Kiora Pharmaceuticals Reports Third Quarter Results; Retinal Disease Pipeline Advancing Two Phase 2 Studies
Kiora Pharmaceuticals (NASDAQ: KPRX) reported Q3 2024 financial results and pipeline updates. The company received approval for ABACUS-2, a Phase 2 study of KIO-301 for retinitis pigmentosa, and finalized the Phase 2 KLARITY trial design for KIO-104. Financial position remains strong with $29.0 million in cash and equivalents, plus $1.8 million in collaboration receivables from Théa partnership. Q3 net loss was $3.4 million, improved from $5.8 million in Q3 2023. R&D expenses were $2.2 million, offset by $0.9 million in Théa reimbursements. The company expects runway into 2027, beyond anticipated clinical trial readouts.
Kiora Pharmaceuticals (NASDAQ: KPRX) ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti sul proprio pipeline. L'azienda ha ricevuto l'approvazione per ABACUS-2, uno studio di Fase 2 su KIO-301 per la retinite pigmentosa, e ha finalizzato il design della sperimentazione di Fase 2 KLARITY per KIO-104. La posizione finanziaria rimane solida con 29,0 milioni di dollari in contante e equivalenti, più 1,8 milioni di dollari in crediti da collaborazioni con il partner Théa. La perdita netta del terzo trimestre è stata di 3,4 milioni di dollari, in miglioramento rispetto ai 5,8 milioni di dollari del terzo trimestre 2023. Le spese per Ricerca e Sviluppo sono state di 2,2 milioni di dollari, compensate da 0,9 milioni di dollari in rimborsi da Théa. L'azienda si aspetta di avere risorse sufficienti fino al 2027, oltre le letture dei trial clinici previste.
Kiora Pharmaceuticals (NASDAQ: KPRX) reportó los resultados financieros del tercer trimestre de 2024 y actualizaciones sobre su pipeline. La compañía recibió la aprobación para ABACUS-2, un estudio de Fase 2 de KIO-301 para la retinitis pigmentosa, y finalizó el diseño del ensayo de Fase 2 KLARITY para KIO-104. La posición financiera se mantiene fuerte con 29,0 millones de dólares en efectivo y equivalentes, más 1,8 millones de dólares en cuentas por cobrar de colaboración con el socio Théa. La pérdida neta del tercer trimestre fue de 3,4 millones de dólares, mejorando desde los 5,8 millones de dólares en el tercer trimestre de 2023. Los gastos de I+D fueron de 2,2 millones de dólares, compensados por 0,9 millones de dólares en reembolsos de Théa. La compañía espera contar con recursos hasta 2027, más allá de los resultados anticipados de los ensayos clínicos.
Kiora Pharmaceuticals (NASDAQ: KPRX)는 2024년 3분기 재무 결과 및 파이프라인 업데이트를 보고했습니다. 이 회사는 KIO-301에 대한 망막색소변성증 치료를 위한 2상 연구 ABACUS-2의 승인을 받았으며, KIO-104를 위한 2상 KLARITY 시험 설계를 완료했습니다. 재무 상태는 2900만 달러의 현금 및 현금동등물, 그리고 Théa 파트너십에서의 180만 달러의 협업 수익금으로 강력하게 유지되고 있습니다. 3분기 순손실은 340만 달러로, 2023년 3분기의 580만 달러에서 개선되었습니다. 연구개발 비용은 220만 달러였으며, 90만 달러는 Théa의 환급으로 상쇄되었습니다. 회사는 예상되는 임상 시험 결과를 넘어서 2027년까지의 자금 확보를 기대하고 있습니다.
Kiora Pharmaceuticals (NASDAQ: KPRX) a rapporté les résultats financiers du troisième trimestre 2024 et des mises à jour sur son pipeline. La société a reçu l'approbation pour ABACUS-2, une étude de phase 2 sur KIO-301 pour la rétinite pigmentaire, et a finalisé le design de l'essai de phase 2 KLARITY pour KIO-104. La position financière reste solide avec 29,0 millions de dollars en liquidités et équivalents, ainsi que 1,8 million de dollars en créances de collaboration avec le partenaire Théa. La perte nette du troisième trimestre était de 3,4 millions de dollars, en amélioration par rapport à 5,8 millions de dollars au troisième trimestre 2023. Les dépenses de R&D étaient de 2,2 millions de dollars, compensation faite par 0,9 million de dollars en remboursements de Théa. L'entreprise prévoit d'avoir des ressources suffisantes jusqu'en 2027, au-delà des résultats d'essais cliniques anticipés.
