CAMBRIDGE, Mass., March 13, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
“2023 was a productive year for Spero and we have been focused on execution across our programs,” said Sath Shukla, President, and Chief Executive Officer of Spero. “We are well poised to unveil top-line data for SPR720 Phase 2a, which is expected in 2H 2024, and our excitement is fueled by the hope it may bring for the rare disease community grappling with nontuberculous mycobacterial pulmonary disease (NTM-PD). On tebipenem HBr, engaging with the FDA and in collaboration with our partner, GSK, we are actively enrolling patients globally in our Phase 3 PIVOT-PO clinical trial. Positioned as the first oral broad-spectrum carbapenem in the United States for cUTI, we believe this product has the potential to change the treatment paradigm for these patients and underscores Spero’s commitment to innovation. We reiterate our expected cash runway into late 2025 based on our year-end cash balance, along with tebipenem HBr development milestone payments from GSK and our disciplined capital allocation.”
Pipeline Update
SPR720
SPR720 is an investigational novel, oral, first-line treatment for NTM-PD.
Tebipenem HBr
Tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary tract infection (cUTI) including acute pyelonephritis (AP) to help patients avoid hospitalizations or reduce duration of in-patient therapy.
SPR206
SPR206 is an innovative, investigational IV-administered direct-acting next generation polymyxin that has shown antibiotic activity against MDR Gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae, Acinetobacter baumannii and Pseudomonas aeruginosa in preclinical studies.
Corporate Highlights
Fourth Quarter and Full Year 2023 Financial Results
For further details on Spero’s financials, refer to Spero’s Annual Report on Form 10-K, filed with the U.S. Securities and Exchange Commission (SEC) today.
Conference Call and Live Webcast Today at 4:30 pm EST
Spero will host a conference call and webcast today at 4:30 p.m. ET. To access the call, please dial 1-877-704-4453 (domestic) or 1-201-389-0920 (international) and refer to conference ID 13744458 or click on this Link and request a return call. The conference call will also be webcast live and can be accessed through this website link, and on Spero's website at www.sperotherapeutics.com on the "Events and Presentations" page under the "Connect" tab. An archived webcast will be available on Spero's website for 30 days following the presentation.
Tebipenem HBr Research Support
Select tebipenem HBr studies have been funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number HHSO100201800015C.
Government Agency Research Support
The views expressed in this press release are those of the authors and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.
Department of Defense
Select SPR206 studies are supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Joint Warfighter Medical Research Program under Award No. W81XWH 19 1 0295. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.
National Institute of Allergy and Infectious Disease
Select SPR206 studies have been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N93021C00022.
About Spero Therapeutics
Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a multi-asset clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and MDR bacterial infections with high unmet need.
For more information, visit www.sperotherapeutics.com.
Forward Looking Statements
This press release may contain forward-looking statements. These statements include, but are not limited to, statements about the design, initiation, timing, progress and results of Spero's preclinical studies and clinical trials and its research and development programs, as well as the regulatory path forward for tebipenem HBr and potential FDA approval, the potential commercialization of tebipenem HBr, the potential receipt under the GSK license agreement of milestone payments and royalties on future sales of tebipenem HBr, and Spero’s cash runway. In some cases, forward-looking statements can be identified by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intent," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether tebipenem HBr, SPR720 and SPR206 will advance through the clinical trial process on a timely basis, or at all, taking into account the effects of possible regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, clinical trial design and clinical outcomes; whether the results of such trials will warrant submission for approval from the FDA or equivalent foreign regulatory agencies; whether the FDA will ultimately approve tebipenem HBr and, if so, the timing of any such approval; whether the FDA will require any additional clinical data or place labeling restrictions on the use of tebipenem HBr that would delay approval and/or reduce the commercial prospects of tebipenem HBr; whether a successful commercial launch can be achieved and market acceptance of tebipenem HBr can be established; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; Spero's reliance on third parties to manufacture, develop, and commercialize its product candidates, if approved; Spero’s need for additional funding; the ability to commercialize Spero's product candidates, if approved; Spero's ability to retain key personnel; Spero’s ongoing leadership transitions; whether Spero's cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; and other factors discussed in the "Risk Factors" set forth in filings that Spero periodically makes with the SEC. The forward-looking statements included in this press release represent Spero's views as of the date of this press release. Spero anticipates that subsequent events and developments will cause its views to change. However, while Spero may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spero's views as of any date subsequent to the date of this press release.
