Kiora Pharmaceuticals Reports Second Quarter Results; Retinal Disease Drug Development Pipeline Advancing Toward Two Phase 2 Studies

Rhea-AI Summary

Kiora Pharmaceuticals (NASDAQ: KPRX) reported its Q2 2024 financial results and provided updates on its retinal disease drug development pipeline. Key highlights include:

1. Finalized trial design for Phase 2 study (ABACUS-2) of KIO-301 for retinitis pigmentosa treatment.

2. Planning Phase 2 clinical trial (CLARITY) of KIO-104 for multiple retinal inflammatory diseases.

3. Ended Q2 with $27.8 million in cash, cash equivalents, and short-term investments, plus $3.7 million in near-term receivables.

4. Expected cash runway into 2027, before potential partnership milestones.

5. Revenue of $20,000 in Q2 2024, compared to no revenue in Q2 2023.

6. Net loss of $2.2 million in Q2 2024, down from $2.6 million in Q2 2023.

Positive

• Finalized trial design for Phase 2 study (ABACUS-2) of KIO-301 for retinitis pigmentosa
• Planning Phase 2 clinical trial (CLARITY) of KIO-104 for retinal inflammatory diseases
• Strong cash position of $27.8 million plus $3.7 million in near-term receivables
• Expected cash runway into 2027
• Decreased net loss from $2.6 million in Q2 2023 to $2.2 million in Q2 2024
• Received Orphan Medicinal Product Designation from EMA for KIO-301
• Reported positive functional MRI results for KIO-301 in ABACUS-1 trial

Negative

• revenue of only $20,000 in Q2 2024
• Increased general and administrative expenses from $1.1 million in Q2 2023 to $1.5 million in Q2 2024

Financial Analyst

Kiora's Q2 results show a mixed financial picture. While revenue remains minimal at $20,000, the company's cash position is strong at $27.8 million, with an additional $3.7 million in near-term receivables. This provides a runway into 2027, which is positive for long-term stability.

The net loss decreased to $2.2 million from $2.6 million year-over-year, primarily due to $1.1 million in offsetting expense credits from the TOI partnership. However, G&A expenses increased to $1.5 million from $1.1 million, which is a point of concern for cost management.

The TOI partnership is proving financially beneficial, providing R&D reimbursements and potential milestone payments. This risk-sharing model could be important for Kiora's future financial health as it progresses through costly clinical trials.

Medical Research Analyst

Kiora's pipeline progress is encouraging. The finalization of the ABACUS-2 Phase 2 study design for KIO-301 in retinitis pigmentosa is a significant milestone. The positive data from ABACUS-1, including statistically significant increases in neural activity in the brain's visual processing center, provides a strong foundation for the upcoming trial.

For KIO-104, the planned Phase 2 CLARITY trial targeting multiple retinal inflammatory diseases represents a broad market approach. The potential to offer an alternative to chronic steroid use or systemic anti-inflammatory drugs could address a significant unmet need in ophthalmology.

The company's focus on functional vision testing as an approvable endpoint, validated by regulators, is a strategic move that could streamline the approval process. However, investors should note that Phase 2 trials are still early-stage and success is not guaranteed.

Market Research Analyst

Kiora's focus on retinal diseases positions it in a growing market with significant unmet needs. The potential first-in-class status for both KIO-301 and KIO-104 could provide a competitive edge if successful.

The partnership with Théa Open Innovation for KIO-301 is a strategic advantage, providing both financial support and potential commercialization pathways. This could be important for a small biotech company navigating the costly drug development process.

The company's approach to developing KIO-104 for multiple inflammatory retinal diseases could expand its market potential. However, this broad approach also carries risks, as it may dilute resources across multiple indications.

Investors should consider the long timeline to potential commercialization, with Phase 2 trials just beginning. While the cash runway into 2027 is positive, additional funding may be needed depending on trial outcomes and potential regulatory hurdles.

Encinitas, California--(Newsfile Corp. - August 9, 2024) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") announces second quarter 2024 financial results and provides an update on its pipeline of therapeutics for the treatment of retinal diseases. During the quarter, Kiora finalized the trial design for the Phase 2 study (ABACUS-2) of KIO-301, a novel molecular photoswitch, for the treatment of retinitis pigmentosa through our partnership with Théa Open Innovation (TOI). In parallel, the Company is planning its Phase 2 clinical trial (CLARITY) of KIO-104, a small molecule targeting the treatment of multiple retinal inflammatory diseases. Kiora ended the quarter with $27.8 million in cash, cash equivalents and short-term investments. Additionally, the Company has near-term receivables from R&D reimbursements from TOI and research incentive tax credits totaling an additional $3.7 million. This provides Kiora with an expected runway into 2027, before any potential partnership milestones.

"We are advancing two exciting and potential first-in-class small molecules toward Phase 2 trials," said Brian M. Strem, Ph.D., President & Chief Executive Officer of Kiora. "Our cash position allows us to invest time upfront to design and implement robust studies, which can reduce time to market and increase our chances for approval and commercial success.

