US Market News
4週前
Kiora Pharmaceuticals Reports First Quarter 2026 Financial Results and Provides Corporate UpdateMay 8, 2026 7:00 AM
NewsfileEncinitas, 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 HighlightsEnrollment 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 trialsSubsequent 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 Théa 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 Théa, compared to $2.5 million, before recognizing $2.0 million in reimbursable expenses from Théa, 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 PharmaceuticalsKiora 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 StatementsSome 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
Investors@kiorapharma.comFinancial Tables FollowCONDENSED CONSOLIDATED BALANCE SHEETS
March 31, 2026 (unaudited)
December 31, 2025
ASSETS
Current Assets:
Cash and Cash Equivalents$10,955,359
$8,696,570
Short-Term Investments
2,916,701
8,392,513
Prepaid Expenses and Other Current Assets
1,206,339
1,141,804
Collaboration Receivables
1,544,253
1,522,770
Tax and Other Receivables
1,906,923
1,793,459
Prepaid Collaboration Expenses
153,273
201,332
Total Current Assets
18,682,848
21,748,448
Non-Current Assets:
Property and Equipment, Net
86,815
91,672
Restricted Cash
4,687
4,566
Intangible Assets and In-Process R&D, Net
2,063,100
2,063,100
Operating Lease Right-of-Use Assets
301,486
285,827
Other Assets
88,153
59,687
Total Assets$21,227,089
$24,253,300
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts Payable$594,874
$1,060,306
Accrued Expenses
2,025,173
2,406,731
Operating Lease Liabilities
178,217
164,461
Total Current Liabilities
2,798,264
3,631,498
Non-Current Liabilities:
Contingent Consideration
2,946,743
2,939,316
Deferred Tax Liability
102,152
102,152
Deferred Collaboration Revenue
1,250,000
1,250,000
Non-Current Operating Lease Liabilities
195,369
203,798
Total Non-Current Liabilities
4,494,264
4,495,266
Total Liabilities
7,292,528
8,126,764
Commitments and Contingencies (Note 9)
Stockholders' Equity:
Preferred Stock, $0.01 Par Value: 10,000,000 shares authorized; 3,750 designated Series A, 0 shares issued and outstanding; 10,000 designated Series B, 0 shares issued and outstanding; 10,000 shares designated Series C, 0 shares issued and outstanding; 20,000 shares designated Series D, 7 shares issued and outstanding; 1,280 shares designated Series E, 0 shares issued and outstanding; 3,908 shares designated Series F, 420 issued and outstanding at March 31, 2026 and December 31, 2025, respectively
4
4
Common Stock, $0.01 Par Value: 150,000,000 shares authorized; 3,993,469 and 3,761,739 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively
277,606
275,289
Additional Paid-In Capital
170,521,007
170,314,656
Accumulated Deficit
(156,635,260)
(154,217,276)Accumulated Other Comprehensive Loss
(228,796)
(246,137)Total Stockholders' Equity
13,934,561
16,126,536
Total Liabilities and Stockholders' Equity$21,227,089
$24,253,300
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(unaudited)
Three Months Ended March 31,
2026
2025
Operating Expenses:
General and Administrative$1,612,267
$1,489,398
Research and Development
2,123,725
2,531,887
Collaboration Credits
(1,233,224)
(1,966,123)Change in Fair Value of Contingent Consideration
7,427
275,192
Total Operating Expenses
2,510,195
2,330,354
Operating Loss
(2,510,195)
(2,330,354)Other Income (Expense), Net:
Interest Income, Net
139,338
276,633
Other Expense, Net
(47,127)
(16,253)Total Other Income, Net
92,212
260,380
Loss Before Income Tax Provision
(2,417,984)
(2,069,974)Income Tax Provision
-
(123,006)Net Loss$(2,417,984)$(2,192,980)Net Loss Attributable to Common Shareholders$(2,417,984)$(2,192,980)Net Loss per Common Share - Basic$(0.58)$(0.52)Weighted Average Shares Outstanding - Basic
4,174,802
4,217,007
Net Loss per Common Share - Diluted$(0.58)$(0.52)Weighted Average Shares Outstanding - Diluted
