Seres Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Updates
– Reported ECOSPOR III Phase 3 study of SER-109 met primary endpoint, demonstrated statistically significant absolute reduction of 30.2% in rate of C. difficile infection recurrence compared to placebo –
– SER-109 anticipated to be first-ever FDA-approved microbiome therapy –
– First patient dosed in SER-301 Phase 1b study in mild-to-moderate ulcerative colitis –
– Strengthened balance sheet with
– Conference call at
“Supported by our positive, highly significant SER-109 Phase 3 results, we expect SER-109 to be the first-ever microbiome therapy approved by the
“In tandem, we continue to advance our deep microbiome pipeline, including SER-287, SER-301, SER-401, and SER-155. These therapeutic candidates span infectious diseases, inflammatory disease, and cancer, and we believe all have the potential to fundamentally improve upon the current standard of care. Most recently, we were pleased to dose the first subject in our SER-301 Phase 1b study in patients with ulcerative colitis. Moving forward, we expect to reach a number of value-creating milestones across multiple therapeutic areas,” concluded
Program and Corporate Updates
SER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection: SER-109 is an investigational, oral, biologically-derived microbiome therapeutic that is designed to reduce recurrence of C. difficile infection (CDI), enabling patients to achieve a sustained clinical response by breaking the vicious cycle of CDI recurrence and restoring the diversity of the gastrointestinal microbiome.
In August, Seres announced topline results from ECOSPOR III, demonstrating that SER-109 met the study’s primary endpoint, showing a 30.2% absolute reduction of recurrence of CDI compared to placebo at eight weeks post-treatment. The SER-109 treatment arm relative risk was 0.27 (95% CI=0.15 to 0.51) versus placebo. The study results were equally compelling when characterized by the alternative metric of sustained clinical response, where 88.9% of patients in the SER-109 arm achieved this objective. Based on feedback from the FDA and the strength of the SER-109 Phase 3 data, Seres believes that ECOSPOR III will be a single pivotal efficacy study supporting product registration.
In October, Seres presented the Phase 3 study result and additional data from ECOSPOR III at the virtual
The SER-109 manufacturing process inactivates vegetative bacteria and other potential pathogens, which have been linked with fecal microbiota transplant (FMT)-associated disease transmission. Seres believes that this unique manufacturing process provides a critically important safety advantage.
Following the topline Phase 3 study results, the FDA reaffirmed its prior guidance regarding the efficacy requirements to support a SER-109 BLA submission, which were exceeded by the positive SER-109 ECOSPOR III study results, and reaffirmed its prior guidance that the safety database prelicensure should be at least 300 subjects.
Seres is conducting an ongoing SER-109 open-label study in patients with recurrent CDI (ClinicalTrials.gov identifier: NCT03183128), which also admits patients with a single recurrence of CDI, to expand the SER-109 safety database. The Company continues to make progress activating new clinical sites and enrolling subjects into the study. Additional information is available at serescdiffstudy.com.
SER-287 Phase 2b ECO-RESET study in ulcerative colitis: SER-287 is an oral, biologically-derived microbiome therapeutic candidate designed to have pharmacological effects on multiple pathways relevant to ulcerative colitis that can be modulated by the gastrointestinal microbiome. Seres has obtained FDA Fast Track designation for SER-287 in active mild-to-moderate UC.
The SER-287 Phase 2b ECO-RESET induction study in patients with active mild-to-moderate UC is ongoing. Seres has implemented a number of COVID-19-related mitigation strategies and the study continues to enroll patients. The study is over 75% enrolled.
SER-301 Phase 1b study first patient dosed: In November, the Company announced that the first patient has been dosed in its Phase 1b study for SER-301, an oral, rationally-designed, fermented microbiome therapeutic. SER-301 is being evaluated in a Phase 1b study in adults with mild-to-moderate ulcerative colitis. The study is being conducted in
A first open-label cohort of 15 subjects will evaluate safety and pharmacokinetics (PK), as measured by bacterial engraftment. In the subsequent second cohort, 50 subjects will be randomized to receive either SER-301 or placebo. The objectives for this cohort are to evaluate drug safety and PK, and to evaluate clinical remission and other measures of efficacy as secondary endpoints.
The consortium of bacteria in SER-301 is designed to modify the microbiome and microbe-associated metabolites in the gastrointestinal tract and modulate pathways linked to gastrointestinal inflammation and epithelial barrier integrity in patients with ulcerative colitis. The design of SER-301 has incorporated learnings from the SER-287 Phase 1b study related to the microbiome signatures associated with clinical efficacy.
