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]

Financial Performance - Total revenue for the six months ended June 30, 2024, was $16,020,000, compared to $20,000 for the same period in 2023[12]. - Net income for the six months ended June 30, 2024, was $11,231,561, compared to a net loss of $(4,482,349) for the same period in 2023, representing a significant turnaround[19]. - 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, representing a 15% improvement[12]. - The company reported a comprehensive loss of $2,203,007 for the three months ended June 30, 2024, compared to a comprehensive loss of $2,624,262 for the same period in 2023, reflecting a 16% improvement[12]. - Net loss for the six months ended June 30, 2024, was $11.23 million, a decrease in loss of $15.71 million compared to a net loss of $4.48 million in the same period in 2023[122]. Operating Expenses - 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[12]. - Operating expenses for the six months ended June 30, 2024, totaled $5.34 million, an increase of $0.79 million from $4.55 million in the same period in 2023[122]. - Kiora's general and administrative expenses increased by $0.47 million for the six months ended June 30, 2024, primarily due to higher professional fees and personnel-related costs[123]. - Research and development expenses for the six months ended June 30, 2024, were $2,400,339, compared to $1,830,382 for the same period in 2023, showing an increase of 31%[12]. - Research and Development expenses increased by $0.6 million, primarily due to UC licensing payments of $0.7 million and drug substance testing costs of $0.6 million[124]. Cash and Investments - Cash, cash equivalents, and restricted cash at the end of the period were $6,579,573, compared to $7,955,800 at the end of June 30, 2023[19]. - As of June 30, 2024, Kiora Pharmaceuticals had unrestricted cash and cash equivalents of $6.6 million and short-term investments of $21.2 million, with an accumulated deficit of $135.7 million[27]. - The total cash, cash equivalents, and restricted cash amounted to $6.58 million as of June 30, 2024, compared to $2.46 million on December 31, 2023, indicating a significant increase[45]. - As of June 30, 2024, the company had unrestricted cash and cash equivalents totaling $6.6 million, compared to $2.5 million at December 31, 2023[128]. - Cash on hand and short-term investments at June 30, 2024, totaled approximately $27.8 million, which is expected to fund operations into 2027[133]. Equity and Stock - Total stockholders' equity increased to $33,101,673 as of June 30, 2024, compared to $10,155,509 as of June 30, 2023, reflecting a growth of approximately 226%[13]. - The weighted average shares outstanding for basic earnings per share increased to 4,170,627 for the three months ended June 30, 2024, compared to 365,530 for the same period in 2023[12]. - The company issued 1,755,556 shares of common stock from a private placement, contributing $158,000 to stock amount and $13,650,815 to additional paid-in capital[17]. - The company raised $14,998,865 from a private placement, net of offering costs of $1,190,049, during the first half of 2024[19]. - The company raised net proceeds of approximately $13.8 million in a private placement offering that closed on February 5, 2024[127]. Collaboration and Revenue Recognition - The company had no collaboration revenue for the three months ended June 30, 2024, while it recorded $16,000,000 in collaboration revenue for the six months ended June 30, 2024[12]. - Kiora recognized a license access fee of $16.0 million in the first quarter of 2024 from a strategic agreement with Théa Open Innovation for the development of KIO-301[40]. - Kiora Pharmaceuticals recognized $16 million in collaboration revenue from a strategic development and commercialization agreement with Théa Open Innovation in January 2024[109]. - The company has not recorded any deferred revenue balance as of June 30, 2024, indicating no amounts received prior to satisfying revenue recognition criteria[35]. Future Outlook and Development - The company is focused on developing therapies for ophthalmic diseases, with ongoing efforts in research and development[21]. - The company plans to initiate a Phase 2 trial for KIO-301 later in 2024, expanding its development to include late-stage Choroideremia and Stargardt disease[110]. - Kiora is designing a Phase 2 clinical trial for KIO-104, expected to start in early 2025, targeting Posterior Non-Infectious Uveitis[111]. - The company anticipates needing additional financing to support future operations and product commercialization efforts[126]. - The company expects to incur significant expenses and increasing operating losses for the foreseeable future as it seeks partnerships for product development[130]. Assets and Liabilities - Total assets measured at fair value amounted to $26,209,635, with cash equivalents at $4,966,964 and short-term investments at $21,242,671[55]. - The Company has a total lease liability of $82.322 million, with future annual minimum lease payments totaling $92.835 million as of June 30, 2024[86]. - The maximum obligation for contingent consideration from acquisitions totals $18.799 million, with a current fair value estimated at $5.237 million[100]. - Contingent consideration liabilities increased to $5,236,999 from $5,128,959, a rise of 2.1%[57]. - The discount rate for contingent consideration increased to 15.0% from 13.1%[58].

Core Insights - Kiora Pharmaceuticals reported its second quarter 2024 financial results and provided updates on its retinal disease drug development pipeline, specifically focusing on two Phase 2 studies for KIO-301 and KIO-104 [3][4]. Financial Performance - The company ended the second quarter with $27.8 million in cash, cash equivalents, and short-term investments, along with an additional $3.7 million in near-term receivables from R&D reimbursements and tax credits, providing a runway into 2027 [3][11]. - Revenue for the second quarter was $20,000, attributed to a grant from the Choroideremia Research Foundation, compared to no revenue in the same quarter of 2023 [12]. - Kiora's net loss for the second quarter was $2.2 million, a decrease from a net loss of $2.6 million in the same period last year, primarily due to expense credits related to KIO-301 [15]. Drug Development Pipeline - KIO-301, a small molecule photoswitch for treating inherited retinal diseases, is advancing towards a Phase 2 trial (ABACUS-2) with a focus on refining approvable endpoints through interactions with the FDA and European regulators [5][6]. - KIO-104, aimed at treating multiple retinal inflammatory diseases, is set to initiate a Phase 2 trial (CLARITY) early next year, building on positive Phase 1b results [7][10]. - The company received Orphan Medicinal Product Designation from the European Medicines Agency for KIO-301 and reported significant functional MRI results from the ABACUS-1 trial [8][9]. Corporate Developments - Kiora promoted Melissa Tosca to Chief Financial Officer and appointed Lisa Walters-Hoffert as an independent board member [10]. - The company anticipates completing clinical validation of functional vision endpoints for KIO-301 and initiating the Phase 2 CLARITY study for KIO-104 in the second half of 2024 [10].

Group 1 - Kiora Pharmaceuticals will participate in the Jones Trading Healthcare Seaside Summit on July 15, 2024, at 6:15 PM Eastern Time [10] - The company invites shareholders to submit questions regarding clinical development plans, investigational therapies, and financials through a dedicated Q&A portal from July 16 to July 19, 2024 [3] - The presentation will be available live and on-demand for 90 days on Kiora's Investor Relations homepage [6] Group 2 - Kiora Pharmaceuticals is a clinical-stage biotechnology company focused on developing treatments for orphan retinal diseases [7] - KIO-301 is being developed for retinitis pigmentosa, choroideremia, and Stargardt disease, aiming to restore vision in patients with retinal degeneration [7] - KIO-104 is being developed for posterior non-infectious uveitis as a next-generation, non-steroidal, immuno-modulatory small-molecule inhibitor [7]

Core Insights - Kiora Pharmaceuticals has appointed Lisa Walters-Hoffert as an independent member of its Board of Directors, bringing extensive experience in biotech and investment banking [16][7] - The company is focused on advancing its pipeline of investigational treatments for retinal diseases, specifically KIO-301 and KIO-104 [2][13] - Ken Gayron will step down from the Board, marking a significant transition as Kiora continues its strategic growth [16][11] Company Overview - Kiora Pharmaceuticals is a clinical-stage biotechnology company dedicated to developing and commercializing products for orphan retinal diseases [13] - KIO-301 is aimed at treating retinitis pigmentosa, choroideremia, and Stargardt disease, while KIO-104 targets posterior non-infectious uveitis [13] - The company has reported promising data from KIO-301 and established a strategic partnership for co-development and commercialization [11] Leadership and Governance - Lisa Walters-Hoffert will serve as chair of the audit committee and a member of the compensation committee [16] - She has over 25 years of experience in investment banking, particularly with small-cap public companies in life sciences and technology [7] - Walters-Hoffert has held significant roles in various financial institutions, including Roth Capital Partners and Citicorp Securities [7] Financial Position - Kiora has capitalized the company with an expected runway for at least the next two years, allowing for continued investment in its therapies [11] - The company is positioned to leverage its financial resources to advance the development of KIO-104 [11]

. Vitreoretinal Surgeon and Key Thought Leader Roger Goldberg, M.D., Joins Kiora Pharmaceuticals' Scientific Advisory Board Encinitas, California--(Newsfile Corp. - June 25, 2024) - Kiora Pharmaceuticals (NASDAQ: KPRX) has appointed Roger A. Goldberg, MD, MBA, a vitreoretinal surgeon at Bay Area Retina Associates (BARA) to its Scientific Advisory Board. As an advisor, Dr. Goldberg will contribute scientific insights and valued clinical perspectives to aid Kiora's development of new therapeutics to address r ...