Financial Performance - Kiora Pharmaceuticals reported a net income of $27,000 for Q3 2025, a significant improvement compared to a net loss of $3.4 million in Q3 2024[7] - The net loss for the three months ended September 30, 2025, was $26,806, a significant improvement compared to a net loss of $3,413,326 in the same period of 2024[16] - The company reported a net loss per common share (basic) of $0.01 for the three months ended September 30, 2025, compared to a loss of $0.81 in 2024[16] - Comprehensive loss income for the three months ended September 30, 2025, was $28,867, compared to a comprehensive loss of $3,242,797 in 2024[16] - The company recognized an income tax benefit of $643,129 for the three months ended September 30, 2025, compared to no tax benefit in the same period of 2024[16] Revenue and Expenses - Total revenue for the nine months ended September 30, 2025, was $16,020,000, compared to $16,000,000 for the same period in 2024[16] - Total operating expenses for the nine months ended September 30, 2025, were $5,520,987, down from $8,945,030 in 2024, indicating a reduction of approximately 38%[16] - Research and development expenses increased to $7,852,267 for the nine months ended September 30, 2025, up from $5,917,868 in 2024, representing a 33% increase[16] - R&D expenses for Q3 2025 were $2.7 million, up from $2.1 million in Q3 2024, primarily due to increased clinical trial activities[6] Cash and Assets - The company ended Q3 2025 with $19.4 million in cash, cash equivalents, and short-term investments, supporting operations into late 2027[4] - Kiora's total current assets decreased to $22.7 million as of September 30, 2025, from $29.7 million at the end of 2024[14] - Total liabilities decreased to $7.5 million as of September 30, 2025, compared to $10.7 million at the end of 2024[14] Collaborations and Trials - Kiora received $1.2 million in reimbursed R&D expenses from Théa for Q2 2025 activities and billed $1.5 million in Q3 2025, with $0.3 million received during the quarter[4] - The ABACUS-2 trial is focused on vision restoration in patients with retinitis pigmentosa, while KLARITY targets patients with inflammatory retinal diseases[2] - Kiora's collaboration with Théa and Senju is crucial for potential registration studies and global commercialization of KIO-301 and KIO-104[2] - The company has expanded patient screening and enrollment for the ABACUS-2 trial, including participants from a functional endpoint validation study[2] General and Administrative Expenses - Kiora maintains a stable G&A spend while increasing R&D investment, partially offset by reimbursements from strategic partners[5] Share Information - The weighted average shares outstanding (basic) increased to 4,289,853 for the three months ended September 30, 2025, compared to 4,214,950 in 2024[16] Interest Income - Interest income for the nine months ended September 30, 2025, was $703,692, a decrease from $813,989 in 2024[16] Fair Value Changes - The company reported a change in fair value of contingent consideration of $(1,721,033) for the three months ended September 30, 2025, compared to $(1,103,991) in 2024[16]

Financial Performance - Total revenue for the nine months ended September 30, 2025, was $16,020,000, a significant decrease compared to $16,000,000 for the same period in 2024[16] - The net loss for the three months ended September 30, 2025, was $26,806, compared to a net loss of $3,413,326 for the same period in 2024, reflecting a substantial improvement[16] - For the nine months ended September 30, 2025, Kiora Pharmaceuticals reported a net loss of $4.32 million compared to a net income of $7.82 million for the same period in 2024[22] - The net loss for the three months ended September 30, 2025, was $26,806, compared to a net loss of $3,413,326 for the same period in 2024[109] Cash and Assets - Cash and cash equivalents increased from $3,792,322 as of December 31, 2024, to $5,508,899 as of September 30, 2025, an increase of approximately 45.3%[14] - The company had unrestricted cash and cash equivalents of $5.51 million and short-term investments of $13.9 million as of September 30, 2025, with an accumulated deficit of $147.7 million[28] - The company’s total cash, cash equivalents, and restricted cash increased to $5.51 million as of September 30, 2025, compared to $3.80 million as of December 31, 2024[48] - Total current assets decreased from $29,706,012 as of December 31, 2024, to $22,693,856 as of September 30, 2025, representing a decline of approximately 23.6%[14] Liabilities and Equity - The total liabilities decreased from $10,724,708 as of December 31, 2024, to $7,452,712 as of September 30, 2025, a reduction of approximately 30.5%[14] - As of September 30, 2025, total stockholders' equity