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 Simtra BioPharma Solutions, a leading contract development and manufacturing organization (CDMO) specializing in sterile injectables, reported that it has formed a five-year strategic alliance with the Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada (Press release, Merck KGaA, JUN 11, 2025, View Source [SID1234653829]). The partnership brings together the strengths of two leaders and creates a turnkey offering for biopharmaceutical companies seeking ADC and bioconjugation, linker/payload manufacturing, drug product formulation development and fill-finish capabilities.

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"By bringing together two experts in the ADC value chain, biopharmaceutical companies should benefit from shorter timelines and less complexity, allowing them to focus their efforts on drug discovery," said Franco Negron, CEO of Simtra BioPharma Solutions. "Harmonizing our processes with designated program management from start to finish will give customers greater confidence that their product will be delivered on time and to the highest quality standards—ultimately accelerating the delivery of life-changing therapies to patients who need them most."

Manufacturing ADCs is complex as it involves combining three different components: a monoclonal antibody, a cytotoxic payload, and a linker – each with its own production challenges – into a single, stable, and effective therapeutic. This new alliance creates a seamless development and contract manufacturing value chain with the bulk drug substance conjugated by MilliporeSigma directly transferred to Simtra for drug product fill/finish. Customers will receive streamlined support with designated project managers at each of the partners’ sites working closely together to ensure smooth transfers and expedite timelines.

The ADC pipeline is experiencing strong growth with an increasing number of biopharma companies developing assets in this space, and currently more than 70% of these drugs are manufactured by CDMOs. A Roots Analysis study showed the market for ADC manufacturing is $1.79 billion today, but is expected to grow to $7 billion by 2035, or a compound annual growth rate of 13%. Early success of ADCs, such as treatments for HER2-positive breast cancer, have helped demonstrate the significant potential of ADCs as a cancer treatment option. However, most biopharmaceutical companies today must seek out multiple manufacturing partners to develop antibodies, high-potency active pharmaceutical ingredient/cytotoxic payloads, and linkers, perform the conjugation and purification step and complete fill-finish.

"Patients can’t wait. With over 200 new ADCs in active clinical trials, it is critical that we work to speed up the manufacturing process, reduce the risk of knowledge or time-loss during handoffs, and enable our clients to advance their programs," said Benjamin Hein, Head of Life Science Services, Life Science business of Merck KGaA, Darmstadt, Germany. "Connecting the bioconjugation and fill-finish steps will be a value-add for our clients, ultimately meeting their ambitious timelines and allowing the broadest number of patients to benefit in the fastest and safest possible way."

On June 11, 2025 Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, reported that it intends to offer and sell $650 million of shares of its common stock in an underwritten public offering (Press release, Insmed, JUN 11, 2025, View Source [SID1234653878]). In addition, Insmed intends to grant the underwriters a 30-day option to purchase up to an additional $97.5 million of shares of common stock. All of the shares to be sold in the offering are to be sold by Insmed. The 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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Goldman Sachs & Co. LLC and Leerink Partners are acting as joint book-running managers for the offering.

The public offering of common stock described above is being made pursuant to Insmed’s shelf registration statement on Form S-3 (File No. 333-272088) that was previously filed with the Securities and Exchange Commission (SEC) and became automatically effective on May 19, 2023. A preliminary prospectus supplement relating to and describing the terms of the 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 prospectus relating to this offering may be obtained, when available, from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected] or Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

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

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 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-class1 targeted and immune-mediated therapeutics to fight cancer, reported that it has entered into a definitive agreement with a single institutional investor for the purchase and sale in a registered direct offering of 739,000 shares of its common stock (or common stock equivalents), at an offering price of $6.25 per share of common stock (or common stock equivalent) (Press release, Tempest Therapeutics, JUN 11, 2025, View Source [SID1234653817]). The closing of the offering is expected to occur on or about June 12, 2025, subject to the satisfaction of customary closing conditions.

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

The aggregate gross proceeds to the Company from the offering are expected to be approximately $4.6 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering primarily for supporting the previously announced strategic alternative process and for working capital and general corporate purposes.

The securities described above are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333- 280918) that was filed with the Securities and Exchange Commission (the SEC), on July 19, 2024, as amended on January 24, 2025, which was declared effective by the SEC on January 27, 2025. The offering of the securities in the registered direct offering is being made only by means of a base prospectus and prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus, when available, may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

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.