
PART I - FINANCIAL INFORMATION Financial Statements This section presents the unaudited condensed consolidated financial statements for Q1 2025 and 2024, showing a shift from $13.5 million net income to a $2.2 million net loss, largely due to a $16.0 million collaboration revenue payment in 2024, with $24.1 million in cash and investments as of March 31, 2025 Condensed Consolidated Balance Sheet Highlights | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and Cash Equivalents | $3,771,024 | $3,792,322 | | Short-Term Investments | $20,334,831 | $22,999,760 | | Total Assets | $34,019,862 | $36,484,484 | | Total Liabilities | $10,319,475 | $10,724,708 | | Total Stockholders' Equity | $23,700,387 | $25,759,776 | Condensed Consolidated Statement of Operations Highlights | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Collaboration Revenue | $0 | $16,000,000 | | Total Operating Expenses | $2,330,354 | $2,777,906 | | Operating (Loss) Income | ($2,330,354) | $13,222,094 | | Net (Loss) Income | ($2,192,980) | $13,453,207 | | Net (Loss) Income per Share - Basic | ($0.52) | $4.67 | Condensed Consolidated Statement of Cash Flows Highlights | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net Cash (Used in) Provided by Operating Activities | ($2,704,199) | $13,624,855 | | Net Cash Provided by Investing Activities | $2,672,782 | $0 | | Net Cash Provided by Financing Activities | $0 | $15,247,632 | | Net (Decrease) Increase in Cash | ($21,274) | $28,821,463 | - In January 2024, the company entered into a strategic agreement with Théa Open Innovation (TOI), granting exclusive worldwide development and commercialization rights (excluding Asia) for KIO-301, receiving a $16.0 million upfront payment recognized as revenue in Q1 20243941 - In March 2025, the company secured a $10.0 million revolving line of credit with UBS, collateralized by its marketable securities, which remained unused as of March 31, 202599 - Subsequent to the quarter, in April 2025, the company terminated a license agreement for KIO-201 with Dômes Pharma, and in May 2025, terminated its Employee Stock Purchase Plan (ESPP)106107 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's financial results, liquidity, and business strategy, attributing the Q1 2025 shift from net income to net loss to the 2024 TOI upfront payment, noting increased R&D for KIO-301 and KIO-104 clinical trials, and projecting current cash and investments of $24.1 million to fund operations into late 2027 - The company is advancing its key clinical programs: KIO-301 for Retinitis Pigmentosa and KIO-104 for retinal inflammatory diseases, with Phase 2 trial enrollment for both expected in Q2 2025115118 - The company believes its cash, cash equivalents, and short-term investments of approximately $24.1 million as of March 31, 2025, are sufficient to fund planned operations into late 2027121130137 Comparison of Operations for the Three Months Ended March 31 | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration Revenue | $0 | $16,000,000 | ($16,000,000) | | Research and Development | $2,531,887 | $1,684,212 | $847,675 | | Collaboration and Research Credits | ($1,966,123) | ($190,553) | ($1,775,570) | | Net (Loss) Income | ($2,192,980) | $13,453,207 | ($15,646,187) | - The $0.8 million increase in R&D expenses was driven by $1.8 million in higher preclinical, CMC, and clinical trial costs, partially offset by a $0.8 million reduction in licensing fees, while the $1.8 million increase in Collaboration and Research Credits is due to full reimbursement of KIO-301 program expenses by TOI125126 - Net cash used in operating activities was $2.7 million in Q1 2025, a significant decrease from the $13.6 million provided by operations in Q1 2024, which benefited from the TOI upfront payment, with no financing activities in Q1 2025 compared to $15.2 million in Q1 2024 from a private placement and warrant exercises131133 Quantitative and Qualitative Disclosures about Market Risk This section is not applicable to the company for this reporting period - The company, as a smaller reporting company, has indicated that this disclosure is not applicable142 Controls and Procedures The company's management, including the CEO and CFO, evaluated the effectiveness of its disclosure controls and procedures, concluding they were effective as of March 31, 2025, with no material changes in internal control over financial reporting during the quarter - Based on an evaluation as of March 31, 2025, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective145 - There were no changes in the company's internal control over financial reporting during the first quarter of 2025 that have materially affected, or are reasonably likely to materially affect, internal controls146 PART II - OTHER INFORMATION Legal Proceedings As of March 31, 2025, the company is not a party to any material legal proceedings - The company reports that it is not currently a party to any legal proceedings as of March 31, 2025147 Risk Factors The company states that there have been no material changes to the risk factors previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2024 - There have been no material changes from the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2024148 Unregistered Sales of Equity Securities and Use of Proceeds During the first quarter of 2025, the company did not conduct any unregistered sales of its equity securities, nor did it repurchase any of its own equity securities - The company had no unregistered sales of equity securities during the period149 - The company did not purchase any of its registered equity securities during the period covered by the report150 Defaults Upon Senior Securities This item is not applicable to the company - Not applicable151 Mine Safety Disclosures This item is not applicable to the company - Not applicable152 Other Information The company reports that no officers or directors adopted or terminated a Rule 10b5-1 trading plan during the quarter, and in May 2025, it terminated its Employee Stock Purchase Plan (ESPP) - No officers or directors adopted, modified, or terminated a Rule 10b5-1 trading arrangement during the quarter ended March 31, 2025153 - In May 2025, the company terminated its Employee Stock Purchase Plan (ESPP) effective as of April 30, 2025154 Exhibits This section references the list of exhibits filed as part of the Quarterly Report on Form 10-Q - The exhibits filed with the Form 10-Q are listed in the Exhibit Index155