[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]

Core Insights - Kiora Pharmaceuticals reported its 2024 financial results and provided updates on its retinal disease drug development pipeline, indicating a strong focus on advancing clinical trials and maintaining financial stability through 2027 [1][2]. Clinical Development - Kiora is preparing to initiate two Phase 2 clinical trials: KLARITY for KIO-104 targeting retinal inflammation and ABACUS-2 for KIO-301 focusing on advanced retinitis pigmentosa, with patient enrollment expected to begin soon [2][4]. - The KLARITY study aims to explore multiple doses of KIO-104 in patients with inflammatory retinal diseases, while ABACUS-2 will involve a 36-patient, multi-center, randomized, controlled study [2][4]. - The company emphasizes the importance of demonstrating functional vision improvement for regulatory approval and reimbursement, which will guide the refinement of clinical endpoints [3]. Financial Performance - Kiora ended 2024 with $26.8 million in cash, cash equivalents, and short-term investments, alongside $0.9 million in collaboration and tax receivables, providing a financial runway into 2027 [5][7]. - The company reported a net loss of $4.2 million for Q4 2024, compared to a net loss of $2.3 million in Q4 2023, but achieved a net income of $3.6 million for the full year 2024, a significant improvement from a net loss of $12.5 million in 2023 [8][19]. - Collaboration revenue from Laboratoires Théa contributed $16 million in 2024, which was a key factor in the positive financial turnaround [8][19]. Research and Development Expenses - R&D expenses for Q4 2024 were $1.9 million, up from $1.1 million in Q4 2023, reflecting increased activities related to KIO-301 and KIO-104 [9][10]. - Total R&D expenses for 2024 were $7.8 million, compared to $4.0 million in 2023, with expectations for further increases in 2025 due to patient enrollment costs for the KLARITY study [10]. General and Administrative Expenses - G&A expenses for Q4 2024 were $1.3 million, compared to $0.9 million in Q4 2023, and totaled $5.5 million for the full year 2024, up from $4.7 million in 2023 [11].

Financial Position - Kiora Pharmaceuticals ended Q3 2024 with $29.0 million in cash, cash equivalents, and short-term investments, along with $1.8 million in collaboration receivables from the Théa partnership[6]. - Kiora's cash runway is expected to extend into 2027, excluding any potential partnership milestones[6]. - The company recorded a $1.5 million increase in cash position from the prior quarter due to R&D incentive tax credits[6]. Research and Development - Research and development expenses for Q3 2024 were $2.2 million, resulting in net R&D expenses of $1.3 million, an increase from $1.1 million in Q3 2023[7]. - Kiora received approval to initiate the ABACUS-2 Phase 2 study for KIO-301, which will enroll 36 patients with retinitis pigmentosa[3]. - The KLARITY trial for KIO-104 is planned to begin in the first half of 2025, focusing on multiple doses for inflammatory retinal diseases[5]. - KIO-301 targets patients with over 150 known gene mutations associated with retinitis pigmentosa, enhancing the likelihood of success for the upcoming trials[3]. - Kiora's partnership with Théa supports R&D activities, allowing further investment in KIO-104[5]. - Research and development expenses for the nine months ended September 30, 2024, increased to $3,717,570, up from $2,915,392 in 2023, representing a 27.5% increase[13]. Financial Performance - The net loss for Q3 2024 was $3.4 million, a decrease from a net loss of $5.8 million in Q3 2023, primarily due to a non-cash component related to the strategic focus on KIO-301 and KIO-104[9]. - Net loss attributable to common shareholders for the nine months ended September 30, 2024, was $7,818,235, a significant improvement from a loss of $10,776,275 in the same period of 2023[13]. - Total revenue for the nine months ended September 30, 2024, was $16,020,000, compared to $20,000 for the same period in 2023[13]. - Net income (loss) per common share - basic for the nine months ended September 30, 2024, was $2.08, compared to a loss of $23.35 in 2023[13]. - Comprehensive income for the nine months ended September 30, 2024, was $7,925,830, compared to a loss of $10,328,720 in 2023[13]. - Total operating expenses for the nine months ended September 30, 2024, were $8,945,030, down from $10,468,247 in 2023, reflecting a decrease of 14.6%[13]. - Interest income for the nine months ended September 30, 2024, was $813,989, compared to $128,464 in 2023, indicating a substantial increase[13]. - Unrealized gain on marketable securities for the nine months ended September 30, 2024, was $73,607, compared to no gain in 2023[13]. Administrative Expenses - General and administrative expenses remained stable at $1.4 million for Q3 2024, unchanged from Q3 2023[8]. - General and administrative expenses for the nine months ended September 30, 2024, were $4,215,411, up from $3,782,596 in 2023, marking an increase of 11.5%[13]. Shareholder Information - The weighted average shares outstanding - basic for the nine months ended September 30, 2024, was 3,757,467, compared to 438,687 in 2023, showing a significant increase in shares[13].

