Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced
financial results for the third quarter ended September 30, 2022
and provided a business update.
“Recent accomplishments added strength to our
balance sheet, investor base, and executive team,” said Ankit
Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “We
achieved alignment with the FDA on key components of a pivotal
study design for tebipenem HBr. Our progress and the therapeutic
potential of tebipenem helped us secure an exclusive license
agreement and equity investment from GSK. In addition to a $66
million upfront payment, and a $9 million equity investment, the
license agreement provides upside in the form of potential
milestone payments and royalties, extends our cash runway beyond
2024, and provides validation from a long-standing commercial
leader in infectious diseases. We also achieved a regulatory
milestone in our SPR206 program during the quarter, triggering a $5
million payment under our 2021 license agreement with Pfizer.”
Dr. Mahadevia continued, “Spero made additional
progress on our lead SPR720 program, which has the potential to
deliver the first FDA-approved agent for the first-line treatment
of non-tuberculosis mycobacterium pulmonary disease. We remain on
track, having initiated a Phase 2 proof-of-concept trial in the
current quarter, and under the leadership of our recently appointed
Chief Medical Officer, we have taken important steps to fine tune
our development strategy for a 1H 2024 top line data readout.”
Program Highlights and Upcoming Milestones
SPR720:
- Spero has initiated the Phase 2
clinical trial of SPR720, a potential novel first-line oral therapy
for nontuberculous mycobacterial infections (NTM), which is
supported by preclinical studies demonstrating SPR720’s potent
activity against a range of NTM species, as well as Phase 1 results
that showed it to be well-tolerated at exposures above predicted
therapeutic levels. Spero has opened the first clinical trial site
with expectations to screen and dose its first patient in the
current quarter.
- The Phase 2 clinical trial of
SPR720 is expected to enroll up to 35 treatment-naïve or
treatment-inexperienced NTM-pulmonary disease (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. For more
information on the trial and its design, see ClinicalTrials.gov
identifier NCT05496374.
- Spero continues to expect top line
data of the Phase 2 clinical trial of SPR720 in the first half of
2024 and no longer plans to provide a 2023 interim data
readout.
Tebipenem HBr:
- In September 2022, Spero entered
into an exclusive license agreement with GSK for tebipenem HBr, an
investigational drug being developed as the first oral carbapenem
antibiotic for the treatment of complicated urinary tract
infections (cUTI), including pyelonephritis, caused by certain
bacteria. Pursuant to the license agreement, Spero will receive $66
million upfront from GSK and is eligible to receive up to $525
million in development, sales, and commercial milestones payments,
as well as low single-digit to low double-digit tiered royalties on
net product sales. In exchange, GSK received an exclusive license
to develop and commercialize tebipenem pivoxil and tebipenem
pivoxil HBr in all territories, except Japan and certain other
Asian countries, territories which will be retained by Spero
partner Meiji Seika. In connection with the license agreement, and
pursuant to a stock purchase agreement, Spero received a $9 million
equity investment, with an affiliate of GSK purchasing 7,450,000
shares of Spero’s common stock at a purchase price of approximately
$1.20805 per share.
- Per the license agreement, Spero is
responsible for the execution and costs of a follow-up Phase 3
clinical trial of tebipenem HBr. GSK is responsible for the
execution and costs of additional development, including Phase 3
regulatory filing and commercialization activities for tebipenem
HBr outside of the Meiji Seika territory.
- Following customary closing
conditions, including requirements of Hart-Scott-Rodino, the Spero
and GSK tebipenem HBr agreement has been deemed effective, as
previously disclosed in Spero’s November 8th press release.
- Prior to entering into the
exclusive license agreement with GSK, Spero completed a Type A
meeting with the U.S. Food and Drug Administration (FDA) to discuss
the regulatory pathway forward for potential approval of tebipenem
HBr. During the meeting, the FDA indicated that positive results
from a single additional Phase 3 clinical trial supported by
confirmatory nonclinical evidence of efficacy could be sufficient
to support the approval of tebipenem HBr for the treatment of cUTI,
including pyelonephritis for a limited use indication. Spero and
the FDA also achieved alignment on key components of the proposed
pivotal Phase 3 trial design which will be the subject of a Special
Protocol Assessment request, to be confirmed once the clinical
protocol is finalized.
