Company to host conference call on
Tuesday, May 16, 2023 at 8:00 a.m. ET
BOSTON and ATLANTA, May 15, 2023
/PRNewswire/ -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT)
(Inhibikase or Company), a clinical-stage pharmaceutical company
developing protein kinase inhibitor therapeutics to modify the
course of Parkinson's disease ("PD"), Parkinson's-related disorders
and other diseases of the Abelson Tyrosine Kinases, today reported
financial results for the first quarter ended March 31, 2023 and highlighted recent
developments.
"With a clear clinical path ahead, we are focused on executing
across our pipeline portfolio in 2023," said Dr. Milton H. Werner, President and Chief Executive
Officer of Inhibikase. "Our recent industry presentations and
publications have highlighted the exciting promise of our lead
IkT-148009 program in neurodegenerative disease. We began screening
patients in April at 7 sites for our Phase 2 '201' trial for
Parkinson's disease and anticipate up to fourteen sites to be
screening patients by the end of May. In addition, we are rapidly
advancing our '501' bioequivalence study for IkT-001Pro for
Stable-Phase CML and anticipate commencing the confirmatory
analysis portion of the study in June
2023. We look forward to providing updates on both our
clinical and preclinical efforts later this year."
Recent Developments and Upcoming Milestones:
- Actively screening patients across multiple sites in the
Phase 2 '201' Clinical Trial of IkT-148009 for the
Treatment of Parkinson's Disease: The '201' trial is a
1:1:1:1 randomized, double-blind, twelve-week dosing trial intended
to assess the safety, tolerability and steady-state
pharmacokinetics of IkT-148009 as primary endpoints. Inhibikase
plans to enroll 120 patients with untreated Parkinson's Disease
(Hoehn & Yahr < 3.0) who have yet to require symptomatic
therapy. The study will evaluate three doses of IkT-148009 on a
staggered schedule with 50 and 100 mg doses preceding 200 mg
enrollment. The trial will also measure a hierarchy of fifteen
Parkinson's-related disease assessments in the brain and gut as
secondary or exploratory endpoints. Thirty-six clinical sites have
now been selected with 27 fully contracted. Up to 14 sites could be
actively screening patients by the end of May 2023.
In March 2023, Inhibikase completed
an evaluation of safety and steady-state pharmacokinetic (PK)
profile of the 200 mg dose of IkT-148009 in six healthy volunteers
and submitted the data to the FDA in April
2023. The Company is completing an ethics committee review
at all sites to add this dose into the '201' trial.
- Completed Dose escalation portion of the '501'
bioequivalence study of IkT-001Pro: IkT-001Pro is the Company's
prodrug formulation of imatinib mesylate intended to enhance the
safety and efficacy of imatinib (marketed as Gleevec®)
in patients with Chronic Myelogenous Leukemia (CML). In
May 2023, Inhibikase completed dosing
of the four dose escalation cohorts evaluating 300, 400 and 500 and
600 mg IkT-001Pro. As the Company completes the pharmacokinetic
analysis of these four cohorts, Inhibikase anticipates identifying
the dose of IkT-001Pro that delivers the equivalent dose of
commercial 400 mg imatinib mesylate. IkT-001Pro has shown a
favorable safety profile, with fewer adverse events observed
relative to 400 mg imatinib mesylate and none of clinical
significance. Inhibikase anticipates commencing the confirmatory
analysis of the bioequivalent dose of IkT-001Pro in thirty-two
additional healthy volunteers using a two-period crossover design
in June 2023. The Company expects to
complete this confirmatory analysis by the end of the second
quarter 2023. Inhibikase is also considering the addition of a
cohort that will measure bioequivalence for high-dose imatinib
delivered by prodrug that is equivalent to 600 mg imatinib mesylate
to further explore the safety benefit of IkT-001Pro over
standard-of-care, subject to agreement with the FDA.
- Advancing preclinical development of IkT-148009 in MSA:
In March 2023, Inhibikase announced
that the Investigational New Drug (IND) application for the Phase 2
trial of IkT-148009 in MSA was opened. An ongoing MSA animal model
study has shown that pre-exposure prophylaxis of IkT-148009
precludes loss of function in a transgenic model of MSA; an
independent model is running concurrently with the transgenic model
to confirm the apparent functional benefit of IkT-148009 treatment.
