On March 15, 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 fourth quarter and full-year ended December 31, 2020 (Press release, Sesen Bio, MAR 15, 2021, View Source [SID1234576656]). The Company’s lead program, Vicineum, also known as VB4-845, is currently in the follow-up stage of a Phase 3 registration trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In February 2021, the Food and Drug Administration (FDA) accepted for filing the Company’s Biologics License Application (BLA) for Vicineum under Priority Review.
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"We continue to make tremendous progress on our regulatory path with potential US approval later this year," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Our talented and growing team is laser-focused on bringing a best-in-class treatment to the market that has the potential to improve patient outcomes while reducing healthcare costs. With a strong balance sheet and clear regulatory path forward in both the US and Europe, we are positioned to fully realize the potentially significant global opportunity for Vicineum. We expect 2021 to be a transformative year for Sesen Bio and the patients we serve."
US and European Regulatory Update
US:
On February 12, 2021, Sesen Bio received notice from the FDA that the BLA for Vicineum for the treatment of BCG-unresponsive NMIBC was accepted for filing as of February 16th and granted Priority Review. The FDA set an accelerated 6-month target Prescription Drug User Fee Act (PDUFA) date of August 18, 2021 for a decision on the BLA. The FDA also stated that they are not currently planning to hold an advisory committee meeting to discuss the BLA for Vicineum.
Europe:
On March 5, 2021, Sesen Bio submitted the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Vicineum for the treatment of BCG-unresponsive NMIBC. In December 2020, the Company successfully completed all pre-submission activities supporting the MAA. Sesen Bio anticipates potential approval of the MAA in early 2022.
1This amount is preliminary and is subject to change upon completion of the Company’s financial statements for the quarterly period ended March 31, 2021.
Business Development Update
Middle East and North Africa (MENA):
In November 2020, Sesen Bio signed a partnership agreement with Hikma Pharmaceuticals for the registration and commercialization of Vicineum for the treatment of BCG-unresponsive NMIBC and other types of cancer in MENA. Under the terms of the agreement, Sesen Bio granted Hikma an exclusive license to register and commercialize Vicineum in all 19 MENA markets in an arrangement anticipated to deliver equal value share to both parties. The Company believes this partnership represents a further step in realizing the significant global opportunity for Vicineum.
China:
In December 2020, Sesen Bio entered into a commercial manufacturing and global supply framework agreement (the "Agreement") with its partner Qilu Pharmaceutical for the treatment of BCG-unresponsive NMIBC and other types of cancer. Under the Agreement, Qilu will be part of the contract manufacturing network for the global commercial supply of Vicineum. In July 2020, the Company and Qilu entered into a partnership which grants Qilu an exclusive license to develop, manufacture and commercialize Vicineum in China. The Company believes that the technology transfer to Qilu for manufacturing of Vicineum is on track to be completed in mid-2021. Upon completion of the technology transfer, Sesen Bio is entitled to receive a $2M milestone payment. In addition to Fujifilm and Baxter, the global supply partnership with Qilu expands the Company’s network of world-class partners committed to providing reliable supply of Vicineum around the world.
In January 2021, the Investigational New Drug Application (IND) for Vicineum for the treatment of BCG-unresponsive NMIBC was accepted for review by China’s Center for Drug Evaluation (CDE). In the next one to two months, the Company expects to receive an update from Qilu regarding the potential approval of the IND by the CDE, triggering a $3M milestone payment by Qilu to Sesen Bio.
Leiden University Medical Center (LUMC):
In December 2020, Sesen Bio entered into agreement with LUMC to advancetheir existing partnership for the continued co-development of an imaging agent (the "Imaging Agent") comprised of an antibody fragment of Vicineum and an imaging molecule supplied by LUMC. A Phase 1/2 clinical trial of the Imaging Agent was successfully completed by LUMC with favorable tolerability and demonstrated tumor detection, which the Company believes further supports the targeting specificity of Vicineum. The agreement with LUMC provides Sesen Bio with an option to obtain an exclusive, worldwide license to any intellectual property related to the Imaging Agent and enables the parties to begin negotiating terms for the next clinical trial, which is anticipated to begin after the anticipated US approval of Vicineum for the treatment of BCG-unresponsive NMIBC.
