Sesen Bio Reports Fourth Quarter and Full-Year 2020 Financial Results and Significant Regulatory and Commercial Readiness Progress for the Company’s Lead Product Candidate Vicineum™
Strengthened balance sheet:
Biologics License Application accepted by the FDA under Priority Review
Marketing Authorization Application submitted in
Company to host conference call at
“We continue to make tremendous progress on our regulatory path with potential US approval later this year,” said Dr.
US and European Regulatory Update
US:
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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 ofFebruary 16 th and granted Priority Review. The FDA set an accelerated 6-month target Prescription Drug User Fee Act (PDUFA) date ofAugust 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.
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On
March 5, 2021 ,Sesen Bio submitted the Marketing Authorization Application (MAA) to theEuropean Medicines Agency (EMA) for Vicineum for the treatment of BCG-unresponsive NMIBC. InDecember 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
Business Development Update
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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 grantedHikma 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.
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In
December 2020 ,Sesen Bio entered into a commercial manufacturing and global supply framework agreement (the “Agreement”) with its partnerQilu 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. InJuly 2020 , the Company and Qilu entered into a partnership which grants Qilu an exclusive license to develop, manufacture and commercialize Vicineum inChina . 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’sCenter 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 toSesen Bio .
Leiden
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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 providesSesen 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
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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 toSesen 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 , theInstitute for Clinical and Economic Review (ICER) issued favorable results for the cost-effectiveness of Vicineum in its final report. ICER is the leadingHealth Technology Assessment body inthe 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 theICER 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
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Cash Position: Cash, cash equivalents and restricted cash were
$55.4 million as ofDecember 31, 2020 , compared to$48.1 million as ofDecember 31, 2019 . As of the end ofFebruary 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 endedMarch 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 endedDecember 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 endedDecember 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 endedDecember 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
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
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Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, the Company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the timing for the FDA’s decision on the Company’s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC based on the FDA granting the BLA Priority Review, the PDUFA date of
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||||||
(In thousands, except per share data) | |||||||||||||
(Unaudited) | |||||||||||||
Three Months ended | Twelve Months ended | ||||||||||||
2020 |
|
2019 |
|
2020 |
|
2019 |
|||||||
Revenue | |||||||||||||
License revenue |
$ - |
$ - |
|
$ - |
|||||||||
Total revenue |
- |
- |
11,236 |
- |
|||||||||
Operating expenses: | |||||||||||||
Research and development |
|
5,420 |
29,191 |
24,663 |
|||||||||
General and administrative |
|
3,298 |
14,302 |
12,208 |
|||||||||
Change in change in fair value of contingent consideration |
|
25,020 |
(11,180) |
71,620 |
|||||||||
Total operating expenses |
14,627 |
33,738 |
32,313 |
108,491 |
|||||||||
Loss from operations |
(14,627) |
(33,738) |
(21,077) |
(108,491) |
|||||||||
Other income (expense): | |||||||||||||
Other income (expense), net |
|
185 |
125 |
991 |
|||||||||
Net loss and comprehensive loss, before taxes |
|
|
|
|
|||||||||
Provision for income taxes |
|
$ - |
|
$ - |
|||||||||
Net loss and comprehensive loss |
|
|
|
|
|||||||||
Deemed dividend on adjustment of exercise price of certain warrants |
$ - |
$ - |
|
$ - |
|||||||||
Net loss and comprehensive loss available to common stockholders |
|
|
|
|
|||||||||
Net loss per common share - basic and diluted |
|
|
|
|
|||||||||
Weighted-average common shares outstanding - basic and diluted |
131,522 |
103,848 |
118,221 |
90,929 |
CONSOLIDATED BALANCE SHEETS | |||||||||||
(In thousands, except share and per share data) | |||||||||||
(Unaudited) | |||||||||||
2020 |
|
2019 |
|||||||||
Assets | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents |
|
|
|||||||||
Prepaid expense and other current assets |
7,478 |
6,326 |
|||||||||
Restricted Cash |
3,000 |
- |
|||||||||
Total current assets |
62,867 |
54,447 |
|||||||||
Restricted cash |
20 |
20 |
|||||||||
Property and equipment, net |
123 |
238 |
|||||||||
Intangibles |
46,400 |
46,400 |
|||||||||
13,064 |
13,064 |
||||||||||
Other assets |
349 |
196 |
|||||||||
Total Assets |
|
|
|||||||||
Liabilities and Stockholders' Deficit | |||||||||||
Current liabilities: | |||||||||||
Accounts payable |
|
|
|||||||||
Accrued expenses |
3,973 |
6,169 |
|||||||||
Deferred revenue |
1,500 |
- |
|||||||||
Contingent consideration |
8,985 |
- |
|||||||||
Other current liabilities |
489 |
446 |
|||||||||
Total current liabilities |
18,049 |
8,517 |
|||||||||
Contingent consideration, net of current portion |
99,855 |
120,020 |
|||||||||
Deferred revenue, net of current portion |
1,500 |
- |
|||||||||
Deferred tax liability |
12,528 |
12,528 |
|||||||||
Other liabilities |
118 |
- |
|||||||||
Total Liabilities |
132,050 |
141,065 |
|||||||||
Commitments and contingencies | |||||||||||
Stockholders' Deficit: | |||||||||||
Preferred stock, |
|||||||||||
2020 and |
- |
- |
|||||||||
Common stock. |
|||||||||||
outstanding at |
140 |
107 |
|||||||||
Additional paid-in capital |
306,554 |
266,717 |
|||||||||
Accumulated deficit |
(315,921) |
(293,524) |
|||||||||
Total Stockholders' Deficit |
(9,227) |
(26,700) |
|||||||||
Total Liabilities and Stockholders' Deficit |
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20210315005210/en/
ir@sesenbio.com
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