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Seres Therapeutics Reports First Quarter Financial Results and Provides Clinical Pipeline Progress Update - Four significant microbiome program milestones expected during 2020, including readouts from two late-stage deve

Key Takeaway: Seres Therapeutics Reports First Quarter Financial Results and Provides Clinical Pipeline Progress Update - Four significant microbiome program milestones expected during 2020, including readouts from two late-stage development programs - SER-287 Fast Track designation obtaine

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Seres Therapeutics Reports First Quarter Financial Results and Provides Clinical Pipeline Progress Update
- Four significant microbiome program milestones expected during 2020,
including readouts from two late-stage development programs
- SER-287 Fast Track designation obtained for active mild-to-moderate ulcerative colitis;
Phase 2b study enrollment expected to be completed by mid-2020 and
top-line data expected in Q3 2020
- SER-109 Phase 3 study design modified; enrollment expected to be completed by
the end of 2019 and top-line data now expected in early 2020
- Conference call at 8:30 a.m. ET today
CAMBRIDGE, Mass., May 2, 2019 Seres Therapeutics, Inc. (Nasdaq: MCRB) ( Seres or the Company )
today reported first quarter 2019 financial results and provided business updates.
In recent months, Seres has made significant corporate and
clinical progress to concentrate our resources on our highest priority therapeutic candidates with the goal of rapidly achieving key pipeline milestones. This has included the appointment of new leadership, pipeline focusing and prioritization,
streamlining of costs, initiation of two clinical studies and the initiation of an oncology-focused collaboration with AstraZeneca, said Eric D. Shaff, President and Chief Executive Officer at Seres. As part of this strategy, we are
announcing today the modification of our ongoing SER-109 Phase 3 ECOSPOR III study in patients with recurrent C. difficile infection. We believe this modification meaningfully accelerates the expected
timing for top-line data readout while maintaining a high level of scientific and statistical rigor. We remain enthusiastic about the potential for SER-109, which is
supported by compelling clinical and mechanistic evidence.
With our corporate strategy clearly defined, we look forward to a data-rich 2020
with four significant milestones expected: SER-287 Phase 2b readout in mild-to-moderate ulcerative colitis; SER-109 Phase 3 readout in recurrent C. difficile infection; SER-401 Phase 1b readout in metastatic melanoma; and advancing our rationally-designed, fermented SER-301 preclinical program to clinical development for ulcerative colitis. We are also excited to expand the development of new microbiome-based therapeutic approaches for cancer through our recent collaboration
with AstraZeneca, concluded Mr. Shaff.
Program Updates and Corporate Highlights
The SER-287 Phase 2b ECO-RESET study was initiated in December 2018 and is expected to enroll approximately 201 patients with mild-to-moderate ulcerative
colitis. Based on FDA feedback, Seres expects that with positive Phase 2b study results, the study could serve as one of two pivotal trials to enable a SER-287 Biologics License Application (BLA) submission.
Seres expects to complete enrollment of the SER-287 Phase 2b
ECO-RESET study by mid-2020 and report top-line data in the third quarter of 2020.
The original 320 patient ECOSPOR III trial was designed to evaluate SER-109 efficacy, a comprehensive
safety database, and to serve as a single pivotal study supporting BLA submission. Consistent with the Company s strategy to obtain rigorous, near-term clinical data, the Company has implemented a revised ECOSPOR III study design that reduces
the size of the study to 188 patients. The new size and powering calculations are informed by prior SER-109 study results, published C. difficile infection trial data utilizing cytotoxin testing and
preliminary blinded and open label C. difficile infection recurrence rate data from the ongoing ECOSPOR III study. Seres has informed the FDA regarding the ECOSPOR III study modification and plans to further discuss options to expedite the SER-109 development path toward potential BLA submission.
In prior communications with the FDA regarding a potential reduction in ECOSPOR III study
size, the agency indicated that if the statistical significance of the outcome of the study is insufficient to support BLA submission, the Company could be required to obtain additional confirmatory evidence of efficacy, such as a second Phase 3
study. Reducing the study size would likely require additional patient exposure to further establish safety. The Company believes that this study revision is designed to provide rigorous efficacy data. Furthermore, based on the safety results
observed in all of its microbiome therapeutics clinical trials to date, the Company expects to be able to work with FDA to satisfy additional safety data requirements, if needed.
As of April 30, 2019, ECOSPOR III had enrolled 135 patients. Seres expects to complete enrollment of
SER-109 ECOSPOR III by the end of 2019 and report top-line data in early 2020.
Seres expects to obtain SER-401 Phase 1b preliminary study results in 2020.
Seres expects to file an Investigational New Drug (IND) application and initiate clinical development for SER-301 in early 2020.
Seres reported a net loss of
$24.3 million for the first quarter of 2019, as compared to a net loss of $27.9 million for the same period in 2018. The first quarter net loss was driven primarily by clinical and development expenses, personnel expenses and ongoing
development of the Company s microbiome therapeutics platform. The first quarter net loss figure was inclusive of $7.3 million in recognized revenue associated primarily with the Company s collaboration with Nestl Health
Research and development expenses for the first quarter of 2019 were $22.9 million, as compared to $23.5 million for the same period
in 2018. The research and development expense was primarily related to Seres microbiome therapeutics platform, the clinical development of SER-109 and SER-287, as
well as the Company s immuno-oncology efforts.