4,174,802
4,217,007
Other Comprehensive Loss:
Net Loss$(2,417,984)$(2,192,980)Unrealized Loss on Marketable Securities
(8,353)
(16,099)Foreign Currency Translation Adjustments
25,694
1,072
Comprehensive Loss$(2,400,643)$(2,208,007) To view the source version of this press release, please visit https://www.newsfilecorp.com/release/296558 Original: Kiora Pharmaceuticals Reports First Quarter 2026 Financial Results and Provides Corporate Update
US Market News
2月前
Kiora's Phase 1 ABACUS Study of KIO-301 in Retinitis Pigmentosa Published in Nature Medicine; Phase 2 Trial UnderwayApril 14, 2026 7:00 AM
NewsfileEncinitas, California--(Newsfile Corp. - April 14, 2026) - Kiora Pharmaceuticals (NASDAQ: KPRX) today announced the publication of the results from its Phase 1 ABACUS-1 study of KIO-301 in Nature Medicine. The publication adds clinical detail to a program aimed at restoring light responsiveness with a small molecule "photoswitch" in patients with the advanced inherited retinal disease, retinitis pigmentosa. The publication may be accessed at the following link - https://www.nature.com/articles/s41591-026-04317-6The open-label, first-in-human, dose-escalation trial assessed safety and feasibility in people with late-stage retinitis pigmentosa, irrespective of the underlying genetic mutation. KIO-301 was delivered intravitreally to 12 eyes in six participants. The primary endpoint was ocular and systemic safety over 30 days, with secondary and exploratory endpoints spanning functional vision testing, visual acuity, kinetic visual fields, functional MRI and participant-reported outcomes."Publication of the KIO-301 Phase 1 findings in Nature Medicine is a meaningful milestone that brings early clinical support for a molecular photoswitch into the peer-reviewed literature," said Dr. Robert Casson, Principal Investigator of the study from the Royal Adelaide Hospital. "The results of the trial provide evidence of short-term ocular safety and feasibility, while underscoring that larger, controlled studies are still needed to determine whether any functional changes translate into reliable, everyday vision benefit.""Based on Phase 1 results, we initiated a randomized, controlled Phase 2 clinical trial, dubbed ABACUS-2," said Brian M. Strem, Ph.D., President and Chief Executive Officer of Kiora. "The trial is designed to evaluate higher doses of KIO-301 with the goal of measuring, among other endpoints, functional visual improvements and comparing them to a control group, who will be eligible for KIO-301 treatment as part of an open-label extension. We appreciate the invaluable participation of patients, along with work by our team, investigators and the strategic and financial support from our development and commercialization partner(s), including Théa Open Innovation."As described in the publication, the primary safety outcome was met with no serious adverse events nor dose-limiting toxicities, drug-related intraocular inflammation, nor structural retinal changes (as assessed by autofluorescence or optical coherence tomography). Reported ocular adverse events were described as mild and transient and consistent with known effects of intravitreal injection procedures, including transient discomfort and mild elevations in intraocular pressure in a single patient.Secondary and Exploratory Endpoints in ABACUS-1