Financial Performance - Total revenue for the nine months ended September 30, 2024, was $16,020,000, compared to $20,000 for the same period in 2023[14]. - Net loss attributable to common shareholders for the nine months ended September 30, 2024, was $7,818,235, compared to a net loss of $10,776,275 for the same period in 2023[14]. - The company reported a net income per common share of $2.08 for the nine months ended September 30, 2024, compared to a net loss of $23.35 for the same period in 2023[14]. - Net income for the nine months ended September 30, 2024, was $7,818,235, compared to a net loss of $(10,245,290) for the same period in 2023, representing a significant turnaround[20]. - The company reported a comprehensive loss of $3,242,797 for the three months ended September 30, 2024, compared to a comprehensive loss of $5,803,251 for the same period in 2023[14]. - Net income for the three months ended September 30, 2024, was a loss of $3,413,326, improving by $2,349,615 from a loss of $5,762,941 in 2023[142]. Operating Expenses - Operating expenses for the nine months ended September 30, 2024, totaled $8,945,030, a decrease of 14.5% from $10,468,247 in the same period of 2023[14]. - Research and development expenses for the nine months ended September 30, 2024, were $3,717,570, up from $2,915,392 in the same period of 2023[14]. - The company reported stock-based compensation of $496,413 for the nine months ended September 30, 2024, down from $572,600 in the same period of 2023[20]. - General and administrative expenses for the three months ended September 30, 2024, decreased by $34,847 to $1,380,997, driven by reductions in proxy-related expenses and D&O insurance premiums[142]. - Total stock-based compensation expense for the three months ended September 30, 2024, was $171.176 million, a decrease of 35.3% from $264.865 million in the same period of 2023[98]. - For the nine months ended September 30, 2024, total stock-based compensation expense was $496.413 million, down 13.3% from $572.600 million in 2023[98]. Equity and Capital - Total stockholders' equity increased to $30,030,052 as of September 30, 2024, from $6,109,654 at the end of 2023[12]. - The company had 3,000,788 shares issued and outstanding as of September 30, 2024, compared to 856,182 shares at December 31, 2023[12]. - The total additional paid-in capital increased to $168,996,195 as of September 30, 2024, from $153,001,469 as of September 30, 2023[19]. - The company raised $14,998,865 from a private placement in 2024, with issuance costs of $(1,190,049)[20]. - The total net proceeds from a private placement on January 31, 2024, were approximately $13.8 million[80]. - The company completed a public offering on June 6, 2023, resulting in net proceeds of approximately $5.6 million[85]. Cash Flow and Liquidity - Cash provided by operating activities for the nine months ended September 30, 2024, was $10,811,473, compared to cash used of $(6,975,610) in the prior year[20]. - The balance of cash, cash equivalents, and restricted cash at the end of the period was $5,641,539, compared to $5,404,529 at the end of September 30, 2023[20]. - Total cash, cash equivalents, and restricted cash increased to $5,641,539 as of September 30, 2024, from $2,458,951 as of December 31, 2023, representing a growth of approximately 129%[55]. - Cash on hand and short-term investments as of September 30, 2024, totaled approximately $29 million, providing sufficient liquidity to fund operations into 2027[153][161]. - The company anticipates having sufficient cash to fund planned operations into 2027, with cash on hand and short-term investments totaling approximately $29 million as of September 30, 2024[139]. Research and Development - The company incurred impairment of in-process R&D amounting to $2,008,000 for the nine months ended September 30, 2024, compared to $1,904,314 in the same period of 2023[20]. - Research and development expenses for the nine months ended September 30, 2024, increased by $802,178 to $3,717,570, primarily due to CMC expenses and licensing payments[149]. - The company has initiated a Phase 2 clinical trial (ABACUS-2) for KIO-301, expected to enroll the first patient in the first half of 2025[126]. - KIO-301 has received Orphan Drug Designation from the FDA and Orphan Medicinal Product Designation from the European Medicines Agency for treating retinal diseases[132]. - The company plans to develop KIO-104 for retinal inflammatory diseases and expects to initiate a Phase 2 clinical trial in early 2025[136]. Legal and Compliance - The company's disclosure controls and procedures were evaluated as effective as of September 30, 2024, by the Chief Executive Officer and Chief Financial Officer[170]. - There were no changes in the company's internal control over financial reporting during the three months ended September 30, 2024, that materially affected internal control[171]. - The company is not currently a party to any legal proceedings as of September 30, 2024[173]. Future Outlook - The company expects to continue focusing on its growth strategies and market expansion efforts in the upcoming quarters[8]. - Future financing needs will be supported through a combination of equity sales, debt financing, and collaborations, with no committed external sources of funds currently available[160]. - The Company has incurred annual losses and negative cash flows since inception, with future losses anticipated; however, management believes capital resources will be sufficient to fund operations for at least 12 months[27].

Core Insights - Kiora Pharmaceuticals reported its third quarter 2024 financial results, highlighting advancements in its retinal disease pipeline, including the initiation of two Phase 2 studies for its drug candidates KIO-301 and KIO-104 [2][4]. Financial Highlights - The company ended the third quarter with $29.0 million in cash, cash equivalents, and short-term investments, alongside $1.8 million in collaboration receivables from its partnership with Théa [3][9]. - Research and development expenses for Q3 2024 were $2.2 million, with net expenses of $1.3 million after accounting for $0.9 million in reimbursements from Théa, compared to $1.1 million in the same quarter of 2023 [10]. - The net loss for Q3 2024 was $3.4 million, a decrease from a net loss of $5.8 million in Q3 2023, primarily due to a non-cash component related to the strategic focus on KIO-301 and KIO-104 [12]. Pipeline Developments - Kiora received FDA approval to initiate the ABACUS-2 study for KIO-301, targeting retinitis pigmentosa, with plans to enroll patients with various gene mutations associated with the condition [5][6]. - The KLARITY trial for KIO-104, aimed at treating multiple retinal inflammatory diseases, is set to begin in the first half of 2025 [7]. - The company is collaborating with Théa and the Choroideremia Research Foundation to validate functional vision endpoints, which are crucial for marketing authorization and reimbursement [6]. Strategic Positioning - Kiora's CEO emphasized the company's strong position with two innovative drug candidates entering Phase 2 trials and a solid balance sheet to support development through 2027 [4][8]. - The partnership with Théa is expected to enhance the overall pipeline progress by reimbursing Kiora's R&D activities, allowing further investment in KIO-104 [8].

Financial Position - Kiora ended Q2 2024 with $27.8 million in cash, cash equivalents, and short-term investments, with an additional $3.7 million in near-term receivables from R&D reimbursements and tax credits, providing a runway into 2027[1][7] - Cash and cash equivalents increased to $6,575,394 as of June 30, 2024, from $2,454,684 at December 31, 2023[12] - Total current assets rose significantly to $31,830,805 as of June 30, 2024, compared to $4,738,031 at December 31, 2023[12] - Total assets increased to $40,814,265 as of June 30, 2024, from $13,711,870 at December 31, 2023[12] - Total liabilities, commitments, and contingencies were $7,712,592 as of June 30, 2024, compared to $7,602,216 at December 31, 2023[12] - The accumulated deficit decreased to $(135,745,294) as of June 30, 2024, from $(146,976,855) at December 31, 2023[12] Revenue and Expenses - Revenue for Q2 2024 was $20,000, compared to no revenue in Q2 2023, recognized from a grant for validating functional vision assessments[8] - Total revenue for the six months ended June 30, 2024, was $16,020,000, compared to $20,000 for the same period in 2023[13] - Kiora spent $2.0 million on R&D in Q2 2024, resulting in net R&D expenses of $0.9 million after $1.1 million in reimbursement credits, down from $1.4 million in Q2 2023[8][9] - General and administrative expenses increased to $1.5 million in Q2 2024 from $1.1 million in Q2 2023, attributed to technical accounting and legal advisory services[9] - Operating expenses for the three months ended June 30, 2024, were $2,564,887, a decrease of 2.6% from $2,633,012 in the same period of 2023[13] - The net loss for Q2 2024 was $2.2 million, an improvement from a net loss of $2.6 million in Q2 2023, primarily due to KIO-301 expense credits[9] - Net loss for the three months ended June 30, 2024, was $2,221,646, compared to a net loss of $2,613,813 for the same period in 2023[13] - The company reported interest income of $342,102 for the three months ended June 30, 2024, compared to $45,087 for the same period in 2023[13] Research and Development - Kiora is advancing KIO-301 and KIO-104 toward Phase 2 trials, with KIO-301 targeting retinitis pigmentosa and KIO-104 aimed at multiple retinal inflammatory diseases[2][4] - KIO-301 received Orphan Medicinal Product Designation from the EMA for inherited retinal diseases, and the company is finalizing clinical validation of functional vision endpoints for the ABACUS-2 trial[4][5] - Kiora plans to initiate the Phase 2 CLARITY study for KIO-104 in H1 2025, following positive Phase 1b results and ongoing non-clinical work[4][7] - The company anticipates completing the clinical validation of functional vision endpoints for ABACUS-2 and receiving approval to initiate the study in H2 2024[7] Strategic Outlook - Kiora's cash position allows for robust study designs, potentially reducing time to market and increasing chances for approval and commercial success[2]