Inhibikase Therapeutics Announces Second Quarter 2025 Financial Results and Highlights Recent Activity
Inhibikase Therapeutics (Nasdaq: IKT) reported Q2 2025 financial results and provided updates on its PAH drug development program. The company is preparing to launch IMPROVE-PAH, a Phase 2b clinical study for IKT-001, their re-engineered prodrug of imatinib mesylate, in the second half of 2025.
The study will involve 150 PAH participants randomized to receive either 300mg IKT-001, 500mg IKT-001, or placebo. Previous studies showed imatinib's efficacy in PAH, with patients on 400mg achieving a 45-meter improvement in 6-minute walk distance. The company ended Q2 2025 with $87.7 million in cash and reported a net loss of $9.9 million ($0.11 per share).
Inhibikase Therapeutics (Nasdaq: IKT) ha comunicato i risultati finanziari del secondo trimestre 2025 e aggiornato il proprio programma di sviluppo per la PAH. L'azienda si sta preparando a lanciare IMPROVE-PAH, uno studio clinico di fase 2b su IKT-001, il loro profarmaco ristrutturato dell'imatinib mesilato, nella seconda metà del 2025.
Lo studio arruolerà 150 pazienti con PAH che verranno randomizzati a ricevere 300 mg di IKT-001, 500 mg di IKT-001 o placebo. Studi precedenti avevano mostrato l'efficacia dell'imatinib nella PAH, con pazienti trattati con 400 mg che hanno riportato un miglioramento di 45 metri nella distanza percorsa in 6 minuti. Al termine del Q2 2025 l'azienda disponeva di 87,7 milioni di dollari in contanti e ha riportato una perdita netta di 9,9 milioni di dollari (pari a 0,11 $ per azione).
Inhibikase Therapeutics (Nasdaq: IKT) informó los resultados financieros del segundo trimestre de 2025 y proporcionó actualizaciones sobre su programa de desarrollo para la PAH. La compañía se está preparando para lanzar IMPROVE-PAH, un estudio clínico de fase 2b para IKT-001, su profármaco rediseñado de imatinib mesilato, en la segunda mitad de 2025.
El estudio incluirá a 150 participantes con PAH asignados aleatoriamente para recibir 300 mg de IKT-001, 500 mg de IKT-001 o placebo. Estudios previos demostraron la eficacia del imatinib en PAH, con pacientes que recibieron 400 mg alcanzando una mejora de 45 metros en la distancia de caminar en 6 minutos. Al cierre del Q2 2025 la compañía contaba con 87,7 millones de dólares en efectivo y registró una pérdida neta de 9,9 millones de dólares (0,11 $ por acción).
Inhibikase Therapeutics (Nasdaq: IKT)는 2025년 2분기 재무실적을 발표하고 폐동맥고혈압(PAH) 약물 개발 프로그램에 대한 최신 상황을 공유했습니다. 회사는 2025년 하반기에 재설계된 이미티닙 메실산염 프로드럭인 IKT-001을 대상으로 하는 IMPROVE-PAH 2b상 임상시험을 개시할 준비를 하고 있습니다.
이 연구는 150명의 PAH 참여자를 등록해 300mg IKT-001, 500mg IKT-001 또는 플라세보를 무작위 배정할 예정입니다. 이전 연구에서는 이미티닙이 PAH에 효과를 보였으며, 400mg 투여 환자들은 6분 보행거리에서 45미터 향상을 달성했습니다. 2025년 2분기 말 기준 회사는 8,770만 달러의 현금을 보유하고 있었고 990만 달러의 순손실(주당 0.11달러)을 보고했습니다.
Inhibikase Therapeutics (Nasdaq: IKT) a publié ses résultats financiers du deuxième trimestre 2025 et fait le point sur son programme de développement contre l'HTAP. La société se prépare à lancer IMPROVE-PAH, une étude clinique de phase 2b portant sur IKT-001, son prodrogue réingénieré de l'imatinib mésylate, au second semestre 2025.
