Inhibikase Therapeutics Announces Closing of up to $275 Million Financing and Advancement of IkT-001Pro into a Late Stage Clinical Trial in Pulmonary Arterial Hypertension
Inhibikase Therapeutics (Nasdaq: IKT) has closed a private placement of approximately $110 Million with potential aggregate financing of up to $275 Million. The funds will support the Phase 2b '702' trial of IkT-001Pro in Pulmonary Arterial Hypertension (PAH). IkT-001Pro, containing imatinib, is being developed as a New Molecular Entity and the first oral, potentially disease-modifying treatment for PAH, a rapidly fatal disease primarily affecting women aged 30-60.
The company has appointed four new Board members: Roberto Bellini (Independent Chairperson), Amit Munshi, Arvind Kush, and David Canner. This investment from top-tier healthcare funds recognizes IkT-001Pro's potential to improve PAH patients' lives by potentially addressing the safety and tolerability issues that prevented imatinib's approval over a decade ago.
Inhibikase Therapeutics (Nasdaq: IKT) ha chiuso un collocamento privato di circa 110 milioni di dollari con una potenziale raccolta complessiva di fino a 275 milioni di dollari. I fondi supporteranno il trial di Fase 2b '702' di IkT-001Pro per l'ipertensione arteriosa polmonare (PAH). IkT-001Pro, contenente imatinib, viene sviluppato come una Nuova Entità Molecolare e il primo trattamento orale, potenzialmente modificante la malattia per la PAH, una malattia rapidamente fatale che colpisce principalmente donne di età compresa tra 30 e 60 anni.
L'azienda ha nominato quattro nuovi membri del Consiglio: Roberto Bellini (Presidente Indipendente), Amit Munshi, Arvind Kush e David Canner. Questo investimento da fondi sanitari di alto livello riconosce il potenziale di IkT-001Pro nel migliorare la vita dei pazienti con PAH affrontando potenzialmente le questioni di sicurezza e tollerabilità che hanno impedito l'approvazione dell'imatinib oltre un decennio fa.
Inhibikase Therapeutics (Nasdaq: IKT) ha cerrado una colocación privada de aproximadamente 110 millones de dólares con una financiación agregada potencial de hasta 275 millones de dólares. Los fondos apoyarán el ensayo de Fase 2b '702' de IkT-001Pro para la hipertensión arterial pulmonar (PAH). IkT-001Pro, que contiene imatinib, se está desarrollando como una Nueva Entidad Molecular y el primer tratamiento oral, potencialmente modificador de la enfermedad para la PAH, una enfermedad rápidamente fatal que afecta principalmente a mujeres de entre 30 y 60 años.
La empresa ha nombrado cuatro nuevos miembros de la Junta: Roberto Bellini (Presidente Independiente), Amit Munshi, Arvind Kush y David Canner. Esta inversión de fondos de salud de primer nivel reconoce el potencial de IkT-001Pro para mejorar la vida de los pacientes con PAH al abordar potencialmente los problemas de seguridad y tolerabilidad que impidieron la aprobación del imatinib hace más de una década.
Inhibikase Therapeutics (Nasdaq: IKT)는 약 1억 1천만 달러의 사모펀드를 마감했으며, 최대 2억 7천5백만 달러의 잠재적 종합 재정 지원이 가능하다. 이 자금은 ‘702’ 2b상 임상 시험을 지원할 것이다 IkT-001Pro는 폐동맥 고혈압 (PAH)에 대해. imatinib이 포함된 IkT-001Pro는 신규 분자 실체로 개발되고 있으며, PAH에 대한 첫 번째 경구 복용 가능하며 잠재적으로 질병 수정 치료제이다. PAH는 주로 30세에서 60세 사이의 여성에게 급속도로 치명적인 질병이다.
회사는 새로운 이사 4명을 임명했다: Roberto Bellini(독립 의장), Amit Munshi, Arvind Kush, David Canner. 일류 의료 기금에서의 이 투자는 IkT-001Pro가 imatinib의 승인에 10년 이상 걸린 안전성과 내약성 문제를 해결함으로써 PAH 환자의 삶을 개선할 잠재력을 인식한 것이다.
Inhibikase Therapeutics (Nasdaq: IKT) a clôturé un placement privé d'environ 110 millions de dollars avec un financement global potentiel allant jusqu'à 275 millions de dollars. Les fonds soutiendront le procès de Phase 2b '702' de IkT-001Pro pour l'hypertension artérielle pulmonaire (PAH). IkT-001Pro, contenant de l'imatinib, est développé en tant que nouvelle entité moléculaire et le premier traitement oral, potentiellement modificateur de la maladie pour la PAH, une maladie rapidement fatale qui touche principalement les femmes âgées de 30 à 60 ans.
