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As filed with the Securities and Exchange Commission\non October 19, 2026

Registration No. 333-299332

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Pre-Effective Amendment No. 2

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

ACTUATE THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

\n \n \n \n \n \n \n \n \n \n \n \n \n

Delaware

8731

47-3044785

(State or other jurisdiction of
\nincorporation or organization)

(Primary Standard Industrial

Classification Code)

(I.R.S. Employer
\nIdentification No.)

1751 River Run, Suite 400
\nFort Worth, Texas 76107
\n(817) 887-8455

(Address, including zip code, and telephone number,\nincluding area code, of registrant’s principal executive offices)

Daniel Schmitt
\nPresident and Chief Executive Officer
\n1751 River Run, Suite 400
\nFort Worth, Texas 76107
\n(817) 887-8455

(Name, address, including zip code, and telephone number,\nincluding area code, of agent for service)

Copies to:

\n \n \n \n

\n \n

Daniel K. Donahue, Esq.

Marilyn Kim, Esq.

Greenberg Traurig, LLP

18565 Jamboree Road, Suite 500

Irvine, California 92612

(949) 732-6557

Joseph M. Lucosky, Esq.

Lawrence Metelitsa, Esq.
\n Patrick J. Egan, Esq.

Lucosky Brookman LLP

101 Wood Avenue South, 5th Floor

Woodbridge, New Jersey 08830

(732) 395-4400

Approximate date of\ncommencement of proposed sale to the public: As soon as practicable after this Registration Statement becomes effective.

If any of the securities being\nregistered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933,\ncheck the following box. ý

If this Form is filed to\nregister additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list\nthe Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective\namendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement\nnumber of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective\namendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement\nnumber of the earlier effective registration statement for the same offering. ☐

Indicate by check mark\nwhether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an\nemerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller\nreporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

\n \n \n \n \n \n \n \n \n \n

Large accelerated filer ☐	Accelerated filer ☐
Non-accelerated filer ý	Smaller reporting company ý
	Emerging growth company\n ý

如果是一家新兴成长公司，如果发行人选择不使用根据《证券法》第7(a)(2)(B)条提供的任何新修订的财务会计标准的延长过渡期，请用复选标记表示。☐

发行人在此声明，将在必要时在某一日期或某些日期对本注册声明进行修订，以延迟其生效日期，直至发行人提交进一步修订文件，该文件明确表示本注册声明将在根据《1933年证券法》第8(a)条的规定生效，或直至证券交易委员会根据该第8(a)条的规定确定本注册声明在某一日生效。

本初步招股说明书中的信息不完整，可能会被更改。在向证券交易委员会提交的注册声明生效之前，我们不得出售这些证券。本初步招股说明书不是出售这些证券的要约，也不是在任何允许要约或出售的司法管辖区 soliciting 买入这些证券的要约。

\n \n \n \n \n

初步招股说明书

待完成

日期\n 2026年10月19日

$\"\"$

40,000,000股普通股

购买20,000,000股普通股的认股权证

购买认股权证所涵盖的20,000,000股普通股

购买40,000,000股普通股的预先认股权证

预先认股权证所涵盖的40,000,000股普通股

我们正在出售40,000,000股普通股和20,000,000张认股权证（每张称为“购买认股权证”），每张购买权证允许持有人以每股$的价格购买一股我们的普通股。每两股普通股将与一张配套的购买认股权证一起以假设的合并发行价格$1.00出售，该价格是我们在2026年10月15日纳斯达克全球市场报告的最后交易价格的两倍。在定价时，我们与承销商之间将确定每两股普通股和配套购买认股权证的实际合并公开发行价格，可能会低于此假设发行价格。因此，本招股说明书中使用的假设合并公开发行价格可能不反映最终的合并发行价格。

我们的普通股和配套的购买认股权证可以立即分离并分别发行，但只能在此发行中一起购买。购买认股权证可以立即行使，自发行之日起五年到期，每股行权价为$。该发行还包括在任何时候根据购买认股权证行使时发行的普通股。购买认股权证将根据我们与Broadridge Corporate Issuer Solutions, LLC（“认股权证代理机构”）之间的认股权证代理协议以簿记形式发行。

我们还为每位购买者提供机会，如果其在本次发行中购买我们普通股股票会导致购买者及其关联方和某些关联方在本次发行完成后立即直接或间接持有我们发行在外的普通股超过4.99%（或由持有者选择的9.99%），则购买者可以选择购买40,000,000股普通股的预先出资认股权证（每项称为“预先出资认股权证”），而不是普通股股票。每项预先出资认股权证可行使一次，以购买我们的一股普通股股票。每项预先出资认股权证的购买价格将等于本次发行中向公众出售的普通股股票的每股价格减去0.0001美元，每项预先出资认股权证的行权价格为每股0.0001美元。预先出资认股权证将根据我们与认股权证代理机构之间的认股权证代理协议以证书形式发行，而不是以账面记录形式发行。

