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, today announced financial results for the third quarter
ended September 30, 2023, and provided a business update.
"Having made substantial progress across our
late-stage programs throughout 2023, we look forward to important
milestones before year-end,” said Sath Shukla, President, and Chief
Executive Officer of Spero. “In our SPR720 program, enrollment for
our Phase 2 clinical proof-of-concept trial, evaluating the product
in non-tuberculous mycobacterial pulmonary disease, continues to
advance. Enrollment of our first patients in the Phase 3 PIVOT-PO
clinical trial of tebipenem HBr is expected to begin in the fourth
quarter. Further, we expect to file an IND for SPR206, in the
fourth quarter of this year, as well, with the goal of conducting a
Phase 2 clinical trial in patients with hospital-acquired or
ventilator-associated bacterial pneumonia."
Program Highlights and Upcoming
Anticipated Milestones
Tebipenem HBr
- 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, 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, pivotal Phase 3 clinical trial of oral tebipenem HBr
vs. intravenous (IV) imipenem cilastatin, in hospitalized adult
patients with cUTI/AP. Patients will be randomized 1:1 to receive
tebipenem HBr (600 mg) orally every six hours, or imipenem
cilastatin (500 mg) IV every six hours, for a total of seven
to ten days. The primary efficacy endpoint will be overall response
(composite of clinical cure plus microbiological eradication) at
the test-of-cure visit. The primary analysis for the trial will be
an assessment of non-inferiority (NI) in the microbiological
intention-to-treat population, based on a 10% NI margin. The trial
is designed to enroll approximately 2,648 patients, with
randomization stratified by age, baseline diagnosis (cUTI or AP),
and the presence or absence of urinary tract instrumentation.
For further details on the trial, refer to clinicaltrials.gov
identifier NCT06059846.
- Pursuant to its exclusive license
agreement with GSK, Spero received a $30 million development
milestone payment. 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
- Patient enrollment and dosing
continues at 26 active sites in the ongoing Phase 2a clinical trial
of SPR720, a potential novel first-line oral therapy for
nontuberculous mycobacterial pulmonary disease (NTM-PD). 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. Topline data are expected in the second half of 2024.
For more information on the trial and its design, see
ClinicalTrials.gov identifier NCT05496374.
- A paper, titled Nontuberculous
mycobacterial pulmonary disease and the potential role of SPR720
(Kevin Winthrop et al), was published online, Oct 20, 2023, in the
Expert Review of Anti-infective Therapy. The authors discuss the
unmet need in NTM-PD, explaining that current treatment options are
limited and the challenges of managing the disease, including
length of therapy, poor efficacy, drug intolerance, recurrence, and
resistance development. They reviewed data on SPR720 which
demonstrated activity against a range of NTM species, including
mycobacterium avium complex (MAC) and mycobacterium abscessus
(MAB). Encouraging in vitro and pre-clinical data demonstrate that
SPR720 is active both alone and in combination with
standard-of-care agents, with no evidence of cross-resistance to
such agents. The authors concluded that SPR720 should be studied
further in the context of a multidrug regimen.
SPR206
- Spero is preparing to advance
SPR206, a novel, investigational, IV administered next generation
polymyxin antibiotic being developed to treat MDR Gram-negative
bacterial infections, into a Phase 2 clinical 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 the Phase 2 clinical trial
in the fourth quarter of 2023. Funding of SPR206’s clinical
development is currently being provided by the Department of
Defense and National Institute of Allergy and Infectious
Disease.
- The results from the Phase 1
bronchoalveolar lavage (BAL) study of SPR206 were published in a
paper, titled Pharmacokinetics of SPR206 in Plasma, Pulmonary
Epithelial Lining Fluid, and Alveolar Macrophages following
Intravenous Administration to Healthy Adult Subjects (Keith Rodvold
et al), in Antimicrobial Agents and Chemotherapy in June 2023. The
results showed SPR206 to be well-tolerated and achieved lung
exposures consistent with predicted therapeutic levels when
administered three times daily at 100 mg.
- A paper, titled Safety and
pharmacokinetics of SPR206 in subjects with varying degrees of
renal impairment (Jon B. Bruss et al), was published in
Antimicrobial Agents and Chemotherapy in October 2023. The paper
summarizes the results of a study evaluating the safety,
tolerability, and pharmacokinetic (PK) of SPR206 with a 100-mg
single IV dose in subjects with normal renal function, subjects
with varying degrees of renal impairment (RI), and subjects with
end-stage renal disease (ESRD) on hemodialysis (HD). SPR206 was
generally safe and well-tolerated, and the PK of SPR206 was well
characterized in subjects with RI.
Management Update
- Effective August 1, 2023, 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, Mr. Shukla succeeded
Spero’s prior President and CEO, Ankit Mahadevia, M.D., who became
Chairman of the Board of Directors, effective August 1, 2023.
- On November 1, 2023, Spero
announced the appointment of Esther Rajavelu as the Company’s new
Chief Financial Officer and Chief Business Officer. Ms. Rajavelu
brings over 20 years of experience in growth strategy, investor
relations, financing, and M&A.
