Anticipated 2019 Events include Enrollment in the Planned SPR994
Pivotal Phase 3 Clinical Trial and Top-Line Data from SPR720 and
SPR206 Phase 1 Clinical Trials in 2H19
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 multi-drug resistant (MDR) bacterial infections and rare
diseases, today announced financial results for the fourth quarter
and full year ended December 31, 2018 and provided a
pipeline review.
“In 2018, we made significant progress advancing our pipeline
candidates, all of which are designed to address serious unmet
needs of multi-drug resistant infections,” said Ankit
Mahadevia, M.D., Chief Executive Officer of Spero
Therapeutics. “SPR994 is now entering a single pivotal Phase 3
clinical trial required for regulatory approval in cUTI, after we
successfully identified a dose based on a completed Phase 1
clinical trial of SPR994 in 2018 and filed an IND with the FDA in
early 2019. Additionally, we advanced SPR720 and SPR206 into Phase
1 clinical trials based on successful preclinical testing conducted
in 2018. We look forward to an eventful 2019 with enrollment into
our planned SPR994 Phase 3 trial, as well as Phase 1 data from
SPR720 and SPR206 clinical trials expected in the second half of
2019.”
Recent Clinical Highlights and Upcoming Milestones
SPR994:
Spero’s lead product candidate, SPR994, is designed to be the
first oral carbapenem antibiotic approved for use in adults to
treat MDR Gram-negative infections. In February 2019, Spero
announced the FDA’s acceptance of the IND application for SPR994 in
cUTI, enabling Spero to initiate U.S. enrollment in its planned
global, single pivotal Phase 3 clinical trial of SPR994 in cUTI
entitled ADAPT-PO. The pivotal Phase 3 clinical trial is designed
as a double-blind, double-dummy trial to compare oral SPR994 with
an existing standard of care intravenous (IV) antibiotic,
ertapenem, in approximately 1,200 patients randomized 1:1 in each
arm. Spero has begun start-up activities for the ADAPT-PO clinical
trial and anticipates opening trial sites around the end of March
2019 to support study enrollment. The trial will incorporate a
lead-in cohort of 70 patients with an intensive
pharmacokinetics assessment to confirm the dose and exposure in the
cUTI patient population. Spero expects to receive pharmacokinetic
data from the lead-in cohort in the second half of 2019.
SPR720:
SPR720 is an orally administered antimicrobial agent being
developed for the treatment of a rare, orphan disease,
non-tuberculous mycobacterial (NTM)
infections. Pre-clinical in vitro and in
vivo studies have demonstrated the potency of SPR720 against a
range of bacteria that cause pulmonary NTM infections,
including Mycobacterium avium complex
and Mycobacterium abscessus. The collective data to date
suggest that SPR720 has an acceptable safety profile, encouraging
target pathogen efficacy, drug distribution to key sites of
infection, such as the lung, and a wide therapeutic margin. Spero
initiated a SPR720 Phase 1 clinical trial in January 2019 designed
as a double-blind, placebo-controlled clinical trial to assess the
safety, tolerability and pharmacokinetics of SPR720 in healthy
volunteers. Spero expects to receive top-line data from the Phase 1
clinical trial in the second half of 2019.
SPR206:
SPR206 is an IV-administered product candidate from Spero’s
Potentiator Platform being developed as an innovative option to
treat MDR Gram-negative bacterial infections. In preclinical
studies, SPR206 showed activity as a single agent against MDR and
extensively drug resistant (XDR) bacterial strains, including
isolates of Pseudomonas aeruginosa, Acinetobacter baumannii and
carbapenem-resistant Enterobacteriaceae, in both in vitro and in
vivo models of infection. Spero initiated a Phase 1 clinical trial
of SPR206 in December 2018, designed as a double-blind,
placebo-controlled, ascending dose, multi-cohort study in healthy
subjects. Spero expects to receive top-line data from this trial in
the second half of 2019.
Fourth Quarter and Full-year 2018 Financial Results
Spero reported a net loss for the fourth quarter and year
ended December 31, 2018 of $10.6 million
and $41.7 million, or $0.60 and $2.60 per common
share, respectively. Net loss for the fourth quarter and year
ended December 31, 2017 was $14.8
million and $46.1 million, or $1.59 and $17.82
per common share, respectively.
Grant revenue for the fourth quarter and year
ended December 31, 2018 totaled $1.7
million and $4.0 million, respectively, and was comprised
of reimbursement for all of the pipeline programs. Grant revenue
for the year ended December 31, 2018 was $2.0
million higher than the same period of 2017 due to an increase
in available awards, such as the BARDA award of up to $44.2 million
announced in July 2018, as well as a greater spend on our product
candidates that was reimbursable under the awarded grants.
Research and development expenses for the fourth quarter
2018 of $9.1 million were lower than $12.5
million for the same period of 2017 due to lower direct
clinical trial expense in the fourth quarter 2018 and the addition
of milestone payments payable in the fourth quarter 2017. Research
and development expenses for the year ended December 31,
2018 were $33.9 million compared to $32.9
million for the year ended December 31, 2017, with
increased expenses in 2018 versus 2017 due to greater spend on
SPR994 and SPR720 program expenses partially offset by lower spend
on the Potentiator Platform product candidates. The Company expects
that its research and development expenses will increase throughout
2019 due to greater planned clinical spend associated with the
SPR994 pivotal ADAPT-PO trial, as well as the SPR720 and SPR206
Phase 1 clinical trials, along with increased personnel spend to
support such programs.
