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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Sesen Bio Inc | NASDAQ:SESN | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.6288 | 0.6005 | 0.629 | 0 | 01:00:00 |
Company continues to assess potential strategic alternatives with the goal of maximizing shareholder value
Strong balance sheet of $161 million in cash, cash equivalents and marketable securities as of June 30, 2022
Sesen Bio (Nasdaq: SESN) today reported operating results for the second quarter ended June 30, 2022. During the quarter, the Company paused clinical development of its lead asset, Vicineum™ for the treatment of non-muscle invasive bladder cancer (NMIBC), and turned its primary focus to the assessment of potential strategic alternatives with the goal of maximizing shareholder value, which it believes will be complete by the end of 2022.
Business Updates
Second Quarter 2022 Financial Results
About Vicineum™
Vicineum, a locally administered fusion protein, 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 Sesen Bio, EpCAM has been shown to be overexpressed in non-muscle invasive bladder cancer (NMIBC) cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio has completed the follow-up stage of a Phase 3 clinical trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company’s Biologics License Application (BLA) file for Vicineum for the treatment of BCG-unresponsive NMIBC, granted Priority Review for the BLA and set a Prescription Drug User Fee Act (PDUFA) date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. On July 18, 2022, Sesen Bio announced that it had made the strategic decision to voluntarily pause further development of Vicineum in the US. The decision was based on a thorough reassessment of Vicineum, which included the incremental development timeline and associated costs, following recent discussions with the FDA. The Company continues to believe that Vicineum has benefits for patients and healthcare providers that can be maximized through a company with a larger infrastructure, and as such intends to seek a partner for further development of Vicineum while it continues to assess potential strategic alternatives with the goal of maximizing shareholder value. 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 therapies, 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.
About Sesen Bio
Sesen Bio, Inc. is a late-stage clinical company focused on targeted fusion protein therapeutics for the treatment of patients with cancer. The Company’s lead program, Vicineum™, also known as oportuzumab monatox, has completed the follow-up stage of a Phase 3 clinical trial for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company’s BLA file for Vicineum for the treatment of BCG-unresponsive NMIBC, granted Priority Review for the BLA and set a PDUFA date of August 18, 2021. On August 13, 2021, the Company received a CRL from the FDA regarding its BLA for Vicineum. The Company intends to seek a partner for further development of Vicineum while it continues to assess potential strategic alternatives with the goal of maximizing shareholder value. Sesen Bio retains worldwide rights to Vicineum with the exception of Greater China, for which the Company has partnered with Qilu Pharmaceutical for commercialization. Vicineum is a locally administered targeted fusion protein composed of an anti-EpCAM antibody fragment tethered to a truncated form of Pseudomonas Exotoxin A. For more information, please visit the Company’s website at www.sesenbio.com.
COVID-19 Pandemic Potential Impact
Sesen Bio continues to monitor the rapidly evolving environment regarding the potential impact of the COVID-19 pandemic on the Company. The Company has not yet experienced any disruptions to its operations as a result of COVID-19, however, the Company is not able to quantify or predict with certainty the overall scope of potential impacts to its business, including, but not limited to, its ability to identify and assess potential strategic alternatives and seek a partner for the further development of Vicineum. Sesen Bio remains committed to the health and safety of patients, caregivers and employees.
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,” “expect,” “intend,” “may,” “plan,” “predict,” “target,” “potential,” “will,” “would,” “should,” “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 Company’s plans to continue to assess potential strategic alternatives with the goal of maximizing shareholder value, the Company’s belief that such process will be complete by the end of 2022, the Company’s intentions to seek a partner for the further development of Vicineum, any future payments from Roche to the Company pursuant to the Roche Asset Purchase Agreement, the Company’s belief that Vicineum has benefits for patients and healthcare providers that can be maximized through a company with larger infrastructure, the expected timing for incurring costs associated with the restructuring plan, and the impact of COVID-19 on the Company, including its ability to identify and assess potential strategic alternatives and seek a partner for the further development of Vicineum. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the risk that the Company may not be successful in identifying one or more strategic alternatives or a partner for the further development of Vicineum, the risk that the Company may not ultimately be successful in seeking such a partner or pursuing a strategic alternative that delivers the anticipated benefits or enhances shareholder value within the anticipated timeframe or at all, the risk that the Company’s assessment of strategic alternatives or its intentions to seek a partner for the further development of Vicineum may cause the Company’s stock price to fluctuate significantly, the risk that the Company’s assessment of strategic alternatives or its intentions to seek a partner for the further development of Vicineum may be time consuming and involve the dedication of significant resources and may require the Company to incur significant costs and expenses, the risk that the Company’s assessment of strategic alternatives or its intentions to seek a partner for the further development of Vicineum could negatively impact the Company’s ability to attract, retain and motivate key employees and expose the Company to potential litigation in connection with such intentions to seek a partner or the process of assessing strategic alternatives or any resulting transaction, the risk that the Company may not be entitled to or receive any future payments from Roche pursuant to the Roche Asset Purchase Agreement, the risk that the Company may not be able to implement the restructuring plan as currently anticipated or within the timing currently anticipated, unanticipated difficulties with preserving capital, unanticipated difficulties in terminating certain contracts and arrangements pursuant to the restructuring plan, unanticipated charges not currently contemplated that may occur as a result of the restructuring plan, and other factors discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.