Commercial Update
In October 2020, Sesen Bio entered into an exclusive agreement with Cardinal Health for third-party logistics (3PL) and specialty pharmacy distribution services for Vicineum for the treatment of BCG-unresponsive NMIBC in the US. As part of the agreement, Cardinal Health will provide comprehensive end-to-end 3PL, order-to-cash management and specialty pharmaceutical distribution services to Sesen Bio in support of commercialization in the US. In addition to Fujifilm and Baxter, the Cardinal Health relationship completes the selection of major supply chain partners in support of the commercial distribution of Vicineum, if approved. The Company believes that the supply chain will be ready to support the potential commercial launch of Vicineum with product supply available in Urology clinics by the fourth quarter of 2021.
In December 2020, the Institute for Clinical and Economic Review (ICER) issued favorable results for the cost-effectiveness of Vicineum in its final report. ICER is the leading Health Technology Assessment body in the United States, and is an independent non-profit, research organization that conducts assessments to examine the clinical and economic value of health care innovations such as prescription medications. In the report, ICER cites that the majority of the ICER Council (8 yes votes; 3 no votes) judged Vicineum as superior to best supportive care with an estimate that treatment with Vicineum results in a decrease in cumulative health care costs compared to usual care of approximately $101,000 by year five. The Company believes that the results of the report further support that treatment with Vicineum has the potential to improve patient outcomes while reducing health care costs.
Fourth Quarter and Full-Year 2020 Financial Results
Cash Position: Cash, cash equivalents and restricted cash were $55.4 million as of December 31, 2020, compared to $48.1 million as of December 31, 2019. As of the end of February 2021 cash and cash equivalents were $98 million. This amount is preliminary and is subject to change upon completion of the Company’s financial statements for the quarterly period ended March 31, 2021.
R&D Expenses: Research and development expenses for the fourth quarter of 2020 were $5.6 million compared to $5.4 million for the same period in 2019. For the year ended December 31, 2020, research and development expenses were $29.2 million compared to $24.7 million for the same period in 2019. The full year increase of $4.5 million was due primarily to increased costs associated with technology transfer and manufacturing scale-up for commercial supply ($6.0 million), license milestone fees ($1.2 million), and professional fees in support of regulatory activities ($0.4 million), partially offset by lower employee-related compensation ($1.1 million), lower clinical trial expenses ($1.6 million) as a result of the Company’s Phase 3 VISTA Trial winding down, and other decreases ($0.4 million).
G&A Expenses: General and administrative expenses for the fourth quarter of 2020 were $3.4 million compared to $3.3 million for the same period in 2019. For the year ended December 31, 2020, general and administrative expenses were $14.3 million compared to $12.2 million for the same period in 2019. The full year increase of $2.1 million was due primarily to increases in employee-related compensation ($1.3 million), insurance ($0.5 million), legal fees ($0.6 million), and other increases ($0.2 million), partially offset by lower market research ($0.5 million).
Net Loss: Net loss was $15.0 million, or $0.11 per share, for the fourth quarter of 2020, compared to $33.6 million, or $0.32 per share, for the same period in 2019. For the year ended December 31, 2020, net loss was $22.5 million, or $0.19 per share, compared to $107.5 million, or $1.18 per share, for the same period in 2019. The full year decrease in net loss was attributable 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
Sesen Bio will host a conference call and webcast today at 8:00 AM ET with Dr. Neal Shore, medical director of the Carolina Urologic Research Center, who will provide a clinical perspective on Vicineum for the treatment of BCG-unresponsive NMIBC, and members of the management team who will provide a corporate update. Dr. Shore is a paid consultant to Sesen Bio and served as a clinical investigator for the Phase 2 and Phase 3 clinical trials of Vicineum. To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 2441628. 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 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.