Quarterly report pursuant to Section 13 or 15(d)

Organization, Business

v3.21.2
Organization, Business
9 Months Ended
Sep. 30, 2021
Organization, Business  
Organization, Business

1. Organization, Business

On November 5, 2021, Kiora Pharmaceuticals, Inc. (formerly known as EyeGate Pharmaceuticals, Inc.) (“Kiora” or the “Company”) filed with the Secretary of State of the State of Delaware, a Certificate of Ownership and Merger, merging its wholly-owned Delaware subsidiary, Kiora Pharmaceuticals, Inc., (incorporated in October 2021) into the Company and amending the Company's certificate of incorporation to change its name to “Kiora Pharmaceuticals, Inc.” effective November 8, 2021 (the “Name Change”). The Company also amended and restated its bylaws to reflect the change to the Company's name (the “Bylaws Amendment”). The Name Change and the Bylaws Amendment each became effective on November 8, 2021. The Company’s common shares commenced trading on the Nasdaq Capital Market under the new ticker symbol "KPRX" and a new CUSIP number (49721T101) effective at the market open on November 8, 2021. Kiora is a clinical-stage specialty pharmaceutical company developing and commercializing products for treating ophthalmic diseases.

In the fourth quarter of 2020, Kiora acquired Panoptes Pharma Ges.m.b.H. (“Panoptes”) adding to its pipeline KIO-101(formerly known as PP-001), a next-generation, non-steroidal, immuno-modulatory and small-molecule inhibitor of Dihydroorotate Dehydrogenase (“DHODH”), with what Kiora believes to be a best-in-class picomolar potency and a validated immune modulating mechanism designed to overcome the off-target side effects and safety issues associated with DHODH inhibitors. KIO-101 has been developed in two clinical-stage ophthalmic formulations: an intravitreal injection for inflammatory diseases of the eye including posterior uveitis, and a novel nano carrier technology eye drop for ocular surface diseases such as dry eye disease. Other administration routes are also in development.

In addition, Kiora is developing KIO-201(formerly known as Ocular Bandage Gel or “OBG”), a modified form of the natural polymer hyaluronic acid, designed to protect the ocular surface to permit re-epithelialization of the cornea and improve ocular surface integrity. KIO-201, with unique properties that help hydrate and protect the ocular surface, is in clinical evaluation for patients undergoing photorefractive keratectomy (“PRK”) surgery for corneal wound repair after refractive surgery and patients with punctate epitheliopathies (“PE”) as a result of dry eye. A type-B meeting was held with the U.S. Food and Drug Administration’s (“FDA”) Center for Drug Evaluation and Research (“CDER”) division during the first quarter of 2021 to discuss eligibility of continuing KIO-201 clinical studies as a drug. As a result, development of KIO-201 has shifted from a medical device to a drug, which allows for reimbursement under Medicare Part D.

Since its inception, Kiora has devoted substantially all of its efforts to business planning, research and development, and raising capital.

The accompanying Condensed Consolidated Financial Statements have been prepared assuming that Kiora will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. At September 30, 2021, Kiora had unrestricted Cash and Cash Equivalents of $11.107 million, and an Accumulated Deficit of $116.356 million. Kiora has incurred losses and negative cash flows since inception, and future losses are anticipated. Based on its cash on hand at September 30, 2021, the Company anticipates having sufficient cash to fund planned operations into the second half of 2022, however, the acceleration or reduction of cash outflows by Company management can significantly impact the timing for the need to raise additional capital to complete development of its products. To continue development, Kiora will need to raise additional capital through equity financing, license agreements, and/or additional U.S. government grants. Although historically the Company has been successful at raising capital, most recently raising net proceeds of approximately $9.8 million in a registered direct offering that closed on August 11, 2021, additional capital may not be available on terms favorable to Kiora, if at all. On May 13, 2019, the SEC declared effective Kiora’s registration statement on Form S-3, registering a total of $50,000,000 of its securities for sale to the public from time to time in what is known as a “shelf offering”. The Company does not know if any future offerings, including offerings pursuant to its shelf registration statement, will succeed. Accordingly, no assurances can be given that Company management will succeed in these endeavors. The Company’s recurring losses from operations have caused management to determine there is substantial doubt about the Company’s ability to continue as a going concern. The Condensed Consolidated Financial Statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities or any other adjustments that might be necessary should the Company be unable to continue as a going concern.