UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 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: 001-40703 INVIVYD, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 85-14 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 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: 001-40703 INVIVYD, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 85-14 ...

财务数据和关键指标变化 - 2022年全年研发费用(包括在研费用)为1.836亿美元,较2021年同期的1.904亿美元有所下降,主要是由于adintrevimab临床试验的减少,部分被合同制造费用的增加(包括adintrevimab的商业供应和支持管线项目VYD-222)以及人员相关费用的增加所抵消 [31] - 2022年全年销售、一般及管理费用为4700万美元,较2021年同期的3650万美元有所增加,主要是由于人员相关费用、专业费用以及作为上市公司运营支持的成本增加 [32] - 2022年全年净亏损为2.413亿美元,较2021年同期的2.268亿美元有所增加,主要是由于2022年第四季度发生了1740万美元的一次性费用,与向Population Health Partners发行的认股权相关 [33] 各条业务线数据和关键指标变化 - 公司目前主要专注于开发针对SARS-CoV-2的单克隆抗体,尚未有其他业务线 [7][8][9][10] 各个市场数据和关键指标变化 - 2022年SARS-CoV-2单克隆抗体市场规模约为80亿美元,尽管未来可能会有所下降,但仍是一个巨大的未满足医疗需求 [46][47] - 公司认为,由于现有单克隆抗体产品只触及了部分易感人群,对于免疫抑制患者等脆弱人群来说,仍有大量未满足的需求 [48] 公司战略和发展方向及行业竞争 - 公司致力于持续开发针对SARS-CoV-2的新一代单克隆抗体,以应对病毒的快速进化 [7][8][9][10][15][25][26][27][28][29] - 公司拥有行业领先的抗体发现、工程和筛选能力,可以快速发现和优化针对新型冠状病毒变异株的广谱中和抗体 [25][26][27][28][29] - 公司正在开发针对流感的单克隆抗体,未来可能拓展到其他病毒性疾病 [52][53] 管理层对经营环境和未来前景的评论 - 公司认为,新冠疫情将持续存在,对人类健康造成巨大负担,现有预防和治疗手段非常有限,公司有独特优势持续开发新产品应对病毒进化 [7][8][9][10] - 公司认为,尽管普通人群感染后症状相对较轻,但长期后果仍未知,而免疫抑制患者等脆弱人群仍面临较高的重症风险和死亡率 [8][9] - 公司对VYD-222进入临床试验以及未来开发更多针对新冠的单克隆抗体表示乐观,认为这是一个巨大且持续的市场机会 [10][15] 问答环节重要的提问和回答 问题1 **Evan Wang 提问** 询问VYD-222临床试验的进展情况,包括试验设计、时间线等 [37][38][39][40][41][42][43] **Dave Hering 和 Pete Schmidt 回答** - 公司计划本季度开始VYD-222的I期临床试验,主要评估药代动力学和安全性 - 后续计划尽快启动III期关键性临床试验,具体设计还在与监管机构沟通中 - 由于VYD-222与之前临床试验成功的adintrevimab高度相似,可能会获得一些加速开发的优势 [39][40][41][42][43] 问题2 **Sidharth Mehta 提问** 1) 考虑到其他公司对单抗市场前景的担忧,公司如何看待未来市场机会 2) 公司是否已与FDA就使用相关性指标作为III期试验终点进行过讨论 [46][47][48][49] **Dave Hering 回答** - 公司认为,尽管整体市场可能会有所下降,但对于针对免疫抑制等脆弱人群的单抗仍有巨大未满足需求 - 公司正在与FDA等监管机构就使用相关性指标作为III期试验终点进行讨论,但尚未有最终确定 [46][47][48][49]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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 001-40703 INVIVYD, INC. (Exact name of Registrant as specified in its Charter) Delaware 85-1403134 (State or other jurisdiction of (I.R.S ...

TD Cowen 43rd Annual Health Care Conference March 6, 2023 FORWARD LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are forward-looking statements. Words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negativ ...

Invivyd, Inc. (NASDAQ:IVVD) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants Kyra Faircloth - VP, Government Affairs, Advocacy and Corporate Communication David Hering - CEO Laura Walker - Chief Scientific Officer Fred Driscoll - Interim Chief Financial Officer Conference Call Participants PJ Solit - Potomac Capital Management Dana Buska - Feltl Advisors Operator Welcome to the Invivyd Third Quarter 2022 Update Call. I will now turn the call over to Kyra Faircloth, Vice Pre ...

INVIVYD Corporate Presentation November 2022 Transcending the limitations of the immune system Forward Looking Statements This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are forward-looking statements. Words such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "estimate," "believe," "predict," "po ...

INVIVYD Investor Presentation September 2022 Transcending the limitations of the immune system Forward Looking Statements 2 This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are forward-looking statements. Words such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "estimate," "believe," "predict," " ...