Investor Relations Contact:
Ashley R. Robinson
Managing Director, LifeSci Advisors, LLC
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(617) 775-5956
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Spero Therapeutics, Inc. | ||||||||||
Condensed Consolidated Balance Sheet Data | ||||||||||
(in thousands) | ||||||||||
(Unaudited) | ||||||||||
December 31, | December 31, | |||||||||
2023 | 2022 | Change | ||||||||
Cash, cash equivalents and marketable securities | $ | 76,333 | $ | 109,107 | $ | (32,774 | ) | |||
Other assets | 106,057 | 15,695 | 90,362 | |||||||
Total assets | $ | 182,390 | $ | 124,802 | $ | 57,588 | ||||
Total liabilities | $ | 75,496 | $ | 48,868 | $ | 26,628 | ||||
Total stockholder's equity | 106,894 | 75,934 | 30,960 | |||||||
Total liabilities and stockholders' equity | $ | 182,390 | $ | 124,802 | $ | 57,588 | ||||
Spero Therapeutics, Inc. | ||||||||||||||||
Condensed Consolidated Statements of Operations | ||||||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
(unaudited) | ||||||||||||||||
Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Revenues: | ||||||||||||||||
Grant revenue | $ | 1,698 | $ | 1,087 | $ | 7,046 | $ | 4,930 | ||||||||
Collaboration revenue - related party | 71,603 | 46,076 | 95,802 | 46,076 | ||||||||||||
Collaboration revenue | 223 | 278 | 933 | 2,503 | ||||||||||||
Total revenues | 73,524 | 47,441 | 103,781 | 53,509 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 16,558 | 15,089 | 51,440 | 47,593 | ||||||||||||
General and administrative | 6,433 | 6,495 | 25,554 | 36,483 | ||||||||||||
Impairment of long-term asset | — | — | 5,306 | — | ||||||||||||
Restructuring | — | (67 | ) | — | 11,630 | |||||||||||
Total operating expenses | 22,991 | 21,517 | 82,300 | 95,706 | ||||||||||||
Loss from operations | 50,533 | 25,924 | 21,481 | (42,197 | ) | |||||||||||
Other income (expense) | 1,046 | 847 | 3,923 | (4,218 | ) | |||||||||||
Net income (loss) before income taxes | 51,579 | 26,771 | 25,404 | (46,415 | ) | |||||||||||
Income tax expense | (387 | ) | — | (2,598 | ) | — | ||||||||||
Net income (loss) attributable to common shareholders of Spero Therapeutics, Inc. | $ | 51,192 | $ | 26,771 | $ | 22,806 | $ | (46,415 | ) | |||||||
Net loss per share attributable to common shareholders per share, basic | $ | 0.97 | $ | 0.55 | $ | 0.43 | $ | (1.23 | ) | |||||||
Net loss per share attributable to common shareholders per share, diluted | $ | 0.96 | $ | 0.55 | $ | 0.43 | $ | (1.23 | ) | |||||||
Weighted average shares outstanding, basic: | 52,999,491 | 48,715,409 | 52,703,467 | 37,585,075 | ||||||||||||
Weighted average shares outstanding, diluted: | 53,108,270 | 48,942,616 | 52,989,030 | 37,585,075 | ||||||||||||
Last Trade: | US$1.60 |
Daily Change: | -0.05 -3.03 |
Daily Volume: | 99,811 |
Market Cap: | US$86.220M |
February 28, 2024 January 02, 2024 November 13, 2023 November 01, 2023 |
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