Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset,
clinical-stage, biopharmaceutical company, focused on identifying
and developing novel therapies for rare diseases and multi-drug
resistant (MDR) bacterial infections with high unmet need, today
provided a corporate update highlighting its recent accomplishments
and anticipated milestones for 2024.
“We look forward to another productive year for
Spero in 2024, having achieved important clinical and regulatory
milestones over the past twelve months,” said Sath Shukla,
President, and CEO of Spero Therapeutics. "We are very pleased to
move forward with the PIVOT-PO clinical trial, evaluating tebipenem
HBr in complicated urinary tract infections, as we recently began
dosing patients. Our Phase 2a trial of SPR720 in nontuberculous
mycobacterial pulmonary disease is on track, and we look forward to
reporting topline data, which is expected in the second half of
2024. Additionally, we ended 2023 with a strong cash balance, and
believe our cash and cash equivalents, together with milestone
payments from our tebipenem HBr commercial partner, GSK, will
provide runway into late 2025.”
2023 Pipeline Updates and 2024
Anticipated Milestones
SPR720 for Nontuberculous Mycobacterial
Pulmonary Disease (NTM-PD)
- In 2H 2024, the
company expects to share topline data from the ongoing Phase 2a
clinical trial of SPR720, which is being developed as a novel
first-line oral treatment for non-tuberculous mycobacterial
pulmonary disease (NTM-PD).
- The trial is
expected to enroll up to 35 treatment-naïve or
treatment-experienced non-refractory participants with NTM-PD, due
to Mycobacterium avium complex. For more information on the trial,
see ClinicalTrials.gov identifier NCT05496374.
Tebipenem HBr for complicated urinary
tract infections (cUTI), including acute pyelonephritis
(AP)
- In December
2023, Spero achieved first patient, first visit in PIVOT-PO, the
global pivotal Phase 3 clinical trial of tebipenem HBr in patients
with complicated urinary tract infections (cUTI), including acute
pyelonephritis (AP), with a target enrollment of approximately
2,648 patients, which we expect to be completed in 2H of 2025.
- 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.
- As part of its
license agreement with GSK, Spero is entitled to receive an
additional $95 million in development milestone payments, payable
in four equal installments over two years.
SPR206 for Bacterial
Pneumonia
- SPR206 is being developed in
patients diagnosed with hospital-acquired or ventilator-associated
bacterial pneumonia caused by carbapenem-resistant Acinetobacter
baumannii-calcoaceticus complex (CRABC) or carbapenem-resistant
Pseudomonas aeruginosa (CRPA).
Financial Guidance
- Cash and cash equivalents as of
December 31, 2023, were approximately $76.3 million (unaudited).
The company believes its cash and cash equivalents, together with
the development milestone payments due under its license agreement
with GSK, will be sufficient to fund anticipated operating and
capital expenditure requirements into late 2025.The information
presented above reflects the company’s preliminary estimate,
subject to the completion of the company’s financial closing
procedures and the annual audit of its financial statements by its
auditors. As a result, this preliminary estimate may differ from
the actual results that will be reflected in the company’s audited,
consolidated financial statements for the fiscal year ended
December 31, 2023, when they are completed and publicly
disclosed.
Link: SPRO Corporate
Presentation
Tebipenem HBr Research
Support
Select tebipenem HBr studies have been funded in
part with federal funds from the U.S. 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. 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 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 TherapeuticsSpero
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.
- Spero Therapeutics is developing
SPR720 as a novel first-line oral therapy candidate for the
treatment of a rare, orphan pulmonary disease caused by
NTM-PD.
- Tebipenem HBr is an investigational
drug in the United States being developed for the treatment of
cUTI, including pyelonephritis, caused by certain bacteria, in
adult patients who have limited treatment options; tebipenem HBr is
not FDA-approved.
- Spero Therapeutics also has an
IV-administered next generation polymyxin product candidate,
SPR206, developed from its potentiator platform, which is in
development to treat MDR Gram-negative infections in the hospital
setting.
For more information, visit
https://sperotherapeutics.com.
Forward Looking StatementsThis
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
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, and the
potential receipt under the GSK license agreement of milestone
payments and royalties on future sales of tebipenem HBr, and
Spero’s cash forecast and 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 that would delay
approval of tebipenem HBr; 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; Spero's ability to
retain key personnel; whether Spero's cash resources will be
sufficient to fund its continuing operations for the periods and/or
trials anticipated; changes to Spero’s financial results for the
year ended December 31, 2023 due to the completion of financial
closing procedures; 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 JenkinsVice
President, Investor Relations and Strategic
FinanceIR@sperotherapeutics.com(617) 798-4039
Media Inquiries: Lora Grassilli, Health Media
RelationsZeno Grouplora.grassilli@zenogroup.com646-932-3735
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