General and administrative expenses for the fourth quarter
2018 of $3.6 million were higher than $2.5
million for the same period of 2017, primarily due to
increased headcount and greater costs associated with operating as
a public company. General and administrative expenses for the year
ended December 31, 2018 were $12.9
million compared to $10.8 million for the year
ended December 31, 2017, with the increased expenses in 2018
versus 2017 primarily due to an increase in headcount partially
offset by lower professional and consultant fees. The Company
expects general and administrative expenses to increase in 2019 due
to additional headcount and professional fees to support the
advancement of its lead asset SPR994 towards regulatory
approval.
As of December 31, 2018, the Company had cash and cash
equivalents of $115.4 million. Spero believes that its
existing cash, cash equivalents and marketable securities, together
with the initial funding committed under its BARDA award, will
enable funding of operating expenses and capital expenditure
requirements into the second half of 2020, including through the
top-line data readout of the planned pivotal ADAPT-PO clinical
trial of SPR994.
Upcoming Scientific and Investor Presentations
- Corporate presentation at the
Oppenheimer 29th Annual Healthcare Conference on March 20, 2019 in
New York, New York
- Corporate presentation at the H. C.
Wainwright Annual Global Life Sciences
Conference on April 8-9, 2019 in London,
England
- Multiple scientific presentations at
the 29th European Congress of Clinical Microbiology and
Infectious Diseases from April 13-16,
2019 in Amsterdam, Netherlands
- Corporate presentation at the
2019 Bank of America Merrill Lynch Health
Care Conference from May 14-16, 2019 in Las Vegas,
Nevada
- Multiple scientific presentations
at American Society of Microbiology (ASM) Microbe 2019
from June 20-24, 2019 in San Francisco,
California
About Spero
Spero Therapeutics, Inc. is a multi-asset, clinical-stage
biopharmaceutical company focused on identifying, developing and
commercializing novel treatments for multidrug-resistant (MDR)
bacterial infections and rare diseases.
Spero’s lead product candidate, SPR994, is designed to be the
first oral carbapenem-class antibiotic for use in adults to treat
MDR Gram-negative infections.
Spero is also advancing SPR720, its novel oral therapy product
candidate designed for the treatment of rare, orphan disease caused
by pulmonary non-tuberculous mycobacterial (NTM) infections.
Spero also has a platform technology known as its Potentiator
Platform that it believes will enable it to develop drugs that will
expand the spectrum and potency of existing antibiotics, including
formerly inactive antibiotics, against Gram-negative bacteria.
Spero’s lead product candidates generated from its Potentiator
Platform are two IV-administered agents, SPR741 and SPR206,
designed to treat MDR Gram-negative infections in the hospital
setting.
For more information,
visit https://sperotherapeutics.com.
Forward Looking Statements
This press release may contain forward-looking statements. These
statements include, but are not limited to, statements about
Spero’s expectation that positive results from a single pivotal
Phase 3 clinical trial of SPR994 and ancillary supportive studies
to be conducted in parallel with the planned Phase 3 trial will
support the approval of SPR994; the initiation, timing, progress
and results of Spero’s preclinical studies and clinical trials and
its research and development programs, including the anticipated
timing of the opening of sites to support enrollment into the
planned pivotal Phase 3 clinical trial of SPR994; statements
regarding management’s assessment of the results of such
preclinical studies and clinical trials; the timing of clinical
data, including the availability of pharmacokinetic data from the
lead-in cohort in the planned Phase 3 clinical trial of SPR994 and
top-line data from the Phase 1 clinical trial of SPR206 and the
Phase 1 clinical trial of SPR720; and Spero’s cash forecast and
anticipated expenses, the sufficiency of its cash resources 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
the FDA will accept a single pivotal study for approval
of SPR994; whether results obtained in preclinical studies and
clinical trials will be indicative of results obtained in future
clinical trials; whether Spero’s product candidates will advance
through the preclinical development and 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 U.S. Food and Drug
Administration or equivalent foreign regulatory agencies;
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
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.
Spero Therapeutics, Inc.
Condensed Consolidated Statements of
Operations
(unaudited, amounts in thousands, except
share and per share data)
Three Months EndedDecember
31,
Twelve Months EndedDecember
31,
2018 2017
2018 2017
Grant revenue $ 1,692 $ 993
$ 3,966 $ 1,979 Operating expenses: Research
and development 9,127 12,503 33,885 32,869 General and
administrative 3,649 2,490
12,887 10,840 Total operating expenses
12,776 14,993 46,772
43,709 Loss from operations (11,084 ) (14,000 ) (42,806 )
(41,730 ) Other income (expense) 485 (770 )
1,144 (4,367 )
Net loss attributable to common
stockholders of SperoTherapeutics, Inc.
$ (10,599 ) $ (14,770 ) $ (41,662 ) $ (46,097 )
Net loss per share attributable to common
stockholders per share,basic and diluted
$ (0.60 ) $ (1.59 ) $ (2.60 ) $ (17.82 ) Weighted average
shares outstanding, basic and diluted: 17,736,996 9,273,783
16,001,832 2,586,865
Spero Therapeutics, Inc.
Condensed Consolidated Balance Sheet
Data
(unaudited, amounts in thousands)
As of December 31, 2018
2017 Cash, cash equivalents and marketable securities $
115,443 $ 87,288 Other assets 13,563 6,191
Total
assets $ 129,006 $ 93,479
Total liabilities 13,151 8,522 Total stockholder's equity
115,855 84,957
Total liabilities and stockholders'
equity $ 129,006 $ 93,479
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version on businesswire.com: https://www.businesswire.com/news/home/20190314005843/en/
Spero Investors and Media:Sharon KlahreDirector, Investor
Relations857-242-1547IR@sperotherapeutics.com
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