Full Press Release Details
Seres Therapeutics Reports Second Quarter Financial Results and Provides Progress Update
- Four significant microbiome program milestones expected during 2020, including readouts from two late-stage development programs
- Completed public offering of common stock, raising net proceeds of $61M and extending the operating runway into 2021
- Conference call at 8:00 a.m. ET today
CAMBRIDGE, Mass., Aug. 6, 2019 Seres Therapeutics, Inc. (Nasdaq: MCRB) today reported second quarter 2019 financial results and provided
We remain focused on the execution of our clinical programs and we look forward to a data-rich 2020 with four significant
expected milestones including: SER-287 Phase 2b readout in mild-to-moderate ulcerative colitis;
SER-109 Phase 3 readout in recurrent C. difficile infection; SER-401 Phase 1b readout in metastatic melanoma; and the advancement of our rationally-designed,
fermented SER-301 program into clinical development for ulcerative colitis, said Eric D. Shaff, President and Chief Executive Officer at Seres. We are also pleased to have strengthened Seres
balance sheet through a public equity offering, giving us the resources needed to operate the Company into 2021 and to reach multiple important value inflection points, continued Mr. Shaff.
Program Updates and Corporate Highlights
Seres reported a net loss of $10.8 million for the second quarter of 2019, as compared to a net loss of $27.8 million for the same period in 2018.
The second quarter net loss was driven primarily by clinical and development expenses, personnel expenses and ongoing development of the Company s microbiome therapeutics platform. The second quarter net loss figure was inclusive of
$12.5 million in recognized revenue associated primarily with the Company s collaborations with Nestl Health Science and AstraZeneca.
Research and development expenses for the second quarter of 2019 were $17.9 million, as compared to $24.1 million for the same period in 2018. The
research and development expense was primarily related to Seres microbiome therapeutics platform, the clinical development of SER-109 and SER-287, as well as the
Company s immuno-oncology efforts.
General and administrative expenses for the second quarter of 2019 were $5.6 million, as compared to
$8.7 million for the same period in 2018. General and administrative expenses were primarily due to headcount, professional fees and facility costs.
Seres ended the second quarter with approximately $102.2 million in cash and cash equivalents that
included the first of three $6.7 million annual installment payments due under the terms of the collaboration with AstraZeneca. In June 2019 the Company completed a public equity offering of common stock, resulting in net proceeds of $60.6M.
Cash use in the second quarter declined relative to prior periods as a result of the cost cutting corporate changes implemented earlier this year. Seres
expects the lower expense levels incurred this quarter to be a proxy for subsequent quarters leading up to the clinical readouts expected in 2020. Based on the Company s current operating plan, cash resources are expected to fund operating
expenses and capital expenditure requirements, excluding net cash flows from future business development activities or potential incoming milestone payments, into the first quarter of 2021.
Conference Call Information
Seres management will
host a conference call today, Aug. 6, 2019, at 8:00 a.m. ET. To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 7773387. To join the live webcast, please visit the Investors and Media section of the Seres website at
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 Seres Therapeutics
Seres Therapeutics, Inc. (Nasdaq: MCRB) is a leading microbiome therapeutics platform company developing a novel class of biological drugs that are designed to
treat disease by restoring the function of a dysbiotic microbiome, where the state of bacterial diversity and function is imbalanced. Seres SER-287 program has obtained Fast Track and Orphan Drug
designation from the U.S. Food and Drug Administration and is being evaluated in a Phase 2b study in patients with active mild-to-moderate ulcerative colitis.
