KPRX
KioraDDocument history
Earnings documents stored for KPRX.
Investor releaseQuarter not tagged2026-08-07Kiora Pharmaceuticals Reports Second Quarter 2026 Financial Results and Provides Corporate Update
TMX Newsfile
Kiora Pharmaceuticals Reports Second Quarter 2026 Financial Results and Provides Corporate Update
Encinitas, Califfornia--(Newsfile Corp. - August 7, 2026) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) today reported financial results for the second quarter ended June 30, 2026, and provided an update on its clinical pipeline of small-molecule therapies for retinal diseases and its corporate development activities. Second Quarter 2026 and Recent Highlights Advanced enrollment in the Phase 2 ABACUS-2 clinical trial of KIO-301 into the higher-dose cohort Continued enrollment in the higher-dose cohort of the Phase 2 KLARITY clinical trial of KIO-104 Ended the quarter with approximately $16.8 million in cash and short-term investments, providing an expected operating runway into late 2028 Secured a private placement for up to $24.0 million in gross proceeds, including $5.0 million received upfront, with the remaining proceeds contingent on the exercise of near-term milestone-based warrants KIO-301 "Patient demand for ABACUS-2 remains high as we have begun to enroll the higher 100 µg dose cohort," said Brian Strem, Ph.D., President and Chief Executive Officer of Kiora. "ABACUS-2 is a randomized, double-masked, controlled Phase 2 trial evaluating KIO-301 in patients with late-stage retinitis pigmentosa. KIO-301 is our small-molecule molecular photoswitch designed to restore light sensitivity after the loss of naturally light-sensing photoreceptors and is being developed as a potential mutation agnostic treatment option for patients with retinitis pigmentosa. Following treatment of the first few patients in the higher-dose cohort, an independent, predefined safety review will be conducted before enrollment of the remaining patients proceeds. We expect the last patient, first visit in the first quarter of 2027 with topline data in the third quarter of 2027. Kiora is responsible for conducting the ABACUS-2 trial, with development costs fully reimbursed under its collaboration with Théa Open Innovation, who holds exclusive rights to develop and commercialize KIO-301 in the U.S., Europe, and other select countries outside Asia. In Asia, we have an option agreement with Senju covering Japan, China and other select countries and are evaluating a potential commercial partner for South Korea, the remaining major territory. Kiora believes its current and potential regional partners could support planning for a coordinated global Phase 3 registration study, subject to regu…Read full documentShow less
Encinitas, Califfornia--(Newsfile Corp. - August 7, 2026) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) today reported financial results for the second quarter ended June 30, 2026, and provided an update on its clinical pipeline of small-molecule therapies for retinal diseases and its corporate development activities. Second Quarter 2026 and Recent Highlights Advanced enrollment in the Phase 2 ABACUS-2 clinical trial of KIO-301 into the higher-dose cohort Continued enrollment in the higher-dose cohort of the Phase 2 KLARITY clinical trial of KIO-104 Ended the quarter with approximately $16.8 million in cash and short-term investments, providing an expected operating runway into late 2028 Secured a private placement for up to $24.0 million in gross proceeds, including $5.0 million received upfront, with the remaining proceeds contingent on the exercise of near-term milestone-based warrants KIO-301 "Patient demand for ABACUS-2 remains high as we have begun to enroll the higher 100 µg dose cohort," said Brian Strem, Ph.D., President and Chief Executive Officer of Kiora. "ABACUS-2 is a randomized, double-masked, controlled Phase 2 trial evaluating KIO-301 in patients with late-stage retinitis pigmentosa. KIO-301 is our small-molecule molecular photoswitch designed to restore light sensitivity after the loss of naturally light-sensing photoreceptors and is being developed as a potential mutation agnostic treatment option for patients with retinitis pigmentosa. Following treatment of the first few patients in the higher-dose cohort, an independent, predefined safety review will be conducted before enrollment of the remaining patients proceeds. We expect the last patient, first visit in the first quarter of 2027 with topline data in the third quarter of 2027. Kiora is responsible for conducting the ABACUS-2 trial, with development costs fully reimbursed under its collaboration with Théa Open Innovation, who holds exclusive rights to develop and commercialize KIO-301 in the U.S., Europe, and other select countries outside Asia. In Asia, we have an option agreement with Senju covering Japan, China and other select countries and are evaluating a potential commercial partner for South Korea, the remaining major territory. Kiora believes its current and potential regional partners could support planning for a coordinated global Phase 3 registration study, subject to regulatory feedback, and future commercialization to bring KIO-301 to patients living with RP globally." KIO-104 "For KIO-104, we are enrolling patients in the higher-dose group of the Phase 2 KLARITY trial, which is evaluating the therapeutic in patients with macular edema due to retinal inflammation. KIO-104 is a non-steroidal, small-molecule inhibitor of dihydroorotate dehydrogenase, or DHODH, designed for local intravitreal administration. KIO-104 has been well tolerated based on safety information available to date. We expect to report initial clinical data in late 2026. These data are intended to assess the drug's activity across retinal conditions involving inflammation and macular edema and will inform the next stage of development." Business & Future Pipeline "On the business front, Kiora continues to evaluate potential strategic transactions that could diversify and expand our development pipeline. If completed by early next year, a transaction would satisfy a warrant acceleration milestone provision from our recent private placement that, to the extent warrants are exercised, could provide additional capital. In anticipation, we're pursuing a range of business activities, including identifying select personnel and planning for the operating capabilities needed to move quickly following completion of any potential transaction." Second Quarter 2026 Financial Results "We continue to efficiently allocate capital primarily toward our ongoing clinical trials. All KIO-301 research and development expenses associated with ABACUS-2 continue to be reimbursed under our collaboration with Théa" said Melissa Tosca, Chief Financial Officer of Kiora. "Based on our current operating plan, expected collaboration reimbursements and available capital, we expect our current resources to fund operations into late 2028." Kiora ended the quarter with approximately $16.8 million in cash and short-term investments, compared with $13.9 million at March 31, 2026. The increase primarily reflected proceeds from the strategic equity financing completed during the quarter, partially offset by cash used in operations. The Company also recorded approximately $1.1 million in collaboration receivables and $1.8 million in tax and other receivables as of June 30, 2026. Research and development expenses were approximately $2.1 million for the second quarter of 2026, before recognizing $1.3 million in reimbursable expenses from Théa, compared with $2.6 million, before recognizing $1.7 million in reimbursable expenses, for the second quarter of 2025. The change primarily reflected lower expenses related to preclinical and CMC activities due to trial progression moving into clinical activities. General and administrative expenses remained consistent at approximately $1.4 million in the second quarter of 2026 and 2025. Net loss for the second quarter of 2026 was approximately $2.1 million, compared with a net loss of $2.2 million for the second quarter of 2025. About Kiora Pharmaceuticals Kiora Pharmaceuticals is a clinical-stage biotechnology company developing therapies for retinal diseases. The Company uses small molecules to target biological pathways involved in inherited retinal degeneration, retinal inflammation and vision loss. KIO-301 is a molecular photoswitch being developed initially to restore vision in patients with late-stage retinitis pigmentosa, regardless of the genetic mutation responsible for the disease. The program may also have potential applications in other retinal degenerative conditions. Kiora has granted Théa Open Innovation an exclusive license to develop and commercialize KIO-301 outside Asia. KIO-104 is a non-steroidal, small-molecule inhibitor of DHODH being developed for retinal inflammation and associated macular edema. It is designed for local ocular administration to regulate immune-cell activity within the eye while limiting systemic exposure. In addition to news releases and SEC filings, Kiora expects to post information on its website, www.kiorapharma.com, and its social media accounts that could be relevant to investors. Investors are encouraged to follow Kiora on X and LinkedIn and to visit the Company's website or subscribe to email alerts. Forward-Looking Statements Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements concerning, among other matters, the timing, conduct, enrollment, safety reviews and results of the ABACUS-2 