Seres is entitled to receive a
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 in patients with metastatic melanoma is supported by the
SER-155 Phase 1b clinical study activities: Seres continues to advance SER-155, an oral, rationally-designed, fermented microbiome therapeutic, toward a Phase 1b clinical study. SER-155 is designed to prevent mortality due to gastrointestinal infections, bacteremia, and graft versus host disease (GvHD) in immunocompromised patients, including patients receiving allogeneic hematopoietic stem cell transplantation. SER-155 is a consortium of bacterial species designed using microbiome biomarker data from human clinical data, human cell-based assays, and in vivo disease models. The composition aims to decrease infection and translocation of antibiotic-resistant bacteria in the gastrointestinal tract and modulate host immune responses to decrease GvHD.
The SER-155 program is supported by a CARB-X grant that provides financial and operational support through Phase 1b clinical development. The Company intends to advance SER-155 into a Phase 1b study early next year in collaboration with
Strengthened leadership team: In October, Seres announced the appointments of
Financial Results
Seres reported a net loss of
Research and development expenses for the third quarter of 2020 were
General and administrative expenses for the third quarter of 2020 were
Seres ended the third quarter with approximately
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 SER-109
SER-109 is an investigational, oral, biologically-sourced microbiome therapeutic that is designed to reduce recurrence of C. difficile infection (CDI), enabling patients to achieve a sustained clinical response by breaking the vicious cycle of CDI recurrence and restoring the diversity of the gastrointestinal microbiome. SER-109 is a consortium of purified Firmicute bacteria in spore form, manufactured by fractionating targeted bacteria from the stool of healthy human donors with further steps to inactivate potential pathogens. The FDA has granted SER-109 Breakthrough Therapy designation and Orphan Drug designation for the treatment of recurrent CDI.
SER-109 is fundamentally distinct from fecal microbiota transplantation (FMT) and FMT-like products. SER-109 is comprised of a highly purified consortium of commensal bacteria in spore form, manufactured in accordance with Current Good Manufacturing Practice (cGMP) conditions using stringent standards to ensure product quality and consistency. To support product safety, Seres utilizes a unique manufacturing process designed to inactivate numerous potential pathogens, including species of non-spore bacteria, such as Escherichia coli, and viruses such as SARS-CoV-2.
About C. difficile Infection (CDI) and Current Treatments
C. difficile infection (CDI) is one of the top three most urgent antibiotic-resistant bacterial threats in the
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 potential for the Company to file a BLA and/or commercialize SER-109, the promise and potential impact of our microbiome therapeutics platform, the results from ECOSPOR III providing an efficacy basis for a BLA submission, any requirements for additional safety data, the receipt of milestone payments, the timing and results of studies related to the Company’s therapeutic candidates, ability of SER-109 to transform the treatment of CDI, inferences related to the currently-observed efficacy and safety profile of SER-109, 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 to manufacture, develop, and commercialize our product candidates, if approved; the ability to develop and commercialize our product candidates, if approved; the potential impact of the COVID-19 pandemic; our ability to retain key personnel and to manage our growth; and that 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
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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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|
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||
|
|
2020 |
|
|
2019 |
|
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Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
207,326 |
|
|
$ |
65,126 |
|
Short term investments |
|
|
90,588 |