SPR206:
- In Q3 2022, Spero received a $5
million payment from Pfizer Inc. in connection with the achievement
of a regulatory milestone specified in a license agreement for
SPR206, a novel, investigational, intravenously (IV) administered
next generation polymyxin antibiotic being developed to treat
multi-drug resistant (MDR) Gram-negative bacterial infections. This
license agreement was entered into alongside Pfizer's previously
announced $40 million equity investment in Spero. Pursuant to the
license agreement between the two 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 a total of $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 October 2022, the U.S. Patent
and Trademark Office issued U.S. Patent No. 11,459,357, which
covers the SPR206 composition of matter, formulations thereof, and
methods of treating a bacterial infection with SPR206. The patent
is assigned to Spero and has a lifespan extending into at least
June 2039.
- Spero expects to initiate a Phase 2
clinical trial of SPR206 in the fourth quarter of 2023. The planned
trial is designed to enroll patients with MDR pathogens. 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.
- 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).
Management Highlights:
- Kamal Hamed, MD, MPH, MBA joined
Spero as Chief Medical Officer in September 2022. Dr. Hamed has
over 20 years of experience leading various anti-infective clinical
development programs in antibacterials, antivirals, antimalarials,
and antifungals, along with stewardship for 10 regulatory drug
approvals. Before joining Spero, he was the CMO at Lysovant
Sciences and held senior positions in clinical development and
medical affairs at Novartis (including Therapeutic Area Head for
Anti-infectives), Bristol-Myers Squibb, and Bayer, spearheading the
successful global development, approval, and post-marketing medical
affairs support of multiple anti-infective products.
Key Opinion Leader and Patient Advocate
Engagement:
- In October 2022, Spero held a
virtual R&D event featuring a NTM-PD patient and Kevin L.
Winthrop, MD, MPH, from the Division of Infectious Disease, OHSU
Medical School. To view a replay of the event, please click
here.
Medical Congress Engagement
- In October 2022, Spero attended the
Infectious Disease Society of America (IDSA) IDWeek™ 2022.
Spero-affiliated presentations included seven posters showcasing
clinical and non-clinical data on tebipenem HBr, health outcome and
epidemiologic data highlighting tebipenem HBr’s potential utility
to address unmet medical need, and clinical and in vitro data on
SPR206.
Third Quarter 2022 Financial
Results
Spero reported a net loss for the third quarter
ended September 30, 2022, of $11.7 million or $.33 per common
share, compared to a net loss of $22.5 million or $.70 per common
share reported for the same period in 2021.
Total revenues for the third quarter of 2022
were $2 million, compared with revenues of $3.1 million in the
third quarter of 2021. The revenue decrease was primarily due to a
$1.5 million decrease in funding under our DoD agreement relating
to SPR206, a $0.2 million decrease in qualified expenses under the
BARDA contract for tebipenem HBr, partially offset by an increase
of $0.2 million under the NIAID agreement relating to SPR206 and
recognition of $1.1 million in collaboration revenue relating to
the Pfizer agreement.
Research and development expenses for the third
quarter of 2022 were $7.4 million, compared with $14.4 million of
research and development expenses for the same period in 2021. This
year-over-year decrease was primarily due to a $4.5 million
reduction direct costs associated with program activity for
tebipenem HBr, a $1.2 million decrease due to reduced clinical
activity during the period for SPR206 and a decrease in
personnel-related costs of $2.7 million, related to a reduction in
research and development headcount due to the May 2022 strategic
restructuring, partially offset by $1.3 million of increased costs
due to increased clinical and preclinical activity for SPR720.
General and administrative expenses for the
third quarter of 2022 of $6.6 million were lower than the $11.2
million reported in the same period in 2021, primarily as a result
of a decrease in personnel-related costs, as a result of a decrease
in headcount in commercial, general and administrative functions
due to our strategic restructuring, and a decrease in professional
and consultant fees of $2.6 million.
As of September 30, 2022, Spero had cash, cash
equivalents, and marketable securities of $50.4 million. This does
not include the $75 million in total gross proceeds from the
upfront payment and equity investment being made by GSK, in
connection with the exclusive license agreement for tebipenem HBr.
Subsequent to the end of quarter, the $9 million equity investment
has been received, while the $66 million upfront payment has been
invoiced and is expected to be delivered before the end of the
month. Based on its current projections, Spero believes that its
existing cash, cash equivalents, and marketable securities,
together with other non-dilutive funding commitments and the
anticipated proceeds expected from the GSK licensing agreement,
equity investment and milestones, will be sufficient to fund its
operating expenses and capital expenditure requirements beyond
2024.
