Full Press Release Details
Seres Therapeutics Reports Second Quarter Financial Results and Provides Operational Updates
- Company preparing to initiate SER-287 Phase 2b study for ulcerative
- Initiation of SER-401 clinical study
expected in patients with metastatic melanoma
treated with checkpoint inhibitors by year end -
- Recent Seres R&D event highlighted microbiome scientific leadership across several
clinical and preclinical programs -
- Conference call at 8:30 a.m. ET today -
CAMBRIDGE, Mass., August 2, 2018 Seres Therapeutics, Inc. (NASDAQ:MCRB) today reported second quarter 2018 financial results and
provided an operational update.
Seres has made excellent progress across our deep pipeline of early and late, clinical and preclinical stage
microbiome programs, and we were pleased to demonstrate the depth of our scientific leadership in this new therapeutic modality at our recent investor R&D event highlighting how we can change immunological tone using microbiome drugs.
said Roger J. Pomerantz, M.D., President, CEO and Chairman of Seres. We continue to execute our SER-109 Phase 3 clinical study in patients with multiply-recurrent C. difficile infection.
Following constructive meetings with the FDA, we are nearing initiation of a SER-287 Phase 2b clinical study in patients with active
mild-to-moderate ulcerative colitis. Based on our FDA interactions, we expect the SER-287 Phase 2b study could be a pivotal trial
that may serve as one of two required studies for product registration. We are also advancing work with our collaborators at MD Anderson Cancer Center and the Parker Institute for Immunotherapy to begin a Phase 1b study with SER-401 by year end to assess the potential for this microbiome therapy to augment clinical responses to checkpoint inhibitors in patients with metastatic melanoma.
Recent Highlights and Events
Seres reported a net loss of
$27.8 million for the second quarter of 2018, as compared to a net loss of $28.0 million for the same period in 2017. 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 $4.6 million in recognized revenue primarily associated with the Company s collaboration with
Nestl Health Science.
Research and development expenses for the second quarter were $24.1 million, as compared to $23.1 million
for the same period in 2017. 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, SER-155 and immuno-oncology
preclinical programs.
General and administrative expenses for the second quarter were $8.7 million, as compared to $8.4 million for the
same period in the prior year. General and administrative expenses were primarily due to headcount, professional fees, and facility costs.
in cash, cash equivalents and investments balance during the quarter was $26.1 million. Seres ended the second quarter with approximately $96.1 million in cash, cash equivalents and investments. Current resources are expected to fund the
Company into the second quarter of 2019. This estimate does not include a $20.0 million milestone payment that the Company expects to receive with the start of the SER-287 Phase 2b study.
Conference Call Information
Seres management will host a conference call today, August 2, 2018, at 8:30 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
8181429. Accompanying slides will be made available on the Seres website prior to the call. To join the live webcast, please visit the Investors and Media section of the Seres website at www.serestherapeutics.com.
A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.
About Seres Therapeutics
Seres Therapeutics, Inc.
(Nasdaq:MCRB) 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 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.
SER-287 has successfully completed a Phase 1b study in patients with mild-to-moderate ulcerative colitis. Seres is developing SER-262, the first ever synthetic microbiome therapeutic candidate, in a Phase 1b study in patients with primary C.
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 our development plans, the ability of ECOSPOR III to support SER-109 approval, the promise and potential impact of any of our microbiome therapeutics or clinical trial data, timing of and plans to
initiate clinical studies of SER-287 and SER-401, the timing and results of any clinical studies, and the sufficiency of cash to fund operations.
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; our limited operating history; our unproven approach to
therapeutic intervention; the lengthy, expensive, and uncertain process of clinical drug development; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize
our product candidates, if approved; our lack of experience in manufacturing, selling, marketing, and distributing our product candidates; failure to compete successfully against other drug companies; protection of our proprietary technology and the
confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; our ability
to retain key personnel and to manage our growth; the potential volatility of our common stock; and our
management and principal stockholders have the ability to control or significantly influence our business. 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 9, 2018 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, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 57,960 | $ | 36,088 | ||||
| Investments | 38,106 | 113,895 | ||||||
| Prepaid expenses and other current assets | 5,471 | 5,095 | ||||||
| Total current assets | 101,537 | 155,078 | ||||||
| Property and equipment, net | 29,904 | 32,931 | ||||||
| Restricted cash | 1,513 | 1,513 | ||||||
| Total assets | $ | 132,954 | $ | 189,522 | ||||
| Liabilities and Stockholders Equity/(Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,158 | $ | 7,033 | ||||
| Accrued expenses and other current liabilities | 13,651 | 12,513 | ||||||
| Deferred revenue - related party | 17,962 | 12,079 | ||||||
| Total current liabilities | 36,771 | 31,625 | ||||||
| Lease incentive obligation, net of current portion | 8,119 | 8,989 | ||||||
| Deferred Rent | 2,231 | 2,233 | ||||||
| Deferred revenue, net of current portion - related party | 97,959 | 84,847 | ||||||
| Other long-term liabilities | 1,129 | 1,129 | ||||||
| Total liabilities | 146,209 | 128,823 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized at June 30, 2018 and December 31, 2017; no shares issued and outstanding at June 30, 2018 and December 31, 2017 | ||||||||
| Common stock, $0.001 par value; 200,000,000 shares authorized at June 30, 2018 and December 31, 2017; 40,754,681 and 40,571,015 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively | 40 | 40 | ||||||
| Additional paid-in capital | 332,870 | 324,376 | ||||||
| Accumulated other comprehensive loss | (29 | ) | (146 | ) | ||||
| Accumulated deficit | (346,136 | ) | (263,571 | ) | ||||
| Total stockholders equity/(deficit) | (13,255 | ) | 60,699 | |||||
| Total liabilities and stockholders equity | $ | 132,954 | $ | 189,522 |
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, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenue: | ||||||||||||||||
| Collaboration revenue - related party | $ | 4,271 | $ | 3,014 | $ | 8,037 | $ | 6,029 | ||||||||
| Grant revenue | 341 | 546 | ||||||||||||||
| Total revenue | 4,612 | 3,014 | 8,583 | 6,029 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 24,053 | 23,060 | 47,513 | 43,203 | ||||||||||||
| General and administrative expenses | 8,695 | 8,370 | 17,472 | 17,132 | ||||||||||||
| Total operating expenses | 32,748 | 31,430 | 64,985 | 60,335 | ||||||||||||
| Loss from operations | (28,136 | ) | (28,416 | ) | (56,402 | ) | (54,306 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 349 | 615 | 696 | 1,390 | ||||||||||||
| Other income (expense) | (217 | ) | (576 | ) | ||||||||||||
| Total other income, net | 349 | 398 | 696 | 814 | ||||||||||||
| Net loss | $ | (27,787 | ) | $ | (28,018 | ) | $ | (55,706 | ) | $ | (53,492 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.68 | ) | $ | (0.69 | ) | $ | (1.37 | ) | $ | (1.32 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 40,661,464 | 40,394,605 | 40,645,040 | 40,381,643 | ||||||||||||
| Other comprehensive (loss) income: | ||||||||||||||||
| Unrealized (loss) gain on investments, net of tax of $0 | 77 | $ | (25 | ) | $ | 117 | $ | (27 | ) | |||||||
| Total other comprehensive (loss) income | 77 | (25 | ) | 117 | (27 | ) | ||||||||||
| Comprehensive loss | $ | (27,710 | ) | $ | (28,043 | ) | $ | (55,589 | ) | $ | (53,519 | ) |
Tanzi, Ph.D., Seres Therapeutics, 617-203-3467
Vice President, Investor
Relations and Corporate Communications