“In 2017, we made significant progress with the completion of our IPO in November and advancement of our pipeline highlighted by the initiation of the SPR994 Phase 1 trial and SPR741 Phase 1b trial,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “We expect this momentum to continue during 2018 with several important catalysts, including a Phase 3 trial initiation for SPR994 around year-end 2018 and data from our pipeline compounds, all of which address the critical need for novel anti-infective therapies to current and emerging drug-resistant infections.”
Recent Clinical Highlights and Upcoming Milestones
The Company’s most advanced product candidate, SPR994, is designed to be the first broad-spectrum oral carbapenem-class antibiotic for use in adults to treat MDR Gram-negative infections. Spero initiated a Phase 1 study in healthy subjects in
Potentiator Platform (SPR741 and SPR206):
Spero’s potentiator platform is an innovative approach to treating MDR Gram-negative bacterial infections and includes two compounds, SPR741 and SPR206. Both product candidates within the potentiator program are advancing, and Spero expects to bring forward a candidate from this program for further clinical testing in 2018.
SPR741 is an IV-administered agent designed to expand the spectrum and increase the potency of a partner antibiotic when administered in combination. In
SPR206 is designed to have antibiotic activity as a single agent against MDR and extremely drug resistant (XDR) bacterial strains and multiple susceptibility testing studies suggests that SPR206 is capable of potent activity against MDR Enterobacteriaceae, carbapenem resistant Pseudomonas aeruginosa and carbapenem resistant Acinetobacter baumanii. The Company expects to have additional data from ongoing preclinical studies in the second quarter of 2018.
SPR720 is an oral antibiotic designed for the treatment of an orphan disease, pulmonary non-tuberculous mycobacterial (NTM) infections. SPR720 has shown activity in in vitro and in vivo studies as good or better than positive controls, including in an acute model infection caused by Mycobacterium abscessus murine pneumonia. It is currently in preclinical testing and, pending results from additional toxicity studies, Spero plans to initiate a Phase 1 clinical trial in the first half of 2019.
Fourth Quarter and Full-year 2017 Financial Results
The Company reported a net loss for the fourth quarter and year ended December 31, 2017 of $14.8 million and
Grant revenue for the fourth quarter and year ended December 31, 2017 totaled
Research and development expenses for the fourth quarter 2017 were $12.5 million compared to $6.9 million for the same period of 2016 as expenses increased with pipeline advancement, including the initiations of the SPR994 Phase 1 trial and SPR741 Phase 1b trial. Research and development expenses for the year ended December 31, 2017 were $32.9 million compared to $26.3 million for the year ended December 31, 2016, with increased expenses in 2017 primarily related to costs associated with formulation development and manufacturing of clinical material offset by lower preclinical program expense. Research and development expense in 2017 included
General and administrative expenses for the fourth quarter 2017 were $2.5 million compared to $2.2 million for the same period of 2016, with the increase primarily due to greater costs associated with operating as a public company and our initial public offering. General and administrative expenses for the year ended December 31, 2017 were $10.8 million compared to $7.2 million for the year ended
Upcoming Scientific and Investor Presentations
- Corporate presentation at the H. C. Wainwright Annual
Global Life Sciences Conferenceon April 10, 2018in Monte Carlo, Monaco
- Multiple scientific presentations at the 28th European Congress of Clinical Microbiology and Infectious Diseases from
April 21-24, 2018in Madrid, Spain
- Corporate presentation at the 2018 Bank of America Merrill Lynch Healthcare Conference from
May 15-17, 2018in Las Vegas, Nevada
- Corporate presentation at the Jefferies 2018 Global Healthcare Conference from
June 5-8, 2018in New York, New York
- Multiple scientific presentations at
American Society of Microbiology (ASM) Microbe2018 from June 7-10, 2018in Atlanta, Georgia
Spero Therapeutics is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections.
Spero is advancing SPR994, which is designed to be the first broad-spectrum oral antibiotic for use in adults to treat MDR Gram-negative infections.
Spero is also advancing its Potentiator Platform, which it believes will enable it to develop drugs that will expand the spectrum and potency of existing antibiotics, including formerly inactive antibiotics, against Gram-negative bacteria. The product candidates are two IV-administered agents, SPR741 and SPR206, designed to treat MDR Gram-negative infections in the hospital setting.
Spero is also advancing SPR720, its novel oral therapy product candidate designed for the treatment of pulmonary non-tuberculous mycobacterial (NTM) infection, an orphan infectious disease.
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 initiation, timing, progress and results of the Company’s preclinical studies and clinical trials and the Company’s research and development programs, the timing of clinical data, the Company’s cash forecast and anticipated expenses and the sufficiency of the Company’s cash resources. 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 results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether the Company’s product candidates will advance through the preclinical development and clinical trial process on a timely basis, or at all; whether the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether the Company’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” section of the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 2, 2018, and risks described in other filings the Company may make with the Securities and Exchange Commission in the future. The forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments will cause its views to change. However, while the Company 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 the Company’s views as of any date subsequent to the date of this press release.
Spero Investor Contact:
Director, Investor Relations
|Condensed Consolidated Statement of Operations|
|(in thousand, except share and per share amounts)|
|Three Months Ended December 31,||Year Ended December 31,|
|Research and development||12,503||6,927||32,869||26,333|
|General and administrative||2,490||2,218||10,840||7,223|
|Total operating expenses||14,993||9,145||43,709||33,556|
|Loss from operations||(14,000||)||(8,810||)||(41,730||)||(33,221||)|
|Other income (expense)||(770||)||477||(4,367||)||3,293|
|Net loss attributable to common shareholders of Spero Therapeutics, Inc.||$||(14,770||)||$||(8,333||)||$||(46,097||)||$||(29,928||)|
|Net loss per share attributable to common shareholders per share, basic and diluted||$||(1.59||)||$||(25.68||)||$||(17.82||)||$||(95.87||)|
|Weighted average shares outstanding, basic and diluted:||9,273,783||324,521||2,586,865||312,169|
|Condensed Consolidated Balance Sheet Data|
|As of December 31,|
|Cash,cash equivalents and investments||$||87,288||$||10,315|
|Total stockholders' equity (deficit)||84,957||(49,248||)|
|Total liabilities and stockholders' equity (deficit)||$||93,479||$||(41,837||)|
Source: Spero Therapeutics, Inc.