Eyenovia(EYEN)
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Eyenovia Announces Pricing of $5M Registered Direct Offering
GlobeNewswire News Room· 2024-06-28 20:00
NEW YORK, June 28, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (“Eyenovia” or the “Company”) (NASDAQ: EYEN), a commercial-stage ophthalmic company, announced today that it has entered into a securities purchase agreement with an institutional investor and its current largest stockholder, providing for the purchase and sale of 7,575,757 shares of common stock, and warrants to purchase up to 7,575,757 shares of common stock (the "Offering"). The combined offering price for each share of common stock and accompany ...
All You Need to Know About Eyenovia (EYEN) Rating Upgrade to Buy
zacks.com· 2024-05-21 01:01
Eyenovia, Inc. (EYEN) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Since a changing earnings p ...
Eyenovia(EYEN) - 2024 Q1 - Earnings Call Transcript
2024-05-18 09:12
财务数据和关键指标变化 - 公司在2024年第一季度报告净亏损约1090万美元,每股亏损0.23美元,加权平均股数约4660万股 [71] - 2024年第一季度研发费用约440万美元,较2023年同期增加75.7% [72] - 2024年第一季度管理费用约380万美元,较2023年同期增加30.6% [73] - 2024年3月31日公司拥有约800万美元的无限制现金,不包括2024年4月额外筹集的220万美元资金 [74] 各条业务线数据和关键指标变化 - 公司正在推进MicroPine III期临床试验,计划在第四季度进行中期数据分析,有望大幅加快上市进程 [21][22] - 公司已获批上市的clobetasol产品,预计将在今夏正式商业化推广,有望在术后炎症和疼痛治疗领域占据重要地位 [25][26][27][28][32] - Mydcombi已进入商业化阶段,销售团队正在积极推广,已有50家医疗机构采用该产品 [40][41][42][43][44][45][46][47][48] 各个市场数据和关键指标变化 - 公司估计儿童渐进性近视市场在美国和中国每年价值约18亿美元,MicroPine有望成为该领域的潜在"爆款" [14][15][16][17] - 术后炎症和疼痛治疗市场在美国每年价值约13亿美元,clobetasol有望在该领域占据中单位市场份额 [32] - 干眼症市场在美国每年价值约36亿美元,公司正在开发联合Optejet的干眼症新疗法 [38] 公司战略和发展方向及行业竞争 - 公司正在推进Optejet第二代设备的开发和注册,预计明年底前可上市,将大幅降低产品成本 [86][87][88][89][90][91][92][93][94][95][96][97][98][99][100][101][102][103] - 公司正在探索通过合作开发等方式拓展产品管线,如与SGN Nanopharma合作开发干眼症新疗法 [35][36][37][38][39][109] - 公司正在积极参与行业内重要学术会议,提高产品知名度和推广力度 [53][54][55][56][57] 管理层对经营环境和未来前景的评论 - 管理层认为公司目前拥有两款FDA批准上市产品和一款潜在"爆款"MicroPine,加上Optejet技术平台,为未来业绩增长奠定了坚实基础 [10][11][12][13] - 管理层对MicroPine临床试验加快进程和clobetasol商业化前景表示乐观 [21][22][25][26][27][28][32] - 管理层认为Optejet第二代设备的上市将大幅提升产品毛利率,是实现公司盈利的关键 [111][112][113][114] 问答环节重要的提问和回答 问题1 **Matt Kaplan 提问** 询问Optejet第二代设备的开发进度和FDA沟通计划 [85][86][87][88][89][90] **Michael Rowe 回答** 公司需要证明第二代设备与第一代性能一致,并进行小规模临床试验,预计明年底前可完成注册 [86][87][88][89][90] 问题2 **Matthew Caufield 提问** 询问公司在老花眼领域的发展计划 [96][97][98][99][100] **Michael Rowe 回答** 公司目前不会大规模投入老花眼市场,而是等待其他公司先行开拓,待市场发展到一定规模后再考虑介入 [97][98][99][100] 问题3 **Kemp Dolliver 提问** 询问公司的现金流和融资计划 [104][105][106][107][108][109][110][111][112][113][114] **John Gandolfo 回答** 公司目前现金储备和预期收入足以支持运营,同时也在探索其他融资方式确保未来发展所需资金 [104][105][106][107][108][109][110][111][112][113][114]
Eyenovia(EYEN) - 2024 Q1 - Quarterly Results
2024-05-16 04:19
Exhibit 99.1 Eyenovia Reports First Quarter 2024 Financial Results and Provides Updates on its Myopia Phase III Program and its Two FDA Approved Commercial Products, Mydcombi and Clobetasol Remains on track towards accelerating development of its late-stage product candidate in the multi-billion-dollar pediatric progressive myopia market, MicroPine Preparing for a 3Q 2024 launch of the first new ophthalmic steroid in 15 years, clobetasol propionate ophthalmic suspension 0.05%, for the treatment of inflammat ...