What was evaluatedReported resultParticipants/dosingSix participants; 12 eyes; intravitrealDosed eyes monitored for 30 daysPrimary endpointOcular & systemic safety > 30 daysMetFunctional visionLight perception and functional vision measuresTemporal variation observed in some participantsNeuroimagingfMRI BOLD signal in visual cortexLight-induced changes consistent with pharmacodynamic activityPatient-reported outcomesQuality-of-life measuresScores improved over study period "The science of molecular photoswitches, including KIO-301, has come a long way from our early research at the University of Washinton and UC Berkeley to a successful Phase 1 study and ongoing Phase 2 randomized, controlled trial," said Russell N. Van Gelder, M.D., Ph.D., Professor and Chair, Department of Ophthalmology, University of Washington School of Medicine. "This publication reflects this progress and ongoing need to determine, with additional trials, if these early signals translate into consistent functional benefit."Exploratory assessments identified temporal variation in light perception and functional vision measures in some participants. The researchers also reported light-induced changes in neural activity (using functional MRI) within the visual cortical region of the brain following dosing, with a time course consistent with the pharmacodynamic activity window. Participant-reported quality-of-life scores also showed improvements during the study period.KIO-301 is a small molecule designed to include a light-reactive azobenzene. Its mechanism of action, based on preclinical and in vitro research, suggests it preferentially targets and enters retinal ganglion cells downstream of degenerated photoreceptors. From here, it renders voltage-gated ion channels responsive to light, causing neural activation and direct signaling to the brain. This MOA is potentially applicable to patients with multiple types of retinal degeneration irrespective of the underlying gene mutation or age-related cause. The authors noted that repeated intravitreal injections are widely used in retinal care as part of in-office procedures and this dosing regimen is incorporated into the ABACUS-2 trial. About Kiora PharmaceuticalsKiora 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-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). 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.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 StatementsSome 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, and the positioning of KIO-301 for potential success in clinical trials and potential 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
investors@kiorapharma.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/292220
Original: Kiora's Phase 1 ABACUS Study of KIO-301 in Retinitis Pigmentosa Published in Nature Medicine; Phase 2 Trial Underway
US Market News
2月前
Kiora Pharmaceuticals Reports Fourth-Quarter and Full-Year 2025 Results; Company Advances Retinal Disease Pipeline with Two Active Phase 2 Clinical TrialsMarch 25, 2026 7:00 AM
NewsfileEncinitas, 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 50µg dose as well as clearance to then initiate the 100µg 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 Théa, 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 Théa ("Théa") 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 Théa, compared with $1.9 million before recognizing $0.7 million in reimbursable expenses from Théa in the fourth quarter of 2024.R&D expenses for 2025 were $10.8 million before recognizing $7.1 million in reimbursable expenses from Théa, compared with $7.8 million in 2024 before recognizing $2.9 million in reimbursed R&D expenses from Théa.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 Théa as collaboration revenue in 2024.About Kiora PharmaceuticalsKiora 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 StatementsSome 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
Investors@kiorapharma.comFinancial Tables FollowCONSOLIDATED BALANCE SHEETS
December 31,
2025
2024
ASSETS
Current Assets:
Cash and Cash Equivalents$8,696,570
$3,792,322
Short-Term Investments
8,392,513
22,999,760
Prepaid Expenses and Other Current Assets
1,141,804
2,042,487
Collaboration Receivables
1,522,770
601,197
Tax and Other Receivables
1,793,459
270,246
Prepaid Collaboration Expenses
201,332
—
Total Current Assets
21,748,448
29,706,012
Non-Current Assets:
Property and Equipment, Net
91,672
5,232
Restricted Cash
4,566
