Seres Therapeutics Reports Third Quarter 2015 Financial Results and Provides Business Update
“Over the past few months, we have continued to make significant
progress in the microbiome space by advancing our promising pipeline of
Ecobiotic® therapeutics,” said
“We also have accomplished meaningful development progress in SER-262, our drug candidate to prevent the primary recurrence of CDI infection, and we intend to have this in the clinic in mid-2016, as the first synthetic microbiome investigational therapy. In addition, we expect to bring SER-287 in ulcerative colitis to the clinic by the end of this year. SER-287 will be the first microbiome therapeutic candidate to be studied for treatment of a chronic disease. These recent advances in key programs show our commitment to the mission of delivering Ecobiotic® medicines to patients in dire need, and demonstrate well our leadership in this new field in biomedicine.”
Third Quarter and Recent Business Highlights:
-
SER-109 granted Orphan Drug Designation by the
FDA , facilitating the development process through advantages, including an extended seven-year period of market exclusivity upon approval, tax credits for clinical research expenses incurred inthe United States , and an exemption fromFDA application user fees. In addition, SER-109 was granted Breakthrough Designation by theFDA inJune 2015 . - Continued to advance pipeline of Ecobiotic® candidates, including the ongoing Phase 2 clinical trial of SER-109 in recurrent CDI with data expected in mid-2016; completion of IND-enabling preclinical studies for SER-287 for treatment of ulcerative colitis, with a Phase 1b study expected to begin by the end of 2015; and important bioprocess advancement supporting SER-262 for treatment of primary C. difficile infection (CDI) recurrence, with clinical studies anticipated to begin in mid-2016.
- Advanced research and translational science functions n developing microbiome agents to prevent bacterial infections and graft versus host disease (GVHD) in human stem cell transplant patients (SER-155). Research is also underway on microbiome drugs to address certain rare genetic diseases and to treat colitis induced by immuno-oncology therapies.
-
Closing of Seres’ initial public offering, including
receipt of approximately
$139 million of proceeds, inclusive of the full exercise of underwriter’s option and net of underwriting discounts and offering expenses. -
Appointed
Kurt Graves to Board of Directors. Mr. Graves is currently the Chairman, President and CEO of Intarcia Therapeutics.
Third Quarter Financial Results:
For the third quarter of 2015, Seres reported a net loss of
-
Research and Development: R&D expenses for the third quarter of
2015 were
$9.9 million , compared to$2.5 million for the same period in 2014. The increase was largely due to expenditures in connection with Seres’ microbiome therapeutic platform and clinical development of SER-109. -
General and Administrative Expenses: G&A expenses for the third
quarter of 2015 were
$4.7 million , compared with$1.1 million for the same period in 2014. The increase was primarily due to Seres’ continued investment in business personnel, facility expansion to support the company’s overall growth, and increased professional fees and other costs associated with operating as a public company. -
Cash Position: Seres had cash, cash equivalents and investments
of
$219.3 million as ofSeptember 30, 2015 , compared to$91.8 million as ofJune 30, 2015 .
Financial Guidance:
Based on the company’s current operating plan, Seres expects that cash,
cash equivalents and investments as of
About
To receive additional information about Seres, please visit the website at www.Serestherapeutics.com, which does not form a part of this press release.
Ecobiotic is a registered trademark of Seres. All other brand names, product names, trademarks or service marks belong to their respective holders.
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 statements regarding Seres' cash position, Seres' expectations regarding how long its current cash, cash equivalents and investments will last, statements regarding the Seres’ microbiome therapeutics platform, Seres' expectations regarding SER-109 as a treatment of recurrent Clostridium Difficile infection (CDI), Seres' expectations regarding SER-287 as a treatment of Ulcerative colitis, Seres’ expectation regarding SER-262 as a treatment of Primary CDI, and Seres’ expectation regarding pre-clinical screening of SER-155.