Seres SER-109 program has obtained Breakthrough Therapy and Orphan Drug designations from the FDA and is in Phase 3 development for recurrent C. difficile infection. Seres is also developing SER-401 in a Phase 1b study in patients with metastatic melanoma. 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 timing and results of each of Seres clinical studies, the potential for any of the Company s studies to serve as a pivotal trial to enable a BLA submission, Seres plan to file an IND application for SER-301, the receipt of future milestone payments, the potential impact of any of Seres development candidates, the reduction in patient enrollment in the SER-109 Phase 3 trial leading to expedited results,
the sufficiency of the Company s cash resources to fund operating expenses and capital expenditure requirements 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 Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission, or SEC, on May 2, 2019 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)
| June 30, | December 31, | |||||||
| 2019 | 2018 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 102,230 | $ | 85,820 | ||||
| Prepaid expenses and other current assets | 5,160 | 6,845 | ||||||
| Accounts receivable | 1,604 | |||||||
| Total current assets | 108,994 | 92,665 | ||||||
| Property and equipment, net | 22,945 | 26,294 | ||||||
| Operating lease assets | 12,640 | |||||||
| Restricted investments | 1,400 | 1,400 | ||||||
| Restricted cash | 114 | 113 | ||||||
| Total assets | $ | 146,093 | $ | 120,472 | ||||
| Liabilities and Stockholders Deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,764 | $ | 6,415 | ||||
| Accrued expenses and other current liabilities | 10,589 | 15,207 | ||||||
| Operating lease liabilities | 4,449 | |||||||
| Deferred revenue - related party | 20,582 | 20,419 | ||||||
| Deferred revenue | 2,689 | |||||||
| Total current liabilities | 43,073 | 42,041 | ||||||
| Operating lease liabilities, net of current portion | 17,969 | |||||||
| Lease incentive obligation, net of current portion | 6,776 | |||||||
| Deferred rent | 2,216 | |||||||
| Deferred revenue, net of current portion - related party | 99,608 | 116,840 | ||||||
| Deferred revenue, net of current portion | 2,752 | |||||||
| Other long-term liabilities | 659 | 644 | ||||||
| Total liabilities | 164,061 | 168,517 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders deficit: | ||||||||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized at June 30, 2019 and December 31, 2018; no shares issued and outstanding at June 30, 2019 and December 31, 2018 | ||||||||
| Common stock, $0.001 par value; 200,000,000 shares authorized at June 30, 2019 and December 31, 2018; 69,913,410 and 40,936,735 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | 70 | 41 | ||||||
| Additional paid-in capital | 406,424 | 341,284 | ||||||
| Accumulated deficit | (424,462 | ) | (389,370 | ) | ||||
| Total stockholders deficit | (17,968 | ) | (48,045 | ) | ||||
| Total liabilities and stockholders deficit | $ | 146,093 | $ | 120,472 |
SERES THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited, in thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Revenue: | ||||||||||||||||
| Collaboration revenue - related party | $ | 10,454 | $ | 4,271 | $ | 17,069 | $ | 8,037 | ||||||||
| Grant revenue | 260 | 341 | 706 | 546 | ||||||||||||
| Revenue | 1,817 | 2,077 | ||||||||||||||
| Total revenue | 12,531 | 4,612 | 19,852 | 8,583 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 17,905 | 24,053 | 40,792 | 47,513 | ||||||||||||
| General and administrative expenses | 5,574 | 8,695 | 13,069 | 17,472 | ||||||||||||
| Restructuring expenses | 1,492 | |||||||||||||||
| Total operating expenses | 23,479 | 32,748 | 55,353 | 64,985 | ||||||||||||
| Loss from operations | (10,948 | ) | (28,136 | ) | (35,501 | ) | (56,402 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income (expense), net | 189 | 349 | 409 | 696 | ||||||||||||
| Total other income (expense), net | 189 | 349 | 409 | 696 | ||||||||||||
| Net loss | $ | (10,759 | ) | $ | (27,787 | ) | $ | (35,092 | ) | $ | (55,706 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.24 | ) | $ | (0.68 | ) | $ | (0.81 | ) | $ | (1.37 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 45,140,830 | 40,661,464 | 43,095,686 | 40,645,040 | ||||||||||||
| Net loss | (10,759 | ) | (27,787 | ) | (35,092 | ) | (55,706 | ) | ||||||||
| Other comprehensive income: | ||||||||||||||||
| Unrealized gain on investments, net of tax of $0 | $ | $ | 77 | $ | $ | 117 | ||||||||||
| Total other comprehensive income | 77 | 117 | ||||||||||||||
| Comprehensive loss | $ | (10,759 | ) | $ | (27,710 | ) | $ | (35,092 | ) | $ | (55,589 | ) |
Tanzi, Ph.D., Seres Therapeutics, 617-203-3467
Vice President, Investor
Relations and Corporate Communications