SESEN BIO, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited; In thousands, except share and per share data) June 30, 2022 December 31, 2021 Assets Current assets: Cash and cash equivalents$
72,090
$
162,636
Short term marketable securities
69,454
Accounts receivable
73
21,011
Other receivables
14,046
3,482
Prepaid expenses and other current assets
757
18,476
Total current assets
156,420
205,605
Non-current assets: Restricted cash
30
20
Marketable securities
19,641
-
Property and equipment, net
30
43
Intangible assets
-
14,700
Goodwill
-
13,064
Long term prepaid expenses
-
7,192
Other assets
42
123
Total non-current assets
19,743
35,142
Total Assets
$
176,163
$
240,747
Liabilities and Stockholders’ Equity Current liabilities: Accounts payable
$
1,667
$
2,853
Accrued expenses
29,851
8,255
Other current liabilities
487
460
Total current liabilities
32,005
11,568
Non-current liabilities: Contingent consideration
1,800
52,000
Deferred tax liability
-
3,969
Deferred revenue
-
1,500
Total non-current liabilities
1,800
57,469
Total liabilities
33,805
69,037
Stockholders’ Equity: Preferred stock, $0.001 par value per share; 5,000,000 shares authorized at June 30, 2022 and December 31, 2021; no shares issued and outstanding at June 30, 2022 and December 31, 2021
-
-
Common stock, $0.001 par value per share; 400,000,000 shares authorized at June 30, 2022 and December 31, 2021; 199,463,645 shares issued and outstanding at June 30, 2022 and December 31, 2021
199
199
Additional paid-in capital
491,464
487,768
Other comprehensive loss
(281
)
-
Accumulated deficit
(349,024
)
(316,257
)
Total Stockholders’ Equity
142,358
171,710
Total Liabilities and Stockholders’ Equity
$
176,163
$
240,747
SESEN BIO, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited; In thousands, except per share data) Three Months Ended June 30, Six Months Ended June 30,
2022
2021
2022
2021
Revenue: License and related revenue$
-
$
2,234
$
-
$
6,544
Total revenue
$
-
$
2,234
$
-
$
6,544
Operating expenses: Research and development
$
29,944
$
7,228
$
34,705
$
13,306
General and administrative
15,589
6,805
24,564
12,098
Intangibles impairment charge
27,764
-
27,764
-
Change in fair value of contingent consideration
(37,300
)
13,600
(50,200
)
61,760
Total operating expenses
$
35,997
$
27,633
$
36,833
$
87,164
Loss from Operations
$
(35,997
)
$
(25,399
)
$
(36,833
)
$
(80,620
)
Other income (expense), net
162
(43
)
191
(46
)
Loss Before Taxes$
(35,835
)
$
(25,442
)
$
(36,642
)
$
(80,666
)
Benefit for income taxes
3,875
-
3,875
(288
)
Net Loss After Taxes$
(31,960
)
$
(25,442
)
$
(32,767
)
$
(80,954
)
Net loss attributable to common stockholders - basic and diluted$
(31,960
)
$
(25,442
)
$
(32,767
)
$
(80,954
)
Net loss per common share - basic and diluted$
(0.16
)
$
(0.15
)
$
(0.16
)
$
(0.49
)
Weighted-average common shares outstanding - basic and diluted
199,464
175,393
199,464
166,264
SESEN BIO, INC. CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited; In thousands, except per share data) Three Months Ended June 30, Six Months Ended June 30,
2022
2021
2022
2021
Net loss$
31,960
$
25,442
$
32,767
$
80,954
Unrealized loss on marketable securities
(281
)
-
(281
)
-
Total comprehensive loss
$
32,241
$
25,442
$
33,048
$
80,954
View source version on businesswire.com: https://www.businesswire.com/news/home/20220808005070/en/
Investors: Erin Clark, Vice President, Corporate Strategy & Investor Relations ir@sesenbio.com
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