“In 2019 and continuing into 2020, we have made significant clinical progress with positive clinical data reported for all of our pipeline programs, all of which are designed to address serious unmet needs and to treat multi-drug resistant infections,” said
Recent Clinical Highlights and Upcoming Milestones
Spero’s lead product candidate, tebipenem HBr, has the potential to be the first oral carbapenem antibiotic approved for use in adults to treat MDR Gram-negative infections. Spero’s pivotal Phase 3 clinical trial of tebipenem HBr for the treatment of cUTI, ADAPT-PO, is currently enrolling patients. The ADAPT-PO trial compares an all oral regimen of tebipenem HBr with an existing standard of care intravenous (IV) antibiotic, ertapenem, in approximately 1,200 patients with cUTI or acute pyelonephritis, randomized 1:1 in each arm. In
SPR720 is an orally administered antimicrobial agent being developed by Spero for the treatment of non-tuberculous mycobacterial (NTM) disease, a rare orphan disease, as well as other infections, including Mycobacterium tuberculosis. In
SPR206 is an IV-administered product candidate being developed as an innovative option to treat MDR Gram-negative bacterial infections. In January 2020, Spero reported positive preliminary Phase 1 clinical trial data for SPR206 in healthy volunteers demonstrating that SPR206 was well-tolerated at doses likely to be within a therapeutic range for MDR Gram-negative bacterial infections. The Phase 1 clinical trial was designed as a double-blind, placebo-controlled, single and multiple ascending dose, multi-cohort study in healthy volunteers. Spero expects to present final data from the Phase 1 clinical trial in the first half of 2020. In conjunction with Everest Medicines, and through its grant from the U.S. Department of Defense awarded in July 2019, Spero plans to conduct a Phase 1 bronchoalveolar lavage (BAL) clinical trial assessing the penetration of SPR206 into the pulmonary compartment in the second half of 2020 and initiate a renal impairment study of SPR206.
Fourth Quarter and Full-Year 2019 Financial Results
Spero reported a net loss for the fourth quarter and year ended
Total revenue for the fourth quarter and year ended
Research and development expenses for the fourth quarter 2019 of
General and administrative expenses for the fourth quarter 2019 of
Upcoming Scientific and Investor Presentations
- Multiple scientific presentations at the 30th
European Congress of Clinical Microbiology and Infectious Diseasesfrom April 18-21, 2020
- Corporate presentation at the H. C. Wainwright Annual
Global Life Sciences Conferencefrom April 20-21, 2020
- Corporate presentation at the 2020
Bank of America Merrill Lynch Health Care Conferencefrom May 12-14, 2020
Spero’s lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is designed to be the first oral carbapenem-class antibiotic for use in adults to treat MDR Gram-negative infections.
Spero is also advancing SPR720, its novel oral therapy product candidate designed for the treatment of rare, orphan disease caused by pulmonary non-tuberculous mycobacterial (NTM) infections.
Spero also has a platform technology known as its Potentiator Platform that includes an IV-administered product candidate, SPR206, 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 Spero’s expectation that positive results from a single pivotal Phase 3 clinical trial of tebipenem HBr and ancillary supportive studies to be conducted in parallel with the Phase 3 trial will support the approval of tebipenem HBr; the design, initiation, timing, progress and results of Spero’s preclinical studies and clinical trials and its research and development programs, including the timing of Spero’s regulatory meeting with the FDA regarding SPR720, the timing of Spero’s IND submission with the FDA regarding SPR720, the commencement of Spero’s planned Phase 2a clinical trial of SPR720 and the commencement of Spero’s planned Phase 1 bronchoalveolar lavage (BAL) clinical trial assessing the penetration of SPR206 into the pulmonary compartment; management’s assessment of the results of such preclinical studies and clinical trials; the timing of clinical data, including the availability of pharmacokinetic data from the lead-in cohort in the Phase 3 clinical trial of tebipenem HBr, final data from the Phase 1 clinical trial of SPR720 and final data from the Phase 1 clinical trial of SPR206; 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 whether the FDA will accept a single pivotal study for approval of tebipenem HBr; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether Spero’s product candidates will advance through the preclinical development and 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 U.S. Food and Drug Administration or equivalent foreign regulatory agencies; 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; whether Spero’s clinical and preclinical development programs are delayed or disrupted due to the coronavirus; 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:
Senior Director, Investor Relations
|Condensed Consolidated Balance Sheet Data|
|Cash, cash equivalents and marketable securities||$||82,045||$||115,443|
|Total stockholder's equity||74,574||115,855|
|Total liabilities and stockholders' equity||$||106,103||$||129,006|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended
||Twelve Months Ended
|Research and development||25,728||9,127||65,775||33,885|
|General and administrative||3,785||3,649||15,588||12,887|
|Total operating expenses||29,513||12,776||81,363||46,772|
|Loss from operations||(25,883)||(11,084)||(63,216)||(42,806)|
|Other income (expense)||674||485||2,291||1,144|
|Net loss attributable to common shareholders of
|Net loss per share attributable to common shareholders per share, basic and diluted||$||(1.32)||$||(0.60)||$||(3.35)||$||(2.60)|
|Weighted average shares outstanding, basic and diluted:||19,052,827||17,736,996||18,160,525||16,001,832|
Source: Spero Therapeutics, Inc.