Seres Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Updates

$MCRB
Biotechnology: Pharmaceutical Preparations
Health Care
Get the next $MCRB alert in real time by email

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

)

 

Get the next $MCRB alert in real time by email

Chat with this insight

Save time and jump to the most important pieces.

Recent Analyst Ratings for
$MCRB

DatePrice TargetRatingAnalyst
10/24/2024Neutral → Underweight
JP Morgan
6/26/2023$12.00Outperform
Oppenheimer
4/21/2023$7.00Neutral
JP Morgan
7/23/2021$42.00 → $29.00Buy
Canaccord Genuity
7/23/2021$30.00 → $16.00Buy
Chardan Capital
7/23/2021$36.00 → $18.00Outperform
Oppenheimer
7/23/2021$46.00 → $25.00Buy
HC Wainwright & Co.
7/23/2021$24.00 → $7.00Neutral → Sell
Goldman Sachs
More analyst ratings

$MCRB
Press Releases

Fastest customizable press release news feed in the world

See more
  • Seres Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates

    Recent FDA feedback received on SER-155 allogeneic hematopoietic stem cell transplant (allo-HSCT) next study provides support for the proposed primary efficacy endpoint of reduction in bloodstream infections (BSIs) at day 30 post-HSCT; Company expects to submit draft study protocol to FDA in Q2 2025 SER-155 Phase 1b placebo-controlled study exploratory translational biomarker data reinforce intended mechanisms of action, are consistent with clinical results that showed a significant reduction (77% relative risk reduction) in BSIs, and support potential for live biotherapeutics to address inflammatory and immune diseases Company advances SER-155 strategic partnership discussions to acce

    $MCRB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Seres Therapeutics to Announce Fourth Quarter and Full Year 2024 Financial Results and Provide Business Updates on March 13, 2025

    CAMBRIDGE, Mass., March 04, 2025 (GLOBE NEWSWIRE) --  Seres Therapeutics, Inc. (NASDAQ:MCRB), a leading live biotherapeutics company, today announced that management will host a conference call and live audio webcast on March 13, 2025 at 8:30 a.m. ET to discuss fourth quarter and full year 2024 financial results and provide business updates. To access the conference call, please dial 800-715-9871 (domestic) or 646-307-1963 (international) and reference the conference ID number 6331602. 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 tw

    $MCRB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Seres Therapeutics Receives Feedback From FDA on SER-155 Allogeneic Hematopoietic Stem Cell Transplant (allo-HSCT) Development Approach

    FDA has provided input on key elements of the SER-155 allo-HSCT clinical development plans including support for the proposed primary efficacy endpoint of reduction in bloodstream infections (BSIs) as of 30 days post HSCT in the next study Seres has submitted clarification questions to FDA and expects a response in the coming weeks, which will inform the proposed protocol for the next SER-155 study in allo-HSCT, which the Company anticipates submitting to FDA in Q2 CAMBRIDGE, Mass., March 03, 2025 (GLOBE NEWSWIRE) -- Seres Therapeutics, Inc. (NASDAQ:MCRB) (Seres or the Company), a leading live biotherapeutics company, today announced that it has received constructive feedback from a Typ

    $MCRB
    Biotechnology: Pharmaceutical Preparations
    Health Care

$MCRB
Analyst Ratings

Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

See more

$MCRB
Insider Trading

Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

See more

$MCRB
SEC Filings

See more

$MCRB
FDA approvals

Live FDA approvals issued by the Food and Drug Administration and FDA breaking news

See more

$MCRB
Leadership Updates

Live Leadership Updates

See more
  • Flagship Appoints Amy O'Shea as CEO-Partner and Chief Executive Officer of Invaio Sciences

    O'Shea is a Seasoned Global Executive with more than 20 Years' Experience across the Agriculture, Food and Pharmaceutical Industries CAMBRIDGE, Mass., April 8, 2024 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, and Invaio Sciences, a bioplatform company accelerating the leap to nature-positive agriculture, today announced that Amy O'Shea has joined Flagship Pioneering as CEO-Partner and Invaio as Chief Executive Officer and Board Director. O'Shea is a seasoned global executive with more than 20 years' experience across the agriculture, food, and phar