|
|
|
29,690 |
|
Prepaid expenses and other current assets |
|
|
6,703 |
|
|
|
3,588 |
|
Accounts receivable |
|
|
3,393 |
|
|
|
1,785 |
|
Total current assets |
|
|
308,010 |
|
|
|
100,189 |
|
Property and equipment, net |
|
|
14,729 |
|
|
|
19,495 |
|
Operating lease assets |
|
|
9,664 |
|
|
|
11,356 |
|
Restricted investments |
|
|
1,400 |
|
|
|
1,400 |
|
Long term investments |
|
|
22,398 |
|
|
|
— |
|
Total assets |
|
$ |
356,201 |
|
|
$ |
132,440 |
|
Liabilities and Stockholders’ Equity (Deficit) |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
6,201 |
|
|
$ |
4,859 |
|
Accrued expenses and other current liabilities |
|
|
11,318 |
|
|
|
10,884 |
|
Operating lease liabilities |
|
|
4,950 |
|
|
|
4,456 |
|
Deferred revenue - related party |
|
|
16,517 |
|
|
|
20,960 |
|
Deferred revenue |
|
|
6,784 |
|
|
|
4,834 |
|
Total current liabilities |
|
|
45,770 |
|
|
|
45,993 |
|
Note payable, net of discount |
|
|
24,977 |
|
|
|
24,648 |
|
Operating lease liabilities, net of current portion |
|
|
11,894 |
|
|
|
15,676 |
|
Deferred revenue, net of current portion - related party |
|
|
82,826 |
|
|
|
89,111 |
|
Deferred revenue, net of current portion |
|
|
1,695 |
|
|
|
4,834 |
|
Other long-term liabilities |
|
|
987 |
|
|
|
502 |
|
Total liabilities |
|
|
168,149 |
|
|
|
180,764 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders’ deficit: |
|
|
|
|
|
|
|
|
Preferred stock, |
|
|
— |
|
|
|
— |
|
Common stock, |
|
|
91 |
|
|
|
70 |
|
Additional paid-in capital |
|
|
718,483 |
|
|
|
411,255 |
|
Accumulated other comprehensive income |
|
|
2 |
|
|
|
— |
|
Accumulated deficit |
|
|
(530,524 |
) |
|
|
(459,649 |
) |
Total stockholders’ equity (deficit) |
|
|
188,052 |
|
|
|
(48,324 |
) |
Total liabilities and stockholders’ equity (deficit) |
|
$ |
356,201 |
|
|
$ |
132,440 |
|
|
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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
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Nine Months Ended
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2020 |
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2019 |
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|
2020 |
|
|
2019 |
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Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue - related party |
$ |
80 |
|
|
$ |
4,840 |
|
|
$ |
10,728 |
|
|
$ |
21,909 |
|
Grant revenue |
|
1,337 |
|
|
|
85 |
|
|
|
2,907 |
|
|
|
791 |
|
Collaboration revenue |
|
— |
|
|
|
2,106 |
|
|
|
2,016 |
|
|
|
4,183 |
|
Total revenue |
|
1,417 |
|
|
|
7,031 |
|
|
|
15,651 |
|
|
|
26,883 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
23,861 |
|
|
|
18,317 |
|
|
|
65,703 |
|
|
|
59,109 |
|
General and administrative expenses |
|
7,551 |
|
|
|
5,897 |
|
|
|
20,180 |
|
|
|
18,966 |
|
Restructuring expenses |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,492 |
|
Total operating expenses |
|
31,412 |
|
|
|
24,214 |
|
|
|
85,883 |
|
|
|
79,567 |
|
Loss from operations |
|
(29,995 |
) |
|
|
(17,183 |
) |
|
|
(70,232 |
) |
|
|
(52,684 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
100 |
|
|
|
335 |
|
|
|
333 |
|
|
|
744 |
|
Interest expense |
|
(730 |
) |
|
|
— |
|
|
|
(2,165 |
) |
|
|
— |
|
Other income |
|
345 |
|
|
|
439 |
|
|
|
1,189 |
|
|
|
439 |
|
Total other (expense) income, net |
|
(285 |
) |
|
|
774 |
|
|
|
(643 |
) |
|
|
1,183 |
|
Net loss |
$ |
(30,280 |
) |
|
$ |
(16,409 |
) |
|
$ |
(70,875 |
) |
|
$ |
(51,501 |
) |
Net loss per share attributable to common stockholders, basic and diluted |
$ |
(0.36 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.93 |
) |
|
$ |
(0.99 |
) |
Weighted average common shares outstanding, basic and diluted |
|
83,531,617 |
|
|
|
69,944,068 |
|
|
|
75,914,361 |
|
|
|
52,143,492 |
|
Net loss |
|
(30,280 |
) |
|
|
(16,409 |
) |
|
|
(70,875 |
) |
|
|
(51,501 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on investments, net of tax of |
|
1 |
|
|
|
7 |
|
|
|
2 |
|
|
|
7 |
|
Total other comprehensive gain |
|
1 |
|
|
|
7 |
|
|
|
2 |
|
|
|
7 |
|
Comprehensive loss |
$ |
(30,279 |
) |
|
$ |
(16,402 |
) |
|
$ |
(70,873 |
) |
|
$ |
(51,494 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20201109005391/en/
PR Contact
lisa@tenbridgecommunications.com
IR Contact
ctanzi@serestherapeutics.com
Source: