Sesen Bio Reports Second Quarter 2021 Financial Results and Significant Global Progress for Vicineum™
The Company believes it remains on track for an FDA decision on its BLA for Vicineum by
The Company also believes it remains on track for potential approval in
Strengthened balance sheet with
“We are excited about the regulatory progress we are making across our global markets,” said Dr.
US and Outside of the US (OUS) Regulatory Update
US:
-
On
July 13, 2021 ,Sesen Bio participated in a productive Late-Cycle Meeting with the FDA regarding the BLA for Vicineum for the treatment of BCG-unresponsive NMIBC. In the meeting, the FDA confirmed that there is no Advisory Committee meeting planned at this time, and that no post-marketing requirements, including a confirmatory trial, have been identified at this time. Also in the meeting, the Company and the FDA discussed remaining questions related to manufacturing facility inspections, product quality information requests and additional information related to chemistry, manufacturing and controls (CMC), and a timeline to submit additional supporting information was agreed upon. The Company believes it remains on track for an FDA decision on its BLA for Vicineum by the target PDUFA date ofAugust 18, 2021 .
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In
Europe , the Company believes it remains on track for potential approval of Vysyneum™ in 2022. The Company has received the Day 80 and Day 120 questions from theEuropean Medicines Agency (EMA) and is responding to inquiries and providing supporting information as part of the official review process.
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On
July 20, 2021 ,Sesen Bio andQilu Pharmaceutical , the Company’s partner inGreater China , announced that the first patient had been enrolled inChina in the clinical trial to assess the efficacy and safety of Vicineum in patients with BCG-unresponsive NMIBC. The trial, which plans to enroll approximately 53 patients with carcinoma in situ (CIS), is being run at the sole cost ofQilu Pharmaceutical . If the trial is successful,Qilu Pharmaceutical anticipates submission of the product market application for Vicineum inChina in 2022, with potential approval expected in 2023.
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The Company continues to work closely with its partner in MENA, Hikma Pharmaceuticals, to submit marketing authorization applications for Vicineum in 2021 in seven key markets in the region:
Kingdom of Saudi Arabia ,Jordan ,Morocco ,Egypt ,Lebanon ,Kuwait andAlgeria . These markets represent a significant opportunity, with some of the most advanced healthcare systems and largest economies in the MENA region. The Company believes it is on track for potential market approvals to begin in the region in 2022.
Business Development Update
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On
June 1, 2021 , the Company entered into a global supply agreement withQilu Pharmaceutical to become part of the manufacturing network for global commercial supply of Vicineum drug substance and drug product. This was an expansion of the initial commercial manufacturing and supply framework agreement entered into bySesen Bio andQilu Pharmaceutical inDecember 2020 , and sets specific terms such as capacity, forecasts, pricing and product delivery. Along with existing world-class supply partners,Sesen Bio expects the global supply agreement withQilu Pharmaceutical will enable the Company to meet anticipated significant global demand for Vicineum.
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On
August 5, 2021 ,Sesen Bio announced it had entered into a licensing agreement with Eczacibasi Pharmaceuticals Marketing (EIP) for the registration and commercialization of Vicineum inTurkey . Under the terms of the licensing agreement,Sesen Bio will receive an upfront payment of$1.5 million , is eligible to receive additional regulatory and commercial milestone payments and is also entitled to receive a 30% royalty on net sales inTurkey . EIP was granted an exclusive license to register and commercialize Vicineum for the treatment of BCG-unresponsive NMIBC inTurkey , where bladder cancer is the sixth most commonly diagnosed cancer and 11th most common cause of death. This agreement represents the third OUS partnership thatSesen Bio has entered to date.
Commercial Planning Update
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Sesen Bio completed its commercial build phase in preparation for the anticipated launch of Vicineum, if approved, in the US, and has advanced to the implementation phase that will commence promptly, if approved, and will focus on executing the Company’s commercial strategy for Vicineum. The Company has completed the hiring of ~25 talented internal employees to support the Company cross-functionally, as well as the hiring of 35 sales representatives as part of the contract sales organization who will target approximately 2,000 high-prescribers of BCG to drive awareness, trial and adoption of Vicineum for the treatment of patients with BCG-unresponsive NMIBC.
In addition to building its sales force, as part of the
Promotional efforts will begin immediately upon the anticipated approval of Vicineum in the US, and the Company expects Vicineum product to be available to physicians and patients in the fourth quarter of 2021.
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Results of market research conducted by the Company show that when given the choice between the product profile of Vicineum, based on Phase III clinical trial data1, and the product profile of Keytruda®, physicians will choose Vicineum over 80% of the time. This data highlights urologists’ preferences that the Company believes spans clinical, emotional and economic reasons to prescribe Vicineum. If approved by the FDA, the Company believes Vicineum could be a best-in-class treatment option for patients, and a critical step in
Sesen Bio realizing its mission to save and improve the lives of patients with cancer.
[1]The Phase III clinical data are based on the data submitted in the BLA on
Second Quarter 2021 Financial Results
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Cash Position: Cash, cash equivalents and restricted cash were
$151.1 million as ofJune 30, 2021 , compared to$55.4 million as ofDecember 31, 2020 . -
R&D Expenses: Research and development expenses for the second quarter of 2021 were
$7.2 million compared to$4.6 million for the same period in 2020. The increase of$2.7 million was due to increased costs associated with technology transfer and manufacturing ($1.0 million ), professional services in support of regulatory activity ($0.7 million ), employee-related compensation ($0.7 million ), and other increases ($0.3 million ). -
G&A Expenses: General and administrative expenses for the second quarter of 2021 were
$6.8 million compared to$3.3 million for the same period in 2020. The increase of$3.5 million was due primarily to increases in sales and marketing expense for Vicineum pre-commercial launch planning ($1.6 million ), employee-related compensation driven by increased headcount as part of the commercial build ($1.3 million ), and other increases for commercial launch preparation ($0.6 million ). -
Net Loss: Net loss was
$25.4 million , or$0.15 per share, for the second quarter of 2021, compared to net loss of$26.3 million , or$0.24 per share, for the second quarter of 2020. The change was attributable to license revenue recognized ($2.2 million ), offset by higher operating expenses ($1.3 million ).
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 to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by
About
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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,” “potential,” “target,” “strategy,” “will,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. For example, statements regarding 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 BALANCE SHEETS | |||||||
(In thousands, except share and per share data) | |||||||
(Unaudited) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents |
$ |
151,036 |
|
$ |
52,389 |
|
|
Accounts receivable |
|
2,303 |
|
|
- |
|
|
Prepaid expenses and other current assets |
|
21,760 |
|
|
7,478 |
|
|
Restricted cash |
|
- |
|
|
3,000 |
|
|
Total current assets |
|
175,099 |
|
|
62,867 |
|
|
Non-current assets: | |||||||
Restricted cash |
|
20 |
|
|
20 |
|
|
Property and equipment, net |
|
109 |
|
|
123 |
|
|
Intangible assets |
|
46,400 |
|
|
46,400 |
|
|
|
13,064 |
|
|
13,064 |
|
||
Long term prepaid expenses |
