WALTHAM, MA, March 4, 2020 – EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG) (“EyeGate” or “the Company”), a clinical-stage company focused on developing products for treating disorders of the eye, today announced financial results for the year ended December 31, 2019 and provided an update on recent corporate and operational activities.
Stephen From, Chief Executive Officer of EyeGate, said, “2019 was a positive year for EyeGate. We demonstrated superiority against standard-of-care in our pivotal wound healing study in patients who have undergone photorefractive keratectomy (“PRK”) surgery. In addition, we completed enrollment in our follow-on pilot study to treat patients with dry eye. There is a large market opportunity for treating patients with moderate dry eye, which was the patient population that we focused on for this study. We anticipate topline data in the first half of 2020.”
2019 and Recent Business Highlights:
– Received positive topline data in the corneal wound healing pivotal study in patients who have undergone PRK surgery. The results of this pivotal study demonstrated statistically significant improvement in corneal re-epithelialization in patients treated with EyeGate’s Ocular Bandage Gel (“OBG”) eye drop versus the standard-of-care, a bandage contact lens (“BCL”).
– Completed enrollment in the follow-on pilot study for punctate epitheliopathies (“PE”), with a focus on patients with moderate dry eye, where the OBG eye drop will be used to evaluate several different exploratory endpoints. Data for this study is expected in the first half of 2020, after which EyeGate plans to meet with the FDA to discuss the results and confirm the most ideal endpoint to move forward into the pivotal study.
– Completed a registered direct offering priced at-the-market under Nasdaq Rules of 500,000 shares of the Company’s common stock at a purchase price of $10.00 per share for aggregate gross proceeds of $5.0 million.
– Completed a private placement for gross proceeds of approximately $1.9 million with an affiliate of Armistice Capital.
– Received approximately $2.2 million from the exercise of warrants throughout the year.
2019 Financial Review:
EyeGate recognized revenue of $2.686 million for the year ended December 31, 2019, compared to $1.653 million for the year ended December 31, 2018. 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. (“BHC”) and no further revenue will be recognized related to these agreements. The revenue recognized for the year ended December 31, 2018 was related to milestone payments earned from BHC under the new standard for revenue recognition.
Research and development expenses were $5.389 million for the year ended December 31, 2019, compared to $8.056 million for the year ended December 31, 2018. The decrease of $2.666 million was due to lower clinical costs and other activity related to EGP-437, OBG pilot study costs from clinical work completed in 2018, and personnel related costs. These decreases were partially offset by costs for OBG‘s pivotal wound healing and follow-on pilot PE clinical studies.
General and administrative expenses were $4.406 million for the year ended December 31, 2019, compared to $4.441 million for the year ended December 31, 2018. The decrease of $0.036 million was mainly due to a decrease in professional fees, offset by an increase in personnel-related costs and other corporate expenses.
Other income, net was $0.108 million for the year ended December 31, 2019, compared to $0.119 million for the year ended December 31, 2018 representing interest earned on the Company’s cash balances.
Income tax expense was $0.095 million for the year ended December 31, 2019, compared to $0.086 million for the year ended December 31, 2018. The 2019 tax expense was a result of an increase in the state blended tax rate, which was applied to the deferred tax liability balance. The 2018 tax expense was a result of the 2017 partial release of valuation allowance against our previously recorded deferred tax assets as a result of the impact of legislation commonly known as the Tax Cuts and Jobs Act where future reversals of deductible temporary differences, such as those from our indefinite-lived in-process research and development, can offset taxable temporary differences from future net operating loss carryforwards due to their indefinite carryforward period under the new tax law.
Cash and cash equivalents were $3.777 million as of December 31, 2019, compared to $8.004 million as of December 31, 2018. The decrease in cash and cash equivalents was primarily due to cash outflows to fund the Company’s operations, partially offset by cash received from warrant exercises and the completion of a private placement.
EyeGate is a clinical-stage specialty pharmaceutical company focused on developing and commercializing products for treating diseases and disorders of the eye.
EyeGate’s lead product, Ocular Bandage Gel (“OBG”), is based on a modified form of the natural polymer hyaluronic acid, which is a gel that possesses unique properties providing hydration and healing when applied to the ocular surface. EyeGate is in the clinic for two different patient populations: photorefractive keratectomy (“PRK”) surgery to demonstrate corneal wound repair and punctate epitheliopathies (“PE”), which includes dry eye.
The objective of OBG is to re-epithelialize the cornea, reduce the risk of infection, improve symptoms, and improve ocular surface integrity. Often current treatments fall short as they are ineffective in protecting and enabling corneal re-epithelialization.
If EyeGate receives FDA approval following its successful completion of the PRK pivotal study, EyeGate believes OBG will be the only prescription hyaluronic acid eye drop in the U.S. and the only eye drop in the U.S. approved for the healing of corneal epithelial defects. Additionally, if the clinical trial for patients with PE is successful, EyeGate believes OBG will be the only eye drop in the U.S. approved for the treatment of PE.
For more information, please visit www.EyeGatePharma.com.
EyeGate Social Media
EyeGate uses its website (www.EyeGatePharma.com), Facebook page (https://www.facebook.com/ EyeGatePharma/), corporate Twitter account (https://twitter.com/EyeGatePharma), and LinkedIn page (https://www.linkedin.com/company/135892/) as channels of distribution of information about EyeGate and its product candidates. Such information may be deemed material information, and EyeGate may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor EyeGate’s website and its social media accounts in addition to following its press releases, SEC filings, public conference calls, and webcasts. The social media channels that EyeGate intends to use as a means of disclosing the information described above may be updated from time to time as listed on EyeGate’s investor relations website.
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 OBG product, its EGP-437 Combination Product, 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 1, 2019 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.