General and administrative expenses for the first quarter of 2019 were $7.5 million, as compared
to $8.8 million for the same period in 2018. General and administrative expenses were primarily due to headcount, professional fees and facility costs.
During the first quarter of 2019 Seres recognized $1.5 million in restructuring expenses related to the corporate changes discussed earlier.
Seres ended the first quarter with approximately $53.6 million in cash and cash equivalents compared with $85.8 million at December 31, 2018.
In April 2019 and following the close of the first quarter of 2019, the Company received the first of three $6.7 million annual installment payments due under the terms of the collaboration with AstraZeneca.
Based on the Company s current operating plan, cash resources are expected to fund operating expenses and capital expenditure requirements, excluding net
cash flows from future business development activities or potential incoming milestone payments, into the fourth quarter of 2019.
Seres management will host a conference call today, May 2, 2019, 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
3368968. To join the live webcast, please visit the Investors and Media section of the Seres website at www.serestherapeutics.com.
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 SER-287 program has obtained Fast Track and Orphan Drug
designation from the U.S. Food and Drug Administration and is being evaluated in a Phase 2b study in patients with active mild-to-moderate ulcerative colitis.
Seres SER-109 program has obtained Breakthrough Therapy and Orphan Drug designations from the FDA and is in Phase 3 development for recurrent C. difficile infection. Seres is also developing SER-401 in a Phase 1b study in patients with metastatic melanoma. For more information, please visit www.serestherapeutics.com.
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 the timing and results of each of Seres clinical studies, the potential for any of the Company s studies to serve as a pivotal trial to enable a BLA submission, Seres plan to file an IND application for SER-301, the receipt of future milestone payments, the potential impact of any of Seres development candidates, the reduction in patient enrollment in the SER-109 Phase
3 trial leading to expedited results, the sufficiency of the Company s cash resources to fund operating expenses and capital expenditure requirements and other statements that are not historical facts.
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; the success of our leadership transition; our ability to retain key personnel and to manage our growth; 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on
March 6, 2019 and our other reports filed with the SEC 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)
March 31, December 31,
2019 2018
Assets
Current assets:
Cash and cash equivalents $ 53,600 $ 85,820
Accounts receivable 6,667
Prepaid expenses and other current assets 7,488 6,845
Total current assets 67,755 92,665
Property and equipment, net 24,571 26,294
Operating lease assets 13,202
Restricted investments 1,400 1,400
Restricted cash 114 113
Total assets $ 107,042 $ 120,472
Liabilities and Stockholders Deficit
Current liabilities:
Accounts payable $ 3,918 $ 6,415
Accrued expenses and other current liabilities 11,789 15,207
Operating lease liabilities 4,407
Deferred revenue - related party 18,685 20,419
Deferred revenue 2,770
Total current liabilities 41,569 42,041
Operating lease liabilities, net of current portion 19,066
Lease incentive obligation, net of current portion 6,776
Deferred rent 2,216
Deferred revenue, net of current portion - related party 111,959 116,840
Deferred revenue, net of current portion 3,637
Other long-term liabilities 644 644
Total liabilities 176,875 168,517
Commitments and contingencies
Stockholders deficit:
Preferred stock, $0.001 par value; 10,000,000 shares authorized at March 31, 2019 and December 31, 2018; no shares issued and outstanding at March 31, 2019 and December 31, 2018
Common stock, $0.001 par value; 200,000,000 shares authorized at March 31, 2019 and December 31, 2018; 41,094,832 and 40,936,735 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively 41 41
Additional paid-in capital 343,829 341,284
Accumulated deficit (413,703 ) (389,370 )
Total stockholders deficit (69,833 ) (48,045 )
Total liabilities and stockholders deficit $ 107,042 $ 120,472
SERES THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited, in thousands, except share and per share data)
Three Months Ended March 31,
2019 2018
Revenue:
Collaboration revenue - related party $ 6,615 $ 3,766
Grant revenue 446 205
Revenue 260
Total revenue 7,321 3,971
Operating expenses:
Research and development expenses 22,887 23,460
General and administrative expenses 7,495 8,777
Restructuring expenses 1,492
Total operating expenses 31,874 32,237
Loss from operations (24,553 ) (28,266 )
Other income (expense):
Interest income (expense), net 220 347
Total other income (expense), net 220 347
Net loss $ (24,333 ) $ (27,919 )
Net loss per share attributable to common stockholders, basic and diluted $ (0.59 ) $ (0.69 )
Weighted average common shares outstanding, basic and diluted 41,027,824 40,628,434
Net loss (24,333 ) (27,919 )
Other comprehensive income:
Unrealized gain on investments, net of tax of $0 $ $ 40
Total other comprehensive income 40
Comprehensive loss $ (24,333 ) $ (27,879 )
Carlo Tanzi, Ph.D., Seres Therapeutics, 617-203-3467
Vice President, Investor Relations and Corporate Communications
Last updated: May 2, 2019