|
6,150 |
|
|
- |
|
|
Other assets |
|
205 |
|
|
349 |
|
|
Total non-current assets |
|
65,948 |
|
$ |
59,956 |
|
|
Total Assets |
$ |
241,047 |
|
$ |
122,823 |
|
|
Liabilities and Stockholders’ (Deficit) Equity | |||||||
Current liabilities: | |||||||
Accounts payable |
$ |
1,228 |
|
$ |
3,102 |
|
|
Accrued expenses |
|
5,301 |
|
|
3,973 |
|
|
Deferred revenue |
|
1,500 |
|
|
1,500 |
|
|
Contingent consideration |
|
10,300 |
|
|
8,985 |
|
|
Other current liabilities |
|
498 |
|
|
489 |
|
|
Total current liabilities |
|
18,827 |
|
|
18,049 |
|
|
Non-current liabilities: | |||||||
Contingent consideration, net of current portion |
|
160,300 |
|
|
99,855 |
|
|
Deferred tax liability |
|
12,528 |
|
|
12,528 |
|
|
Deferred revenue, net of current portion |
|
- |
|
|
1,500 |
|
|
Other non-current liabilities |
|
43 |
|
|
118 |
|
|
Total non-current liabilities |
|
172,871 |
|
|
114,001 |
|
|
Total liabilities |
|
191,698 |
|
|
132,050 |
|
|
Stockholders’ Equity ( Deficit): | |||||||
Preferred stock, |
|
- |
|
|
- |
|
|
Common stock, at issued and outstanding at |
|
188 |
|
|
140 |
|
|
Additional paid-in capital |
|
446,036 |
|
|
306,554 |
|
|
Accumulated deficit |
|
(396,875 |
) |
|
(315,921 |
) |
|
Total Stockholders’ Equity (Deficit) |
|
49,349 |
|
|
(9,227 |
) |
|
Total Liabilities and Stockholders’ Equity |
$ |
241,047 |
|
$ |
122,823 |
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||
AND COMPREHENSIVE (LOSS) INCOME | |||||||||||||
(In thousands, except per share data) | |||||||||||||
(Unaudited) | |||||||||||||
Three Months ended |
Six Months ended |
||||||||||||
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
||
License and related revenue |
$ |
2,234 |
|
$ |
- |
|
$ |
6,544 |
|
$ |
- |
|
|
Operating expenses: | |||||||||||||
Research and development |
$ |
7,228 |
|
$ |
4,562 |
|
$ |
13,306 |
|
$ |
13,429 |
|
|
General and administrative |
$ |
6,805 |
|
$ |
3,318 |
|
$ |
12,098 |
|
$ |
6,766 |
|
|
Change in fair value of contingent consideration |
$ |
13,600 |
|
$ |
18,480 |
|
$ |
61,760 |
|
$ |
(35,220 |
) |
|
Total operating expenses |
|
27,633 |
|
$ |
26,360 |
|
$ |
87,164 |
|
|
(15,025 |
) |
|
(Loss) Income from Operations |
|
(25,399 |
) |
$ |
(26,360 |
) |
$ |
(80,620 |
) |
|
15,025 |
|
|
Other (expense) income , net |
$ |
(43 |
) |
$ |
16 |
|
$ |
(46 |
) |
$ |
195 |
|
|
Net (Loss) Income and Comprehensive (Loss) Income Before Taxes |
$ |
(25,442 |
) |
$ |
(26,344 |
) |
$ |
(80,666 |
) |
$ |
15,220 |
|
|
Provision for income taxes |
$ |
- |
|
$ |
- |
|
$ |
(288 |
) |
$ |
- |
|
|
Net (Loss) Income and Comprehensive (Loss) Income After Taxes |
$ |
(25,442 |
) |
$ |
(26,344 |
) |
$ |
(80,954 |
) |
$ |
15,220 |
|
|
Net (loss) income attributable to common stockholders - basic |
$ |
(25,442 |
) |
$ |
(26,491 |
) |
$ |
(80,954 |
) |
$ |
14,751 |
|
|
Net (loss) income attributable to common stockholders - diluted |
$ |
(25,442 |
) |
$ |
(26,491 |
) |
$ |
(80,954 |
) |
$ |
12,600 |
|
|
Net (loss) income per common share - basic |
$ |
(0.15 |
) |
$ |
(0.24 |
) |
$ |
(0.49 |
) |
$ |
0.13 |
|
|
Weighted-average common shares outstanding - basic |
|
175,393 |
|
|
112,569 |
|
|
166,264 |
|
|
111,189 |
|
|
Net (loss) income per common share - diluted |
$ |
(0.15 |
) |
$ |
(0.24 |
) |
$ |
(0.49 |
) |
$ |
0.11 |
|
|
Weighted-average common shares outstanding - diluted |
|
175,393 |
|
|
112,569 |
|
|
166,264 |
|
|
111,203 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20210809005157/en/
ir@sesenbio.com
Media:
lrocco@elixirhealthpr.com
Source: