Seres Therapeutics Reports Second Quarter Financial Results and Provides Progress Update
- Four significant microbiome program milestones expected during 2020, including readouts from two late-stage development programs –
- Completed public offering of common stock, raising net proceeds of
- Conference call at
“We remain focused on the execution of our clinical programs and we look forward to a data-rich 2020 with four significant expected milestones including: 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 the advancement of our rationally-designed, fermented SER-301 program into clinical development for ulcerative colitis,” said
Program Updates and Corporate Highlights
- SER-287 Phase 2b ECO-RESET study in ulcerative colitis: SER-287 is an oral, donor-derived microbiome therapeutic candidate designed to normalize the gastrointestinal microbiome of individuals with ulcerative colitis. Seres continues to enroll the SER-287 Phase 2b ECO-RESET induction study in patients with active mild-to-moderate ulcerative colitis. 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 onFDA 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 report Phase 2b ECO-RESET study top line results in the third quarter of 2020.
- SER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection: SER-109 is an oral, donor-derived microbiome therapeutic candidate designed to restore the depleted, or dysbiotic, gastrointestinal microbiome of patients with recurrent C. difficile infection. The Company continues to enroll the ECOSPOR III trial. ECOSPOR III is designed to evaluate efficacy and safety in 188 patients with recurrent C. difficile infection. All patients enrolled in ECOSPOR III are required to test positive for C. difficile cytotoxin to ensure enrollment of only patients with an active C. difficile infection. Seres expects to report SER-109 ECOSPOR III top line study results in early 2020.
- SER-401 Phase 1b in metastatic melanoma: SER-401 is an oral, donor-derived microbiome therapeutic candidate comprising a bacterial signature similar to that observed in checkpoint inhibitor immunotherapy responders. The ongoing Phase 1b study, supported by the
Parker Institute for Cancer Immunotherapy andThe University of Texas MD Anderson Cancer Center , will evaluate the potential for SER-401 to augment response to nivolumab, an approved anti-PD-1 checkpoint inhibitor therapy, and will assess a variety of biological measures of response. Seres expects to obtain SER-401 Phase 1b preliminary study results in the second half of 2020.
- SER-301 preclinical candidate: Seres also continues to advance its rationally-designed, fermented microbiome drug discovery and development capabilities. These efforts are focused on advancing SER-301, a preclinical therapeutic candidate for ulcerative colitis, into clinical development. The Company is entitled to a
$10 million milestone payment associated with the initiation of SER-301 clinical development from its ongoing collaboration with Nestlé Health Science. Seres expects to file an Investigational New Drug (IND) application and initiate clinical development for SER-301 in early 2020.
- Public equity offering (
June 2019 ): Seres completed a public equity offering of common stock, resulting in net proceeds of$60.6 million .The financing involved both new and existing investors, including from a new fund managed by Flagship Pioneering.
- Appointment of
Stephen Berenson to its Board of Directors (August 2019 ): Mr. Berenson is a managing partner at Flagship Pioneering and previously spent his career as an investment banker at J.P. Morgan.
Financial Results
Seres reported a net loss of
Research and development expenses for the second quarter of 2019 were
General and administrative expenses for the second quarter of 2019 were
Seres ended the second quarter with approximately
Cash use in the second quarter declined relative to prior periods as a result of the cost cutting corporate changes implemented earlier this year. Seres expects the lower expense levels incurred this quarter to be a proxy for subsequent quarters leading up to the clinical readouts expected in 2020. 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 first quarter of 2021.
