Seres Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Updates
– Data from Phase 3 study of SER-109 in recurrent C. difficile infection expected mid-2020; Potential to be the single pivotal study supporting product registration with the FDA –
– Webcast SER-109 investor event to be held
– Conference call at
“We were pleased to have recently achieved the important milestone of completing enrollment of our SER-109 Phase 3 ECOSPOR III clinical study in recurrent C. difficile infection, and we look forward to topline results from this study mid-year. In preparation for successful SER-109 clinical data, we are working to prepare for a potential FDA regulatory submission and executing commercial readiness activities,” said
Program Updates and Corporate Highlights
Corporate impact of COVID-19: Seres is closely monitoring how the COVID-19 pandemic is affecting the Company and a number of actions have been implemented to protect employee safety and continuation of business operations. Administrative employees continue their work from home, while laboratory research and development activity remains ongoing, with modifications made to prioritize employee safety.
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 (CDI).
This first-in-field microbiome therapeutic candidate has been granted Orphan Drug and Breakthrough Therapy designations by the
On
All enrolled patients are required to undergo a rigorous C. difficile cytotoxin diagnostic test to confirm active CDI, both at entry into the study and to confirm recurrence of C. difficile infection during the study. The primary endpoint of ECOSPOR III is the reduction of CDI recurrence at up to eight weeks following SER-109 administration.
The FDA has issued several safety alerts related to fecal microbiota transplantation (FMT) and the risk of pathogen transmission including warnings related to multi-drug resistant organisms (MDROs) and SARS-CoV-2, the virus linked to COVID-19 (including:
SER-109 is fundamentally distinct from FMT and is comprised of a highly purified consortia of spore-based commensal bacteria and manufactured under Good Manufacturing Practices (GMP) conditions using stringent standards to ensure product quality and consistency. To maximize product safety, Seres utilizes a unique manufacturing process that inactivates numerous potential pathogens, including species of non-spore bacteria, such as Escherichia coli, and viruses such as SARS-CoV-2.
Seres expects to report top-line results from ECOSPOR III in mid-2020. Based on prior discussions with the FDA, Seres believes that ECOSPOR III has the potential to be the single pivotal study supporting product registration; however, this will 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.
The SER-287 Phase 2b ECO-RESET induction study in patients with active mild-to-moderate ulcerative colitis remains ongoing. COVID-19 has impacted clinical operations and slowed enrollment. Seres has implemented a number of mitigation strategies to continue operational progress, including providing increased clinical support to clinical sites and additional flexibility regarding data capture. The Company is also evaluating various options consistent with the goal of obtaining a high-quality, clinically meaningful dataset.
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. Innovative, novel manufacturing methods have been utilized to produce SER-301. The composition includes strains delivered in spore form, as well as strains fermented in non-spore, vegetative form and delivered using enterically-protected technology designed to release in the colon. 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 improve epithelial barrier integrity in patients with ulcerative colitis.
The Company has initiated clinical development and continues to execute on activities for a SER-301 Phase 1 study in patients with ulcerative colitis. The study is planned 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
SER-155 composition selected: Seres has advanced SER-155, a rationally designed, fermented microbiome therapeutic toward clinical development. SER-155 is designed to prevent mortality due to gastrointestinal infections, bacteremia and graft versus host disease (GvHD) in immunocompromised patients, including in patients receiving allogeneic hematopoietic stem cell transplantation. SER-155 is a consortium of bacterial species that incorporates biomarkers from human clinical data and preclinical assessment using human cell-based assays and in vivo disease models. The composition is designed 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 move SER-155 into a Phase 1b study later this year in collaboration with
Chief Medical Officer appointment: In April, Series announced that
Board of Directors appointment: In March, Seres announced that
Upcoming investor events: Seres plans to hold a webcast conference call on
Financial Results
Seres reported a net loss of
Research and development expenses for the first quarter of 2020 were
General and administrative expenses for the first quarter of 2020 were
Seres ended the first 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 approximately 21 days.
