abrooklyn
10月前
EyePoint Pharmaceuticals Reports Fourth Quarter and Full-Year 2023 Financial Results and Highlights Recent Corporate Developments
Source: GlobeNewswire Inc.
EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases, today announced financial results for the fourth quarter and year ended December 31, 2023, and highlighted recent corporate developments.
“2023 was an exceptional year of execution and results for EyePoint Pharmaceuticals. The highlights include positive data from our Phase 2 DAVIO 2 trial of EYP-1901 in wet AMD, the continued advancement of our ongoing Phase 2 trials in NPDR and DME and the strengthening of our balance sheet with a $230 million oversubscribed financing in December along with the sale of rights to YUTIQ® for $82.5 million plus future royalties last May,” said Jay Duker, M.D., President and Chief Executive Officer of EyePoint Pharmaceuticals. “The DAVIO 2 clinical trial for EYP-1901 achieved all primary and secondary endpoints, highlighting its potential to become a paradigm-altering maintenance treatment for patients with wet AMD. We look forward to discussing our Phase 3 plans with the U.S. Food and Drug Administration (FDA) at a planned end of Phase 2 meeting this April and initiating the first pivotal trial in the second half of this year.”
Dr. Duker continued, “We anticipate topline data for the Phase 2 PAVIA clinical trial of EYP-1901 in moderately severe-to-severe non-proliferative diabetic retinopathy (NPDR) in the second quarter of 2024. We are excited about the potential of EYP-1901 in NPDR, a chronic disease where over 90% of patients currently receive no course of treatment until they develop sight-threatening complications. 2024 promises to be another transformative year as we continue to advance EYP-1901 through clinical development across these three very significant indications.”
R&D Highlights and Updates
Announced positive topline efficacy and safety data from the Phase 2 DAVIO 2 clinical trial of EYP-1901 in wet AMD in December 2023. DAVIO 2 met all primary and secondary endpoints with both EYP-1901 doses demonstrating a statistically non-inferior change in best corrected visual acuity (BCVA) compared to aflibercept control and a favorable safety profile with no EYP-1901-related ocular or systemic serious adverse events (SAEs).
DAVIO 2 Phase 2 data and sub-group analyses which underscore the favorable clinical profile of EYP-1901, were presented at Angiogenesis, Exudation, and Degeneration 2024 Meeting and at the 47th Annual Meeting of the Macula Society in February 2024.
The Company plans to conduct an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in April 2024, with the initiation of the first Phase 3 pivotal trial in wet AMD expected in the second half of 2024.
Announced first patient dosed in the Phase 2 VERONA clinical trial of EYP-1901 for the treatment of diabetic macular edema (DME). Topline data are expected in the first quarter of 2025.
Accepted to present at the upcoming 2024 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in May. The Company will be presenting an encore presentation of the DAVIO 2 clinical trial results, the design and function of EYP-1901, plasma PK data of EYP-1901, and the mechanism of action (MOA) of vorolanib and differentiation from other anti-VEGF TKIs.
Recent Corporate Highlights
Announced the appointment of Ramiro Ribeiro, M.D., Ph.D. as Chief Medical Officer in March. Dr. Ribeiro joins EyePoint from Apellis Pharmaceuticals, where he served as Vice President, Head of Clinical Development.
Completed an upsized underwritten public offering with gross proceeds of $230.0 million in December. The Company sold 13,529,411 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,764,705 shares of common stock. The shares of common stock were sold at a public offering price of $17.00 per share.
Review of Results for the Fourth Quarter Ended December 31, 2023
For the quarter ended December 31, 2023, total net revenue was $14.0 million compared to $10.5 million for the quarter ended December 31, 2022. Net product revenue for the quarter ended December 31, 2023, was $0.7 million, compared to net product revenue for the quarter ended December 31, 2022, of $9.9 million. The decrease in net product revenue resulted from the strategic exit from our commercial business in 1H 2023.
Net revenue from royalties and collaborations for the quarter ended December 31, 2023, totaled $13.3 million compared to $0.7 million in the corresponding period in 2022. The increase was primarily due to partial recognition of deferred revenue from the license of the YUTIQ franchise, which beginning in 2Q 2023 will be recognized over a 2-year period in connection with the delivery of YUTIQ supply units.