"KIO-301 is our small molecule photoswitch for the treatment of inherited retinal diseases, such as retinitis pigmentosa (RP). Under our development and commercialization partnership with TOI, we are responsible for conducting the Phase 2 clinical trial. Strategic benefits from this partnership include reimbursement for KIO-301 R&D as well as potential milestone payments when pre-defined clinical development triggers are met.

"A key initiative in the second quarter was to gain clarity on details of the approvable endpoints for KIO-301. Through multiple interactions with the FDA and European regulators, functional vision testing, such as navigation course and object identification, remains the path to approval. While we deployed functional vision testing in our ABACUS-1 trial, we sought to further refine the assessments being used, and have begun clinical validation of these improvements prior to our planned initiation of our Phase 2 ABACUS-2 trial later this year. The goal of the clinical validation, supported in part by a grant from the Choroideremia Research Foundation (CRF), is to finalize endpoints to be used for the ABACUS-2 trial and become a standard measure for clinical trials of vision restoring therapeutics. ABACUS-2 follows on the positive data reported in ABACUS-1, reported at the most recent American Academy of Ophthalmology and the Association for Research in Vision and Ophthalmology annual conferences.

"KIO-104 is a potent, locally delivered small molecule we are developing to treat several inflammatory retinal diseases. The goal is to offer patients and providers the hope of an alternative to chronic steroid use or systemic anti-inflammatory drugs, both of which can lead to complications. KIO-104 acts by suppressing the number and function of specific T cells causing damaging levels of inflammation. Early next year we plan to initiate a Phase 2 trial, building on positive Phase 1b results, where we will explore multiple doses and enroll patients with several forms of inflammatory retinal disease, such as non-infectious uveitis, diabetic macular edema and retinal vein occlusion. Findings in the study will inform a dose expansion trial in one or more specific indications. Additional non-clinical work is currently underway to support final trial design and we anticipate initiating the clinical trial early next year."

Chief Financial Officer, Melissa Tosca, added, "We maintained our strong cash position, ending the second quarter with effectively $31.5 million and a cash runway of more than two years, excluding any potential milestone payments or warrant exercise accelerators. This provides us the financial resources to implement, complete and report data on two robust Phase 2 studies."

Milestones achieved during and after the end of the second quarter of 2024 include:

KIO-301

• Received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) for the treatment of a group of inherited retinal diseases (IRDs) that include retinitis pigmentosa, choroideremia and more.
• Reported quantitative functional MRI results at the Association of Research in Vision and Ophthalmology (ARVO) annual conference from ABACUS-1, showing a statistically significant increase in neural activity over baseline specifically within the brain's visual processing center. This increase in observed brain activity was time-dependent and concordant with previously reported improvements in visual field, visual acuity, and functional vision improvements.
• Received grant funding from the CRF in support of validating functional vision assessments for patients with profound blindness to be used in ABACUS-2 and other inherited retinal disease clinical trials.

KIO-104

• Initiated Investigational New Drug enabling preclinical work in support of planned phase 2 retinal inflammation clinical trial.
• Developed framework of Phase 2 clinical trial (CLARITY) design for KIO-104 in the treatment of retinal inflammatory diseases.

Corporate

• Promoted Melissa Tosca to Chief Financial Officer.
• Appointed Lisa Walters-Hoffert as an independent member to the Company's Board of Directors.

Kiora anticipates achieving the following clinical and regulatory milestones:

KIO-301

• 2H 2024: Complete clinical validation of functional vision endpoints for ABACUS-2
• 2H 2024: Receive approval to initiate Phase 2 ABACUS-2 study

KIO-104

• 2H 2024: Complete non-clinical, Phase 2 enabling package
• 1H 2025: Initiate Phase 2 CLARITY study

Second Quarter Financial Highlights

Kiora ended the second quarter of 2024 with $27.8 million in cash and cash equivalents and short-term investments. In addition, the Company recorded $1.3 million in collaboration receivables from TOI for reimbursed R&D expenses and $2.3 million R&D incentive tax credits.

Revenue was $20,000 for the second quarter of 2024, compared to no revenue in the second quarter of 2023. The revenue was recognized as part of the grant received from Choroideremia Research Foundation in support of validating functional vision assessments for patients with profound blindness.

Kiora spent $2.0 million on research and development in the second quarter of 2024. After $1.1 million in offsetting expense reimbursement credits related to the strategic development and commercialization agreement with TOI, Kiora is recording net research and development expenses of $0.9 million, compared to $1.4 million for the second quarter of 2023.

General and administrative expenses were $1.5 million for the second quarter of 2024, compared to $1.1 million for the second quarter of 2023. The increase is due in part to technical accounting advisory services related to the strategic development and commercialization agreement with TOI, a benchmarking survey, and legal and other advisory services related to the reverse stock split.

Net loss was $2.2 million for the second quarter of 2024 compared to a net loss of $2.6 million for the second quarter of 2023. The decrease in net loss is primarily attributed to offsetting KIO-301 expense credits of $1.1 million dollars related to the strategic development and commercialization agreement of KIO-301 with TOI.

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.

Contacts:

Investors
investors@kiorapharma.com

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, KIO-301, KIO-201 and KIO-101, 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 a Phase 2b 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 2024. 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 satisfy the closing conditions related to the offering, 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 August 9, 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.