我们的普通股在纳斯达克全球市场上市，股票代码为“ACTU”。2026年10月15日，我们在纳斯达克全球市场的最后一笔销售价格为每股0.50美元。我们无意将购买认股权证或预先出资认股权证在任何全国性证券交易所上市。

投资我们的证券涉及高度风险。在做出投资决定之前，您应仔细审查并考虑本招股说明书和此处引用文件中列出的所有信息，包括本招股说明书第5页开始的“风险因素”中描述的风险和不确定性以及本招股说明书引用的风险因素。

美国证券交易委员会或任何州证券委员会均未批准或否决这些证券，也未确定本招股说明书是否真实或完整。与此相反的任何陈述均属刑事犯罪。

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

价格
\n 每两
股和
配套
认股权证

价格\n 每
\n 预先出资
\n 认股权证

总计

公开发行价格

承销折扣和佣金⁽¹⁾

我们收到的净收益（扣除费用前）

\n \n \n \n \n

⁽¹⁾	不包括我们同意支付的承销商某些费用的报销。请参见“承销”从第20页开始，了解有关承销商将收到的总报酬的更多信息。

我们已授予承销商45天的期权，以公开发行价格减去承销折扣和佣金的方式，从我们处购买最多6,000,000股普通股和3,000,000份购买认股权证。如果承销商全部行使该期权，应付的总承销折扣和佣金将为$ ，我们扣除费用前的总收益将为$ 。

承销商预计将在2026年前后交付普通股股票、购买认股权证和预先出资认股权证。

唯一主承销商

Newbridge Securities Corporation

本招股说明书的日期为，2026。

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

本招股说明书简介	ii
招股说明书摘要	1
本次发行	3
风险因素	6
关于前瞻性声明的注意事项	12
募集资金的使用	14
我们发行证券的描述	15
每股收益稀释	20
承销	21
法律事项	27
专家	27
引用加入	28
您可获取更多信息的地点	29

关于本招股说明书

本招股说明书，包括此处引用的资料，是我们向美国证券交易委员会（SEC）提交的注册声明的一部分，该声明是根据《1933年证券法》（经修订）或《证券法》提交的。本招股说明书向您提供了我们公司和我们发行证券的一般描述。

对于美国以外的投资者：我们和承销商并未采取任何行动，允许在任何要求为此目的采取行动的司法管辖区进行本次发行或持有或分发本招股说明书，除了美国以外。在美国以外地区获得本招股说明书的人士必须自行了解并遵守有关我们证券发行和在美国以外地区分发本招股说明书的任何限制。

我们向SEC提交的注册声明包括提供本招股说明书所讨论事项的更多细节的附录。本招股说明书，包括此处引用的信息，包含了此处描述的一些文件中的某些条款的摘要，但有关完整信息请参考实际文件。所有摘要均受实际文件的完整条款约束。此处提到的一些文件副本已提交、将提交或将在本招股说明书所属的注册声明中作为附录引用。在做出投资决策前，请阅读本招股说明书以及提交给SEC的相关附录，以及在此处的“您可获取更多信息的地点”和“引用加入”标题下描述的附加信息。

您应仅依赖本招股说明书、此处引用的信息和注册声明。我们和承销商未授权任何人向您提供本招股说明书或本招股说明书引用的信息以外的其他或额外信息。如果有人向您提供不同或不一致的信息，您不应依赖它。仅在允许出售和销售我们普通股的司法管辖区进行出售和购买要约。您应假设本招股说明书或引用的信息仅在相关文件的日期准确。自这些日期以来，我们的业务、财务状况、经营成果和前景可能已发生变化。

招股说明书摘要

本招股说明书摘要重点介绍了本招股说明书及其他我们向美国证券交易委员会（SEC）提交并在此招股说明书中有引用的文件中出现的部分信息。由于这只是一个摘要，可能不包含所有对您重要的信息。为了全面了解此次发行，您应仔细阅读本招股说明书的全部内容，包括此处引用的信息、标题为“风险因素”的部分以及本招股说明书中有引用的我们的财务报表和相关附注。

概述

我们是一家临床阶段的生物制药公司，专注于通过抑制糖原合成酶激酶-3（\"GSK-3\"）来开发治疗高影响、难以治疗的癌症的疗法。我们正在开发elraglusib，这是一种ATP竞争性小分子，旨在进入癌细胞并阻断糖原合成酶激酶-3β（\"GSK-3β\"）的酶功能，GSK-3β是复杂生物信号级联反应的主调节器，包括由癌基因介导的信号，这些信号导致肿瘤细胞的存活、生长、迁移和侵袭。我们认为，GSK-3β信号的阻断最终会导致癌细胞的死亡和抗肿瘤免疫的调节。目前尚无获批的高亲和力GSK-3β抑制剂，我们认为elraglusib是临床开发中最先进的GSK-3β抑制剂之一。