Third Quarter 2023 Financial
Results
Spero reported a net loss for the third quarter
ended September 30, 2023, of $3.2 million or $0.06 per basic and
diluted share of common stock, compared to a net loss of $11.7
million or $0.33 per basic and diluted share of common stock
reported for the same period in 2022.
Total revenues for the third quarter of 2023
were $25.5 million, compared with revenues of $2.0 million in the
third quarter of 2022. Revenues were approximately $23.5 million
higher year over year primarily due to $23.2 million in
collaboration revenue related to the license agreement with GSK in
the third quarter of 2023.
Research and development expenses for the third
quarter of 2023 were $16.4 million, compared with $7.4 million of
research and development expenses for the same period in 2022. This
year over year increase, of approximately $9 million, was primarily
due to higher direct costs related to the tebipenem HBr and SPR720
programs. These included increased clinical activity related to the
ongoing Phase 2a clinical trial of SPR720 as well as startup
clinical activities and increased preclinical activities related to
the planned Phase 3 clinical trial of tebipenem HBr.
General and administrative expenses for the
third quarter of 2023 were $5.7 million compared with $6.6 million
in the same period in 2022. The decrease year over year was
primarily a result of decreased personal related costs, as well as
lower facility and other related expenses, offset in part by an
increase in professional and consultant fees.
An impairment expense was incurred in the third
quarter of 2023, as the Company concluded that it no longer had
need for commercial manufacturing of tebipenem HBr, provided under
a service agreement with Savior Lifetec Corporation. An impairment
expense of $5.3 million was recorded as the Company fully impaired
the long-term asset, related to the Savior service agreement.
As of September 30, 2023, Spero had cash and
cash equivalents of $93.8 million. The Company believes that its
cash and cash equivalents will be sufficient to provide funding
into the second half of 2025.
For further details on Spero’s financials,
including results for the nine-month period ended September 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
WebcastSpero 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 13741831 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) |
|
|
|
|
|
September 30, |
|
December 31, |
|
2023 |
|
2022 |
Cash, cash equivalents and marketable securities |
$ |
93,825 |
|
$ |
109,107 |
Other assets |
|
13,276 |
|
|
15,695 |
Total
assets |
$ |
107,101 |
|
$ |
124,802 |
|
|
|
|
Total liabilities |
|
53,396 |
|
|
48,868 |
Total stockholder's equity |
|
53,705 |
|
|
75,934 |
Total liabilities and
stockholders' equity |
$ |
107,101 |
|
$ |
124,802 |
Spero Therapeutics, Inc. |
Condensed Consolidated Statements of
Operations |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenues: |
|
|
|
|
|
|
|
Grant revenue |
$ |
2,091 |
|
|
$ |
924 |
|
|
$ |
5,349 |
|
|
$ |
3,843 |
|
Collaboration revenue |
|
23,382 |
|
|
|
1,082 |
|
|
|
24,910 |
|
|
$ |
2,225 |
|
Total revenues |
|
25,473 |
|
|
|
2,006 |
|
|
|
30,259 |
|
|
|
6,068 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
16,393 |
|
|
|
7,360 |
|
|
|
34,883 |
|
|
|
32,504 |
|
General and
administrative |
|
5,708 |
|
|
|
6,632 |
|
|
|
19,121 |
|
|
|
29,988 |
|
Impairment of long-term
asset |
|
5,306 |
|
|
|
— |
|
|
|
5,306 |
|
|
|
— |
|
Restructuring |
|
— |
|
|
|
(152 |
) |
|
|
— |
|
|
|
11,697 |
|
Total operating expenses |
|
27,407 |
|
|
|
13,840 |
|
|
|
59,310 |
|
|
|
74,189 |
|
Loss from operations |
|
(1,934 |
) |
|
|
(11,834 |
) |
|
|
(29,051 |
) |
|
|
(68,121 |
) |
Other income (expense) |
|
940 |
|
|
|
159 |
|
|
|
2,877 |
|
|
|
(5,065 |
) |
Net loss before income
taxes |
|
(994 |
) |
|
|
(11,675 |
) |
|
|
(26,174 |
) |
|
|
(73,186 |
) |
Income tax expense |
|
(2,211 |
) |
|
|
— |
|
|
|
(2,211 |
) |
|
|
— |
|
Net loss |
$ |
(3,205 |
) |
|
$ |
(11,675 |
) |
|
$ |
(28,385 |
) |
|
$ |
(73,186 |
) |
Net loss attributable to
common shareholders of Spero Therapeutics, Inc. |
$ |
(3,205 |
) |
|
$ |
(11,675 |
) |
|
$ |
(28,385 |
) |
|
$ |
(73,186 |
) |
|
|
|
|
|
|
|
|
Net loss per share
attributable to common shareholders per share, basic and
diluted |
$ |
(0.06 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.54 |
) |
|
$ |
(2.16 |
) |
|
|
|
|
|
|
|
|
Weighted average shares
outstanding, basic and diluted: |
|
52,710,280 |
|
|
|
35,882,076 |
|
|
|
52,603,709 |
|
|
|
33,834,198 |
|
Grafico Azioni Spero Therapeutics (NASDAQ:SPRO)
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Da Apr 2024 a Mag 2024
Grafico Azioni Spero Therapeutics (NASDAQ:SPRO)
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Da Mag 2023 a Mag 2024