[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].

[Corporate Highlights and Pipeline Update](index=1&type=section&id=Corporate%20Highlights%20and%20Pipeline%20Update) Kiora Pharmaceuticals advances its retinal disease pipeline with two Phase 2 trials for KIO-104 and KIO-301, focusing on key clinical endpoints - The company is initiating two Phase 2 clinical trials: the KLARITY study for **KIO-104** (retinal inflammation) and the ABACUS-2 study for **KIO-301** (retinitis pigmentosa)[2](index=2&type=chunk) - For the **KIO-301 ABACUS-2 trial**, Kiora is focusing on tailoring clinically meaningful functional vision endpoints for patients with ultra-low vision, a critical step for potential market approval[3](index=3&type=chunk) - **KIO-104**, a small molecule DHODH inhibitor, is being developed as a locally delivered alternative to chronic steroids for inflammatory retinal diseases, with first patient enrollment expected in **Q2 2025**[4](index=4&type=chunk) - The company received approval to start the **KLARITY Phase 2 trial** for **KIO-104** and continued patient enrollment in a functional endpoint validation study for **KIO-301**[5](index=5&type=chunk) [First Quarter Financial Highlights](index=1&type=section&id=First%20Quarter%20Financial%20Highlights) Kiora ended Q1 2025 with **$24.1 million** cash and a runway into late 2027, reporting a **$2.2 million net loss** due to non-recurring prior year revenue - Ended Q1 2025 with **$24.1 million** in cash, cash equivalents, and short-term investments, with a projected cash runway into **late 2027**[4](index=4&type=chunk)[5](index=5&type=chunk)[6](index=6&type=chunk) - Received **$1.8 million** in reimbursed R&D expenses for Q4 2024 activities from its partnership with Laboratoires Théa, with total reimbursements reaching **$5.6 million** since the collaboration began[4](index=4&type=chunk)[5](index=5&type=chunk) Q1 2025 vs Q1 2024 Financial Performance | Metric | Q1 2025 (Millions) | Q1 2024 (Millions) | Change Driver | | :--- | :--- | :--- | :--- | | **Net (Loss) Income** | $(2.2) | $13.4 | Absence of $16M upfront collaboration revenue in 2025 | | **R&D Expenses (Gross)** | $2.5 | $1.7 | Increased clinical trial activities | | **G&A Expenses** | $1.5 | $1.3 | General increase in administrative costs | [Financial Statements](index=4&type=section&id=Financial%20Statements) Kiora's Q1 2025 financial statements detail its position and operational results, highlighting a net loss from non-recurring prior-year collaboration revenue [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Presents Kiora's financial position as of March 31, 2025, detailing assets, liabilities, and stockholders' equity Balance Sheet Summary | Account | March 31, 2025 (Thousands) | December 31, 2024 (Thousands) | | :--- | :--- | :--- | | Cash and Short-Term Investments | $24,106 | $26,792 | | Total Current Assets | $27,107 | $29,706 | | **Total Assets** | **$34,020** | **$36,484** | | Total Current Liabilities | $5,275 | $6,009 | | **Total Liabilities** | **$10,319** | **$10,725** | | **Total Stockholders' Equity** | **$23,700** | **$25,760** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Details Kiora's operational results for the first quarter, showing revenue, expenses, and net loss compared to the prior year Statement of Operations Summary (Three Months Ended March 31) | Metric | 2025 (Millions) | 2024 (Millions) | | :--- | :--- | :--- | | Collaboration Revenue | $0.00 | $16.00 | | Total Operating Expenses | $2.33 | $2.78 | | Operating (Loss) Income | $(2.33) | $13.22 | | **Net (Loss) Income** | **$(2.19)** | **$13.45** | | **Net (Loss) Income per Share - Basic** | **$(0.52)** | **$4.67** | [About Kiora Pharmaceuticals](index=2&type=section&id=About%20Kiora%20Pharmaceuticals) Kiora Pharmaceuticals is a clinical-stage biotech developing small molecule therapies for retinal diseases like retinitis pigmentosa and retinal inflammation - Kiora is a clinical-stage biotech developing small molecule therapies for **retinal diseases**[10](index=10&type=chunk) - Key product candidates include **KIO-301** for retinitis pigmentosa and **KIO-104** for retinal inflammation[10](index=10&type=chunk)

Core Insights - Kiora Pharmaceuticals reported its first quarter 2025 financial results and announced the initiation of two Phase 2 clinical trials for retinal diseases, with sufficient cash to fund operations into late 2027 [1][2][4] Financial Highlights - The company ended Q1 2025 with $24.1 million in cash, cash equivalents, and short-term investments, alongside $2.0 million in collaboration receivables and tax credits [4][6] - Kiora reported a net loss of $2.2 million for Q1 2025, a significant decrease from a net income of $13.4 million in Q1 2024, primarily due to a $16 million upfront payment recognized as collaboration revenue in the previous year [7] - Research and development (R&D) expenses for Q1 2025 were $2.5 million, up from $1.7 million in Q1 2024, driven by clinical trial activities [8] - General and administrative (G&A) expenses increased to $1.5 million in Q1 2025 from $1.3 million in Q1 2024 [9] Clinical Development Updates - Kiora is preparing to initiate enrollment in two Phase 2 clinical trials: the KLARITY study for KIO-104 targeting retinal inflammation and the ABACUS-2 study for KIO-301 focusing on retinitis pigmentosa [2][4] - The ABACUS-2 trial will involve 36 patients with ultra-low vision or no light perception due to retinitis pigmentosa, with a focus on demonstrating improvements in functional vision [3][4] - KIO-104 is a small molecule DHODH inhibitor aimed at treating inflammatory retinal diseases, with the first patient expected to be enrolled in Q2 2025 [5] Cash Management and Future Outlook - The company has extended its cash runway into late 2027, which is expected to cover anticipated data readouts for the KLARITY and ABACUS-2 trials [4][5] - Kiora has received $1.8 million in reimbursed R&D expenses from Laboratoires Théa, contributing to its financial stability [4][6]

[PART I - FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) 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 2024[39](index=39&type=chunk)[41](index=41&type=chunk) - 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, 2025[99](index=99&type=chunk) - 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)[106](index=106&type=chunk)[107](index=107&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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 2025[115](index=115&type=chunk)[118](index=118&type=chunk) - 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 2027[121](index=121&type=chunk)[130](index=130&type=chunk)[137](index=137&type=chunk) 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 TOI[125](index=125&type=chunk)[126](index=126&type=chunk) - 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 exercises[131](index=131&type=chunk)[133](index=133&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) 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 applicable[142](index=142&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) 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 effective[145](index=145&type=chunk) - 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 controls[146](index=146&type=chunk) [PART II - OTHER INFORMATION](index=33&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) 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, 2025[147](index=147&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) 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, 2024[148](index=148&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) 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 period[149](index=149&type=chunk) - The company did not purchase any of its registered equity securities during the period covered by the report[150](index=150&type=chunk) [Defaults Upon Senior Securities](index=33&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company - Not applicable[151](index=151&type=chunk) [Mine Safety Disclosures](index=33&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[152](index=152&type=chunk) [Other Information](index=33&type=section&id=Item%205.%20Other%20Information) 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, 2025[153](index=153&type=chunk) - In May 2025, the company terminated its Employee Stock Purchase Plan (ESPP) effective as of April 30, 2025[154](index=154&type=chunk) [Exhibits](index=33&type=section&id=Item%206.%20Exhibits) 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 Index[155](index=155&type=chunk)

Core Insights - Kiora Pharmaceuticals will present at the 24th Annual Needham Virtual Healthcare Conference on April 10, 2025, at 2:15 PM EDT [1] - The presentation will include updates on the company's pipeline and planned Phase 2 clinical trials for KIO-104 and KIO-301 [2] Company Overview - Kiora Pharmaceuticals is a clinical-stage biotechnology company focused on developing therapies for retinal diseases [3] - The company targets critical pathways in retinal diseases using innovative small molecules to address vision loss [3] - KIO-301 is aimed at treating retinitis pigmentosa, choroideremia, and Stargardt disease, while KIO-104 is designed for retinal inflammation [3] Investor Engagement - Kiora Pharmaceuticals encourages investors to follow the company on social media and visit its website for relevant updates [4]

Financial Performance - The net loss for Q4 2024 was $4.2 million, compared to a net loss of $2.3 million in Q4 2023; however, net income for 2024 was $3.6 million, a significant improvement from a net loss of $12.5 million in 2023[7] - Total revenue for 2024 reached $16,020,000, compared to $0 in 2023[18] - Collaboration revenue was $16,000,000, while grant revenue was $20,000[18] - Operating income before other income was $4,510,288, a significant improvement from a loss of $12,586,896 in 2023[18] - Net income for 2024 was $3,594,733, compared to a net loss of $12,513,896 in 2023[18] - Net income per common share (basic) was $0.93, a recovery from a loss of $24.25 per share in 2023[18] - Comprehensive income for 2024 was $3,495,375, compared to a loss of $12,513,956 in 2023[18] Research and Development - R&D expenses for 2024 totaled $7.8 million, up from $4.0 million in 2023, primarily due to activities related to KIO-301 and KIO-104[9] - Kiora received $3.3 million in reimbursed R&D expenses in 2024 from Laboratoires Théa, with $2.9 million recognized in offsetting collaboration credits[5] - The company initiated two Phase 2 clinical trials: KLARITY for KIO-104 and ABACUS-2 for KIO-301, with patient enrollment expected to begin soon[2] - KIO-301 is being developed for retinitis pigmentosa, with a 36-patient, multi-center study approved to evaluate its efficacy[2] - KIO-104 aims to provide an alternative to chronic steroid use for treating inflammatory retinal diseases, with the first patient expected to be dosed in Q2 2025[4] - The company anticipates increased net R&D expenses in 2025 primarily due to costs related to patient enrollment in the KLARITY study[9] - Research and development expenses increased to $7,842,207 from $4,027,037 in 2023, indicating a focus on innovation[18] Cash and Assets - Kiora ended 2024 with $26.8 million in cash, cash equivalents, and short-term investments, with an expected runway into 2027[5] - Total assets increased to $36.5 million in 2024, up from $13.7 million in 2023, reflecting growth in cash and investments[17] Operating Expenses - General and administrative expenses for 2024 were $5.5 million, compared to $4.7 million in 2023, with expectations to remain consistent in 2025[10] - Total operating expenses decreased to $11,509,712 from $12,586,896 in 2023[18] - Weighted average shares outstanding (basic) increased to 3,872,644 from 538,007 in 2023, reflecting potential dilution[18] Marketable Securities - The company reported an unrealized gain on marketable securities of $29,719 in 2024[18]