On May 10, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported operating results for the first quarter ended March 31, 2021 (Press release, Sesen Bio, MAY 10, 2021, View Source [SID1234579604]). The Company’s Biologics License Application (BLA) for the Company’s lead program, Vicineum, is currently under Priority Review with the Food and Drug Administration (FDA) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with a target Prescription Drug User Fee Act (PDUFA) date of August 18, 2021.

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"We are very pleased with the tremendous progress we continue to make in our four biggest global markets: the US, Europe, the Middle East and North Africa region and China," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "In the US, we continue to work with the FDA as we approach our target PDUFA date, and we are making substantial progress toward launch readiness. We are laser focused on bringing a product to market that we believe will improve patient outcomes while reducing overall healthcare costs to patients globally, and we expect to continue to make progress around the world in the coming months."

US and OUS Regulatory Update

US:

In February 2021, Sesen Bio received notice from the FDA that the BLA for Vicineum was accepted for filing. Along with the acceptance, the Company was granted Priority Review with a target PDUFA date of August 18, 2021 for a decision on the BLA. The FDA also stated that an advisory committee meeting was not currently planned to discuss the BLA.
Europe:

On March 25, 2021, the Company was notified by the European Medicines Agency (EMA) that the Company’s Marketing Authorization Application (MAA) for Vysyneum was found to be valid and that the review procedure had officially started. Sesen Bio submitted the MAA on March 5, 2021, and the Company remains on-track for potential approval of Vysyneum in the EU in early 2022.
On March 31, 2021, the Company received notice from the Committee for Medicinal Products for Human Use (CHMP) of the EMA that the CHMP has conditionally accepted the proprietary brand name Vysyneum for the Company’s product candidate, oportuzumab monatox, in the EU. The Company believes Vysyneum is a brand name with strong marketing potential given its identical pronunciation to the US proprietary brand name Vicineum. Final approval of the Vysyneum brand name is conditional on EMA product approval.
China:

The Investigational New Drug (IND) application for Vicineum for the treatment of BCG-unresponsive NMIBC submitted to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) was approved on March 19, 2021 ahead of the original timeline of April 2021. This approval triggers a $3M milestone payment to the Company, and authorizes Qilu Pharmaceutical, the Company’s partner in China, to conduct the proposed clinical trial to assess the efficacy and safety of Vicineum in China, at the sole cost of Qilu Pharmaceutical. Assuming a successful trial, Qilu Pharmaceutical anticipates submission of the product market application for Vicineum in 2022, with potential approval in China expected in 2023.
Middle East and North Africa (MENA):

The Company continues to work closely with its partner, Hikma Pharmaceuticals, to submit marketing authorization applications for Vicineum in 2021 in four key markets in the region: the Kingdom of Saudi Arabia, Jordan, Morocco and Egypt. These four markets represent a significant opportunity in the MENA region, as Saudi Arabia, Jordan and Morocco have some of the most advanced healthcare systems in the region while Egypt is the second largest economy in Africa. The Company anticipates the first wave of potential country approvals for Vicineum in the MENA region as early as 2022.
Commercial Update

The Company continues to build its commercial organization with key leadership appointments and a partnership with a leading contract sales organization (CSO), Syneos Health, as it prepares for the anticipated commercial launch of Vicineum in the US in 3Q 2021. Sesen Bio has begun to hire key commercial roles and has entered into a partnership with Syneos Health who will provide speed and logistical support in the hiring and deployment of the sales force. The sales force will include 35 sales representatives across four regions to target approximately 2,000 high prescribers of BCG.
First Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and restricted cash were $110 million as of March 31, 2021, compared to $55.4 million as of December 31, 2020.
R&D Expenses: Research and development expenses for the first quarter of 2021 were $6.1 million compared to $8.9 million for the same period in 2020. The decrease of $2.8 million was due to decreased costs associated with technology transfer and manufacturing ($4.4 million) and lower clinical trial expense as a result of the Company’s Phase 3 VISTA trial winding down ($0.1 million). This was partially offset by increases in professional services in support of the MAA submission to the EMA ($0.9 million), license milestone fees ($0.6 million) and employee-related compensation ($0.2 million).
G&A Expenses: General and administrative expenses for the first quarter of 2021 were $5.3 million compared to $3.4 million for the same period in 2020. The increase of $1.9 million was due primarily to increases in legal fees ($0.7 million), employee-related compensation driven by increased headcount as part of the commercial build ($0.7 million), professional services ($0.3 million), and other increases ($0.2 million).
Net Loss: Net loss was $55.5 million, or $0.35 per share, for the first quarter of 2021, compared to net income of $41.6 million, or $0.31 per basic share and $0.31 per diluted share, for the first quarter of 2020. The change from net income to net loss was attributable primarily to differences in the non-cash change in the fair value of contingent consideration that is recognized in earnings (or loss) for each respective period.
Conference Call and Webcast Information
Members of the Sesen Bio management team will host a conference call and webcast today at 8:00 AM ET to provide a corporate update and review the Company’s financial results. To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 6229838. The webcast can be accessed in the Investor Relations section of the Company’s website at www.sesenbio.com. The replay of the webcast will be available in the investor section of the Company’s website at www.sesenbio.com for 60 days following the call.

About Vicineum
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.