EyePoint Pharmaceuticals Reports Third Quarter 2023 Financial Results and Highlights Recent Corporate Developments
– Positive masked safety data update for EYP-1901 in ongoing
– Leadership strengthened with the appointment of
– Topline data for Phase 2 DAVIO 2 trial anticipated in
– Management to host a conference call and webcast today at 8:30 a.m. ET –
“We continued advancing EYP-1901 through clinical development in the third quarter, announcing positive masked safety results for our lead product candidate EYP-1901 in the ongoing DAVIO 2 and
R&D Highlights and Updates
- Accepted to present at the upcoming
American Academy of Ophthalmology (AAO) Annual Meeting in November, including at AAO’s Eyecelerator pre-meeting tomorrow,November 2, 2023 . At Eyecelerator, the Company will be presenting interim masked safety data throughOctober 1, 2023 from its ongoing DAVIO 2 andPAVIA Phase 2 clinical trials. - At the AAO Annual Meeting, EyePoint will be presenting an encore presentation of preclinical data highlighting the potential neuroprotective effect of vorolanib, the active drug in EYP-1901, against photoreceptor degeneration in a validated rodent retinal detachment model.
- Presented subgroup analyses of the Phase 1 DAVIO trial of EYP-1901 demonstrating reduced treatment burden in wet AMD at the
EURETINA Congress and theRetina Society Annual Meeting in October. - Presented a comparison of the antiangiogenic profile of tyrosine kinase inhibitors vorolanib, axitinib, and sunitinib at the
Retina Society Annual Meeting in October demonstrating effective inhibition of receptors involved in pathological angiogenesis with vorolanib not having a physiological impact on TIE 2 function. - Announced EYP-2301, razuprotafib (a TIE-2 agonist) in Durasert E as a potential sustained delivery treatment for patients with serious retinal diseases.
- Presented interim masked safety and baseline patient demographics of the DAVIO 2 clinical trial in wet AMD at the OIS Retina Innovation Summit in July. In addition to positive safety data, an analysis of the reported patient demographics suggests that Phase 2 DAVIO 2 patients have, on average, better starting visual acuity and less central subfield thickness than the Phase 1 DAVIO cohort.
- Presented 12-month ocular pharmacokinetic results from a study evaluating EYP-1901’s drug delivery through the Durasert platform at the
American Society of Retina Specialists (ASRS) Annual Meeting in July. The Company also presented an encore subgroup analysis of the EYP-1901 final twelve-month Phase 1 DAVIO results, which showed that 67% of the DAVIO patients with no excess fluid at screening did not require a supplemental anti-VEGF injection up to the six-month visit. - Plans to initiate VERONA, a Phase 2 clinical trial evaluating EYP-1901 in diabetic macular edema (DME) in the first quarter of 2024 remain on track.
Recent Corporate Highlights
- Announced the promotion of
George Elston to Executive Vice President and the appointment ofStuart M. Duty to the Company’s Board of Directors inOctober 2023 . - Appointed
Jay S. Duker , M.D. as President and Chief Executive Officer and member of the Board of Directors as part of a CEO transition inJuly 2023 . Dr. Duker was previously Chief Operating Officer and President. Nancy S. Lurker transitioned to the role of Executive Vice Chair of the Board of Directors from the position of CEO. - Appointed
Marcia Sellos-Moura , Ph.D. as Senior Vice President, Program Leadership onJuly 31, 2023 .Dr. Sellos-Moura brings over 20 years of biopharmaceutical experience to the Company.