Operating expenses for the quarter ended December 31, 2023, totaled $30.4 million compared to $54.3 million in the prior year period. This decrease was primarily driven by the strategic exit from our commercial business in 1H 2023 and a one-time intangible asset impairment charge in 4Q 2022.
Net non-operating income totaled $2.3 million and net loss was $14.1 million, or ($0.33) per share, compared to a net loss of $43.5 million, or ($1.16) per share, for the prior year period.
Review of Results for the Full Year Ended December 31, 2023
For the full year ended December 31, 2023, total net revenue was $46.0 million compared to $41.4 million for the year ended December 31, 2022. Net product revenue for the full year ended December 31, 2023, was $14.2 million, compared to net product revenues for the full year ended December 31, 2022, of $39.9 million. The decrease in net product revenue resulted from the Company’s strategic exit from its commercial business in 1H 2023.
Net revenue from royalties and collaborations for the full year ended December 31, 2023, totaled $31.8 million compared to $1.5 million in the corresponding period in 2022.
Operating expenses for the full year ended December 31, 2023, totaled $121.1 million versus $141.0 million in the prior year period. This decrease was primarily driven by the strategic exit from our commercial business in 1H 2023 and a one-time intangible asset impairment charge in 4Q 2022.
Net non-operating expense totaled $4.4 million and net loss was $70.8 million, or ($1.82) per share, compared to a net loss of $102.3 million, or ($2.74) per share, for the prior year period.
Cash, cash equivalents and investments in marketable securities on December 31, 2023, totaled $331.1 million compared to $144.6 million as of December 31, 2022.
Financial Outlook
We expect that our cash, cash equivalents, and investments on December 31, 2023, will enable us to fund operations through topline data for the planned Phase 3 clinical trials of EYP-1901 for wet AMD in 2026.
Conference Call Information
EyePoint will host a conference call today at 8:30 a.m. ET to discuss the results for the fourth quarter and year ended December 31, 2023 and recent corporate developments. To access the live conference call, please register at https://register.vevent.com/register/BI91be5d0e320646e887cf4047c70fe73c. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepointpharma.com. A webcast replay will also be available on the corporate website at the conclusion of the call.
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, EYP-1901, is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with Durasert E™. Pipeline programs include EYP-2301, a promising TIE-2 agonist, razuprotafib, f/k/a AKB-9778, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases. The proven Durasert® drug delivery technology has been safely administered to thousands of patient eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.
Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan.
EYEPOINT PHARMACEUTICALS 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 and EYP-2301; the potential for EYP-1901 as a novel sustained delivery treatment for serious eye diseases, including wet age-related macular degeneration (wet AMD) and non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME); the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals including potential U.S. Food and Drug Administration (FDA) regulatory approval of EYP-1901 and EYP-2301; the success of current and future license agreements; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; the success of Durasert® as a drug delivery platform in FDA approved 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 impact of general business and economic conditions; 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.
Investors:
Christina Tartaglia
Stern IR
Direct: 212-698-8700
christina.tartaglia@sternir.com
Media Contact:
Amy Phillips
Green Room Communications
Direct: 412-327-9499
aphillips@greenroompr.com
subslover
1年前
EyePoint Pharmaceuticals Announces Positive Topline Data from the Phase 2 DAVIO 2 Trial of EYP-1901 in Wet AMD Achieving All Primary and Secondary Endpoints
– Both EYP-1901 cohorts demonstrated a statistically non-inferior change in BCVA versus aflibercept control with a numerical difference of only -0.3 and -0.4 letters, respectively for the 2 mg and 3 mg dose at blended six-month endpoint –
– Positive safety profile continues with no EYP-1901-related ocular or systemic SAEs –
– Key secondary endpoints were achieved with both EYP-1901 doses. These include an over 80% reduction in treatment burden, with nearly two-thirds of eyes supplement-free up to six-months –
– Strong anatomical control in both EYP-1901 cohorts documented by optical coherence tomography (OCT) –
– Conference call to discuss the results to be held today, December 4, 2023 at 8:00 a.m. ET –
WATERTOWN, Mass., Dec. 04, 2023 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases, today announced positive topline results of its Phase 2 DAVIO 2 trial of EYP-1901, an investigational sustained delivery maintenance treatment for wet age-related macular degeneration (wet AMD) combining vorolanib, a selective tyrosine kinase inhibitor with bioerodible Durasert E™. The clinical trial met its primary endpoint with both EYP-1901 doses demonstrating statistical non-inferiority change in best corrected visual acuity (BCVA) compared to aflibercept control and a favorable safety profile with no EYP-1901-related ocular or systemic serious adverse events (SAEs). The trial also achieved key secondary endpoints with both EYP-1901 doses, including an over 80% reduction in treatment burden, nearly two-thirds of eyes supplement-free up to six months and over 80% receiving only zero or one supplement up to six-months. Additionally, there was strong anatomical control with both EYP-1901 cohorts as measured by optical coherence tomography (OCT).
“We are incredibly pleased by these highly positive Phase 2 results which underscore EYP-1901’s potential as a paradigm-altering maintenance treatment for patients with wet AMD, with a positive safety profile. Since EYP-1901 achieved statistical non-inferiority to the aflibercept control in this trial there is potential for meaningfully lower sized and lower cost pivotal Phase 3 trials,” said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint Pharmaceuticals. “I would like to thank the patients and the investigators who participated in the DAVIO 2 trial as well as our employees who helped advance us to this important milestone.”
Dr. Duker continued, “the DAVIO 2 clinical trial was designed to support the initiation of Phase 3 clinical trials based on feedback received from the U.S. Food and Drug Administration (FDA) at a Type C meeting last year. The 32-week topline DAVIO 2 data strongly supports our planned Phase 3 non-inferiority design, consistent with the FDA’s recent guidance for wet AMD clinical trials. We look forward to continuing our dialogue regarding our Phase 3 plans with the FDA as we prepare to initiate our first pivotal trial for wet AMD in the second half of 2024.”
“These highly positive Phase 2 results are the result of years of hard work by the dedicated EyePoint team coupled with our proven Durasert technology which continues to demonstrate the benefit of zero order kinetics drug delivery. I look forward to initiation of Phase 3 and potentially bringing this innovative and much needed new drug to market for patients suffering from these blinding eye diseases,” said Nancy Lurker, Executive Vice Chair of EyePoint Pharmaceuticals. “I want to congratulate the EyePoint team on the continued execution of this program.”
DAVIO 2 topline interim results include:
Both EYP-1901 doses (2mg and 3mg) achieved all primary and secondary endpoints.
Statistical non-inferiority in change in BCVA (at a confidence interval of 95%) compared to aflibercept control, at weeks 28 and weeks 32 combined. The 2mg and 3mg doses were only -0.3 and -0.4 letters different, respectively, versus on-label aflibercept. The lower limit of the non-inferiority margin is defined as a -4.5 letters by the FDA with 5 letters representing one line on the eye chart.
Continued positive safety and tolerability profile with no EYP-1901-related ocular or systemic SAEs.
89% and 85% reduction in treatment burden, respectively, for the 2mg and 3mg EYP-1901 doses.
65% and 64% of eyes were supplement free up to six-months, respectively, for the 2mg and 3mg doses of EYP-1901.
Both EYP-1901 doses demonstrated strong anatomic control with OCT difference below 10 microns at week 32 compared to the aflibercept control.
Patient discontinuation up to week 32 was low at 4%.
“Wet AMD is a prevalent and progressive lifetime disease. With frequent treatment, patients can maintain their visual acuity, but the unfortunate reality is that many patients end up undertreated due to the burden of dosing of the currently available, short-acting anti-VEGF therapies,” said Carl Regillo, M.D., Chief of Retina Service at Wills Eye Hospital. “I am very encouraged by the data generated from both the Phase 1 DAVIO and Phase 2 DAVIO 2 trials with the latter showing essentially no difference in visual outcome at the blended six-month endpoint from a single injection of EYP-1901 compared to on-label, bimonthly aflibercept injections. Based on the meaningful reduction in treatment burden and supplement-free rates observed, along with the consistently favorable safety profile, I believe that EYP-1901 could be a paradigm shift in how patients with wet AMD are treated.”
DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in previously treated patients with wet AMD. Originally designed to enroll 144 patients, the trial enrolled 160 patients in total due to strong investigator and patient interest. All enrolled patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary non-inferiority efficacy endpoint is change in BCVA compared to the aflibercept control, approximately six-months after the EYP-1901 injection. Secondary endpoints include safety, change in CST as measured by OCT, the number of eyes that remain free of supplemental anti-VEGF injections, and number of aflibercept injections in each group. More information about the trial is available at clinicaltrials.gov (identifier: NCT05381948).
