Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset
clinical-stage biopharmaceutical company, focused on identifying,
developing and commercializing treatments in high unmet need areas
involving rare diseases and multi-drug resistant (MDR) bacterial
infections, announced today financial results for the second
quarter ended June 30, 2023, and provided a business update.
"We are very pleased with the progress across
our late-stage programs during the second quarter and in recent
weeks,” said Sath Shukla, President, and Chief Executive Officer of
Spero. "Receipt of the written agreement from the FDA, under a
Special Protocol Assessment, regarding the overall design of our
planned pivotal Phase 3 PIVOT-PO study, was a crucial milestone in
our tebipenem HBr program. We look forward to enrolling the first
patients in the trial, which we expect to begin in the fourth
quarter of this year. Additionally, enrollment for our Phase 2
clinical proof-of-concept trial evaluating SPR720 in
non-tuberculous mycobacterial pulmonary disease continues to
advance. Lastly, we also expect to file an IND for SPR206 in the
fourth quarter of this year, with the goal of conducting a Phase 2
trial in patients with hospital-acquired or ventilator-associated
bacterial pneumonia."
Program Highlights and Upcoming
Anticipated Milestones
Tebipenem HBr
- On July 31,
2023, Spero announced that it 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, a pivotal
Phase 3 clinical trial of tebipenem HBr in patients with
complicated urinary tract infection (cUTI), including acute
pyelonephritis (AP). PIVOT-PO is a global, randomized,
double-blind, Phase 3 clinical trial of oral tebipenem HBr vs.
intravenous imipenem cilastatin, in hospitalized adult patients
with cUTI/AP. The FDA has indicated that positive and persuasive
results from PIVOT-PO, along with previously completed studies,
could be sufficient to support approval of tebipenem HBr as a
treatment for cUTI, including pyelonephritis, for a limited use
indication. The trial is expected to begin with First Patient,
First Visit in 4Q 2023.
- Spero is
entitled to receive a $30 million development milestone payment,
pursuant to its exclusive license agreement with GSK. Spero is also
eligible to receive the following additional milestone/royalty
payments under the terms of its license agreement with GSK,
conditional upon achievement of certain progression of milestones:
(1) up to an additional $120 million in development milestones as
the Phase 3 clinical trial progresses; (2) up to $150 million in
potential commercial milestones based on first commercial sales;
(3) up to $225 million in potential sales-based milestones; and (4)
low-single digit to low-double digit (if sales exceed $1 billion)
tiered royalties on net product sales of tebipenem HBr in all
territories, except Japan and certain other Asian countries.
SPR720
- The Phase 2a
clinical trial of SPR720, a potential novel first-line oral therapy
for nontuberculous mycobacterial pulmonary disease (NTM-PD),
continues to enroll participants at approximately 25 active sites,
with topline data expected in the second half of 2024. The trial is
expected to enroll up to 35 treatment-naïve or
treatment-experienced participants with NTM-PD, who do not have
treatment-refractory NTM-PD, due to Mycobacterium avium complex.
The primary endpoint is evaluating changes in bacterial load in
sputum samples from baseline to the end of the 56-day treatment
period. Key secondary endpoints include assessments of clinical
response, quality of life, pharmacokinetics, and safety and
tolerability. For more information on the trial and its design, see
ClinicalTrials.gov identifier NCT05496374.
SPR206
- Spero is
preparing to advance SPR206, a novel, investigational,
intravenously administered next generation polymyxin antibiotic
being developed to treat MDR Gram-negative bacterial infections,
into a Phase 2 trial in participants with hospital-acquired or
ventilator-associated bacterial pneumonia. Spero expects to submit
an Investigational New Drug (IND) application to the FDA to support
this Phase 2 trial in the fourth quarter of 2023.
Management Update
- Satyavrat
"Sath" Shukla, Spero's prior Chief Financial Officer and Treasurer,
became President and Chief Executive Officer (CEO) of the company,
and a member of the Board of Directors, effective August 1, 2023.
Mr. Shukla succeeded Spero's prior CEO and President, Ankit
Mahadevia, M.D., who became Chairman of the Board of Directors,
effective August 1, 2023. The prior Chairman of the Board, Milind
Deshpande, Ph.D., is remaining on the Board of Directors as an
independent director, and current Board member, Patrick Vink, MD.,
has been appointed Lead Director.
Second Quarter 2023 Financial
Results
Spero reported a net loss for the second quarter
ended June 30, 2023 of $11.9 million or $0.23 per basic and diluted
share of common stock, compared to a net loss of $28.7 million or
$0.87 per basic and diluted share of common stock reported for the
same period in 2022.
Total revenues for the second quarter of 2023
were $2.7 million, compared with revenues of $2.0 million in the
second quarter of 2022. Revenue was approximately $0.7 million
higher year over year due to revenue recognition associated with
the GSK transaction.