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CONDENSED CONSOLIDATED BALANCE SHEETS

		June 30, 2024 (unaudited)				December 31, 2023
ASSETS
Current Assets:
Cash and Cash Equivalents	$	6,575,394			$	2,454,684
Short-Term Investments		21,242,671				—
Prepaid Expenses and Other Current Assets		339,646				233,382
Collaboration Receivables		1,341,297				—
Tax and Other Receivables		2,331,797				2,049,965
Total Current Assets		31,830,805				4,738,031
Non-Current Assets:
Property and Equipment, Net		63,487				8,065
Restricted Cash		4,179				4,267
Intangible Assets and In-Process R&D, Net		8,801,350				8,813,850
Operating Lease Assets with Right-of-Use		82,322				106,890
Other Assets		32,122				40,767
Total Assets	$	40,814,265			$	13,711,870
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts Payable	$	268,638			$	206,260
Accrued Expenses		1,345,192				1,380,666
Operating Lease Liabilities		42,126				47,069
Total Current Liabilities		1,655,956				1,633,995
Non-Current Liabilities:
Contingent Consideration		5,236,999				5,128,959
Deferred Tax Liability		779,440				779,440
Operating Lease Liabilities		40,197				59,822
Total Non-Current Liabilities		6,056,636				5,968,221
Total Liabilities		7,712,592				7,602,216
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, 2024 and December 31, 2023, respectively		4				4
Common Stock, $0.01 Par Value: 150,000,000 and 50,000,000 shares authorized; 2,970,545 and 856,182 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively		267,373				77,078
Additional Paid-In Capital		168,825,325				153,192,228
Accumulated Deficit		(135,745,294	)			(146,976,855	)
Accumulated Other Comprehensive Loss		(245,875	)			(182,801	)
Total Stockholders' Equity		33,101,673				6,109,654
Total Liabilities and Stockholders' Equity	$	40,814,265			$	13,711,870

 

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

		Three Months Ended June 30,								Six Months Ended, June 30,
		2024				2023				2024				2023
Revenue:
Collaboration Revenue	$	—			$	—			$	16,000,000			$	—
Grant Revenue		20,000				—				20,000				—
Total Revenue		20,000				—				16,020,000				—
Operating Expenses:
General and Administrative		1,537,973				1,097,294				2,834,414				2,366,752
Research and Development		906,680				1,392,099				2,400,339				1,830,382
Change in Fair Value of Contingent Consideration		120,234				143,619				108,040				352,545
Total Operating Expenses		2,564,887				2,633,012				5,342,793				4,549,679
Operating Income (Loss)		(2,544,887	)			(2,633,012	)			10,677,207				(4,549,679	)
Other Income, Net:
Interest Income, Net		342,102				45,087				565,149				78,552
Other Income, Net		(18,861	)			(25,888	)			(10,795	)			(11,222	)
Total Other Income, Net		323,241				19,199				554,354				67,330
Net Income (Loss)	$	(2,221,646	)		$	(2,613,813	)		$	11,231,561			$	(4,482,349	)
Net Income (Loss) per Common Share - Basic	$	(0.53	)		$	(7.15	)		$	3.19			$	(15.63	)
Weighted Average Shares Outstanding - Basic		4,170,627				365,530				3,526,211				286,729
Net Income (Loss) per Common Share - Diluted	$	(0.53	)		$	(7.15	)		$	2.79			$	(15.63	)
Weighted Average Shares Outstanding - Diluted		4,170,627				365,530				4,031,174				286,729
Other Comprehensive Income (Loss):
Net Income (Loss)	$	(2,221,646	)		$	(2,613,813	)		$	11,231,561			$	(4,482,349	)
Unrealized Loss on Marketable Securities		(2,828	)			—				(2,828	)			—
Foreign Currency Translation Adjustments		21,467				(10,449	)			(60,246	)			(43,120	)
Comprehensive Income (Loss)	$	(2,203,007	)		$	(2,624,262	)		$	11,168,627			$	(4,525,469	)

 

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/219299

FAQ

What were Kiora Pharmaceuticals' (KPRX) Q2 2024 financial results?

Kiora reported $27.8 million in cash and investments, $20,000 in revenue, and a net loss of $2.2 million for Q2 2024.

What are the main drug candidates in Kiora's (KPRX) pipeline?

Kiora's main drug candidates are KIO-301 for retinitis pigmentosa and KIO-104 for retinal inflammatory diseases.

When does Kiora (KPRX) expect to initiate the Phase 2 ABACUS-2 study for KIO-301?

Kiora anticipates receiving approval to initiate the Phase 2 ABACUS-2 study for KIO-301 in the second half of 2024.

What is the expected cash runway for Kiora Pharmaceuticals (KPRX)?

Kiora expects its current cash position to provide a runway into 2027, before any potential partnership milestones.

When does Kiora (KPRX) plan to initiate the Phase 2 CLARITY study for KIO-104?

Kiora plans to initiate the Phase 2 CLARITY study for KIO-104 in the first half of 2025.