Inducement AwardsIn connection
with Dr. Hamed joining Spero, on September 12, 2022 (the Start
Date), the Human Capital Management Committee of Spero’s Board
of Directors granted Dr. Hamed (i) 210,000 restricted stock units
(the RSUs) and (ii) 140,000 performance stock units (the PSUs)
(collectively, the Inducement Awards), under the Spero
Therapeutics, Inc. 2019 Inducement Equity Incentive Plan, as
amended (the 2019 Inducement Plan). The Inducement Awards were
granted as inducements material to Dr. Hamed becoming an employee
of Spero in accordance with Nasdaq Listing Rule 5635(c)(4). The
RSUs will vest in four equal annual installments beginning on the
first anniversary the Start Date. The PSUs will be eligible to vest
to the extent certain performance goals are met by May 31, 2023, as
determined by the Human Capital Management Committee. To the
extent a goal is determined to have been met, the portion of the
PSUs associated with such goal will vest 50% on the first
anniversary of the Start Date and 50% on the second anniversary of
the Start Date, subject to Dr. Hamed’s continued employment with
Spero on such vesting dates. The Inducement Awards are subject to
the terms and conditions of the 2019 Inducement Plan and the terms
and conditions of a restricted stock unit agreement and performance
stock unit agreement covering the grants.
Conference Call and
WebcastSpero will host a conference call and webcast today
at 4:30 p.m. ET. To access the call, please dial
1-855-327-6837 (domestic) or 1-631-891-4304 (international) and
refer to conference ID 10020538. 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, 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 multi-drug resistant
Gram-negative infections in the hospital setting.
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
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, the
design, initiation, timing, progress and results of Spero's
preclinical studies and clinical trials and its research and
development programs, 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 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; 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 FinanceIR@sperotherapeutics.com (617)
798-4039
Media Inquiries:Lora Grassilli,
Health Media RelationsZeno
Grouplora.grassilli@zenogroup.com646-932-3735
|
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, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Revenues: |
|
|
|
|
|
|
|
Grant revenue |
$ |
924 |
|
|
$ |
2,356 |
|
|
$ |
3,843 |
|
|
$ |
12,698 |
|
Collaboration revenue |
|
1,082 |
|
|
|
708 |
|
|
|
2,225 |
|
|
|
2,814 |
|
Total revenues |
|
2,006 |
|
|
|
3,064 |
|
|
|
6,068 |
|
|
|
15,512 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
7,360 |
|
|
|
14,436 |
|
|
|
32,504 |
|
|
|
47,301 |
|
General and administrative |
|
6,632 |
|
|
|
11,152 |
|
|
|
29,988 |
|
|
|
28,680 |
|
Restructuring |
|
(152 |
) |
|
|
— |
|
|
|
11,697 |
|
|
|
— |
|
Total operating expenses |
|
13,840 |
|
|
|
25,588 |
|
|
|
74,189 |
|
|
|
75,981 |
|
Loss from operations |
|
(11,834 |
) |
|
|
(22,524 |
) |
|
|
(68,121 |
) |
|
|
(60,469 |
) |
Other income (expense) |
|
159 |
|
|
|
3 |
|
|
|
(5,065 |
) |
|
|
(47 |
) |
Net loss |
$ |
(11,675 |
) |
|
$ |
(22,521 |
) |
|
$ |
(73,186 |
) |
|
$ |
(60,516 |
) |
Net loss attributable to
common shareholders of Spero Therapeutics, Inc. |
$ |
(11,675 |
) |
|
$ |
(22,521 |
) |
|
$ |
(73,186 |
) |
|
$ |
(60,516 |
) |
|
|
|
|
|
|
|
|
Net loss per share
attributable to common shareholders per share, basic and
diluted |
$ |
(0.33 |
) |
|
$ |
(0.70 |
) |
|
$ |
(2.16 |
) |
|
$ |
(1.99 |
) |
|
|
|
|
|
|
|
|
Weighted average shares
outstanding, basic and diluted: |
|
35,882,076 |
|
|
|
32,132,500 |
|
|
|
33,834,198 |
|
|
|
30,417,305 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spero Therapeutics, Inc. |
|
|
Condensed Consolidated Balance Sheet Data |
|
|
(in thousands) |
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
|
2022 |
|
|
2021 |
|
Change |
Cash, cash equivalents and marketable securities |
$ |
50,446 |
|
$ |
146,402 |
|
$ |
(95,956 |
) |
Other assets |
|
14,030 |
|
|
24,670 |
|
|
(10,640 |
) |
Total
assets |
$ |
64,476 |
|
$ |
171,072 |
|
$ |
(106,596 |
) |
|
|
|
|
|
|
Total liabilities |
|
31,992 |
|
|
82,783 |
|
|
(50,791 |
) |
Total stockholder's equity |
|
32,484 |
|
|
88,289 |
|
|
(55,805 |
) |
Total liabilities and
stockholders' equity |
$ |
64,476 |
|
$ |
171,072 |
|
$ |
(106,596 |
) |
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