Kiora Pharmaceuticals Reports Second Quarter 2025 Results; Company Advances Pipeline with Two Active Phase 2 Clinical Trials for Retinal Diseases

Rhea-AI Summary

Kiora Pharmaceuticals (NASDAQ: KPRX) reported Q2 2025 financial results and pipeline updates for retinal disease treatments. The company initiated two Phase 2 clinical trials: KLARITY for KIO-104 (retinal inflammation) and ABACUS-2 for KIO-301 (retinitis pigmentosa). Kiora secured a potential $110M partnership with Senju Pharmaceutical for KIO-301 development in Asia.

Financial highlights include a $20.7M cash position, with additional $2.4M in collaboration receivables and $0.7M in tax credits. The company reported a net loss of $2.2M in Q2 2025, unchanged from Q2 2024. R&D expenses increased to $2.6M (before $1.7M in reimbursements), while G&A expenses decreased to $1.4M. Cash runway extends into late 2027, beyond anticipated clinical trial readouts.

Positive

• Secured potential $110M partnership deal with Senju for KIO-301 in Asian markets
• Extended patent protection for KIO-104 until 2043
• Maintained strong cash position of $20.7M with runway into late 2027
• Received $1.3M in R&D expense reimbursement from Théa
• Successfully launched two Phase 2 clinical trials with validated endpoints

Negative

• Net loss of $2.2M in Q2 2025
• Increased R&D expenses from $2.0M to $2.6M year-over-year

Insights

Biotech Investment Analyst

Kiora advances two Phase 2 trials while securing Asian partnership worth up to $110M, extending cash runway through 2027 despite ongoing R&D investments.

Kiora's Q2 2025 report shows strategic advancement on multiple fronts. The company has initiated two key Phase 2 clinical trials - KLARITY for KIO-104 (targeting retinal inflammation) and ABACUS-2 for KIO-301 (targeting vision restoration in retinitis pigmentosa). The latter is particularly noteworthy as it employs a validated efficacy endpoint that could streamline the path to registration trials.

The company has substantially strengthened its intellectual property position by extending KIO-104's market exclusivity to 2043, creating a potentially valuable long-term asset if clinical trials prove successful. This patent specifically covers methods for optimizing treatment of ocular inflammatory diseases.

Financially, Kiora has executed a strategic partnership move by signing an option agreement with Senju Pharmaceutical for Asian markets with potential value up to $110 million plus royalties. The company already received a non-refundable $1.25 million option fee, demonstrating immediate value creation beyond purely clinical milestones.

The balance sheet remains healthy with $20.7 million in cash/investments, $2.4 million in collaboration receivables, and $0.7 million in research tax credits. Management projects this will extend their runway into late 2027, comfortably beyond expected data readouts from both Phase 2 trials. The net loss for the quarter was $2.2 million, unchanged from Q2 2024, with R&D expenses of $2.6 million ($0.9 million net after reimbursements) driven by clinical trial activities.

The existing partnership with Théa continues to provide meaningful financial support through R&D reimbursements, enhancing capital efficiency while advancing the clinical programs. The strategic partnership approach allows Kiora to extend global reach without significant infrastructure investment while securing non-dilutive funding.

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
Investors@kiorapharma.com

CONDENSED CONSOLIDATED BALANCE SHEETS

		June 30, 2025 (unaudited)			December 31, 2024
ASSETS
Current Assets:
Cash and Cash Equivalents	$	1,028,324		$	3,792,322
Short-Term Investments		19,637,812			22,999,760
Prepaid Expenses and Other Current Assets		957,095			2,042,487
Collaboration Receivables		2,418,022			601,197
Tax Receivables		696,002			270,246
Total Current Assets		24,737,255			29,706,012
Non-Current Assets:
Property and Equipment, Net		106,843			5,232
Restricted Cash		4,461			4,057
Intangible Assets and In-Process R&D, Net		6,687,100			6,687,100
Operating Lease Right-of-Use Assets		349,017			57,170
Other Assets		61,007			24,913
Total Assets	$	31,945,683		$	36,484,484
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts Payable	$	282,537		$	415,590
Accrued Expenses		2,540,493			4,588,657
Accrued Collaboration Credit		219,625			981,111
Operating Lease Liabilities		143,327			23,355
Total Current Liabilities		3,185,982			6,008,713
Non-Current Liabilities:
Contingent Consideration		4,604,456			4,191,490
Deferred Tax Liability		490,690			490,690
Deferred Collaboration Revenue		1,250,000			-
Non-Current Operating Lease Liabilities		287,079			33,815
Total Non-Current Liabilities		6,632,225			4,715,995
Total Liabilities		9,818,207			10,724,708
Commitments and Contingencies (Note 8)
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 June 30, 2025 and December 31, 2024, respectively		4			4
Common Stock, $0.01 Par Value: 150,000,000 shares authorized; 3,433,491 and 3,000,788 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively		272,006			267,679
Additional Paid-In Capital		169,828,797			169,156,374
Accumulated Deficit		(147,727,561	)		(143,382,122	)
Accumulated Other Comprehensive Loss		(245,770	)		(282,159	)
Total Stockholders' Equity		22,127,476			25,759,776
Total Liabilities and Stockholders' Equity	$	31,945,683		$	36,484,484