increased to $22,410,742 from $22,127,478 at June 30, 2025, reflecting a growth of approximately 1.3%[18] - The accumulated deficit increased from $(143,382,122) as of December 31, 2024, to $(147,700,755) as of September 30, 2025, indicating a worsening of approximately 3.5%[14] Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $7,852,267, compared to $5,917,868 for the same period in 2024, representing an increase of approximately 33%[16] - The Company incurred $1,467,935 in R&D expenses for the quarter ended September 30, 2025, with $1,422,731 reimbursed[114] - The Company recognized an impairment loss of $2.0 million for in-process R&D assets as of August 31, 2024, due to a strategic decision to cease future development[43] Stock and Compensation - Stock-based compensation for the nine months ended September 30, 2025, amounted to $665,788, compared to $496,413 for the same period in 2024, representing a 34% increase[19] - Total stock-based compensation expense for the three months ended September 30, 2025, was $254,398, compared to $171,176 for the same period in 2024, representing a 48.6% increase[77] - The weighted-average grant date fair value of options granted for the nine months ended September 30, 2025, was $2.68, with an expected stock price volatility of 136.6%[78] Investments and Fair Value - The unrealized gain on investments as of September 30, 2025, was $11,214, compared to an unrealized loss of $(16,001) for the same period in 2024, indicating a positive shift in investment performance[19] - As of September 30, 2025, total assets measured at fair value amounted to $17,499,722, with cash equivalents of $3,633,176 and short-term investments of $13,866,546[58] Collaboration and Agreements - The Company entered into an exclusive option agreement with Senju Pharmaceutical Co., Ltd, which includes a non-refundable upfront payment of $1.25 million[82][83] - The License Agreement with Théa Open Innovation included a non-refundable payment of $16.0 million, recognized in the first quarter of 2024[85][86] Future Outlook - The company anticipates having sufficient cash to fund its planned operations into late 2027 without an immediate need to raise additional capital[28] - Kiora has incurred annual losses and negative cash flows since inception, with future losses anticipated[28]

Core Insights - Kiora Pharmaceuticals reported its third quarter 2025 financial results and provided updates on its clinical pipeline for retinal diseases, highlighting the advancement of two actively enrolling Phase 2 clinical trials [1][2]. Clinical Trials Update - The company is actively recruiting participants for two Phase 2 clinical trials: ABACUS-2 for KIO-301 aimed at vision restoration in retinitis pigmentosa, and KLARITY for KIO-104 targeting retinal inflammation [2][5]. - The ABACUS-2 trial has expanded its screening and enrollment to include patients from a functional endpoint validation study, potentially increasing the patient population for KIO-301 [2][3]. - KLARITY is designed as a two-stage, multi-dose study focusing on patients with inflammatory retinal diseases causing macular edema, with a pre-defined safety assessment [3]. Financial Highlights - Kiora received $1.2 million in reimbursed R&D expenses from Théa for KIO-301 activities in Q2 2025 and billed $1.5 million in Q3 2025, with $0.3 million received in the same quarter [5][6]. - The company ended Q3 2025 with $19.4 million in cash, cash equivalents, and short-term investments, alongside $1.2 million in collaboration receivables and $1.5 million in tax and research credit receivables [5][6]. - Kiora's cash runway is projected to extend into late 2027, beyond anticipated data readouts for both clinical trials, with potential for further extension through partnership milestones [6]. R&D and Operating Expenses - R&D expenses for Q3 2025 were $2.7 million, an increase from $2.1 million in Q3 2024, primarily due to clinical trial activities [7]. - General and administrative expenses remained stable at $1.4 million for both Q3 2025 and Q3 2024 [7]. Income Statement Overview - Kiora reported a net income of $27 thousand for Q3 2025, a significant improvement from a net loss of $3.4 million in Q3 2024, attributed to favorable tax impacts and control of operating costs [8][14]. - The company recorded total revenue of $16 million for the nine months ended September 30, 2024, primarily from collaboration revenue [14]. Company Profile - Kiora Pharmaceuticals is a clinical-stage biotechnology company focused on developing therapies for retinal diseases using innovative small molecules [9]. - KIO-301 is being developed for retinitis pigmentosa, with plans to expand into other retinal diseases, while KIO-104 targets retinal inflammation [9].

Core Insights - Kiora Pharmaceuticals (KPRX) is a clinical-stage biopharmaceutical company focused on developing advanced treatments for retinal diseases [2] Drug Candidates - Kiora has two drug candidates: KIO-301 for inherited retinal diseases and KIO-104 for retinal inflammation [2][7] - KIO-301 targets surviving retinal ganglion cells to restore visual function in patients with retinitis pigmentosa [3] - KIO-104 suppresses T-cells and cytokines to reduce inflammation in the eye [7] Clinical Trials - KIO-301 is undergoing a Phase 2 clinical trial (ABACUS-2) to assess safety, tolerability, and efficacy in patients with late-stage retinitis pigmentosa, enrolling 36 patients [3][4] - KIO-104 is in a Phase 2 clinical trial (KLARITY) for retinal macular edema, with plans to enroll up to 28 patients [8][9] - Results from both clinical trials are expected in early 2027 [10] Financial Position - Kiora ended Q2 2025 with $20.7 million in cash and equivalents, plus $3.1 million in receivables and tax credits, providing a cash runway through late 2027 [11] Company Background - Kiora Pharmaceuticals was formerly known as EyeGate Pharmaceuticals Inc. and rebranded on November 8, 2021 [12] - The company's stock has traded between $2.21 and $4.18 over the past year, closing at $2.47, up 6.93% [12]

Core Insights - Kiora Pharmaceuticals has joined the Global Genes' RARE-X Vision Consortium to enhance collaboration in developing therapies for rare ocular disorders [1][3][9] Group 1: Consortium Objectives - The RARE-X Vision Consortium aims to facilitate collaboration among advocacy, research, and industry stakeholders to advance research for vision-improving therapies [1][2] - The consortium will create a global, centralized data repository to aid in patient identification and recruitment for clinical trials [4] - It seeks to develop meaningful outcome measures for clinical trials by aggregating various data types to identify endpoints that correlate with significant vision changes [4] Group 2: Kiora Pharmaceuticals' Role - Kiora is focused on developing innovative treatments for inherited retinal diseases, including KIO-301 and KIO-104, which target critical pathways to slow or restore vision loss [7] - The company emphasizes the importance of collaboration to accelerate the development of new therapies for rare ocular diseases [3][7] Group 3: Stakeholder Engagement - The Vision Consortium includes various patient advocacy groups, enhancing the representation of diverse perspectives in clinical trial design [4][5] - Kiora's involvement is expected to strengthen the consortium's efforts in addressing the challenges of drug development in the rare disease space [3][9]

[Company Overview and Q2 2025 Highlights](index=1&type=section&id=Company%20Overview%20and%20Q2%202025%20Highlights) Kiora Pharmaceuticals reports Q2 2025 financial results and significant progress in its retinal disease treatment pipeline, including clinical advancements and strategic partnerships [Executive Summary](index=1&type=section&id=1.1%20Executive%20Summary) Kiora Pharmaceuticals announced its Q2 2025 financial results and provided updates on its retinal disease treatment pipeline, making substantial progress in two key Phase 2 clinical trials and expanding its global commercialization network, with cash flow projected to support operations until late 2027 - Kiora Pharmaceuticals announced Q2 2025 financial results and updated progress on its retinal disease treatment pipeline[1](index=1&type=chunk) - The company made substantial progress on its KIO-301 and KIO-104 Phase 2 clinical programs, including trial initiation and patient enrollment[4](index=4&type=chunk) - Global commercialization network expanded through a partnership with Senju, with cash flow projected to extend until **late 2027**[4](index=4&type=chunk)[5](index=5&type=chunk) [Key Corporate Highlights (Q2 & YTD 2025)](index=1&type=section&id=1.2%20Key%20Corporate%20Highlights%20%28Q2%20%26%20YTD%202025%29) This quarter, Kiora achieved significant advancements in clinical development, strategic collaborations, and financial standing, including initiating two pivotal Phase 2 clinical trials, securing a KIO-104 patent, entering a potential **$110 million** partnership with Senju, and maintaining robust cash reserves with a long cash runway forecast [Operational Progress](index=1&type=section&id=1.2.1%20Operational%20Progress) The company initiated the KLARITY Phase 2 clinical trial for KIO-104 in retinal inflammation and the ABACUS-2 Phase 2 clinical trial for KIO-301 in retinitis pigmentosa, which utilizes a validated functional vision assessment as a key efficacy endpoint - Initiated KLARITY, a Phase 2 clinical trial evaluating KIO-104 in patients with retinal inflammation[5](index=5&type=chunk) - Initiated the Phase 2 ABACUS-2 clinical trial for KIO-301 to restore vision in patients with retinitis pigmentosa, using a validated efficacy endpoint to assess functional