Kiora Pharmaceuticals Reports 2021 Results and Provides Business Update

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Salt Lake City, Utah--(Newsfile Corp. - April 15, 2022) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX), ("Kiora" or the "Company") today reported its financial results for the quarter and year ended December 31, 2021 and provided an update on recent corporate and operational activities.

"We are making significant progress advancing our pipeline of treatments for ocular disease," said Brian M. Strem, Ph.D., President and Chief Executive Officer of Kiora. "KIO-301 was recently granted orphan drug designation and we are moving toward a first-in-human study in Retinitis Pigmentosa as early as the third quarter. Additionally, we have refined our development plan for KIO-101, where we have identified an important need and path to market for the treatment of ocular surface disease due to Rheumatoid Arthritis. This ocular presentation of dry eye-like signs and symptoms in RA patients causes significant morbidity, directly affecting quality of life and ocular discomfort."

Kiora has recently achieved several milestones, including the following:

  • KIO-301 received Orphan Drug Designation by FDA in March 2022, which provides extended market exclusivity for up to seven years in the U.S.

  • Announced the top-line data results of our Phase 1 study of KIO-101 showing favorable safety and tolerability as well as statistically significant improvements in conjunctival hyperemia.

  • Expanded our board of directors with the appointments of David Hollander, MD, MBA and Erin Parsons, who bring relevant industry and commercial expertise, respectively, in eyecare.

We have planned several milestones in 2022, and expect to:

  • Initiate a Phase 1b clinical trial in the third quarter of 2022 in patients with later-stage Retinitis Pigmentosa.

  • Initiate a Phase 2 trial for KIO-101 in the fourth quarter of 2022 to treat the Ocular Presentation of Rheumatoid Arthritis.

  • Strengthen the Company's balance sheet to continue advancing clinical trials for KIO-301 and KIO-101 as well as to continue conducting related preclinical research.

Fourth Quarter 2021 Financial Results

"Strategically, we are prioritizing internal development KIO-301 and KIO-101," added Dr. Strem. "We have identified these programs as the most attractive in terms of patient need and offering an efficient path to market. To keep these programs advancing on our current development timelines, we are pursuing several options to strengthen our balance sheet this year."

Research and development expenses were $5.350 million for the year 2021, compared to $3.566 million in 2020. The increase of $1.784 million was primarily due to development costs for KIO-101, as well as personnel-related costs from the Panoptes acquisition in December 2020. These increases were partially offset by decreases in development costs related to KIO-201. The Company expects to increase research and development expenses in 2022 as we prepare to initiate and conduct clinical trials for KIO-301 and KIO-101.

General and administrative expenses were $5.323 million for the year 2021, compared to $4.658 million spent in 2020. This increase was primarily due to increases in personnel related costs and professional fees.

Cash and cash equivalents were $7.854 million as of December 2021, compared to $1.186 million as of December 31, 2020. The increase in cash and cash equivalents was mainly due to net proceeds of $7.989 million received from the completion of a private placement in January 2021, as well as net proceeds of $9.756 million from the completion of a registered direct offering in August 2021.

During 2021, the company recorded an impairment loss of approximately $6.2 million on goodwill and intangible assets. This impairment loss was determined when comparing the fair value carrying value of the goodwill. For the intangible assets, the company recorded an impairment loss for KIO-201.

​​About Kiora Pharmaceuticals
Kiora is a clinical-stage biotechnology company developing and commercializing products for treating ophthalmic diseases. KIO-301 is being developed for the treatment of retinitis pigmentosa. It is a molecular photoswitch that has the potential to restore light perception in patients with inherited and/or age-related retinal degeneration. KIO-101 is being developed for the treatment of the Ocular Presentation of Rheumatoid Arthritis. It is a next-generation, non-steroidal, immuno-modulatory and small molecule inhibitor of Dihydroorotate Dehydrogenase ("DHODH") with best-in-class picomolar potency and a validated immune modulating mechanism (blocks T cell proliferation and proinflammatory cytokine release) designed to overcome the off-target side effects and safety issues associated with other DHODH inhibitors. In addition, Kiora is developing KIO-201, a modified form of the natural polymer hyaluronic acid, designed to accelerate corneal wound healing. For more information, please visit www.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. Such statements include statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. These "forward-looking" statements include statements relating to, among other things, the development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's products, including KIO-101, 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, expected corporate milestones for 2022, and expected research and development expenditures during 2022. 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, Kiora's ability to receive regulatory approvals on a timely basis or at all; the effectiveness and timeliness of Kiora's clinical trials; Kiora's dependence on third parties in connection with its clinical trials; volatility of stock price; possible dilution; absence of dividends; the continued impact of the COVID-19 pandemic on the medical community and the global economy and the impact of general business and economic conditions; protection of Kiora's intellectual property; retention of key personnel; manufacturing risks; 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 April 15, 2022 or described in Kiora's other public filings. Kiora's results may also be affected by factors of which Kiora is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Kiora expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions, or circumstances on which any such statement is based, except as required by law.

Investor Contact
Francina Agosti, PhD
(617) 546-0742
fagosti@reportablenews.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/120508

SOURCE Kiora Pharmaceuticals, Inc.

Released April 15, 2022