Lucid Capital Markets, LLC has provided a fairness opinion to Galera’s Board of Directors. Sidley Austin LLP is serving as legal counsel to Galera. Cooley LLP is serving as legal counsel to Nova.

On December 31, 2024 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported it has granted equity awards to new non-executive employees who joined the Company (Press release, Abeona Therapeutics, DEC 31, 2024, View Source [SID1234649367]). The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

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On December 30, 2024, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to five individuals hired by Abeona, which equity awards relate to, in the aggregate, up to 28,600 restricted shares of Abeona common stock. One-third of the shares subject to such restricted stock awards will vest yearly on each anniversary of the Grant Date, such that the shares subject to such restricted stock awards granted to each employee will be fully vested on the third anniversary of the Grant Date, in each case, subject to each employee’s continued employment with Abeona on the applicable vesting dates.