and KLARITY clinical trials; the expected timing of the last patient, first visit and topline results from ABACUS-2; the expected timing and content of clinical data from KLARITY; the potential for KIO-301 and KIO-104 to address multiple indications; the possibility of future global registration studies and commercialization; the potential for pipeline expansion and potential warrant exercises in connection with any transaction; the Company's ability to complete a potential strategic transaction; the potential for a commercial partner in South Korea; and the sufficiency of the Company's existing cash and short-term investments to fund operations for specified periods. These statements involve risks and uncertainties that may cause actual results to differ materially from those expressed or implied by such forward-looking statements, including, among other things, Kiora's ability to conduct and complete clinical trials on a timely basis; obtain regulatory or marketing approvals for its development-stage products, including KIO-301 and KIO-104; successfully develop or commercialize its product candidates; complete a potential strategic transaction on the anticipated terms or timeline, or at all; and other market, operational and regulatory conditions. Additional risks are described under the heading "Risk Factors" contained in Kiora's Annual Report on Form 10-K filed with the SEC on March 25, 2026 and Kiora's other public filings with the SEC. Kiora's results may also be affected by factors of which Kiora is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Kiora expressly disclaims any obligation or undertaking to publicly update or revise any forward-looking statement to reflect any change in its expectations or any change in the events, conditions or circumstances on which such statement is based, except as required by law. Contacts: Investors [email protected] Financial Tables Follow KIORA PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS KIORA PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(unaudited) To view the source version of this press release, please visit https://www.newsfilecorp.com/release/308423
Investor releaseQuarter not tagged2026-05-08Kiora Pharmaceuticals Reports First Quarter 2026 Financial Results and Provides Corporate Update
TMX Newsfile
Kiora Pharmaceuticals Reports First Quarter 2026 Financial Results and Provides Corporate Update
Encinitas, California--(Newsfile Corp. - May 8, 2026) - Kiora Pharmaceuticals (NASDAQ: KPRX) today reported financial results for the first quarter ended March 31, 2026, and provided an update on its clinical pipeline of small molecules for the treatment of retinal diseases. First Quarter 2026 and Recent Highlights Enrollment in the Phase 2 ABACUS-2 study of KIO-301 remains very active, with expansion of clinical trial sites to accommodate the strong patient demand to participate in the trial Publication of ABACUS-1 clinical trial results in Nature Medicine, providing external validation of KIO-301's potential for vision restoration in patients with late-stage retinitis pigmentosa Continued progress in the Phase 2 KLARITY study of KIO-104, with an upcoming, pre-defined safety review to support advancement to the next dose level Kiora has an operational runway into late 2028, well beyond the anticipated clinical data readouts from both ongoing clinical trials Subsequent to the end of the quarter, Kiora executed a strategic equity financing, led by Perceptive Advisors that further strengthens the balance sheet "We are encouraged by the continued progress across both of our clinical programs, including the strong momentum we are seeing with KIO-301 enrollment," said Brian Strem, Ph.D., President and Chief Executive Officer of Kiora. "Recruitment in our ABACUS-2 study continues to advance, with close to 50% already completed, ongoing or scheduled to be followed by dose escalation of the drug in our second cohort of patients. We are seeing significant interest from both patients and physicians. This partially reflects the high unmet need within this rare disease community and the close-knit network of treating specialists. Importantly, the publication of our ABACUS-1 data in Nature Medicine this past April provides meaningful external validation of our molecular photoswitch technology and reinforces our confidence in the drug's potential as a novel therapeutic approach. To meet the growing demand to participate in the ABACUS-2 trial from patients with retinitis pigmentosa, we are expanding the network of trial sites, while also working closely with our partners to establish the groundwork to be prepared for potential future global registration studies and hopeful commercial launch. "For KIO-104, we are making steady progress in the KLARITY study and are approachi…Read full documentShow less
Encinitas, California--(Newsfile Corp. - May 8, 2026) - Kiora Pharmaceuticals (NASDAQ: KPRX) today reported financial results for the first quarter ended March 31, 2026, and provided an update on its clinical pipeline of small molecules for the treatment of retinal diseases. First Quarter 2026 and Recent Highlights Enrollment in the Phase 2 ABACUS-2 study of KIO-301 remains very active, with expansion of clinical trial sites to accommodate the strong patient demand to participate in the trial Publication of ABACUS-1 clinical trial results in Nature Medicine, providing external validation of KIO-301's potential for vision restoration in patients with late-stage retinitis pigmentosa Continued progress in the Phase 2 KLARITY study of KIO-104, with an upcoming, pre-defined safety review to support advancement to the next dose level Kiora has an operational runway into late 2028, well beyond the anticipated clinical data readouts from both ongoing clinical trials Subsequent to the end of the quarter, Kiora executed a strategic equity financing, led by Perceptive Advisors that further strengthens the balance sheet "We are encouraged by the continued progress across both of our clinical programs, including the strong momentum we are seeing with KIO-301 enrollment," said Brian Strem, Ph.D., President and Chief Executive Officer of Kiora. "Recruitment in our ABACUS-2 study continues to advance, with close to 50% already completed, ongoing or scheduled to be followed by dose escalation of the drug in our second cohort of patients. We are seeing significant interest from both patients and physicians. This partially reflects the high unmet need within this rare disease community and the close-knit network of treating specialists. Importantly, the publication of our ABACUS-1 data in Nature Medicine this past April provides meaningful external validation of our molecular photoswitch technology and reinforces our confidence in the drug's potential as a novel therapeutic approach. To meet the growing demand to participate in the ABACUS-2 trial from patients with retinitis pigmentosa, we are expanding the network of trial sites, while also working closely with our partners to establish the groundwork to be prepared for potential future global registration studies and hopeful commercial launch. "For KIO-104, we are making steady progress in the KLARITY study and are approaching a planned safety review that we expect will enable advancement to the higher dose cohort. We believe this program has the potential to address significant unmet need in inflammatory retinal diseases, and we remain focused on generating data to guide future development. "Finally, the strategic equity investment from Perceptive Advisors and ADAR1 completed subsequent to the quarter enhances our financial flexibility and supports the continued advancement of both programs as well as optionality around potential pipeline expansion." First Quarter 2026 Financial Results "We continued to carefully manage our cash resources while advancing our clinical programs during the first quarter," said Melissa Tosca, Chief Financial Officer of Kiora. "With our current cash position, expected collaboration reimbursements, and additional capital raised subsequent to quarter end, we believe we have sufficient runway to fund operations into late 2028, beyond our anticipated clinical data readouts, providing flexibility as we continue to execute on our development strategy." Kiora ended the quarter with $13.9 million in cash and short-term investments. In addition, the Company recorded $1.5 million in collaboration receivables from Th←a and approximately $2.0 million in tax and other receivables. Subsequent to the end of the quarter, Kiora raised an additional $5.0 million in gross proceeds from the strategic equity investment. Research and development expenses were approximately $2.1 million, before recognizing $1.2 million in reimbursable expenses from Th←a, compared to $2.5 million, before recognizing $2.0 million in reimbursable expenses from Th←a, in the prior-year period, primarily reflecting the timing of clinical activities and collaboration credits. General and administrative expenses were approximately $1.6 million, compared to $1.5 million in the first quarter of 2025. About Kiora Pharmaceuticals Kiora Pharmaceuticals is a clinical-stage biotechnology company developing advanced therapies for retinal disease. We target critical pathways underlying retinal diseases using innovative small molecules to slow, stop, or restore vision loss. KIO-301 is being developed initially for the treatment of retinitis pigmentosa, with potential to expand into choroideremia and Stargardt disease. It is a molecular photoswitch that has the potential to restore vision in patients with inherited and/or age-related retinal degeneration. KIO-104 is being developed for the treatment of macular edema due to retinal inflammation. It is a next-generation, non-steroidal, immuno-modulatory, and small-molecule inhibitor of dihydroorotate dehydrogenase (DHODH). In addition to news releases and SEC filings, we expect to post information on our website, www.kiorapharma.com, and social media accounts that could be relevant to investors. We encourage investors to follow us on X and LinkedIn as well as to visit our website and/or subscribe to email alerts. Forward-Looking Statements Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements include statements relating to, among other things, Kiora's ability to execute on development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's development-stage products, including KIO-104 and KIO-301, as well as the success thereof, which such approvals or success may not be obtained or achieved on a timely basis or at all, the sufficiency of existing cash and short-term investments on hand to fund operations for specific periods, the timeline of anticipated readouts, the potential for pipeline expansion, the potential to add trial centers, expand the geographic footprint of trials and/or accelerate enrollment, the potential for KIO-301 and KIO-104 to address multiple indications, and the possibility of future global registration studies and commercialization. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the ability to conduct clinical trials on a timely basis, market and other conditions and certain risk factors described under the heading "Risk Factors" contained in Kiora's Annual Report on Form 10-K filed with the SEC on March 25, 2026 or described in Kiora's other public filings, including on Form 10-Q filed with the SEC on May 8, 2026. Kiora's results may also be affected by factors of which Kiora is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Kiora expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions, or circumstances on which any such statement is based, except as required by law. Contacts: Investors [email protected] Financial Tables Follow CONDENSED CONSOLIDATED BALANCE SHEETS CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) To view the source version of this press release, please visit https://www.newsfilecorp.com/release/296558
Investor releaseQuarter not tagged2026-03-25Kiora Pharmaceuticals Reports Fourth-Quarter and Full-Year 2025 Results; Company Advances Retinal Disease Pipeline with Two Active Phase 2 Clinical Trials
TMX Newsfile
Kiora Pharmaceuticals Reports Fourth-Quarter and Full-Year 2025 Results; Company Advances Retinal Disease Pipeline with Two Active Phase 2 Clinical Trials
Encinitas, California--(Newsfile Corp. - March 25, 2026) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided a year-end business update on its pipeline of small molecules for the treatment of retinal diseases. Key fourth-quarter, full-year 2025, and recent corporate highlights include: Advanced KIO-301 from regulatory clearance to patient dosing in ABACUS-2, a Phase 2 randomized, controlled clinical trial in patients with advanced retinitis pigmentosa. Strengthened the strategic global commercial network for KIO-301 through an option agreement with Senju Pharmaceutical Co. Ltd. covering key Asian markets with potential deal value of up to $110 million plus royalties, if exercised. Advanced KIO-104 from regulatory clearance to patient dosing in KLARITY, a Phase 2 dose-escalating trial evaluating the treatment of macular edema due to retinal inflammation. Ended 2025 with $17.1 million in cash, cash equivalents, and short-term investments, plus $3.5 million in receivables consisting of $1.5 million in collaboration receivables, $1.0 million in tax receivables, and $1.0 million in research credit and other receivables. Reported fourth-quarter and full-year 2025 net cash used in operating activities of $2.2 million and $10.0 million, respectively. Identified the potential for platform expansion of KIO-300 as an ion-channel modulator through a preclinical ex vivo proof of concept study in the treatment of epilepsy. Based on current operating plans, expects existing cash, cash equivalents, and short-term investments to fund operations into late 2027, beyond anticipated topline data readouts for ABACUS-2 and KLARITY. "Our success in 2025 was defined by transitioning from trial preparation to trial execution for our two lead programs," said Brian M. Strem, Ph.D., President and Chief Executive Officer of Kiora. "We started the year with approvals to begin KLARITY and ABACUS-2 and exited the year with both Phase 2 trials underway, actively recruiting and dosing patients. These milestones meaningfully advanced our goal of delivering new treatment options for patients with retinal diseases and position us for anticipated clinical data in the first half of 2027. "For KIO-301, we completed validation of the functional vision endpoints to support…Read full documentShow less
Encinitas, California--(Newsfile Corp. - March 25, 2026) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided a year-end business update on its pipeline of small molecules for the treatment of retinal diseases. Key fourth-quarter, full-year 2025, and recent corporate highlights include: Advanced KIO-301 from regulatory clearance to patient dosing in ABACUS-2, a Phase 2 randomized, controlled clinical trial in patients with advanced retinitis pigmentosa. Strengthened the strategic global commercial network for KIO-301 through an option agreement with Senju Pharmaceutical Co. Ltd. covering key Asian markets with potential deal value of up to $110 million plus royalties, if exercised. Advanced KIO-104 from regulatory clearance to patient dosing in KLARITY, a Phase 2 dose-escalating trial evaluating the treatment of macular edema due to retinal inflammation. Ended 2025 with $17.1 million in cash, cash equivalents, and short-term investments, plus $3.5 million in receivables consisting of $1.5 million in collaboration receivables, $1.0 million in tax receivables, and $1.0 million in research credit and other receivables. Reported fourth-quarter and full-year 2025 net cash used in operating activities of $2.2 million and $10.0 million, respectively. Identified the potential for platform expansion of KIO-300 as an ion-channel modulator through a preclinical ex vivo proof of concept study in the treatment of epilepsy. Based on current operating plans, expects existing cash, cash equivalents, and short-term investments to fund operations into late 2027, beyond anticipated topline data readouts for ABACUS-2 and KLARITY. "Our success in 2025 was defined by transitioning from trial preparation to trial execution for our two lead programs," said Brian M. Strem, Ph.D., President and Chief Executive Officer of Kiora. "We started the year with approvals to begin KLARITY and ABACUS-2 and exited the year with both Phase 2 trials underway, actively recruiting and dosing patients. These milestones meaningfully advanced our goal of delivering new treatment options for patients with retinal diseases and position us for anticipated clinical data in the first half of 2027. "For KIO-301, we completed validation of the functional vision endpoints to support later-stage development; activated multiple trial sites for the 36-patient ABACUS-2 ascending dose, randomized, controlled, clinical trial; and dosed the first cohort of patients. Further, we received approval following a planned safety review checkpoint to complete the remaining patients in the 50ᄉg dose as well as clearance to then initiate the 100ᄉg dose cohort. Based on the current enrollment rate and follow-up, the six-week dosing period, and the three-month follow-up, we anticipate an initial data readout in the third quarter of 2027. Combined with the Senju regional partnership and our collaboration with Laboratoires Th←a, we believe we finished 2025 with considerable momentum across the business and support from strong development and commercial partners. "The potential of KIO-300 as an ion-channel modulator platform extends beyond ophthalmic indications. As an example, last year our discovery team demonstrated preclinical ex vivo proof of concept in the treatment of epilepsy. The platform may also have broader relevance in other therapeutic spaces where ion-channel modulators may dampen excess excitatory effects in cells that contribute to unwanted disease-related signaling. "For KIO-104, we initiated and began dosing patients in KLARITY and cleared the early planned safety review checkpoint. This Phase 2 trial is a two-stage study designed to evaluate multiple doses of KIO-104 in patients with macular edema due to retinal inflammation. Findings from the initial stage will inform the dose-expansion stage in one or more specific indications." Fourth-Quarter and Full-Year Financial Highlights "With two Phase 2 trials now active, we enter the year with continued operational focus and financial discipline," said Melissa Tosca, Chief Financial Officer of Kiora. "We ended 2025 with a strong cash position, support from our strategic collaboration partners, and a projected cash runway into late 2027. Importantly, we believe this runway extends beyond the anticipated initial data readouts from both ongoing clinical trials, positioning us to execute our near-term milestones and continue advancing our pipeline." Cash Position: Kiora ended the year with $17.1 million in cash, cash equivalents, and