Inhibikase Therapeutics Reports Second Quarter Financial Results and Highlights Recent Period Activity
14 Agosto 2024 - 3:25PM
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 second quarter ended June 30, 2024 and highlighted
recent developments.
“The first half of 2024 has showcased the
strength of our pipeline through the continued execution of key
milestones for both risvodetinib (risvo) and IkT-001Pro,” said Dr.
Milton H. Werner, President and Chief Executive Officer of
Inhibikase. “We completed enrollment of The 201 Trial evaluating
risvo in untreated Parkinson’s disease, and anticipate the last
patient exiting the study in September, 2024. We anticipate
reporting topline data in November, 2024. Additionally, 001Pro has
advanced as a potential treatment for Pulmonary Arterial
Hypertension (PAH). We have filed our IND and we intend to ramp up
the 702 trial following IND clearance. Finally, the manufacturing
requirements for 001Pro necessary for potential approval is
advancing with the on-going development of a scalable process.”
Recent Developments and Upcoming
Milestones:
- Completed enrollment of the
Phase 2 ‘201’ trial evaluating risvodetinib in untreated
Parkinson’s disease: On June 17, 2024, Inhibikase
announced that the final participant had been enrolled in The 201
Trial evaluating the safety and tolerability of risvodetinib as a
treatment in untreated Parkinson’s patients. The trial has enrolled
and randomized 126 patients total. The last patient will exit the
trial in September, 2024. As of July 29, 2024, 84 participants have
completed the 12-week dosing period. There have been 41 mild and 8
moderate adverse events observed that may be related to risvo
treatment. Six people withdrew from the trial without completing 12
weeks of treatment. Forty-six people have agreed to participate in
biomarker studies of the change in synuclein aggregate deposition
in the skin and seven have agreed to biomarker studies of the
status of synuclein aggregate in the spinal fluid.
- Expanded Pipeline with
advancement of IkT-001Pro as a therapy in Pulmonary Arterial
Hypertension: Following receipt of final meeting minutes
from Inhibikase’s pre-IND meeting with the FDA in May 2024, the
Company submitted its IND to the FDA and plans to begin ramp-up of
the Phase 2 702 trial to evaluate IkT-001Pro as a treatment for
PAH, subject to receipt of the Study May Proceed letter from the
FDA. In the final meeting minutes, the FDA stated that Inhibikase
had built a bridge between imatinib’s use in blood and
gastrointestinal cancers and PAH and that the Company’s Phase 2
design, to be known as the 702 trial, was reasonable. The Company
has completed the requested pre-clinical hERG safety study showing
that IkT-001Pro does not inhibit hERG and therefore is unlikely to
induce QTcF prolongation in treated patients. Imatinib has
previously been shown to induce QTcF prolongation in some
patients.The active ingredient in IkT-001Pro, imatinib, has
previously been shown to be disease-modifying for PAH. The Company
believes that 001Pro could have a more favorable safety and
tolerability profile compared to imatinib for this indication. If
approved, IkT-001Pro could be a branded product with all the value
drivers of a novel treatment for an indication with high unmet need
valued at $7.66 billion in 2023 according to global sales data from
Evaluate Pharma.
- Scaled manufacturing of
IkT-001Pro: Following the Company’s pre-NDA meeting with
the U.S. FDA in January 2024, Inhibikase scaled its process
development efforts for IkT-001Pro to support late-stage clinical
development and NDA batch requirements. Ongoing activities include
development of new dosage forms, a more efficient production
process and a high throughput tableting process that will lead to
dosage forms for 001Pro tablets that are differentiated from
generic imatinib mesylate in alignment with FDA feedback.
- Successfully raised $4.0
Million in a registered direct offering and concurrent private
placement: In May 2024, Inhibikase raised $4 million in
aggregate gross proceeds from its registered direct offering and
concurrent private placement. The Company is using the net proceeds
from the offering to progress risvodetinib towards its planned
Phase 3 trials in 2025 and completed pre-clinical studies requested
by the FDA that enabled the IND filing for 001Pro in PAH.
