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Inhibikase Therapeutics Issues Letter to Shareholders and Provides Update on Development Programs BOSTON and ATLANTA

Key Takeaway: Inhibikase Therapeutics has provided an update on its development programs, highlighting that the enrollment for its 201 Trial is 75% complete, with expectations to finish by mid-June 2024. The company has been engaging positively with the FDA regarding IkT-001Pro and plans to initiate a 12-month extension study. Additionally, Inhibikase is exploring new indications for IkT-001Pro, including potential applications in cardiopulmonary diseases and Multiple System Atrophy. Despite these advancements, the company highlighted the need for further financial resources to support these initiatives.

Market Sentiment Analysis

POSITIVE FACTORS

  • Approximately 75% of enrollment completed for the 201 Trial.
  • Constructive interactions with the FDA regarding IkT-001Pro.
  • Progress towards initiating a 12-month extension study for the 201 Trial.
  • Three new potential indications being explored for IkT-001Pro.

CONCERNS & RISKS

  • Need for additional financial resources to conduct the extension study.
  • Uncertainty regarding the ability to complete enrollment on time.
  • Significant doubt regarding the company's ability to continue as a going concern, as mentioned in the forward-looking statements.

Full Press Release Details

Inhibikase Therapeutics Issues Letter to Shareholders and Provides Update on Development Programs
BOSTON and ATLANTA, April 18, 2024 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 issued a Letter to Shareholders.
Dear Fellow Shareholders of Inhibikase Therapeutics:
2024 has been off to a productive start for Inhibikase. Our 201 Trial is approximately 75% enrolled, with the last patient anticipated to enter the trial in
June. We have had consistent and constructive interactions with the U.S. Food and Drug Administration for IkT-001Pro, culminating in the recent completion of a pre-IND
meeting as we evaluate 001Pro s potential in cardiopulmonary disease and a pre-NDA meeting with relation to the cancer indications for which imatinib is approved. As we look forward, we recognize the
urgency to initiate the 12-month extension study for our 201 trial, and we are planning our end of Phase 2 meeting with the FDA in Parkinson s and developing our Phase 3 protocols. In addition, we
continue to evaluate potential pathways to initiate a Phase 2/3 trial in Multiple System Atrophy and continue to explore multiple indications for which IkT-001Pro could be a novel new agent.
In neurodegeneration, the combined efforts of our internal team, site investigators and staff as well as our digital media campaign through the201trial.com
has enabled us to efficiently enroll participants across all 32 open sites. We have only 30 patients left to enroll as of April 18, 2024, and we expect to complete enrollment in approximately mid-June.
Looking ahead, the initiation of the extension to the 201 Trial of up to 12 months is an essential activity to evaluate long-term effects of risvodetinib on safety, tolerability, biomarkers and whether improvements in motor and non-motor function will be realized, which will require additional financial resources. Emerging biomarker data from the 201 Trial evaluating pathological alpha-synuclein in multiple tissues and fluids supported our
recent grant submissions to the National Institute of Neurological Disease and Stroke (NINDS), an Institute of the National Institutes of Health (NIH). One of these grants, if approved, will introduce our newly developed monoclonal antibody to track
phospho-Tyr39-alpha-synuclein in the clinical trial setting, which we believe will enhance the meaning of biomarker measurements. We believe the utilization
of this antibody in tissue biopsy and fluid analysis will enable us to confirm target engagement and evaluate the effect of risvodetinib on the underlying pathology responsible for disease. Upon completion of the double-blinded phase of the 201
Trial, we expect to request an end of Phase 2 meeting with the FDA by the end of 2024, which further accelerates our goal to begin enrolling the extension study as soon as possible.
As we continue to explore the breadth of potential indications for IkT-001Pro, we believe that there is an opportunity
worth exploring for Pulmonary Arterial Hyptertension (PAH). Imatinib was shown to be a disease-modifying treatment for PAH more than 10 years ago, however, unfavorable safety and tolerability precluded its approval at that time. Changes to standard-of-care for these patients coupled with the exclusion of anti-coagulant use and the potentially more favorable tolerability profile of 001Pro over imatinib mesylate
suggests to us that 001Pro could offer an alternative path to success in this area. Our recent pre-IND meeting with the FDA was constructive and we expect to provide an update from this meeting following
receipt of the formal meeting minutes. If considered a new molecular entity for PAH, IkT-001Pro might enjoy a long period of patent exclusivity.
3350 Riverwood Parkway SE, Ste 1900 1 Cranberry Hill, Suite 200
Atlanta, GA 30339 Lexington, MA 02421
678-392-3419 info@inhibikase.com 617-936-0184
Altogether, 2024 is shaping up to be a year of execution across our portfolio. We believe our work to date
supports the continued development of both risvodetinib and 001Pro, and we appreciate the support of our shareholders as we continue on this journey to bring transformative treatments for patients across our therapeutic pipeline.
Milton H. Werner, PhD.
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. 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 Disclaimer
Investors 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 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. 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, whether results from our animal studies may be replicated in humans, our need for additional capital especially to conduct the 12 month extension study of our
201 trial, the substantial doubt regarding our ability to continue as a going concern, 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.
3350 Riverwood Parkway SE, Ste 1900 1 Cranberry Hill, Suite 200
Atlanta, GA 30339 Lexington, MA 02421
678-392-3419 info@inhibikase.com 617-936-0184
Milton H. Werner, PhD
3350 Riverwood Parkway SE, Ste 1900 1 Cranberry Hill, Suite 200
Atlanta, GA 30339 Lexington, MA 02421
678-392-3419 info@inhibikase.com 617-936-0184

Frequently Asked Questions

What is the primary focus of Inhibikase Therapeutics?

Inhibikase focuses on developing therapeutics for Parkinson's disease and related disorders.

When is the projected completion of the 201 Trial enrollment?

The enrollment for the 201 Trial is expected to complete by mid-June 2024.

What updates does Inhibikase provide about IkT-001Pro?

IkT-001Pro is being evaluated for its potential in cardiopulmonary disease and cancer.

What is the significance of the monoclonal antibody in trials?

The monoclonal antibody aims to enhance biomarker measurements in clinical trials.

How does Inhibikase plan to support its ongoing studies?

Inhibikase will seek additional financial resources for the 12-month extension study.

Last updated: Apr 18, 2024