vision outcomes[5](index=5&type=chunk) [Strategic Partnerships & Intellectual Property](index=1&type=section&id=1.2.2%20Strategic%20Partnerships%20%26%20Intellectual%20Property) Kiora extended KIO-104's market exclusivity until **2043** by securing a patent and signed an option agreement with Senju Pharmaceutical Co., Ltd. for KIO-301, with a potential transaction value of up to **$110 million**, having already received a **$1.25 million** non-refundable option fee - Extended KIO-104's market exclusivity until **2043** by securing a patent covering optimized methods for treating ocular inflammatory diseases[5](index=5&type=chunk) - Signed an option agreement with Senju Pharmaceutical Co., Ltd. to develop and commercialize KIO-301 in key Asian countries, including Japan and China, with a potential transaction value of up to **$110 million** plus royalties if exercised[5](index=5&type=chunk) - Recorded **$1.25 million** in deferred revenue from the non-refundable Senju option fee related to the KIO-301 collaboration[5](index=5&type=chunk) [Financial Position & Outlook](index=1&type=section&id=1.2.3%20Financial%20Position%20%26%20Outlook) As of the end of Q2 2025, the company held **$20.7 million** in cash, cash equivalents, and short-term investments, with cash flow projected to last until **late 2027**, covering the anticipated data readouts for KLARITY and ABACUS-2 - Held **$20.7 million** in cash, cash equivalents, and short-term investments at the end of the second quarter[5](index=5&type=chunk)[6](index=6&type=chunk) - Projected cash flow to extend until **late 2027**, beyond the anticipated data readouts for KLARITY and ABACUS-2, with potential for further extension through collaboration milestones[5](index=5&type=chunk)[6](index=6&type=chunk) - Received **$1.3 million** in Q1 2025 R&D expense reimbursement from Théa Open Innovation for KIO-301 activities[5](index=5&type=chunk) [Pipeline Development Update](index=1&type=section&id=Pipeline%20Development%20Update) Kiora provides updates on its KIO-301 and KIO-104 programs, highlighting clinical trial progress and intellectual property advancements [KIO-301 Program Update](index=1&type=section&id=2.1%20KIO-301%20Program%20Update) The Phase 2 ABACUS-2 clinical trial for KIO-301 has been initiated to restore vision in patients with retinitis pigmentosa, utilizing a validated functional vision assessment as a key efficacy endpoint, and the company has established a strategic collaboration with Senju to expand KIO-301's commercial potential in Asian markets - The Phase 2 ABACUS-2 clinical trial for KIO-301 has been initiated for vision restoration in patients with retinitis pigmentosa[5](index=5&type=chunk) - The ABACUS-2 trial employs a validated efficacy endpoint to assess functional vision outcomes, which is expected to serve as an approvable endpoint for future registration trials[5](index=5&type=chunk) - A strategic collaboration has been established with Senju Pharmaceutical Co., Ltd. to develop and commercialize KIO-301 in key Asian countries[4](index=4&type=chunk)[5](index=5&type=chunk) [KIO-104 Program Update](index=1&type=section&id=2.2%20KIO-104%20Program%20Update) The KLARITY Phase 2 clinical trial for KIO-104 is actively recruiting patients to evaluate its efficacy in various inflammatory retinal diseases, including posterior non-infectious uveitis and diabetic macular edema, and KIO-104's market exclusivity has been extended until **2043** through a new patent - The KLARITY clinical trial is actively recruiting patients to evaluate KIO-104's efficacy in various inflammatory retinal diseases, including posterior non-infectious uveitis and diabetic macular edema[4](index=4&type=chunk)[5](index=5&type=chunk) - KIO-104's market exclusivity has been extended until **2043** by securing a patent covering optimized methods for treating ocular inflammatory diseases[5](index=5&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Kiora Pharmaceuticals reports its second quarter 2025 financial results, detailing net loss, cash position, and expense breakdowns [Summary of Financial Performance](index=2&type=section&id=3.1%20Summary%20of%20Financial%20Performance) Kiora Pharmaceuticals reported a net loss of **$2.2 million** in Q2 2025, consistent with the prior year, and held **$20.7 million** in cash, cash equivalents, and short-term investments, along with receivables from collaborators at quarter-end - Net loss for Q2 2025 was **$2.2 million**, consistent with the net loss of **$2.2 million** in Q2 2024[7](index=7&type=chunk) - As of the end of Q2 2025, the company held **$20.7 million** in cash, cash equivalents, and short-term investments[6](index=6&type=chunk) - The company also recorded **$1.2 million** in reimbursable R&D expenses receivable from Théa and **$1.25 million** in option fees receivable from Senju[6](index=6&type=chunk) [Research and Development (R&D) Expenses](index=2&type=section&id=3.2%20Research%20and%20Development%20%28R%26D%29%20Expenses) R&D