4,057
Intangible Assets and In-Process R&D, Net
2,063,100
6,687,100
Operating Lease Assets with Right-of-Use
285,827
57,170
Other Assets
59,687
24,913
Total Assets$24,253,300
$36,484,484
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts Payable$1,060,306
$415,590
Accrued Expenses
2,406,731
4,588,657
Accrued Collaboration Credit
—
981,111
Operating Lease Liabilities
164,461
23,355
Total Current Liabilities
3,631,498
6,008,713
Non-Current Liabilities:
Contingent Consideration
2,939,316
4,191,490
Deferred Tax Liability
102,152
490,690
Deferred Collaboration Revenue
1,250,000
—
Non-Current Operating Lease Liabilities
203,798
33,815
Total Non-Current Liabilities
4,495,266
4,715,995
Total Liabilities
8,126,764
10,724,708
Commitments and Contingencies (Note 12)
Stockholders' Equity:
Preferred Stock, $0.01 Par Value: 10,000,000 shares authorized at December 31, 2025 and 2024; 3,750 designated Series A, 0 shares issued and outstanding at December 31, 2025 and 2024; 10,000 designated Series B, 0 shares issued and outstanding at December 31, 2025 and 2024; 10,000 shares designated Series C, 0 shares issued and outstanding at December 31, 2025 and 2024; 20,000 shares designated Series D, 7 shares issued and outstanding at December 31, 2025 and 2024; 1,280 shares designated Series E, 0 shares issued and outstanding at December 31, 2025 and 2024; 3,908 shares designated Series F, 420 shares issued and outstanding at December 31, 2025 and 2024
4
4
Common Stock, $0.01 Par Value: 150,000,000 shares authorized at December 31, 2025 and 2024; 3,761,739 and 3,000,788 shares issued and outstanding at December 31, 2025 and 2024, respectively
275,289
267,679
Additional Paid-In Capital
170,314,656
169,156,374
Accumulated Deficit
(154,217,276)
(143,382,122)Accumulated Other Comprehensive Loss
(246,137)
(282,159)Total Stockholders' Equity
16,126,536
25,759,776
Total Liabilities and Stockholders' Equity$24,253,300
$36,484,484
KIORA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
Year Ended December 31,
2025
2024
Revenue:
Collaboration Revenue$—
$16,000,000
Grant Revenue
—
20,000
Total Revenue
—
16,020,000
Operating Expenses:
General and Administrative
5,745,087
5,542,324
Research and Development
10,780,397
7,842,207
Collaboration Credits
(7,066,237)
(2,945,350)In-Process R&D Impairment
4,624,000
2,008,000
Change in Fair Value of Contingent Consideration
(1,252,174)
(937,469)Total Operating Expenses
12,831,073
11,509,712
Operating (Loss) Income Before Other Income (Expense), Net
(12,831,073)
4,510,288
Other Income, Net:
Impairment of Intangible Assets
—
(104,167)Loss on Disposal of Fixed Assets
—
(3,859)Interest Income
894,002
1,252,849
Interest Expense
(19,960)
(21,446)Other (Expense) Income, Net
(160,272)
26,073
Total Other Income, Net
713,770
1,149,450
(Loss) Income Before Income Tax Expense
(12,117,303)
5,659,738
Income Tax Benefit (Expense)
1,282,149
(2,065,005)Net (Loss) Income
(10,835,154)
3,594,733
Net (Loss) Income Attributable to Common Shareholders$(10,835,154) $3,594,733
Net (Loss) Income per Common Share - Basic$(2.60) $0.93
Weighted Average Shares Outstanding - Basic
4,166,692
3,872,644
Net (Loss) Income per Common Share - Diluted$(2.64) $0.87
Weighted Average Shares Outstanding - Diluted
4,103,873
4,125,075
Other Comprehensive (Loss) Income:
Net (Loss) Income$(10,835,154) $3,594,733
Unrealized (Loss) Gain on Marketable Securities
(20,073)
29,719
Foreign Currency Translation Adjustments
56,096
(129,077)Comprehensive (Loss) Income$(10,799,131) $3,495,375
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/289753
Original: Kiora Pharmaceuticals Reports Fourth-Quarter and Full-Year 2025 Results; Company Advances Retinal Disease Pipeline with Two Active Phase 2 Clinical Trials
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1年前
Kiora Pharmaceuticals and Senju Pharmaceutical Partner on KIO-301 for the Treatment of Retinal Diseases in Asia
Newsfile Corp.
Newsfile Corp
Total potential deal value of $110 million plus royalties
Kiora to receive an immediate $1.25 million exclusive option fee
If the option is exercised, Kiora will receive an additional mid-single digit million up-front payment, development, regulatory, and commercial milestones, plus tiered royalties on sales
Encinitas, California--(Newsfile Corp. - June 3, 2025) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced it has granted Senju Pharmaceutical Co., Ltd. (Senju) an exclusive option to exercise rights to an exclusive development and commercialization agreement for KIO-301 for the treatment of ophthalmic diseases. The agreement will cover key Asian marketplaces, including Japan and China.
"Like elsewhere in the world, patients in Asia with inherited retinal diseases, including retinitis pigmentosa, have no therapeutic options to slow their disease progression nor restore what has already been lost. KIO-301 is a very promising, novel therapeutic with the potential to give vision back to affected individuals. We are extremely excited to partner with Kiora and work collaboratively to bring this promising candidate to this underserved community," said Shuhei Yoshida, President of Senju.
Under the terms of the agreement, Senju has a defined period to enter into an exclusive development and commercialization agreement. This window begins after topline data from the ongoing ABACUS-2 Phase 2 clinical trial is reported. This structure affords Senju an opportunity to collaborate with Théa Open Innovation (Laboratoires Théa or Théa), Kiora's exclusive global development and commercialization partner for KIO-301 outside of Asia.
"This option agreement represents a critical step toward establishing a long-term strategic partnership with Senju and extends the global commercial reach of KIO-301 by building on the foundation established by Théa," said Brian Strem, PhD, CEO of Kiora. "As a leading ophthalmic pharmaceutical company in Asia, Senju's interest in KIO-301 reinforces the need and opportunity for new treatments for inherited retinal conditions like retinitis pigmentosa (RP), and other retinal diseases."
The key terms and conditions of the exclusive development and commercialization agreement have been agreed to, subject to Senju exercising its option. Under the development agreement Senju would be responsible for all development, regulatory, and commercial activities in the licensed territory. Additional terms include country-specific regulatory and commercial milestones as well as tiered royalties on net sales.
In January 2024, Kiora and Théa entered into their ongoing exclusive worldwide co-development and commercialization agreement, excluding Asia, for KIO-301 in the treatment of retinal diseases. Under the combined relationships with Théa in 2024 and the new relationship with Senju, the total potential value of strategic partnerships exceeds $400 million, plus significant royalties on sales.
KIO-301 is currently in a Phase 2 clinical trial, 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 RP. KIO-301 is a new type of therapy under development for inherited retinal diseases that acts as a "molecular photoswitch." Many inherited retinal diseases, including RP, cause the eye's light-sensing cells (rods and cones) to degenerate, leading to vision loss. KIO-301 targets surviving cells in the retina (the Retinal Ganglion Cells or RGCs), which connect the eye to the brain. The molecule enters these RGCs and, when activated by light, allows them to send signals to the brain, aiming to restore visual function.
This agreement further strengthens Kiora's balance sheet and supports the Company's expected cash runway into late 2027, beyond the projected readout of Kiora's two ongoing Phase 2 clinical trials.
KO Law PC and BlankRome LLP are serving as legal advisors to Kiora.
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.
About Senju Pharmaceutical Co., Ltd.
Senju is a privately held, research-based Japanese pharmaceutical company that develops, manufactures, and commercializes a variety of innovative products, focusing on the field of ophthalmology to improve the health and quality of vision for people worldwide.
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2年前
Kiora Pharmaceuticals Announces Private Placement of up to Approximately $45 Million
Newsfile Corp.
Newsfile Corp
$15 million in upfront financing with the potential to receive up to an additional approximately $30 million in potential warrant exercise proceeds for an aggregate of up to approximately $45 million in total gross proceeds
Encinitas, California--(Newsfile Corp. - January 31, 2024) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics to improve sight in patients with severe vision loss due to inherited or age-related orphan retinal diseases, today announced that it has entered into a securities purchase agreement with healthcare focused institutional investor(s) to raise up to approximately $45 million in gross proceeds, including initial upfront funding of $15 million and up to an additional approximately $30 million upon exercise of accompanying warrants at the election of the investors.
