Seres Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates
– SER-109 Biologics License Application (BLA) under review with
– Anticipate SER-109 commercial launch soon after potential FDA approval decision –
– SER-155 Phase 1b study cohort 2 enrollment ongoing; anticipate reporting initial SER-155 safety and pharmacological data from Cohort 1 in
– Conference call at
“We are eagerly looking forward to the upcoming potential FDA approval of SER-109, an investigational first-in-class oral microbiome therapeutic for recurrent C. difficile infection (rCDI). Pending FDA approval, we anticipate a commercial launch in the weeks following a favorable decision. With nearly 156,000 cases in the
“We have also made meaningful progress advancing additional microbiome therapeutic candidates. Enrollment is ongoing in Cohort 2 of our Phase 1b study of SER-155, designed to prevent infections and/or GvHD in medically compromised individuals and we plan to report safety and pharmacological data from study Cohort 1 in May of this year,” added
Fourth Quarter and Recent Program and Corporate Updates
SER-109 Phase 3 program in recurrent C. difficile infection: SER-109, an investigational oral, live microbiome therapeutic, achieved its primary endpoint of superiority to placebo in reducing recurrence in patients with rCDI in the ECOSPOR III study. These results, initially published in the
A SER-109 Biologics License Application has been accepted for Priority Review by the FDA based on its Breakthrough Therapy designation and a PDUFA target action date has been set for
In
In
On
The Company has SER-109 drug supply ready in anticipation of product approval and continues to make progress expanding commercial-scale production of SER-109 to prepare for anticipated future market demand. An ongoing agreement with Bacthera, a global leader in biopharmaceutical product manufacturing, is designed to increase longer-term SER-109 product supply and adds to existing manufacturing capabilities.
SER-155 Phase 1b clinical study: SER-155 is an investigational oral, rationally designed, cultivated microbiome therapeutic designed to reduce the incidence of gastrointestinal (GI) infections, bloodstream infections, and GvHD in patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT). The SER-155 Phase 1b study includes two cohorts with Cohort 1 designed to assess safety and drug pharmacology including the engraftment of drug bacteria in the gastrointestinal tract.
In Cohort 1, 13 subjects received SER-155 (i.e., safety population). The study’s Data and Safety Monitoring Board (DSMB) reviewed available Cohort 1 clinical data and cleared advancement to Cohort 2. The Company expects to report preliminary SER-155 Cohort 1 safety and pharmacology data in
Study Cohort 2 incorporates a randomized, double-blinded placebo-controlled design to further evaluate safety and engraftment, as well as clinical outcomes, and will enroll approximately 60 subjects administered either SER-155 or placebo at a 1:1 ratio. The trial will assess the impact of SER-155 administration on infections and/or graft versus host disease (GvHD) in adult subjects who are undergoing allo-HSCT. The study is being conducted at leading medical institutions including
SER-155 is a consortium of bacterial species selected using Seres’ reverse translation discovery and development platform technologies. The design incorporates microbiome biomarker data from human clinical data and nonclinical human cell-based assays and in vivo disease models. The SER-155 composition aims to decrease the colonization and abundance of bacterial pathogens that can harbor antibiotic resistance and to enhance epithelial barrier integrity in the GI tract to both reduce the likelihood of pathogen translocation and decrease the incidence of bloodstream infections. Further, SER-155 is designed to modulate host immune responses to decrease GvHD.
Infection Protection research: The Company continues to conduct research to bring forward new microbiome therapeutics as a novel approach for Infection Protection for medically compromised individuals, including those with cancer neutropenia, cirrhosis, or solid organ transplant. Preclinical studies are evaluating the potential to reduce the abundance of targeted pathogens to decrease the potential for pathogen transmission, strengthen epithelial barriers to further reduce translocation and the frequency of bloodstream infections, and to modulate immune responses to tackle medical complications such as graft versus host disease GvHD. The Company plans to announce an additional Infection Protection clinical development program in 2023.
Ulcerative Colitis (UC) research: The Company previously reported clinical, microbiome and metabolomic data from the SER-287 Phase 2b study and the first cohort of its SER-301 Phase 1b study. Available data for these investigational microbiome therapeutics suggest that there may be an opportunity to utilize biomarker-based patient selection and stratification for future studies. Research activities remain ongoing to inform potential further development activities.
Financial Results
Seres reported a net loss of
Research and development expenses for the fourth quarter of 2022 were
General and administrative expenses for the fourth quarter of 2022 were
As of
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
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 potential approval and launch of SER-109; the anticipated indication for SER-109; the anticipated supply of SER-109; the potential for microbiome therapeutics to protect against infection; the timing of clinical results; our development plans; and other statements which are not historical fact.
