アイポイントファーマの適時開示・決算・その他

米国証券取引委員会ワシントンD.C.20549

FORM 8-K

現行レポート

1934年米国証券取引所法第13条または第15条(d)に基づき

    報告日（最も古いイベントの報告日）：2024年1月10日

   

EyePoint Pharmaceuticals, Inc.

(チャーターで指定された登録者の正確な名前)


デラウェア	000-51122	26-2774444
(会社設立の州またはその他の管轄区域)	(Commission File Number)	(IRS EmployerIdentification No.)

480 Pleasant Street
Watertown, Massachusetts		02472
(主要経営陣の住所)		(Zip Code)

    登録者の電話番号（エリアコードを含む）。(617) 926-5000

   

(前回の報告書以降に変更があった場合、旧姓または旧住所)

Form8-Kの提出が、以下の条項のいずれかに基づく登録者の提出義務を同時に満たすことを意図している場合は、以下の該当するチェックボックスをチェックしてください：

☐証券法規則425（17 CFR 230.425）に基づく書面によるコミュニケーション

☐取引所法の規則14a-12（17 CFR 240.14a-12）に基づく資料の勧誘

☐取引所法の規則14d-2(b)(17 CFR 240.14d-2(b))に基づく開始前のコミュニケーション

☐取引所法の規則13e-4(c)(17 CFR 240.13e-4(c))に基づく開始前のコミュニケーション

法第12条(b)項に基づいて登録された証券:


Title of each class	TradingSymbol(s)	登録されている各取引所の名称
普通株式、額面0.001ドル	EYPT	The Nasdaq Global Market

登録者が1933年証券法規則405（本章§230.405）または1934年証券取引法規則12b-2（本章§240.12b-2）で定義される新興成長企業であるかどうかをチェックマークで示す。

Emerging growth company ☐

新興成長企業の場合、登録者が取引所法第13条(a)に従い提供される新規または改訂された財務会計基準に準拠するための移行期間の延長を利用しないことを選択した場合は、チェックマークで示す。☐

Item 2.02. 営業成績および財務状況

2024年1月10日、アイポイント・ファーマシューティカルズ・インク（以下「当社」）は、2023年12月31日現在の財務情報を含む最新の投資家向けプレゼンテーションをウェブサイト（www.eyepointpharma.com）に掲載した。同プレゼンテーションのコピーは別紙99.1として添付され、参照により本書に組み込まれる。

Item 8.01 Other Events

2024年1月10日、当社はプレスリリースを発表し、糖尿病黄斑浮腫（以下「DME」）治療薬EYP-1901の臨床試験第2相における最初の患者への投与を発表した。このプレスリリースのコピーは別紙99.2として添付され、参照により本書に組み込まれる。

本Current Report on Form 8-Kの項目2.02に記載された情報は、参照により本項目8.01に組み込まれる。

Item 9.01 財務諸表および添付資料

(d) Exhibits.


Exhibit No.		Description
99.1 99.2		2024年1月10日付アイポイント・ファーマシューティカルズ・インク投資家向けプレゼンテーション資料 2024年1月10日付アイポイント・ファーマシューティカルズ社プレスリリース
104		カバーページインタラクティブデータファイル（inline xbrlドキュメントに埋め込まれています。)

SIGNATURES

1934年証券取引法の要件に従い、登録者は本報告書に正式に権限を付与された署名者により、登録者を代表して署名させた。


			EYEPOINT PHARMACEUTICALS, INC.

Date:	January 10, 2024	By:	/s/ George O. Elston
			ジョージ・o・エルストン取締役副社長兼最高財務責任者

EX-99.1 2 eypt-ex99_1.htm EX-99.1

Legal Disclaimers ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Various statements made in this presentation are forward-looking, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect, plan or believe may occur in the future, including but not limited to statements about the sufficiency of our existing cash resources through topline data for the Phase 3 DAVIO 3 clinical trials; our expectations 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, non-proliferative diabetic retinopathy and diabetic macular edema; and our longer term financial and business goals and expectations, are forward-looking statements. Some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements are risks and uncertainties inherent in our business including, without limitation: the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; our ability to access needed capital; 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 guidelines, recommendations and studies; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; volatility of our stock price; possible dilution; absence of dividends; the impact of instability in general business and economic conditions, including changes in inflation, interest rates and the labor market; 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. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.

©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. IVT, intravitreal injection Pipeline represents multi billion-dollar opportunities using our bioerodible Durasert E™ IVT delivery technology EYP-1901 – vorolanib, a selective and patented TKI in Durasert E™ Positive topline Phase 2 data in wet AMD First Phase 3 trial in wet AMD planned to initiate in 2H 2024 Topline Phase 2 data in NPDR anticipated in Q2 2024 First patient dosed in Phase 2 trial in DME; topline data in DME anticipated in Q1 2025 EYP-2301 – razuprotafib, a patented TIE-2 agonist for serious retinal diseases in Durasert E™ Durasert® - proven, safe IVT drug delivery technology Bioerodible Durasert E™ and non-erodible formulations Safely administered to thousands of patient eyes across four FDA approved products with non-erodible formulations Strong Balance Sheet Over $330M of cash and investments on December 31, 2023 $230M equity financing completed December 5, 2023 Cash runway through topline data for Phase 3 wet AMD pivotal trials Committed to developing therapeutics to improve the lives of patients with serious retinal diseases

©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. wet AMD, wet age-related macular degeneration; EOP2, End of Phase 2; FPI, first patient in; NPDR, non-proliferative diabetic retinopathy; DME, diabetic macular edema; GA, geographic atrophy Durasert E™ Programs Indication Discovery Pre-Clin Phase 1 Phase 2 Phase 3 Next Milestone EYP-1901 – vorolanib in Durasert E™ (tyrosine kinase inhibitor) Wet AMD NPDR DME EYP-2301 – razuprotafib in Durasert E™ (TIE-2 agonist) serious retinal diseases Complement inhibition GA EOP2 Mtg with FDA, Phase 3 initiation in 2H 2024 Topline data in Q2 2024 Topline data in Q1 2025 Pre-clin tox and PK data in 2024 Potential product candidate in 2024 trial underway trial planned non-clinical single-dose, 6-month maintenance therapy 160 patients complete with positive Phase 2 topline data single-dose, 9-month treatment 77 patients single-dose, 6-month treatment Pipeline Represents Multibillion Dollar Product Opportunities

©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Safe, Sustained IVT Drug Delivery Delivered via a standard in-office IVT injection Continuous, stable release of drug Zero-order kinetics Durasert®: non-erodible Drug embedded within a bioerodible matrix covered with non-erodible polyimide shell: YUTIQ®1 ILUVIEN®1 RETISERT®2 VITRASERT®2 Durasert E™: bioerodible Insert consists of drug embedded within a bioerodible matrix Designed to deplete drug load before matrix fully erodes TECHNOLOGYDURASERT® 1- licensed to Alimera; 2 – licensed to Bausch and Lomb Durasert - Intravitreal Sustained-Release Drug Delivery

©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. SoC, standard of care; ANG, angiopoietin; PDGF(R), platelet-derived growth factor (receptor); PLGF, placental growth factor; TIE-2, tyrosine-protein kinase receptor TIE-2; VEGF(R), vascular endothelial growth factor (receptor). Potent and selective pan–VEGF receptor inhibition Composition of matter patent into 2037 (potential patent term extension to 2042) Demonstrated neuroprotection in a validated retinal detachment animal model Blocks PDGF which may lead to antifibrotic benefit Reduced off-target binding - does not inhibit TIE-2 at clinically relevant doses Vorolanib Brings a Potential New MOA to the Treatment of VEGF-Mediated Retinal Diseases by Blocking all Isoforms of VEFG and PDGF

©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Each insert ~1/5000 of vitreous volume Delivered in the physician office via standard intravitreal injection technique Immediately bioavailable featuring an initial burst of drug followed by zero order kinetics release for ~9 months Positive efficacy data in wet AMD from Phase 1 DAVIO and Phase 2 DAVIO 2 clinical trials Favorable safety data in ongoing Phase 2 clinical trials Shipped and stored at ambient temperature EYP-1901: Receptor Binding Vorolanib In Bioerodible Durasert E™ IVEGF – vascular endothelial growth factor: AMD – age related macular degeneration;