The financing includes participation from new healthcare-dedicated investors, including ADAR1 Capital Management, Nantahala Capital Management, Rosalind Advisors, Stonepine Capital Management, and Velan Capital, among others.
"This financing, combined with our agreement with Théa Open Innovation, demonstrates the confidence in our team and development pipeline from healthcare-focused institutional investors and corporate partners," said Brian M. Strem, Ph.D., President and Chief Executive Officer. "The significantly strengthened balance provides us with flexibility to fully-fund KIO-104 for the treatment of non-infectious uveitis and potentially other rare inflammatory indications in the back of the eye."
Maxim Group LLC is acting the sole placement agent for the private placement.
Pursuant to terms of the securities purchase agreement, Kiora will issue an aggregate of 27,154,237 shares of its common stock (or pre-funded warrants in lieu thereof) and accompanying warrants to purchase up to an aggregate of 49,374,590 shares of its common stock at a combined purchase price of $0.5524 per share and accompanying warrants, in accordance with the "Minimum Price" requirement as defined in the Nasdaq rules. The exercise of the accompanying warrants (excluding the pre-funded warrants) are subject to shareholder approval and will consist of two tranches:
Tranche A warrants to purchase up to 24,687,295 shares of common stock at an exercise price of $0.6076 per share for an aggregate of up to approximately $15 million and will expire at the earlier of (i) 30 days following the announcement of full data (expected in Q2 2025) from the Company's Phase 2 clinical trial (ABACUS-2) of KIO-301 in patients with retinitis pigmentosa and the daily VWAP of the Company's common stock equaling or exceeding $1.1048 per share for 30 consecutive trading days following the announcement and (ii) five years from the date of shareholder approval of the warrants.
Tranche B warrants to purchase up to 24,687,295 shares of common stock at an exercise price of $0.6076 per share for an aggregate of up to approximately $15 million and will expire at the earlier of (i) 30 days following the announcement of topline data (expected in 2026) from the planned Phase 2 trial of KIO-104 in posterior non-infectious uveitis and the daily VWAP of the Company's common stock equaling or exceeding $1.3810 per share for 30 consecutive trading days following the announcement and (ii) five years from the date of shareholder approval of the warrants.
(ii) five years from the date of shareholder approval of the warrants.
In lieu of shares of common stock, certain investors are purchasing pre-funded warrants at a combined purchase price of $0.5523 per pre-funded warrant and accompanying warrants, which equals the purchase price per share of common stock and accompanying warrant, less the $0.0001 per share exercise price of each pre-funded warrant. The private placement is expected to close on or about February 5, 2024 subject to satisfaction of customary closing conditions.
Kiora intends to use the upfront net proceeds from the private placement to fund the Company's general business operations and ongoing activities related to expediting the development of KIO-104 for posterior non-infectious uveitis and other potential orphan inflammatory diseases. The aggregate net proceeds (assuming exercise of all accompanying warrants) are expected to be sufficient to fund subsequent, potentially pivotal, clinical trials and other work in the Company's ophthalmic programs.
The offer and sale of the foregoing securities are being made in a transaction not involving a public offering, and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock purchased in the private placement and shares of common stock underlying the warrants.
This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.
About Kiora Pharmaceuticals
Kiora Pharmaceuticals is a clinical-stage biotechnology company developing and commercializing products for the treatment of orphan retinal diseases. 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 posterior non-infectious uveitis. It is a next-generation, non-steroidal, immuno-modulatory, and small-molecule inhibitor of dihydroorotate dehydrogenase. 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 Twitter 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 close the private placement and the timing thereof, any proceeds that may be received upon warrant exercises, the anticipated use of the net proceeds of the offering, the expected use of proceeds and the sufficiency of the proceeds from the private placement to fund specific programs, the development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's development-stage products, including KIO-104, KIO-201 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. 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