UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code:
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12 |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
| Item 8.01. | Other Events. |
On January 19, 2022, Spero Therapeutics, Inc. (the “Company”) announced that the Biomedical Advanced Research and Development Authority (BARDA), added, and exercised, a new option on the contract originally awarded to the Company in 2018. The new option increases the total amount of committed funding by $12.9 million to $46.9 million, increasing the total potential contract value to $59.7 million. As previously announced, the Defense Threat Reduction Agency (DTRA) is providing up to approximately $10.0 million, in addition to the total potential award from BARDA, to cover the cost of the nonclinical biodefense aspects of the collaboration program for tebipenem HBr. The additional $12.9 million option is expected to provide support for a clinical trial and related activities for orally administered tebipenem pivoxil’s use in treating pediatric patients with complicated urinary tract infections, including acute pyelonephritis.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| 99.1 | Press Release, dated January 19, 2022. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| SPERO THERAPEUTICS, INC. | ||||||
| Date: January 19, 2022 | By: | /s/ Tamara Joseph | ||||
| Tamara Joseph | ||||||
| Chief Legal Officer | ||||||
Exhibit 99.1
Spero Therapeutics Awarded up to an Additional $12.9 Million by BARDA to Support the Development of Orally Administered Tebipenem Pivoxil in Pediatric Patients
New award option exercised by BARDA brings the total potential funding from its existing contract with Spero up to $59.7 million
CAMBRIDGE, Mass., January 19, 2022 — Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced that the Company and the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, are expanding their existing partnership to develop tebipenem as a treatment for complicated urinary tract infections (cUTI), including pyelonephritis, in pediatric patients.
BARDA added, and exercised, a new option on the contract originally awarded to Spero in 2018. The new option increases the total amount of committed funding by $12.9M to $46.9M, increasing the total potential contract value to $59.7M. As previously announced, the Defense Threat Reduction Agency (DTRA) is providing up to approximately $10.0M, in addition to the total potential award from BARDA, to cover the cost of the nonclinical biodefense aspects of the collaboration program for tebipenem HBr. The additional $12.9M option is expected to provide support for a clinical trial and related activities for orally administered tebipenem pivoxil’s use in treating pediatric patients with cUTI, including AP.
“We are pleased to expand our relationship with BARDA and look forward to continuing our productive collaboration,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “This new option award not only provides further external validation for tebipenem HBr and its robust clinical dataset, but also allows us to pursue development of tebipenem for use in pediatric patients with cUTI. We would like to thank BARDA for their continued collaboration, as we work to address oral alternatives to treat multi-drug resistant bacterial infections, providing therapeutic options to those adults and children with unmet need.”
Spero currently has a New Drug Application (NDA) seeking approval for tebipenem HBr oral tablets for treatment in adult patients with cUTI, including pyelonephritis, caused by susceptible microorganisms, under review by the United States Food and Drug Administration (FDA).
Tebipenem HBr Research Support
This project has been funded in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number HHSO100201800015C.
About Spero Therapeutics
Spero Therapeutics, Inc. is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multi-drug-resistant (MDR) bacterial infections and rare diseases.
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. On January 3, 2022, Spero announced that FDA has accepted its NDA for tebipenem HBr tablets.
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, potential approval of tebipenem HBr by the FDA; potential funding by the DTRA; potential payments under Spero’s agreement with BARDA; future clinical trials for pediatric use of tebipenem HBr; future use of tebipenem HBr for pediatric patients; 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; the sufficiency of Spero’s cash resources and Spero’s anticipated expenses; 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 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:
Ted Jenkins
Vice President, Investor Relations and Specialty Finance
Tjenkins@sperotherapeutics.com
(617) 798-4039
Media Contact:
Jacqueline Pomfret Kirby
Vice President, Corporate Affairs
Jkirby@sperotherapeutics.com
(617) 798-4074
Document and Entity Information |
Jan. 19, 2022 |
|---|---|
| Cover [Abstract] | |
| Amendment Flag | false |
| Entity Central Index Key | 0001701108 |
| Document Type | 8-K |
| Document Period End Date | Jan. 19, 2022 |
| Entity Registrant Name | SPERO THERAPEUTICS, INC. |
| Entity Incorporation State Country Code | DE |
| Entity File Number | 001-38266 |
| Entity Tax Identification Number | 46-4590683 |
| Entity Address, Address Line One | 675 Massachusetts Avenue |
| Entity Address, Address Line Two | 14th Floor |
| Entity Address, City or Town | Cambridge |
| Entity Address, State or Province | MA |
| Entity Address, Postal Zip Code | 02139 |
| City Area Code | (857) |
| Local Phone Number | 242-1600 |
| Written Communications | false |
| Soliciting Material | false |
| Pre Commencement Tender Offer | false |
| Pre Commencement Issuer Tender Offer | false |
| Security 12b Title | Common Stock, $0.001 par value per share |
| Trading Symbol | SPRO |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | true |
| Entity Ex Transition Period | true |