Continued market adoption of VOWST® with
approximately 1,411 patient enrollment forms received,
approximately 1,083 new patient starts, and net sales of $10.1
million during Q1 2024, and accelerated net sales in March and
April
SER-155 Phase 1b placebo-controlled Cohort 2
clinical readout expected end of Q3 2024
Further microbiome therapeutic candidates have
potential to expand product franchise into additional medically
vulnerable patient populations
Conference call at 8:30 a.m. ET today
Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome
therapeutics company, today reported first quarter 2024 financial
results and provided business updates.
"With a broad indication and compelling clinical profile to
prevent the recurrence of Clostridioides difficile infection (CDI)
in adults following antibacterial treatment for recurrent CDI
(rCDI), VOWST enables healthcare providers to fundamentally
transform how they treat this life-threatening disease. Along with
our collaborators at Nestlé Health Science, we have continued to
make progress with the launch of VOWST. Nestlé continues to refine
its launch execution, and we have seen a resulting acceleration of
VOWST sales during March and April,” said Eric Shaff, President and
Chief Executive Officer of Seres.
“Additionally, we completed enrollment of Cohort 2 in our
ongoing SER-155 Phase 1b study and look forward to sharing a
comprehensive topline dataset during the third quarter. These
clinical results could further validate the vast potential of
microbiome therapeutics in preventing adverse outcomes linked to
gastrointestinal pathogens,” continued Mr. Shaff. “Our goal remains
to leverage Seres’ industry-leading microbiome capabilities to
advance the development of SER-155 and other product candidates in
additional indications such as chronic liver disease, cancer
neutropenia, and solid organ transplants, which could protect
millions of medically vulnerable patients from life-threatening
infections. In support of this objective, we are evaluating various
options to provide the Company with additional capital and to
advance our pipeline.”
VOWST Commercial Performance
Commercial adoption of VOWST has continued since its June 2023
launch in the U.S., with increasing breadth of utilization across
healthcare providers. Metrics are noted below as provided by Nestlé
Health Science:
- First quarter 2024 net sales were approximately $10.1 million
and reflected a gross-to-net reduction of approximately 15%.
- An acceleration of net sales occurred with March net sales of
approximately $4.6 million, the highest monthly net sales figure
since product launch, and similar results in April.
- In the first quarter of 2024, approximately 1,411 completed
prescription enrollment forms were received for VOWST and there
were approximately 1,083 new patient starts.
- From launch through March 31, 2024, approximately 4,239
completed prescription enrollment forms were received for VOWST; of
which approximately 3,096 resulted in new patient starts.
- From launch through March 31, 2024, prescription enrollment
forms were submitted by approximately 1,939 unique healthcare
providers (HCPs) (including approximately 609 added in the first
quarter); with approximately 65% from gastroenterology and the
remainder from other specialties; approximately 604 HCPs have
prescribed VOWST to more than one patient.
- VOWST demand has been observed across the recurrent CDI patient
pool, including first recurrence, the largest CDI patient
segment.
Additional Program and Corporate Highlights
- In April, the Company announced the completion of enrollment of
Cohort 2 of the SER-155 Phase 1b study. Initial Cohort 2 study
data, anticipated late in the third quarter, will include safety,
drug pharmacology, and efficacy measures through day 100 following
Allogeneic Hematopoietic Stem Cell Transplantation (Allo HSCT), a
period in which many patients experience infections. The Company
previously announced SER-155 Phase 1b Cohort 1 clinical data that
showed favorable tolerability, successful drug bacteria
engraftment, and a substantial reduction in pathogen domination in
the gastrointestinal (GI) microbiome compared to a reference cohort
of patients. SER-155 has been awarded FDA Fast Track
Designation.
- Favorable SER-155 clinical results could support its continued
development and provide broader validation of the promise of
microbiome therapeutics in preventing poor outcomes associated with
pathogens in the GI tract. Seres intends to evaluate SER-155 and
other microbiome therapeutic candidates in other medically
vulnerable patient populations, including chronic liver disease,
cancer neutropenia, and solid organ transplants.
- Production of VOWST commercial supply remains strong, and the
Company has continued to make progress in expanding manufacturing
capacity.
- In February, Seres announced Marella Thorell's appointment as
Executive Vice President and Chief Financial Officer following
David Arkowitz's retirement.
Financial Results
- Seres reported a net loss of $40.1 million for the first
quarter of 2024, as compared to a net loss of $71.2 million for the
same period in 2023.
- Net sales of VOWST for the first quarter were $10.1 million
based on 642 units of VOWST sold. Following the first commercial
sale of VOWST, Seres shares equally with Nestlé, its collaborator,
in the VOWST commercial profits and losses. Seres’ share of the
VOWST net loss for the first quarter of 2024 was $7.1 million,
which was included in the Company’s operating results within
Collaboration (profit) loss sharing—related party.
- Research and development (R&D) expenses for the first
quarter of 2024 were $21.7 million, compared with $44.0 million for
the same period in 2023. The research and development expenses were
primarily related to investment in our microbiome therapeutics
platform and R&D operations, SER-155 clinical costs and
personnel costs. The year-over-year decrease in R&D expenses is
primarily driven by VOWST commercial manufacturing costs no longer
being recognized in the Seres P&L following the product
approval in April 2023, but instead being capitalized and
recognized on the Company’s balance sheet, and lower personnel and
other costs as a result of the restructuring plan announced in
November 2023.
- General and administrative (G&A) expenses for the first
quarter of 2024 were $15.5 million, compared with $22.5 million for
the same period in 2023. General and administrative expenses were
primarily related to personnel expenses, professional fees, and
facilities. The year-over-year decrease in G&A expenses is
primarily driven by a reduction in professional fees and lower
personnel costs as a result of the restructuring plan.
Cash Runway
As of March 31, 2024, Seres had $111.2 million in cash and cash
equivalents as compared with $128.0 million at the end of 2023.
Based on Seres' current cash and various operating plans, the
Company anticipates it has sufficient resources to support
operations through obtaining the SER-155 Cohort 2 data and into the
fourth quarter of 2024.
The Company’s operating plans include drawing down the $45
million Tranche B under the Company’s existing senior secured debt
facility with Oaktree Capital Management, L.P. if the net sales and
other conditions are met, as well as alternate plans if such
conditions are not met. Operating plans may include selling shares
under the Company’s at the market (ATM) equity offering,
implementing additional cost reduction initiatives, and other
measures.
Conference Call Information
Seres’ management will host a conference call today, May 8,
2024, at 8:30 a.m. ET. The conference call may be accessed by
calling 1-800-715-9871 (international callers dial 1-646-307-1963)
and referencing the conference ID number 5686561. To join the live
webcast, please visit the “Investors and News” section of the Seres
website at www.serestherapeutics.com. 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.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR VOWST
INDICATION
VOWST (fecal microbiota spores, live-brpk) is indicated to
prevent the recurrence of Clostridioides difficile infection (CDI)
in individuals 18 years of age and older following antibacterial
treatment for recurrent CDI (rCDI).
Limitation of Use: VOWST is not indicated for treatment of
CDI.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Transmissible infectious agents: Because VOWST is
manufactured from human fecal matter, it may carry a risk of
transmitting infectious agents. Report any infection that is
suspected to have been transmitted by VOWST to Aimmune
Therapeutics, Inc. at 1-833-246-2566.
Potential presence of food allergens: VOWST may contain
food allergens. The potential to cause adverse reactions due to
food allergens is unknown.
ADVERSE REACTIONS
The most common adverse reactions (reported in ≥5% of
participants) were abdominal distension (31.1%), fatigue (22.2%),
constipation (14.4%), chills (11.1%), and diarrhea (10.0%).
To report SUSPECTED ADVERSE REACTIONS, contact Aimmune
Therapeutics at 1-833-AIM-2KNO (1-833-246-2566), or the FDA at
1-800-FDA-1088, or visit www.fda.gov/MedWatch.
DRUG INTERACTIONS
Do not administer antibacterials concurrently with VOWST.
Please see Full Prescribing Information and
Patient Information
About Seres Therapeutics
Seres Therapeutics, Inc. (Nasdaq: MCRB) is a commercial-stage
company developing novel microbiome therapeutics for serious
diseases. Seres’ lead program, VOWST™, obtained U.S. FDA approval
in April 2023 as the first orally administered microbiome
therapeutic to prevent recurrence of C. difficile infection (CDI)
in adults following antibacterial treatment for recurrent CDI and
is being commercialized in collaboration with Nestlé Health
Science. Seres is evaluating SER-155 in a Phase 1b study in
patients receiving allogeneic hematopoietic stem cell
transplantation. 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 statements about the
potential for VOWST; the timing and results of our clinical
studies; future product candidates and development plans; our
ability to generate additional capital; operating plans and the
sufficiency of cash to fund operations; 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 history of operating losses; the restrictions in our
debt agreement; the ability of our restructuring plan to deliver
cash savings; our novel approach to therapeutic intervention; our
reliance on third parties to conduct our clinical trials and
manufacture our product candidates; the competition we will face;
our ability to protect our intellectual property; 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
Annual Report on Form 10-K filed with the Securities and Exchange
Commission (SEC), on March 5, 2024, and our other reports filed
with the SEC could cause actual results to differ materially from
those indicated by the forward-looking statements made in this
press release. Any such forward-looking statements represent
management’s estimates as of the date of this press release. While
we may elect to update such forward-looking statements at some
point in the future, we disclaim any obligation to do so, even if
subsequent events cause our views to change. These forward-looking
statements should not be relied upon as representing our views as
of any date subsequent to the date of this press release.
