Seres Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Corporate Highlights
– Data-rich period ahead including two expected late-stage microbiome clinical readouts: SER-109 in recurrent C. difficile infection in mid-2020 and SER-287 for ulcerative colitis in H2 2020 –
– Clinical development activities initiated for SER-301, a next-generation, rationally designed product candidate for ulcerative colitis –
– Approximately
– Conference call at
“Throughout 2019, we reinforced Seres’ leadership in microbiome therapeutics and advanced our robust pipeline toward multiple near-term readouts and secured an immuno-oncology collaboration with AstraZeneca. We also strengthened our balance sheet by adding approximately
Program and Corporate Updates
SER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection: SER-109 is an orally-administered, biologically-derived, live microbiome therapeutic candidate designed to restore the depleted, or dysbiotic, gastrointestinal microbiome of patients with recurrent C. difficile infection. Seres’ SER-109 manufacturing process inactivates vegetative bacteria and other potential pathogens that have been linked with FMT-associated disease transmission. Seres believes that this manufacturing process, which is unique to Seres, provides a critically important safety advantage. Enrollment in the Phase 3 ECOSPOR III study is over 95% complete. All ECOSPOR III patients are required to undergo a rigorous C. difficile cytotoxin diagnostic test to confirm active C. difficile infection, both at entry into the study and at completion of treatment. The study is evaluating the efficacy and safety of SER-109 in 188 patients with recurrent C. difficile infection. Seres expects to report top-line results from ECOSPOR III in mid-2020. Based on discussions with the FDA, Seres believes that ECOSPOR III has the potential to be a single pivotal study supporting product registration. However, this would depend on the strength of the data, and additional safety data may be required.
SER-287 Phase 2b ECO-RESET study in ulcerative colitis: SER-287 is an oral, biologically-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 is expected to enroll approximately 201 patients and Seres expects to report top-line results in the second half of 2020. 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.
SER-301 clinical candidate for ulcerative colitis: Seres has nominated SER-301, a rationally designed, fermented microbiome therapeutic as a clinical candidate for ulcerative colitis. Next-generation, rationally designed microbiome therapeutics may provide important benefits that include the optimization of pharmacological properties for targeted diseases and streamlined manufacturing. The consortia of bacteria in SER-301 is designed to modify the microbiome and microbe-associated metabolites in the gastrointestinal tract to modulate anti-inflammatory immune pathways and to improve epithelial barrier integrity in patients with ulcerative colitis. The Company has initiated clinical development activities for a SER-301 Phase 1 study in patients with ulcerative colitis and plans to enroll subjects in
SER-401 Phase 1b study in metastatic melanoma: SER-401 is an orally-administered, biologically-derived, live microbiome therapeutic candidate comprising bacteria that reflect the bacterial signature in the gastrointestinal microbiome associated with patient response to checkpoint inhibitor immunotherapy. The ongoing placebo-controlled Phase 1b study, which is supported by the
Financial Results
Seres reported a net loss of
Research and development expenses for the fourth quarter of 2019 were
General and administrative expenses for the fourth quarter were
Seres ended the fourth quarter with approximately
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 second 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, the receipt of future milestone payments, the potential impact of any of Seres’ development candidates, 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 risks of operating internationally; 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
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2019 |
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2018 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
|
$ |
65,126 |
|
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$ |
85,820 |
|
Investments |
|
|
29,690 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
3,588 |
|
|
|
6,845 |
|
Accounts receivable |
|
|
1,785 |
|
|
|
— |
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Total current assets |
|
|
100,189 |
|
|
|
92,665 |
|
Property and equipment, net |
|
|
19,495 |
|
|
|
26,294 |
|
Operating lease assets |
|
|
11,356 |
|
|
|
— |
|
Restricted investments |
|
|
1,400 |
|
|
|
1,400 |
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Restricted cash |
|
|
— |
|
|
|
113 |
|
Total assets |
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$ |
132,440 |
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|
$ |
120,472 |
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Liabilities and Stockholder's Deficit |
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Current liabilities: |
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Accounts payable |
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$ |
4,859 |
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|
$ |
6,415 |
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Accrued expenses and other current liabilities |
|
|
10,884 |
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|
|
15,207 |
|
Operating lease liabilities |
|
|
4,456 |
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— |
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Deferred revenue - related party |
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20,960 |
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|
20,419 |
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Deferred revenue |
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4,834 |
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— |
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Total current liabilities |
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45,993 |
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|
42,041 |
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Note payable, net of discount |
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24,648 |
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|
— |
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Operating lease liabilities, net of current portion |
|
|
15,676 |