expenses for Q2 2025 were **$2.6 million**, an increase from **$2.0 million** in Q2 2024, primarily due to increased clinical trial activities, though net R&D expenditure was lower after Théa's reimbursement R&D Expenses Comparison (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | | :--- | :--- | :--- | | R&D Expenses (unreimbursed) | $2.6 | $2.0 | | Théa Reimbursement | $1.7 | $1.1 | | R&D Expenses (net) | $0.9 | $0.9 | - The increase in R&D expenses in Q2 2025 was primarily attributable to increased clinical trial activities[8](index=8&type=chunk) [General and Administrative (G&A) Expenses](index=2&type=section&id=3.3%20General%20and%20Administrative%20%28G%26A%29%20Expenses) General and administrative expenses for Q2 2025 were **$1.4 million**, a slight decrease from **$1.5 million** in Q2 2024 General and Administrative Expenses Comparison (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | | :--- | :--- | :--- | | General and Administrative Expenses | $1.4 | $1.5 | [Detailed Financial Statements](index=4&type=section&id=Detailed%20Financial%20Statements) This section presents Kiora's condensed consolidated balance sheets and statements of operations for the second quarter and first half of 2025 [Condensed Consolidated Balance Sheets](index=4&type=section&id=4.1%20Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Kiora's total assets were **$31.95 million**, a decrease from **$36.48 million** on December 31, 2024, with total liabilities at **$9.82 million** and total stockholders' equity at **$22.13 million** Condensed Consolidated Balance Sheets Summary | Metric | June 30, 2025 (USD) | December 31, 2024 (USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $1,028,324 | $3,792,322 | | Short-term investments | $19,637,812 | $22,999,760 | | Accounts receivable - collaborations | $2,418,022 | $601,197 | | Total assets | $31,945,683 | $36,484,484 | | **Liabilities and Stockholders' Equity** | | | | Total liabilities | $9,818,207 | $10,724,708 | | Total stockholders' equity | $22,127,476 | $25,759,776 | [Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income](index=5&type=section&id=4.2%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20%28Loss%29%20Income) For Q2 2025, the company reported zero total revenue, an operating loss of **$2.4 million**, and a net loss of **$2.15 million**, with basic and diluted net loss per share both at **$0.54**, maintaining relative stability in operating and net losses compared to the prior year Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income Summary | Metric | Q2 2025 (USD) | Q2 2024 (USD) | H1 2025 (USD) | H1 2024 (USD) | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $0 | $20,000 | $0 | $16,020,000 | | Operating (loss) income | $(2,396,197) | $(2,544,887) | $(4,726,550) | $10,677,207 | | Net (loss) income | $(2,152,459) | $(2,221,646) | $(4,345,439) | $11,231,561 | | Net (loss) income per share - basic | $(0.54) | $(0.53) | $(1.10) | $3.19 | | Net (loss) income per share - diluted | $(0.54) | $(0.53) | $(1.10) | $2.79 | [About Kiora Pharmaceuticals](index=2&type=section&id=About%20Kiora%20Pharmaceuticals) Kiora Pharmaceuticals is a clinical-stage biotechnology company focused on developing innovative therapies for retinal diseases [Company Profile and Pipeline](index=2&type=section&id=5.1%20Company%20Profile%20and%20Pipeline) Kiora Pharmaceuticals is a clinical-stage biotechnology company dedicated to developing advanced therapies for retinal diseases, utilizing innovative small molecules to target key pathways and aiming to slow, halt, or restore vision loss, with its primary pipeline products including KIO-301 (for retinitis pigmentosa, choroidal ischemia, and Stargardt disease) and KIO-104 (for retinal inflammation) - Kiora Pharmaceuticals is a clinical-stage biotechnology company dedicated to developing advanced therapies for retinal diseases[9](index=9&type=chunk) - The company utilizes innovative small molecules to target key pathways in retinal diseases, aiming to slow, halt, or restore vision loss[9](index=9&type=chunk) - Key pipeline products include KIO-301 (for retinitis pigmentosa, choroidal ischemia, and Stargardt disease) and KIO-104 (for retinal inflammation)[9](index=9&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements regarding Kiora's future operations, clinical development, and financial outlook, subject to inherent risks and uncertainties [Disclaimer](index=2&type=section&id=6.1%20Disclaimer) This press release contains "forward-looking" statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which involve Kiora's development and commercialization efforts, regulatory approvals, cash sufficiency, clinical trial timelines, and potential collaboration benefits, but are subject to risks and uncertainties that could cause actual results to differ materially, and the company undertakes no obligation to publicly update or revise such statements - Certain