Review of Results for the Third Quarter Ended
For the third quarter ended
Net revenue from royalties and collaborations for the third quarter ended
Operating expenses for the third quarter ended
Cash and investments at
Financial Outlook
We expect the cash, cash equivalents and investments on
Conference Call Information
EyePoint will host a conference call today, at 8:30 a.m. ET to discuss the results for the third quarter ended
About
EYEPOINT 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 sufficiency of our existing cash resources into 2025; our plans and any other statements about future expectations, prospects, estimates and other matters that are dependent upon future events or developments, including statements containing the words “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, non-proliferative diabetic retinopathy and diabetic macular edema; our ability to realize the anticipated benefits of the 2023 sale of YUTIQ® to Alimera Sciences including our potential to receive additional payments from Alimera pursuant to the our agreements with Alimera; our ability to manufacture YUTIQ in sufficient quantities pursuant to our commercial supply agreements with Alimera and Ocumension Therapeutics; 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, including our agreements with Alimera, Ocumension,
Investors:
Stern IR
Direct: 212-698-8700
christina.tartaglia@sternir.com
Media Contact:
Direct: 412-327-9499
aphillips@greenroompr.com
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (Unaudited) | ||||||||
| (In thousands) | ||||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 133,035 | $ | 95,633 | ||||
| Marketable securities | 2,977 | 48,928 | ||||||
| Accounts and other receivables, net | 483 | 15,503 | ||||||
| Prepaid expenses and other current assets | 9,091 | 9,858 | ||||||
| Inventory | 4,577 | 2,886 | ||||||
| Total current assets | 150,163 | 172,808 | ||||||
| Operating lease right-of-use assets | 5,250 | 6,038 | ||||||
| Other assets | 4,630 | 1,510 | ||||||
| Total assets | $ | 160,043 | $ | 180,356 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 22,997 | $ | 22,278 | ||||
| Deferred revenue | 39,841 | 1,205 | ||||||
| Short-term borrowings | - | 10,475 | ||||||
| Other current liabilities | 1,058 | 579 | ||||||
| Total current liabilities | 63,896 | 34,537 | ||||||
| Long-term debt | - | 29,310 | ||||||
| Deferred revenue - noncurrent | 32,341 | 13,557 | ||||||
| Operating lease liabilities - noncurrent | 5,185 | 5,984 | ||||||
| Other long-term liabilities | - | 600 | ||||||
| Total liabilities | 101,422 | 83,988 | ||||||
| Stockholders' equity: | ||||||||
| Capital | 785,827 | 766,933 | ||||||
| Accumulated deficit | (728,047 | ) | (671,351 | ) | ||||
| Accumulated other comprehensive income | 841 | 786 | ||||||
| Total stockholders' equity | 58,621 | 96,368 | ||||||
| Total liabilities and stockholders' equity | $ | 160,043 | $ | 180,356 | ||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
| (Unaudited) | |||||||||||||||||
| (In thousands, except per share data) | |||||||||||||||||
| Three Months Ended |
Nine Months Ended |
||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||||
| Revenues: | |||||||||||||||||
| Product sales, net | $ | 816 | $ | 9,720 | $ | 13,483 | $ | 30,048 | |||||||||
| License and collaboration agreements | 14,137 | 52 | 17,768 | 160 | |||||||||||||
| Royalty income | 249 | 240 | 739 | 663 | |||||||||||||
| Total revenues | 15,202 | 10,012 | 31,990 | 30,871 | |||||||||||||
| Operating expenses: | |||||||||||||||||
| Cost of sales, excluding amortization of acquired intangible assets | 1,202 | 1,405 | 3,634 | 4,916 | |||||||||||||
| Research and development | 17,363 | 11,162 | 46,711 | 34,099 | |||||||||||||
| Sales and marketing | 479 | 6,016 | 11,504 | 19,592 | |||||||||||||
| General and administrative | 10,556 | 9,212 | 28,854 | 26,321 | |||||||||||||
| Amortization of acquired intangible assets | - | 615 | - | 1,845 | |||||||||||||
| Total operating expenses | 29,600 | 28,410 | 90,703 | 86,773 | |||||||||||||
| Loss from operations | (14,398 | ) | (18,398 | ) | (58,713 | ) | (55,902 | ) | |||||||||
| Other income (expense): | |||||||||||||||||
| Interest and other income, net | 1,786 | 640 | 4,611 | 1,067 | |||||||||||||
| Interest expense | - | (662 | ) | (1,247 | ) | (2,408 | ) | ||||||||||
| Loss on extinguishment of debt | - | - | (1,347 | ) | (1,559 | ) | |||||||||||
| Total other expense, net | 1,786 | (22 | ) | 2,017 | (2,900 | ) | |||||||||||
| Net loss | $ | (12,612 | ) | $ | (18,420 | ) | $ | (56,696 | ) | $ | (58,802 | ) | |||||
| Net loss per common share - basic and diluted | $ | (0.33 | ) | $ | (0.49 | ) | $ | (1.50 | ) | $ | (1.58 | ) | |||||
| Weighted average common shares outstanding - basic and diluted | 38,341 | 37,338 | 37,804 | 37,305 | |||||||||||||
Source: EyePoint Pharmaceuticals, Inc.
