CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of people with cancer, today reported operating results for the third quarter ended September 30, 2018 and recent highlights from its development program for Vicinium® for patients with high-grade non-muscle invasive bladder cancer (NMIBC).
“2018 has been a year of focused execution for Sesen Bio, led by the advancement of the Phase 3 program for Vicinium for patients with NMIBC,” said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. “NMIBC is a devastating disease and there remains just one recommendation for patients who do not respond or become refractory to today’s standard-of-care treatment: complete bladder removal. Our goal is to help save this essential organ and provide a meaningful treatment option for patients with BCG-unresponsive NMIBC. Our Phase 3 registration clinical trial is well-designed and preliminary data reported earlier this year suggest that Vicinium is active and has a favorable safety profile, consistent with our Phase 2 experience. We look forward to assessing six-month data from the trial next month and twelve-month data in mid-2019. If the VISTA Trial is successful, we believe Vicinium could change the treatment outlook for patients with NMIBC, bringing us closer to achieving our mission of saving and renewing the lives of patients with cancer.”
Recent Highlights
- In September 2018, at the Global Congress on Bladder Cancer 2018, Sesen Bio presented a biomarker update from its Phase 3 VISTA Trial data showing that all screened patient samples expressed EpCAM, the molecular target of Vicinium.
- In 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 Bio to Fujifilm.
Upcoming Events
- Sesen Bio anticipates 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 million as of September 30, 2018, compared to $11.3 million as of September 30, 2017.
- Revenue: There was no revenue for the three-month periods ended September 30, 2018 and 2017, respectively, as no revenue triggering milestones were achieved during either period under the company’s license agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche).
- R&D Expenses: Research and development expenses were $3.4 million for the three months ended September 30, 2018, compared to $3.6 million for 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 million for the three months ended September 30, 2018, compared to $1.6 million for 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 $0.18 per share, for the three months ended September 30, 2018, compared to net loss of $9.1 million, or $0.37 per 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 Bio believes it will have capital sufficient to fund its current operating plans into 2020.
About Sesen Bio
Sesen Bio, Inc. is a late-stage clinical
company advancing targeted fusion protein therapeutics for the treatment
of people with cancer. The company’s lead program, Vicinium®,
also known as VB4-845, is currently in a Phase 3 registration trial, the
VISTA Trial, for the treatment of high-grade non-muscle invasive bladder
cancer. Twelve-month data from the trial are anticipated in mid-2019.
Vicinium incorporates a tumor-targeting antibody fragment and a protein
cytotoxic payload into a single protein molecule designed to selectively
and effectively kill cancer cells, while minimizing toxicity to
non-cancerous bladder cells. For more information, please visit the
company’s website at www.sesenbio.com.
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 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.
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SESEN BIO, INC. |
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| September 30, | December 31, | |||||||||||
| 2018 | 2017 | |||||||||||
| Assets | ||||||||||||
| Current assets: | ||||||||||||
| Cash and cash equivalents | $ | 57,856 | $ | 14,680 | ||||||||
| Prepaid expenses and other current assets | 1,529 | 301 | ||||||||||
|
Total current assets |
59,385 | 14,981 | ||||||||||
|
Property and equipment, net |
365 | 522 | ||||||||||
| Restricted cash | 20 | 10 | ||||||||||
| Intangible assets | 46,400 | 46,400 | ||||||||||
| Goodwill | 13,064 | 13,064 | ||||||||||
| Other assets | 61 | 120 | ||||||||||
| Total assets | $ | 119,295 | $ | 75,097 | ||||||||
| Liabilities and stockholders' equity | ||||||||||||
| Current liabilities: | ||||||||||||
| Accounts payable | $ | 1,391 | $ | 907 | ||||||||
| Accrued expenses | 5,170 | 3,813 | ||||||||||
|
Total current liabilities |
6,561 | 4,720 | ||||||||||
| Other liabilities | 311 | 215 | ||||||||||
| Deferred tax liability | 12,528 | 12,528 | ||||||||||
| Contingent consideration | 49,500 | 39,600 | ||||||||||
| Stockholders' equity: | ||||||||||||
| Common stock | 77 | 35 | ||||||||||
| Additional paid-in capital | 229,585 | 170,330 | ||||||||||
| Accumulated deficit | (179,267 | ) | (152,331 | ) | ||||||||
| Total stockholders' equity | 50,395 | 18,034 | ||||||||||
| Total liabilities and stockholders' equity | $ | 119,295 | $ | 75,097 | ||||||||
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SESEN BIO, INC. |
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| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||
|
2018 |
2017 |
2018 |
2017 |
||||||||||||||||||
| Total revenue | $ | - | $ | - | $ | - | $ | 425 | |||||||||||||
| Operating expenses: | |||||||||||||||||||||
| 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 |
|
14,397 | 9,150 | 27,434 | 23,087 | ||||||||||||||||
| 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 |
77,030 | 24,691 | 56,526 | 24,663 | |||||||||||||||||
