On June 11, 2025 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported the appointment of Jared Kelly as Chief Executive Officer and a member of its Board of Directors (Press release, Oncolytics Biotech, JUN 11, 2025, View Source [SID1234653815]).

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Mr. Kelly is a successful biotech executive who has proven expertise in transformative deals and corporate strategy. Most recently, he played a central role in orchestrating the sale of Ambrx Biopharma to Johnson & Johnson for $2 billion. Prior to Ambrx, he advised multiple leading-edge biotech companies on M&A and licensing transactions at highly respected law firms, including Lowenstein Sandler LLP and Kirkland & Ellis LLP. He is a JD and LLM graduate of Georgetown Law.

"Mr. Kelly’s vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date," said Wayne Pisano, Chair of Oncolytics’ Board of Directors and outgoing Interim CEO. "We believe Mr. Kelly’s well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics’ potential to deliver transformative outcomes for patients and exceptional value for investors."

Mr. Kelly added, "Pelareorep’s clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients. With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy. I am excited to get to work accelerating development and unlocking significant value for stakeholders."

Pelareorep, an intravenously-administered immunotherapeutic agent, has been granted FDA Fast Track designation by the U.S. Food and Drug Administration (FDA) in metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC). It has delivered compelling results in mPDAC, a high-value indication with significant unmet need. In Phase 1 and 2 trials involving more than 140 mPDAC patients, pelareorep has delivered a >60% objective response rate in tumor evaluable patients in the most recent study, which is more than double the benefit observed in historical control trials, and, separately, two-year survival rates 4-6 times those observed in control patients or against the benchmark in prior studies.

In mBC, pelareorep recorded a meaningful survival benefit in two randomized Phase 2 studies of over 100 combined mBC patients, IND-213 and BRACELET-1. Phase 2 objective response rate data in second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA) patients continue to exceed historical data for treatment with a checkpoint inhibitor alone. These consistent efficacy signals, in combination with multiple chemotherapies and checkpoint inhibitors, uniquely position pelareorep as a high-potential asset for further development in-house and/or through strategic partnerships. Pelareorep also has a well-defined and favorable safety profile based on data from >1,100 patients across multiple tumor types.

As a material inducement to Mr. Kelly’s appointment as Chief Executive Officer, and in accordance with NASDAQ Listing Rule 5635(c)(4), Mr. Kelly has been awarded an initial stock option grant exercisable for 2,850,000 shares with an exercise price of CAD$0.57, vesting equally over three years. He also received a performance-based stock option grant exercisable for 1,900,000 shares with an exercise price of CAD$0.57, which will vest upon the achievement of certain financing objectives. All stock option grants have a term of 5 years from the date of grant. The Company also granted Mr. Kelly restricted stock units, which will entitle him to receive that number of Common Shares equal to 2% of the Company’s then outstanding common shares upon the Company entering into a definitive agreement for certain transactions providing for the acquisition of the Company or the exclusive license of pelareorep. Each of these awards is intended to align Mr. Kelly’s long-term incentives with the creation of shareholder value.

On June 11, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported it has secured a debt financing facility of up to $400 million with credit funds managed by SLR Capital Partners, LLC ("SLR") (Press release, Cogent Biosciences, JUN 11, 2025, View Source [SID1234653813]). An initial tranche of $50 million was drawn at closing, with future tranches available based on the achievement of key clinical and commercial milestones aligned with Cogent’s growth strategy.

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"2025 will be a transformative year for Cogent," said Andrew Robbins, the company’s President and Chief Executive Officer. "This strategic financing with SLR provides substantial, non-dilutive capital at very attractive financial terms. It enhances our financial flexibility and enables us to accelerate our bezuclastinib launch planning as we eagerly await the results from SUMMIT, APEX and PEAK pivotal trials this year."

"We’re proud to partner with Cogent in advancing innovative therapies for patients with genetically driven diseases. This investment reflects our ongoing strategy to support high-potential biotech companies as they progress through late-stage development and commercial execution," said Anthony Storino, Partner and Head of Life Science Finance at SLR Capital Partners.

Under the terms of the agreement, Cogent drew $50 million from the facility at closing. An additional $100 million is available during 2025 at Cogent’s discretion, subject to successful top-line data readouts from SUMMIT and PEAK bezuclastinib pivotal trials. An additional $50 million is available upon achievement of early commercial success following bezuclastinib launch. The remaining $200 million is available at mutual agreement of Cogent and SLR.

Cogent remains on track in July to announce top-line results from SUMMIT, a registration-directed, randomized, double-blind, placebo-controlled, global, multicenter, clinical trial of bezuclastinib in patients with NonAdvSM. In the second half of 2025, Cogent is on track to release results from APEX, a registration-directed, global, open-label trial in patients with AdvSM. Finally, before the end of 2025, Cogent expects to release results from PEAK, a global, blinded, randomized Phase 3 clinical trial studying the combination of bezuclastinib and sunitinib versus sunitinib alone in patients with imatinib-resistant GIST.

Leerink Partners served as the exclusive financial advisor to Cogent on the term loan financing.

On June 11, 2025 Niagen Bioscience, Inc. (NASDAQ: NAGE) (formerly ChromaDex Corp.), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, reported its participation in the 2025 BIO International Convention, taking place June 16–19, 2025, in Boston, Massachusetts (Press release, ChromaDex, JUN 11, 2025, View Source [SID1234653812]).

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Hosted by the Biotechnology Innovation Organization (BIO), the BIO International Convention is the world’s largest and most influential biotechnology event, convening more than 20,000 global leaders from across the life sciences ecosystem, including biopharma, academia, investment, and government.

The convention provides companies with unique access to a partnering forum. By participating in BIO 2025, Niagen Bioscience is seeking to initiate discussions with prospective partners to support the development and monetization of its emerging drug product candidates.

Niagen Bioscience is arranging a full slate of one-on-one meetings with pharmaceutical companies focused on neurodegenerative diseases, including Parkinson’s disease (PD), Ataxia Telangiectasia (AT), among others, and plans to have partnering discussions.

Attending from Niagen Bioscience’s executive leadership team will be Ozan Pamir, CFO, Andrew Shao, Ph.D., Senior Vice President of Global Scientific and Regulatory Affairs, and Yasmeen Nkrumah-Elie, Ph.D., Senior Global Director of External Research.

To request a meeting with the team, please reach out to the Company through the BIO Partnering platform at View Source or email [email protected].

On June 10, 2025 Nantes-based biotech XENOTHERA reported the value of its LIS22 antibody in the treatment of peripheral T-cell lymphomas (PTCL). The PALT1 clinical trial (NCT06495723) has just passed a new milestone at the trial’s scientific committee meeting, confirming continued recruitment (Press release, Xenothera, JUN 10, 2025, View Source [SID1234654024]). Clinical and biological safety, as well as injection tolerance, are encouraging. Preliminary efficacy data, yet to be confirmed, are very encouraging.

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To date, 9 patients are participating in the trial. No DLT has been observed, so enrolment at the 6 mg/kg dose is continuing. PALT1 is a Phase I/II trial testing the safety and efficacy of LIS22 in patients with refractory relapsed PTCL. The trial is taking place in France and Italy, with Professor Gandhi Damaj at Caen University Hospital as principal investigator.

The results will be presented orally on Tuesday June 18 at 5:50 p.m. by Firas Bassissi, the biotech’s Scientific Director, at the World Congress on Lymphoma (18th International Conference on Malignant Lymphoma, Lugano, Switzerland, View Source), during the "Experimental Medicines" session under the title "LIS22: An Effective Multimodal Polyclonal Antibody targeting T-Cell Malignancies".

In addition, the PALT1 clinical trial is the subject of an abstract to be published in the proceedings of the same congress (abstract 847: "PALT trial: First in class glyco humanized polyclonal antibody directed against tumoral T cells, in patients with relapsed/refractory peripheral T cells lymphoma (PTCL)").

"To be able to present LIS22 orally and to benefit from an abstract published in the proceedings of the Lugano World Congress is an immense source of pride, and confirms the interest of our treatment, as well as the recognition by the medical and scientific community of the quality and potential of our therapeutic antibody. I am of course delighted to be able to continue this trial, thanks to these results, which are both a validation of our approach and, above all, a source of hope for PTCL patients who have reached a therapeutic impasse. I would like to congratulate the XENOTHERA teams, and above all to thank the patients and medical teams who are working alongside us to analyze the therapeutic potential of LIS22," says Odile Duvaux, President of the biotech company.

On June 10, 2025, Salarius Pharmaceuticals reported to have entered into a Second Amendment to the Merger Agreement ("Amendment No. 2") with Decoy Therapeutics to address significant changes in market conditions and secure necessary consents from Decoy noteholders for the completion of the transaction (Filing, Salarius Pharmaceuticals, JUN 10, 2025, View Source [SID1234653816]).

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Since the execution of the original Merger Agreement in January 2025 and following the execution of Amendment No. 1, the Company’s Common Stock price has experienced substantial deterioration, materially affecting the relative valuations underlying the exchange ratio. As a result, the parties have agreed to reduce the Company’s relative valuation from $4.6 million at the time of the original Merger Agreement to $2.31 million. This reduction results in a change in the exchange ratio such that the number of shares of Common Stock underlying the Company’s Series A Preferred Stock to be issued to Decoy stockholders at Closing will be increased by approximately 17 million shares. Accordingly, under Amendment No. 2, the relative ownership percentages of the combined company will result in Company legacy stockholders retaining 7.6% and Decoy’s legacy stockholders retaining 92.4% of the combined company following the completion of the Merger, in each case calculated on a fully-diluted basis, and before taking into account the dilutive effects of the Qualified Financing and any issuance of shares pursuant to such Qualified Financing after June 10, 2025, the date of Amendment No. 2.

In addition, Amendment No. 2 revises the form of Certificate of Designation (the "Certificate of Designation") for Series A Non-Voting Convertible Preferred Stock (the "Series A Preferred Stock") that will be filed upon Closing to include post-closing anti-dilution price protection for holders of Series A Preferred Stock whereby if, following completion of the Qualified Financing and the Merger, the Company conducts any subsequent dilutive financing of at least $2 million at a weighted average effective price per share below the offering price offered to the public in the Qualified Financing, the conversion ratio will be reset to provide additional shares to preferred stockholders in an amount proportional to the dilution caused by such offering, with such protection applying for one year from issuance. The revised Certificate of Designation also provides that the Series A Preferred Stock will not be convertible until the combined company meets the relevant initial listing standards of Nasdaq and contains a provision designed to prevent holders of Series A Preferred Stock from engaging in short sales of the Company’s common stock. As provided in the original Certificate of Designation, the Series A Preferred Stock will also not convert until the Company obtains stockholder approval pursuant to Nasdaq listing rule 5635.

Except as modified by Amendment No. 2, the terms of the Merger Agreement and Amendment No. 1 remain in full force and effect.

The foregoing descriptions of Amendment No. 2 and the Certificate of Designation are not complete and are qualified in their entirety by reference to the full text of Amendment No. 2 and the Certificate of Designation, copies of which are filed as Exhibit 2.1 and Exhibit 2.2, respectively, to this Current Report on Form 8-K and are incorporated by reference herein.