EyePoint plans to present the DAVIO 2 dataset at Angiogenesis, Exudation, and Degeneration 2024 in February.
The Company remains on track to reach additional clinical milestones with EYP-1901 with the initiation of the Phase 2 VERONA trial in diabetic macular edema (DME) anticipated in the first quarter of 2024 and the readout of topline data from the Phase 2 PAVIA trial in non-proliferative diabetic retinopathy (NPDR) anticipated in the second quarter of 2024.
Conference Call and Webcast Information
EyePoint will host a conference call today, December 4, 2023 at 8:00 a.m. ET to discuss the results. To access the live conference call, please register at https://register.vevent.com/register/BI4c4d93355a394ea284131d7b537fd513. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepointpharma.com. A webcast replay will also be available on the corporate website at the conclusion of the call.
About Wet AMD
Age-related Macular Degeneration (AMD) is a leading cause of irreversible blindness or vision loss in people over the age of 60. Wet AMD is an advanced form of the condition that develops when abnormal blood vessels grow into the macula, leaking blood or fluid that leads to scarring of the macula and potentially rapid and severe vision loss. Wet AMD is a lifelong disease that requires continuous treatment so that patients may maintain visual function. Although multiple treatments are now available, challenges still exist as the current standard-of-care is dosed on average every two months in the United States under a treat-and-extend protocol, and these large molecule anti-VEGF treatments only target one pathology of the disease. This lifetime of frequent treatment represents a tremendous burden for patients, physicians, and the health care system, potentially leading to patient noncompliance and further vision loss.
About EYP-1901
EYP-1901 is being developed as a potential paradigm-altering treatment for patients suffering from VEGF-mediated retinal diseases. EYP-1901 delivers vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) formulated in a solid bioerodible insert using EyePoint’s proprietary sustained-release Durasert E™ technology. Vorolanib brings a new mechanistic approach to the treatment of VEGF-mediated retinal diseases as a pan-VEGF receptor blocker, blocking all VEGF isoforms. Vorolanib features reduced off-target binding and at clinically relevant doses does not inhibit Tie-2, a critical pathway associated with vascular stability, which may result in an improved efficacy. Further, in an in-vivo model of retinal detachment, vorolanib demonstrated neuroprotection, and potential antifibrotic benefits. EYP-1901 is shipped and stored at ambient temperature and is administered with a single intravitreal injection in the physician's office. EYP-1901 is immediately bioavailable, featuring an initial burst of drug, followed by near constant zero-order kinetic release for approximately nine months.
Positive data from both the Phase 1 DAVIO and Phase 2 DAVIO 2 clinical trials of EYP-1901 in wet AMD demonstrated clinically meaningful efficacy data with stable visual acuity and OCT, and a favorable safety profile. Further, the recent DAVIO 2 data demonstrated an impressive treatment burden reduction of over 85% at six months, and over 80% of patients remained supplement-free or only received one supplemental anti-VEGF injection up to 6 months. The data from the DAVIO 2 clinical trial supports the advancement of the wet AMD program to Phase 3 pivotal trials which are anticipated to initiate in the second half of 2024.
EYP-1901 is also being studied in non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME). The Phase 2 PAVIA trial in NPDR is fully enrolled with topline data anticipated in the second quarter of 2024. The Phase 2 VERONA trial in DME is planned to initiate in the first quarter of 2024.
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals (Nasdaq: EYPT) is a clinical-stage company committed to developing and commercializing therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The company’s lead product candidate, EYP-1901, is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI) with Durasert E™. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases. Additional pipeline programs include EYP-2301, a promising Tie-2 activator, razuprotafib, f/k/a AKB-9778, formulated in Durasert E™ to potentially improve outcomes in wet AMD and diabetic eye disease. The proven Durasert® drug delivery platform has been safely administered to over thousands of patient eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. For more information visit www.eyepointpharma.com.
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 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 and EYP-2301; the potential for EYP-1901 as a novel sustained delivery treatment for serious eye diseases, including wet age-related macular degeneration (wet AMD) and non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME); the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals including potential U.S. Food and Drug Administration (FDA) regulatory approval of EYP-1901 and EYP-2
abrooklyn
1年前
EyePoint Pharmaceuticals Reports Third Quarter 2023 Financial Results and Highlights Recent Corporate Developments
Source: GlobeNewswire Inc.
EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with retinal diseases, today announced financial results for the third quarter ended September 30, 2023, and highlighted recent corporate developments.
“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 PAVIA Phase 2 clinical trials,” said Jay Duker, M.D., President and Chief Executive Officer of EyePoint Pharmaceuticals. “We remain on-track to report topline data for the DAVIO 2 trial in wet AMD in December 2023 and the PAVIA trial in non-proliferative diabetic retinopathy in the second quarter of 2024. We also plan to initiate the Phase 2 VERONA trial of EYP-1901 in diabetic macular edema in the first quarter of 2024.”
Dr. Duker continued, “It is an exciting time for EyePoint as we are well-positioned to execute on key near-term milestones and drive value for shareholders. We remain laser focused on our mission of making a difference in the lives of patients suffering from retinal diseases.”
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 through October 1, 2023 from its ongoing DAVIO 2 and PAVIA 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 the Retina 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 of Stuart M. Duty to the Company’s Board of Directors in October 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 in July 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 on July 31, 2023. Dr. Sellos-Moura brings over 20 years of biopharmaceutical experience to the Company.
Review of Results for the Third Quarter Ended September 30, 2023
For the third quarter ended September 30, 2023, total net revenue was $15.2 million compared to $10.0 million for the quarter ended September 30, 2022. Net product revenue for the third quarter was $0.8 million, compared to net product revenues for the third quarter ended September 30, 2022 of $9.7 million. The decrease in net product revenue resulted from sale of the YUTIQ franchise in May 2023 and the discontinuation of DEXYCU commercialization activities in 2023.
Net revenue from royalties and collaborations for the third quarter ended September 30, 2023 totaled $14.4 million compared to $0.3 million in the corresponding period in 2022. The increase was primarily due to partial recognition of deferred revenue from the sale of the YUTIQ franchise which will be recognized over a 2-year period in connection with the delivery of YUTIQ supply units.
Operating expenses for the third quarter ended September 30, 2023 totaled $29.6 million versus $28.4 million in the prior year period. This increase was primarily driven by R&D spending on the ongoing EYP-1901 clinical trials, partially offset by reduced sales and marketing expense. Non-operating expense, net, totaled $1.8 million and net loss was $12.6 million, or ($0.33) per share, compared to a net loss of $18.4 million, or ($.49) per share, for the prior year period.
Cash and investments at September 30, 2023 totaled $136.0 million compared to $144.6 million at December 31, 2022.
Financial Outlook
We expect the cash, cash equivalents and investments on September 30, 2023 will enable us to fund our current and planned operations into 2025.
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 September 30, 2023 and recent corporate developments. To access the live conference call, please register at https://register.vevent.com/register/BI3b701846a11841ad855aab9d0b8aff10. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepointpharma.com. A webcast replay will also be available on the corporate website at the conclusion of the call.
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals (Nasdaq: EYPT) is a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary erodible Durasert E™ technology for sustained intraocular drug delivery including EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment currently in Phase 2 clinical trials. The proven Durasert® drug delivery platform has been safely administered to over 80,000 patient eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. For more information visit www.eyepointpharma.com.
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, Equinox Science and Betta Pharmaceuticals; termination or breach 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; market acceptance of our products, including our out-licensed products; product liability; industry consolidation; compliance with environmental laws; risks and costs of international business operations; volatility of stock price; possible dilution; the impact of instability in general business and economic conditions, including changes in inflation, interest rates and the labor market; the extent to which COVID-19 impacts our business and the medical community; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; manufacturing risks; the sufficiency of the Company’s cash resources and need for additional financing; 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.