La société a nommé quatre nouveaux membres du Conseil : Roberto Bellini (président indépendant), Amit Munshi, Arvind Kush et David Canner. Cet investissement provenant de fonds de santé de premier plan reconnaît le potentiel d'IkT-001Pro à améliorer la vie des patients atteints de PAH en abordant potentiellement les problèmes de sécurité et de tolérabilité qui ont empêché l'approbation de l'imatinib il y a plus d'une décennie.
Inhibikase Therapeutics (Nasdaq: IKT) hat eine Private Placement von etwa 110 Millionen Dollar abgeschlossen, mit einer potenziellen Gesamterfinanzierung von bis zu 275 Millionen Dollar. Die Mittel werden die Phase 2b-Studie '702' von IkT-001Pro zur pulmonalen arteriellen Hypertonie (PAH) unterstützen. IkT-001Pro, das Imatinib enthält, wird als neue molekulare Entität und die erste orale, potenziell krankheitsmodifizierende Behandlung für PAH entwickelt, einer schnell tödlichen Erkrankung, die hauptsächlich Frauen im Alter von 30 bis 60 Jahren betrifft.
Das Unternehmen hat vier neue Vorstandsmitglieder ernannt: Roberto Bellini (Unabhängiger Vorsitzender), Amit Munshi, Arvind Kush und David Canner. Diese Investition aus erstklassigen Gesundheitsfonds erkennt das Potenzial von IkT-001Pro an, das Leben von PAH-Patienten zu verbessern, indem potenziell die Sicherheits- und Verträglichkeitsprobleme angegangen werden, die vor über einem Jahrzehnt die Zulassung von Imatinib verhinderten.
- Secured $110 Million in private placement with potential for up to $275 Million
- Advancing IkT-001Pro into Phase 2b trial for Pulmonary Arterial Hypertension
- Appointed four experienced biopharmaceutical leaders to the Board of Directors
- Potential to be the first oral, disease-modifying treatment for PAH
- Previous attempts with imatinib had unacceptable safety and tolerability profile
- Two board members resigned (Gisele Dion and Dr. Paul Grint)
Insights
This financing deal is a significant development for Inhibikase Therapeutics. The company has secured
The investment from "top tier dedicated healthcare investment funds" signals strong confidence in IkT-001Pro's potential. The addition of experienced biopharmaceutical leaders to the board, including former executives from successful companies like BELLUS Health and Arena Pharmaceuticals, brings valuable expertise and industry connections.
For investors, this news indicates a significant de-risking of Inhibikase's near-term operations and a clear path forward for its lead candidate. However, it's important to note that the full
IkT-001Pro represents a potentially groundbreaking approach to treating PAH, a rare but serious condition primarily affecting women aged 30-60. The drug aims to be the first oral, disease-modifying treatment for PAH, which could be a significant advancement over current therapies that primarily manage symptoms.
The active ingredient, imatinib, has shown promise in improving heart health and clinical outcomes in PAH patients. However, its previous formulation had safety and tolerability issues. Inhibikase's approach with IkT-001Pro aims to overcome these hurdles, potentially offering a more viable treatment option.
The advancement to a Phase 2b trial is a important step in clinical development. If successful, it could position Inhibikase as a leader in PAH treatment. However, investors should remain cautious as Phase 2b results are still pending and drug development carries inherent risks, especially in complex diseases like PAH.
-- IkT-001Pro to be developed as a New Molecular Entity as the first oral, potentially disease-modifying treatment for a rapidly fatal disease primarily afflicting women between the ages of 30 and 60 --
BOSTON and ATLANTA, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Cardiopulmonary and Neurodegenerative disease through Abelson Tyrosine Kinase inhibition, today announced the closing of a private placement of approximately
“This transformational financing for Inhibikase is a testament to the Company’s persistent scientific and medical focus to develop disease-modifying therapeutics that could improve the lives of millions of patients afflicted with cardiopulmonary and neurodegenerative diseases,” noted Dr. Milton Werner, President and Chief Executive of Inhibikase. “Imatinib, the active ingredient in IkT-001Pro, had previously been shown to provide significant clinical benefit and improve heart health as an oral, once a day therapy, albeit with an unacceptable safety and tolerability profile. We believe imatinib delivered as IkT-001Pro has the potential to ameliorate the safety and tolerability profile that precluded approval of imatinib more than 10 years ago. With this investment, top tier dedicated healthcare investment funds recognized the potential of IkT-001Pro to improve the lives of patients afflicted with PAH. As with risvodetinib in Parkinson’s-related diseases, IkT-001Pro is a product of the Company’s innovative medicinal chemistry program that designs and develops novel kinase inhibitor therapeutics.”