我们已独家授权了elraglusib，这是一种专有的、受专利保护的GSK-3抑制剂，由伊利诺伊大学芝加哥分校董事会与西北大学合作开发。

我们认为elraglusib代表了一种“分子中的管线”，凭借其多模式的作用机制、已完成或正在进行的临床研究以及非临床生物、细胞和动物数据的不断涌现，我们有可能围绕我们的主要资产启动并推进多个药物开发项目。动物肿瘤模型数据、临床研究数据和基于人工智能的计算方法已确定了elraglusib可能发挥干预作用的多个未满足临床需求领域，包括胰腺癌、转移性黑色素瘤、肺癌、结肠癌、乳腺癌、肾癌和卵巢癌、白血病和淋巴瘤，以及一些儿童癌症，包括尤文氏肉瘤、神经母细胞瘤和儿童白血病。

到目前为止，我们在1期和2期研究中通过静脉注射（“Elraglusib注射剂”）治疗了超过500名患者。我们还开发了Elraglusib的口服制剂（“Elraglusib口服片剂”），我们认为这将使我们能够通过更方便的给药方式探索多种癌症适应症，并具备每日给药的能力。我们在2026年4月向美国食品药品监督管理局（“FDA”）提交了“研究新药”（“IND”）申请，以推进Elraglusib口服片剂进入1/2期临床研究，以确定最大耐受剂量（“MTD”）和推荐2期剂量（“RP2D”）在晚期、难治性癌症成人患者中，我们已获得FDA批准继续进行1/2期临床研究，前提是获得额外资金。一旦确定RP2D，根据以往研究的数据（包括但不限于一线转移性胰管腺癌（“mPDAC”）、难治性转移性黑色素瘤、难治性转移性结直肠癌和非小细胞肺癌），已确定若干2期或注册研究以进一步开发Elraglusib口服片剂，前提是获得额外资金。

此外，我们在一线治疗mPDAC患者时，通过每周一次的静脉输注Elraglusib获得了有希望的结果。我们针对mPDAC的2期研究，即Actuate-1801第3B部分研究，是一项随机、对照的2期研究，纳入了286名未接受过转移性疾病系统治疗的患者。该研究的主要终点是中位总生存期（“mOS”），总生存期（“OS”）在整个研究过程中通过1年生存率的估计值进行总结。2026年1月在美国内科肿瘤学会泌尿生殖系统癌症研讨会（“ASCO GI”）上公布的更新数据，数据截止日期为2025年11月22日，显示该研究达到了主要终点，证明与单独使用GnP相比，Elraglusib联合GnP（“GnP”）在mOS方面有统计学显著改善。在ASCO GI上公布的数据显示：

Elraglusib/GnP组相比GnP对照组在mOS方面有统计学显著益处（mOS分别为10.1个月和7.2个月，p=0.02，HR=0.62）；

GnP组的12个月生存率几乎翻倍，从22.3%增加到Elraglusib/GnP组的44.4%；以及

GnP对照组的24个月生存率增加了近五倍，从2.6%增加到Elraglusib/GnP组的12.9%，强调了长期临床获益的潜力。

虽然这些数据令人印象深刻，在每周一次给药的患者中，我们认为通过在RP2D下使用Elraglusib口服片剂，可以进一步改善患者的预后，包括在I期研究中确定更频繁的给药方案。我们认为这种策略将进一步与其他针对mPDAC的新治疗方法一致，这些方法通过口服给药的试验性产品进行治疗。此外，迄今为止在超过500名患者中，elraglusib的安全性表现表明该药物作为单药治疗以及与化疗联合使用时耐受性良好。我们认为这将使Elraglusib口服片剂能够与其他试验性产品联合使用，包括但不限于RAS和MEK抑制剂，其中可能具有协同或相加的作用机制，从而增强使用包含elraglusib的联合疗法患者的治疗效果。

除了Elraglusib口服片剂的开发计划外，我们还推进了Elraglusib注射剂在复发/难治性实体瘤儿科癌症患者中的开发。这项名为Actuate-1902的试验是一项I/II期试验，在试验的I期部分，评估了elraglusib作为单药以及与伊立替康或环磷酰胺/托泊替康联合使用的递增剂量。参与Actuate-1902试验的患者在联合化疗组中也出现了多种客观反应，基于这些数据，我们确定尤文肉瘤和神经母细胞瘤可能是Elraglusib注射剂进一步开发的新适应症，前提是获得主要专注于非稀释性资金或资本的额外资助，从而进一步扩大elraglusib的潜在用途和积极治疗影响。2026年6月，我们与伯明翰大学达成初步协议，评估elraglusib在BEACON2临床研究中的应用，这是一项国际性、多臂、多阶段的平台临床研究，旨在确定并推进针对复发和难治性神经母细胞瘤儿童的有前景的治疗方案。计划中的临床研究预计将在剂量确认队列中招募最多20名复发和难治性神经母细胞瘤患者，以评估安全性，并确定elraglusib与地努图昔单抗β联合化疗的MTD、RP2D和药代动力学特征，具体取决于额外的资金支持。在完成剂量确认阶段后，该方案可能会进入研究的随机部分，届时将招募约75名患者，并计划进行中期分析。

