Pipeline rapidly advancing with three clinical trials
planned to initiate by early 2019, including a SPR994 Phase 3
initiation around year-end 2018
Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset
clinical-stage biopharmaceutical company focused on identifying,
developing and commercializing novel treatments for multi-drug
resistant (MDR) bacterial infections, today announced financial
results for the third quarter ended September 30, 2018 and provided
a pipeline overview.
“We continue to make significant progress across
all of our product candidates,” said Ankit Mahadevia, M.D., Chief
Executive Officer of Spero Therapeutics. “Positive news on all of
our product candidates within the past six months, coupled with our
recent follow-on offering and non-dilutive funding award from
BARDA, puts us in a strong position to execute on our clinical plan
and further our mission of developing new treatments to address the
critical unmet need of drug-resistant infections. We look forward
to starting the Phase 3 SPR994 trial and Phase 1 SPR206 trial
around year-end 2018 followed by the Phase 1 SPR720 trial in early
2019.”
Recent Clinical Highlights and Upcoming
Milestones
SPR994:
The Company’s lead product candidate, SPR994, is
designed to be the first broad-spectrum oral carbapenem-class
antibiotic for use in adults to treat MDR Gram-negative infections.
In September 2018, Spero announced positive results from a final
analysis of its single ascending dose (SAD) and multiple ascending
dose (MAD) Phase 1 clinical trial of SPR994. Data demonstrated that
repeat dose administration of both 300 mg and 600 mg of SPR994 was
well tolerated, with a safety profile consistent with the
carbapenem class of antibiotics. Final results demonstrated a
linear and proportional increase in plasma exposure over the dose
range tested, with peak urine concentrations approximately 50 to
100-fold higher than the maximum concentrations in plasma,
supporting SPR994’s potential utility as treatment for patients
with complicated urinary tract infection (cUTI). Spero believes the
data support the advancement of SPR994 at a dose of 600 mg
administered three times per day (TID) into a pivotal Phase 3
clinical trial in cUTI. Following a scheduled pre-Phase 3 meeting
with the U.S. Food and Drug Administration in the fourth quarter of
2018, Spero expects to submit an investigational new drug
application (IND) and initiate a pivotal Phase 3 clinical trial of
SPR994 for the treatment of cUTI around year-end 2018. To support
clinical development of SPR994, in July 2018 the Biomedical
Advanced Research and Development Authority (BARDA) and the Defense
Threat Reduction Agency (DTRA) awarded the Company up to $54
million in non-dilutive funding and support over a five-year
period.
Potentiator Platform (SPR206 and SPR741):
Spero’s Potentiator Platform is an innovative
approach to treating MDR Gram-negative bacterial infections and
includes two IV-administered compounds, SPR741 and SPR206. SPR741
is designed to expand the spectrum and increase the potency of a
partner antibiotic when administered in combination. SPR741
completed a positive Phase 1b drug-drug interaction clinical trial
in May 2018, and data demonstrated pharmacokinetic compatibility
and tolerability of SPR741 when co-administered with beta-lactam
antibiotics. SPR206 is designed to have antibiotic activity as a
single agent against MDR and extremely drug resistant (XDR)
bacterial strains. Results from the SPR206 IND-enabling studies
announced in May 2018 demonstrated the potential for wide
therapeutic margins and broad antimicrobial spectrum as a single
agent in the setting of serious hospital Gram-negative infections,
supporting progression to clinical studies. Spero now plans to
initiate a Phase 1 clinical trial for SPR206 around year-end 2018,
earlier than its prior expectation of 2019. The Company continues
to expect that data from a Phase 1 clinical trial of SPR206,
together with the data from its completed Phase 1b clinical trial
of SPR741, will enable the selection of a lead candidate from the
Potentiator Platform to move forward into late stage development.
Spero continues to assess clinical development strategies,
partnering opportunities and non-dilutive funding for both
Potentiator Platform product candidates.
SPR720:
SPR720 is an oral antibiotic designed for the
treatment of an orphan disease, pulmonary non-tuberculous
mycobacterial (NTM) infection. In early November 2018, Spero
announced positive results from preclinical IND-enabling studies of
SPR720. The data suggest that SPR720 has an acceptable safety
profile, encouraging target pathogen efficacy, and a wide
therapeutic margin. In vitro minimum inhibitory concentration (MIC)
studies demonstrated potent activity for SPR720 against prevalent
NTM pathogens, including Mycobacterium avium complex and
Mycobacterium abscessus, and in vivo studies in murine models of
pneumonia demonstrated favorable efficacy relative to
standard-of-care comparator agents. These results, in conjunction
with the recent regulatory interactions Spero has had, support the
further development of SPR720. Spero plans to initiate a
First-in-Human Phase 1 clinical trial of SPR720 in early 2019.
Third Quarter 2018 Financial
Results
The Company reported a net loss of $(10.5)
million, or $(0.60) per basic and diluted share, for the third
quarter of 2018 versus a net loss of $(12.1) million and $(36.02)
per common share, respectively, for the same period in 2017.
Revenue from government awards totaled $658,000
for the third quarter of 2018, higher than third quarter of 2017
revenue of $597,000, and was comprised of reimbursement of program
expenses for SPR994 and SPR206. Research and development expenses
were $8.5 million for the third quarter of 2018, higher than third
quarter of 2017 expenses of $6.9 million, primarily due to higher
spending on the SPR994 and SPR720 development programs. General and
administrative expenses were $3.1 million for the third quarter of
2018, lower than third quarter of 2017 expenses of $3.7 million,
largely due to lower professional and consultant fees.
The Company continues to expect that its
research and development expenses will increase through the
remainder of 2018 in connection with increased planned clinical and
preclinical activities related to our product candidates as it
prepares to initiate three clinical trials by early 2019, including
the initiation of the Phase 3 SPR994 clinical trial around year-end
2018. The Company expects general and administrative expenses to
increase through the remainder of 2018 due to additional headcount
and consultant fees as it advances its clinical pipeline and incurs
additional costs associated with operating as a public company.
As of September 30, 2018, the Company’s cash,
cash equivalents and marketable securities totaled $131.2 million.
In early July 2018, Spero completed a follow-on offering in which
it issued 3,780,000 shares of common stock at a price of $12.50 per
share, and 2,220 shares of Series A Convertible Preferred Stock at
a price of $12,500 per share, for net proceeds before expenses of
$70.5 million after deducting underwriting discounts and
commissions. Spero continues to believe that its existing cash,
cash equivalents and marketable securities as of September 30,
2018, together with initial committed funding of $15.7 million
under the BARDA award, will fund operations into the second half of
2020, including through top-line data readout of the planned
pivotal Phase 3 clinical trial of SPR994.
About Spero Therapeutics
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.
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 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 intravenous (IV)-administered
agents, SPR741 and SPR206, designed to treat MDR Gram-negative
infections in the hospital setting.
Spero is also advancing SPR720, its novel oral
therapy product candidate designed for the treatment of pulmonary
non-tuberculous mycobacterial (NTM) infections.
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 the initiation, timing, progress and results of
Spero’s preclinical studies and clinical trials and its research
and development programs, including statements regarding
management’s assessment of the results of such preclinical studies
and clinical trials, the timing of clinical data, 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 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; 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 we periodically make 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 Investor and Media Contact: Sharon
Klahre Director, Investor Relations 857-242-1547
IR@sperotherapeutics.com
Spero Therapeutics, Inc.
Condensed Consolidated Balance Sheet Data (In
thousands)(Unaudited)
|
|
September 30, |
|
December 31, |
|
|
|
2018 |
|
2017 |
|
Cash, cash equivalents
and marketable securities |
|
$ |
131,225 |
|
$ |
87,288 |
|
Other assets |
|
|
4,895 |
|
|
6,191 |
|
Total
assets |
|
$ |
136,120 |
|
$ |
93,479 |
|
|
|
|
|
|
|
Total liabilities |
|
|
10,568 |
|
|
8,522 |
|
Total stockholder's
equity |
|
|
125,552 |
|
|
84,957 |
|
Total
liabilities and stockholders' equity |
|
$ |
136,120 |
|
$ |
93,479 |
|
Spero Therapeutics, Inc.
Condensed Consolidated Statements of Operations (In thousands,
except share and per share data) (Unaudited)
|
|
Three Months
EndedSeptember 30, |
|
Nine Months
EndedSeptember 30, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
658 |
|
|
$ |
597 |
|
|
$ |
2,274 |
|
|
$ |
986 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
8,459 |
|
|
|
6,910 |
|
|
|
24,758 |
|
|
|
20,366 |
|
General
and administrative |
|
|
3,134 |
|
|
|
3,653 |
|
|
|
9,238 |
|
|
|
8,350 |
|
Total
operating expenses |
|
|
11,593 |
|
|
|
10,563 |
|
|
|
33,996 |
|
|
|
28,716 |
|
Loss from
operations |
|
|
(10,935 |
) |
|
|
(9,966 |
) |
|
|
(31,722 |
) |
|
|
(27,730 |
) |
Other income
(expense) |
|
|
472 |
|
|
|
(2,110 |
) |
|
|
659 |
|
|
|
(3,597 |
) |
Net loss attributable
to common stockholders of Spero Therapeutics, Inc. |
|
$ |
(10,463 |
) |
|
$ |
(12,076 |
) |
|
$ |
(31,063 |
) |
|
$ |
(31,327 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders per share, basic and
diluted |
|
$ |
(0.60 |
) |
|
$ |
(36.02 |
) |
|
$ |
(2.01 |
) |
|
$ |
(93.96 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding, basic and diluted: |
|
|
17,471,462 |
|
|
|
335,285 |
|
|
|
15,417,087 |
|
|
|
333,402 |
|
|
|
|
|
|
|
|
|
|
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