Submitted NDA to
Entered into a non-dilutive revenue interest financing agreement with
Conference call and live webcast at
“During the quarter, we strengthened both our leadership team and financial position, while moving tebipenem HBr closer to a point where cUTI patients may soon have a solution to their existing unmet need,” said
Clinical Highlights and Upcoming Milestones
The Company expects a commercial launch for tebipenem HBr in the second half of 2022, subject to its approval by the FDA.
In December 2020, SPR720 advanced into a Phase 2a dose-ranging clinical trial in patients with nontuberculous mycobacterial pulmonary disease (NTM-PD) based on positive data from a Phase 1 clinical trial that evaluated the safety, tolerability and pharmacokinetics of oral SPR720, as well as supportive data from a series of non-clinical GLP toxicology and safety pharmacology studies.
In February 2021, Spero received data from a chronic toxicology study in adult non-human primates in which mortalities with inconclusive causality to treatment were observed. Spero then informed the FDA it had paused dosing in its Phase 2a clinical trial as a precautionary measure. In response, the Company subsequently received a formal clinical hold letter in which the FDA requested additional information from the non-human primate toxicology study, including a study report. To avoid incurring costs associated with the Phase 2a clinical trial while it was on hold and best facilitate potential future adjustments to the trial protocol, Spero decided to discontinue the Phase 2a clinical trial as it worked to understand the cause of the non-human primate mortalities. Spero completed the non-human primate toxicology study in the third quarter, has finalized the study report, and initiated engagement with the FDA in the fourth quarter.
SPR206 is an IV-administered next generation polymyxin antibiotic candidate being developed as an innovative option to treat multi-drug resistant (MDR) Gram-negative bacterial infections. Data from a prior Phase 1 clinical trial showed that SPR206 was generally well tolerated with a lack of nephrotoxicity at predicted therapeutic dose levels.
SPR206 is currently being evaluated in two ongoing Phase 1 trials. These trials include a bronchoalveolar lavage (BAL) clinical trial assessing the penetration of SPR206 into the pulmonary compartment and a renal impairment clinical trial. Data from the BAL and renal impairment clinical trials are expected in early 2022. Funding for these studies is provided by the United States Department of Defense under Award Number W81XWH-1910295.
The SPR206 program is also supported by funding from the
Medical Congress Engagement
Spero participated in three medical meetings during the quarter. In
Third Quarter 2021 Financial Results
Spero reported a net loss for the third quarter ended September 30, 2021, of $22.5 million or $0.70 per common share, compared to a net loss of $18.9 million or $0.86 per common share reported for the same period in 2020.
Total revenues for the third quarter of 2021 were $3.1 million, compared with revenues of $4.0 million in the third quarter of 2020. The revenue decrease was primarily due to a decrease in qualified expenses, incurred under the BARDA contract for tebipenem HBr, partially offset by an increase in funding under our
Research and development expenses for the third quarter of 2021 were $14.4 million, compared with $17.7 million of research and development expenses for the same period of 2020. This year-over-year decrease was due to the completion of significant activities in the Phase 3 clinical trial for tebipenem HBr and decreased spending associated with the clinical hold on the Phase 2a clinical trial for SPR720, offset partially by increased clinical study costs for SPR206 and an increase in personnel costs associated with additional research and development headcount.
General and administrative expenses for the third quarter of 2021 of $11.2 million were higher than the $5.3 million reported in the same period of 2020, primarily due to an increase in headcount in commercial, general, and administrative functions, as well as an increase in professional and consultant fees, to support potential commercialization of tebipenem HBr.
As of September 30, 2021, Spero had cash, cash equivalents, and marketable securities of $123.4 million. Based on current projections, Spero believes that its existing cash, cash equivalents and marketable securities, together with committed funding from its BARDA contract, and other non-dilutive funding commitments, will be sufficient to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2022. This forecast does not include either the
Conference Call and Webcast
Spero will host a conference call and webcast today at
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
Select SPR206 studies are supported by the
Select SPR206 studies have been funded in whole or in part with Federal funds from the
About Spero Therapeutics
Spero’s lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is being developed as the first oral carbapenem antibiotic for use in cUTI, including pyelonephritis. In October 2021, Spero filed an NDA for tebipenem HBr tablets, which included positive top-line results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in cUTI and AP.
Tebipenem HBr is an investigational drug in the United States and is currently not approved for the treatment of complicated urinary tract infection, including pyelonephritis.
Spero is also developing SPR720 as a novel oral therapy product candidate for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections.
Spero also has an IV-administered next generation polymyxin product candidate, SPR206, developed from its potentiator platform, which is being developed to treat MDR Gram-negative infections in the hospital setting.
For more information, visit https://sperotherapeutics.com.
Forward Looking Statements
This press release may contain forward-looking statements. These statements include, but are not limited to, statements about the potential approval of tebipenem HBr by the FDA; the timing of launch of tebipenem HBr; the potential number of patients who could be treated by tebipenem HBr and market demand for tebipenem HBr generally; the effectiveness of tebipenem HBr and its potential impact on healthcare resource utilizations; the anticipated shift from IV to oral administration, and the length of time for which Spero’s cash resources are expected to be sufficient. 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 any delays in acceptance and review of the NDA submission by the FDA for any reason, including the COVID-19 pandemic; the timing and content of advice given and decisions made by regulators, including the FDA; Spero’s need for additional funding; the lengthy, expensive, and uncertain process of clinical drug development; 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; the ability to develop and commercialize Spero’s product candidates, if approved; the potential impact of the COVID-19 pandemic; Spero’s ability to retain key personnel and to manage its growth; 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 U.S. Securities and Exchange Commission. 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:
Vice President, Head of Investor Relations
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended
||Nine Months Ended
|Research and development||14,436||17,706||47,301||53,798|
|General and administrative||11,152||5,309||28,680||13,942|
|Total operating expenses||25,588||23,015||75,981||67,740|
|Loss from operations||(22,524||)||(19,020||)||(60,469||)||(60,317||)|
|Other income (expense)||3||84||(47||)||622|
|Net loss attributable to common shareholders of
|Net loss per share attributable to common shareholders per share, basic and diluted||$||(0.70||)||$||(0.86||)||$||(1.99||)||$||(2.91||)|
|Weighted average shares outstanding, basic and diluted:||32,132,500||21,933,922||30,417,305||20,712,720|
|Condensed Consolidated Balance Sheet Data|
|Cash, cash equivalents and marketable securities||$||123,417||$||126,906|
|Total stockholder's equity||111,895||132,040|
|Total liabilities and stockholders' equity||$||144,691||$||153,451|
Source: Spero Therapeutics, Inc.