Kiora Pharmaceuticals(KPRX) - 2025 Q2 - Quarterly Results

Company Overview and Q2 2025 Highlights Kiora Pharmaceuticals reports Q2 2025 financial results and significant progress in its retinal disease treatment pipeline, including clinical advancements and strategic partnerships Executive Summary 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] - The company made substantial progress on its KIO-301 and KIO-104 Phase 2 clinical programs, including trial initiation and patient enrollment[4] - Global commercialization network expanded through a partnership with Senju, with cash flow projected to extend until late 2027[4][5] Key Corporate Highlights (Q2 & YTD 2025) 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 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] - 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] Strategic Partnerships & Intellectual Property 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] - 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] - Recorded $1.25 million in deferred revenue from the non-refundable Senju option fee related to the KIO-301 collaboration[5] Financial Position & Outlook 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][6] - 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][6] - Received $1.3 million in Q1 2025 R&D expense reimbursement from Théa Open Innovation for KIO-301 activities[5] Pipeline Development Update Kiora provides updates on its KIO-301 and KIO-104 programs, highlighting clinical trial progress and intellectual property advancements KIO-301 Program Update 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] - 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] - A strategic collaboration has been established with Senju Pharmaceutical Co., Ltd. to develop and commercialize KIO-301 in key Asian countries[4][5] KIO-104 Program Update 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][5] - KIO-104's market exclusivity has been extended until 2043 by securing a patent covering optimized methods for treating ocular inflammatory diseases[5] Second Quarter 2025 Financial Results Kiora Pharmaceuticals reports its second quarter 2025 financial results, detailing net loss, cash position, and expense breakdowns Summary of Financial Performance 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] - As of the end of Q2 2025, the company held $20.7 million in cash, cash equivalents, and short-term investments[6] - 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] Research and Development (R&D) Expenses 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] General and Administrative (G&A) Expenses 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 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 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 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 Kiora Pharmaceuticals is a clinical-stage biotechnology company focused on developing innovative therapies for retinal diseases Company Profile and Pipeline 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] - The company utilizes innovative small molecules to target key pathways in retinal diseases, aiming to slow, halt, or restore vision loss[9] - Key pipeline products include KIO-301 (for retinitis pigmentosa, choroidal ischemia, and Stargardt disease) and KIO-104 (for retinal inflammation)[9] Forward-Looking Statements This section contains forward-looking statements regarding Kiora's future operations, clinical development, and financial outlook, subject to inherent risks and uncertainties Disclaimer 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] - 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] - 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][12]