Second Quarter Financial
Results
Net Loss: Net loss for the quarter ended June
30, 2024, was $5.0 million, or $0.66 per share, compared to a net
loss of $5.8 million, or $0.94 per share in the quarter ended June
30, 2023. The net loss per share for the three and six months ended
June 30, 2023, was adjusted to show an improvement from ($1.11) to
($0.94) and from ($2.09) to ($1.74), respectively.
R&D Expenses: Research and development
expenses were $3.1 million for the quarter ended June 30, 2024
compared to $4.5 million in the quarter ended June 30, 2023. The
$1.5 million decrease in research and development expenses was due
to a decrease of $1.4 million in IkT-001Pro expenses due to the
completion of the three-part dose finding/dose equivalence study in
2023 and a net decrease of $0.1 million in other research and
development expenses.
SG&A Expenses: Selling, general and
administrative expenses for the quarter ended June 30, 2024 were
$2.0 million compared to $1.8 million for the quarter ended June
30, 2023. The $0.2 million increase was primarily driven by a $0.4
million increase legal and consulting fees partially offset by a
$0.1 million decrease in D&O insurance and a $0.1 million net
decrease in all other normal selling, general and administrative
expenses.
Cash Position: Cash, cash
equivalents and marketable securities were $7.9 million as of June
30, 2024. The Company expects that existing cash and cash
equivalents will be sufficient to fund operations into December,
2024.
Conference Call InformationThe
conference call is scheduled to begin at 8:00am ET on August 15,
2024. Participants should dial 1-877-407-0789 (United States) or
1-201-689-8562 (International). 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 Risvodetinib, 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 Abelson 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 for the treatment of certain
hematological or gastrointestinal cancers and in cardiopulmonary
disease. The Company's RAMP™ medicinal chemistry program has
identified several follow-on compounds to Risvodetinib that could
potentially be applied to other cognitive and motor function
diseases of the brain. Inhibikase is headquartered in Atlanta,
Georgia with offices in Lexington, Massachusetts.
Social Media
DisclaimerInvestors and others should note that the
Company announces material financial information to investors using
its investor relations website, press releases, SEC filings and
public conference calls and webcasts. The Company intends to also
use X, 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 StatementsThis
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. Important factors that could cause actual results to
differ materially from those in the forward-looking statements
include our ability to enroll and complete the 201 Trial evaluating
Risvodetinib in untreated Parkinson’s disease, to successfully
apply for and obtain FDA approval for IkT-001Pro in blood and
stomach cancers or other indications, to successfully conduct
clinical trials that are statistically significant and whether
results from our animal studies may be replicated in humans, as
well as such other factors that are included 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, PhDPresident &
CEO678-392-3419info@inhibikase.com
Investor Relations:Alex LoboPrecision
AQAlex.lobo@precisionaq.com
Inhibikase Therapeutics, Inc.Condensed Consolidated Balance
Sheets(Unaudited) |