©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. The DAVIO 2 Clinical Trial A non-inferiority trial evaluating two doses of EYP-1901 against an aflibercept control in wet AMD The DAVIO 2 clinical trial was designed to evaluate EYP-1901 in wet AMD and support Phase 3 clinical trials based on a Type C meeting with FDA Design: Multi-center, randomized, double-masked trial in patients with previously treated wet AMD Anti-VEGF supplement criteria: 5 letter loss with 75 microns of new fluid Other criteria 10 letter loss due to wet AMD 100 microns new fluid x 2 visits New retinal hemorrhage from wet AMD Investigator discretion Primary outcome: difference in mean change in BCVA from Day 1 to Week 28 and 32 (blended) Key secondary endpoints: safety, reduction in treatment burden, percent of eyes supplement-free up to six months and anatomical results

DAVIO 2 Clinical Trial is Randomized, Double-Masked, Aflibercept Controlled* with a Single EYP-1901 Treatment at Two Doses ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. -D14 to -D7 D1 W4 W8 W12 W16 W24 W32 W36 to W56 W20 W28 EYP-1901 2mg low dose n=53 EYP-1901 3mg high dose n=54 Aflibercept 2mg q8W n=54 RANDOMIZATION REQUIRED AFLIBERCEPT INJECTION VISIT VISIT SCHEDULED EYP-1901 DOSE AFLIBERCEPT q8W EYP-1901/AFLIBERCEPT 1⁰ ENDPOINT BLEND W28 AND W32; UNMASK W32 SHAM INJECTION FOR MASKING *Aflibercept on-label control required by FDA

DAVIO 2 Patient Baseline Characteristics Well Balanced Across Arms ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Aflibercept 2mg q8W (n=54) EYP-1901 2mg (n=50) EYP-1901 3mg (n=52) Mean age, years (range) 75.9 (52-93) 76.4 (61-93) 75.4 (56-89) Female, % 53.7% 64.0% 67.3% Mean BCVA, ETDRS letters (range) 73.4 (41-85) 73.9 (52-84) 74.9 (46-85) Mean CST, μm (range) 265.7 (178-348) 267.0 (192-400) 262.9 (186-345) Median length of time for wet AMD diagnosis prior to screening, months (range) 28.1 (2.4-273.6) 24.2 (2.4-168.0) 28.1 (2.4-145.2) Mean # of injections normalized to 12 months prior to screening (range) 9.5 (2.0-12.0) 10.1 (2.0-13.0) 10.0 (2.0-13.3) PRELIMINARY DATA – PENDING FINAL ANALYSIS

EYP-1901 Phase 2 DAVIO 2 Clinical Trial Met All Objectives ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 1. As of November 7, 2023 data cut PRELIMINARY DATA – PENDING FINAL ANALYSIS Endpoint Achieved Endpoint? 2mg 3mg Primary: Non-inferior change in BCVA vs. aflibercept - 0.3 letters - 0.4 letters Secondary: Favorable safety profile1 No EYP-1901 related SAEs Secondary: Reduction in Treatment Burden vs. 6 mos prior 89% 85% Secondary: Reduction in Treatment Burden vs. aflibercept 83% 79% Secondary: Supplement-free up to 6 months 65% 88% of eyes had 0 or only 1 supplemental injections 64% 83% of eyes had 0 or only 1 supplemental injections Secondary: Anatomical control vs aflibercept +9.7um +5.2um

DAVIO 2 Achieved Primary Endpoint of Non-Inferiority Change in Visual Acuity in Both EYP-1901 Arms; Statistically and Numerically Non-Inferior to Control (95% CI) ©2023 EyePoint Pharmaceuticals, Inc. All Rights Reserved. EYP-1901 2mg EYP-1901 3mg Aflibercept 2mg q8W Change in BCVA* vs. Baseline + 1.0 letters + 0.9 letters + 1.3 letters Difference vs. Aflibercept Control - 0.3 letters - 0.4 letters NA Statistics NI (95% CI) NI (95% CI) NA *Blended week 28 and week 32 1 – AAO 2022 presentation, Paolo Lanzetta, on behalf of the PULSAR study investigators NI, Non-inferior; CI, Confidence Interval PRELIMINARY DATA – PENDING FINAL ANALYSIS Non-inferiority Margin = - 4.5 letters per FDA guidance In the Pulsar trial, HD Eylea (16-week 8mg arm) change in BCVA vs. 2mg Eylea was -1.4 letters1

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