Full Press Release Details
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 accelerate next study in allo-HSCT
and support potential expansion into other target populations
With current cash, expected second installment payment from Nestl , and based on current
operating plans, Seres expects to fund operations into Q1 2026
Conference call at 8:30 a.m. ET today
CAMBRIDGE, Mass. March 13, 2025 Seres Therapeutics, Inc. (Nasdaq: MCRB), (Seres or the Company), a leading live biotherapeutics
company, today reported fourth quarter and full year 2024 financial results and provided business updates.
We have made significant progress
advancing SER-155 as a novel live biotherapeutic candidate designed to prevent life-threatening bloodstream infections in allo-HSCT recipients, said Eric Shaff, President and Chief Executive Officer of
Seres. Based on the strength of our Phase 1b placebo-controlled clinical results showing a relative risk reduction of 77% in bloodstream infections (BSIs), SER-155 received Breakthrough Therapy
designation from the FDA. Our productive interactions with the FDA regarding plans to advance SER-155 in allo-HSCT patients have supported and informed our development plans. We are formulating the next SER-155 study design, which could be either a standalone Phase 2 or a Phase 2/3 seamless design, and plan to submit a draft protocol to the FDA in the second quarter of this year. Based on potential additional
agency feedback and perspectives we expect to gain from further partnership discussions, we plan to decide upon the optimal path forward for further SER-155 development.
Mr. Shaff continued, Recently released exploratory translational biomarker results from our SER-155 Phase 1b study provide supportive mechanistic data, consistent with the observed clinical results that showed a reduction in the risk of BSIs. We believe the data also offer further evidence of the potential
of Seres biotherapeutic approach to benefit patients living with inflammatory and immune diseases such as ulcerative colitis and Crohn s disease. The market opportunity for SER-155 is significant,
with clinician and payer research indicating that SER-155, if approved, could result in rapid and deep utilization in allo-HSCT, as well as other sizable patient groups at high risk of BSIs. Our efforts and
investments this year are focused on preparing for the next study of SER-155 in allo-HSCT and continued pursuit of an external partnership with a counterparty who shares our vision to maximize the SER-155 clinical and commercial opportunity.
Recent Corporate Updates
Anticipated Upcoming Milestones and Events
In the December 31, 2024 financial statements, the Company has classified the VOWST business as discontinued operations in the consolidated balance sheet
for the comparative period (December 31, 2023), and all historical operating results for the VOWST business are reflected within discontinued operations in the consolidated statements of operations for all periods presented.
As of December 31, 2024, Seres had $30.8 million in cash and cash equivalents. Based on the Company s current cash (including the
$50 million installment payment received from Nestl in January 2025), an anticipated second installment payment to be received from Nestl in July 2025, transaction-related obligations and current operating plans, the Company
expects to fund operations into the first quarter of 2026.
Conference Call Information
Seres management will host a conference call today, March 13, 2025, 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 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 two hours after the event and will be archived for at least 21 days.
SER-155 is an investigational, oral, live biotherapeutic designed to decolonize gastrointestinal (GI) pathogens, improve epithelial barrier integrity, and induce immune tolerance to prevent bacterial bloodstream and
antimicrobial resistant (AMR) infections, as well as other pathogen associated negative clinical outcomes, in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
SER-155 has been evaluated in a Phase 1b placebo-controlled study in patients undergoing allo-HSCT, which demonstrated
a significant reduction in both bacterial bloodstream infections (BSIs) and systemic antibiotic exposure, as well as lower incidence of febrile neutropenia. SER-155 has received Breakthrough Therapy
designation for the reduction of bloodstream infections in adults undergoing allo-HCST and Fast Track designation for reducing the risk of infection and graft-versus-host disease in patients undergoing allo-HCST. The early development of the program
was supported by Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global non-profit partnership accelerating antibacterial products to
address drug-resistant bacteria.
About Seres Therapeutics
Seres Therapeutics, Inc. (Nasdaq: MCRB) is a clinical-stage company focused on improving patient outcomes in medically vulnerable populations through
novel live biotherapeutics. Seres led the successful development and approval of VOWST , the first FDA-approved orally administered microbiome
therapeutic, which was sold to Nestl Health Science in September 2024. The Company is developing SER-155, which has received Breakthrough Therapy designation for the reduction of bloodstream
infections in adults undergoing allo-HSCT and Fast Track designation for reducing the risk of infection and graft-versus-host disease in adults undergoing allo-HSCT, and which has demonstrated a significant reduction in bloodstream infections and
related complications (as compared to placebo) in a
Phase 1b clinical study in patients undergoing allo-HSCT. SER-155 and the Company s other pipeline programs are designed to target multiple
disease-relevant pathways and are manufactured from standard clonal cell banks via cultivation, rather than from the donor-sourced production process used for VOWST. In addition to allo-HSCT, the Company intends to evaluate SER-155 and other cultivated live biotherapeutic candidates in other medically vulnerable patient populations including autologous-HSCT patients, cancer patients with neutropenia,
CAR-T recipients, individuals with chronic liver disease, solid organ transplant recipients, as well as patients in the intensive care unit and long-term acute care facilities. For more information,
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 timing and results of our clinical studies and data readouts; future product candidates, clinical
development plans and commercial opportunities; communications with, feedback from, or submissions to the FDA; future payments related to the VOWST sale; operating plans and our future cash runway; our ability to secure a partnership and/or generate
additional capital; our planned strategic focus; anticipated timing of any of the foregoing; and other statements that are not historical fact.