short-term investments. The Company also recorded $3.5 million in receivables, consisting of $1.5 million in collaboration receivables from Laboratoires Th←a ("Th←a") for reimbursable R&D expenses, $1.0 million in tax receivables, and $1.0 million in research credit and other receivables. Research and Development: R&D expenses for the fourth quarter of 2025 were $2.9 million before recognizing $1.8 million in reimbursable expenses from Th←a, compared with $1.9 million before recognizing $0.7 million in reimbursable expenses from Th←a in the fourth quarter of 2024. R&D expenses for 2025 were $10.8 million before recognizing $7.1 million in reimbursable expenses from Th←a, compared with $7.8 million in 2024 before recognizing $2.9 million in reimbursed R&D expenses from Th←a. The increases in R&D expense for the quarter and year were driven primarily by clinical trial activities for KIO-301 and KIO-104. General and Administrative: G&A expenses were $1.5 million in the fourth quarter of 2025, compared with $1.3 million in the fourth quarter of 2024. G&A expenses were $5.8 million in 2025, compared with $5.5 million in 2024. The increases in G&A expense for the quarter and year were primarily related to personnel and associated activities. Net Income (Loss): The Company reported a net loss of $6.5 million in the fourth quarter of 2025, compared with a net loss of $4.2 million in the fourth quarter of 2024. The Company reported a net loss of $10.8 million for 2025, compared with net income of $3.6 million in 2024. The increase in net loss for the quarter was driven primarily by a non-cash impairment charge related to KIO-104, resulting from changes in equity market-based valuation inputs. This charge does not reflect any change in development timelines, probability of technical success, or Kiora's strategic focus on KIO-104. The year-over-year shift to a net loss was primarily due to the recognition of the $16.0 million upfront payment from Th←a as collaboration revenue in 2024. About Kiora Pharmaceuticals Kiora Pharmaceuticals is a clinical-stage biotechnology company developing advanced therapies for retinal disease. We target critical pathways underlying retinal diseases using innovative small molecules to slow, stop, or restore vision loss. KIO-301 is being developed initially for the treatment of retinitis pigmentosa, with potential to expand into choroideremia and Stargardt disease. It is a molecular photoswitch that has the potential to restore vision in patients with inherited and/or age-related retinal degeneration. KIO-104 is being developed for the treatment of macular edema due to retinal inflammation. It is a next-generation, non-steroidal, immuno-modulatory, and small-molecule inhibitor of dihydroorotate dehydrogenase (DHODH). In addition to news releases and SEC filings, we expect to post information on our website, www.kiorapharma.com, and social media accounts that could be relevant to investors. We encourage investors to follow us on X and LinkedIn as well as to visit our website and/or subscribe to email alerts. Forward-Looking Statements Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements include statements relating to, among other things, Kiora's ability to execute on development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's development-stage products, including KIO-104 and KIO-301, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all, the sufficiency of existing cash and short-term investments on hand to fund operations for specific periods, the timeline of anticipated readouts, the potential for cash runway extension through partnership milestones, the potential to add trial centers, expand the geographic footprint of trials and/or accelerate enrollment, the potential for KIO-301 and KIO-104 to address multiple indications, and the possibility of future registration studies and global commercialization. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the ability to conduct clinical trials on a timely basis, market and other conditions and certain risk factors described under the heading "Risk Factors" contained in Kiora's Annual Report on Form 10-K filed with the SEC on March 25, 2026 or described in Kiora's other public filings, including on Form 10-Q filed with the SEC on November 7, 2025. Kiora's results may also be affected by factors of which Kiora is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Kiora expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions, or circumstances on which any such statement is based, except as required by law. Contacts: Investors [email protected] Financial Tables Follow CONSOLIDATED BALANCE SHEETS KIORA PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) To view the source version of this press release, please visit https://www.newsfilecorp.com/release/289753
Investor releaseQuarter not tagged2025-11-07Kiora Pharmaceuticals Reports Third Quarter 2025 Results; Company Advances Pipeline with Two Actively Enrolling Phase 2 Clinical Trials for Retinal Diseases
Newsfile
Kiora Pharmaceuticals Reports Third Quarter 2025 Results; Company Advances Pipeline with Two Actively Enrolling Phase 2 Clinical Trials for Retinal Diseases
Encinitas, California--(Newsfile Corp. - November 7, 2025) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced third quarter 2025 financial results and provided an update on its pipeline of small molecules for the treatment of retinal diseases. Key third quarter and 2025 year-to-date corporate highlights include: Continued recruitment and patient dosing in KLARITY, an open-label Phase 2 clinical trial evaluating KIO-104 for the treatment of patients with retinal inflammation. Continued recruitment and patient dosing in the ABACUS-2 trial, a Phase 2, randomized, controlled clinical trial of KIO-301 for vision restoration in patients with retinitis pigmentosa. In the third quarter of 2025, Kiora received $1.2 million in reimbursed R&D expenses from Théa Open Innovation ("Théa") for activities related to KIO-301 performed in the second quarter of 2025. The Company billed $1.5 million in the third quarter of 2025 for reimbursable R&D expenses, of which $0.3 million was received within the quarter. Ended the quarter with $19.4 million in cash, cash equivalents and short-term investments, along with $1.2 million in collaboration receivables and $1.5 million in tax and research credit receivables. Maintained projected cash runway into late 2027, a timeframe beyond anticipated data readouts for both KLARITY and ABACUS-2, with potential for further extension through achievement of partnership milestones. "Both of our Phase 2 clinical trials continue to recruit, screen, and dose participants. Further, we continue to explore adding more trial centers to expand the geographic footprint and accelerate enrollment in both trials," said Brian M. Strem, Ph.D., President & Chief Executive Officer of Kiora. "For ABACUS-2, screening and enrollment has been expanded by patients who participated in Kiora's functional endpoint validation study. This endpoint validation study remains open for patients with less severe vision loss, representing an additional population of individuals potentially helped by KIO-301. We are also maintaining close collaboration with our partners, Théa and Senju, who will be instrumental in potential registration studies and global commercialization. "KLARITY enrollment is targeting patients with one of several inflammatory retinal diseases that cause macular edema in this two-stage, multi-dose study. As part of the de…Read full documentShow less
Encinitas, California--(Newsfile Corp. - November 7, 2025) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced third quarter 2025 financial results and provided an update on its pipeline of small molecules for the treatment of retinal diseases. Key third quarter and 2025 year-to-date corporate highlights include: Continued recruitment and patient dosing in KLARITY, an open-label Phase 2 clinical trial evaluating KIO-104 for the treatment of patients with retinal inflammation. Continued recruitment and patient dosing in the ABACUS-2 trial, a Phase 2, randomized, controlled clinical trial of KIO-301 for vision restoration in patients with retinitis pigmentosa. In the third quarter of 2025, Kiora received $1.2 million in reimbursed R&D expenses from Théa Open Innovation ("Théa") for activities related to KIO-301 performed in the second quarter of 2025. The Company billed $1.5 million in the third quarter of 2025 for reimbursable R&D expenses, of which $0.3 million was received within the quarter. Ended the quarter with $19.4 million in cash, cash equivalents and short-term investments, along with $1.2 million in collaboration receivables and $1.5 million in tax and research credit receivables. Maintained projected cash runway into late 2027, a timeframe beyond anticipated data readouts for both KLARITY and ABACUS-2, with potential for further extension through achievement of partnership milestones. "Both of our Phase 2 clinical trials continue to recruit, screen, and dose participants. Further, we continue to explore adding more trial centers to expand the geographic footprint and accelerate enrollment in both trials," said Brian M. Strem, Ph.D., President & Chief Executive Officer of Kiora. "For ABACUS-2, screening and enrollment has been expanded by patients who participated in Kiora's functional endpoint validation study. This endpoint validation study remains open for patients with less severe vision loss, representing an additional population