These studies will form the basis for determining the timing for
initiation of a planned Phase 2 clinical study of IkT-148009 in
MSA.
First Quarter Financial Results
Net Loss: Net loss for the quarter ended
March 31, 2023 was $4.5 million, or $0.16 per share, compared to a net loss of
$4.6 million, or $0.18 per share in the quarter ended March 31, 2022.
R&D Expenses: Research and development expenses were
$2.9 million for the quarter ended
March 31, 2023 compared to
$3.0 million in the quarter ended
March 31, 2022. The decrease was
primarily due to the company restarting its Phase 2 '201' clinical
trial.
SG&A Expenses: Selling, general and
administrative expenses for the quarter ended March 31, 2023 were $1.9
million compared to $1.7
million for the quarter ended March
31, 2022. The increase was primarily the result of legal,
consulting fees and promotional related costs.
Cash Position: Cash and cash equivalents and
marketable securities were $25.7
million as of March 31, 2023.
This includes the net proceeds from the Company's $10 million January
2023 concurrent registered direct offering and private
placement. The Company expects that existing cash and cash
equivalents will be sufficient to fund operations into the
fourth quarter of 2024.
Conference Call Information
The conference call is
scheduled to begin at 8:00am ET on
May 16, 2023. Participants should
dial 1-844-825-9789 (United
States) or 1-412-317-5180 (International) with the
conference code 8552474. A live webcast may be accessed using the
link here, or by visiting the investors section of the Company's
website at www.inhibikase.com. After the live webcast, the event
will be archived on Inhibikase's website for approximately 90 days
after the call.
About Inhibikase
(www.inhibikase.com)
Inhibikase Therapeutics,
Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company
developing therapeutics for Parkinson's disease and related
disorders. Inhibikase's multi-therapeutic pipeline has a primary
focus on neurodegeneration and its lead program IkT-148009, an
Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of
Parkinson's disease inside and outside the brain as well as other
diseases that arise from Ableson Tyrosine Kinases. Its
multi-therapeutic pipeline is pursuing Parkinson's-related
disorders of the brain and GI tract, orphan indications related to
Parkinson's disease such as Multiple System Atrophy, and drug
delivery technologies for kinase inhibitors such as IkT-001Pro, a
prodrug of the anticancer agent imatinib mesylate that the Company
believes will provide a better patient experience with fewer
on-dosing side-effects. The Company's RAMP™ medicinal chemistry
program has identified a number of follow-on compounds to
IkT-148009 to be potentially applied to other cognitive and motor
function diseases of the brain. Inhibikase is headquartered in
Atlanta, Georgia with an office in
Lexington,
Massachusetts.
Social Media Disclaimer
Investors and others should
note that we announce material financial information to our
investors using our investor relations website, press releases, SEC
filings and public conference calls and webcasts. The Company
intends to also use Twitter, Facebook, LinkedIn
and YouTube as a means of disclosing information about the
Company, its services and other matters and for complying with its
disclosure obligations under Regulation FD.
Forward-Looking Statements
This press release contains
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
terminology such as "believes," "expects," "may," "will," "should,"
"anticipates," "plans," or similar expressions or the negative of
these terms and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are
based on Inhibikase's current expectations and assumptions. Such
statements are subject to certain risks and uncertainties, which
could cause Inhibikase's actual results to differ materially from
those anticipated by the forward-looking statements, including our
ability to successfully conduct clinical trials, that results in
our animal studies may not be replicated in humans and our ability
to maintain our Nasdaq listing. Important factors that could cause
actual results to differ materially from those in the
forward-looking statements include factors that are delineated in
our periodic reports on Form 10-K and Form 10-Q that we file with
the U.S. Securities and Exchange Commission. Any forward-looking
statement in this release speaks only as of the date of this
release. Inhibikase undertakes no obligation to publicly update or
revise any forward-looking statement, whether as a result of new
information, future developments or otherwise, except as may be
required by any applicable securities laws.
Contacts:
Company Contact:
Milton H.
Werner, PhD
President & CEO
678-392-3419
info@inhibikase.com
Investor Relations:
Alex
Lobo
SternIR, Inc.
alex.lobo@sternir.com
Inhibikase
Therapeutics, Inc.
