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 first quarter
ended March 31, 2019 and provided a pipeline
review.
“We have made significant progress to date in
2019 advancing our pipeline candidates, including the initiation of
our pivotal Phase 3 trial of oral SPR994 for the treatment of
cUTI,” said Ankit Mahadevia, M.D., Chief Executive Officer
of Spero Therapeutics. “We look forward to providing
updates on the SPR994 Phase 3 trial, as well as reporting out Phase
1 data from our SPR720 and SPR206 clinical trials in the second
half of 2019.”
Recent Clinical Highlights and Upcoming
Milestones
SPR994: Spero’s
lead product candidate, SPR994, has the potential to be the first
oral carbapenem antibiotic approved for use in adults to treat MDR
Gram-negative infections. Following the FDA’s acceptance of
our investigational new drug (IND) application for SPR994 in
complex urinary tract infection (cUTI), we initiated the single
pivotal Phase 3 clinical trial required for approval of SPR994 in
cUTI entitled ADAPT-PO. We opened clinical trial sites in
April 2019 for the Phase 3 trial and are actively screening
patients. 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 with cUTI or acute pyelonephritis,
randomized 1:1 in each arm. The Company expects to receive
pharmacokinetic data from a lead-in cohort of 70 patients in the
second half of 2019 to confirm the dose and exposure of SPR994 in
the cUTI patient population. In March 2019, the FDA granted
Fast Track Designation for SPR994 for the treatment of cUTI and
acute pyelonephritis, a designation that provides opportunities for
more frequent interaction with the FDA review team to
expedite development and review as well as the potential for
rolling review of the NDA upon request and agreement with
the FDA.
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. In
January 2019, Spero initiated a SPR720 Phase 1 clinical trial
designed as a double-blind, placebo-controlled clinical trial to
assess the safety, tolerability and pharmacokinetics of SPR720 in
healthy volunteers. Spero continues to expect 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. In the first quarter of 2019, SPR206 was
the focus of a license agreement with Everest Medicines under which
Spero granted Everest an exclusive license to develop, manufacture
and commercialize SPR206 in Greater China, South Korea and certain
Southeast Asian countries in exchange for an upfront payment and
royalties on net sales of products containing SPR206, if
approved. In December 2018, Spero initiated a Phase 1
clinical trial of SPR206 designed as a double-blind,
placebo-controlled, ascending dose, multi-cohort study in healthy
subjects. Spero continues to expect top-line data from this trial
in the second half of 2019.
First Quarter 2019 Financial
Results
Spero reported a net loss for the first quarter
ended March 31, 2019 of $5.1 million or $0.29
per common share, lower than the net loss reported for the same
period in 2018 of $10.6 million or $0.74 per common share.
Grant revenue for the first quarter of
2019 totaled $3.9 million, higher than first quarter 2018
revenues of $1.2 million, primarily due to funding for SPR994
received under our BARDA contract announced in July 2018 that
awarded Spero up to $44.2 million for qualified expenses for SPR994
development. Spero also recognized $3.8 million in collaboration
revenue in the first quarter of 2019 related to upfront and
milestone payments from the agreement with Everest that was
announced in January 2019.
Research and development expenses for the first
quarter of 2019 of $9.5 million were higher than $8.9
million for the same period of 2018 due to greater spend on
the SPR994 and SPR720 programs, partially offset by lower spend on
the Potentiator Platform product candidates. General and
administrative expenses for the first quarter of
2019 of $3.9 million were higher than $3.0
million for the same period of 2018, primarily due to
increased headcount and greater costs associated with operating as
a public company.
The Company continues to expect 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 it enrolls patients, as well as the
SPR720 and SPR206 Phase 1 clinical trials, along with increased
personnel spend to support such programs. The Company
continues to expect general and administrative expenses to increase
in 2019 due to additional headcount and professional fees required
to support SPR994 as it advances through a Phase 3 clinical trial
and prepares for possible regulatory approval and
commercialization.
As of March 31, 2019, the Company had cash
and cash equivalents of $106.4 million. Consistent with
previous guidance, 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 pivotal ADAPT-PO clinical trial of SPR994.
Upcoming Scientific and Investor
Presentations
- Bank of America Merrill Lynch Health Care Conference 2019
on May 15, 2019 in Las Vegas, Nevada
- Oral and poster presentations at ASM Microbe 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,
SPR206 and SPR741, 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 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; 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 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 Investor and Media
Contact: Sharon Klahre Director, Investor Relations
857-242-1547 IR@sperotherapeutics.com
|
Spero
Therapeutics, Inc. |
Condensed
Consolidated Statements of Operations |
(Unaudited, amounts
in thousands, except share and per share data) |
|
|
|
|
|
Three Months Ended March 31, |
|
|
2019 |
|
|
|
2018 |
|
Revenues: |
|
|
|
Grant revenue |
$ |
3,911 |
|
|
$ |
1,153 |
|
Collaboration revenue |
|
3,807 |
|
|
|
— |
|
Total revenues |
|
7,718 |
|
|
|
1,153 |
|
Operating expenses: |
|
|
|
Research and development |
|
9,526 |
|
|
|
8,925 |
|
General and administrative |
|
3,888 |
|
|
|
3,044 |
|
Total operating expenses |
|
13,414 |
|
|
|
11,969 |
|
Loss from operations |
|
(5,696 |
) |
|
|
(10,816 |
) |
Other income (expense) |
|
624 |
|
|
|
172 |
|
Net loss attributable to
common shareholders of Spero Therapeutics, Inc. |
$ |
(5,072 |
) |
|
$ |
(10,644 |
) |
|
|
|
|
Net loss per share
attributable to common shareholders per share, basic and
diluted |
$ |
(0.29 |
) |
|
$ |
(0.74 |
) |
|
|
|
|
Weighted average shares
outstanding, basic and diluted: |
|
17,221,120 |
|
|
|
14,369,182 |
|
|
|
|
|
Spero
Therapeutics, Inc. |
Condensed
Consolidated Balance Sheet Data |
(Unaudited, amounts
in thousands) |
|
|
|
|
|
March 31, |
|
December 31, |
|
2019 |
|
2018 |
Cash, cash equivalents and marketable securities |
$ |
106,392 |
|
$ |
115,443 |
Other assets |
|
18,258 |
|
|
13,563 |
Total
assets |
$ |
124,650 |
|
$ |
129,006 |
|
|
|
|
Total liabilities |
|
11,321 |
|
|
13,151 |
Total stockholder's equity |
|
113,329 |
|
|
115,855 |
Total liabilities and
stockholders' equity |
$ |
124,650 |
|
$ |
129,006 |
|
|
|
|
|
|
|
|
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