L'étude impliquera 150 participants atteints d'HTAP randomisés pour recevoir soit 300 mg d'IKT-001, soit 500 mg d'IKT-001, soit un placebo. Des études antérieures ont montré l'efficacité de l'imatinib dans l'HTAP, des patients sous 400 mg ayant obtenu une amélioration de 45 mètres à la distance parcourue en 6 minutes. À la fin du T2 2025, la société disposait de 87,7 millions de dollars en liquidités et a enregistré une perte nette de 9,9 millions de dollars (0,11 $ par action).
Inhibikase Therapeutics (Nasdaq: IKT) berichtete über die Finanzergebnisse des zweiten Quartals 2025 und gab Updates zu seinem PAH‑Entwicklungsprogramm. Das Unternehmen bereitet den Start von IMPROVE-PAH vor, einer Phase‑2b‑Studie zu IKT-001, ihrem neu entwickelten Prodrug des Imatinib‑mesylats, in der zweiten Jahreshälfte 2025.
Die Studie wird 150 PAH-Teilnehmer umfassen, die randomisiert entweder 300 mg IKT-001, 500 mg IKT-001 oder Placebo erhalten. Frühere Studien zeigten die Wirksamkeit von Imatinib bei PAH, wobei Patienten unter 400 mg eine Verbesserung von 45 Metern beim 6‑Minuten‑Gehtest erreichten. Zum Ende des Q2 2025 verfügte das Unternehmen über 87,7 Millionen US-Dollar in bar und meldete einen Nettoverlust von 9,9 Millionen US-Dollar (0,11 $ pro Aktie).
- Strong cash position of $87.7 million as of June 30, 2025
- Previous clinical data showed best-in-class 45-meter improvement in 6-minute walk distance
- Phase 2b trial protocol finalized with clear pathway forward
- Reduced net loss per share from $0.66 in Q2 2024 to $0.11 in Q2 2025
- Net loss increased to $9.9 million in Q2 2025 from $5.0 million in Q2 2024
- R&D expenses increased 71% year-over-year to $5.3 million
- SG&A expenses nearly tripled to $5.9 million from $2.0 million year-over-year
- Cash position decreased from $97.5 million to $87.7 million since December 2024
Insights
Inhibikase advancing IKT-001 to Phase 2b in PAH with strong efficacy potential, amid widening losses and solid $87.7M cash position.
Inhibikase is positioning IKT-001, their re-engineered prodrug of imatinib mesylate, for a Phase 2b trial in Pulmonary Arterial Hypertension (PAH) set to begin in H2 2025. The upcoming IMPROVE-PAH study will enroll approximately 150 PAH patients randomized to receive 300mg IKT-001, 500mg IKT-001, or placebo once daily for 26 weeks. The primary endpoint will measure change in pulmonary vascular resistance, with secondary endpoints including the 6-minute walk distance (6MWD).
The company's approach builds on compelling historical data showing imatinib's efficacy in PAH. In the IMPRES study, patients maintaining 400mg doses demonstrated a placebo-adjusted 45-meter improvement in 6MWD – representing best-in-class outcomes. Contemporary research also showed higher imatinib exposure correlates with greater improvements in total pulmonary resistance. IKT-001 aims to minimize GI side effects while preserving this efficacy profile.
Financially, Inhibikase reported $87.7 million in cash as of June 30, 2025, compared to $97.5 million at the end of 2024, reflecting a quarterly burn rate of approximately $5 million. The company's net loss widened to $9.9 million ($0.11/share) versus $5.0 million ($0.66/share) in Q2 2024. R&D expenses increased to $5.3 million from $3.1 million year-over-year, while SG&A expenses nearly tripled to $5.9 million from $2.0 million. The H1 expenses included a non-cash write-off of $7.4 million related to the CorHepta acquisition and $1.0 million in severance for senior executive transitions.