Research and development expenses for the second
quarter of 2023 were $9.5 million, compared with $8.2 million, of
research and development expenses for the same period in 2022. The
year-over-year increase was primarily due to higher direct costs
related to the SPR720 program arising from increased clinical and
preclinical activity related to the Phase 2 clinical trial., higher
direct costs related to the tebipenem HBr program due to increased
preclinical and clinical activity associated with the planned
pivotal Phase 3 trial of tebipenem HBr, and higher direct costs
associated with the SPR206 program. These increases were offset by
lower R&D headcount expenses associated with the strategic
restructuring announced in May 2022.
General and administrative expenses for the
second quarter of 2023 of $6.1 million were lower than the $8.1
million reported in the same period in 2022, primarily as a result
of decreased professional and consultant fees due to decreased
commercial operation expenses and a decrease in facility-related
and other costs. These decreases were offset by an increase in
personnel-related costs. Personnel-related costs for the three
months ended June 30, 2023 and 2022 included share-based
compensation expense of $1.3 million and $0.8 million,
respectively.
As of June 30, 2023, Spero had cash and cash
equivalents of $77.7 million. Based on our cash and cash
equivalents as of June 30, 2023, and inclusive of the $30 million
development milestone payment to be received from GSK pursuant to
our exclusive license agreement, we believe that our cash runway
will be sufficient to fund us into the second half of 2025.
For further details on Spero’s financials,
including results for the six-month period ended June 30, 2023,
refer to Spero’s Quarterly Report on Form 10-Q, filed with the U.S.
Securities and Exchange Commission (SEC) today.
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
1-855-327-6837 (domestic) or 1-631-891-4304 (international) and
refer to conference ID 10022241 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 SupportSelect 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
TherapeuticsSpero Therapeutics, headquartered in
Cambridge, Massachusetts, is a multi-asset, clinical-stage
biopharmaceutical company focused on identifying, developing, and
commercializing novel treatments for bacterial infections,
including multi-drug resistant bacterial infections and rare
diseases.
- Spero Therapeutics is developing
SPR720 as a novel oral therapy candidate for the treatment of a
rare, orphan pulmonary disease caused by non-tuberculous
mycobacterial infections.
- 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
www.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
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 and its future value, the
potential receipt of milestone payments and royalties on future
sales under the GSK license agreement, 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: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
Spero Therapeutics, Inc. |
Condensed Consolidated Balance Sheet Data |
(in thousands) |
(Unaudited) |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2023 |
|
2022 |
Cash, cash equivalents and marketable securities |
|
$ |
77,690 |
|
$ |
109,107 |
Other assets |
|
|
21,195 |
|
|
15,695 |
Total
assets |
|
$ |
98,885 |
|
$ |
124,802 |
|
|
|
|
|
Total liabilities |
|
|
44,103 |
|
|
48,868 |
Total stockholder's equity |
|
|
54,782 |
|
|
75,934 |
Total liabilities and
stockholders' equity |
|
$ |
98,885 |
|
$ |
124,802 |
|
|
|
|
|
Spero Therapeutics, Inc. |
Condensed Consolidated Statements of
Operations |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
1,928 |
|
|
$ |
1,097 |
|
|
$ |
3,258 |
|
|
$ |
2,919 |
|
Collaboration revenue |
|
|
788 |
|
|
|
896 |
|
|
|
1,528 |
|
|
$ |
1,143 |
|
Total revenues |
|
|
2,716 |
|
|
|
1,993 |
|
|
|
4,786 |
|
|
|
4,062 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
9,510 |
|
|
|
8,173 |
|
|
|
18,489 |
|
|
|
25,144 |
|
General and administrative |
|
|
6,096 |
|
|
|
8,051 |
|
|
|
13,413 |
|
|
|
23,356 |
|
Restructuring |
|
|
— |
|
|
|
11,849 |
|
|
|
— |
|
|
|
11,849 |
|
Total operating expenses |
|
|
15,606 |
|
|
|
28,073 |
|
|
|
31,902 |
|
|
|
60,349 |
|
Loss from operations |
|
|
(12,890 |
) |
|
|
(26,080 |
) |
|
|
(27,116 |
) |
|
|
(56,287 |
) |
Other income (expense) |
|
|
976 |
|
|
|
(2,602 |
) |
|
|
1,936 |
|
|
|
(5,224 |
) |
Net loss |
|
$ |
(11,914 |
) |
|
$ |
(28,682 |
) |
|
$ |
(25,180 |
) |
|
$ |
(61,511 |
) |
Net loss attributable to
common shareholders of Spero Therapeutics, Inc. |
|
$ |
(11,914 |
) |
|
$ |
(28,682 |
) |
|
$ |
(25,180 |
) |
|
$ |
(61,511 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common shareholders per share, basic and
diluted |
|
$ |
(0.23 |
) |
|
$ |
(0.87 |
) |
|
$ |
(0.48 |
) |
|
$ |
(1.88 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding, basic and diluted: |
|
|
52,571,813 |
|
|
|
32,977,807 |
|
|
|
52,549,538 |
|
|
|
32,793,288 |
|
Grafico Azioni Spero Therapeutics (NASDAQ:SPRO)
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