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 have incurred
significant losses, 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; 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. | ||||||||
|
CONSOLIDATED BALANCE SHEETS |
||||||||
| (unaudited, in thousands, except share and per share data) | ||||||||
| September 30, | December 31, | |||||||
| 2015 | 2014 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 69,702 | $ | 114,185 | ||||
| Investments | 149,641 | — | ||||||
| Prepaid expenses and other current assets | 3,020 | 58 | ||||||
| Total current assets | 222,363 | 114,243 | ||||||
| Property and equipment, net | 4,543 | 1,264 | ||||||
| Restricted cash | 139 | 139 | ||||||
| Deferred offering costs | — | 1,684 | ||||||
| Deferred financing costs | — | 15 | ||||||
| Total assets | $ | 227,045 | $ | 117,345 | ||||
| Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 2,089 | 2,166 | ||||||
| Accrued expenses and other current liabilities | 2,757 | 1,737 | ||||||
| Notes payable, current portion | — | 1,200 | ||||||
| Total current liabilities | 4,846 | 5,103 | ||||||
| Notes payable, net of discount | — | 1,304 | ||||||
| Preferred stock warrant liability | — | 1,582 | ||||||
| Total liabilities | 4,846 | 7,989 | ||||||
| Commitments and contingencies | ||||||||
|
Convertible preferred stock (Series A, A-2, B, C, D and D-1), $0.001 par value; 10,000,000 and 24,348,003 shares authorized at September 30, 2015 and December 31, 2014, respectively; 0 and 22,866,987 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively; aggregate liquidation preference of $0 and $137,283 at September 30, 2015 and December 31, 2014, respectively |
— | 136,077 | ||||||
| Stockholders’ equity (deficit): | ||||||||
|
Common stock, $0.001 par value; 200,000,000 and 38,000,000 shares
authorized at September 30, 2015 and December 31, 2014, respectively; 39,055,767 and 6,890,250 shares issued and outstanding at September 30, 2015 and December 31, 2014 , respectively |
39 | 7 | ||||||
| Additional paid-in capital | 285,148 | 1,104 | ||||||
| Accumulated other comprehensive loss | (10 | ) | — | |||||
| Accumulated deficit | (62,978 | ) | (27,832 | ) | ||||
| Total stockholders’ equity (deficit) | 222,199 | (26,721 | ) | |||||
| Total liabilities, convertible preferred stock and stockholders’ equity (deficit) | $ | 227,045 | $ | 117,345 | ||||
| SERES THERAPEUTICS INC. | ||||||||||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||||||||
| (unaudited, in thousands, except share and per share data) | ||||||||||||||||
|
Three Months Ended |
Nine Months Ended |
|||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Revenue | — | — | — | — | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | $ | 9,850 | $ | 2,466 | $ | 24,195 | $ | 5,658 | ||||||||
| General and administrative expenses | 4,711 | 1,113 | 10,873 | 2,211 | ||||||||||||
| Total operating expenses | 14,561 | 3,579 | 35,068 | 7,869 | ||||||||||||
| Loss from operations | (14,561 | ) | (3,579 | ) | (35,068 | ) | (7,869 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income (expense), net | (59 | ) | (61 | ) | (71 | ) | (154 | ) | ||||||||
| Revaluation of preferred stock warrant liability | — | (521 | ) | (7 | ) | (504 | ) | |||||||||
| Total other income (expense), net | (59 | ) | (582 | ) | (78 | ) | (658 | ) | ||||||||
| Net loss | $ | (14,620 | ) | $ | (4,161 | ) | $ | (35,146 | ) | $ | (8,527 | ) | ||||
| Accretion of convertible preferred stock to redemption value | — | (461 | ) | — | (1,019 | ) | ||||||||||
| Net loss attributable to common stockholders | (14,620 | ) | (4,622 | ) | (35,146 | ) | (9,546 | ) | ||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.38 | ) | $ | (0.68 | ) | $ | (1.92 | ) | $ | (1.42 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 38,980,839 | 6,767,951 | 18,292,002 | 6,731,724 | ||||||||||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized loss on investments, net of tax of $0 | (33 | ) | — | (10 | ) | — | ||||||||||
| Total other comprehensive loss | (33 | ) | — | (10 | ) | — | ||||||||||
| Comprehensive loss | $ | (14,653 | ) | $ | (4,622 | ) | $ | (35,156 | ) | $ | (9,546 | ) | ||||
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Source:
Investor Relations
Stern Investor Relations Inc.
Beth
DelGiacco, 212-362-1200
Beth@sternir.com
or
Media
Relations
Ten Bridge Communications Inc.
Dan Quinn,
781-475-7974
Dan@tenbridgecommunications.com