With their current cash position, Inhibikase appears adequately funded to complete the planned Phase 2b study, though the accelerating burn rate bears monitoring as clinical activities intensify.
IKT-001's PAH trial design leverages strong historical imatinib efficacy data while addressing tolerability issues that limited previous development.
The IMPROVE-PAH study design reveals Inhibikase's strategic approach to overcome the historical limitations of imatinib in PAH treatment. The 1:1:1 randomization to 300mg IKT-001, 500mg IKT-001, or placebo allows for dose-response evaluation while targeting exposures comparable to the previously efficacious imatinib doses. The company's bioequivalence studies determined that 500mg of IKT-001 provides similar exposure to 380mg of imatinib, positioning it near the 400mg dose that showed remarkable efficacy in prior studies.
The primary endpoint of pulmonary vascular resistance (PVR) is clinically meaningful and directly measures the hemodynamic improvements central to PAH pathophysiology. This focus on PVR aligns with recent research showing dose-dependent improvements in total pulmonary resistance with imatinib. The inclusion of 6MWD as a secondary endpoint connects to the historical 45-meter improvement seen with imatinib – a benefit that substantially exceeds typical improvements with current therapies.
The planned interim safety review after 12 weeks in at least 50 patients demonstrates appropriate risk management, particularly important given the GI tolerability issues that hindered imatinib's development for PAH despite its efficacy. The 26-week treatment duration provides sufficient time to demonstrate meaningful clinical benefits while balancing patient burden.
The scientific rationale is strengthened by multiple independent studies confirming imatinib's efficacy in PAH, including both the Phase 3 IMPRES trial and more recent mechanistic studies published in the American Journal of Respiratory and Critical Care Medicine. The anti-proliferative mechanism of this tyrosine kinase inhibitor directly addresses the vascular remodeling that characterizes PAH pathology, potentially offering disease-modifying benefits beyond the predominantly vasodilatory effects of current standard therapies.
BOSTON and ATLANTA, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension (“PAH”), today reported financial results for the quarter ended June 30, 2025 and highlighted recent developments.
“During our second quarter of 2025, we continued to position the Company to advance IKT-001 toward a late-stage clinical trial in PAH,” said Mark Iwicki, Chief Executive Officer of Inhibikase. “We have now finalized our study protocol, and we expect to initiate our Phase 2b clinical study of IKT-001, our re-engineered prodrug of imatinib mesylate, in PAH in the second half of 2025.”
Multiple studies including both Phase 2 and the Phase 3 IMPRES study previously demonstrated that imatinib mesylate (“imatinib”), an anti-proliferative tyrosine kinase inhibitor, was highly efficacious in PAH. Notably in the IMPRES study, patients that maintained 400 mg of imatinib for greater than
Recent Developments:
- Advancement of IKT-001 as a therapy in PAH:
- During the first half of 2025, the Company evaluated potential study designs and obtained feedback from various key opinion leaders before finalizing a clinical study protocol for its forthcoming Phase 2b study, known as IMPROVE-PAH.
- IMPROVE-PAH is a multi-center, randomized, double-blind, placebo-controlled study of approximately 150 PAH participants. Participants under IMPROVE-PAH will be randomized 1:1:1 to receive 300 mg IKT-001, 500 mg IKT-001, or placebo once daily for 26 weeks, in addition to stable background PAH therapy. The Company’s bioequivalence studies previously confirmed that 500 mg of IKT-001 has comparable exposure in humans to 380 mg of imatinib. The primary efficacy endpoint is change in pulmonary vascular resistance at Week 26. Secondary endpoints include 6MWD, World Health Organization functional class, and pharmacokinetics. The study protocol also includes an interim safety review for study continuance by the Data Safety Monitoring Board with at least 50 patients at 12-weeks of follow-up.
- The Company expects to initiate IMPROVE-PAH in the second half of 2025.
