We could not find any results for:
Make sure your spelling is correct or try broadening your search.
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 |
Participated in productive CMC Type A Meeting with the FDA
Maintained strong balance sheet with $175M in cash and cash equivalents as of September 30, 2021
Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported operating results for the third quarter ended September 30, 2021. During the quarter, the Company continued to work on its path forward to address chemistry, manufacturing, and controls (CMC) and clinical issues identified by the US Food & Drug Administration (FDA) in its Complete Response Letter (CRL) regarding the Company’s Biologics License Application (BLA) for the Company’s lead program, Vicineum™ for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
“Our team is making progress in advancing our dialogue with the FDA as we work toward potential resolution of the issues raised in the CRL for Vicineum, as demonstrated by our recent CMC Type A Meeting with the agency,” said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. “We remain dedicated to saving and improving the lives of patients, and we look forward to continuing to work collaboratively with the FDA in our upcoming Clinical Type A Meeting, expected later this year, to carry our mission into the next stage of the regulatory process and beyond.”
Regulatory Update
US:
Sesen Bio is preparing for a separate Type A Meeting to discuss the recommendations specific to additional clinical/statistical data and analyses that the FDA raised in the CRL (Clinical Type A Meeting), which the Company expects to occur later this year. As previously disclosed, the Company anticipates needing to conduct an additional clinical trial with 90-100 patients, and will provide further guidance after the Clinical Type A Meeting.
The Company intends to use the information from the CMC Type A Meeting and the Clinical Type A Meeting to synchronize the regulatory reviews of Vicineum for the treatment of BCG-unresponsive NMIBC in the US and the European Union.
European Union:
Other Business Updates
Third Quarter 2021 Financial Results
1 Vysyneum is the proprietary brand name that was conditionally approved by the EMA for oportuzumab monatox in the European Union.
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 Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US 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 and granted the application Priority Review with a target 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. 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 drugs, 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 advancing targeted fusion protein therapeutics for the treatment of patients with cancer. The Company’s lead program, Vicineum™, also known as oportuzumab monatox, is currently in the follow-up stage of a Phase 3 registration 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 and granted the application Priority Review with a target PDUFA date of August 18, 2021. On August 13, 2021, the Company received a CRL from the FDA regarding its BLA for Vicineum. Sesen Bio retains worldwide rights to Vicineum with the exception of Greater China, the Middle East and North Africa (MENA) and Turkey, for which the Company has partnered with Qilu Pharmaceutical, Hikma Pharmaceuticals and Eczacibasi Pharmaceuticals Marketing (EIP), respectively, 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, which is being developed for the treatment of BCG-unresponsive NMIBC. 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 our operations as a result of COVID-19, however, we are not able to quantify or predict with certainty the overall scope of potential impacts to our business, including, but not limited to, our ability to raise capital and, if approved, commercialize 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,” “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 ability to work towards potential resolution of the issues raised in the CRL for Vicineum, the Company’s ability to improve the lives of patients by bringing new treatment options to market, the outcome and timing of the Company’s Clinical Type A Meeting with the FDA to discuss Vicineum, the Company's intentions to use additional information from the CMC Type A Meeting and Clinical Type A Meeting to better synchronize the regulatory reviews of Vicineum in the US and in the European Union, the Company’s ability to utilize Vicineum manufactured during process validation for any potential clinical trials needed to address issues raised in the CRL, and that any such potential clinical trials can proceed while addressing CMC issues, the Company’s belief that it has a clear understanding of the path forward regarding CMC for resubmission of the BLA for Vicineum, the Company’s expectations that it will need to conduct an additional clinical trial for Vicineum with 90-100 patients, the Company’s plans to provide further guidance after the Clinical Type A Meeting, the Company’s expectation that the restructuring plan will better position the Company to execute on next steps as they are determined, the Company's expectations to decrease annual cash costs as a result of the restructuring plan, the Company’s expectations regarding the ability of outside counsel and other experts to work expeditiously to conduct their review, determine the nature and scope of any issues identified, and advise on next steps, the impact of COVID-19 on the Company, including its ability to raise capital, and, if approved, its ability to commercialize Vicineum for the treatment of BCG-unresponsive NMIBC. 