最新进展

在2026年10月2日，我们与Bios Partners, L.P.分别签订了信函协议，代表持有我们公司证券的某些Bios实体（“Bios实体”），以及与Kairos Venture Investments, LLC分别签订了信函协议，代表持有我们公司证券的某些Kairos实体（“Kairos实体”），上述协议分别在2026年10月16日进一步修订，根据该协议，Bios实体和Kairos实体同意，在本次发行结束后的两年内，除某些有限例外情况外，不得直接或间接出售、转让或处置任何我们股本股票或任何可转换、行权或交换为我们的股本股票的证券。作为其协议的对价，我们同意在本次发行结束时，向Bios实体和Kairos实体发行认股权证，分别允许其购买3,000,000股和700,000股我们普通股，行权价格等于本次发行每股价格的150%。向Bios实体和Kairos实体发行的认股权证将基本上与向承销商发行的认股权证条款相同，但行权价格除外。截至本招股说明书日期，Bios实体和Kairos实体实际拥有我们约50%的已发行普通股。Aaron Fletcher博士和Todd Thomson是我们的董事会成员，分别担任Bios实体和Kairos实体的管理人员。Fletcher博士和Thomson先生也同意对其实际拥有的我们证券进行类似的两年锁定期。

公司信息

我们是一家于2015年1月16日作为Apotheca Therapeutics, Inc.成立的特拉华州公司，并于2015年10月1日更名为Actuate Therapeutics, Inc.。我们的主要执行办公室位于德克萨斯州沃思堡市River Run大道1751号400室，邮编76107。我们的电话号码是(817) 887-8455。我们的网址是www.actuatetherapeutics.com。本网站或与其相连的信息不构成本招股说明书或其组成部分的注册声明的一部分，也不通过引用纳入本招股说明书或其组成部分的注册声明中。

更多信息

如需了解与我们业务和运营相关的更多信息，请参阅此处引用的报告，包括我们于2025年12月31日止年度的年度报告10-K表，该报告已于2026年3月26日向证券交易委员会提交，如本招股说明书中题为“引用加入”的部分所述。

本次发行

以下是对本次发行一些条款的简要概述，并完全参考了本招股说明书中其他地方的详细信息。有关我们普通股条款的更完整描述，请参见“我们发行的证券描述”部分。

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我们发行的证券		40,000,000股普通股 (如果承销商全部行使其超额配售选择权，则为46,000,000股)。每两股普通股将与一张购买我们一股普通股的认股权证一起发行和出售。我们的普通股和购买认股权证将分别发行，但将在本次发行中一起购买。

购买认股权证的说明		20,000,000 份认股权证，可购买 20,000,000 股普通股（如果承销商完全行使超额配售选择权，则为 23,000,000 份认股权证，可购买 23,000,000 股普通股）只能用于购买整数股普通股，由于认股权证将与普通股一同出售，因此本次发行中不会发行任何分数股或用于购买分数股的认股权证。认股权证的行权价格为 $ 每股。每份认股权证在发行后立即可以行权，并将在初始发行日期后五年到期。本招股说明书也涉及认股权证行权后发行的普通股。有关认股权证的更多信息，请仔细阅读本招股说明书中标题为“我们发行的证券说明 – 本次发行的认股权证”的章节。

附有资金的认股权证说明		我们还向那些在本次发行中购买普通股的购买者提供附有资金的认股权证，如果该购买者在本次发行完成后，与其关联方和某些相关方共同拥有我们已发行普通股的超过 4.99%（或购买者选择的 9.99%）的权益，那么这些附有资金的认股权证最多可购买 40,000,000 股普通股，以替代原本可能导致超过 4.99%（或适用的 9.99%）的普通股权益。 \n\n\n\n 每份附有资金的认股权证的购买价格将等于本次发行中向公众出售的普通股每股价格，减去 $0.0001，每份附有资金的认股权证的行权价格为 $0.0001 每股。 \n\n\n\n 每份附有资金的认股权证将立即可以行权，并可在任何时候行权，直到全部行权为止。附有资金的认股权证没有到期日。为了更好地理解附有资金的认股权证的条款，请仔细阅读本招股说明书中“我们发行的证券说明 – 本次发行的附有资金的认股权证”的章节。 \n

合并发行价格		$ 每两股普通股及附带的认股权证。

本次发行后将发行的普通股		64,013,577 股（如果承销商完全行使超额配售选择权，则为 70,013,577 股），假设所有附有资金的认股权证全部行权，且没有行权认股权证。

购买额外证券的期权 \n		我们授予承销商一个 45 天的期权，承销商可以随时全部或部分行使该期权，以购买最多额外 6,000,000 股普通股，以及在每股有效公开发行价格为 $ 的情况下，额外最多 3,000,000 股普通股的认股权证，每份认股权证的行权价格为 $ ，每种情况均需扣除承销折扣和佣金，以覆盖可能的超额配售。 \n

