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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 19, 2026

VERADERMICS, INCORPORATED

(Exact name of registrant as specified in its charter)

Delaware

001-43097

84-3304423

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

470 James Street

New Haven, CT

06513

(Address of principal executive offices)

(Zip Code)

(Registrant’s telephone number, including area code): (228) 372-3376

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


o	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

Common Stock, par value $0.00001 per share

MANE

New York Stock Exchange

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company x

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Item 7.01. Regulation FD Disclosure.

On October 19, 2026, Veradermics, Incorporated (the “Company”) issued a press release announcing positive topline data from the Phase 3 clinical trial, Study ‘304’ evaluating VDPHL01 in males with mild-to-moderate pattern hair loss.

一份新闻稿副本作为本8-K表格当前报告的附录99.1提供，公司就“304”研究的初步数据在电话会议和网络直播中进行的演示作为本8-K表格当前报告的附录99.2提供，两者均在此引用。本8-K表格当前报告第7.01项中的信息以及根据本8-K表格当前报告第7.01项提供的附录99.1和99.2中的信息，不应被视为根据1934年《证券交易法》（以下简称“证券交易法”）第18条“提交”的信息，也不应受该条款的任何责任约束，也不应被视为在任何根据证券交易法或证券法提交的文件中被引用，无论该文件中是否包含任何一般性引用语言。

第8.01项其他事件.

2026年10月19日，公司宣布了“304”研究的积极初步数据，该研究评估了VDPHL01在轻度至中度斑秃男性患者中的疗效。‘304’研究是一项多中心、随机、安慰剂对照研究，评估536名受试者的临床疗效、安全性和耐受性，这些受试者被随机分配接受VDPHL01每日一次（“QD”）、VDPHL01每日两次（“BID”）或安慰剂。试验在所有主要和次要终点上均达到高度统计学显著性，显示出一种潜在的差异化临床特征，其特点是起效迅速、患者反应一致，以及毛发数量显著增加，同时总体耐受性良好，没有与治疗相关的严重不良事件（“SAEs”）或心脏起源的不良事件（“AESIs”）。

在研究中，VDPHL01在非绒毛目标区域毛发数量（“TAHC”）和患者报告结果（“PRO”）方面优于安慰剂（p<0.0001），在第6个月时，患者在雄激素性脱发影响评分量表（“AAIRS”）上报告了“改善”或“显著改善”。QD和BID VDPHL01治疗组的非绒毛TAHC平均增加量分别为28.6根/平方厘米（p<0.0001）和36.4根/平方厘米（p<0.0001）。接受安慰剂的患者在第6个月时平均增加了6.6根/平方厘米。

在VDPHL01治疗6个月后，QD剂量组78.8%的患者（p<0.0001）和BID剂量组85.0%的患者（p<0.0001）在AAIRS上报告了毛发覆盖的改善，而安慰剂组为35.3%。此外，QD剂量组55.7%的患者（p<0.0001）和BID剂量组68.7%的患者（p<0.0001）在AAIRS上达到了“改善”或“显著改善”的毛发覆盖，而安慰剂组为15.0%。

除了达到主要终点外，该研究还达到了所有次要终点。通过调查人员使用研究者整体评估（“IGA”）量表对调查人员进行评分，结果显示，在第6个月时，78.4%的QD组男性患者（p<0.0001）和82.7%的BID组男性患者（p<0.0001）的毛发覆盖有所改善（p<0.0001）。在试验中最早测量的时间点也观察到了毛发快速生长，TAHC、PRO和IGA在第2个月时就与安慰剂有统计学上的显著差异。

VDPHL01治疗在6个月内总体耐受性良好，总体安全性特征与公司针对VDPHL01在轻中度雄激素性脱发男性患者中进行的2/3期临床试验Part A的初步结果一致。研究中未观察到与治疗相关的严重不良事件（SAEs）或心脏起源的AESIs。唯一一个在活性药物和安慰剂组之间出现不平衡且发生率超过5%的TEAE是多毛症（每日一次给药组为2.2%，每日两次给药组为9.0%）。

前瞻性声明

本8-K格式的当前报告包含前瞻性声明，这些声明涉及风险、不确定性和或有事项，其中许多是Veradermics无法控制的，可能导致实际结果、表现或成就与预期结果、表现或成就有重大差异。本8-K格式当前报告中除历史事实陈述以外的所有陈述均为前瞻性声明。在某些情况下，可以通过诸如“可能”、“将”、“应该”、“预期”、“计划”、“预期”、“可能”、“打算”、“目标”、“项目”、“考虑”、“相信”、“估计”、“预测”、“潜在”或“继续”等术语，或这些术语的否定形式或其他类似表述来识别前瞻性声明，尽管并非所有前瞻性声明都包含这些词语。我们提醒您不要过分依赖这些前瞻性声明，包括关于VDPHL01的预期疗效；VDPHL01的临床特征，包括其安全性特征；VDPHL01的预期益处；以及对研究‘304’和其他临床试验的临床数据的解释和意义。这些前瞻性声明基于当前的估计和假设，并受各种风险和不确定性的影响，可能导致实际结果与前瞻性声明中预期的结果有重大差异，包括：Veradermics有限的经营历史，没有产品获得商业销售批准；自成立以来，Veradermics经历了重大亏损，预计在可预见的未来将继续发生重大且不断增加的亏损，并需要大量额外资金以实现其目标；Veradermics预计其成功将取决于VDPHL01（其主要产品候选物）的批准和成功商业化，如果Veradermics无法获得VDPHL01或其他当前或未来产品候选物的监管批准并成功商业化，或在此过程中遇到重大延误，其业务将受到重大损害；Veradermics产品候选物可能引起不良事件或不良副作用的风险；来自其他公司的竞争；以及在Veradermics截至2026年6月30日的季度报告10-Q的“风险因素”部分和其他向美国证券交易委员会提交的文件中识别的其他风险和不确定性。前瞻性声明中反映的事件和情况可能不会实现或发生，实际的未来结果、活动水平、表现和事件及情况可能与前瞻性声明中预测的有重大差异。由于前瞻性声明本质上受各种风险和不确定性的制约，其中一些风险和不确定性无法预测或量化，一些超出Veradermics的控制，因此这些前瞻性声明不应被视为对未来事件的保证。此外，Veradermics处于不断演变的环境中。可能会随时出现新的风险和不确定性，管理层无法预测所有风险和不确定性。这些前瞻性声明仅反映本8-K格式当前报告的日期，Veradermics没有义务根据新信息、未来事件或其他情况公开更新或修订任何前瞻性声明，除非适用法律要求。

项目 9.01 财务报表和附录。

(d) 附录


附录编号		描述

99.1		公司于 2026 年 10 月 19 日发布的新闻稿

99.2		2026 年 10 月 19 日的投资者介绍资料

104		封面页面交互式数据文件（嵌入在 Inline XBRL 文档中）

签名

根据 1934 年《证券交易法》的要求，注册人已 duly 促使本报告由在此 duly 授权的代理人签署。


	VERADERMICS, INCORPORATED

	由：	/s/ Reid Waldman, M.D.
		姓名：Reid Waldman, M.D.
		职位：首席执行官

日期：2026 年 10 月 19 日

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