Tebipenem HBr advancing towards NDA submission in the second half of 2021
Conference call and live webcast at 4:30 p.m. EST today
“Over the last year we have made significant progress and completed critical milestones despite the industry-wide challenges brought about by the COVID-19 pandemic,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “Chief among these milestones was our announcement in
Clinical Highlights and Upcoming Milestones
In September 2020, Spero announced positive data from the ADAPT-PO Phase 3 clinical trial demonstrating that oral tebipenem HBr was statistically non-inferior to intravenous ertapenem in the treatment of patients with cUTI and patients with AP with respect to the primary endpoint. The ADAPT-PO clinical trial was the first trial to evaluate an all-oral regimen of tebipenem HBr head-to-head versus an all intravenous (IV) regimen of ertapenem for the treatment of adults with cUTI and AP. The top-line data as well as additional analyses from the trial were subsequently presented at IDWeek in
The Phase 1 clinical trials required for a new drug application (NDA) submission to the
To best facilitate potential adjustments to the Phase 2a SPR720 clinical trial protocol that may be made in the future based on findings from the ongoing toxicology study and FDA feedback, and to avoid incurring costs associated with the clinical trial while it is on hold, Spero has decided to discontinue the Phase 2a clinical trial at this time. Spero continues to work with the FDA to evaluate the non-human primate toxicology study and determine the best development pathway for the SPR720 clinical program.
In January 2020, Spero reported positive Phase 1 clinical trial results for SPR206 in healthy volunteers. Under its agreement with Everest Medicines, Spero received a $2.0 million milestone payment from Everest in the fourth quarter of 2020 for the delivery of the Phase 1 Clinical Study Report. Through its grant from the U.S. Department of Defense awarded in July 2019, and in conjunction with Everest Medicines, Spero continues to expect to initiate a Phase 1 bronchoalveolar lavage (BAL) clinical trial assessing the penetration of SPR206 into the pulmonary compartment in the first half of 2021 and a renal impairment clinical trial of SPR206 in 2021.
Fourth Quarter and Full Year 2020 Financial Results
Spero reported a net loss for the fourth quarter and year ended December 31, 2020 of $18.6 million and $78.8 million, or $0.68 and $3.52 per common share, respectively. Net loss for the fourth quarter and year ended December 31, 2019 was $25.0 million and $60.9 million, or $1.31 and $3.35 per common share, respectively.
Total revenue for the fourth quarter 2020 of $1.9 million was lower than the
Research and development expenses for the fourth quarter 2020 of $13.2 million were lower than the
General and administrative expenses for the fourth quarter 2020 of $7.5 million were higher than the
Conference Call and Webcast
Spero will host a conference call and webcast today at 4:30 p.m. EST. To access the call, please dial (877) 705-6003 (domestic) or (201) 493-6725 (international) and refer to conference ID 13716494. The conference call will also be webcast live and a link to the webcast can be accessed here and also on Spero Therapeutics' website at www.sperotherapeutics.com in the "Investors and Media" section under "Events and Presentations." An archived webcast will be available on Spero's website for 30 days following the presentation.
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 complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). In September 2020, Spero announced positive top-line results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in cUTI and AP.
Spero is also developing SPR720 as a novel oral therapy product candidate for the treatment of rare, orphan pulmonary disease caused by non-tuberculous mycobacterial (NTM) 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.
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
This press release may contain forward-looking statements. These statements include, but are not limited to, statements about the initiation, timing and submission to the FDA of a NDA for tebipenem HBr and the potential approval of tebipenem HBr by the FDA; future commercialization, the potential number of patients who could be treated by tebipenem HBr and market demand for tebipenem HBr generally; expected broad access across payer channels for tebipenem HBr; the expected pricing of tebipenem HBr and the anticipated shift from IV to oral administration; the design, initiation, timing, progress and results of Spero’s preclinical studies and clinical trials and its research and development programs, including the commencement of Spero’s planned Phase 1 bronchoalveolar lavage (BAL) clinical trial assessing the penetration of SPR206 into the pulmonary compartment and its renal impairment study of SPR206; management’s assessment of the results of such preclinical studies and clinical trials; the direct and indirect impact of the pandemic caused by an outbreak of a new strain of coronavirus on Spero’s business and operations, including manufacturing, research and development costs, clinical trials, regulatory processes and employee expenses; and Spero’s cash forecast and anticipated expenses, anticipated payments under Spero’s agreement with Everest Medicines, potential payments under Spero’s agreement with BARDA, the sufficiency of its cash resources and the availability of additional non-dilutive funding from governmental agencies beyond any initially funded awards. 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 Spero’s ability to timely complete related Phase 1 trials for its planned NDA submission for tebipenem HBr, taking into account the possible effects of the COVID-19 pandemic; 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 will satisfy all of the pre-conditions to receipt of the development milestone payment under its agreement with Everest Medicines; whether BARDA elects to exercise its second option under Spero’s agreement with BARDA; 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.
Spero Investor and Media Contact:
Vice President, Investor Relations
|Condensed Consolidated Statements of Operations|
|(Unaudited, Amounts in Thousands, Except Share and Per Share Data)|
|Three Months Ended
|Research and development||13,205||25,728||67,003||65,775|
|General and administrative||7,498||3,785||21,440||15,588|
|Total operating expenses||20,703||29,513||88,443||81,363|
|Loss from operations||(18,796||)||(25,883||)||(79,113||)||(63,216||)|
|Other income (expense)||211||897||833||2,291|
|Net loss attributable to common shareholders of
|Net loss per share attributable to common shareholders per
share, basic and diluted
|Weighted average shares outstanding, basic and diluted:||27,369,943||19,052,827||22,386,122||18,160,525|
|Condensed Consolidated Balance Sheet Data|
|(Unaudited, Amounts in Thousands)|
|Cash, cash equivalents and marketable securities||$||126,906||$||82,045|
|Total stockholder's equity||132,040||74,574|
|Total liabilities and stockholders' equity||$||153,451||$||106,103|
Source: Spero Therapeutics, Inc.