Condensed
Consolidated Balance Sheets
|
|
|
|
|
|
March 31,
2023
|
|
|
December 31,
2022
|
|
|
|
(unaudited)
|
|
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and
cash equivalents
|
|
$
|
3,956,604
|
|
|
$
|
7,188,553
|
|
Marketable
securities
|
|
|
21,761,564
|
|
|
|
15,861,620
|
|
Accounts
receivable
|
|
|
64,521
|
|
|
|
39,881
|
|
Prepaid
research and development
|
|
|
923,128
|
|
|
|
1,117,616
|
|
Prepaid
expenses and other current assets
|
|
|
922,764
|
|
|
|
163,452
|
|
Total current
assets
|
|
|
27,628,581
|
|
|
|
24,371,122
|
|
Equipment
and improvements, net
|
|
|
231,489
|
|
|
|
236,532
|
|
Right-of-use asset
|
|
|
303,263
|
|
|
|
328,643
|
|
Total assets
|
|
$
|
28,163,333
|
|
|
$
|
24,936,297
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
959,078
|
|
|
$
|
1,151,173
|
|
Lease
obligation, current
|
|
|
146,901
|
|
|
|
145,836
|
|
Accrued
expenses and other current liabilities
|
|
|
1,558,221
|
|
|
|
2,398,436
|
|
Total current
liabilities
|
|
|
2,664,200
|
|
|
|
3,695,445
|
|
Lease
obligations, net of current portion
|
|
|
178,110
|
|
|
|
205,451
|
|
Total liabilities
|
|
|
2,842,310
|
|
|
|
3,900,896
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
Preferred stock, $0.001
par value; 10,000,000 shares authorized; 0 shares
issued and outstanding
at March 31, 2023 and December 31, 2022
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.001
par value; 100,000,000 shares authorized; 31,056,238
and 25,227,051 shares
issued and outstanding at March 31, 2023 and
December 31,
2022
|
|
|
31,056
|
|
|
|
25,227
|
|
Additional paid-in
capital
|
|
|
77,473,765
|
|
|
|
68,777,298
|
|
Accumulated other
comprehensive income
|
|
|
165,822
|
|
|
|
104,718
|
|
Accumulated
deficit
|
|
|
(52,349,620)
|
|
|
|
(47,871,842)
|
|
Total stockholders'
equity
|
|
|
25,321,023
|
|
|
|
21,035,401
|
|
Total liabilities and stockholders' equity
|
|
$
|
28,163,333
|
|
|
$
|
24,936,297
|
|
|
|
|
|
|
|
|
Inhibikase
Therapeutics, Inc.
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
(Unaudited)
|
|
|
|
|
|
Three Months
Ended
March 31,
|
|
|
|
2023
|
|
|
2022
|
|
Revenue:
|
|
|
|
|
|
|
Grant
revenue
|
|
$
|
64,521
|
|
|
$
|
46,031
|
|
Total
revenue
|
|
|
64,521
|
|
|
|
46,031
|
|
Costs and
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
|
2,854,119
|
|
|
|
3,016,991
|
|
Selling, general and
administrative
|
|
|
1,925,351
|
|
|
|
1,669,636
|
|
Total costs and
expenses
|
|
|
4,779,470
|
|
|
|
4,686,627
|
|
Loss from
operations
|
|
|
(4,714,949)
|
|
|
|
(4,640,596)
|
|
Interest income
(expense)
|
|
|
237,171
|
|
|
|
(5)
|
|
Net loss
|
|
|
(4,477,778)
|
|
|
|
(4,640,601)
|
|
Other comprehensive
income, net of tax
|
|
|
|
|
|
|
Unrealized gains
on marketable securities
|
|
|
61,104
|
|
|
|
—
|
|
Comprehensive
Loss
|
|
$
|
(4,416,674)
|
|
|
$
|
(4,640,601)
|
|
Net loss per
share – basic and diluted
|
|
$
|
(0.16)
|
|
|
$
|
(0.18)
|
|
Weighted-average number
of common shares – basic and diluted
|
|
|
27,510,077
|
|
|
|
25,205,454
|
|
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SOURCE Inhibikase Therapeutics, Inc.