Sesen Bio, Inc. Stock Price, News & Analysis

Sesen Bio (Nasdaq: SESN) reported its Q4 2021 results, highlighting a strong balance sheet with $163M in cash as of December 31, 2021. The company engaged in productive meetings with the FDA, focusing on the regulatory path for Vicineum™, a treatment for non-muscle invasive bladder cancer. The FDA has encouraged Sesen Bio to submit final Phase 3 trial results and conduct another Phase 3 trial. The company achieved a $20M milestone payment from Roche, and net income improved to $8.9M, or $0.04 per share, for Q4 2021, compared to a net loss in the prior year.

Sesen Bio (NASDAQ: SESN) announced the appointments of Minori Rosales, M.D., Ph.D. as Chief Development Officer and Stephanie Vigue as Director of Finance, effective January 24 and January 17, 2022, respectively. Dr. Rosales brings over 15 years of clinical experience, having managed clinical trials and regulatory compliance, while Ms. Vigue has expertise in corporate finance and budget management. Both will play crucial roles in advancing the company’s Phase 3 clinical trial for Vicineum™, targeted at treating BCG-unresponsive non-muscle invasive bladder cancer.

Sesen Bio (Nasdaq:SESN) announced plans to conduct an additional clinical trial for Vicineum™, targeting BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Following a recent FDA Clinical Type A meeting on December 8, 2021, the company gained clarity on the requirements for resubmission of its Biologics License Application (BLA). The anticipated trial will assess Vicineum against intravesical chemotherapy options. A Type C meeting with the FDA is expected in early 2022 to finalize the trial protocol.

Sesen Bio (NASDAQ: SESN) has appointed Dominika Kowalski as Senior Director of Global Drug Safety, reflecting its commitment to developing Vicineum for treating BCG-unresponsive non-muscle invasive bladder cancer. Kowalski brings 14+ years of experience from firms like Horizon Therapeutics and Abbott. The company is engaging with the FDA following a Complete Response Letter (CRL) concerning its Biologics License Application (BLA) for Vicineum, and a Type A meeting to discuss clinical data is scheduled for December 8, 2021.

Sesen Bio (NASDAQ: SESN) announced that Jane Pritchett Henderson has transitioned from a member of the Board of Directors to a CEO Advisor role, effective November 22, 2021. This change allows her to focus on her other responsibilities while still advising the company. Jason Keyes has been appointed Chair of the Audit Committee, while Jay S. Duker, MD takes over as Chair of the Compensation Committee. The board has undergone significant refreshment recently, with new members bringing regulatory and clinical expertise. Sesen Bio's lead product, Vicineum, is under a Phase 3 trial for BCG-unresponsive non-muscle invasive bladder cancer.

Sesen Bio reported its third-quarter results for 2021, highlighting a strong cash position of $175 million as of September 30. The company is addressing FDA concerns regarding its lead therapy, Vicineum, through productive discussions, including a recent CMC Type A Meeting. While R&D expenses decreased to $5 million, G&A expenses increased to $8.7 million. Notably, net income reached $71.7 million, marking a significant turnaround from a $22.6 million loss in 2020, primarily due to favorable non-cash related expenses despite restructuring costs and reduced license revenue.

Sesen Bio announced a productive Type A Meeting with the FDA on October 29, 2021, to address Chemistry, Manufacturing, and Controls (CMC) concerns regarding its Biologics License Application (BLA) for Vicineum, aimed at treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The FDA confirmed that Vicineum from the proposed commercial process is comparable to that used in previous trials. The company is preparing for a Clinical Type A Meeting later this year to discuss further clinical data. Sesen Bio remains committed to bringing new treatment options to market.

Sesen Bio, a clinical-stage company focused on cancer therapeutics, has expanded its teams by hiring Eun Jang as Senior Director of Analytical Sciences and Chèrie Kaefring as Director of Clinical Operations. This move underscores Sesen Bio's commitment to advancing Vicineum™ for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The company is preparing for CMC and clinical Type A meetings with the FDA, with a request for the CMC meeting expected by the end of October 2021. Non-statutory stock options totaling up to 122,500 shares have been granted to the new hires.

Federman & Sherwood has initiated an investigation into Sesen Bio (NASDAQ: SESN) for potential violations of federal securities laws during the Class Period from August 9, 2021, to August 13, 2021. The complaint alleges that the company made material false representations that artificially inflated the stock price. The lawsuit aims to recover damages for investors who purchased shares during this period and allows potential lead plaintiffs to step forward by October 15, 2021.