Inhibikase Therapeutics Reports Third Quarter Financial Results and Highlights Recent Activity
Inhibikase Therapeutics (IKT) reported Q3 2024 financial results and secured transformative financing of up to $275 million from healthcare investors. The company received a Study May Proceed letter for IkT-001Pro in Pulmonary Arterial Hypertension (PAH) and added four new board members. Q3 net loss was $5.8 million ($0.65/share), with R&D expenses at $4.2 million and SG&A at $1.6 million. Cash position was $3.2 million as of September 30, excluding the recent $110 million private placement. The company expects topline data from the Phase 2 201 Trial of risvodetinib in Parkinson's disease in Q4 2024.
Inhibikase Therapeutics (IKT) ha riportato i risultati finanziari del terzo trimestre del 2024 e ha ottenuto finanziamenti trasformativi fino a 275 milioni di dollari da investitori nel settore sanitario. L'azienda ha ricevuto una lettera di autorizzazione per lo studio di IkT-001Pro per l'ipertensione arteriosa polmonare (PAH) e ha aggiunto quattro nuovi membri al consiglio. La perdita netta nel terzo trimestre è stata di 5,8 milioni di dollari (0,65 dollari per azione), con spese di R&S pari a 4,2 milioni di dollari e spese generali e amministrative a 1,6 milioni di dollari. La posizione di cassa ammontava a 3,2 milioni di dollari al 30 settembre, escludendo il recente collocamento privato di 110 milioni di dollari. L'azienda si aspetta i dati preliminari della fase 2 del Trial 201 di risvodetinib nella malattia di Parkinson nel quarto trimestre del 2024.
Inhibikase Therapeutics (IKT) reportó los resultados financieros del tercer trimestre de 2024 y aseguró un financiamiento transformador de hasta 275 millones de dólares de inversionistas en el sector salud. La compañía recibió una carta de avance del estudio para IkT-001Pro en hipertensión arterial pulmonar (PAH) y añadió cuatro nuevos miembros a su junta directiva. La pérdida neta del tercer trimestre fue de 5.8 millones de dólares (0.65 dólares/acción), con gastos en I+D de 4.2 millones de dólares y gastos generales y administrativos de 1.6 millones de dólares. La posición de efectivo era de 3.2 millones de dólares al 30 de septiembre, excluyendo la reciente colocación privada de 110 millones de dólares. La compañía espera obtener datos preliminares del estudio de fase 2, el Trial 201 de risvodetinib en la enfermedad de Parkinson, en el cuarto trimestre de 2024.
Inhibikase Therapeutics (IKT)는 2024년 3분기 재무 결과를 발표하고, 의료 투자자로부터 최대 2억 7천5백만 달러의 변혁적 자금을 확보했습니다. 이 회사는 폐동맥 고혈압(PAH) 치료를 위한 IkT-001Pro에 대해 '연구 진행 가능' 통지를 받았으며, 이사회의 새로운 멤버 4명을 추가했습니다. 3분기 순손실은 580만 달러(주당 0.65달러)였으며, 연구개발비는 420만 달러, 일반 관리비는 160만 달러였습니다. 9월 30일 기준 현금 보유액은 최근의 1억 1천만 달러의 개인 거래를 제외하고 320만 달러였습니다. 이 회사는 2024년 4분기에 파킨슨병 치료를 위한 리스보데티닙의 2상 201 시험에서 주요 데이터를 기대하고 있습니다.
Inhibikase Therapeutics (IKT) a annoncé les résultats financiers du troisième trimestre 2024 et a sécurisé un financement transformateur de jusqu'à 275 millions de dollars de la part d'investisseurs en santé. L'entreprise a reçu une lettre d'autorisation pour procéder à l'étude de IkT-001Pro dans l'hypertension artérielle pulmonaire (PAH) et a ajouté quatre nouveaux membres au conseil d'administration. La perte nette pour le troisième trimestre s'élevait à 5,8 millions de dollars (0,65 dollar/action), avec des dépenses de recherche et développement de 4,2 millions de dollars et des frais généraux et administratifs de 1,6 million de dollars. La position de trésorerie était de 3,2 millions de dollars au 30 septembre, excluant le récent placement privé de 110 millions de dollars. L'entreprise s'attend à des données principales de l'essai de phase 2, le Trial 201 de risvodetinib dans la maladie de Parkinson, au quatrième trimestre 2024.