SERES THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in
thousands, except share and per share data)
March 31,
December 31,
2024
2023
Assets
Current assets:
Cash and cash equivalents
$
111,184
$
127,965
Collaboration receivable - related
party
7,418
8,674
Inventories
41,973
29,647
Prepaid expenses and other current
assets
4,606
9,124
Total current assets
165,181
175,410
Property and equipment, net
19,115
22,457
Operating lease assets
105,669
109,793
Restricted cash
8,430
8,185
Restricted investments
1,401
1,401
Other non-current assets (1)
41,466
41,354
Total assets
$
341,262
$
358,600
Liabilities and Stockholders’
Deficit
Current liabilities:
Accounts payable
$
5,219
$
3,641
Accrued expenses and other current
liabilities (2)
76,317
80,611
Operating lease liabilities
8,833
6,677
Deferred income - related party
8,109
7,730
Total current liabilities
98,478
98,659
Long term portion of note payable, net of
discount
102,009
101,544
Operating lease liabilities, net of
current portion
103,341
105,715
Deferred revenue - related party
95,364
95,364
Warrant liabilities
130
546
Other long-term liabilities
1,678
1,628
Total liabilities
401,000
403,456
Commitments and contingencies (Note
15)
Stockholders’ deficit:
Preferred stock, $0.001 par value;
10,000,000 shares authorized at March 31, 2024 and December 31,
2023; no shares issued and outstanding at March 31, 2024 and
December 31, 2023
—
—
Common stock, $0.001 par value;
240,000,000 shares authorized at March 31, 2024 and December 31,
2023, respectively; 151,442,034 and 135,041,467 shares issued and
outstanding at March 31, 2024 and December 31, 2023,
respectively
151
135
Additional paid-in capital
958,479
933,244
Accumulated other comprehensive loss
—
—
Accumulated deficit
(1,018,368
)
(978,235
)
Total stockholders’ deficit
(59,738
)
(44,856
)
Total liabilities and stockholders’
deficit
$
341,262
$
358,600
[1] Includes $38,877 as of March 31, 2024
and December 31, 2023, of milestones related to the construction of
the Company's dedicated manufacturing suite at BacThera AG, or
Bacthera
[2] Includes related party amounts of
$36,211 and $28,053 at March 31, 2024 and December 31, 2023,
respectively
SERES THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS (unaudited, in thousands, except share
and per share data)
Three Months Ended March
31,
2024
2023
Revenue:
Collaboration revenue - related party
$
—
$
(522
)
Total revenue
—
(522
)
Operating expenses:
Research and development expenses
21,702
43,969
General and administrative expenses
15,466
22,470
Collaboration (profit) loss sharing -
related party
2,418
3,607
Total operating expenses
39,586
70,046
Loss from operations
(39,586
)
(70,568
)
Other income (expense):
Interest income
1,648
1,032
Interest expense
(4,663
)
(1,948
)
Other income
2,468
310
Total other expense, net
(547
)
(606
)
Net loss
$
(40,133
)
$
(71,174
)
Net loss per share attributable to common
stockholders, basic and diluted
$
(0.27
)
$
(0.57
)
Weighted average common shares
outstanding, basic and diluted
146,101,581
125,862,975
Other comprehensive income (loss):
Unrealized gain (loss) on investments, net
of tax of $0
—
12
Currency translation adjustment
—
2
Total other comprehensive income
(loss)
—
14
Comprehensive loss
$
(40,133
)
$
(71,160
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240508453019/en/
Investor and Media Contact: IR@serestherapeutics.com
Seres Therapeutics (NASDAQ:MCRB)
Graphique Historique de l'Action
De Avr 2024 à Mai 2024
Seres Therapeutics (NASDAQ:MCRB)
Graphique Historique de l'Action
De Mai 2023 à Mai 2024