statements in this press release are "forward-looking" statements, protected under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995[11](index=11&type=chunk) - These statements relate to Kiora's development and commercialization efforts, regulatory or marketing approvals, the sufficiency of existing cash and short-term investments, the timely completion of 2025 plans, the timing of clinical trial results, the potential of KIO-301 and KIO-104, anticipated trends in R&D and general and administrative expenses, KIO-104's market exclusivity, and the potential benefits of the Senju strategic collaboration[11](index=11&type=chunk) - These statements involve risks and uncertainties that could cause actual results to differ materially from those stated, and the company undertakes no obligation to publicly update or revise such statements[11](index=11&type=chunk)[12](index=12&type=chunk)

[PART I - FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The company's financial statements show decreased total assets due to cash used in operations and a net loss for H1 2025, contrasting with a net income in H1 2024 which included significant collaboration revenue [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $31.9 million as of June 30, 2025, driven by a reduction in cash and short-term investments Condensed Consolidated Balance Sheet Highlights (unaudited) | Balance Sheet Item | June 30, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and Cash Equivalents | 1,028,324 | 3,792,322 | | Short-Term Investments | 19,637,812 | 22,999,760 | | Total Current Assets | 24,737,255 | 29,706,012 | | **Total Assets** | **31,945,683** | **36,484,484** | | **Current Liabilities** | | | | Total Current Liabilities | 3,185,982 | 6,008,713 | | **Total Liabilities** | **9,818,207** | **10,724,708** | | **Total Stockholders' Equity** | **22,127,476** | **25,759,776** | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a $4.3 million net loss for H1 2025, a significant shift from an $11.2 million net income in H1 2024, due to the recognition of $16.0 million in collaboration revenue in the prior year Condensed Consolidated Statements of Operations Highlights (unaudited) | Metric | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | — | 20,000 | — | 16,020,000 | | Research and Development | 2,590,489 | 2,048,665 | 5,122,376 | 3,732,877 | | Collaboration and Research Credits | (1,685,917) | (1,141,985) | (3,652,040) | (1,332,538) | | Operating (Loss) Income | (2,396,197) | (2,544,887) | (4,726,550) | 10,677,207 | | Net (Loss) Income | (2,152,459) | (2,221,646) | (4,345,439) | 11,231,561 | | Net (Loss) Income per Share - Basic | (0.54) | (0.53) | (1.10) | 3.19 | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $6.5 million for H1 2025, a reversal from cash provided in H1 2024, which had benefited from a large upfront payment Condensed Consolidated Statements of Cash Flows Highlights (unaudited, Six Months Ended June 30) | Cash Flow Activity | 2025 ($) | 2024 ($) | | :--- | :--- | :--- | | Net Cash (Used in) Provided by Operating Activities | (6,507,633) | 9,891,416 | | Net Cash Provided by (Used in) Investing Activities | 3,336,954 | (21,224,904) | | Net Cash Provided by Financing Activities | 265,359 | 15,498,155 | | **Net (Decrease) Increase in Cash** | **(2,763,595)** | **4,120,622** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The company is a clinical-stage pharmaceutical firm with sufficient cash to fund operations into late 2027, supported by key collaboration agreements and a new credit facility - The company is a clinical-stage specialty pharmaceutical company focused on developing and commercializing therapies for ophthalmic diseases[23](index=23&type=chunk) - As of June 30, 2025, the company had $1.0 million in cash and cash equivalents and $19.6 million in short-term investments, and anticipates having **sufficient cash to fund planned operations into late 2027**[28](index=28&type=chunk) - In May 2025, the company entered into an exclusive option agreement with Senju Pharmaceutical, receiving a **nonrefundable upfront payment of $1.25 million** for the rights to KIO-301 in key Asian countries[83](index=83&type=chunk)[84](index=84&type=chunk) - In January 2024, the company entered a license agreement with Théa Open Innovation (TOI) for KIO-301, recognizing a **$16.0 million upfront payment** as revenue in the first quarter of 2024[86](index=86&type=chunk)[87](index=87&type=chunk) - In March 2025, the company established a **$10.0 million revolving line of credit** with UBS, secured by its marketable securities[104](index=104&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its focus on ophthalmic disease treatments, key partnerships, and financial results, highlighting increased R&D spending on advancing clinical trials and a cash runway into late 2027 [Executive Summary](index=29&type=section&id=Executive%20Summary) Kiora is advancing its lead ophthalmic candidates, KIO-301 