of individuals potentially helped by KIO-301. We are also maintaining close collaboration with our partners, Théa and Senju, who will be instrumental in potential registration studies and global commercialization. "KLARITY enrollment is targeting patients with one of several inflammatory retinal diseases that cause macular edema in this two-stage, multi-dose study. As part of the design, we have a pre-defined sentinel assessment of safety and tolerability. "Collectively, the progress across both studies represents the execution of our strategy to advance a diversified pipeline targeting rare and common retinal diseases, with each asset having potential to address several indications." Third Quarter Financial Highlights "Our cash position continues to support an anticipated runway into late 2027, well beyond the anticipated clinical readouts for both ABACUS-2 and KLARITY," said Melissa Tosca, Chief Financial Officer. "This outlook is further supported by an approximate $1.0 million income tax receivable, resulting from changes under the OBBBA enacted in July 2025 that modified the treatment of capitalized R&D. These revisions provide greater flexibility in applying prior R&D expenses against net income. We continue to manage our capital efficiently, maintaining a stable G&A spend while increasing R&D investment that is partially offset by reimbursement from our strategic partner." Kiora ended the third quarter of 2025 with $19.4 million in cash, cash equivalents, and short-term investments. The Company also recorded $1.2 million in collaboration receivables from Théa for reimbursable R&D expenses and $1.5 million in tax and other receivables, of which 1.0 million is from income tax receivables and $0.5 million is related to research tax credits. R&D expenses for the third quarter of 2025 were $2.7 million, before recognizing $1.7 million in reimbursable expenses from Théa. In comparison, R&D expenses for the third quarter of 2024 were $2.1 million, with $0.9 million in offsetting reimbursable expenses from Théa. The increase in R&D for the third quarter of 2025 was mainly attributed to clinical trial activities. G&A expenses were $1.4 million for the third quarter of 2025, consistent with $1.4 million in the third quarter of 2024. The Company reported net income of $27 thousand for the third quarter of 2025, compared to a net loss of $3.4 million in the third quarter of 2024. The improvement was driven by favorable tax impacts, noncash gains from the remeasurement of existing contingent consideration liabilities, and continued control of operating costs. About Kiora Pharmaceuticals Kiora Pharmaceuticals is a clinical-stage biotechnology company developing advanced therapies for retinal disease. We target critical pathways underlying retinal diseases using innovative small molecules to slow, stop, or restore vision loss. KIO-301 is being developed initially for the treatment of retinitis pigmentosa, with plans to expand into choroideremia, and Stargardt disease. It is a molecular photoswitch that has the potential to restore vision in patients with inherited and/or age-related retinal degeneration. KIO-104 is being developed for the treatment of retinal inflammation. It is a next-generation, non-steroidal, immuno-modulatory, and small-molecule inhibitor of dihydroorotate dehydrogenase (DHODH). In addition to news releases and SEC filings, we expect to post information on our website, www.kiorapharma.com, and social media accounts that could be relevant to investors. We encourage investors to follow us on X and LinkedIn as well as to visit our website and/or subscribe to email alerts. Forward-Looking Statements Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements include statements relating to, among other things, Kiora's ability to execute on development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's development-stage products, including KIO-104 and KIO-301, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all, the sufficiency of existing cash and short-term investments on hand to fund operations for specific periods, the timeline of anticipated readouts, the potential for cash runway extension through partnership milestones, the potential to add trial centers, expand the geographic footprint of trials and/or accelerate enrollment, the potential for KIO-301 and KIO-104 to address multiple indications, and the possibility of future registration studies and global commercialization. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the ability to conduct clinical trials on a timely basis, market and other conditions and certain risk factors described under the heading "Risk Factors" contained in Kiora's Annual Report on Form 10-K filed with the SEC on March 25, 2025 or described in Kiora's other public filings, including on Form 10-Q filed with the SEC on November 7, 2025. Kiora's results may also be affected by factors of which Kiora is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Kiora expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions, or circumstances on which any such statement is based, except as required by law. Contacts: Investors [email protected] Financial Tables Follow CONDENSED CONSOLIDATED BALANCE SHEETS CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME (unaudited) To view the source version of this press release, please visit https://www.newsfilecorp.com/release/273499
Investor releaseQuarter not tagged2025-08-08Kiora Pharmaceuticals Reports Second Quarter 2025 Results; Company Advances Pipeline with Two Active Phase 2 Clinical Trials for Retinal Diseases
Newsfile
Kiora Pharmaceuticals Reports Second Quarter 2025 Results; Company Advances Pipeline with Two Active Phase 2 Clinical Trials for Retinal Diseases
Encinitas, California--(Newsfile Corp. - August 8, 2025) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced second quarter 2025 financial results and provided an update on its pipeline of therapeutics for the treatment of retinal diseases. Key second quarter and 2025 year-to-date corporate highlights include: KIO-104 Initiated KLARITY, a Phase 2 clinical trial evaluating KIO-104 for the treatment of patients with retinal inflammation. Strengthened and extended market exclusivity of KIO-104 into 2043 (absent any patent term extensions) with receipt of a patent covering methods for optimizing treatment of ocular inflammatory diseases. KIO-301 Entered into an option agreement, which would allow for a strategic partnership with Senju Pharmaceutical Co., Ltd. ("Senju") to develop and commercialize KIO-301 in key countries in Asia, including Japan and China, which, if exercised, would have a potential deal value of up to $110 million plus royalties. Initiated the Phase 2 ABACUS-2 clinical trial of KIO-301 for vision restoration in patients with retinitis pigmentosa. ABACUS-2 uses a validated efficacy endpoint to assess functional vision outcomes in patients with moderate to advanced vision loss due to retinal degeneration. These functional vision assessments will likely serve as the approvable endpoint for a future registration trial(s) of KIO-301. Operations and Financials Received $1.3 million in reimbursed Q1 2025 R&D expenses from Théa Open Innovation ("Théa") for activities related to KIO-301. Recorded deferred revenue of $1.25 million related to a non-refundable option fee from Senju, comprising part of the KIO-301 partnership. Ended the quarter with $20.7 million in cash, cash equivalents and short-term investments, along with $2.4 million in collaboration receivables and $0.7 million in research incentive tax credits. Maintained projected cash runway into late 2027, a timeframe beyond anticipated data readouts for KLARITY and ABACUS-2, with potential for further extension through achievement of partnership milestones. "In the second quarter, we materially advanced our Phase 2 clinical programs through site activations and initiating patient recruiting efforts," said Brian M. Strem, Ph.D., President & Chief Executive Officer of Kiora. "For KIO-301, having a validated functional vision assessment to serve as a critical en…Read full documentShow less
