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Supernus Pharmaceuticals to Acquire Sage Therapeutics, Strengthening its Neuropsychiatry Product Portfolio

On June 16, 2025 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) and Sage Therapeutics, Inc. (Nasdaq: SAGE), reported a definitive agreement for Supernus to acquire Sage through a tender offer for $8.50 per share in cash (or an aggregate of approximately $561 million), payable at closing, plus one non-tradable contingent value right (CVR) collectively worth up to $3.50 per share in cash (or an aggregate of approximately $234 million), for total consideration of $12.00 per share in cash (or an aggregate of up to approximately $795 million) (Press release, Supernus, JUN 16, 2025, View Source [SID1234653924]). The CVR is payable upon achieving certain net sales and commercial milestones. The transaction is expected to close in the third quarter of 2025.

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The transaction will provide Supernus with an innovative marketed product: ZURZUVAE (zuranolone) capsules CIV, the first and only U.S. Food and Drug Administration (FDA)-approved oral medicine indicated for the treatment of adults with postpartum depression. Through a collaboration agreement with Biogen, Inc., Supernus will report collaboration revenue that is 50% of total net revenue Biogen records for ZURZUVAE in the U.S.

"This acquisition represents a major step in bolstering our future growth. It augments our growth profile by adding a significant fourth growth product to our portfolio and further diversifies our sources of future growth. ZURZUVAE aligns with our focus of acquiring novel value-enhancing and clinically-differentiated medicines to treat CNS conditions," said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "We have a proven track record of strong commercial execution, and we look forward to building on ZURZUVAE’s U.S. growth momentum and collaboration with Biogen, so that more women with postpartum depression can benefit from this novel treatment."

"Since our founding, Sage Therapeutics has been committed to pioneering new solutions in brain health, one of the most complex and underserved areas of medicine," said Barry Greene, Chief Executive Officer, Sage Therapeutics. "We are proud of what we’ve accomplished, including successfully developing and commercializing ZURZUVAE, the first and only oral treatment for women with postpartum depression. This transaction follows a comprehensive strategic review by our Board of Directors, and I am confident this deal maximizes value for shareholders. I want to express my deepest gratitude to the Sage team for their unwavering commitment to brain health and improving the lives of patients. We look forward to our next chapter with Supernus."

Strategic and Financial Benefits

Strengthens psychiatry portfolio with ZURZUVAE (zuranolone) capsules CIV, the first and only FDA-approved oral medicine indicated for the treatment of postpartum depression in adults.
Diversifies and increases revenue base and cash flow.
Collaboration revenue from net sales of ZURZUVAE (representing 50% of the net revenue recorded by Biogen) was $36.1 million and $13.8 million for the full year 2024 and for the first quarter of 2025, respectively.
Combined with its three other growth products (Qelbree, ONAPGOTM, and GOCOVRI), Supernus believes it is poised for significant future growth.
Augments Supernus central nervous system (CNS) discovery platforms and expertise.
Strong fit with existing Supernus infrastructure is expected to result in cost synergies of up to $200 million on an annual basis.
The acquisition is expected to be significantly accretive in 2026.

Terms and Financing

Under the terms of the agreement, Supernus will commence a tender offer to acquire all outstanding shares of Sage Therapeutics, Inc. for a purchase price of $8.50 per share in cash (or an aggregate of approximately $561 million) payable at closing plus one non-tradable CVR. All cash consideration will be funded through existing balance sheet cash.

The CVR entitles Sage stockholders to receive up to an additional $3.50 per share payable upon ZURZUVAE achieving certain sales and commercial milestones within certain specified periods (subject to the terms and conditions contained in a Contingent Value Rights Agreement detailing the terms of the CVR). These milestones include (1) $1.00 per share payable if in any calendar year between closing and end of 2027, annual net sales of ZURZUVAE allocable to Supernus reach $250 million or more in the U.S., (2) $1.00 per share payable if in any calendar year between closing and end of 2028, annual net sales of ZURZUVAE allocable to Supernus reach $300 million or more in the U.S., (3) $1.00 per share payable if in any calendar year between closing and end of 2030, annual net sales of ZURZUVAE allocable to Supernus reach $375 million or more in the U.S., and (4) $0.50 per share at first commercial sale in Japan to a third-party customer after regulatory approval for ZURZUVAE for the treatment of major depressive disorder (MDD) in Japan by June 30, 2026.