|
|
June 30,2024 |
|
|
December 31,2023 |
|
|
(unaudited) |
|
|
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
3,086,455 |
|
|
$ |
9,165,179 |
Marketable securities |
|
|
4,853,559 |
|
|
|
4,086,873 |
Prepaid research and development |
|
|
306,300 |
|
|
|
219,817 |
Prepaid expenses and other current assets |
|
|
356,487 |
|
|
|
739,179 |
Total current assets |
|
|
8,602,801 |
|
|
|
14,211,048 |
Equipment and improvements, net |
|
|
60,235 |
|
|
|
73,372 |
Right-of-use asset |
|
|
163,762 |
|
|
|
222,227 |
Total assets |
|
$ |
8,826,798 |
|
|
$ |
14,506,647 |
Liabilities and
stockholders’ equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
1,340,538 |
|
|
$ |
646,767 |
Lease obligation, current |
|
|
152,224 |
|
|
|
150,095 |
Accrued expenses and other current liabilities |
|
|
2,034,525 |
|
|
|
2,259,955 |
Insurance premium financing payable |
|
|
177,256 |
|
|
|
381,784 |
Total current liabilities |
|
|
3,704,543 |
|
|
|
3,438,601 |
Lease obligation, net of current portion |
|
|
25,606 |
|
|
|
90,124 |
Total liabilities |
|
|
3,730,149 |
|
|
|
3,528,725 |
Commitments and
contingencies |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Preferred stock, $0.001 par
value; 10,000,000 shares authorized; 0 shares issued and
outstanding at June 30, 2024 and December 31, 2023 |
|
|
— |
|
|
|
— |
Common stock, $0.001 par value;
100,000,000 shares authorized; 7,216,145 and 6,186,280 shares
issued and outstanding at June 30, 2024 and December 31, 2023 |
|
|
7,216 |
|
|
|
6,186 |
Additional paid-in capital |
|
|
81,600,425 |
|
|
|
77,871,584 |
Accumulated other comprehensive
(loss) income |
|
|
(1,024 |
) |
|
|
877 |
Accumulated deficit |
|
|
(76,509,968 |
) |
|
|
(66,900,725 |
Total stockholders' equity |
|
|
5,096,649 |
|
|
|
10,977,922 |
Total liabilities and stockholders’ equity |
|
$ |
8,826,798 |
|
|
$ |
14,506,647 |
|
|
|
|
|
|
Inhibikase Therapeutics, Inc.Condensed Consolidated
Statements of Operations and Comprehensive
Loss(Unaudited) |
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Revenue: |
|
|
|
|
|
|
|
Grant revenue |
$ |
— |
|
$ |
116,410 |
|
$ |
— |
|
$ |
180,931 |
|
Total revenue |
|
— |
|
|
|
116,410 |
|
|
|
— |
|
|
|
180,931 |
|
Costs and expenses: |
|
|
|
|
|
|
|
Research and development |
|
3,075,830 |
|
|
4,535,698 |
|
|
5,827,109 |
|
|
7,389,817 |
|
Selling, general and administrative |
|
1,974,705 |
|
|
|
1,783,113 |
|
|
|
4,005,786 |
|
|
|
3,708,464 |
|
Total costs and expenses |
|
5,050,535 |
|
|
|
6,318,811 |
|
|
|
9,832,895 |
|
|
|
11,098,281 |
|
Loss from operations |
|
(5,050,535 |
) |
|
|
(6,202,401 |
) |
|
|
(9,832,895 |
) |
|
|
(10,917,350 |
) |
Interest income (expense) |
|
90,927 |
|
|
|
424,435 |
|
|
|
223,652 |
|
|
|
661,606 |
|
|
|
|
|
|
|
|
|
Net loss |
|
(4,959,608 |
) |
|
|
(5,777,966 |
) |
|
|
(9,609,243 |
) |
|
|
(10,255,744 |
) |
Other comprehensive income,
net of tax |
|
|
|
|
|
|
|
Unrealized (loss) gains on marketable securities |
|
776 |
|
|
|
(167,536 |
) |
|
|
(1,901 |
) |
|
|
(106,432 |
) |
Comprehensive Loss |
$ |
(4,958,832 |
) |
|
$ |
(5,945,502 |
) |
|
$ |
(9,611,144 |
) |
|
$ |
(10,362,176 |
) |
Net loss per share – basic and
diluted |
$ |
(0.66 |
) |
|
$ |
(0.94 |
) |
|
$ |
(1.38 |
) |
|
$ |
(1.74 |
) |
Weighted-average number of
common shares – basic and diluted |
|
7,535,667 |
|
|
|
6,162,280 |
|
|
|
6,939,779 |
|
|
|
5,883,895 |
|
Inhibikase Therapeutics (NASDAQ:IKT)
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