Inhibikase Therapeutics (IKT) hat die finanziellen Ergebnisse für das 3. Quartal 2024 veröffentlicht und transformative Finanzierungen von bis zu 275 Millionen Dollar von Gesundheitsinvestoren gesichert. Das Unternehmen erhielt einen Brief zur Genehmigung des Studienfortschritts für IkT-001Pro bei pulmonaler arterieller Hypertension (PAH) und fügte vier neue Vorstandsmitglieder hinzu. Der Nettoverlust im 3. Quartal betrug 5,8 Millionen Dollar (0,65 Dollar/Aktie), mit Forschungs- und Entwicklungskosten von 4,2 Millionen Dollar und allgemeinen Verwaltungsaufwendungen von 1,6 Millionen Dollar. Die Liquiditätsposition lag am 30. September bei 3,2 Millionen Dollar, ohne die kürzliche Privatplatzierung von 110 Millionen Dollar. Das Unternehmen erwartet im 4. Quartal 2024 wichtige Daten aus der Phase-2-Studie 201 von Risvodetinib bei Parkinson.
- Secured significant financing of up to $275 million, including $110 million immediate private placement
- Received FDA Study May Proceed letter for IkT-001Pro PAH trial
- High trial completion rate with 120 of 126 patients completing the Phase 2 201 Trial
- Increased net loss to $5.8 million in Q3 2024 from $4.6 million in Q3 2023
- R&D expenses increased to $4.2 million from $3.23 million year-over-year
- Low cash position of $3.2 million as of September 30, 2024
Insights
The
Q3 financials show increased R&D spend at
The advancement of IkT-001Pro into late-stage trials for Pulmonary Arterial Hypertension (PAH) represents a significant opportunity. The prodrug approach to imatinib delivery could overcome the previous safety and tolerability issues that prevented its approval for PAH a decade ago. The FDA's Study May Proceed letter and manufacturing process enhancements align with regulatory requirements for differentiation from generic imatinib mesylate.
The addition of experienced biotech executives to the board, particularly those with successful exit experience like Roberto Bellini (BELLUS Health) and Amit Munshi (Arena Pharmaceuticals), brings valuable late-stage development and commercialization expertise.
-- Transformative Financing worth up to
-- Advancement of IkT-001Pro into a Late-Stage Clinical Trial Program in Pulmonary Arterial Hypertension --
--201 Trial Results to be reported in 4Q2024 --
BOSTON and ATLANTA, Nov. 14, 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 reported financial results for the third quarter ended September 30, 2024 and highlighted recent developments.
“The financing we concluded in October was a transformational moment for Inhibikase, and positioned us to advance IkT-001Pro into a late-stage clinical trial in Pulmonary Arterial Hypertension (PAH),” said Dr. Milton Werner, President and Chief Executive of Inhibikase. “This investment, with top tier dedicated healthcare investment funds, recognized the potential of IkT-001Pro to improve the lives of patients afflicted with PAH. We believe IkT-001Pro, a prodrug of imatinib, has the potential to ameliorate the safety and tolerability profile that precluded approval of imatinib for the treatment of PAH more than 10 years ago. This investment further validates the Company’s innovative approach to the development of kinase inhibitor therapeutics in the non-oncology setting.”
Recent Developments and Upcoming Milestones:
- Closed up to
$275 million financing in October 2024 in support of advancing IkT-001Pro into a late-stage clinical trial in PAH- Private placement of approximately
$110 million from the issuance and sale of shares of the Company’s common stock and accompanying warrants with potential aggregate financing of up to approximately$275 million upon the full cash exercise of the warrants issued in the private placement, before deducting placement fees and offering expenses. The financing will fund execution of the Phase 2b ‘702’ trial in Pulmonary Arterial Hypertension (PAH) and general corporate purposes.
- Private placement of approximately
- Added three highly accomplished leaders in biopharmaceutical development and a Partner of Soleus Capital to the Board of Directors coincident with the financing:
- Roberto Bellini, Managing Partner of BSQUARED Capital and former Chief Executive Officer of BELLUS Health Inc.
- Amit Munshi, Chief Executive Officer of Orna Therapeutics and former CEO of Arena Pharmaceuticals,
- Arvind Kush, Chief Financial Officer and Chief Business Officer of Candid Therapeutics and former CFO of RayzeBio
- David Canner, Partner at Soleus Capital
- In addition to joining the Board of Directors, Messers. Bellini, Munshi and Kush each participated in the financing; Mr. Bellini has been appointed Independent Chairperson of the Inhibikase Board.
- Advancement of IkT-001Pro as a therapy in Pulmonary Arterial Hypertension:
- The Company received its Study May Proceed letter on September 9, 2024.
- The active ingredient in IkT-001Pro, imatinib, has previously been shown to be disease-modifying for PAH. The Company believes that IkT-001Pro could have a more favorable safety and tolerability profile compared to imatinib for this indication.
- Following the Company’s pre-NDA meeting with the FDA in January 2024, Inhibikase enhanced its manufacturing process development efforts for IkT-001Pro to support late-stage clinical development. 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.
- The last patient and last visit in the Phase 2 201 Trial evaluating risvodetinib (also known as IkT-148009) in untreated Parkinson’s disease occurred in October, 2024; topline data is expected in the fourth quarter of 2024. The trial randomized 126 patients total, 120 of which completed the 12 week double blind dosing period.
