EyePoint Pharmaceuticals Reports First Quarter 2023 Financial Results and Highlights Recent Corporate Developments
– Completed enrollment in the oversubscribed Phase 2 DAVIO 2 clinical trial evaluating EYP-1901 in wet age-related macular degeneration (AMD); topline data anticipated in 4Q 2023
– Enrollment ahead of schedule in the Phase 2 PAVIA clinical trial evaluating EYP-1901 in non-proliferative diabetic retinopathy (NPDR); trial size reduced based on robust body of clinical evidence and proof-of-concept for vorolanib and EYP-1901
– YUTIQ net product revenue increased 60% to
– Management to host a conference call and webcast today at 8:30 a.m. ET
“In the first quarter, we continued to successfully execute on our key objectives across all areas of the business. Most importantly, we announced the completion of enrollment in our Phase 2 DAVIO 2 clinical trial evaluating EYP-1901 in wet AMD. We were particularly pleased by the high level of physician and patient interest, which resulted in the oversubscription of the trial to 160 patients compared to the original target of 144 patients. We look forward to announcing topline data from the DAVIO 2 trial in the fourth quarter of this year,” said
R&D Highlights and Updates
- EyePoint presented preclinical data on the neuroprotective effect of vorolanib, the active drug in EYP-1901, in a mouse model of retinal detachment at ARVO 2023. An encore presentation of the final twelve-month Phase 1 DAVIO results for EYP-1901was also presented.
- The Company announced completion of enrollment in the Phase 2 DAVIO 2 clinical trial evaluating EYP-1901 as a potential six-month maintenance treatment for wet AMD in
March 2023. The trial was oversubscribed and exceeded its original target of 144 patients, enrolling a total of 160 patients. All patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 or to an aflibercept on-label control. Topline data remain on track for the fourth quarter of 2023.
- The size of the Phase 2 PAVIA clinical trial evaluating EYP-1901 as a potential nine-month treatment for moderate to severe NPDR was modified based on the body of evidence and proof-of-concept (POC) data for vorolanib, with enrollment completion now anticipated in the second quarter of 2023. The body of evidence collected on EYP-1901 from both the clinical and non-clinical data to date, combined with vorolanib’s proven anti-VEGF pharmacological mechanism across VEGF-mediated retinal diseases, support a strong POC for EYP-1901 in NPDR. Accordingly, the Phase 2 PAVIA clinical trial size has been reduced to enroll a minimum of 60 patients, allowing for an accelerated path to Phase 2 data and the initiation of Phase 3 clinical trials.
- EyePoint and Rallybio announced a research collaboration to evaluate Rallybio’s complement inhibitor C5 (component 5) using EyePoint’s proprietary Durasert® technology for sustained intraocular drug delivery. The initial focus of the collaboration will be on developing a potential long-acting treatment for geographic atrophy, an advanced form of age-related macular degeneration that leads to irreversible vision loss.
- EyePoint was accepted to present an encore presentation of the Phase 1 DAVIO clinical trial twelve-month results at the
European Society of Ophthalmology (SOE) Congress2023 taking place June 15– 17th in Prague. This presentation marks the first time that EYP-1901 clinical trial results will be presented outside of the U.S.
- At the
American Society of Retina Specialists(ASRS) 41st Annual Meeting in July, Rishi Singh, MD, Staff Physician, Cleveland Clinic Florida and President of the Cleveland Clinic Martin Hospitals, will present pharmacokinetic results from a study evaluating EYP-1901’s drug delivery through the Durasert platform. The Company was also accepted to present clinical data at the ASRS Annual Meeting, including a subgroup analysis of the EYP-1901 final twelve-month Phase 1 DAVIO results and an update on the YUTIQ® CALM registry study. The CALM study is a Phase 4, multi-center registry study and a collaboration between EyePoint and the Cleveland Clinic.
- Plans to initiate a Phase 2 trial evaluating EYP-1901 in diabetic macular edema (DME) in the first quarter of 2024 remain on track.
Recent Corporate Highlights
- The Company entered into a lease agreement in January for the construction of a 40,000-square-foot standalone commercial manufacturing facility in
Northbridge, Massachusettsto support global product supply of EYP-1901 and YUTIQ. The Company was awarded $1.9 millionof state and local grants for the facility with lease payments not commencing until completion of construction, anticipated in the second half of 2024. Jay S. Duker, M.D., who served as the Company’s Chief Operating Officer (COO) since November 2021, was promoted to the additional role of President in January 2023. In addition to continuing to oversee his duties as COO, in his expanded role, Dr. Dukerwill also oversee regulatory affairs.
YUTIQ Commercial Performance in First Quarter 2023
Net product revenue for YUTIQ for the first quarter ended
Customer demand for YUTIQ in the first quarter of 2023 was approximately 930 units compared with 650 units in the first quarter of 2022, which represents a 43% increase.
Review of Results for the First Quarter Ended
For the first quarter ended
Net revenue from royalties and collaborations for the first quarter ended
Operating expenses for the first quarter ended
Cash and investments at
The Company expects the cash, cash equivalents and investments on hand at
Conference Call Information
EyePoint will host a conference call today, at 8:30 a.m. ET to discuss the results for the first quarter ended
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the use of proceeds for the offering and other 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. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this includes uncertainties regarding the timing and clinical development of our product candidates, including EYP-1901; the potential for EYP-1901 as a novel sustained delivery treatment for serious eye diseases, including wet age-related macular degeneration and non-proliferative diabetic retinopathy; the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the success of current and future license agreements; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; effects of competition and other developments affecting sales of our commercialized products, YUTIQ® and DEXYCU®; the loss of pass-through reimbursement status for DEXYCU at the end of 2022; market acceptance of our products; product liability; industry consolidation; compliance with environmental laws; risks and costs of international business operations; volatility of stock price; possible dilution; absence of dividends; the extent to which the COVID-19 pandemic impacts EyePoint's business, the medical community and the global economy; the impact of instability in general business and economic conditions, including changes in inflation, interest rates and the labor market; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; manufacturing risks; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share data)|
|Three Months Ended
|Product sales, net||$||7,394||$||9,010|
|License and collaboration agreements||34||59|
|Cost of sales, excluding amortization of acquired intangible assets||640||1,777|
|Research and development||13,618||9,945|
|Sales and marketing||5,737||6,693|
|General and administrative||9,242||8,548|
|Amortization of acquired intangible assets||-||615|
|Total operating expenses||29,237||27,578|
|Loss from operations||(21,554||)||(18,284||)|
|Other income (expense):|
|Interest and other income, net||1,202||61|
|Gain (loss) on extinguishment of debt||-||(1,559||)|
|Total other expense, net||390||(2,692||)|
|Net loss per common share - basic and diluted||$||(0.56||)||$||(0.56||)|
|Weighted average common shares outstanding - basic and diluted||37,486||37,253|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||105,765||$||95,633|
|Accounts and other receivables, net||10,422||15,503|
|Prepaid expenses and other current assets||9,081||9,858|
|Total current assets||146,057||172,808|
|Operating lease right-of-use assets||5,777||6,038|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||19,938||$||22,278|
|Other current liabilities||772||579|
|Total current liabilities||27,242||34,537|
|Deferred revenue - noncurrent||13,270||13,557|
|Operating lease liabilities - noncurrent||5,721||5,984|
|Other long-term liabilities||600||600|
|Accumulated other comprehensive income||843||786|
|Total stockholders' equity||78,390||96,368|
|Total liabilities and stockholders' equity||$||154,593||$||180,356|
Source: EyePoint Pharmaceuticals, Inc.