Encinitas, California--(Newsfile Corp. - August 8, 2025) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced second quarter 2025 financial results and provided an update on its pipeline of therapeutics for the treatment of retinal diseases. Key second quarter and 2025 year-to-date corporate highlights include: KIO-104 Initiated KLARITY, a Phase 2 clinical trial evaluating KIO-104 for the treatment of patients with retinal inflammation. Strengthened and extended market exclusivity of KIO-104 into 2043 (absent any patent term extensions) with receipt of a patent covering methods for optimizing treatment of ocular inflammatory diseases. KIO-301 Entered into an option agreement, which would allow for a strategic partnership with Senju Pharmaceutical Co., Ltd. ("Senju") to develop and commercialize KIO-301 in key countries in Asia, including Japan and China, which, if exercised, would have a potential deal value of up to $110 million plus royalties. Initiated the Phase 2 ABACUS-2 clinical trial of KIO-301 for vision restoration in patients with retinitis pigmentosa. ABACUS-2 uses a validated efficacy endpoint to assess functional vision outcomes in patients with moderate to advanced vision loss due to retinal degeneration. These functional vision assessments will likely serve as the approvable endpoint for a future registration trial(s) of KIO-301. Operations and Financials Received $1.3 million in reimbursed Q1 2025 R&D expenses from Théa Open Innovation ("Théa") for activities related to KIO-301. Recorded deferred revenue of $1.25 million related to a non-refundable option fee from Senju, comprising part of the KIO-301 partnership. Ended the quarter with $20.7 million in cash, cash equivalents and short-term investments, along with $2.4 million in collaboration receivables and $0.7 million in research incentive tax credits. Maintained projected cash runway into late 2027, a timeframe beyond anticipated data readouts for KLARITY and ABACUS-2, with potential for further extension through achievement of partnership milestones. "In the second quarter, we materially advanced our Phase 2 clinical programs through site activations and initiating patient recruiting efforts," said Brian M. Strem, Ph.D., President & Chief Executive Officer of Kiora. "For KIO-301, having a validated functional vision assessment to serve as a critical endpoint for both ABACUS-2 and a potential registration study(s) represents both progress and promise for those affected by inherited retinal diseases. We continue to bring online ABACUS-2 sites and anticipate many eligible patients will come from the functional vision assessment validation study, facilitating enrollment targets and timelines. Strategically, we expanded our global commercialization network by entering a partnership with Senju, adding to our ability to ensure KIO-301 can potentially benefit the global population in need. Similarly, the KLARITY clinical trial is actively recruiting patients to assess KIO-104 across several inflammatory retinal diseases, including posterior non-infectious uveitis and diabetic macular edema. Due to our efficient capital management, our anticipated runway remains into late 2027 based on existing cash reserves, beyond the anticipated readouts for ABACUS-2 and KLARITY." Second Quarter Financial Highlights Kiora ended the second quarter of 2025 with $20.7 million in cash, cash equivalents, and short-term investments. The Company also recorded $1.2 million in collaboration receivables from Théa for reimbursable R&D expenses, $1.25 million in collaboration receivables from Senju related to the option fee and $0.7 million in research incentive tax credits. The Company reported a net loss of $2.2 million for the second quarter of 2025 consistent with the net loss of $2.2 million in the second quarter of 2024. R&D expenses for the second quarter of 2025 were $2.6 million, before recognizing $1.7 million in reimbursable expenses from Théa. In comparison, R&D expenses for the second quarter of 2024 were $2.0 million, with $1.1 million in offsetting reimbursable expenses from Théa. The increase in R&D for the second quarter of 2025 was mainly attributable to clinical trial activities. G&A expenses were $1.4 million for the second quarter of 2025, down from $1.5 million in the second quarter of 2024. About Kiora Pharmaceuticals Kiora Pharmaceuticals is a clinical-stage biotechnology company developing advanced therapies for retinal disease. We target critical pathways underlying retinal diseases using innovative small molecules to slow, stop, or restore vision loss. KIO-301 is being developed for the treatment of retinitis pigmentosa, choroideremia, and Stargardt disease. It is a molecular photoswitch that has the potential to restore vision in patients with inherited and/or age-related retinal degeneration. KIO-104 is being developed for the treatment of retinal inflammation. It is a next-generation, non-steroidal, immuno-modulatory, and small-molecule inhibitor of dihydroorotate dehydrogenase (DHODH). In addition to news releases and SEC filings, we expect to post information on our website, www.kiorapharma.com, and social media accounts that could be relevant to investors. We encourage investors to follow us on X and LinkedIn as well as to visit our website and/or subscribe to email alerts. Forward-Looking Statements Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements include statements relating to, among other things, Kiora's ability to execute on development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's development-stage products, including KIO-104 and KIO-301, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all, the sufficiency of existing cash and short-term investments on hand to fund operations for specific periods, the ability to timely complete planned initiatives for 2025, including Phase 2 clinical development of KIO-301 and KIO-104, the completion of enrollment and the timing of topline results from the ABACUS-2 Phase 2 trial, the potential for KIO-301 to be the first treatment options for patients with inherited degenerative diseases like RP, the potential for KIO-104 to reduce inflammation, the timing of topline results from the Phase 2 KLARITY trial of KIO-104, the potential for KIO-104 to apply to other retinal inflammatory diseases, expected trends for research and development and general and administrative spending in 2025, the expectations for market exclusivity of KIO-104, the potential proceeds that could be received from the Senju strategic partnership, and the expected endpoints for future KIO-301 trials. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the ability to conduct clinical trials on a timely basis, market and other conditions and certain risk factors described under the heading "Risk Factors" contained in Kiora's Annual Report on Form 10-K filed with the SEC on March 25, 2025 or described in Kiora's other public filings, including on Form 10-Q filed with the SEC on August 8, 2025. Kiora's results may also be affected by factors of which Kiora is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Kiora expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions, or circumstances on which any such statement is based, except as required by law. Contacts: Investors [email protected] CONDENSED CONSOLIDATED BALANCE SHEETS CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME (unaudited) To view the source version of this press release, please visit https://www.newsfilecorp.com/release/261730
Investor releaseQuarter not tagged2025-05-09Kiora Pharmaceuticals Reports First Quarter Results; Initiating Two Phase 2 Trials for Treatment of Retinal Diseases; Cash and Short-term Investments Expected to Fund Operations into Late 2027
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Kiora Pharmaceuticals Reports First Quarter Results; Initiating Two Phase 2 Trials for Treatment of Retinal Diseases; Cash and Short-term Investments Expected to Fund Operations into Late 2027
Encinitas, California--(Newsfile Corp. - May 9, 2025) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced first quarter 2025 financial results and provided an update on its pipeline of therapeutics for the treatment of retinal diseases. Key first quarter and 2025 year-to-date corporate highlights include: Received approval to initiate KLARITY, a Phase 2 clinical trial evaluating KIO-104 for the treatment of retinal inflammation. Reported preclinical data on KIO-104 at ARVO 2025, further supporting its potential as a treatment for inflammatory and proliferative retinal diseases. Continued patient enrollment in the ongoing functional endpoint study, work designed to validate functional vision outcomes and serve as an on-ramp study to ABACUS-2. This validation effort supports discussions with regulatory bodies that have indicated that this assessment is the likely approvable endpoint for the future registration trial of KIO-301. Received $1.8 million in reimbursed Q4 2024 R&D expenses from Théa Open Innovation (Laboratoires Théa) for activities related to KIO-301. Ended the quarter with $24.1 million in cash, cash equivalents and short-term investments, along with $2.0 million in collaboration receivables and tax credits. Extended the projected cash runway into late 2027, a timeframe beyond anticipated data readouts for KLARITY and ABACUS-2, with potential for further extension through achievement of partnership milestones. "In the first quarter, we continued preparations to initiate enrollment in two Phase 2 clinical trials in retinal diseases," said Brian M. Strem, Ph.D., President & Chief Executive Officer of Kiora. "The KLARITY study will evaluate KIO-104 in patients with retinal inflammation, while ABACUS-2 will evaluate KIO-301 in patients with retinitis pigmentosa. "For KIO-301, we are approved to initiate ABACUS-2, a multi-center, double-masked, randomized, controlled, multi-dose study in 36 patients with ultra-low vision or no light perception due to retinitis pigmentosa. Based on feedback from regulators, retinal specialists, and patient groups, we recognize the need to demonstrate improvements in measures of functional vision as a pathway to market. Accordingly, we are dedicating the appropriate time to tailor clinically meaningful endpoints for this patient population, one for which no 'off-the-shelf' solution exi…Read full documentShow less