and KIO-104, through Phase 2 trials supported by strategic partnerships and sufficient funding into late 2027 - KIO-301 is a potential vision-restoring small molecule designed for patients with inherited and age-related degenerative retinal diseases, such as **Retinitis Pigmentosa**[119](index=119&type=chunk) - The company has a strategic development and commercialization agreement with TOI for KIO-301, which included a **$16 million upfront payment** and potential for up to $285 million in milestones plus royalties[121](index=121&type=chunk) - In May 2025, Kiora entered an exclusive option agreement with Senju for KIO-301 development and commercialization rights in key Asian markets, receiving a **$1.25 million upfront payment**[124](index=124&type=chunk) - The **ABACUS-2 Phase 2 clinical trial for KIO-301** and a Phase 2 trial for KIO-104 in retinal inflammation both began enrollment in the second quarter of 2025[122](index=122&type=chunk)[125](index=125&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) The H1 2025 net loss was driven by the absence of a large 2024 collaboration payment, while increased R&D expenses from clinical trial activities were largely offset by partner reimbursements Comparison of Operations for the Three Months Ended June 30 | Metric | 2025 ($) | 2024 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Research and Development | 2,590,489 | 2,048,665 | 541,825 | | Collaboration and Research Credits | (1,685,917) | (1,141,985) | (543,932) | | Net (Loss) Income | (2,152,459) | (2,221,646) | 69,187 | Comparison of Operations for the Six Months Ended June 30 | Metric | 2025 ($) | 2024 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Total Revenue | — | 16,020,000 | (16,020,000) | | Research and Development | 5,122,376 | 3,732,877 | 1,389,500 | | Collaboration and Research Credits | (3,652,040) | (1,332,538) | (2,319,502) | | Net (Loss) Income | (4,345,439) | 11,231,561 | (15,577,000) | [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) With approximately $20.6 million in cash and investments, the company has sufficient funds for operations into late 2027, though future financing will be required for long-term plans - Based on cash and short-term investments of approximately $1.0 million and $19.6 million, respectively, at June 30, 2025, the company anticipates having **sufficient cash to fund planned operations into late 2027**[142](index=142&type=chunk)[149](index=149&type=chunk) - **Net cash used in operating activities for H1 2025 was $6.5 million**, compared to $9.9 million provided by operations in H1 2024, with the difference primarily due to the $16 million TOI collaboration revenue in 2024[143](index=143&type=chunk) - Net cash provided by financing activities **decreased by $15.2 million year-over-year**, as H1 2024 included $13.8 million in net proceeds from a private offering[145](index=145&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This item is not applicable for the reporting period - The company has indicated that Quantitative and Qualitative Disclosures About Market Risk are **not applicable**[154](index=154&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal controls during the quarter - Based on an evaluation as of June 30, 2025, the Chief Executive Officer and Chief Financial Officer concluded that the company's **disclosure controls and procedures were effective**[157](index=157&type=chunk) - **No changes in internal control over financial reporting** occurred during the three months ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[158](index=158&type=chunk) [PART II - OTHER INFORMATION](index=36&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) As of June 30, 2025, the company is not currently a party to any legal proceedings - The company is **not currently a party to any legal proceedings** as of June 30, 2025[159](index=159&type=chunk) [Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) 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, 2024 - The company does not believe there have been **any material changes from the risk factors** previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2024[160](index=160&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - There were **no unregistered sales of equity securities** during the reporting period[161](index=161&type=chunk) [Other Information](index=36&type=section&id=Item%205.%20Other%20Information) The company terminated its Employee Stock Purchase Plan (ESPP) effective April 30, 2025 - In May 2025, the company **terminated its Employee Stock Purchase Plan (ESPP)** effective as of April 30, 2025[166](index=166&type=chunk) [Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Quarterly Report on Form 10-Q, including agreements and officer certifications

