Sesen Bio Reports Third Quarter 2020 Financial Results and Positive Progress Towards Completing the BLA Submission for VicineumTM in December 2020
Manufacturing of Vicineum drug substance and drug product PPQ batches has been completed
Emerging manufacturing data provides strong support for analytical comparability between clinical and commercial material
On track to complete BLA submission to the FDA in
“We are rapidly advancing toward the finalization of our BLA in December as well as a potential MAA submission in
Manufacturing Update
Manufacturing and release testing of the three drug substance PPQ batches has been completed and all quality acceptance criteria were met. Manufacturing of the three drug product batches has also been completed and release testing has been completed for the first and second batch, with all quality acceptance criteria met. Testing of the third drug product PPQ batch is expected to be completed in
As part of the analytical comparability plan submitted to the FDA, the Company also committed to conduct extensive biophysical characterization and forced degradation testing on Vicineum manufactured using the proposed commercial process. These studies were completed in
EMA Regulatory Process
On
Supply Chain
The Company recently announced an exclusive agreement with Cardinal Health for third-party logistics and specialty pharmaceutical distribution services related to the commercial distribution of Vicineum in
On
Third Quarter 2020 Financial Results
-
Cash Position: Cash and cash equivalents were
$42.0 million as ofSeptember 30, 2020 , compared to$48.1 million as ofDecember 31, 2019 . This change includes$8.2 million of net proceeds received during the third quarter of 2020 provided by our ATM offering. -
Revenue: Revenue for the third quarter of 2020 was
$11.2 million , which was due to the recognition of revenue from the Company’s license agreement with Qilu. The Company did not record any revenue for the third quarter of 2019. -
R&D Expenses: Research and development expenses for the third quarter of 2020 were
$10.2 million compared to$6.6 million for the same period in 2019. The third quarter increase was due primarily to costs related to the ongoing technology transfer process with Fujifilm and Baxter as the Company scales-up for commercial manufacturing, partially offset by lower clinical expenses related to the Phase 3 VISTA trial for Vicineum and lower regulatory consulting fees in support of the Company’s ongoing BLA submission with the FDA. -
G&A Expenses: General and administrative expenses for the third quarter of 2020 were
$4.1 million compared to$3.2 million for the same period in 2019. The third quarter increase was due primarily to increases in investment banking and legal fees related to the Company’s license agreement with Qilu. -
Net Loss: Net loss was
$22.6 million , or$0.19 per basic share and diluted share, for the three months endedSeptember 30, 2020 , compared to a net loss of$13.1 million , or$0.13 per basic and diluted share, for the same period in 2019. The change was due primarily to revenue recognized in the third quarter of 2020 related to the Company’s license agreement with Qilu, offset by higher technology transfer costs and a non-cash change in fair value of contingent consideration due to changes in discount rates.
Conference Call and Webcast Information
Members of the
About the VISTA Clinical Trial
The VISTA trial is an open-label, multicenter, single-arm Phase 3 clinical trial evaluating the efficacy and tolerability of VicineumTM as a monotherapy in patients with high-risk, bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC). The primary endpoints of the trial are the complete response rate and the duration of response in patients with carcinoma in situ with or without papillary disease. Patients in the trial received locally administered Vicineum twice a week for six weeks, followed by once-weekly treatment for another six weeks, then treatment every other week for up to two years. To learn more about the Phase 3 VISTA trial, please visit www.clinicaltrials.gov and search the identifier NCT02449239.
