Sesen Bio Reports First Quarter 2021 Financial Results and Commercial Launch Readiness Update in the US for Vicineum™
Strengthened balance sheet with
Company remains on track for potential approval in the US in
Company to host conference call at
“We are very pleased with the tremendous progress we continue to make in our four biggest global markets: the US,
US and OUS Regulatory Update
US:
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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 ofAugust 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.
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On
March 25, 2021 , the Company was notified by theEuropean 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 onMarch 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.
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The Investigational New Drug (IND) application for Vicineum for the treatment of BCG-unresponsive NMIBC submitted to the
Center for Drug Evaluation (CDE) of theChina National Medical Products Administration (NMPA) was approved onMarch 19, 2021 ahead of the original timeline ofApril 2021 . This approval triggers a$3M milestone payment to the Company, and authorizesQilu Pharmaceutical , the Company’s partner inChina , to conduct the proposed clinical trial to assess the efficacy and safety of Vicineum inChina , at the sole cost ofQilu Pharmaceutical . Assuming a successful trial,Qilu Pharmaceutical anticipates submission of the product market application for Vicineum in 2022, with potential approval inChina expected in 2023.
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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 andEgypt . These four markets represent a significant opportunity in the MENA region, asSaudi Arabia ,Jordan andMorocco have some of the most advanced healthcare systems in the region whileEgypt is the second largest economy inAfrica . The Company anticipates the first wave of potential country approvals for Vicineum in the MENA region as early as 2022.
Commercial Update
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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
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Cash Position: Cash, cash equivalents and restricted cash were
$110 million as ofMarch 31, 2021 , compared to$55.4 million as ofDecember 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
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
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 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 target PDUFA date of
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME (In thousands, except per share data) (Unaudited) |
||||||||||||
Three Months ended
|
||||||||||||
2021 |
2020 |
Flux |
||||||||||
Revenue | ||||||||||||
License revenue |
$ |
4,310 |
|
$ |
- |
|
$ |
4,310 |
|
|||
Operating expenses: | ||||||||||||
Research and development |
$ |
6,078 |
|
$ |
8,867 |
|
$ |
(2,789 |
) |
|||
General and administrative |
$ |
5,293 |
|
$ |
3,448 |
|
$ |
1,845 |
|
|||
Change in fair value of contingent consideration |
$ |
48,160 |
|
$ |
(53,700 |
) |
$ |
101,860 |
|
|||
Total operating expenses |
|
59,531 |
|
|
(41,385 |
) |
|
100,916 |
|
|||
(Loss) Income from operations |
|
(55,221 |
) |
|
41,385 |
|
|
(96,606 |
) |
|||
Other (expense) income, net: |
|
- |
|
|||||||||
Other (expense) income, net |
$ |
(3 |
) |
$ |
179 |
|
$ |
(182 |
) |
|||
Net (Loss) Income and Comprehensive (Loss) Income, Before Taxes |
$ |
(55,224 |
) |
$ |
41,564 |
|
$ |
(96,788 |
) |
|||
Provision for income taxes |
$ |
(288 |
) |
$ |
- |
|
$ |
(288 |
) |
|||
Net (Loss) Income and Comprehensive (Loss) Income After Taxes |
$ |
(55,512 |
) |
$ |
41,564 |
|
$ |
(97,076 |
) |
|||
$ |
- |
|
||||||||||
Net (Loss) Income attributable to common stockholders - basic |
$ |
(55,512 |
) |
$ |
34,407 |
|
||||||
Net (Loss) income attributable to common stockholders - diluted |
$ |
(55,512 |
) |
$ |
34,408 |
|
||||||
Net (Loss) Income per common share - basic |
$ |
(0.35 |
) |
$ |
0.31 |
|
$ |
(0.67 |
) |
|||
Weighted-average common shares outstanding - basic |
|
157,032 |
|
|
109,808 |
|
|
47,224 |
|
|||
|
- |
|
||||||||||
Net (Loss) Income per common share - diluted |
$ |
(0.35 |
) |
$ |
0.31 |
|
$ |
(0.67 |
) |
|||
Weighted-average common shares outstanding - diluted |
|
157,032 |
|
|
109,823 |
|
|
47,209 |
|
CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share data) (Unaudited) |
||||||||
|
|
|||||||
2021 |
2020 |
|||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents |
$ |
109,965 |
|
$ |
52,389 |
|
||
Accounts receivables |
|
2,886 |
|
|
- |
|
||
Prepaid expense and other current assets |
|
13,728 |
|
|
7,478 |
|
||
Restricted Cash |
|
- |
|
|
3,000 |
|
||
Total current assets |
|
126,579 |
|
|
62,867 |
|
||
Restricted cash |
|
20 |
|
|
20 |
|
||
Property and equipment, net |
|
93 |
|
|
123 |
|
||
Intangibles |
|
46,400 |
|
|
46,400 |
|
||
|
13,064 |
|
|
13,064 |
|
|||
Other assets |
|
258 |
|
|
349 |
|
||
Total Assets |
|
186,414 |
|
$ |
122,823 |
|
||
Liabilities and Stockholders' Equity (Deficit) | ||||||||
Current liabilities: | ||||||||
Accounts payable |
$ |
2,004 |
|
$ |
3,102 |
|
||
Accrued expenses |
|
3,538 |
|
|
3,973 |
|
||
Deferred revenue |
|
1,500 |
|
|
1,500 |
|
||
Contingent consideration |
|
9,835 |
|
|
8,985 |
|
||
Other current liabilities |
|
490 |
|
|
489 |
|
||
Total current liabilities |
|
17,367 |
|
|
18,049 |
|
||
Contingent consideration, net of current portion |
|
147,165 |
|
|
99,855 |
|
||
Deferred revenue, net of current portion |
|
- |
|
|
1,500 |
|
||
Deferred tax liability |
|
12,528 |
|
|
12,528 |
|
||
Other liabilities |
|
84 |
|
|
118 |
|
||
Total Liabilities |
|
177,144 |
|
|
132,050 |
|
||
Commitments and contingencies | ||||||||
Stockholders' Equity (Deficit): | ||||||||
Preferred stock, 2021 and |
|
- |
|
|
- |
|
||
Common stock. outstanding at |
|
172 |
|
|
140 |
|
||
Additional paid-in capital |
|
380,531 |
|
|
306,554 |
|
||
Accumulated deficit |
|
(371,433 |
) |
|
(315,921 |
) |
||
Total Stockholders' Equity (Deficit) |
|
9,270 |
|
|
(9,227 |
) |
||
Total Liabilities and Stockholders' Equity (Deficit) |
$ |
186,414 |
|
$ |
122,823 |
|
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