Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced
financial results for the second quarter ended June 30, 2022 and
provided a business update.
“We believe Spero is well positioned to create
value with a clear strategic focus, strong clinical and preclinical
data, and cash runway extending through key anticipated catalysts,”
said Ankit Mahadevia, M.D., Chief Executive Officer of Spero
Therapeutics. “These include the expected initiation of a Phase 2
clinical trial of SPR720 in NTM-PD patients in the fourth quarter
of this year, with a subsequent interim data readout in mid-2023.
This study is designed to provide clinical proof-of-concept for
SPR720 as a potential first-line therapy for the 75% of NTM-PD
patients who are non-refractory and lack approved treatment
options. Given the permanent lung damage that often comes with
refractory disease, we believe focusing on treatment for these
patients with early-stage disease represents the best strategy to
improve clinical outcomes and quality of life.”
Dr. Mahadevia continued, “Alongside efforts with
SPR720, we continue to work to enable the advancement of our
partnership-directed programs. We previously secured non-dilutive
funding to fully support the development of SPR206 through Phase 2
and have requested and completed a Type A meeting with the FDA, as
we seek a path forward for tebipenem HBr. While receiving a
Complete Response Letter for tebipenem’s New Drug Application was
disappointing, it does not change our view of the asset’s value
proposition. Looking forward, we remain committed to being good
stewards of capital and leveraging partnerships where appropriate
as we work to address the unmet needs of patients with serious
drug-resistant infections.”
Program Highlights and Upcoming
Milestones
SPR720:
- Spero is finalizing the design of a
planned Phase 2 clinical trial of SPR720, its investigational oral
antimicrobial agent being developed as a treatment for
nontuberculous mycobacterial-pulmonary disease (NTM-PD). The trial
is expected to enroll approximately 35 treatment-naïve or treatment
inexperienced NTM-PD patients across four cohorts. Cohorts will
include a blinded placebo cohort, blinded SPR720 cohorts receiving
500 or 1000 mg of study drug daily, and an open-label SPR720 cohort
receiving 1000 mg of study drug daily. The primary endpoint of the
trial will evaluate changes in bacterial load in sputum samples
from baseline to the end of the trial’s 56-day treatment period.
Key secondary endpoints will include assessments of clinical
response, quality of life, study drug pharmacokinetics, and safety
and tolerability. The trial and its design will be posted on
ClinicalTrials.gov in the coming weeks.
- Spero expects the SPR720 Phase 2
clinical trial to begin in the fourth quarter of 2022, with interim
data expected in mid-2023 and topline data expected in 2024. The
Phase 2 trial is supported by preclinical studies demonstrating
SPR720’s potent activity against a range of NTM species as well as
Phase 1 clinical trial results that showed it to be well tolerated
at exposures above predicted therapeutic levels.
SPR206:
- Multiple external, non-dilutive
funding sources have supported, or continue to support, the SPR206
program. These include United States Department of Defense (DoD)
Award Number W81XWH-1910295, and a previously announced award from
the National Institute of Allergy and Infectious Diseases (NIAID).
SPR206 is also the subject of a license agreement with Pfizer Inc.,
which was entered into alongside Pfizer’s previously announced $40
million equity investment in Spero. Pursuant to the licensing
agreement between the parties, Pfizer has the right to develop,
manufacture, and commercialize SPR206 in ex-U.S. and ex-Asia
territories. In exchange for these rights, Spero is eligible to
receive up to $80 million in development and sales milestone
payments, and high single digit to low double-digit royalties on
net sales of SPR206 in these territories.
- In July 2022, Spero achieved a
SPR206 regulatory milestone under Spero’s license agreement with
Pfizer, which will precipitate a $5 million milestone payment
expected in the third quarter of 2022.
- Spero is planning a Phase 2,
cross-indication resistant pathogen clinical trial of SPR206, a
novel investigational intravenously (IV) administered next
generation polymyxin antibiotic being developed to treat
multi-drug resistant (MDR) Gram-negative bacterial infections. The
planned trial is designed to enroll patients with complicated
urinary tract infection (cUTI), hospital-acquired and
ventilator-associated bacterial pneumonia (HABP/VABP), and
bloodstream infections (BSI). It is supported by preclinical data
as well as the results of multiple Phase 1 clinical trials. These
Phase 1 trials have demonstrated SPR206’s lack of nephrotoxicity at
predicted therapeutic dose levels and its ability to continuously
achieve mean lung epithelial lining fluid exposures above its MIC
(minimum inhibitory concentration) for targeted gram-negative
pathogens, when administered three times daily at 100 mg. Spero
expects to initiate the planned Phase 2 trial of SPR206 in the
third quarter of 2023.
Tebipenem HBr:
- In May 2022, Spero announced it was
suspending commercialization activities for tebipenem HBr based on
feedback from a Late Cycle Meeting with the FDA, regarding a
previously filed New Drug Application (NDA), seeking approval for
treatment in adult patients with certain bacterial microorganisms
that cause complicated urinary tract infection (cUTI), including
pyelonephritis. In late June 2022, the FDA issued a Complete
Response Letter for the NDA, where the FDA concluded that Spero’s
Phase 3 cUTI clinical trial of tebipenem HBr (ADAPT-PO) was
insufficient to support approval and that additional clinical study
would be required. Spero has since requested and recently completed
a Type A meeting with the FDA, discussing the regulatory pathway
forward for potential approval of tebipenem HBr. Upon receipt of
the Type A meeting minutes, and proposed regulatory guidance
regarding additional clinical study, Spero plans to advance
additional Phase 3 clinical development, and eventual
commercialization through external partnership.
- In April 2022, The New
England Journal of Medicine published the results of
ADAPT-PO, a global, randomized, placebo-controlled Phase 3 clinical
trial that showed oral tebipenem HBr to be well-tolerated and
non-inferior to IV ertapenem in the treatment of adult patients
with cUTI or acute pyelonephritis.
Medical Congress
Engagement:
- In April 2022, tebipenem HBr was
the subject of two oral and four poster presentations at the 32nd
European Congress of Clinical Microbiology and Infectious Diseases
(ECCMID). The oral presentations discussed tebipenem HBr’s effects
on the normal gut microbiota of healthy adults as well as plasma
pharmacokinetics and intrapulmonary penetration in healthy
subjects. The four poster presentations included additional data on
tebipenem HBr. These included poster P0213, describing clinical
outcomes in patients with bacteremia from ADAPT-PO, which was
selected by the ECCMID Program Committee as one of the top-rated
posters for this year's Congress.
Second Quarter 2022 Financial
Results
Spero reported a net loss for the second quarter
ended June 30, 2022 of $28.7 million or $0.87 per common share,
compared to a net loss of $18.6 million or $0.63 per common share
reported for the same period in 2021.
Total revenues for the second quarter of 2022
were $2.0 million, compared with revenues of $5.1 million in the
second quarter of 2021. The revenue decrease was primarily due to a
$1.2 million decrease in qualified expenses incurred under Spero’s
BARDA contract for tebipenem HBr, a $1.0 million decrease in
funding under Spero’s DoD agreement relating to SPR206 and a
decrease in collaboration revenues related to the Pfizer license
agreement, offset by an increase of $0.3 million under Spero’s
NIAID agreement related to SPR206
Research and development expenses for the second
quarter of 2022 were $8.2 million, compared with $14.5 million of
research and development expenses for the same period in 2021. This
year-over-year decrease was primarily due to reduced program
activity for tebipenem HBr, as a result of Spero’s strategic
restructuring announced in May 2022, as well as reduced costs
associated with Spero’s SPR720 and SPR206 programs, and a decrease
in research and development headcount costs after the
restructuring.
General and administrative expenses for the
second quarter of 2022 of $8.1 million were lower than the $9.2
million reported in the same period in 2021, primarily as a result
of a decrease in headcount in Spero’s commercial, general and
administrative functions due to the strategic restructuring, as
well as a decrease in professional and consultant fees.
Restructuring expenses of $11.8 million were
incurred during the quarter. These expenses were primarily
comprised of $8.7 million of severance and other employee costs,
$2.6 million of discontinuation costs such as contract termination
fees, and $0.6 million of lease impairment expenses.
As of June 30, 2022, Spero had cash, cash
equivalents, and marketable securities of $45.4 million. Based on
the previously announced restructuring and the cessation of
commercialization activities for the tebipenem HBr program, Spero
believes that its existing cash, cash equivalents and marketable
securities, together with other non-dilutive funding commitments,
will be sufficient to fund its planned operating expenses and
capital expenditures pursuant to the priorities of its strategic
refocusing into late 2023. During this period, the strategic
refocusing prioritizes advancing SPR720 and SPR206 to key Phase 2
milestones.
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 13731565. The conference call will also be
webcast live and a link to the webcast can be accessed
here and on Spero Therapeutics' website
at www.sperotherapeutics.com in the
"Investors and Media" section under "Events and Presentations." 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; Office of the Assistant Secretary for
Preparedness and Response; Biomedical Advanced Research and
Development Authority, under contract number HHSO100201800015C.
Government Agency Research
SupportThe 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 DefenseSelect
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 DiseaseSelect 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 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.
- Spero Therapeutics also has an IV-administered next generation
polymyxin product candidate, SPR206, developed from its potentiator
platform, which is in development to treat multi-drug resistant
Gram-negative infections in the hospital setting.