Approvals and Timing of Close

The transaction, which has been approved by the boards of directors of both companies, is expected to close in the third quarter of 2025, subject to customary closing conditions, including receipt of required regulatory approvals and the tender of a majority of the outstanding shares of Sage’s common stock. Following the successful closing of the tender offer, Supernus will acquire any shares of Sage that are not tendered in the tender offer through a second-step merger at the same consideration as paid in the tender offer.

Full Year Financial Guidance

Supernus will provide revised full year 2025 financial guidance after the closing of the transaction, which is expected in the third quarter of 2025.

Advisors

Moelis & Company LLC is acting as the exclusive financial advisor to Supernus. Goldman Sachs & Co. LLC is acting as the exclusive financial advisor to Sage. Saul Ewing LLP is serving as legal counsel to Supernus. Kirkland & Ellis LLP is serving as legal counsel to Sage.

Conference Call and Webcast Information

A conference call and a live webcast will be hosted today, June 16, 2025, at 8:30 a.m. ET, to discuss the transaction. A live webcast will be available in the Events & Presentations section of the Supernus Investor Relations website www.supernus.com/investors.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Supernus Investor Relations website www.supernus.com/investors. The webcast will be available on the Supernus website for 60 days following the live call.

Sona Engages Clinical Trial Clinic for First-in-Human Early Feasibility Study of its THT Cancer Therapy

On June 16, 2025 Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona") an oncology-focused life sciences company developing innovative therapies based on its uniquely biocompatible gold nanorod technology, reported that it has entered into a clinical trial agreement for an early feasibility study clinical trial of its Targeted Hyperthermia Therapy ("THT") (Press release, Sona Nanotech, JUN 16, 2025, View Source [SID1234653923]). Sona has engaged Bradford Hill Investigacion Clinica ("Bradford Hill") in Santiago, Chile for a study of Sona’s THT treatment for up to ten patients with advanced melanoma.

The study’s principal investigator and Bradford Hill executive director, Dr. Carlos Rojas, commented, "With extensive experience in conducting clinical trials in melanoma for tier-one global pharmaceutical companies, we are excited to partner with Sona Nanotech to assess the potential for their novel cancer treatment with patients in Chile."

Sona CMO, Dr. Carman Giacomantonio, commented, "As an early feasibility study, the primary data to be gathered from this study are for the safety and tolerability of THT in human subjects. We will also look to assess preliminary efficacy as determined by whether each patient’s immune system is engaged by Sona’s THT treatment. Indicators of success will include findings of tumor cell death in tumors treated with THT and evidence of associated enhanced immunity in these patients."

The study is designed to assess safety, tolerability, and preliminary efficacy and will include two treatments of Sona’s THT, one week apart, for patients with advanced melanoma who are on but have failed to respond to a standard of care immunotherapy protocol. The study is subject to final ethics committee approval, and enrollment of the first patients is anticipated by the end of June with interim results this summer and final results expected this fall.

Sona Nanotech believes that its THT treatment may provide benefits over current standard of care immunotherapy treatments alone which have shown limited response rates and can have undesirable side effects.

Northwest Biotherapeutics Announces Upcoming Presentation On Next Generation Dendritic Cells for Enhanced Anti-Tumor Treatments

On June 16, 2025 Northwest Biotherapeutics (OTCQB:NWBO) (the "Company" or "NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that Dr. Marnix Bosch, its Chief Technical Officer, will make a presentation on "Next Generation Dendritic Cell Treatments to Improve Anti-Tumor Responses" at the upcoming Frontiers in Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) of the New York Academy of Sciences (Press release, Northwest Biotherapeutics, JUN 16, 2025, View Source [SID1234653922]). Dr. Bosch will address certain factors and combinations of factors that may lead to supercharged dendritic cells with enhanced anti-tumor effects.

The presentation will take place on Monday, June 16, at 2:50 p.m. The slides will be posted on the Company’s website after the presentation.