Conference Call Information
Seres’ management will host a conference call today,
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
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-Q filed with the
SERES THERAPEUTICS, INC. |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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(unaudited, in thousands, except share and per share data) |
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June 30, |
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December 31, |
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||
|
|
2019 |
|
|
2018 |
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||
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
102,230 |
|
|
$ |
85,820 |
|
Prepaid expenses and other current assets |
|
|
5,160 |
|
|
|
6,845 |
|
Accounts receivable |
|
|
1,604 |
|
|
|
— |
|
Total current assets |
|
|
108,994 |
|
|
|
92,665 |
|
Property and equipment, net |
|
|
22,945 |
|
|
|
26,294 |
|
Operating lease assets |
|
|
12,640 |
|
|
|
— |
|
Restricted investments |
|
|
1,400 |
|
|
|
1,400 |
|
Restricted cash |
|
|
114 |
|
|
|
113 |
|
Total assets |
|
$ |
146,093 |
|
|
$ |
120,472 |
|
Liabilities and Stockholders’ Deficit |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
4,764 |
|
|
$ |
6,415 |
|
Accrued expenses and other current liabilities |
|
|
10,589 |
|
|
|
15,207 |
|
Operating lease liabilities |
|
|
4,449 |
|
|
|
— |
|
Deferred revenue - related party |
|
|
20,582 |
|
|
|
20,419 |
|
Deferred revenue |
|
|
2,689 |
|
|
|
— |
|
Total current liabilities |
|
|
43,073 |
|
|
|
42,041 |
|
Operating lease liabilities, net of current portion |
|
|
17,969 |
|
|
|
— |
|
Lease incentive obligation, net of current portion |
|
|
— |
|
|
|
6,776 |
|
Deferred rent |
|
|
— |
|
|
|
2,216 |
|
Deferred revenue, net of current portion - related party |
|
|
99,608 |
|
|
|
116,840 |
|
Deferred revenue, net of current portion |
|
|
2,752 |
|
|
|
— |
|
Other long-term liabilities |
|
|
659 |
|
|
|
644 |
|
Total liabilities |
|
|
164,061 |
|
|
|
168,517 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders’ deficit: |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized at June 30, 2019 and December 31, 2018; no shares issued and outstanding at June 30, 2019 and December 31, 2018 |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 200,000,000 shares authorized at June 30, 2019 and December 31, 2018; 69,913,410 and 40,936,735 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively |
|
|
70 |
|
|
|
41 |
|
Additional paid-in capital |
|
|
406,424 |
|
|
|
341,284 |
|
Accumulated deficit |
|
|
(424,462 |
) |
|
|
(389,370 |
) |
Total stockholders’ deficit |
|
|
(17,968 |
) |
|
|
(48,045 |
) |
Total liabilities and stockholders’ deficit |
|
$ |
146,093 |
|
|
$ |
120,472 |
|
SERES THERAPEUTICS, INC. |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
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(unaudited, in thousands, except share and per share data) |
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Three Months Ended June 30, |
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|
Six Months Ended June 30, |
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|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
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Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue - related party |
$ |
10,454 |
|
|
$ |
4,271 |
|
|
$ |
17,069 |
|
|
$ |
8,037 |
|
Grant revenue |
|
260 |
|
|
|
341 |
|
|
|
706 |
|
|
|
546 |
|
Revenue |
|
1,817 |
|
|
|
— |
|
|
|
2,077 |
|
|
|
— |
|
Total revenue |
|
12,531 |
|
|
|
4,612 |
|
|
|
19,852 |
|
|
|
8,583 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
17,905 |
|
|
|
24,053 |
|
|
|
40,792 |
|
|
|
47,513 |
|
General and administrative expenses |
|
5,574 |
|
|
|
8,695 |
|
|
|
13,069 |
|
|
|
17,472 |
|
Restructuring expenses |
|
— |
|
|
|
— |
|
|
|
1,492 |
|
|
|
— |
|
Total operating expenses |
|
23,479 |
|
|
|
32,748 |
|
|
|
55,353 |
|
|
|
64,985 |
|
Loss from operations |
|
(10,948 |
) |
|
|
(28,136 |
) |
|
|
(35,501 |
) |
|
|
(56,402 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income (expense), net |
|
189 |
|
|
|
349 |
|
|
|
409 |
|
|
|
696 |
|
Total other income (expense), net |
|
189 |
|
|
|
349 |
|
|
|
409 |
|
|
|
696 |
|
Net loss |
$ |
(10,759 |
) |
|
$ |
(27,787 |
) |
|
$ |
(35,092 |
) |
|
$ |
(55,706 |
) |
Net loss per share attributable to common stockholders, basic and diluted |
$ |
(0.24 |
) |
|
$ |
(0.68 |
) |
|
$ |
(0.81 |
) |
|
$ |
(1.37 |
) |
Weighted average common shares outstanding, basic and diluted |
|
45,140,830 |
|
|
|
40,661,464 |
|
|
|
43,095,686 |
|
|
|
40,645,040 |
|
Net loss |
|
(10,759 |
) |
|
|
(27,787 |
) |
|
|
(35,092 |
) |
|
|
(55,706 |
) |
Other comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on investments, net of tax of $0 |
$ |
— |
|
|
$ |
77 |
|
|
$ |
— |
|
|
$ |
117 |
|
Total other comprehensive income |
|
— |
|
|
|
77 |
|
|
|
— |
|
|
|
117 |
|
Comprehensive loss |
$ |
(10,759 |
) |
|
$ |
(27,710 |
) |
|
$ |
(35,092 |
) |
|
$ |
(55,589 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20190806005161/en/
Source:
Carlo Tanzi, Ph.D., Seres Therapeutics, 617-203-3467
Vice President, Investor Relations and Corporate Communications
ctanzi@serestherapeutics.com