Encinitas, California--(Newsfile Corp. - May 9, 2025) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced first quarter 2025 financial results and provided an update on its pipeline of therapeutics for the treatment of retinal diseases. Key first quarter and 2025 year-to-date corporate highlights include: Received approval to initiate KLARITY, a Phase 2 clinical trial evaluating KIO-104 for the treatment of retinal inflammation. Reported preclinical data on KIO-104 at ARVO 2025, further supporting its potential as a treatment for inflammatory and proliferative retinal diseases. Continued patient enrollment in the ongoing functional endpoint study, work designed to validate functional vision outcomes and serve as an on-ramp study to ABACUS-2. This validation effort supports discussions with regulatory bodies that have indicated that this assessment is the likely approvable endpoint for the future registration trial of KIO-301. Received $1.8 million in reimbursed Q4 2024 R&D expenses from Théa Open Innovation (Laboratoires Théa) for activities related to KIO-301. Ended the quarter with $24.1 million in cash, cash equivalents and short-term investments, along with $2.0 million in collaboration receivables and tax credits. Extended the projected cash runway into late 2027, a timeframe beyond anticipated data readouts for KLARITY and ABACUS-2, with potential for further extension through achievement of partnership milestones. "In the first quarter, we continued preparations to initiate enrollment in two Phase 2 clinical trials in retinal diseases," said Brian M. Strem, Ph.D., President & Chief Executive Officer of Kiora. "The KLARITY study will evaluate KIO-104 in patients with retinal inflammation, while ABACUS-2 will evaluate KIO-301 in patients with retinitis pigmentosa. "For KIO-301, we are approved to initiate ABACUS-2, a multi-center, double-masked, randomized, controlled, multi-dose study in 36 patients with ultra-low vision or no light perception due to retinitis pigmentosa. Based on feedback from regulators, retinal specialists, and patient groups, we recognize the need to demonstrate improvements in measures of functional vision as a pathway to market. Accordingly, we are dedicating the appropriate time to tailor clinically meaningful endpoints for this patient population, one for which no 'off-the-shelf' solution exists. We are currently activating sites for ABACUS-2, and as an on-ramp study, we anticipate that patients enrolled in the validation study will be eligible for ABACUS-2, serving to meet our recruitment goals. "KIO-104 is our potent, locally delivered small molecule DHODH inhibitor being developed to treat inflammatory retinal diseases. Our aim is to provide an alternative to chronic steroid use or systemic anti-inflammatory drugs, which carry known side effects and risks. Building on encouraging data from our first-in-human study, we are now approved, activating sites, and expect to enroll our first patient in the second quarter of this year. This Phase 2 trial will evaluate two doses of KIO-104 across several inflammatory retinal diseases, including posterior non-infectious uveitis and diabetic macular edema. Results from the initial stage will inform dose expansion into one or more specific indications." Kiora's Chief Financial Officer, Melissa Tosca, added, "We ended the quarter with a cash runway extending into late 2027, positioning us well beyond the anticipated data readouts for ABACUS-2 and KLARITY. This extended runway reflects both the reimbursed expenses from our Laboratoires Théa partnership, totaling $5.6 million since the collaboration began, and our disciplined approach to capital management. We remain focused on advancing our programs efficiently and rapidly. Attainment of key development milestones related to KIO-301 could further strengthen our cash position and extend our runway even longer." First Quarter Financial Highlights Kiora ended the first quarter of 2025 with $24.1 million in cash, cash equivalents, and short-term investments. The Company also recorded $1.3 million in collaboration receivables from Laboratoires Théa for reimbursed R&D expenses, and $0.7 million in R&D incentive tax credits. The Company reported a net loss of $2.2 million for the first quarter of 2025 compared to net income of $13.4 million in the first quarter of 2024. This year-over-year change was primarily driven by the recognition of a $16 million upfront payment from Laboratoires Théa recorded as collaboration revenue in the first quarter of 2024. R&D expenses for the first quarter of 2025 were $2.5 million, before recognizing $1.3 million in reimbursed expenses from Laboratoires Théa. In comparison, R&D expenses for the first quarter of 2024 were $1.7 million, with $0.2 million in reimbursed expenses from Laboratoires Théa. The increase in R&D for the first quarter of 2025 was mainly attributable to clinical trial activities. Kiora continues to anticipate higher net R&D expenses throughout 2025, driven by patient enrollment costs for the KLARITY study. G&A expenses were $1.5 million for the first quarter of 2025, up from $1.3 million in the first quarter of 2024. About Kiora Pharmaceuticals Kiora Pharmaceuticals is a clinical-stage biotechnology company developing advanced therapies for retinal disease. We target critical pathways underlying retinal diseases using innovative small molecules to slow, stop, or restore vision loss. KIO-301 is being developed for the treatment of retinitis pigmentosa, choroideremia, and Stargardt disease. It is a molecular photoswitch that has the potential to restore vision in patients with inherited and/or age-related retinal degeneration. KIO-104 is being developed for the treatment of retinal inflammation. It is a next-generation, non-steroidal, immuno-modulatory, and small-molecule inhibitor of dihydroorotate dehydrogenase (DHODH). In addition to news releases and SEC filings, we expect to post information on our website, www.kiorapharma.com, and social media accounts that could be relevant to investors. We encourage investors to follow us on X and LinkedIn as well as to visit our website and/or subscribe to email alerts. Forward-Looking Statements Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements include statements relating to, among other things, Kiora's ability to execute on development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's development-stage products, including KIO-104 and KIO-301, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all, the sufficiency of existing cash and short-term investments on hand to fund operations for specific periods, the ability to timely complete planned initiatives for 2025, including Phase 2 clinical development of KIO-301 and KIO-104, the completion of enrollment and the timing of topline results from the ABACUS-2 Phase 2 trial, the potential for KIO-301 to be the first treatment options for patients with inherited degenerative diseases like RP, the potential for KIO-104 to reduce inflammation, the timing of topline results from the Phase 2 KLARITY trial of KIO-104, the potential for KIO-104 to apply to other retinal inflammatory diseases, and expected trends for research and development and general and administrative spending in 2025. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the ability to conduct clinical trials on a timely basis, market and other conditions and certain risk factors described under the heading "Risk Factors" contained in Kiora's Annual Report on Form 10-K filed with the SEC on March 25, 2025 or described in Kiora's other public filings, including on Form 10-Q filed with the SEC on May 9, 2025. Kiora's results may also be affected by factors of which Kiora is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Kiora expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions, or circumstances on which any such statement is based, except as required by law. Contacts: Investors [email protected] Financial Tables Follow KIORA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS KIORA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME (unaudited) To view the source version of this press release, please visit https://www.newsfilecorp.com/release/251299
Investor releaseQuarter not tagged2025-03-25Kiora Pharmaceuticals Reports 2024 Results; Retinal Disease Drug Development Pipeline Continues to Advance; Cash and Short-Term Investments Expected to Fund Operations into 2027
Newsfile
Kiora Pharmaceuticals Reports 2024 Results; Retinal Disease Drug Development Pipeline Continues to Advance; Cash and Short-Term Investments Expected to Fund Operations into 2027
Encinitas, California--(Newsfile Corp. - March 25, 2025) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced its 2024 financial results and provided an update on its pipeline of therapeutics for the treatment of retinal diseases. Key fourth quarter and 2025 year-to-date corporate highlights include: Received approval to initiate KLARITY, a Phase 2 trial of KIO-104 for the treatment retinal inflammation. Received approval to initiate ABACUS-2, a Phase 2 study of KIO-301 in retinitis pigmentosa (RP) in collaboration with Théa Open Innovation (Laboratoires Théa). Received $3.3 million in reimbursed R&D expenses in 2024 from Laboratoires Théa for development activities related to KIO-301, of which $2.9 million was recognized in offsetting collaboration credits. Ended the year with $26.8 million in cash, cash equivalents and short-term investments plus $0.9 million in collaboration and tax receivables. Expected runway into 2027, excluding any potential partnership milestones, beyond the data readouts from KLARITY and ABACUS-2 expected in 2026. "In 2024, our team undertook extensive preparations to initiate two Phase 2 clinical trials that have received approval and will begin enrolling patients in the coming months," said Brian M. Strem, Ph.D., President & Chief Executive Officer of Kiora. "The KLARITY study will evaluate KIO-104 in patients with retinal inflammation and ABACUS-2 will evaluate KIO-301 in patients with advanced retinitis pigmentosa. Getting these studies underway are our two greatest priorities for this year with data expected from both in 2026." "For KIO-301, we received approval in the fourth quarter to initiate ABACUS-2, a 36-patient, multi-center, double-masked, randomized, controlled, multi-dose study in patients with ultra-low vision or no light perception due to retinitis pigmentosa. Dosing of the first patient will begin this year following the completion of an ongoing clinical endpoint validation study. We anticipate that the patients we've enrolled already for this validation work meet enrollment criteria and will participate in ABACUS-2. "Following interactions with the FDA and European regulators, retinal specialists, and patient advocacy groups, it's clear that demonstrating improvement in functional vision is essential for marketing authorization as well as reimbursement. This underscores the impor…Read full documentShow less