- Tebipenem HBr is an investigational drug in the United States
being developed for the treatment of cUTI, including
pyelonephritis, caused by certain microorganisms, in adult patients
who have limited treatment options; tebipenem HBr is not
FDA-approved.
For more information,
visit https://sperotherapeutics.com.
Forward Looking StatementsThis
press release may contain forward-looking statements. These
statements include, but are not limited to, statements about the
potential regulatory path forward for tebipenem HBr and the
potential approval of tebipenem HBr by the FDA and the timing
thereof; the potential value of tebipenem HBr; the potential for a
partnership of the tebipenem HBr franchise; the future development
and commercialization of SPR720, SPR206, and tebipenem HBr; the
design, initiation, timing, progress and results of Spero’s
preclinical studies and clinical trials and its research and
development programs; management’s assessment of the results of
such preclinical studies and clinical trials; and Spero’s
anticipated expenses and its anticipated 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 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 add costs for Spero, delay approval and/or reduce the
commercial prospects of tebipenem HBr; whether any third parties
would be interested in partnering with Spero to pursue continued
efforts to obtain FDA approval of tebipenem HBr, or acquiring
rights to the tebipenem HBr program from Spero through a
partnership arrangement; the COVID-19 pandemic; Spero’s need for
additional funding; the risk that Spero may not be able to address
the FDA's concerns with respect to tebipenem HBr; the lengthy,
expensive, and uncertain process of clinical drug development for
SPR720 and SPR206; 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; the ability to commercialize Spero’s product candidates,
if approved; Spero’s ability to retain key personnel; 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 and 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.
Investor Relations Contact: Ted
JenkinsVice President, Investor Relations and Strategic
FinanceTJenkins@sperotherapeutics.com (617) 798-4039
Media Inquiries:
media@sperotherapeutics.com
|
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, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Revenues: |
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
1,097 |
|
|
$ |
3,042 |
|
|
$ |
2,919 |
|
|
$ |
10,342 |
|
Collaboration revenue |
|
|
896 |
|
|
|
2,106 |
|
|
|
1,143 |
|
|
|
2,106 |
|
Total revenues |
|
|
1,993 |
|
|
|
5,148 |
|
|
|
4,062 |
|
|
|
12,448 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
8,173 |
|
|
|
14,461 |
|
|
|
25,144 |
|
|
|
32,865 |
|
General and administrative |
|
|
8,051 |
|
|
|
9,229 |
|
|
|
23,356 |
|
|
|
17,528 |
|
Restructuring |
|
|
11,849 |
|
|
|
— |
|
|
|
11,849 |
|
|
|
— |
|
Total operating expenses |
|
|
28,073 |
|
|
|
23,690 |
|
|
|
60,349 |
|
|
|
50,393 |
|
Loss from operations |
|
|
(26,080 |
) |
|
|
(18,542 |
) |
|
|
(56,287 |
) |
|
|
(37,945 |
) |
Other income (expense) |
|
|
(2,602 |
) |
|
|
(30 |
) |
|
|
(5,224 |
) |
|
|
(50 |
) |
Net loss |
|
$ |
(28,682 |
) |
|
$ |
(18,572 |
) |
|
$ |
(61,511 |
) |
|
$ |
(37,995 |
) |
Net loss attributable to
common shareholders of Spero Therapeutics, Inc. |
|
$ |
(28,682 |
) |
|
$ |
(18,572 |
) |
|
$ |
(61,511 |
) |
|
$ |
(37,995 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common shareholders per share, basic and
diluted |
|
$ |
(0.87 |
) |
|
$ |
(0.63 |
) |
|
$ |
(1.88 |
) |
|
$ |
(1.29 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding, basic and diluted: |
|
|
32,977,807 |
|
|
|
29,675,399 |
|
|
|
32,793,288 |
|
|
|
29,545,496 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spero Therapeutics, Inc. |
Condensed Consolidated Balance Sheet Data |
(in thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
|
2022 |
|
2021 |
|
Change |
Cash, cash equivalents and marketable securities |
|
$ |
45,401 |
|
|
$ |
146,402 |
|
|
$ |
(101,001 |
) |
Other assets |
|
|
18,227 |
|
|
|
24,670 |
|
|
|
(6,443 |
) |
Total
assets |
|
$ |
63,628 |
|
|
$ |
171,072 |
|
|
$ |
(107,444 |
) |
|
|
|
|
|
|
|
Total liabilities |
|
|
27,705 |
|
|
|
82,783 |
|
|
|
(55,078 |
) |
Total stockholder's equity |
|
|
35,923 |
|
|
|
88,289 |
|
|
|
(52,366 |
) |
Total liabilities and
stockholders' equity |
|
$ |
63,628 |
|
|
$ |
171,072 |
|
|
$ |
(107,444 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
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