Sesen Bio Reports Third Quarter 2018 Financial Results and Planned VISTA Trial Readouts
Company Expects to Report Six-Month Update from VISTA Trial in
“2018 has been a year of focused execution for
September 2018, at the Global Congress on Bladder Cancer2018, Sesen Biopresented a biomarker update from its Phase 3 VISTA Trial data showing that all screened patient samples expressed EpCAM, the molecular target of Vicinium.
October 2018, the company entered into an agreement with FUJIFILM Diosynth Biotechnologies U.S.A., Inc.to provide supply services in support of the manufacturing of Vicinium for the treatment of high-grade NMIBC. The Agreement facilitates a transfer of manufacturing technology from Sesen Bioto Fujifilm.
Sesen Bioanticipates reporting six-month data from the ongoing Phase 3 VISTA Trial in December 2018. A conference call will be held to review the data, with details to follow.
Third Quarter 2018 Financial Results
- Cash Position: Cash and cash equivalents were
$57.9 millionas of September 30, 2018, compared to $11.3 millionas of September 30, 2017.
- Revenue: There was no revenue for the three-month periods ended
September 30, 2018and 2017, respectively, as no revenue triggering milestones were achieved during either period under the company’s license agreement with F. Hoffmann-La Roche Ltdand Hoffmann-La Roche Inc.( Roche).
- R&D Expenses: Research and development expenses were
$3.4 millionfor the three months ended September 30, 2018, compared to $3.6 millionfor the same period in 2017. The decrease was due primarily to a reduction in Vicinium-related development expenses.
- G&A Expenses: General and administrative expenses were
$3.8 millionfor the three months ended September 30, 2018, compared to $1.6 millionfor the same period in 2017. The increase was due primarily to an increase in professional fees as well as higher personnel-related expenses.
- Net Loss: Net loss was
$14.0 million, or $0.18per share, for the three months ended September 30, 2018, compared to net loss of $9.1 million, or $0.37per share, for the same period in 2017. The increase was due primarily to the change in the fair value of contingent consideration and increased general and administrative expenses.
- Financial Guidance: Based on current operating plans,
Sesen Biobelieves it will have capital sufficient to fund its current operating plans into 2020.
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 uncertainties inherent in the initiation and conduct of clinical trials, the possibility that the three-month or six-month data of the Phase 3 VISTA Trial are not indicative of final clinical results and final clinical trial results may not be positive with regard to the safety or efficacy of Vicinium®, our ability to successfully develop our product candidates and complete our planned clinical programs, our ability to obtain marketing approvals for our product candidates, expectations regarding our ongoing clinical trials, availability and timing of data from clinical trials, whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical studies will be indicative of the results of future studies, the adequacy of any clinical models, expectations regarding regulatory approvals, expectations regarding the adequacy of our existing capital resources to fund our operations into 2020 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
SESEN BIO, INC.
|September 30,||December 31,|
|Cash and cash equivalents||$||57,856||$||14,680|
|Prepaid expenses and other current assets||1,529||301|
Total current assets
Property and equipment, net
|Liabilities and stockholders' equity|
Total current liabilities
|Deferred tax liability||12,528||12,528|
|Additional paid-in capital||229,585||170,330|
|Total stockholders' equity||50,395||18,034|
|Total liabilities and stockholders' equity||$||119,295||$||75,097|
SESEN BIO, INC.
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||3,372||3,619||9,406||9,402|
|General and administrative||3,825||1,631||8,128||6,085|
|Loss from change in fair value of contingent consideration||7,200||3,900||9,900||7,600|
Total operating expenses
|Loss from operations||(14,397||)||(9,150||)||(27,434||)||(22,662||)|
|Other income, net||382||45||498||180|
|Net loss and comprehensive loss||$||(14,015||)||$||(9,105||)||$||(26,936||)||$||(22,482||)|
|Net loss per share —basic and diluted||$||(0.18||)||$||(0.37||)||$||(0.48||)||$||(0.91||)|
Weighted-average number of common shares used in net loss per share —basic and diluted