Seres also plans to hold a webcast conference call on
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, results and initiation of our 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 potential impact of the COVID-19 pandemic, the sufficiency of the Company’s cash resources to fund operating expenses and capital expenditure requirements, the availability of additional cash resources 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
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Assets |
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Current assets: |
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|
|
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Cash and cash equivalents |
|
$ |
54,857 |
|
|
$ |
65,126 |
|
Investments |
|
|
20,237 |
|
|
|
29,690 |
|
Prepaid expenses and other current assets |
|
|
3,385 |
|
|
|
3,588 |
|
Accounts receivable |
|
|
2,084 |
|
|
|
1,785 |
|
Total current assets |
|
|
80,563 |
|
|
|
100,189 |
|
Property and equipment, net |
|
|
17,836 |
|
|
|
19,495 |
|
Operating lease assets |
|
|
10,820 |
|
|
|
11,356 |
|
Restricted investments |
|
|
1,400 |
|
|
|
1,400 |
|
Total assets |
|
$ |
110,619 |
|
|
$ |
132,440 |
|
Liabilities and Stockholders’ Deficit |
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|
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Current liabilities: |
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|
|
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Accounts payable |
|
$ |
5,521 |
|
|
$ |
4,859 |
|
Accrued expenses and other current liabilities |
|
|
9,141 |
|
|
|
10,884 |
|
Operating lease liabilities |
|
|
4,623 |
|
|
|
4,456 |
|
Deferred revenue - related party |
|
|
19,974 |
|
|
|
20,960 |
|
Deferred revenue |
|
|
4,855 |
|
|
|
4,834 |
|
Total current liabilities |
|
|
44,114 |
|
|
|
45,993 |
|
Note payable, net of discount |
|
|
24,754 |
|
|
|
24,648 |
|
Operating lease liabilities, net of current portion |
|
|
14,444 |
|
|
|
15,676 |
|
Deferred revenue, net of current portion - related party |
|
|
84,635 |
|
|
|
89,111 |
|
Deferred revenue, net of current portion |
|
|
3,641 |
|
|
|
4,834 |
|
Other long-term liabilities |
|
|
680 |
|
|
|
502 |
|
Total liabilities |
|
|
172,268 |
|
|
|
180,764 |
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Commitments and contingencies |
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Stockholders’ deficit: |
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Preferred stock, |
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— |
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— |
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Common stock, |
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|
72 |
|
|
|
70 |
|
Additional paid-in capital |
|
|
417,819 |
|
|
|
411,255 |
|
Accumulated other comprehensive income (loss) |
|
|
(10 |
) |
|
|
— |
|
Accumulated deficit |
|
|
(479,530 |
) |
|
|
(459,649 |
) |
Total stockholders’ deficit |
|
|
(61,649 |
) |
|
|
(48,324 |
) |
Total liabilities and stockholders’ deficit |
|
$ |
110,619 |
|
|
$ |
132,440 |
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Three Months Ended
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2020 |
2019 |
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Revenue: |
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Collaboration revenue - related party |
$ |
5,462 |
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$ |
6,615 |
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Grant revenue |
|
739 |
|
|
446 |
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Collaboration revenue |
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1,988 |
|
|
260 |
|
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Total revenue |
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8,189 |
|
|
7,321 |
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Operating expenses: |
|
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||||||
Research and development expenses |
|
21,743 |
|
|
22,887 |
|
||
General and administrative expenses |
|
6,138 |
|
|
7,495 |
|
||
Restructuring expenses |
|
— |
|
|
1,492 |
|
||
Total operating expenses |
|
27,881 |
|
|
31,874 |
|
||
Loss from operations |
|
(19,692 |
) |
|
(24,553 |
) |
||
Other income (expense): |
|
|
||||||
Interest income |
|
159 |
|
|
220 |
|
||
Interest expense |
|
(716 |
) |
|
— |
|
||
Other income |
|
368 |
|
|
— |
|
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Total other income (expense), net |
|
(189 |
) |
|
220 |
|
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Net loss |
$ |
(19,881 |
) |
$ |
(24,333 |
) |
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Net loss per share attributable to common stockholders, basic and diluted |
$ |
(0.28 |
) |
$ |
(0.59 |
) |
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Weighted average common shares outstanding, basic and diluted |
|
70,821,514 |
|
|
41,027,824 |
|
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Net loss |
|
(19,881 |
) |
|
(24,333 |
) |
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Other comprehensive loss: |
|
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Unrealized loss on investments, net of tax of |
$ |
(10 |
) |
$ |
— |
|
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Total other comprehensive loss |
|
(10 |
) |
|
— |
|
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Comprehensive loss |
$ |
(19,891 |
) |
$ |
(24,333 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20200507005090/en/
PR Contact
lisa@tenbridgecommunications.com
IR Contact
ctanzi@serestherapeutics.com
Source: