Full Press Release Details
Seres Therapeutics Reports Second Quarter 2017 Financial Results and Provides Update on Operational
- Initiated SER-109 Phase 3 study in patients with multiply recurrent C. difficile
- SER-287 Phase 1b study in mild-to-moderate ulcerative colitis patients, failing first line therapy, fully enrolled; Top-line data read-out expected
in the second half of 2017 -
- Conference call at 8 a.m. ET today -
CAMBRIDGE, Mass., August 3, 2017 Seres Therapeutics, Inc. (NASDAQ:MCRB) today reported second quarter 2017
financial results and provided a progress update on multiple microbiome clinical programs, including three clinical-stage therapeutic candidates seeking to address serious human diseases.
Seres continues to make excellent progress advancing our pipeline of clinical stage microbiome therapeutic candidates, and we believe we are on track to
develop SER-109 as the first FDA-approved microbiome product, said Roger J. Pomerantz, M.D., President, CEO and Chairman of Seres. We recently initiated the SER-109 Phase 3 study in patients with multiply recurrent C. difficile infection and are working with alacrity to enroll the study. This Phase 3 study is the first pivotal trial of a microbiome drug candidate
in this new field of medicine. We have also now fully enrolled our Phase 1b study of SER-287, the first microbiome therapeutic candidate for a chronic disease, in patients with
mild-to-moderate ulcerative colitis, who are failing first line therapy, and are looking forward to obtaining microbiome and clinical data from the SER-287 trial in the second half of 2017.
Recent Highlights and Events
Seres reported a net loss of $28.0 million for the second quarter of 2017, as compared to a net loss of $27.9 million for the same period
in 2016. The second quarter net loss was driven primarily by clinical and development expenses, personnel expenses, and ongoing development of the Company s microbiome therapeutics platform. The second quarter net loss figure was inclusive
of $3.0 million in recognized revenue associated with the Company s collaboration with Nestl Health Science.
development expenses for the second quarter were $23.1 million, as compared to $22.2 million for the same period in 2016. The research and development expense was primarily related to Seres microbiome therapeutics platform,
the clinical development of SER-109, SER-262 and SER-287, as well as the Company s
SER-301 and SER-155 preclinical programs.
General and administrative
expenses for the second quarter were $8.4 million, as compared to $9.0 million for the same period in the prior year. General and administrative expenses were primarily due to headcount, professional fees, and facility costs.
The Company expects to account for receipt of the previously disclosed $20.0 milestone payment associated with
the start of the SER-109 Phase 3 study, under its collaboration agreement with Nestl , in the third quarter of 2017.
The decrease in cash balance during the quarter was $27.0 million. Seres ended the second quarter with approximately $175.2 million in cash,
cash equivalents and investments.
Conference Call Information
Seres management will host a conference call today, August 3, 2017, at 8:00 a.m. ET. To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number
62118608. To join the live webcast, please visit the Investors and Media section of the Seres website at www.serestherapeutics.com.
About Seres Therapeutics
Seres Therapeutics, Inc.,
is a leading microbiome therapeutics platform Company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the natural state of bacterial diversity and function is
imbalanced. Seres lead program, SER-109, has obtained Breakthrough Therapy and Orphan Drug designations from the U.S. Food and Drug Administration and is in Phase 3 development for multiply recurrent
C. difficile infection. Seres clinical candidate SER-287 is being evaluated in a Phase 1b study in patients with
mild-to-moderate ulcerative colitis. Seres is also developing SER-262, the first ever synthetic microbiome therapeutic candidate,
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 timing of data for our clinical studies, the design of our clinical studies, whether we are on track in our clinical development plans, any potential approval or registration of our various
therapeutic candidates, the objective for SER-109 to meaningfully reduce the risk of recurrence of C. diff. infection, the potential for SER-287 to offer a novel,
non-immunosuppressive treatment option for ulcerative colitis patients, and the timing of accounting for the Nestl SER-109 Phase 3 milestone payment.
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 United States patent law; potential lawsuits for infringement of third-party intellectual property; our patents being found invalid or unenforceable; compliance with patent
regulations; claims challenging the inventorship or ownership of our patents and other intellectual property; claims asserting that we or our employees misappropriated a third-party s intellectual property or otherwise claiming ownership of
what we regard as our intellectual property; adequate protection of our trademarks; ability to attract and retain key executives; managing our growth could result in difficulties; risks associated with international operations; potential system
failures; the price of our common stock may fluctuate substantially; our executive officers, directors, and principal stockholders have the ability to control all matters submitted to the stockholders; a significant portion of our total outstanding
shares are eligible to be sold into the market; unfavorable or lacking analyst research or reports; and we are currently subject to securities class action litigation. These and other important factors discussed under the caption Risk
Factors in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on May 4, 2017 and our other reports filed with the SEC, including the Quarterly Report we
intend to file later today, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management s estimates as of the date
of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be
relied upon as representing our views as of any date subsequent to the date of this press release.
SERES THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands, except share and per share data)
| June 30, 2017 | December 31, 2016 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 33,642 | $ | 54,539 | ||||
| Investments | 137,570 | 138,704 | ||||||
| Prepaid expenses and other current assets | 4,839 | 5,126 | ||||||
| Total current assets | 176,051 | 198,369 | ||||||
| Property and equipment, net | 34,813 | 36,125 | ||||||
| Long-term investments | 3,962 | 36,752 | ||||||
| Restricted cash | 1,513 | 1,400 | ||||||
| Total assets | $ | 216,339 | $ | 272,646 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,889 | $ | 7,587 | ||||
| Accrued expenses and other current liabilities | 9,718 | 10,812 | ||||||
| Deferred revenue related party | 12,058 | 12,058 | ||||||
| Total current liabilities | 25,665 | 30,457 | ||||||
| Lease incentive obligation, net of current portion | 9,859 | 10,730 | ||||||
| Deferred rent | 2,159 | 2,072 | ||||||
| Deferred revenue, net of current portion related party | 90,727 | 96,756 | ||||||
| Total liabilities | 128,410 | 140,015 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized at June 30, 2017 and December 31, 2016; no shares issued and outstanding at June 30, 2017 and December 31, 2016 | ||||||||
| Common stock, $0.001 par value; 200,000,000 shares authorized at June 30, 2017 and December 31, 2016; 40,412,035 and 40,355,753 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively | 40 | 40 | ||||||
| Additional paid-in capital | 315,748 | 306,931 | ||||||
| Accumulated other comprehensive loss | (176 | ) | (149 | ) | ||||
| Accumulated deficit | (227,683 | ) | (174,191 | ) | ||||
| Total stockholders equity | 87,929 | 132,631 | ||||||
| Total liabilities and stockholders equity | $ | 216,339 | $ | 272,646 |
SERES THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited, in thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Revenue: | ||||||||||||||||
| Collaboration revenue related party | $ | 3,014 | $ | 3,004 | $ | 6,029 | $ | 5,714 | ||||||||
| Total revenue | 3,014 | 3,004 | 6,029 | 5,714 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 23,060 | 22,174 | 43,203 | 37,590 | ||||||||||||
| General and administrative expenses | 8,370 | 8,970 | 17,132 | 16,180 | ||||||||||||
| Total operating expenses | 31,430 | 31,144 | 60,335 | 53,770 | ||||||||||||
| Loss from operations | (28,416 | ) | (28,140 | ) | (54,306 | ) | (48,056 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 615 | 495 | 1,390 | 763 | ||||||||||||
| Other income (expense) | (217 | ) | (268 | ) | (576 | ) | (324 | ) | ||||||||
| Total other income, net | 398 | 227 | 814 | 439 | ||||||||||||
| Net loss | $ | (28,018 | ) | $ | (27,913 | ) | $ | (53,492 | ) | $ | (47,617 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.69 | ) | $ | (0.70 | ) | $ | (1.32 | ) | $ | (1.21 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 40,394,605 | 39,600,344 | 40,381,643 | 39,393,238 | ||||||||||||
| Other comprehensive (loss) income: | ||||||||||||||||
| Unrealized (loss) gain on investments, net of tax of $0 | $ | (25 | ) | $ | (25 | ) | $ | (27 | ) | $ | 53 | |||||
| Total other comprehensive (loss) income | (25 | ) | (25 | ) | (27 | ) | 53 | |||||||||
| Comprehensive loss | $ | (28,043 | ) | $ | (27,938 | ) | $ | (53,519 | ) | $ | (47,564 | ) |
Carlo Tanzi, Ph.D., Seres Therapeutics, 617-203-3467
Head of Investor Relations and Corporate Communications