    $DNLI
    $FHTX
    $MCRB
    $MRNA
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Biotechnology: Pharmaceutical Preparations
  • Seres Therapeutics Announces the Appointment of Marella Thorell as Chief Financial Officer and the Retirement of David Arkowitz

    Seres Therapeutics, Inc. (NASDAQ:MCRB), a leading microbiome therapeutics company, announced today that Marella Thorell will join as Executive Vice President and Chief Financial Officer (CFO), as of March 25th, following David Arkowitz's retirement. Mr. Arkowitz has served as CFO since June 2021 and will be available to assist in the transition. Ms. Thorell is a seasoned enterprise leader with deep life sciences and biotechnology industry experience in both public and private companies. Prior to joining Seres, she served in executive positions with Evelo Biosciences, Centessa Pharmaceuticals, Palladio Biosciences and Realm Therapeutics. "I am excited to welcome Marella and look forward

    $MCRB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • DEAN BANKS APPOINTED CEO OF INDIGO AG AND CEO-PARTNER OF FLAGSHIP PIONEERING

    Banks was Most Recently the President and CEO of Tyson Foods and has been a Board Member of Indigo since July 2022 Company Closes Financing Round at Nearly $270 Million Indigo Also Appoints Nader Bekhouche and Noubar Afeyan to Board of Directors  CAMBRIDGE, Mass., Jan. 9, 2024 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, and Indigo Ag, an innovative leader and trusted partner in sustainable agriculture, today announced that Dean Banks will join Flagship Pioneering as CEO-Partner and CEO of Indigo Ag, effective February 1, 2024. Banks will also continue as an Indigo board member, a role he has held since July 2022. Indigo also announced the appointments of Nader Be

    $DNLI
    $FHTX
    $MCRB
    $MRNA
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Biotechnology: Pharmaceutical Preparations

$MCRB
Financials

Live finance-specific insights

See more
  • Seres Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates

    Recent FDA feedback received on SER-155 allogeneic hematopoietic stem cell transplant (allo-HSCT) next study provides support for the proposed primary efficacy endpoint of reduction in bloodstream infections (BSIs) at day 30 post-HSCT; Company expects to submit draft study protocol to FDA in Q2 2025 SER-155 Phase 1b placebo-controlled study exploratory translational biomarker data reinforce intended mechanisms of action, are consistent with clinical results that showed a significant reduction (77% relative risk reduction) in BSIs, and support potential for live biotherapeutics to address inflammatory and immune diseases Company advances SER-155 strategic partnership discussions to acce

    $MCRB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Seres Therapeutics to Announce Fourth Quarter and Full Year 2024 Financial Results and Provide Business Updates on March 13, 2025

    CAMBRIDGE, Mass., March 04, 2025 (GLOBE NEWSWIRE) --  Seres Therapeutics, Inc. (NASDAQ:MCRB), a leading live biotherapeutics company, today announced that management will host a conference call and live audio webcast on March 13, 2025 at 8:30 a.m. ET to discuss fourth quarter and full year 2024 financial results and provide business updates. To access the conference call, please dial 800-715-9871 (domestic) or 646-307-1963 (international) and reference the conference ID number 6331602. 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 tw

    $MCRB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Seres Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Updates

    SER-155 Phase 1b placebo-controlled clinical results demonstrated significant reduction in both bacterial bloodstream infections and systemic antibiotic exposure, as well as lower incidence of febrile neutropenia, as compared to placebo, through day 100 post allo-HSCT Financial position strengthened following completion of VOWST™ sale; based on existing cash, projected 2025 deal economics and current operating plans, Seres expects to fund operations into Q4 2025 Seeking SER-155 strategic partnership to accelerate next study in allo-HSCT and expand to multiple target populations Conference call at 8:30 a.m. ET today CAMBRIDGE, Mass., Nov. 13, 2024 (GLOBE NEWSWIR

    $MCRB
    Biotechnology: Pharmaceutical Preparations
    Health Care

$MCRB
Large Ownership Changes

This live feed shows all institutional transactions in real time.

See more