 

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE (LOSS) INCOME
(unaudited)

		Three Months Ended June 30,						Six Months Ended June 30,
		2025			2024			2025			2024
Revenue:
Collaboration Revenue	$	-		$	-		$	-		$	16,000,000
Grant Revenue		-			20,000			-			20,000
Total Revenue		-			20,000			-			16,020,000
Operating Expenses:
General and Administrative		1,353,850			1,537,973			2,843,248			2,834,414
Research and Development		2,590,489			2,048,665			5,122,376			3,732,877
Collaboration and Research Credits		(1,685,917	)		(1,141,985	)		(3,652,040	)		(1,332,538	)
Change in Fair Value of Contingent Consideration		137,774			120,234			412,966			108,040
Total Operating Expenses		2,396,197			2,564,887			4,726,550			5,342,793
Operating (Loss) Income		(2,396,197	)		(2,544,887	)		(4,726,550	)		10,677,207
Other Income (Expense), Net:
Interest Income, Net		225,237			342,102			501,870			565,149
Other (Expense) Income, Net		(93,556	)		(18,861	)		(109,809	)		(10,795	)
Total Other Income, Net		131,680			323,241			392,060			554,354
(Loss) Income Before Income Tax Expense		(2,264,516	)		(2,221,646	)		(4,334,490	)		11,231,561
Income Tax (Expense) Benefit		112,057			-			(10,949	)		-
Net (Loss) Income	$	(2,152,459	)	$	(2,221,646	)	$	(4,345,439	)	$	11,231,561
Net (Loss) Income Attributable to Common Shareholders	$	(2,152,459	)	$	(2,221,646	)	$	(4,345,439	)	$	11,231,561
Net (Loss) Income per Common Share - Basic	$	(0.54	)	$	(0.53	)	$	(1.10	)	$	3.19
Weighted Average Shares Outstanding - Basic		3,989,042			4,170,627			3,936,649			3,526,211
Net (Loss) Income per Common Share - Diluted	$	(0.54	)	$	(0.53	)	$	(1.10	)	$	2.79
Weighted Average Shares Outstanding - Diluted		3,989,042			4,170,627			3,936,649			4,031,174
Other Comprehensive (Loss) Income:
Net (Loss) Income	$	(2,152,459	)	$	(2,221,646	)	$	(4,345,439	)	$	11,231,561
Unrealized Loss on Marketable Securities		(11,116	)		(2,828	)		(27,215	)		(2,828	)
Foreign Currency Translation Adjustments		62,532			21,467			63,604			(60,106	)
Comprehensive (Loss) Income	$	(2,101,044	)	$	(2,203,007	)	$	(4,309,050	)	$	11,168,627

 

 

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/261730

FAQ

What were Kiora Pharmaceuticals (KPRX) Q2 2025 financial results?

Kiora reported a net loss of $2.2M, with $20.7M in cash and equivalents. R&D expenses were $2.6M (before $1.7M reimbursement), and G&A expenses were $1.4M.

What is the potential value of Kiora's partnership with Senju Pharmaceutical?

The partnership has a potential deal value of up to $110 million plus royalties for developing and commercializing KIO-301 in key Asian markets, including Japan and China.

How long will Kiora's current cash runway last?

Kiora's cash runway extends into late 2027, beyond the anticipated data readouts for both KLARITY and ABACUS-2 clinical trials.

What clinical trials is Kiora currently conducting?

Kiora is conducting two Phase 2 trials: KLARITY for KIO-104 (treating retinal inflammation) and ABACUS-2 for KIO-301 (vision restoration in retinitis pigmentosa patients).

When does Kiora's patent protection for KIO-104 expire?

Kiora's patent protection for KIO-104 extends to 2043, excluding any potential patent term extensions.