Full Press Release Details
Spero Therapeutics Announces Fourth Quarter and Full Year 2021 Operating
Results and Provides Business Update
Provides update on ongoing FDA review of Tebipenem HBr NDA
Phase 2 trial of SPR720 in nontuberculous mycobacterial-pulmonary disease on track for
initiation in 2H 2022 following lifting of FDA clinical hold
Topline results from Phase 1 bronchoalveolar lavage trial support further development of
SPR206 in the setting of hospital-acquired pneumonia and ventilator-associated pneumonia
Conference call and live webcast at 4:30 p.m. ET today
CAMBRIDGE, Mass., March 31, 2022 Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced financial results for the fourth quarter
and full-year ended December 31, 2021 and provided a business update.
The U.S. Food and Drug Administration (FDA) has notified Spero that, as part
of its ongoing review of Spero s New Drug Application (NDA) for tebipenem HBr, it has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The FDA stated that the notification
does not reflect a final decision on the information under review. Spero intends to work with the FDA to seek to resolve the deficiencies expeditiously.
The FDA previously assigned a Prescription Drug User Fee Act (PDUFA) goal action date of June 27, 2022, for completion of its review of the NDA, and
initially targeted the midpoint of that review period to communicate proposed labeling and, if necessary, any post-marketing requirement and/or commitment requests to Spero. The Company noted that there are three months remaining before the PDUFA
goal action date. Spero also has a late cycle review meeting scheduled with the FDA and expects to provide an update on or before its next earnings call in May 2022.
We continue to have an active dialogue with the FDA, said Ankit Mahadevia, M.D., Chief Executive Officer of Spero. We are focused on doing
everything we can to address the deficiencies and, given how early in the review period the labeling discussions were originally scheduled, we believe there would be sufficient time to progress to labeling discussions within the existing PDUFA
timeframe. However, we do not yet know the effect of this notification, if any, on our anticipated timelines or on the ultimate approval prospects of tebipenem HBr. We continue to prepare for an anticipated commercial launch of tebipenem HBr in the
second half of 2022, as we work with the FDA. If approved by the FDA, we believe tebipenem HBr may offer healthcare providers, payers and patients an important oral antibiotic alternative to IV treatment for cUTI for patients with limited oral
With respect to Spero s other clinical programs, Dr. Mahadevia continued, we also recently announced
the FDA s lifting of SPR720 s clinical hold and Phase 1 data of SPR206 that support its continued development as a treatment for life-threating lung infections. Looking forward, we expect the continued advancement of these clinical
programs to provide additional opportunities for value-creation and to serve as an important complement to our research efforts.
Program Highlights and Upcoming Milestones
For more information on the BAL and renal impairment trials and their design see
ClinicalTrials.gov identifiers NCT04868292 (BAL trial) and NCT04865393 (renal impairment trial).
Full Year 2021 Corporate and Leadership Highlights:
Fourth Quarter and Full Year 2021 Financial Results
Spero reported a net loss for the fourth quarter and year ended December 31, 2021, of $29.2 million and $89.8 million, or $0.90 and $2.91 per
common share, respectively. Net loss for the fourth quarter and full-year ended December 31, 2020, was $18.6 million and $78.8 million, or $0.68 and $3.52 per common share, respectively.
Total revenue for the fourth quarter of 2021 of $2.7 million increased from $1.9 million for the same period a year ago. Revenue mix was composed of
reimbursement for pipeline candidates under collaboration agreements with third parties, and grants from various government agencies. Total revenue for the year ended December 31, 2021, was $18.3 million compared to $9.3 million for
the year ended December 31, 2020. Revenue growth was driven by increased grant revenue received from Spero s contracts with DoD relating to SPR206 and with BARDA relating to tebipenem HBr, and collaboration revenue from the Company s
license agreements with Pfizer and Everest Medicines.
Research and development expenses for the fourth quarter of 2021 of $17.2 million were higher
than the $13.2 million for the same period of 2020 primarily due to increased direct costs related to SPR206 and an increase in research and development headcount. Research and development expenses for the year ended December 31, 2021,
were $64.5 million compared to $67.0 million for the year ended December 31, 2020, with decreased expenses due to the completion of significant activities and related costs of the Phase 3 clinical trial for tebipenem HBr, offset by
increased direct costs related to SPR206 and an increase in research and development headcount. Spero expects to continue to incur research and development expenses in 2022, similar to 2021, in support of its pipeline candidates.