Kiora Pharmaceuticals (NASDAQ: KPRX) berichtete über die finanziellen Ergebnisse des dritten Quartals 2024 und aktualisierte Informationen zu seiner Pipeline. Das Unternehmen erhielt die Genehmigung für ABACUS-2, eine Phase-2-Studie zu KIO-301 bei Netzhauterkrankungen, und finalisierte das Design der Phase-2-Studie KLARITY für KIO-104. Die Finanzlage bleibt stark mit 29,0 Millionen Dollar in Bargeld und liquiden Mitteln, sowie 1,8 Millionen Dollar an Forderungen aus der Zusammenarbeit mit Théa. Der Nettoverlust im dritten Quartal betrug 3,4 Millionen Dollar, eine Verbesserung gegenüber 5,8 Millionen Dollar im dritten Quartal 2023. Die F&E-Ausgaben beliefen sich auf 2,2 Millionen Dollar, die durch 0,9 Millionen Dollar an Erstattungen von Théa ausgeglichen wurden. Das Unternehmen rechnet mit ausreichend Mitteln bis 2027, über die erwarteten Leseergebnisse klinischer Studien hinaus.
- Strong cash position of $29.0 million plus $1.8 million in receivables
- Reduced net loss to $3.4 million from $5.8 million YoY
- Extended cash runway into 2027
- FDA approval received for Phase 2 ABACUS-2 study
- R&D cost sharing through Théa partnership reducing expenses
- Increased R&D expenses year-over-year
- Expected increase in future R&D expenses for KLARITY trial
Insights
The Q3 results reveal a strong financial position with
The Théa partnership provides significant value by funding KIO-301 development, allowing internal resources to be directed toward KIO-104. With projected runway into 2027, the company has sufficient capital to reach key clinical milestones for both Phase 2 programs. The strategic decision to discontinue KIO-201 development reflects prudent resource allocation.
The advancement of two Phase 2 programs represents significant clinical progress. KIO-301's ABACUS-2 trial approval for retinitis pigmentosa is noteworthy, as the molecular photoswitch approach could potentially treat patients regardless of genetic mutation - addressing a market of 150+ mutations. The focus on validating functional vision endpoints demonstrates scientific rigor and regulatory awareness.
KIO-104's development for inflammatory retinal diseases targets an important medical need, offering a potential alternative to problematic chronic steroid treatments. The dual-program approach in posterior non-infectious uveitis and diabetic macular edema provides multiple shots on goal.
Encinitas, California--(Newsfile Corp. - November 8, 2024) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced third quarter 2024 financial results and provided an update on its pipeline of therapeutics for the treatment of retinal diseases. Key third quarter and recent corporate highlights include:
Investigational new drug application approval to initiate ABACUS-2, the Phase 2 study of KIO-301, a novel molecular photoswitch, for the treatment of retinitis pigmentosa.
Finalized the design of the Phase 2 KLARITY trial of KIO-104, a small molecule targeting the treatment of multiple retinal inflammatory diseases, with submission for trial approval on track for Q4 2024.
Ended the quarter with
$29.0 million in cash, cash equivalents and short-term investments plus$1.8 million in collaboration receivables related to the Company's Théa Open Innovation (TOI or Théa) partnership.Expected runway into 2027, excluding any potential partnership milestones.
"Kiora remains in a strong position with two compelling and innovative drug candidates entering Phase 2 clinical trials and a strong balance sheet to fund development and operations beyond anticipated readouts for both studies," said Brian M. Strem, Ph.D., President & Chief Executive Officer of Kiora. "During the third quarter, we worked diligently to prepare for these trials, which will increase their likelihood of success.
"Regarding KIO-301, we recently received approval 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. Based on KIO-301's differentiated mechanism of action as a small molecule, we will enroll patients with any of the known 150-plus underlying gene mutations associated with retinitis pigmentosa. Dosing of the first patient with KIO-301 will begin next year following the completion of the ongoing validation work around functional vision endpoints.
"Following multiple 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. Thus, throughout the third quarter and continuing into the fourth, we've invested time to validate functional vision endpoints, increasing the probability of success of ABACUS-2 and a potential Phase 3 study in the US and Europe. This validation work is being performed in collaboration with our partner Théa, with additional support from the Choroideremia Research Foundation.
"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. KIO-104 acts by suppressing specific types of T cells and their resulting biomolecules (cytokines) that underlie damaging inflammation. Following a previously successful first-in-man study, we now plan to initiate KLARITY in the first half of next year. This study will be a Phase 2 clinical trial to explore multiple doses of KIO-104 in patients with inflammatory retinal diseases, including posterior non-infectious uveitis and diabetic macular edema. Findings in the study will inform a dose expansion trial in one or more specific indications."
Kiora's Chief Financial Officer, Melissa Tosca, added, "We continue to efficiently manage our cash while creating value by investing in our pipeline. Our Théa partnership enables our overall pipeline progress through their reimbursement of our KIO-301 R&D activities, allowing us to invest further in KIO-104. Going forward, we anticipate R&D expenses will increase as we begin patient enrollment in the KLARITY trial. However, we maintain a cash runway into 2027, before any potential partnership milestones, and beyond the expected data readouts from ABACUS-2 and KLARITY."
Third Quarter Financial Highlights
Kiora ended the third quarter of 2024 with
Research and development expenses for the third quarter of 2024 were
General and administrative expenses were
Net loss was
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 retinal inflammation. 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 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 on hand to fund operations for specific periods, the projected cash runway, the ability to timely complete planned initiatives for 2024, including phase 2 clinical development of KIO-301 and KIO-104, the potential for KIO-301 to be the first treatment options for patients with inherited degenerative diseases like RP, Kiora's plans to further fund development of KIO-104, the potential for KIO-104 to reduce inflammation, the timing of topline results from clinical trials of KIO-104, the potential for KIO-104 to apply to other retinal inflammatory diseases, the anticipated readout dates for Kiora's clinical trials and their likelihood of success, and expected trends for research and development and general and administrative spending in 2024. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release 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, 2024 or described in Kiora's other public filings including on Form 10-Q filed with the SEC on November 8, 2024. 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.
###
Contact:
investors@kiorapharma.com
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30, 2024 (unaudited) | December 31, 2023 | |||||
| ASSETS | ||||||
| Current Assets: | ||||||
| Cash and Cash Equivalents | $ | 5,637,019 | $ | 2,454,684 | ||
| Short-Term Investments | 23,398,016 | - | ||||
| Prepaid Expenses and Other Current Assets | 470,424 | 233,382 | ||||
| Collaboration Receivables | 1,783,472 | - | ||||
| Tax and Other Receivables | 363,706 | 2,049,965 | ||||
| Total Current Assets | 31,652,637 | 4,738,031 | ||||
| Non-Current Assets: | ||||||
| Property and Equipment, Net | 62,609 | 8,065 | ||||
| Restricted Cash | 4,520 | 4,267 | ||||
| Intangible Assets and In-Process R&D, Net | 6,687,100 | 8,813,850 | ||||
| Operating Lease Assets with Right-of-Use | 72,637 | 106,890 | ||||
| Other Assets | 29,851 | 40,767 | ||||
| Total Assets | $ | 38,509,354 | $ | 13,711,870 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
| Current Liabilities: | ||||||
| Accounts Payable | $ | 660,415 | $ | 206,260 | ||
| Accrued Expenses | 1,714,211 | 1,380,666 | ||||
| Accrued Collaboration Credit | 1,119,591 | - | ||||
| Operating Lease Liabilities | 33,447 | 47,069 | ||||
| Total Current Liabilities | 3,527,664 | 1,633,995 | ||||
| Non-Current Liabilities: | ||||||
| Contingent Consideration | 4,133,008 | 5,128,959 | ||||
| Deferred Tax Liability | 779,440 | 779,440 | ||||
| Operating Lease Liabilities | 39,190 | 59,822 | ||||
| Total Non-Current Liabilities | 4,951,638 | 5,968,221 | ||||
| Total Liabilities | 8,479,302 | 7,602,216 | ||||
| Commitments and Contingencies (Note 8) | ||||||
| Stockholders' Equity: | ||||||
| Preferred Stock, | 4 | 4 | ||||
| Common Stock, | 267,679 | 77,078 | ||||
| Additional Paid-In Capital | 168,996,195 | 153,192,228 | ||||
| Accumulated Deficit | (139,158,620 | ) | (146,976,855 | ) | ||
| Accumulated Other Comprehensive Loss | (75,206 | ) | (182,801 | ) | ||
| Total Stockholders' Equity | 30,030,052 | 6,109,654 | ||||
| Total Liabilities and Stockholders' Equity | $ | 38,509,354 | $ | 13,711,870 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE INCOME (LOSS)
(unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Revenue: | ||||||||||||
| Collaboration Revenue | $ | - | $ | - | $ | 16,000,000 | $ | - | ||||
| Grant Revenue | - | - | 20,000 | - | ||||||||
| Total Revenue | - | - | 16,020,000 | - | ||||||||
| Operating Expenses: | ||||||||||||
| General and Administrative | 1,380,997 | 1,415,844 | 4,215,411 | 3,782,596 | ||||||||
| Research and Development | 1,317,231 | 1,085,010 | 3,717,570 | 2,915,392 | ||||||||
| In-Process R&D Impairment | 2,008,000 | 1,904,314 | 2,008,000 | 1,904,314 | ||||||||
| Change in Fair Value of Contingent Consideration | (1,103,991 | ) | 1,513,400 | (995,951 | ) | 1,865,945 | ||||||
| Total Operating Expenses | 3,602,237 | 5,918,568 | 8,945,030 | 10,468,247 | ||||||||
| Operating Income (Loss) | (3,602,237 | ) | (5,918,568 | ) | 7,074,970 | (10,468,247 | ) | |||||
| Other Income (Expense), Net: | ||||||||||||
| Interest Income, Net | 248,840 | 49,912 | 813,989 | 128,464 | ||||||||
| Other Income (Expense), Net | (59,929 | ) | 105,715 | (70,724 | ) | 94,493 | ||||||
| Total Other Income, Net | 188,911 | 155,627 | 743,265 | 222,957 | ||||||||
| Net Income (Loss) | $ | (3,413,326 | ) | $ | (5,762,941 | ) | $ | 7,818,235 | $ | (10,245,290 | ) | |
| Deemed Dividends from Warrant Reset Provision | - | (530,985 | ) | - | (530,985 | ) | ||||||
| Net Loss Attributable to Common Shareholders | $ | (3,413,326 | ) | $ | (6,293,926 | ) | $ | 7,818,235 | $ | (10,776,275 | ) | |
| Net Income (Loss) per Common Share - Basic | $ | (0.81 | ) | $ | (7.30 | ) | $ | 2.08 | $ | (23.35 | ) | |
| Weighted Average Shares Outstanding - Basic | 4,214,950 | 789,656 | 3,757,467 | 438,687 | ||||||||
| Net Income (Loss) per Common Share - Diluted | $ | (0.81 | ) | $ | (7.30 | ) | $ | 1.91 | $ | (23.35 | ) | |
| Weighted Average Shares Outstanding - Diluted | 4,214,950 | 789,656 | 4,092,880 | 438,687 | ||||||||
| Other Comprehensive Income (Loss): | ||||||||||||
| Net Income (Loss) | $ | (3,413,326 | ) | $ | (5,762,941 | ) | $ | 7,818,235 | $ | (10,245,290 | ) | |
| Unrealized Gain on Marketable Securities | 76,435 | - | 73,607 | - | ||||||||
| Foreign Currency Translation Adjustments | 94,094 | (40,310 | ) | 33,988 | (83,430 | ) | ||||||
| Comprehensive Income (Loss) | $ | (3,242,797 | ) | $ | (5,803,251 | ) | $ | 7,925,830 | $ | (10,328,720 | ) | |
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