Inhibikase Therapeutics(IKT) - 2025 Q1 - Quarterly Results

First Quarter 2025 Earnings Release Overview Inhibikase Therapeutics reported Q1 2025 results, highlighting IKT-001's advancement for PAH into a late-stage clinical trial program Company Announcement and Strategic Focus Inhibikase reported Q1 2025 results, advancing IKT-001 for PAH into a late-stage clinical trial, targeting Phase 2b initiation in H2 2025 - Inhibikase Therapeutics is a clinical-stage pharmaceutical company focused on small molecule kinase inhibitor therapeutics to treat pulmonary arterial hypertension (PAH)[1] - The company is advancing IKT-001 into a late-stage clinical trial program in PAH[1] - The Phase 2b clinical study of IKT-001 in PAH is well placed to initiate in the second half of 2025[2] - IKT-001 is believed to provide strong efficacy and be well tolerated for PAH patients, building on previous IMPRES Phase 3 study results for imatinib mesylate[2] Recent Corporate Developments Inhibikase announced key senior leadership appointments and refined the study design for the upcoming Phase 2b clinical study of IKT-001 in PAH - New senior leadership appointments include Mark Iwicki (CEO), Chris Cabell (President and Head of Research & Development), John Adams (Chief Scientific Officer), and David McIntyre (Chief Financial Officer)[8] - The company is refining the study design for the forthcoming Phase 2b clinical study of IKT-001 in PAH with key opinion leaders and expects to finalize it in the ensuing weeks[8] - A 'Study May Proceed' letter for the Phase 2b trial was received in September 2024, noting imatinib's prior demonstrated impact on key efficacy parameters in advanced PAH[8] First Quarter 2025 Financial Results Inhibikase reported a net loss of $13.7 million in Q1 2025, driven by increased R&D and SG&A expenses, with $93.2 million in cash Key Financial Highlights For Q1 2025, Inhibikase reported a net loss of $13.7 million, significantly higher than Q1 2024, primarily due to increased R&D and SG&A expenses | Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | Change (YoY) (in millions) | | :-------------------------------- | :---------- | :---------- | :----------- | | Net Loss | $(13.7) | $(4.6) | $(9.1) | | Net Loss per Share | $(0.15) | $(0.73) | $(0.58) | | R&D Expenses | $10.5 | $2.8 | $7.7 | | SG&A Expenses | $5.2 | $2.0 | $3.2 | - R&D expenses for Q1 2025 included a non-cash charge for in-process research and development expense of $7.4 million associated with the Company's acquisition of CorHepta, effective February 21, 2025[5] - Cash, cash equivalents and marketable securities were $93.2 million as of March 31, 2025[7] Consolidated Balance Sheets As of March 31, 2025, total assets decreased slightly to $94.3 million, while total current liabilities significantly increased to $8.6 million | Balance Sheet Item | March 31, 2025 (in dollars) | December 31, 2024 (in dollars) | Change (in dollars) | | :-------------------------------- | :--------------- | :---------------- | :------- | | Cash and cash equivalents | $73,441,391 | $56,490,579 | +$16,950,812 | | Marketable securities | $19,738,900 | $41,052,949 | -$21,314,049 | | Total current assets | $94,164,758 | $98,451,309 | -$4,286,551 | | Total assets | $94,281,322 | $98,599,846 | -$4,318,524 | | Accounts payable | $1,692,051 | $943,019 | +$749,032 | | Accrued expenses and other current liabilities | $3,513,248 | $2,680,030 | +$833,218 | | Contingent consideration liability | $3,270,579 | — | +$3,270,579 | | Total current liabilities | $8,550,650 | $3,733,566 | +$4,817,084 | | Total stockholders' equity | $85,730,672 | $94,866,280 | -$9,135,608 | - The increase in current liabilities was significantly impacted by the introduction of a $3,270,579 contingent consideration liability[14] Condensed Consolidated Statements of Operations and Comprehensive Loss Inhibikase reported a net loss of $13.7 million for Q1 2025, driven by substantial rises in R&D and SG&A expenses, with increased interest income | Income Statement Item | Q1 2025 (in dollars) | Q1 2024 (in dollars) | Change (YoY) (in dollars) | | :-------------------------------- | :---------- | :---------- | :----------- | | Research and development | $10,513,579 | $2,751,279 | +$7,762,300 | | Selling, general and administrative | $5,249,291 | $2,031,081 | +$3,218,210 | | Change in fair value contingent consideration | $(1,164,864) | — | $(1,164,864) | | Total costs and expenses | $14,598,006 | $4,782,360 | +$9,815,646 | | Loss from operations | $(14,598,006) | $(4,782,360) | $(9,815,646) | | Interest income | $919,271 | $132,725 | +$786,546 | | Net loss | $(13,678,735) | $(4,649,635) | $(9,029,100) | | Net loss per share – basic and diluted | $(0.15) | $(0.73) | +$0.58 (due to share count) | | Weighted-average number of shares – basic and diluted | 89,537,171 | 6,340,697 | +83,196,474 | - The significant increase in weighted-average shares outstanding (from 6,340,697 to 89,537,171) impacted the net loss per share comparison, making the per-share loss appear smaller despite a larger total net loss[16] Company Information and Disclosures This section provides details about Inhibikase Therapeutics, its social media disclosure policy, forward-looking statements, and investor contacts About Inhibikase Inhibikase Therapeutics, Inc. is a clinical-stage pharmaceutical company specializing in developing Abelson Tyrosine Kinase inhibitor therapeutics for Cardiopulmonary disease - Inhibikase Therapeutics, Inc. is a clinical-stage pharmaceutical company developing Abelson Tyrosine Kinase inhibitor therapeutics for Cardiopulmonary disease[9] - IKT-001, a prodrug of imatinib mesylate, leads Inhibikase's cardiopulmonary disease portfolio for PAH[9] Social Media Disclaimer Inhibikase informs investors that material financial information is disclosed via its investor relations website, press releases, SEC filings, and public conference calls/webcasts - The Company announces material financial information to investors using its investor relations website, press releases, SEC filings and public conference calls and webcasts[10] - The Company intends to also use LinkedIn and YouTube as a means of disclosing information and for complying with its disclosure obligations under Regulation FD[10] Forward-Looking Statements The press release contains forward-looking statements regarding future activities, subject to risks and uncertainties, with no obligation to update except as required by law - Forward-looking statements include statements related to 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; and expectations regarding the anticipated contribution of our new leadership team[11] - These forward-looking statements are based on current expectations and assumptions and are subject to certain risks and uncertainties, which could cause actual results to differ materially[11] - Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, except as may be required by any applicable securities laws[11] Contacts Investor relations contact information is provided for Michael Moyer of LifeSci Advisors - Investor Relations contact: Michael Moyer, LifeSci Advisors, mmoyer@lifesciadvisors.com[12]