Encinitas, California--(Newsfile Corp. - March 25, 2025) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced its 2024 financial results and provided an update on its pipeline of therapeutics for the treatment of retinal diseases. Key fourth quarter and 2025 year-to-date corporate highlights include: Received approval to initiate KLARITY, a Phase 2 trial of KIO-104 for the treatment retinal inflammation. Received approval to initiate ABACUS-2, a Phase 2 study of KIO-301 in retinitis pigmentosa (RP) in collaboration with Théa Open Innovation (Laboratoires Théa). Received $3.3 million in reimbursed R&D expenses in 2024 from Laboratoires Théa for development activities related to KIO-301, of which $2.9 million was recognized in offsetting collaboration credits. Ended the year with $26.8 million in cash, cash equivalents and short-term investments plus $0.9 million in collaboration and tax receivables. Expected runway into 2027, excluding any potential partnership milestones, beyond the data readouts from KLARITY and ABACUS-2 expected in 2026. "In 2024, our team undertook extensive preparations to initiate two Phase 2 clinical trials that have received approval and will begin enrolling patients in the coming months," said Brian M. Strem, Ph.D., President & Chief Executive Officer of Kiora. "The KLARITY study will evaluate KIO-104 in patients with retinal inflammation and ABACUS-2 will evaluate KIO-301 in patients with advanced retinitis pigmentosa. Getting these studies underway are our two greatest priorities for this year with data expected from both in 2026." "For KIO-301, we received approval in the fourth quarter to initiate ABACUS-2, a 36-patient, multi-center, double-masked, randomized, controlled, multi-dose study in patients with ultra-low vision or no light perception due to retinitis pigmentosa. Dosing of the first patient will begin this year following the completion of an ongoing clinical endpoint validation study. We anticipate that the patients we've enrolled already for this validation work meet enrollment criteria and will participate in ABACUS-2. "Following interactions with the FDA and European regulators, retinal specialists, and patient advocacy groups, it's clear that demonstrating improvement in functional vision is essential for marketing authorization as well as reimbursement. This underscores the importance of the investment in time that we are making to refine the clinical endpoints that can measure clinically meaningful improvement in patients with no vision or bare light perception. This will increase our confidence in the data we generate from ABACUS-2 as this same endpoint would likely serve as the primary endpoint for a Phase 3 registration study. "Our other active program is KIO-104, a potent, locally delivered small molecule that we are developing to treat inflammatory retinal diseases. The goal is to offer patients and providers an alternative to chronic steroid use or systemic anti-inflammatory drugs, both of which often lead to complications. Following a previously successful first-in-man study, and recent approval to initiate KLARITY, we anticipate dosing our first patient in the second quarter of this year. This Phase 2 clinical trial will explore multiple doses of KIO-104 in patients with inflammatory retinal diseases, including posterior non-infectious uveitis, diabetic macular edema and others. Findings in the first part of the study will inform a dose expansion part two of the study in one or more specific indications." Kiora's Chief Financial Officer, Melissa Tosca, added, "We ended the year with a runway into 2027, beyond the anticipated 2026 readouts for the KLARITY and ABACUS-2 trials. Our partnership around KIO-301 with Laboratoires Théa, who reimburses us fully for research and development expenses of KIO-301, frees up capital to develop a second promising candidate in KIO-104, and advance both compounds to critical inflection points." Fourth Quarter and Full Year Financial Highlights Kiora ended 2024 with $26.8 million in cash, cash equivalents, and short-term investments. In addition, the Company recorded $0.6 million in collaboration receivables from Laboratoires Théa for reimbursed R&D expenses and $0.3 million R&D incentive tax credits. Net loss was $4.2 million for the fourth quarter of 2024 compared to a net loss of $2.3 million for the fourth quarter of 2023. Net income for 2024 was $3.6 million compared to a net loss of $12.5 million in 2023. The change in income for the year is attributable to the recognition of $16 million in collaboration revenue from the strategic collaboration with Laboratoires Théa. R&D expenses for the fourth quarter of 2024 were $1.9 million, before recognizing $0.7 million in reimbursed R&D expenses from Laboratoires Théa. This compares to R&D expenses of $1.1 million in the fourth quarter of 2023, during which time there were no partnership-related reimbursement credits. R&D expenses for 2024 were $7.8 million, before recognizing $2.9 million in reimbursed R&D expenses from Laboratoires Théa. This compares to R&D expenses of $4.0 in 2023, during which time there were no partnership-related reimbursement credits. The increase in R&D for the quarter and full year was primarily due to research activities related to KIO-301 and KIO-104. Kiora expects net R&D to increase in 2025 primarily due to costs related to patient enrollment in the KLARITY study. G&A expenses for the fourth quarter of 2024 were $1.3 million, compared to $0.9 million in the fourth quarter of 2023. G&A expenses for 2024 were $5.5 million compared to $4.7 million in 2023. G&A expenses in 2025 are expected to remain consistent with expenses from 2024. About Kiora Pharmaceuticals Kiora Pharmaceuticals is a clinical-stage biotechnology company developing advanced therapies for retinal disease. We target critical pathways underlying retinal diseases using innovative small molecules to slow, stop, or restore vision loss. KIO-301 is being developed for the treatment of retinitis pigmentosa, choroideremia, and Stargardt disease. It is a molecular photoswitch that has the potential to restore vision in patients with inherited and/or age-related retinal degeneration. KIO-104 is being developed for the treatment of retinal inflammation. It is a next-generation, non-steroidal, immuno-modulatory, and small-molecule inhibitor of dihydroorotate dehydrogenase (DHODH). In addition to news releases and SEC filings, we expect to post information on our website, www.kiorapharma.com, and social media accounts that could be relevant to investors. We encourage investors to follow us on X and LinkedIn as well as to visit our website and/or subscribe to email alerts. Forward-Looking Statements Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements include statements relating to, among other things, Kiora's ability to execute on development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's development-stage products, including KIO-104 and KIO-301, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all, the sufficiency of existing cash and short-term investments on hand to fund operations for specific periods, the ability to timely complete planned initiatives for 2025, including Phase 2 clinical development of KIO-301 and KIO-104, the completion of enrollment and the timing of topline results from the ABACUS-2 Phase 2 trial, the potential for KIO-301 to be the first treatment options for patients with inherited degenerative diseases like RP, the potential for KIO-104 to reduce inflammation, the timing of topline results from the Phase 2 KLARITY trial of KIO-104, the potential for KIO-104 to apply to other retinal inflammatory diseases, and expected trends for research and development and general and administrative spending in 2025. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the ability to conduct clinical trials on a timely basis, market and other conditions and certain risk factors described under the heading "Risk Factors" contained in Kiora's Annual Report on Form 10-K filed with the SEC on March 25, 2025 or described in Kiora's other public filings. Kiora's results may also be affected by factors of which Kiora is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Kiora expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions, or circumstances on which any such statement is based, except as required by law. Contacts: Investors [email protected] KIORA PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS KIORA PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) To view the source version of this press release, please visit https://www.newsfilecorp.com/release/245802