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; the impact of the COVID-19 pandemic; 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; and our ability to retain key personnel and to manage our growth. 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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CONSOLIDATED BALANCE SHEETS |
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(In thousands, except share and per share data) |
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|
2022 |
2021 |
||||||
Assets |
|
|
||||||
Current assets: |
|
|
||||||
Cash and cash equivalents |
$ |
163,030 |
|
$ |
180,002 |
|
||
Short term investments |
|
18,311 |
|
|
110,704 |
|
||
Prepaid expenses and other current assets |
|
13,423 |
|
|
12,922 |
|
||
Total current assets |
|
194,764 |
|
|
303,628 |
|
||
Property and equipment, net |
|
22,985 |
|
|
17,938 |
|
||
Operating lease assets |
|
110,984 |
|
|
18,208 |
|
||
Restricted cash |
|
8,185 |
|
|
8,000 |
|
||
Restricted investments |
|
1,401 |
|
|
1,401 |
|
||
Long term investments |
|
— |
|
|
495 |
|
||
Other non-current assets |
|
10,465 |
|
|
5,189 |
|
||
Total assets |
$ |
348,784 |
|
$ |
354,859 |
|
||
Liabilities and Stockholder's Equity |
|
|
||||||
Current liabilities: |
|
|
||||||
Accounts payable |
$ |
17,440 |
|
$ |
13,735 |
|
||
Accrued expenses and other current liabilities (1) |
|
59,840 |
|
|
45,094 |
|
||
Operating lease liabilities |
|
3,601 |
|
|
6,610 |
|
||
Short term portion of note payable, net of discount |
|
456 |
|
|
— |
|
||
Deferred revenue - related party |
|
4,259 |
|
|
16,819 |
|
||
Total current liabilities |
|
85,596 |
|
|
82,258 |
|
||
Long term portion of note payable, net of discount |
|
50,591 |
|
|
24,643 |
|
||
Operating lease liabilities, net of current portion |
|
107,942 |
|
|
17,958 |
|
||
Deferred revenue, net of current portion - related party |
|
92,430 |
|
|
86,998 |
|
||
Other long-term liabilities (2) |
|
1,442 |
|
|
11,495 |
|
||
Total liabilities |
|
338,001 |
|
|
223,352 |
|
||
Commitments and contingencies |
|
|
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Stockholders’ equity: |
|
|
||||||
Preferred stock, |
|
— |
|
|
— |
|
||
Common stock, |
|
125 |
|
|
92 |
|
||
Additional paid-in capital |
|
875,181 |
|
|
745,829 |
|
||
Accumulated other comprehensive loss |
|
(12 |
) |
|
(60 |
) |
||
Accumulated deficit |
|
(864,511 |
) |
|
(614,354 |
) |
||
Total stockholders’ equity |
|
10,783 |
|
|
131,507 |
|
||
Total liabilities and stockholders’ equity |
$ |
348,784 |
|
$ |
354,859 |
|
[1] Includes related party amounts of
[2] Includes related party amounts of
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CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
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(In thousands, except share and per share data) |
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Year Ended |
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2022 |
2021 |
2020 |
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Revenue: |
|
|
|
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Collaboration revenue - related party |
$ |
7,128 |
|
$ |
143,857 |
|
$ |
11,897 |
|
|||
Grant revenue |
|
— |
|
|
1,070 |
|
|
4,157 |
|
|||
Collaboration revenue |
|
— |
|
|
— |
|
|
17,161 |
|
|||
Total revenue |
|
7,128 |
|
|
144,927 |
|
|
33,215 |
|
|||
Operating expenses: |
|
|
|
|||||||||
Research and development expenses |
$ |
172,920 |
|
$ |
141,891 |
|
$ |
90,570 |
|
|||
General and administrative expenses |
|
79,694 |
|
|
69,261 |
|
|
30,775 |
|
|||
Collaboration (profit) loss sharing - related party |
|
1,004 |
|
|
(1,732 |
) |
|
— |
|
|||
Total operating expenses |
|
253,618 |
|
|
209,420 |
|
|
121,345 |
|
|||
Loss from operations |
|
(246,490 |
) |
|
(64,493 |
) |
|
(88,130 |
) |
|||
Other (expense) income: |
|
|
|
|||||||||
Interest income |
|
3,058 |
|
|
2,870 |
|
|
946 |
|
|||
Interest expense |
|
(6,020 |
) |
|
(2,910 |
) |
|
(2,924 |
) |
|||
Other (expense) income |
|
(705 |
) |
|
(1,045 |
) |
|
981 |
|
|||
Total other (expense) income, net |
|
(3,667 |
) |
|
(1,085 |
) |
|
(997 |
) |
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Net loss |
$ |
(250,157 |
) |
$ |
(65,578 |
) |
$ |
(89,127 |
) |
|||
Net loss per share attributable to common stockholders, basic and diluted |
$ |
(2.31 |
) |
$ |
(0.72 |
) |
$ |
(1.12 |
) |
|||
Weighted average common shares outstanding, basic and diluted |
|
108,077,043 |
|
|
91,702,866 |
|
|
79,789,220 |
|
|||
Other comprehensive loss: |
|
|
|
|||||||||
Unrealized gain (loss) on investments, net of tax of |
|
49 |
|
|
(12 |
) |
|
(47 |
) |
|||
Currency translation adjustment |
|
(1 |
) |
|
(1 |
) |
|
— |
|
|||
Total other comprehensive income (loss) |
|
48 |
|
|
(13 |
) |
|
(47 |
) |
|||
Comprehensive loss |
$ |
(250,109 |
) |
$ |
(65,591 |
) |
$ |
(89,174 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20230307005092/en/
IR and PR Contact
ctanzi@serestherapeutics.com
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