• Spero Therapeutics Announces Fourth Quarter and Full Year 2023 Operating Results and Provides a Business Update

    ソース: Nasdaq GlobeNewswire / 13 3 2024 15:01:00   America/Chicago

    • On track for topline data from SPR720 Phase 2a proof-of-concept trial in treatment-naive and treatment-experienced non-refractory NTM-PD patients, expected in 2H 2024
    • Initiated enrollment in PIVOT-PO, a pivotal Phase 3 clinical trial of oral Tebipenem HBr in cUTI
    • Submitted IND for SPR206 and received FDA clearance to proceed with Phase 2 clinical trial
    • Reiterate expected cash runway into late 2025
    • Conference call and webcast at 4:30pm ET today

    CAMBRIDGE, Mass., March 13, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

    “2023 was a productive year for Spero and we have been focused on execution across our programs,” said Sath Shukla, President, and Chief Executive Officer of Spero. “We are well poised to unveil top-line data for SPR720 Phase 2a, which is expected in 2H 2024, and our excitement is fueled by the hope it may bring for the rare disease community grappling with nontuberculous mycobacterial pulmonary disease (NTM-PD). On tebipenem HBr, engaging with the FDA and in collaboration with our partner, GSK, we are actively enrolling patients globally in our Phase 3 PIVOT-PO clinical trial. Positioned as the first oral broad-spectrum carbapenem in the United States for cUTI, we believe this product has the potential to change the treatment paradigm for these patients and underscores Spero’s commitment to innovation. We reiterate our expected cash runway into late 2025 based on our year-end cash balance, along with tebipenem HBr development milestone payments from GSK and our disciplined capital allocation.”

    Pipeline Update

    SPR720

    SPR720 is an investigational novel, oral, first-line treatment for NTM-PD.

    Tebipenem HBr

    Tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary tract infection (cUTI) including acute pyelonephritis (AP) to help patients avoid hospitalizations or reduce duration of in-patient therapy.

    • Spero commenced enrollment in PIVOT-PO, a global, randomized, double-blind, Phase 3 clinical trial of tebipenem HBr in patients with cUTI, including AP in December 2023. The trial compares oral tebipenem HBr with intravenous imipenem cilastatin, in hospitalized adult patients with cUTI/AP. The primary endpoint is the number of patients with overall response (a combination of clinical cure and favorable microbiological response) at the Test-of-Cure (TOC) visit. The trial is expected to enroll approximately 2,648 patients, with enrollment completion anticipated in 2H 2025. For more information on PIVOT-PO, refer to ClinicalTrials.gov ID NCT06059846.

    • In July 2023, Spero received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design and size of PIVOT-PO. The FDA has indicated that positive and persuasive results from PIVOT-PO, supported with confirmatory evidence of efficacy, could be sufficient to support approval of tebipenem HBr as a treatment for cUTI, including pyelonephritis, for a limited use indication.

    • Under the terms of its license agreement with GSK, in December 2023, upon dosing the first patient, Spero earned $95 million in development milestones payable in four equal installments over two years. Spero also received a $30 million development milestone payment following the SPA. Further details on the agreement with GSK can be found here.

    SPR206

    SPR206 is an innovative, investigational IV-administered direct-acting next generation polymyxin that has shown antibiotic activity against MDR Gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae, Acinetobacter baumannii and Pseudomonas aeruginosa in preclinical studies.

    Corporate Highlights

    • Satyavrat “Sath” Shukla successfully transitioned to President and Chief Executive Officer (CEO) of the company, and a member of the Board of Directors in August 2023. Mr. Shukla had previously been Chief Financial Officer and Treasurer of the company. Mr. Shukla succeeded Spero’s prior CEO and President, Ankit Mahadevia, M.D., who became Chair of the Board of Directors in August 2023.
    • Esther Rajavelu was appointed as Chief Financial Officer, Chief Business Officer, and Treasurer in November 2023. Ms. Rajavelu brings over 20 years of experience working in the biotech and financial sectors focused on growth strategy, M&A, and financing.

    Fourth Quarter and Full Year 2023 Financial Results

    • Spero reported net income of $51.2 million for the fourth quarter and an overall net income of $22.8 million, for the year ended December 31, 2023, or a diluted net income per share of common stock of $0.96 and $0.43, respectively. Net income for the fourth quarter and net loss for the year ended December 31, 2022, was $26.8 million and $(46.4) million, or $0.55 and $(1.23) per share of common stock, respectively.
    • Total revenue for the fourth quarter of 2023 was $73.5 million, compared with total revenue of $47.4 million for the fourth quarter of 2022. The revenue increase for the fourth quarter of 2023 was primarily due to $71.8 million in collaboration revenue related to our agreements with GSK and Pfizer. Total revenue for the year ended December 31, 2023 was $103.8 million, compared to $53.5 million for the year ended December 31, 2022. The revenue increase for the year ended December 31, 2023, was primarily due to the aforementioned collaboration revenue related to our agreements with GSK and Pfizer.
    • Research and development expenses for the fourth quarter of 2023 were $16.6 million, compared to $15.1 million of research and development expenses for the same period in 2022. Research and development expenses for the year ended December 31, 2023 were $51.4 million, compared to $47.6 million for the year ended December 31, 2022. The increase in research and development expenses year-over-year was primarily due to increased clinical activity during the period related to the ongoing Phase 2a clinical trial of SPR720, offset by personnel-related costs.
    • General and administrative expenses for the fourth quarter of 2023 were $6.4 million, compared to $6.5 million of general and administrative expenses for the same period in 2022. This year-over-year decrease was primarily due to changes in personnel-related costs, offset by increased professional and consulting fees. General and administrative expenses for the year ended December 31, 2023, were $25.6 million, compared to $36.5 million for the year ended December 31, 2022, with lower expenses in 2023 compared to 2022 primarily due to decreases in both personnel-related costs and professional and consulting fees.
    • As of December 31, 2023, Spero had cash and cash equivalents of $76.3 million. Since the year-end closing of financials, the company received $23.8 million, the first tranche of the $95.0 million in development milestones from GSK. Based on its current operating plans, Spero expects that its cash and cash equivalents, together with other non-dilutive funding commitments, will be sufficient to fund its operating expenses and capital expenditure requirements into late 2025.

    For further details on Spero’s financials, refer to Spero’s Annual Report on Form 10-K, filed with the U.S. Securities and Exchange Commission (SEC) today.

    Conference Call and Live Webcast Today at 4:30 pm EST
    Spero will host a conference call and webcast today at 4:30 p.m. ET. To access the call, please dial 1-877-704-4453 (domestic) or 1-201-389-0920 (international) and refer to conference ID 13744458 or click on this Link and request a return call. The conference call will also be webcast live and can be accessed through this website link, and on Spero's website at www.sperotherapeutics.com on the "Events and Presentations" page under the "Connect" tab. An archived webcast will be available on Spero's website for 30 days following the presentation.

    Tebipenem HBr Research Support
    Select tebipenem HBr studies have been funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number HHSO100201800015C.

    Government Agency Research Support
    The views expressed 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, headquartered in Cambridge, Massachusetts, is a multi-asset clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and MDR bacterial infections with high unmet need.

    For more information, visit www.sperotherapeutics.com.

    Forward Looking Statements

    This press release may contain forward-looking statements. These statements include, but are not limited to, statements about the design, initiation, timing, progress and results of Spero's preclinical studies and clinical trials and its research and development programs, as well as the regulatory path forward for tebipenem HBr and potential FDA approval, the potential commercialization of tebipenem HBr, the potential receipt under the GSK license agreement of milestone payments and royalties on future sales of tebipenem HBr, and Spero’s cash runway. 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 tebipenem HBr, SPR720 and SPR206 will advance through the 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 FDA or equivalent foreign regulatory agencies; whether the FDA will ultimately approve tebipenem HBr and, if so, the timing of any such approval; whether the FDA will require any additional clinical data or place labeling restrictions on the use of tebipenem HBr that would delay approval and/or reduce the commercial prospects of tebipenem HBr; whether a successful commercial launch can be achieved and market acceptance of tebipenem HBr can be established; 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; Spero’s need for additional funding; the ability to commercialize Spero's product candidates, if approved; Spero's ability to retain key personnel; Spero’s ongoing leadership transitions; 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 SEC. 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:
    Ashley R. Robinson
    Managing Director, LifeSci Advisors, LLC
    arr@lifesciadvisors.com
    (617) 775-5956

    Media Inquiries: media@sperotherapeutics.com

       
    Spero Therapeutics, Inc.
    Condensed Consolidated Balance Sheet Data
    (in thousands)
    (Unaudited)
           
      December 31,  December 31,  
      2023 2022 Change
    Cash, cash equivalents and marketable securities $76,333 $109,107 $(32,774)
    Other assets  106,057  15,695  90,362 
    Total assets $ 182,390 $ 124,802 $ 57,588 
           
    Total liabilities $75,496 $48,868 $26,628 
    Total stockholder's equity  106,894  75,934  30,960 
    Total liabilities and stockholders' equity $ 182,390 $ 124,802 $ 57,588 
           

     

    Spero Therapeutics, Inc.
    Condensed Consolidated Statements of Operations
    (in thousands, except share and per share data)
    (unaudited)
             
      Three Months Ended December 31,  Year Ended December 31,
       2023   2022   2023   2022 
    Revenues:        
    Grant revenue $1,698  $1,087  $7,046  $4,930 
    Collaboration revenue - related party  71,603   46,076   95,802   46,076 
    Collaboration revenue  223   278   933   2,503 
    Total revenues  73,524   47,441   103,781   53,509 
    Operating expenses:        
    Research and development  16,558   15,089   51,440   47,593 
    General and administrative  6,433   6,495   25,554   36,483 
    Impairment of long-term asset  —   —   5,306   — 
    Restructuring  —   (67)  —   11,630 
    Total operating expenses  22,991   21,517   82,300   95,706 
    Loss from operations  50,533   25,924   21,481   (42,197)
    Other income (expense)  1,046   847   3,923   (4,218)
    Net income (loss) before income taxes  51,579   26,771   25,404   (46,415)
    Income tax expense  (387)  —   (2,598)  — 
    Net income (loss) attributable to common shareholders of Spero Therapeutics, Inc. $51,192  $26,771  $22,806  $(46,415)
             
    Net loss per share attributable to common shareholders per share, basic $0.97  $0.55  $0.43  $(1.23)
    Net loss per share attributable to common shareholders per share, diluted $0.96  $0.55  $0.43  $(1.23)
             
    Weighted average shares outstanding, basic:  52,999,491   48,715,409   52,703,467   37,585,075 
    Weighted average shares outstanding, diluted:  53,108,270   48,942,616   52,989,030   37,585,075 
             

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