Core Insights - Kiora Pharmaceuticals reported its second quarter 2025 financial results and provided updates on its pipeline for retinal disease treatments, highlighting advancements in clinical trials and partnerships [1][4][6]. Financial Performance - The company ended Q2 2025 with $20.7 million in cash, cash equivalents, and short-term investments, alongside $2.4 million in collaboration receivables and $0.7 million in research incentive tax credits [8]. - Kiora recorded a net loss of $2.2 million for Q2 2025, consistent with the net loss reported in Q2 2024 [9]. - Research and development (R&D) expenses for Q2 2025 were $2.6 million, an increase from $2.0 million in Q2 2024, primarily due to clinical trial activities [10]. Clinical Trials and Pipeline Development - Kiora initiated the KLARITY Phase 2 clinical trial for KIO-104, targeting retinal inflammation, and the ABACUS-2 Phase 2 trial for KIO-301, aimed at vision restoration in patients with retinitis pigmentosa [6][7]. - The company has strengthened market exclusivity for KIO-104 until 2043 and entered a partnership option with Senju Pharmaceutical Co., Ltd. for KIO-301, potentially valued at up to $110 million plus royalties [6][7]. - The ABACUS-2 trial utilizes a validated efficacy endpoint for assessing functional vision outcomes, which may serve as an approvable endpoint for future registration trials [6][7]. Strategic Partnerships and Collaborations - Kiora received $1.3 million in reimbursed R&D expenses from Théa Open Innovation for KIO-301 activities and recorded $1.25 million in deferred revenue related to the Senju partnership [6][8]. - The partnership with Senju aims to develop and commercialize KIO-301 in key Asian markets, including Japan and China [6][7]. Company Overview - Kiora Pharmaceuticals is a clinical-stage biotechnology company focused on developing therapies for retinal diseases, utilizing innovative small molecules to address vision loss [11].

Core Points - Kiora Pharmaceuticals has been granted a U.S. patent (US Patent No. 12,364,680) for KIO-104, which covers treatment for various ocular diseases, including ocular inflammation, uveitis, and age-related macular degeneration, extending market exclusivity until 2043 [1][2] - The patent enhances Kiora's intellectual property strategy by protecting KIO-104's proprietary structure, delivery methods, and therapeutic applications, positioning it as a significant alternative to existing steroid treatments [2] - KIO-104 is currently undergoing a Phase 2 clinical trial (KLARITY study) to evaluate its efficacy in treating inflammatory retinal diseases, with initial results expected to guide further development [3] Company Overview - Kiora Pharmaceuticals is a clinical-stage biotechnology company focused on developing therapies for retinal diseases, utilizing innovative small molecules to address vision loss [5] - KIO-104 is a next-generation, non-steroidal, immuno-modulatory small-molecule inhibitor of dihydroorotate dehydrogenase (DHODH), aimed at treating retinal inflammation [5] - The company is also developing KIO-301 for retinitis pigmentosa and other retinal degenerative diseases, which has the potential to restore vision in affected patients [5]

Core Viewpoint - Kiora Pharmaceuticals, Inc. (KPRX) has received an upgrade to a Zacks Rank 1 (Strong Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][4]. Earnings Estimates and Ratings - The Zacks rating system is based on the Zacks Consensus Estimate, which aggregates EPS estimates from sell-side analysts for the current and following years [2]. - Changes in earnings estimates are crucial for near-term stock price movements, making the Zacks rating system valuable for investors [3][5]. Impact of Institutional Investors - Institutional investors utilize earnings estimates to determine the fair value of stocks, leading to buying or selling actions that affect stock prices [5]. Business Improvement Indicators - The upgrade in Kiora Pharmaceuticals' rating suggests an improvement in the company's underlying business, which could lead to an increase in stock price as investors respond positively [6]. Importance of Earnings Estimate Revisions - Research indicates a strong correlation between earnings estimate revisions and stock movements, highlighting the significance of tracking these revisions for investment decisions [7]. Zacks Rank System Performance - The Zacks Rank system categorizes stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [8]. Specific Earnings Estimates for Kiora Pharmaceuticals - For the fiscal year ending December 2025, Kiora Pharmaceuticals is expected to earn -$2.23 per share, unchanged from the previous year, but the Zacks Consensus Estimate has increased by 25.4% over the past three months [9]. Overall Rating System Characteristics - The Zacks rating system maintains a balanced distribution of "buy" and "sell" ratings across over 4,000 stocks, with only the top 5% receiving a "Strong Buy" rating [10]. - Kiora Pharmaceuticals' upgrade to Zacks Rank 1 places it in the top 5% of stocks based on estimate revisions, suggesting potential for market-beating returns [11].