Financial Results
Cash Position: As of June 30, 2025, cash, cash equivalents and marketable securities were
Net Loss: Net loss for the quarter ended June 30, 2025, was
R&D Expenses: Research and development expenses were
SG&A Expenses: Selling, general and administrative expenses for the quarter ended June 30, 2025 were
About Inhibikase (www.inhibikase.com)
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, PAH, that arise from aberrant signaling through the Abelson Tyrosine Kinase, and type III receptor tyrosine kinases including platelet derived growth factor receptors and c-KIT. Our lead product candidate is IKT-001, a prodrug of imatinib mesylate, for PAH which is an orphan indication. PAH is a progressive, life-threatening disease characterized by pulmonary vascular remodeling and elevated pulmonary vascular resistance that affects approximately 50,000 Americans.
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 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 include, but are not limited to, statements that express the Company’s intentions, beliefs, expectations, strategies, predictions or any other statements related to the potential effects of IKT-001, the initiation of the Company’s Phase 2b trial of IKT-001 in PAH and the Company’s future activities, or future events or conditions. 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 trial to evaluate IKT-001 as a treatment for PAH, 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:
Investor Relations:
Michael Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
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| Inhibikase Therapeutics, Inc. Condensed Consolidated Balance Sheets (Unaudited) | ||||||||
| June 30, 2025 | December 31, 2024 | |||||||
| (unaudited) | (Note 3) | |||||||
| Assets | | |||||||
| Current assets: | | |||||||
| Cash and cash equivalents | $ | 77,742,669 | $ | 56,490,579 | ||||
| Marketable securities | 9,923,100 | 41,052,949 | ||||||
| Prepaid research and development | 138,855 | 81,308 | ||||||
| Deferred offering costs | 307,373 | — | ||||||
| Prepaid expenses and other current assets | 682,628 | 826,473 | ||||||
| Total current assets | 88,794,625 | 98,451,309 | ||||||
| Equipment and improvements, net | 23,687 | 47,100 | ||||||
| Right-of-use asset | 34,918 | 101,437 | ||||||
| Total assets | $ | 88,853,230 | $ | 98,599,846 | ||||
| Liabilities and stockholders’ equity | | |||||||
| Current liabilities: | | |||||||
| Accounts payable | $ | 2,703,554 | $ | 943,019 | ||||
| Lease obligation, current | 37,944 | 110,517 | ||||||
| Accrued expenses and other current liabilities | 3,145,888 | 2,680,030 | ||||||
| Contingent consideration liability | 2,912,159 | — | ||||||
| Total current liabilities | 8,799,545 | 3,733,566 | ||||||
| Total liabilities | 8,799,545 | 3,733,566 | ||||||
| Commitments and contingencies (see Note 16) | | |||||||
| Stockholders’ equity: | | | ||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 74,516 | 69,362 | ||||||
| Additional paid-in capital | 197,996,982 | 189,254,777 | ||||||
| Accumulated other comprehensive loss | (2,944 | ) | (37,248 | ) | ||||
| Accumulated deficit | (118,014,869 | ) | (94,420,611 | ) | ||||
| Total stockholders' equity | 80,053,685 | 94,866,280 | ||||||
| Total liabilities and stockholders’ equity | $ | 88,853,230 | $ | 98,599,846 | ||||
| Inhibikase Therapeutics, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) | ||||||||||||||||
| Three Months Ended June 30, | Six months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Costs and expenses: | ||||||||||||||||
| Research and development | $ | 5,270,967 | $ | 3,075,830 | $ | 15,784,546 | $ | 5,827,109 | ||||||||
| Selling, general and administrative | 5,919,731 | 1,974,705 | 11,169,022 | 4,005,786 | ||||||||||||