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资金用途		我们估计此次发行的净收益将约为 $ （或约为 $ ，如果承销商全部行使其超额配售选择权），在扣除承销折扣和佣金以及我们应付的预计发行费用后，不包括行使购买认股权证所得的收益。我们预计此次发行的净收益将用于营运资金和一般公司用途。有关更多信息，请参见“资金用途”。

风险因素		投资我们的证券涉及很高的风险。在决定是否投资我们的证券之前，请仔细考虑本招股说明书中“风险因素”中的信息以及本招股说明书中包含或引用的文件中提到的其他风险。

禁售期		根据承销协议，我们同意在此次发行结束后的最多120天内，除特定例外情况外，不直接或间接出售、转让或处置我们股本股票或任何可转换、可行使或可交换为股本股票的证券。

		此外，根据2026年10月2日签署的单独信函协议，经进一步修订，Bios实体、Kairos实体及其管理人、Aaron Fletcher博士和Todd Thomson分别同意，在此次发行结束后的两年内，除有限例外情况外，不直接或间接出售、转让或处置他们所持有的我们股本股票或任何可转换、可行使或可交换为我们的股本股票的证券。我们的其他高管和董事也同意，在此次发行结束后的120天内，除有限例外情况外，不直接或间接出售、转让或处置他们所持有的我们股本股票或任何可转换、可行使或可交换为我们的股本股票的证券。

		有关更多信息，请参见“承销”。

承销商认股权证		我们已同意向本次发行的承销商Newbridge Securities Corporation或其指定方发行认股权证（“承销商认股权证”），作为与本次发行相关的承销补偿的一部分，该认股权证可购买我们普通股的股份，占本次发行给投资者的普通股和预提认股权证总数量的3.5%。承销商认股权证的行权价为每股美元（每股公开发行价的125%），自本次发行证券销售开始之日起五年内有效，符合金融行业监管局，Inc.（“FINRA”）规则5110(g)(8)(A)的规定。FINRA已将承销商认股权证视为补偿，因此根据FINRA规则5110(e)的规定，须遵守180天的锁定期。本招股说明书所属的注册声明注册了承销商认股权证以及行使承销商认股权证时可发行的我们普通股的销售。有关这些认股权证的更详细描述，请参见“承销 — 承销商认股权证”。

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合格小型企业股票		我们认为，在本次发行结束时（i）我们将是《1986年国内税收法典》（以下简称“法典”）第1202(e)(4)条定义的“合格公司”，（ii）在结束日前一年内，我们没有进行任何购买本公司股票的行为，其总价值不超过该期间开始时我们所有股票总价值的5%，以及（iii）根据法典第1202(d)(1)(B)条定义，我们的总毛资产在任何时候和至结束时均未超过或超过7500万美元，包括根据法典第1202(d)(3)条必须与我们合并的任何公司的资产。因此，我们认为，本次发行的普通股应根据法典第1202(c)条被认定为“合格小型企业股票”。某些潜在购买者可能有资格获得联邦所得税资本利得税的豁免，前提是其持有“合格小型企业股票”超过五年。为了使该豁免适用于该购买者，我们必须在潜在购买者持有期间的大部分时间内满足某些活跃业务测试，这些测试可能受到我们未来运营及本次发行资金使用情况的影响。我们无法保证我们能够在潜在购买者持有期间的大部分时间内满足所有或任何这些测试。潜在购买者应就法典第1202条的适用性或解释自行咨询其税务顾问。

NASDAQ股票市场代码		“ACTU。”

流通股数量基于2026年6月30日的24,013,577股流通普通股，并排除：

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	·	2026年6月30日尚未行权的股票期权可发行的2,755,836股普通股，加权平均行权价为每股5.14美元；
	·	2026年6月30日尚未行权的限制性股票单位（“RSUs”）可发行的275,181股普通股；
	·	截至2026年6月30日，已发行认股权证可兑换922,096股普通股，加权平均行权价为每股7.87美元；
	·	截至2026年6月30日，根据我们的2024年股票激励计划（“2024计划”）预留了2,432,742股普通股用于未来发行；
	·	根据2025年3月27日签署的普通股购买协议（“承诺股权计划”）与B. Riley Principal Capital II（“B. Riley”）可兑换3,364,407股普通股；
	·	20,000,000股我们普通股（如果承销商完全行使超额配售选择权，则为23,000,000股）预留用于行使本次发行的购买认股权证，行权价为每股$ ；
	·	1,400,000股我们普通股（如果承销商完全行使超额配售选择权，则为1,610,000股）预留用于行使认股权证，行权价为每股$ ，该等股份将在本次发行结束时发行给承销商；
	·	3,000,000股我们普通股预留用于行使认股权证，行权价为每股$ ，该等股份将在本次发行结束时发行给Bios实体；
	·	700,000股我们普通股预留用于行使认股权证，行权价为每股$ ，该等股份将在本次发行结束时发行给Kairos实体。