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 FDA may not schedule the Clinical Type A Meeting with the Company within the currently expected timing, or at all, the risk that the Company may not be able to determine a path forward for the development of Vicineum for the treatment of BCG-unresponsive NMIBC, the risk that the Company may not resume its plans to pursue regulatory approval for Vicineum in the US or in the European Union, the risk that clinical trials of Vicineum for the treatment of BCG-unresponsive NMIBC, including any clinical trial needed to address issues raised in the CRL, may fail to demonstrate safety and efficacy to the satisfaction of the FDA or the EMA, or otherwise produce favorable results, the risk that the FDA may not approve the BLA for Vicineum for the treatment of BCG-unresponsive NMIBC if the Company resubmits the BLA at a future time, the risk that the European Commission may not approve the Company’s MAA for Vicineum for the treatment of BCG-unresponsive NMIBC if the Company resubmits the MAA at a future time, the risk that Vicineum for the treatment of BCG-unresponsive NMIBC may cause undesirable side effects, serious adverse events or have other properties that could delay or halt clinical trials, delay or prevent its regulatory approval by the FDA or the European Commission, limit the commercial profile of its labeling, if approved, or result in significant negative consequences following any marketing approval, the risk that the restructuring plan may not achieve its intended purposes, including positioning the Company to execute on next steps as they are determined, the risk that the Company’s internal review may identify misconduct or other improper activities by the Company’s employees or third-parties involved in the Company’s clinical or regulatory activities related to Vicineum, 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 (In thousands, except share and per share data) (Unaudited) September 30, 2021 December 31, 2020 Assets Current assets: Cash and cash equivalents$ 175,236
$ 52,389
Accounts receivable1,107
-
Prepaid expenses and other current assets24,137
7,478
Restricted cash-
3,000
Total current assets200,480
62,867
Non-current assets: Restricted cash20
20
Property and equipment, net53
123
Intangible assets14,700
46,400
Goodwill13,064
13,064
Long term prepaid expenses7,192
-
Other assets162
349
Total non-current assets35,191
$ 59,956
Total Assets$ 235,671
$ 122,823
Liabilities and Stockholders’ (Deficit) Equity Current liabilities: Accounts payable$ 3,909
$ 3,102
Accrued expenses8,186
3,973
Deferred revenue-
1,500
Contingent consideration-
8,985
Other current liabilities499
489
Total current liabilities12,594
18,049
Non-current liabilities: Contingent consideration, net of current portion56,600
99,855
Deferred tax liability3,969
12,528
Deferred revenue, net of current portion1,500
1,500
Other non-current liabilities-
118
Total non-current liabilities62,069
114,001
Total liabilities74,663
132,050
Stockholders’ Equity ( Deficit): Preferred stock, $0.001 par value per share; 5,000,000 shares authorized at September 30, 2021 and December 31, 2020; no shares issued and outstanding at September 30, 2021 and December 31, 2020-
-
Common stock, $0.001 par value per share; 400,000,000 and 200,000,000 shares authorized at September 30, 2021 and December 31, 2020, respectively; 199,463,645 and 140,449,647 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively199
140
Additional paid-in capital486,010
306,554
Accumulated deficit(325,201)
(315,921)
Total Stockholders’ Equity (Deficit)161,008
(9,227)
Total Liabilities and Stockholders’ Equity$ 235,671
$ 122,823
SESEN BIO, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (OPERATIONS) AND COMPREHENSIVE INCOME (LOSS) (In thousands, except per share data) (Unaudited)Three Months ended September 30,
Nine Months ended September 30,
2021
2020
2021
2020
License and related revenue$
-
$
11,236
$
6,544
$
11,236
Operating expenses: Research and development
4,967
10,196
18,273
23,625
General and administrative
8,699
4,115
20,797
10,882
Restructuring charge
5,522
-
5,522
-
Intangibles impairment charge
31,700
-
31,700
-
Change in fair value of contingent consideration
(114,000)
18,400
(52,240)
(16,820)
Total operating expenses
(63,112)
32,711
24,052
17,687
Income (Loss) from Operations
63,112
(21,475)
(17,508)
(6,451)
Other income (expense), net
1
(1)
(45)
195
Income (Loss) Before Taxes
63,113
(21,476)
(17,553)
(6,256)
Benefit (provision) for income taxes
8,561
(1,132)
8,273
(1,132)
Net Income (Loss) and Comprehensive Income (Loss) After Taxes$
71,674
$
(22,608)
$
(9,280)
$
(7,388)
Net income (loss) attributable to common stockholders - basic$
71,622
$
(22,608)
$
(9,280)
$
(7,535)
Net income (loss) attributable to common stockholders - diluted$
71,623
$
(22,608)
$
(9,280)
$
(7,535)
Net income (loss) per common share - basic$
0.36
$
(0.19)
$
(0.05)
$
(0.07)
Weighted-average common shares outstanding - basic
196,778
117,886
176,547
113,437
Net income (loss) per common share - diluted$
0.36
$
(0.19)
$
(0.05)
$
(0.07)
Weighted-average common shares outstanding - diluted
201,017
117,886
176,547
113,437
View source version on businesswire.com: https://www.businesswire.com/news/home/20211108005378/en/
Investors: Erin Clark, Vice President, Corporate Strategy & Investor Relations ir@sesenbio.com
1 Year Sesen Bio Chart |
1 Month Sesen Bio Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions