Seres Therapeutics Reports Second Quarter 2015 Financial Results and Provides Business Update
- Phase 2 study initiated for lead microbiome therapeutic SER-109 for
prevention of recurrent Clostridium difficile infection (CDI) in adults
-
FDA Breakthrough Therapy Designation received for SER-109
-
Successfully completed initial public offering
“We have made significant progress this quarter to advance our mission
of delivering Ecobiotic ® microbiome medicines to patients,
which we believe will have a strong impact in multiple therapeutic
areas,” said
Second Quarter and Recent Business Highlights:
• Initiated Phase 2 study of SER-109, Seres’ lead Ecobiotic® microbiome therapeutic for the prevention of recurrent CDI in adults. The randomized, placebo-controlled, multicenter study is underway and will be conducted at approximately 35 centers across the U.S., with data readouts expected in the middle of 2016.
• SER-109 granted Breakthrough Therapy Designation from the
• Advanced pipeline development of other Ecobiotic® candidates, including ongoing preclinical studies for SER-287 for the treatment of ulcerative colitis, with a Phase 1 study anticipated to begin by the end of 2015, and SER-262 to prevent an initial recurrence of CDI, with clinical studies anticipated to begin in the middle of 2016. In addition, Seres continued to grow its efforts in infectious diseases, inflammatory diseases and metabolic diseases with key hires from academia and industry.
• Successfully completed initial public offering. Seres’ common
stock began trading on the NASDAQ Global Select Market under the ticker
symbol “MCRB” on June 26, 2015. The offering priced at
• Elected
Second Quarter Financial Results:
For the second quarter of 2015, Seres reported a net loss attributable
to common stockholders of
• Research and Development: R&D expenses for the second quarter of 2015
were
• General and Administrative Expenses: G&A expenses for the second
quarter of 2015 were
• Cash Position: Seres had cash, cash equivalents and investments of
Financial Guidance
Based on its current operating plan, Seres expects that its cash, cash equivalents and investments as of June 30, 2015, together with the proceeds from the recent initial public offering, will enable it to fund operating expenses and capital expenditure requirements, excluding cash inflows or outflows from business development activities, through at least the first half of 2017.
About
Seres is a microbiome therapeutics platform company developing a novel class of biological drugs, which are designed to treat disease by restoring the function of a dysbiotic microbiome.
To receive additional information about
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the Company’s financial guidance, including the sufficiency of its cash, cash equivalents and investments to fund its operations, the potential impact of its microbiome therapeutics platform on disease, the progress and development of its product candidates, and the timing of data from clinical trials.
These forward-looking statements are based on management’s current
expectations. These statements are neither promises nor guarantees, but
involve known and unknown risks, uncertainties and other important
factors that may cause our actual results, performance or achievements
to be materially different from any future results, performance or
achievements expressed or implied by the forward-looking statements,
including, but not limited to, the following: we are not currently
profitable and may never become profitable; our need for additional
funding, which may not be available; our limited operating history; the
unpredictable nature of our early stage development efforts for
marketable drugs; the unproven approach to therapeutic intervention of
our microbiome therapeutics; the lengthy and expensive process of
clinical drug development, which has an uncertain outcome; potential
delays in enrollment of patients which could affect the receipt of
necessary regulatory approvals; potential delays in regulatory approval,
which would impact the ability to commercialize our product candidates
and affect our ability to generate revenue; any fast track or
Breakthrough Therapy designation may not lead to faster development,
regulatory approval or marketing approval; our possible inability to
receive orphan drug designation should we choose to seek it; our
reliance on third parties to conduct our clinical trials and the
potential for those third parties to not perform satisfactorily; our
reliance on third parties to manufacture our product candidates, which
may delay, prevent or impair our development and commercialization
efforts; our lack of experience in manufacturing our product candidates;
the potential failure of our product candidates to be accepted on the
market by the medical community; our lack of experience selling,
marketing and distributing products and our lack of internal capability
to do so; failure to compete successfully against other drug companies;
potential competition from biosimilars; developments by competitors may
render our products or technologies obsolete or non-competitive; failure
to obtain marketing approval internationally; post-marketing
restrictions or withdrawal from the market; anti-kickback, fraud, abuse,
and other healthcare laws and regulations exposing us to potential
criminal sanctions; recently enacted or future legislation; compliance
with environmental, health, and safety laws and regulations; protection
of our proprietary technology; protection of the confidentiality of our
trade secrets; changes in
SERES THERAPEUTICS, INC. |
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June 30, 2015 |
December 31, 2014 |
||||||||
Assets | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 36,338 | $ | 114,185 | |||||
Investments | 55,438 | — | |||||||
Prepaid expenses and other current assets | 2,288 | 58 | |||||||
Total current assets | 94,064 | 114,243 | |||||||
Property and equipment, net | 3,319 | 1,264 | |||||||
Restricted cash | 139 | 139 | |||||||
Deferred offering costs | 3,748 | 1,684 | |||||||
Deferred financing costs | 11 | 15 | |||||||
Total assets | $ | 101,281 | $ | 117,345 | |||||
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit) | |||||||||
Current liabilities: | |||||||||
Accounts payable | 1,688 | 2,166 | |||||||
Accrued expenses and other current liabilities | 2,753 | 1,737 | |||||||
Notes payable, current portion | 1,200 | 1,200 | |||||||
Total current liabilities | 5,641 | 5,103 | |||||||
Notes payable, net of discount | 727 | 1,304 | |||||||
Preferred stock warrant liability | — | 1,582 | |||||||
Total liabilities | 6,368 | 7,989 | |||||||
Commitments and contingencies | |||||||||
Convertible preferred stock (Series A, A-2, B, C, D and D-1),
$0.001 par value; |
— | 136,077 | |||||||
Stockholders’ equity (deficit): | |||||||||
Common stock, $0.001 par value; 65,000,000 and 38,000,000 |
31 | 7 | |||||||
Additional paid-in capital | 143,217 | 1,104 | |||||||
Accumulated other comprehensive income | 23 | — | |||||||
Accumulated deficit | (48,358 | ) | (27,832 | ) | |||||
Total stockholders’ equity (deficit) | 94,913 | (26,721 | ) | ||||||
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) | $ | 101,281 | $ | 117,345 | |||||
SERES THERAPEUTICS, INC. |
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Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||||||
2015 |
2014 |
2015 |
2014 |
||||||||||||||
Revenue | — | — | — | — | |||||||||||||
Operating expenses: | |||||||||||||||||
Research and development expenses | $ | 8,784 | $ | 2,160 | $ | 14,345 | $ | 3,192 | |||||||||
General and administrative expenses | 3,556 | 458 | 6,162 | 1,098 | |||||||||||||
Total operating expenses | 12,340 | 2,618 | 20,507 | 4,290 | |||||||||||||
Loss from operations | (12,340 | ) | (2,618 | ) | (20,507 | ) | (4,290 | ) | |||||||||
Other income (expense): | |||||||||||||||||
Interest income (expense), net | 5 | (56 | ) | (12 | ) | (93 | ) | ||||||||||
Revaluation of preferred stock warrant liability | (220 | ) | (3 | ) | (7 | ) | 17 | ||||||||||
Total other income (expense), net | (215 | ) | (59 | ) | (19 | ) | (76 | ) | |||||||||
Net loss | (12,555 | ) | (2,677 | ) | (20,526 | ) | (4,366 | ) | |||||||||
Accretion of convertible preferred stock to redemption value | — | (325 | ) | — | (558 | ) | |||||||||||
Net loss attributable to common stockholders | $ | (12,555 | ) | $ | (3,002 | ) | $ | (20,526 | ) | $ | (4,924 | ) | |||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (1.45 | ) | $ | (0.45 | ) | $ | (2.64 | ) | $ | (0.73 | ) | |||||
Weighted average common shares outstanding, basic and diluted | 8,640,218 | 6,725,625 | 7,777,679 | 6,706,392 | |||||||||||||
Other comprehensive income: | |||||||||||||||||
Unrealized gain (loss) on investments, net of tax of $0 | (8 | ) | — | 23 | — | ||||||||||||
Total other comprehensive income | (8 | ) | — | 23 | — | ||||||||||||
Comprehensive loss | $ | (12,563 | ) | $ | (2,677 | ) | $ | (20,503 | ) | $ | (4,366 | ) | |||||
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Source:
For Seres Therapeutics
Investor Relations
Stern
Investor Relations Inc.
Beth DelGiacco, 212-362-1200
Beth@sternir.com
or
Media
Relations
Feinstein Kean Healthcare
Liz Melone,
617-256-6622
liz.melone@fkhealth.com