General and administrative expenses for the fourth quarter of 2021 of $13.0 million were higher than the $7.5 million for the same period of 2020
primarily due to increased headcount and professional fees to support pre-commercial activities and growth of the business. General and administrative expenses for the year ended December 31, 2021, were
$41.7 million compared to
$21.4 million for the year ended December 31, 2020, with increased expenses in 2021 compared to
2020 due to increased headcount and professional fees to support pre-commercial activities and growth of the business. Spero expects that its general and administrative expenses will increase in 2022 relative
to 2021 as it continues to build its commercial capabilities and expand its infrastructure ahead of a potential tebipenem HBr commercial launch in 2022, subject to FDA approval.
As of December 31, 2021, Spero had cash, cash equivalents, and marketable securities of $146.4 million. Based on current projections, Spero believes
that its existing cash, cash equivalents and marketable securities, together with committed funding from its BARDA contract and other non-dilutive funding commitments, will be sufficient to fund its operating
expenses and capital expenditure requirements into the second half of 2023. This forecast includes the $50 million in upfront proceeds received under the revenue interest financing agreement with HealthCare Royalty Partners and the additional $50 million milestone payment payable under such financing agreement upon approval of tebipenem HBr in 2022. If the upfront proceeds from HealthCare Royalty Partners and the additional $50 million milestone payment payable under such financing agreement are excluded, Spero should have sufficient funding into the fourth quarter of 2022.
Conference Call and Webcast
Spero will host a conference
call and webcast today at 4:30 p.m. ET. To access the call, please dial 1-877-705-6003 (domestic) or 1-201-493-6725 (international) and refer to conference ID 13727002. 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.
Tebipenem HBr Research
Select tebipenem HBr studies have 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.
Government Agency Research Support
in this press release are those of the authors and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.
Department of Defense
Select SPR206 studies are
supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Joint Warfighter Medical Research Program under Award No. W81XWH 19 1 0295. Opinions, interpretations, conclusions and recommendations are those of
the author and are not necessarily endorsed by the Department of Defense.
National Institute of Allergy and Infectious Disease
Select SPR206 studies have been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious
Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N93021C00022.
About Spero Therapeutics
Spero Therapeutics, Inc. is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel
treatments for 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 caused by certain microorganisms, in adult patients who have limited oral treatment options. On January 3, 2022, Spero announced that
the FDA has accepted its NDA for tebipenem HBr tablets.
Tebipenem HBr is an investigational drug in the United States being developed for the
treatment of cUTI, including pyelonephritis. Tebipenem HBr is currently not FDA-approved.
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,
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 and
the timing thereof; Spero s anticipated commercial launch of tebipenem HBr following FDA approval and the timing thereof; the sufficiency of Spero s cash resources and Spero s anticipated expenses; potential payments under
Spero s agreement with BARDA; the ability of the Company to receive payments under the HCR financing facility; future clinical trials for pediatric use of tebipenem HBr; future use of tebipenem HBr for pediatric patients; 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;; 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 Spero s NDA for tebipenem HBr, for which Spero is currently engaged in discussions with the FDA, is sufficient for approval of tebipenem HBr; whether any additional information we provide to the FDA during
the NDA review process may cause delays or extend the PDUFA goal action date; whether the FDA will require any additional clinical data or place labeling restrictions on the use of tebipenem HBr that would add costs for us, delay approval and/or
reduce the commercial
prospects of tebipenem HBr; Spero s readiness for an anticipated launch of tebipenem HBr if approval is
obtained; if the NDA for tebipenem HBr is not approved by December 31, 2022, Spero s obligation to repay $50 million in upfront proceeds received under its revenue interest financing agreement; 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 commercialize Spero s product candidates, if
approved; 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:
Vice President, Investor Relations and Specialty Finance
Jacqueline Pomfret Kirby
Vice President, Corporate Affairs