Eyenovia(EYEN) - 2024 Q1 - Quarterly Report
2024-05-16 04:19
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER: 001-38365 EYENOVIA, INC. (Exact name of Registrant as Specified in Its Charter) DELAWARE 47-1178401 (State or Other Jurisdict ...
Eyenovia Reports First Quarter 2024 Financial Results and Provides Updates on its Myopia Phase III Program and its Two FDA Approved Commercial Products, Mydcombi and Clobetasol
Newsfilter· 2024-05-16 04:01
Remains on track towards accelerating development of its late-stage product candidate in the multi-billion-dollar pediatric progressive myopia market, MicroPine Preparing for a 3Q 2024 launch of the first new ophthalmic steroid in 15 years, clobetasol propionate ophthalmic suspension 0.05%, for the treatment of inflammation and pain following ocular surgery Company to host conference call and webcast today, May 15th, at 4:30 pm ET NEW YORK, May 15, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a co ...
Eyenovia to Report First Quarter 2024 Results on Wednesday, May 15th
Newsfilter· 2024-05-14 19:00
NEW YORK, May 14, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced that the Company will release financial results for the first quarter ended March 31, 2024 on Wednesday, May 15th, 2024, after the markets close. Following the release, Eyenovia management will host a conference call and webcast at 4:30 p.m. ET to review the financial and operating results. Participants should di ...
Eyenovia Provides Clinical and Scientific Update on FDA-Approved Products Mydcombi™ and Clobetasol Propionate Ophthalmic Suspension
Newsfilter· 2024-04-25 19:00
文章核心观点 - 公司宣布完成了一项针对Mydcombi的IV期临床试验,旨在确定最低有效剂量(每只眼睛8微升)的疗效和持续时间 [1][2][4][5] - 公司将在ARVO年会上介绍一项研究,展示Formosa Pharmaceuticals的APNT技术如何提高眼科药物的溶解度和生物利用度 [7][8][9] - 公司计划在今年夏季推出使用APNT技术的眼科糖皮质激素药物clobetasol,这将与Mydcombi形成互补 [8][9] 关于Mydcombi的临床试验 - 该试验旨在确定Mydcombi最低有效剂量(8微升)的瞳孔扩散疗效和持续时间 [2][4] - 结果显示: - 给药30分钟后,约67%的患者达到了临床意义上的瞳孔扩散 [5] - 60分钟后,这一比例增加到86% [5] - 大多数患者在给药3.5-6小时后瞳孔缩回到5毫米以下,93%的患者在6小时内达到此状态 [5] - 使用较低剂量8微升时,耐受性良好,不良事件较少 [5][6] 关于APNT技术的研究 - 公司将在ARVO年会上介绍一项研究,展示APNT技术如何提高眼科药物的溶解度和生物利用度 [7][8] - 公司在2023年8月从Formosa Pharmaceuticals获得了使用APNT技术的眼科糖皮质激素药物clobetasol的许可,该药物于2024年3月获FDA批准用于治疗术后炎症和疼痛 [8] - 公司计划在今年夏季推出clobetasol,作为Mydcombi的补充产品 [8][9] - 公司表示APNT技术有望应用于未来的眼科产品,并有望在价值超过13亿美元的眼科糖皮质激素市场取得成功 [9]
Eyenovia (EYEN) Down 18% on Disappointing Corporate Update
Zacks Investment Research· 2024-04-09 22:31
Eyenovia公司财务状况 - Eyenovia公司股票在上一交易日下跌了18%,因为宣布考虑一系列选项,包括公司或资产的潜在出售,合并或其他战略行动,以应对严重的现金短缺和市场推出的药物表现不佳[1] Eyenovia公司产品信息 - Eyenovia公司目前拥有两种获得FDA批准的产品,Mydcombi和clobetasol propionate,分别用于办公室瞳孔扩张和术后眼部炎症和疼痛[4] - Eyenovia公司计划在2024年夏季末推出其最新产品clobetasol propionate,用于术后疼痛和炎症管理[12]
Eyenovia Announces Updated Strategy and Corporate Priorities to Focus on Shareholder Value Generation and Immediate Commercial Opportunities
Newsfilter· 2024-04-08 19:00
Company focusing on multi-billion dollar opportunity in pediatric progressive myopia represented by MicroPine, with interim analysis planned for 4Q 2024 and a potential NDA to the FDA in 2025Continuing to advance commercialization of Mydcombi for mydriasis and preparing to launch clobetasol propionate ophthalmic suspension 0.05% for post-surgical management of pain and inflammation; both represent large multi-million-dollar opportunitiesCompany exploring wide range of strategic alternatives NEW YORK, April ...