About Vicineum™
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk 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
About
COVID-19 Pandemic Potential Impact
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 Company’s ability to successfully develop its product candidates and complete its planned clinical programs, expectations regarding the completion of the Company’s PPQ runs; expectations that the Company’s remaining PPQ batches will meet the required acceptance criteria in support analytical comparability, expectations that the Company will complete its BLA submission for Vicineum in
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||||||||
(In thousands, except per share data) | ||||||||||||||||
(Unaudited) | ||||||||||||||||
Three Months ended | Nine Months ended | |||||||||||||||
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|||||
License revenue |
$ |
11,236 |
|
$ |
- |
|
$ |
11,236 |
|
$ |
- |
|
||||
Operating expenses: | ||||||||||||||||
Research and development |
|
10,196 |
|
|
6,613 |
|
|
23,625 |
|
|
19,243 |
|
||||
General and administrative |
|
4,115 |
|
|
3,238 |
|
|
10,882 |
|
|
8,910 |
|
||||
Change in change in fair value of contingent consideration |
|
18,400 |
|
|
3,600 |
|
|
(16,820 |
) |
|
46,600 |
|
||||
Total operating expenses |
|
32,711 |
|
|
13,451 |
|
|
17,687 |
|
|
74,753 |
|
||||
Loss from operations |
|
(21,475 |
) |
|
(13,451 |
) |
|
(6,451 |
) |
|
(74,753 |
) |
||||
Other income (expense): | ||||||||||||||||
Other income (expense), net |
|
(1 |
) |
|
319 |
|
|
195 |
|
|
806 |
|
||||
Net Loss and Comprehensive Loss Before Taxes |
$ |
(21,476 |
) |
$ |
(13,132 |
) |
$ |
(6,256 |
) |
$ |
(73,947 |
) |
||||
Provision for income taxes |
|
(1,132 |
) |
|
- |
|
|
(1,132 |
) |
|
- |
|
||||
Net Loss and Comprehensive Loss After Taxes |
$ |
(22,608 |
) |
$ |
(13,132 |
) |
$ |
(7,388 |
) |
$ |
(73,947 |
) |
||||
Deemed dividend |
|
- |
|
|
- |
|
|
(147 |
) |
|
- |
|
||||
Net Loss and Comprehensive Loss Available to Common Stockholders |
$ |
(22,608 |
) |
$ |
(13,132 |
) |
$ |
(7,535 |
) |
$ |
(73,947 |
) |
||||
Net loss per common share - basic and diluted |
$ |
(0.19 |
) |
$ |
(0.13 |
) |
$ |
(0.07 |
) |
$ |
(0.85 |
) |
||||
Weighted-average common shares outstanding - basic and diluted |
|
117,886 |
|
|
101,266 |
|
|
113,437 |
|
|
86,575 |
|
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(In thousands, except share and per share data) | ||||||||
(Unaudited) | ||||||||
|
2020 |
|
|
2019 |
|
|||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents |
$ |
41,969 |
|
$ |
48,121 |
|
||
Prepaid expense and other current assets |
|
7,072 |
|
|
6,326 |
|
||
Total current assets |
|
49,041 |
|
|
54,447 |
|
||
Restricted cash |
|
20 |
|
|
20 |
|
||
Property and equipment, net |
|
154 |
|
|
238 |
|
||
Intangibles |
|
46,400 |
|
|
46,400 |
|
||
|
13,064 |
|
|
13,064 |
|
|||
Other assets |
|
349 |
|
|
196 |
|
||
Total Assets |
$ |
109,028 |
|
$ |
114,365 |
|
||
Liabilities and Stockholders' Deficit | ||||||||
Current liabilities: | ||||||||
Accounts payable |
$ |
1,524 |
|
$ |
1,902 |
|
||
Accrued expenses |
|
7,703 |
|
|
6,169 |
|
||
Other current liabilities |
|
481 |
|
|
446 |
|
||
Total current liabilities |
|
9,708 |
|
|
8,517 |
|
||
Contingent consideration |
|
103,200 |
|
|
120,020 |
|
||
Deferred tax liability |
|
12,528 |
|
|
12,528 |
|
||
Other liabilities |
|
145 |
|
|
- |
|
||
Total Liabilities |
|
125,581 |
|
|
141,065 |
|
||
Commitments and contingencies | ||||||||
Stockholders' Deficit: | ||||||||
Preferred stock, |
||||||||
Common stock. |
|
123 |
|
|
107 |
|
||
Additional paid-in capital |
|
284,236 |
|
|
266,717 |
|
||
Accumulated deficit |
|
(300,912 |
) |
|
(293,524 |
) |
||
Total Stockholders' Deficit |
|
(16,553 |
) |
|
(26,700 |
) |
||
Total Liabilities and Stockholders' Deficit |
$ |
109,028 |
|
$ |
114,365 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20201109005057/en/
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