Investors:
Christina Tartaglia
Stern IR
Direct: 212-698-8700
christina.tartaglia@sternir.com
Media Contact:
Amy Phillips
Green Room Communications
Direct: 412-327-9499
aphillips@greenroompr.com
EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands)
September 30, December 31,
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
EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share data)
Three Months Ended
September 30, Nine Months Ended
September 30,
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
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conix
3年前
EyePoint Pharma announces positive 12-month safety and efficacy data from phase 1 DAVIO trial of EYP-1901 to treat wet AMD
Watertown, Massachusetts
Monday, July 18, 2022, 14:00 Hrs [IST]
EyePoint Pharmaceuticals, Inc announced 12-month data from the phase 1 "Durasert and Vorolanib in Ophthalmology" (DAVIO) clinical trial evaluating EYP-1901, a sustained delivery anti-vascular endothelial growth factor (anti-VEGF) therapy targeting wet age-related macular degeneration (wet AMD) as a potential every six-month treatment. These data are being presented at the American Society of Retina Specialists (ASRS) 2022 Annual Meeting by Rishi Singh, M.D., Staff physician, Cleveland Clinic Florida, president – Cleveland Clinic Martin Hospitals.
"The final 12-month results from the DAVIO clinical trial highlight EYP-1901's continued positive safety and efficacy profile with promising durability as a potential every six-month maintenance therapy for previously treated wet AMD," said Rishi Singh, M.D., a member of EyePoint's Scientific Advisory Board. "We are grateful to the patients, investigators and site staff who participated in the phase 1 DAVIO trial."
"We are extremely pleased with the excellent safety and efficacy results from our phase 1 DAVIO trial. There remains a significant opportunity for a safe and effective sustained delivery maintenance treatment in wet AMD, and the DAVIO trial demonstrates that EYP-1901 has the potential to maintain a majority of patients for up to six months with no supplemental anti-VEGF therapy," said Nancy Lurker, chief executive officer of EyePoint Pharmaceuticals. "We look forward to beginning to dose patients in the Phase 2 DAVIO2 clinical trial for EYP-1901 in wet AMD and anticipate top line data in the second half of 2023."
The final twelve-month data presented from the phase 1 DAVIO clinical trial showed no reports of ocular SAEs or drug-related systemic SAEs. There were no reported events of vitreous floaters, endophthalmitis, retinal detachment, implant migration in the anterior chamber, retinal vasculitis, posterior segment inflammation, or retinal vascular occlusive events. Additionally, updated data from the twelve-month follow-up confirm stable best corrected visual acuity (BCVA) (-4.12 ETDRS letters), stable central subfield thickness (CST) on optical coherence tomography (OCT) (-2.76 µm), and an expected late increase in supplemental anti-VEGF therapy given the insert's expected drug depletion, with 35% of eyes supplement free up to twelve months versus 53% supplement free up to six months. Additionally, there continued to be positive treatment burden reduction of 74% at twelve months versus 79% at six-months.
EyePoint anticipates that the first patient in the twelve-month, randomized, controlled phase 2 clinical trial (DAVIO2) of EYP-1901 for wet AMD will be dosed in Q3 2022. The trial is expected to enroll approximately 150 wet AMD patients previously treated with a standard-of-care anti-VEGF therapy and randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) versus an on-label aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the DAVIO2 trial is non-inferiority to the aflibercept control, as measured by change in BCVA six-months after the EYP-1901 injection. Secondary efficacy endpoints include change in CST as measured by OCT, time to first supplemental anti-VEGF, and safety. More information about the study is available at clinicaltrials.gov (identifier: NCT05381948).
EYP-1901 is being developed as an investigational sustained delivery treatment, initially in wet age-related macular degeneration (wet AMD) combining a bioerodible formulation of EyePoint's proprietary Durasert delivery technology with vorolanib, a tyrosine kinase inhibitor. Positive twelve-month safety and efficacy data from the phase 1 DAVIO clinical trial of EYP-1901 showed no reports of ocular or drug-related systemic serious adverse events and no dose limiting toxicities with stable visual acuity and OCT. Further, 53% of eyes did not require supplemental anti-VEGF injections up to six months following a single dose of EYP-1901. A phase 2 trial for wet AMD (DAVIO2) is expected in Q3 2022 and phase 2 studies are planned for non-proliferative diabetic retinopathy and diabetic macular edema in 2H 2022 and 2023, respectively. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases.
Age-related macular degeneration (AMD) impacts as many as 11 million Americans. About 15% of those affected have neovascular or wet AMD - the hallmark of which is fluid and bleeding in the center of the retina, which may lead to irreversible vision loss. The majority of patients with wet AMD require intravitreal injections every month or two to control the disease. This intense treatment regimen represents an ongoing challenge for patients, caregivers, and physicians.
EyePoint Pharmaceuticals is a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders.
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