除非另有说明，本招股说明书中的所有信息均假设（i）完全行使预付认股权证，（ii）不行使已发行的期权和认股权证（包括本次发行的购买认股权证）或RSU的归属，以及不根据承诺股权计划发行股份，如上所述，以及（iii）承销商不行使购买额外最多6,000,000股普通股和额外购买3,000,000股普通股认股权证的选择权。

风险因素

投资我们的普通股涉及高度风险。在决定是否购买我们的普通股之前，请仔细考虑以下风险以及在本招股说明书引用的我们2025年12月31日财年年度报告10-K表第I部分第1A项中“风险因素”标题下描述的风险和不确定性，包括我们的审计财务报表和相关附注。如果任何此类风险实际发生，我们的业务、财务状况、经营成果、现金流和前景可能会受到重大不利影响。因此，我们普通股的交易价格可能会下跌，您可能会损失在我们普通股中的全部或部分投资。

与本次发行及我们普通股相关的风险

由于本次发行的我们普通股的公开发行价格明显高于本次发行后我们已发行普通股的每股有形账面价值，新投资者将立即且大幅稀释。

本次发行的普通股每股发行价明显高于本次发行前我们普通股的每股净有形账面价值。因此，如果您在本次发行中购买普通股，您将立即且大幅稀释，约每股0.20美元，这代表了假设的每股发行价0.50美元与截至2026年6月30日调整后的每股净有形账面价值之间的差额。此外，如果我们的未行使期权或认股权证被行使，您可能会经历进一步的稀释。有关您在本次发行中购买我们普通股时将遭受的稀释的更详细讨论，请参见“稀释”。“

作为投资者，您可能会损失全部投资。

投资我们的普通股涉及很高的风险。作为投资者，您可能永远无法收回全部或部分投资，也可能无法获得任何投资回报。您必须做好损失全部投资的准备。

由于我们将在如何使用本次发行的净收益方面拥有广泛的自主权和灵活性，我们可能会以您不同意的方式使用这些净收益。

我们计划将本次发行的净收益用于营运资金和一般公司用途。有关更多信息，请参见“募集资金的用途”。因此，我们的管理层在应用本次发行的净收益方面将有重大自主权和灵活性。您将依赖我们管理层对这些净收益使用的判断，而在您的投资决策过程中，您将没有机会评估这些净收益是否被适当使用。有可能净收益将被以不产生有利或任何回报的方式进行投资。管理层未能有效使用这些资金可能会对我们的业务、财务状况、经营成果和现金流量产生重大不利影响。

在本次发行后，为了执行我们的商业计划和资助运营，我们需要额外的融资，而这种额外融资可能无法以合理条款获得，甚至可能无法获得。

截至2026年6月30日，公司拥有现金及现金等价物4,425,841美元和营运资金942,745美元。我们认为，本次发行的净收益加上本招股说明书发布日我们手头的现金足以支持我们拟议的运营计划，至少到。

自成立以来，我们尚未从产品销售中获得任何收入，并已产生重大运营亏损和经营性现金流为负。随着我们推进elraglusib及任何未来产品候选人的临床开发，我们预计在可预见的未来将产生重大费用和运营亏损。我们的未经审计的合并财务报表是在我们继续作为持续经营企业的情况下编制的，这设想了资产的变现和负债在正常业务过程中得到清偿。

在我们能够产生显著产品收入之前，或者如果永远无法实现这一点，我们预计将继续通过股权发行、债务融资或其他资本来源（包括当前或潜在的未来合作、许可和其他类似安排）来为运营提供资金。鉴于我们近期寻求额外融资，我们可能无法在需要时以有利的条款或根本无法筹集到额外资金或达成其他安排。我们筹集额外资金的能力可能会受到商业状况、全球经济状况、美国及全球信贷和金融市场中断和波动以及流动性减少和信贷可用性下降的不利影响。如果我们通过出售股权或可转换债务证券来筹集额外资金，股东在我们普通股中的所有权利益将被稀释，这些证券的条款可能包含清算或其他偏好，这可能不利地影响我们普通股股东的权利。如果可以获得债务融资和优先股融资，可能涉及包含限制或限制我们采取特定行动的协议，例如增加债务、进行收购、参与收购、合并或合作交易、出售或许可我们的资产、进行资本支出、赎回我们的股票、进行某些投资或宣布股息。如果我们通过与第三方的合作或许可协议筹集额外资金，我们可能不得不放弃我们技术的宝贵权利、未来收入流、研究计划或产品候选人的权利，或在对我们不利的条款下授予许可。如果我们无法在需要时通过股权、债务或其他融资筹集到额外资金，我们可能被迫延迟、限制、减少或终止我们的产品开发或未来商业化努力，或授予他人开发和销售我们原本希望自行开发和销售的产品候选人的权利，甚至停止运营。