Concurrent with the closing of this financing, three highly accomplished leaders in biopharmaceutical development and a Partner of Soleus Capital with deep experience in financing cardiopulmonary therapeutics development will join the Board of Directors at the closing of this transaction. Roberto Bellini (former Chief Executive of BELLUS Health Inc. and current Managing Partner of BSQUARED Capital), Amit Munshi (current Chief Executive of Orna Therapeutics and former CEO of Arena Pharmaceuticals), Arvind Kush (current CFO of Candid Therapeutics and former CFO of RayzeBio) and David Canner (Partner at Soleus Capital) have been appointed to the Inhibikase Board of Directors. In addition to joining the Board of Directors, Messers. Bellini, Munshi and Kush will each participate in the transaction. Mr. Bellini has been appointed Independent Chairperson of the Inhibikase Board coincident with the closing. In addition to these new Board members, Ms. Gisele Dion, Chair of the Audit Committee and Dr. Paul Grint, Chair of the Compensation Committee, have resigned from their service on the Board. The Company is grateful for their dedicated service, their thoughtful guidance and efforts that were an integral part of the program advancements leading to this investment.
“I am excited about IkT-001Pro as a potential treatment for PAH patients,” noted Mr. Bellini. “I look forward to leveraging my recent experience at BELLUS Health to support the company’s strategic growth.”
“I want to express my excitement to join the Inhibikase Board at this transformative moment for the company,” said Mr. Munshi. “Inhibikase, under Dr. Werner’s leadership, is poised to create a fundamental shift in the lives of patients suffering from these debilitating and fatal diseases,” said Mr. Munshi.
“This financing is an important milestone for Inhibikase, and I’m thrilled to be joining the Board,” added Mr. Kush. “The capital from top tier investors is transformative and will enable the rapid development of IkT-001Pro for PAH.”
About Roberto Bellini
Roberto Bellini is currently a Managing Partner at BSQUARED Capital, a family office biotech fund. He previously served as President and CEO of BELLUS Health between January 2010 and July 2023. Under his leadership BELLUS Health developed camlipixant, a P2X3 antagonist for chronic cough from preclinical to Phase 3. BELLUS Health was subsequently acquired by GSK plc in 2023. Mr. Bellini holds a Bachelor of Science in Biochemistry from McGill University.
About Amit Munshi
Amit Munshi is a 30-year industry veteran who is currently Chief Executive Officer of Orna Therapeutics and former President, Chief Executive Officer and board member of ReNAgade Therapeutics. Previously Mr. Munshi served as President and CEO of Arena Pharmaceuticals Inc., which was subsequently sold to Pfizer, Inc.
About Arvind Kush
Arvind Kush, the Chief Financial and Chief Business Officer of Candid Therapeutics, has over 15 years of finance and investment banking experience. Prior to Candid, Arvind was Chief Financial Officer at RayzeBio, where he helped the company raise over
About David Canner
David Canner is a Partner at Soleus Capital. David has served on the board for a number of companies. Prior to joining Soleus in 2018, David completed his PhD at MIT in Biology after finishing his undergraduate studies at Princeton University where he received a BA in Chemistry.
About IkT-001Pro
IkT-001Pro is a prodrug formulation of imatinib mesylate and has been developed to improve the safety of the first FDA-approved Abelson (Abl) kinase inhibitor, imatinib (originally marketed as Gleevec®). Imatinib is commonly taken for hematological and gastrointestinal cancers that arise from Abl kinase mutations found in the bone marrow or for gastrointestinal cancers that arise from c-Kit and/or PDGFRa/b mutations in the stomach; c-Kit, PDGFRa/b and Abl are all members of the Abelson Tyrosine Kinase protein family. In a previously published Phase 3 trial (the IMPRES trial, published in 2013 in the journal Circulation, volume 127, pages 1128-1138), imatinib was shown to induce a clinically meaningful improvement in 6 minute walking distance (6MWD) of approximately 40 meters and reduce pulmonary vascular resistance by more than 300 dyne-sec/cm, improve other measures of heart health and approximately
The securities (including the shares of common stock underlying the pre-funded warrants and warrants) were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and have not been registered under the Securities Act, or any state or other applicable jurisdictions’ securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.
About Inhibikase (www.inhibikase.com)
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing Abelson Tyrosine Kinase inhibitor therapeutics for Cardiopulmonary and Neurodegenerative disease. Inhibikase's multi-therapeutic pipeline includes its neurodegenerative disease portfolio led by risvodetinib in Parkinson’s disease, Multiple System Atrophy and other diseases that may arise from alpha-synuclein aggregate formation. Inhibikase’s cardiopulmonary disease portfolio is led by IkT-001Pro, a prodrug of imatinib mesylate, for Pulmonary Arterial Hypertension that will deliver imatinib in a form 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 clinical trials with risvodetinib or IkT-001Pro that demonstrate a statistically significant clinical benefit to the trial participants 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, PhD
President & CEO
678-392-3419
info@inhibikase.com
Investor Relations:
Michael Moyer
Life Science Advisors
617-308-4306
mmoyer@lifesciadvisors.com
FAQ
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