Third Quarter Financial Results
Net Loss: Net loss for the quarter ended September 30, 2024, was
R&D Expenses: Research and development expenses were
SG&A Expenses: Selling, general and administrative expenses for the quarter ended September 30, 2024 were
Cash Position: Cash, cash equivalents and marketable securities were
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 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. Inhibikase's neurodegenerative disease portfolio is led by risvodetinib, a selective c-Abl inhibitor to treat Parkinson’s and Parkinson’s-related disease. 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 commence and execute a Phase 2b ‘702’ trial to evaluate IkT-001Pro as a treatment for Pulmonary Arterial Hypertension (PAH), whether our top line data from our Phase 2 201 Trial evaluating risvodetinib in untreated Parkinson’s disease will show a statistically significant clinical benefit to trial participants, 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
LifeSci Advisors
mmoyer@lifesciadvisors.com
| Inhibikase Therapeutics, Inc. Condensed Consolidated Balance Sheets (Unaudited) | ||||||||
| September 30, 2024 | December 31, 2023 | |||||||
| (unaudited) | (Note 2) | |||||||
| Assets | | |||||||
| Current assets: | | |||||||
| Cash and cash equivalents | $ | 913,420 | $ | 9,165,179 | ||||
| Marketable securities | 2,330,226 | 4,086,873 | ||||||
| Prepaid research and development | 112,225 | 219,817 | ||||||
| Deferred offering costs | 553,318 | — | ||||||
| Prepaid expenses and other current assets | 280,914 | 739,179 | ||||||
| Total current assets | 4,190,103 | 14,211,048 | ||||||
| Equipment and improvements, net | 53,667 | 73,372 | ||||||
| Right-of-use asset | 133,105 | 222,227 | ||||||
| Total assets | $ | 4,376,875 | $ | 14,506,647 | ||||
| Liabilities and stockholders’ equity | | |||||||
| Current liabilities: | | |||||||
| Accounts payable | $ | 2,529,220 | $ | 646,767 | ||||
| Lease obligation, current | 145,210 | 150,095 | ||||||
| Accrued expenses and other current liabilities | 2,161,374 | 2,259,955 | ||||||
| Insurance premium financing payable | 71,662 | 381,784 | ||||||
| Total current liabilities | 4,907,466 | 3,438,601 | ||||||
| Lease obligation, net of current portion | — | 90,124 | ||||||
| Total liabilities | 4,907,466 | 3,528,725 | ||||||
| Commitments and contingencies (see Note 13) | | |||||||
| Stockholders’ equity: | | | ||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 7,464 | 6,186 | ||||||
| Additional paid-in capital | 81,748,225 | 77,871,584 | ||||||
| Accumulated other comprehensive (loss) income | 1,754 | 877 | ||||||
| Accumulated deficit | (82,288,034 | ) | (66,900,725 | ) | ||||
| Total stockholders' equity | (530,591 | ) | 10,977,922 | |||||
| Total liabilities and stockholders’ (deficit) equity | $ | 4,376,875 | $ | 14,506,647 | ||||
| Inhibikase Therapeutics, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Revenue: | |||||||||||||||
| Grant revenue | $ | — | $ | 79,569 | $ | — | $ | 260,500 | |||||||
| Total revenue | — | 79,569 | — | 260,500 | |||||||||||
| Costs and expenses: | |||||||||||||||
| Research and development | 4,189,873 | 3,225,551 | 10,016,982 | 10,615,368 | |||||||||||
| Selling, general and administrative | 1,637,603 | 1,622,894 | 5,643,386 | 5,331,358 | |||||||||||
| Total costs and expenses | 5,827,476 | 4,848,445 | 15,660,368 | 15,946,726 | |||||||||||
| Loss from operations | (5,827,476 | ) | (4,768,876 | ) | (15,660,368 | ) | (15,686,226 | ) | |||||||
| Interest income (expense) | 49,410 | 173,677 | 273,059 | 835,283 | |||||||||||
| Net loss | (5,778,066 | ) | (4,595,199 | ) | (15,387,309 | ) | (14,850,943 | ) | |||||||
| Other comprehensive loss, net of tax | |||||||||||||||
| Unrealized gains (loss) on marketable securities | 2,778 | 1,571 | 877 | (104,861 | ) | ||||||||||
| Comprehensive Loss | $ | (5,775,288 | ) | $ | (4,593,628 | ) | $ | (15,386,432 | ) | $ | (14,955,804 | ) | |||
| Net loss per share – basic and diluted | $ | (0.65 | ) | $ | (0.75 | ) | $ | (2.03 | ) | $ | (2.48 | ) | |||
| Weighted-average number of common shares – basic and diluted | 8,882,570 | 6,162,671 | 7,592,103 | 5,977,841 | |||||||||||
FAQ
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