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: (1) our need for additional
funding; (2) our ability to continue as a going concern; (3) we have incurred significant losses, are not currently profitable and may never become profitable; (4) our history of operating losses; (5) the expected payments from
the VOSWT sale are subject to risks and uncertainties; (6) we may not be able to realize the anticipated benefits of the VOWST sale, and may face new challenges as a smaller, less diversified company; (7) we have received a notice of the
failure to satisfy a continued listing rule from The Nasdaq Stock Market LLC; (8) our novel approach to therapeutic intervention; (9) our reliance on third parties to conduct our clinical trials and manufacture our product candidates;
(10) our ability to achieve market acceptance necessary for commercial success; (11) the competition we will face; (12) our ability to protect our intellectual property; and (13) 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 13,
2025, 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.
CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands, except share and per share data)
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 30,793 | $ | 127,965 | ||||
| Accounts receivable due from SPN - related party | 2,068 | |||||||
| Prepaid expenses and other current assets (1) | 5,813 | 8,049 | ||||||
| Current assets of discontinued operations | 39,396 | |||||||
| Total current assets | 38,674 | 175,410 | ||||||
| Property and equipment, net | 11,534 | 17,614 | ||||||
| Operating lease assets | 80,903 | 90,417 | ||||||
| Restricted cash | 8,668 | 8,185 | ||||||
| Restricted investments | 1,401 | |||||||
| Other non-current assets | 31 | 2,187 | ||||||
| Non-current assets of discontinued operations (2) | 63,386 | |||||||
| Total assets | $ | 139,810 | $ | 358,600 | ||||
| Liabilities and Stockholder s Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,079 | $ | 3,641 | ||||
| Accrued expenses and other current liabilities | 10,719 | 22,509 | ||||||
| Accrued liabilities due to SPN - related party | 17,750 | |||||||
| Operating lease liabilities | 8,674 | 5,587 | ||||||
| Current liabilities of discontinued operations (3) | 66,922 | |||||||
| Total current liabilities | 41,222 | 98,659 | ||||||
| Long term portion of note payable, net of discount | 101,544 | |||||||
| Operating lease liabilities, net of current portion | 82,966 | 91,652 | ||||||
| Warrant liability | 546 | |||||||
| Other long-term liabilities | 1,838 | 1,628 | ||||||
| Non-current liabilities of discontinued operations | 109,427 | |||||||
| Total liabilities | 126,026 | 403,456 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity (deficit): | ||||||||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized at December 31, 2024 and 2023; no shares issued and outstanding at December 31, 2024 and 2023 | ||||||||
| Common stock, $0.001 par value; 360,000,000 and 240,000,000 shares authorized at December 31, 2024 and 2023, respectively; 173,008,198 and 135,041,467 shares issued and outstanding at December 31, 2024 and 2023, respectively | 173 | 135 | ||||||
| Additional paid-in capital | 991,710 | 933,244 | ||||||
| Accumulated deficit | (978,099 | ) | (978,235 | ) | ||||
| Total stockholders equity (deficit) | 13,784 | (44,856 | ) | |||||
| Total liabilities and stockholders equity | $ | 139,810 | $ | 358,600 |
SERES THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(unaudited, in thousands, except share and per share data)
| Year Ended December 31, | ||||||||||||
| 2024 | 2023 | 2022 | ||||||||||
| Operating expenses: | ||||||||||||
| Research and development expenses | $ | 64,600 | $ | 117,597 | $ | 109,651 | ||||||
| General and administrative expenses | 53,183 | 77,500 | 70,263 | |||||||||
| Manufacturing services | 3,532 | |||||||||||
| Total operating expenses | 121,315 | 195,097 | 179,914 | |||||||||
| Loss from operations | (121,315 | ) | (195,097 | ) | (179,914 | ) | ||||||
| Other (expense) income: | ||||||||||||
| Gain on sale of VOWST Business | 5,684 | |||||||||||
| Interest income | 3,967 | 7,301 | 3,058 | |||||||||
| Interest expense | (2,468 | ) | (6,020 | ) | ||||||||
| Other (expense) income, net | (14,107 | ) | 134 | (705 | ) | |||||||
| Total other (expense) income, net | (4,456 | ) | 4,967 | (3,667 | ) | |||||||
| Net loss from continuing operations | $ | (125,771 | ) | $ | (190,130 | ) | $ | (183,581 | ) | |||
| Net income (loss) from discontinued operations, net of tax | $ | 125,907 | $ | 76,406 | $ | (66,576 | ) | |||||
| Net income (loss) | $ | 136 | $ | (113,724 | ) | $ | (250,157 | ) | ||||
| Net loss from continuing operations per share attributable to common stockholders, basic and diluted | $ | (0.81 | ) | $ | (1.49 | ) | $ | (1.70 | ) | |||
| Net income (loss) from discontinued operations per share attributable to common stockholders, basic and diluted | $ | 0.81 | $ | 0.60 | $ | (0.62 | ) | |||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | 0.00 | $ | (0.89 | ) | $ | (2.31 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 155,400,760 | 128,003,294 | 108,077,043 | |||||||||
| Other comprehensive income: | ||||||||||||
| Unrealized gain on investments, net of tax of $0 | 10 | 49 | ||||||||||
| Currency translation adjustment | 2 | (1 | ) | |||||||||
| Total other comprehensive income | 12 | 48 | ||||||||||
| Comprehensive income (loss) | $ | 136 | $ | (113,712 | ) | $ | (250,109 | ) |
Investor and Media Contact:
Kendall Investor Relations