我们认股权证和预付认股权证的持有者在获得我们的普通股之前，没有作为普通股股东的权利。

本次发行的认股权证和预付认股权证不会赋予持有人任何普通股所有权，例如投票权或获得股息的权利，而仅仅是代表以固定价格购买我们普通股的权利，在认股权证的情况下，这种权利仅在有限的时间内有效。具体而言，自发行之日起，认股权证和预付认股权证的持有人可以行使购买普通股并支付每股行权价的权利。对于认股权证，持有人可在自发行之日起五年内行使认股权证，此后任何未行使的认股权证将失效且不再具有任何价值。在认股权证和预付认股权证持有人行使认股权证并购买普通股之前，持有人对于认股权证行权所发行的普通股没有任何权利。在行使认股权证和预付认股权证时，持有人仅在行权后发生的记录日期所涉及的事项上，有权行使股东的权利。无法保证普通股的市场价格会等于或超过认股权证的行权价，因此也无法保证认股权证的持有人是否能通过行权而获利。

本招股说明书所发行的认股权证和预付认股权证具有投机性质，可能没有任何价值。

本招股说明书所发行的认股权证自发行之日起五年内可行使。无法保证我们普通股的市场价格会超过认股权证的行权价。如果在认股权证有效期内我们的普通股价格未超过认股权证的行权价，认股权证可能没有任何价值。

本次发行的预付认股权证不会赋予持有人任何普通股所有权，例如投票权，而仅仅是代表以固定价格购买普通股的权利。具体而言，自发行之日起，预付认股权证的持有人可以以每股普通股0.0001美元的行权价购买该等认股权证行权所发行的普通股。此外，在本次发行之后，预付认股权证的市场价值不确定，无法保证预付认股权证的市场价值会等于或超过购买价格和行权价的总和。无法保证普通股的市场价格会等于或超过预付认股权证的购买价格和行权价的总和，因此也无法保证预付认股权证的持有人是否能通过行权而获利。

本次发行中所发行的认股权证或预付认股权证没有公开市场。

本次招股书所发行的认股权证或预付认股权证没有公开交易市场，我们预计也不会出现这样的市场。此外，我们无意将认股权证或预付认股权证在国家级证券交易所上市。如果没有活跃的市场，认股权证和预付认股权证的流动性将受到限制。

我们普通股的未来销售，或市场认为未来可能销售，可能导致我们的股价下跌。

2025年3月27日，我们与B. Riley签订了一份承诺股权融资协议，根据该协议，我们在36个月内有权（但非义务）向B. Riley出售最多以下两者中的较小者：(i) 5000万美元的新发行普通股，或(ii) 3,904,374股普通股。向B. Riley出售的普通股每股价格根据承诺股权融资协议中定义的普通股成交量加权平均价格减去3%的折扣确定，但受某些限制和条件的约束。我们通过承诺股权融资协议获得的总净收益将取决于我们向B. Riley出售普通股的数量、频率和价格。从2025年3月27日到2025年8月31日，我们通过承诺股权融资协议出售了539,967股普通股，获得了3,800,465美元的净收益。自2025年9月1日起，我们未通过承诺股权融资协议向B. Riley出售任何股票，截至2026年6月30日，我们在承诺股权融资协议下仍有3,364,407股普通股的剩余额度。

2025年11月28日，我们与B. Riley Securities, Inc.和Craig-Hallum Capital Group LLC签订了“按市价发行销售协议”（“ATM协议”），其中B. Riley Securities, Inc.和Craig-Hallum Capital Group LLC各自为“销售代理”，合称为“销售代理”。根据该协议，我们可随时根据自身决定，通过销售代理发行并出售最多1亿美元的普通股。“按市价发行”计划（“ATM计划”）。截至2026年6月30日，我们在ATM计划下仍有约9870万美元的剩余额度。

在本次发行后，我们普通股在公开市场的大量销售，或市场认为这些销售可能发生，可能导致我们普通股的市场价格下跌。我们普通股的大部分流通股，以及本次发行中发行的普通股，将在发行后不受限制地自由交易，且无需进一步注册即可符合证券法规定。

我们股票的市场价格可能会波动和波动。

您可能会损失全部或部分投资。我们普通股的市场价格会因各种因素而大幅波动，其中一些因素是我们无法控制的。这些因素包括：

我们临床试验和非临床研究的结果，以及我们竞争对手或其他同行业公司的试验结果；

我们获得和维持elraglusib或任何未来产品候选物的监管批准的能力，或对其额外适应症的限制，或对其使用特定的标签适应症或患者群体的限制，或监管审查过程的变化或延迟；

关于我们的临床试验进展和结果的公告，我们可能获得elraglusib或任何未来产品候选物的监管批准和商业化的潜力，包括我们从FDA收到的任何要求额外研究或数据的请求，这可能导致获得监管批准或潜在推出elraglusib或任何未来产品候选物的延迟；

