Pipeline rapidly advancing with three clinical trials planned to initiate by early 2019, including a SPR994 Phase 3 initiation around year-end 2018
“We continue to make significant progress across all of our product candidates,” said
Recent Clinical Highlights and Upcoming Milestones
The Company’s lead 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. In
Potentiator Platform (SPR206 and SPR741):
Spero’s Potentiator Platform is an innovative approach to treating MDR Gram-negative bacterial infections and includes two IV-administered compounds, SPR741 and SPR206. SPR741 is designed to expand the spectrum and increase the potency of a partner antibiotic when administered in combination. SPR741 completed a positive Phase 1b drug-drug interaction clinical trial in
SPR720 is an oral antibiotic designed for the treatment of an orphan disease, pulmonary non-tuberculous mycobacterial (NTM) infection. In early
Third Quarter 2018 Financial Results
The Company reported a net loss of
Revenue from government awards totaled
The Company continues to expect that its research and development expenses will increase through the remainder of 2018 in connection with increased planned clinical and preclinical activities related to our product candidates as it prepares to initiate three clinical trials by early 2019, including the initiation of the Phase 3 SPR994 clinical trial around year-end 2018. The Company expects general and administrative expenses to increase through the remainder of 2018 due to additional headcount and consultant fees as it advances its clinical pipeline and incurs additional costs associated with operating as a public company.
Spero’s lead product candidate, SPR994, is designed to be the first oral carbapenem-class antibiotic for use in adults to treat MDR Gram-negative infections.
Spero also has a platform technology known as its Potentiator Platform that 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. Spero’s lead product candidates generated from its Potentiator Platform are two intravenous (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) infections.
For more information, visit https://sperotherapeutics.com.
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 Spero’s preclinical studies and clinical trials and its research and development programs, including statements regarding management’s assessment of the results of such preclinical studies and clinical trials, the timing of clinical data, Spero’s cash forecast and anticipated expenses, 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 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; 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’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 we periodically make with the U.S. Securities 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:
Director, Investor Relations
Spero Therapeutics, Inc.
Condensed Consolidated Balance Sheet Data
|September 30,||December 31,|
|Cash, cash equivalents and marketable securities||$||131,225||$||87,288|
|Total stockholder's equity||125,552||84,957|
|Total liabilities and stockholders' equity||$||136,120||$||93,479|
Spero Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
|Three Months Ended
|Nine Months Ended
|Research and development||8,459||6,910||24,758||20,366|
|General and administrative||3,134||3,653||9,238||8,350|
|Total operating expenses||11,593||10,563||33,996||28,716|
|Loss from operations||(10,935||)||(9,966||)||(31,722||)||(27,730||)|
|Other income (expense)||472||(2,110||)||659||(3,597||)|
|Net loss attributable to common stockholders of Spero Therapeutics, Inc.||$||(10,463||)||$||(12,076||)||$||(31,063||)||$||(31,327||)|
|Net loss per share attributable to common stockholders per share, basic and diluted||$||(0.60||)||$||(36.02||)||$||(2.01||)||$||(93.96||)|
|Weighted average shares outstanding, basic and diluted:||17,471,462||335,285||15,417,087||333,402|
Source: Spero Therapeutics, Inc.