NextCure and Simcere Zaiming Announce Strategic Partnership for a Novel Antibody-Drug Conjugate Targeting CDH6

On June 16, 2025 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, and Simcere Zaiming, an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), reported a strategic partnership to develop SIM0505, a novel antibody-drug conjugate (ADC) targeting CDH6 (cadherin-6 or K-cadherin) for the treatment of solid tumors (Press release, NextCure, JUN 16, 2025, View Source [SID1234653921]). SIM0505 is currently in Phase 1 clinical testing in China; NextCure expects to begin clinical testing in the U.S. in the third quarter of 2025.

SIM0505 is a novel ADC developed by Simcere Zaiming. It is directed to CDH6, a promising anti-tumor target, using a unique binding epitope with increased tumor binding compared to competing candidates. It also features Simcere Zaiming’s proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity while offering high systemic clearance to enlarge the therapeutic window. Preclinical studies have demonstrated robust anti-tumor activity across multiple solid tumor models and a promising safety profile in toxicology models.

SIM0505 is currently in Phase 1 dose escalation studies in China. A global dose expansion study is expected following the dose escalation portion of the study to include multiple tumor types. An Investigational New Drug application has been cleared by the U.S. Food and Drug Administration.

The partnership also includes a license for NextCure to access Simcere Zaiming’s proprietary linker and TOPOi payload for a preclinical-stage novel target ADC developed by NextCure. Simcere Zaiming will have Greater China rights to this additional novel target ADC.

"We believe SIM0505 has the potential to be an important new therapy for cancer patients. Partnering with Simcere Zaiming, a leader in antibody-drug conjugates, provides us with an opportunity to advance a class-leading ADC directed to CDH6. Their proprietary payload is a potent cytotoxin with a potentially improved safety and efficacy profile compared to other topoisomerase inhibitors," said Michael Richman, NextCure’s president and CEO. "We look forward to initiating clinical development of SIM0505 in the United States."

"We are very pleased to collaborate with NextCure on the global development of SIM0505," said Renhong Tang, PhD, CEO of Simcere Zaiming. "SIM0505 is a significantly differentiated CDH6 targeting ADC candidate independently developed by Simcere Zaiming. Our alliance reflects NextCure’s recognition of our proprietary ADC platform, and together, we aim to accelerate drug development to benefit more cancer patients worldwide."

Simcere Zaiming is eligible to receive payments throughout the potential development phases, including upfront payment, development, regulatory and sales milestones up to $745M, as well as tiered royalties up to double digits on net sales outside of the Greater China territory.

NanoCell Secures Seed-Extension Financing from The Institute for Follicular Lymphoma Innovation to Advance Lead Clinical Candidate for B Cell Malignancies

On June 16, 2025 NanoCell Therapeutics, Inc. ("NanoCell"), a biotechnology company developing a non-viral, DNA-based in vivo gene therapy platform, reported the successful closing of a seed-extension financing round, with participation from The Institute for Follicular Lymphoma Innovation ("IFLI"), a leading non-profit organization dedicated exclusively to funding innovative follicular lymphoma research and development (Press release, NanoCell Therapeutics, JUN 16, 2025, View Source [SID1234653920]).

The funding will accelerate IND-enabling development of NanoCell’s lead clinical candidate, NCTX-01, a dual-CAR CD19/CD22 in vivo CAR-T therapy for B cell malignancies. NanoCell will use the capital to further evaluate NCTX-01’s safety, efficacy and durability in treating aggressive forms of lymphoma, including diffuse large B-cell lymphoma and follicular lymphoma.

"IFLI’s support enables us to accelerate NCTX-01 through preclinical development to clinical development," said Maurits Geerlings, MD, President & Chief Executive Officer of NanoCell. "This partnership provides crucial resources to generate the preclinical data package needed for regulatory discussions. IFLI shares our belief that non-viral in vivo approaches have transformative potential to address significant unmet medical needs for patients who currently have limited treatment options.

"NanoCell’s innovative platform offers a novel approach to treating both follicular lymphoma and diffuse large B-cell lymphoma and could potentially overcome many of the current barriers that limit patient access to CAR-T therapies," said Michel Azoulay, MD, MBA, Chief Medical Officer at IFLI. "Supporting this program aligns with IFLI’s mission to accelerate innovative therapies that can make a meaningful difference in the lives of patients."