| Change in fair value contingent consideration | (358,420 | ) | — | (1,523,284 | ) | — | ||||||||||
| Total costs and expenses | 10,832,278 | 5,050,535 | 25,430,284 | 9,832,895 | ||||||||||||
| Loss from operations | (10,832,278 | ) | (5,050,535 | ) | (25,430,284 | ) | (9,832,895 | ) | ||||||||
| Interest income | 916,755 | 90,927 | 1,836,026 | 223,652 | ||||||||||||
| Net loss | (9,915,523 | ) | (4,959,608 | ) | (23,594,258 | ) | (9,609,243 | ) | ||||||||
| Other comprehensive income (loss), net of tax | ||||||||||||||||
| Unrealized gain (loss) on marketable securities | (1,977 | ) | 776 | 34,304 | (1,901 | ) | ||||||||||
| Comprehensive loss | $ | (9,917,500 | ) | $ | (4,958,832 | ) | $ | (23,559,954 | ) | $ | (9,611,144 | ) | ||||
| Net loss per share – basic and diluted | $ | (0.11 | ) | $ | (0.66 | ) | $ | (0.26 | ) | $ | (1.38 | ) | ||||
| Weighted-average number of shares – basic and diluted | 90,009,625 | 7,535,667 | 89,774,703 | 6,939,779 | ||||||||||||
| Inhibikase Therapeutics, Inc. Condensed Consolidated Statements of Cash Flows (Unaudited) | ||||||||
| Six months ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (23,594,258 | ) | $ | (9,609,243 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 36,812 | 13,137 | ||||||
| Stock-based compensation expense | 6,250,938 | 84,131 | ||||||
| Write-off of in-process research and development | 7,357,294 | — | ||||||
| Change in fair value of contingent consideration | (1,523,284 | ) | — | |||||
| Changes in operating assets and liabilities: | ||||||||
| Operating lease right-of-use assets | 66,519 | 58,465 | ||||||
| Prepaid expenses and other assets | 7,526 | 30,719 | ||||||
| Prepaid research and development | (57,547 | ) | (86,483 | ) | ||||
| Accounts payable | 1,592,656 | 875,701 | ||||||
| Operating lease liabilities | (72,573 | ) | (62,389 | ) | ||||
| Accrued expenses and other current liabilities | 258,156 | (225,430 | ) | |||||
| Net cash used in operating activities | (9,677,761 | ) | (8,921,392 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchases of equipment and improvements | (13,399 | ) | — | |||||
| Purchases of investments - marketable securities | — | (9,209,545 | ) | |||||
| Maturities of investments - marketable securities | 31,350,103 | 8,440,958 | ||||||
| Acquired in-process research and development | (438,624 | ) | — | |||||
| Net cash provided by (used in) investing activities | 30,898,080 | (768,587 | ) | |||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of common stock, pre-funded warrants and warrants, net of issuance costs | 150 | 3,611,255 | ||||||
| Issuance of common stock form exercise of stock options | 31,621 | — | ||||||
| Net cash provided by financing activities | 31,771 | 3,611,255 | ||||||
| Net increase (decrease) in cash and cash equivalents | 21,252,090 | (6,078,724 | ) | |||||
| Cash and cash equivalents at beginning of period | 56,490,579 | 9,165,179 | ||||||
| Cash and cash equivalents at end of period | $ | 77,742,669 | $ | 3,086,455 | ||||
| Supplemental disclosures of cash flow information | ||||||||
| Issuance costs | $ | — | $ | 1,203,350 | ||||
| Non cash investing and financing activities | ||||||||
| Non-cash financing costs | $ | — | $ | (181,930 | ) | |||
| CorHepta transaction costs | $ | 175,000 | $ | — | ||||
| Contingent consideration | $ | 2,912,159 | $ | — | ||||
| Deferred offering costs included in accounts payable and accrued expenses | $ | 307,373 | $ | — | ||||
FAQ
What are the key details of Inhibikase's IMPROVE-PAH Phase 2b trial?
How much cash does Inhibikase (IKT) have as of Q2 2025?
What was Inhibikase's (IKT) net loss for Q2 2025?
What were the previous clinical results for imatinib in PAH treatment?
When will Inhibikase (IKT) start its Phase 2b PAH trial?