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|
|
— |
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Lease incentive obligation, net of current portion |
|
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— |
|
|
|
6,776 |
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Deferred rent |
|
|
— |
|
|
|
2,216 |
|
Deferred revenue, net of current portion - related party |
|
|
89,111 |
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|
|
116,840 |
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Deferred revenue, net of current portion |
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|
4,834 |
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|
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— |
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Other long-term liabilities |
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|
502 |
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|
|
644 |
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Total liabilities |
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180,764 |
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|
168,517 |
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Commitments and contingencies |
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Stockholders’ (deficit): |
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Preferred stock,
and 2018; no shares issued and outstanding at |
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— |
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— |
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Common stock, and 2018; 70,143,252 and 40,936,735 shares issued and outstanding
at |
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70 |
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41 |
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Additional paid-in capital |
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411,255 |
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341,284 |
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Accumulated other comprehensive income (loss) |
|
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— |
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— |
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Accumulated deficit |
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|
(459,649 |
) |
|
|
(389,370 |
) |
Total stockholders’ deficit |
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(48,324 |
) |
|
|
(48,045 |
) |
Total liabilities and stockholders’ deficit |
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$ |
132,440 |
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$ |
120,472 |
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Year Ended |
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2019 |
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2018 |
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2017 |
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Revenue: |
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Collaboration revenue - related party |
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$ |
27,188 |
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$ |
26,917 |
|
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$ |
32,100 |
|
Grant revenue |
|
|
1,102 |
|
|
|
1,350 |
|
|
|
— |
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Collaboration revenue |
|
|
6,215 |
|
|
|
— |
|
|
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— |
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Total revenue |
|
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34,505 |
|
|
|
28,267 |
|
|
|
32,100 |
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Operating expenses: |
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Research and development expenses |
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$ |
80,141 |
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$ |
95,955 |
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$ |
89,455 |
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General and administrative expenses |
|
|
24,748 |
|
|
|
32,596 |
|
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|
34,040 |
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Restructuring expenses |
|
|
1,492 |
|
|
|
— |
|
|
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— |
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Total operating expenses |
|
|
106,381 |
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|
|
128,551 |
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|
|
123,495 |
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Loss from operations |
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|
(71,876 |
) |
|
|
(100,284 |
) |
|
|
(91,395 |
) |
Other income (expense): |
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|
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|
|
|
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Interest income |
|
|
1,033 |
|
|
|
1,172 |
|
|
|
1,590 |
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Interest expense |
|
|
(502 |
) |
|
|
— |
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|
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— |
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Other income |
|
|
1,066 |
|
|
|
170 |
|
|
|
425 |
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Total other income (expense), net |
|
|
1,597 |
|
|
|
1,342 |
|
|
|
2,015 |
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Net loss |
|
$ |
(70,279 |
) |
|
$ |
(98,942 |
) |
|
$ |
(89,380 |
) |
Net loss per share attributable to common stockholders, basic and diluted |
|
$ |
(1.24 |
) |
|
$ |
(2.43 |
) |
|
$ |
(2.21 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
56,649,220 |
|
|
|
40,743,492 |
|
|
|
40,449,410 |
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Other comprehensive income (loss): |
|
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|
|
|
|
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|
|
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Unrealized gain (loss) on investments, net of tax of |
|
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— |
|
|
|
146 |
|
|
|
3 |
|
Total other comprehensive income (loss) |
|
|
— |
|
|
|
146 |
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|
|
3 |
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Comprehensive loss |
|
$ |
(70,279 |
) |
|
$ |
(98,796 |
) |
|
$ |
(89,377 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20200302005196/en/
PR Contact
lisa@tenbridgecommunications.com
IR Contact
ctanzi@serestherapeutics.com
Source: