WALTHAM, MA, March 25, 2021 – EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG), (“EyeGate” or the “Company”), a clinical-stage company developing and commercializing products for treating inflammatory and immune diseases with a focus on the eye and nervous system, today announced financial results for the year ended December 31, 2020 and provided an update on recent corporate and operational activities.
“We are extremely pleased by our 2020 progress and our significant corporate advancements that mark a new phase of strategic growth,” said Franz Obermayr, Ph.D., Acting Chief Executive Officer of EyeGate. “The acquisition of Panoptes was a transformative event that will allow EyeGate to make significant strides beyond ophthalmology and develop a robust product pipeline with PP-001, a de-risked, clinical-stage asset with broad therapeutic potential across a diverse range of ocular, autoimmune and neurological indications. We are poised for an exciting year ahead as we anticipate the initiation of multiple clinical studies in both ophthalmology and systemic diseases.”
2020 and Recent Business Highlights:
Panoptes Pharma acquisition: In December, EyeGate acquired Panoptes Pharma (“Panoptes”), a privately held clinical stage biotech company focused on developing a novel proprietary small molecule for the treatment of severe eye diseases with a high unmet medical need.
Pipeline updates: The acquisition transformed EyeGate’s pipeline with the addition of PP-001, a clinical-stage, next-generation, inhibitor of dihydroorotate dehydrogenase (“DHODH”) with a validated immune-modulating mechanism and potential best-in-class specificity and potency to avoid off-target side effects and reduce safety issues.
First-in-class in ophthalmology applications – PP-001 is in development with two clinical-stage ophthalmic formulations: (1) PaniJect, an intravitreal injection for inflammatory diseases of the eye with a Phase 1b/2a safety and efficacy study completed in patients with posterior uveitis, and (2) PaniDrop, an eye drop for conjunctivitis and dry eye disease with a completed Phase 1 safety study in healthy volunteers.
Other administration routes are also in development and IND enabling studies are underway for conditions outside the ocular space.
Management transition: In February, Franz Obermayr, Ph.D., Managing Director and former CEO of Panoptes Pharma, was appointed as Acting Chief Executive Officer and transitioned from his role at EyeGate as EVP Clinical Development. Stephen From transitioned from Chief Executive Officer to Executive Chairman.
Private placement: Completed a private placement in January 2021 for net proceeds of approximately $8.0 million with an affiliate of Armistice Capital.
2020 Financial Review:
EyeGate recognized revenue of $0.012 million for the year ended December 31, 2020, compared to $2.686 million for the year ended December 31, 2019. The revenue recognized for the year ended December 31, 2020 related to the Panoptes acquisition and the accompanying revenue generated from government funds from the date of its acquisition. The revenue recognized for the year ended December 31, 2019 was a result of the termination of the license agreements with Bausch Health Companies, Inc. and no further revenue will be recognized related to these agreements.
Research and development expenses were $3.566 million for the year ended December 31, 2020, compared to $5.389 million for the year ended December 31, 2019. The decrease of $1.823 million was due to lower OBG clinical activities following the completion of the PRK pivotal study in 2019, as well as a $0.500 million adjustment recorded in 2019 to the present value of the Jade earn-out payment due upon FDA approval of OBG. These decreases were partially offset by increases in OBG manufacturing and the expiration of a prepaid agreement in 2020 with a research vendor.
General and administrative expenses were $4.659 million for the year ended December 31, 2020, compared to $4.406 million for the year ended December 31, 2019. The increase of $0.253 million was mainly due to acquisition-related costs for Panoptes, partially offset by a decrease in personnel-related costs.
Other income, net was $0.133 million for the year ended December 31, 2020, compared to $0.108 million for the year ended December 31, 2019. The increase of $0.025 million was mainly due to a gain recognized on the dissolution of EyeGate Pharma S.A.S. in 2020, partially offset by less interest earned on the Company’s cash balances.
Income tax expense was $0.012 million for the year ended December 31, 2020, compared to $0.095 million for the year ended December 31, 2019. Both the 2020 and 2019 tax expense were a result of an increase in the state blended tax rate, which was applied to the deferred tax liability balance.
Cash and cash equivalents were $1.186 million as of December 31, 2020, compared to $3.777 million as of December 31, 2019. The decrease in cash and cash equivalents was primarily due to cash outflows to fund the Company’s operations and to acquire Panoptes, partially offset by cash received from a registered direct offering, loan funds under the Paycheck Protection Program, and warrant exercises.
EyeGate is a clinical-stage pharmaceutical company developing and commercializing products for treating inflammatory and immune diseases with a focus on the eye and nervous system. PP-001, EyeGate’s lead clinical-stage drug product, 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 designed to overcome the off-target side effects and safety issues associated with previous generation DHODH inhibitors. PP-001 has been developed in two clinical-stage ophthalmic formulations; PaniJect, an intravitreal injection for inflammatory diseases of the eye including posterior uveitis, and PaniDrop, a novel nano carrier technology eye drop for ocular surface diseases such as viral conjunctivitis and dry eye disease. Intravenous and oral formulations are also in development for conditions outside the ocular space. In addition, EyeGate is developing Ocular Bandage Gel (“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. OBG, 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. For more information, please visit www.EyeGatePharma.com.
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, the commercialization efforts and other regulatory or marketing approval efforts pertaining to EyeGate’s products, including EyeGate’s PP-001 and OBG products, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. 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, certain risk factors described under the heading “Risk Factors” contained in EyeGate’s Annual Report on Form 10-K filed with the SEC on March 25, 2021 or described in EyeGate’s other public filings. EyeGate’s results may also be affected by factors of which EyeGate is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. EyeGate 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.
Corey Davis, Ph.D.