制药和生物技术行业或整体经济的市场状况；

我们或我们的竞争对手关于重大收购、战略合作伙伴关系、合资企业或资本承诺的公告；

整体股票市场中的股价和交易量波动；

我们招募未来临床研究患者的能力；

elraglusib或任何未来产品候选物（如果获批）未能实现商业成功；

实现预期的产品销售额和盈利能力；

我们或我们的竞争对手推出新产品的公告；

他人产品开发成果或知识产权权利的进展；

关于elraglusib或我们未来潜在产品的安全性问题的诉讼或公众关注；

我们季度运营结果的实际波动，以及投资者对未来可能出现此类波动的担忧；

我们的运营结果与证券分析师或其他分析师评论的预期出现偏差；

关键人员的增减；

我们、我们的内部人员或我们的股东出售我们的股票；

医疗改革立法，包括针对控制药品定价的措施，以及第三方保险覆盖和报销政策；

当前或未来战略合作的进展；以及

财经和科学媒体以及在线投资者社区对我们或我们股价的讨论。

此外，过去，生物制药公司在其股票市场价格波动期间，股东曾对这些公司提起集体诉讼。如果对我们提起此类诉讼，可能会导致我们产生大量费用，分散管理层的注意力和资源，并损害我们的声誉，这可能对我们业务、财务状况、运营结果和前景产生重大不利影响。

我们目前不符合纳斯达克全球市场（Nasdaq Global Market）的上市证券最低市值（“MVLS”）要求的5000万美元。如果我们的普通股从纳斯达克全球市场退市，且我们的普通股未被纳斯达克资本市场接受上市，我们的普通股的市场价格和流动性以及我们筹集额外资本的能力将受到不利影响。

我们的普通股目前在纳斯达克全球市场上市。继续在纳斯达克全球市场上市取决于遵守各种持续上市标准。2026年7月15日，我们收到纳斯达克证券市场（“纳斯达克”）发出的信函（“通知”），通知我们，截至2026年7月14日的30个营业日，我们未能满足纳斯达克市场规则5450(b)(2)(A)中规定的5000万美元最低市值（MVLS）要求，以维持在纳斯达克全球市场的持续上市。

根据纳斯达克规则，我们有180个日历日，或至2027年1月11日（“合规日期”）以恢复合规。为恢复合规，我们的上市证券市值必须在2027年1月11日之前任何时间至少连续10个营业日达到5000万美元。如果我们在合规日期之前未能恢复符合MVLS要求，或无法继续满足其他持续上市标准，包括最低出价1.00美元，纳斯达克将通知我们，我们的证券可能被退市，在此情况下，我们可以向纳斯达克听证小组提出申诉，或选择将我们的普通股在纳斯达克资本市场上市。

目前，该通知不会对本公司证券在纳斯达克全球市场的上市产生影响。我们计划在合规日期前积极监控我们的MVLS，并可能在适当的情况下评估可用选项，包括申请转移到纳斯达克资本市场，以解决不足并恢复合规。尽管我们正在尽最大努力维持证券在纳斯达克的上市，但无法保证我们能够恢复或维持符合纳斯达克全球市场上市标准，或满足将证券上市转移到纳斯达克资本市场的必要要求。

如果我们的普通股从纳斯达克退市，其交易很可能在为未上市证券设立的场外交易市场进行，例如由OTC Markets Group运营的OTCQB Venture Market。投资者可能发现，在场外交易市场出售或寻求购买我们的普通股时获取准确报价将不太方便，许多投资者可能由于难以进入场外交易市场、政策禁止他们在非全国性交易所上市的证券上交易或其他原因而不愿买卖我们的普通股。此外，作为退市证券，我们的普通股将根据美国证券交易委员会（SEC）的规定作为“低价股”受到监管，这会对经纪商/交易商施加额外的披露要求。与低价股相关的法规，加上由于诸如经纪商佣金通常占低价股价格的比例高于高价股价格等因素，导致低价股的每笔交易成本通常更高，这将进一步限制投资者交易我们普通股的能力。

我们预计在可预见的未来不会支付股息。因此，您必须依靠股票增值来获得投资回报。

我们从未就我们的股本支付过任何现金股息，而且我们预计在可预见的未来不会就我们的普通股支付现金股息。任何现金股息的支付还将取决于我们的财务状况、经营成果、资本需求和其他因素，并将由我们的董事会自行决定。因此，您将不得不依赖资本增值（如有）来获得对您在我们普通股上的投资的回报。

关于前瞻性声明的警示说明

This prospectus contains forward-looking\nstatements. Certain statements in this prospectus may constitute “forward-looking statements” for purposes of the federal\nsecurities laws. Our forward-looking statements include, but are not limited to, statements regarding expectations, hopes, beliefs, intentions\nor strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future\nevents or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,”\n“continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,”\n“plan,” “possible,” “potential,” “predict,” “project,” “should,”\n“will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words\ndoes not mean that a statement is not forward-looking. Forward-looking statements in this prospectus may include, for example, statements\nabout:

our expectations for the results of our clinical studies, including our planned Phase 1/2 clinical trial\nof elraglusib in advanced cancer patients using the oral tablet formulation of elraglusib and the design of a future clinical study of\nelraglusib;

our ability to secure sufficient additional capital in the near term or implement other strategies needed\nto alleviate our current substantial doubt about our ability to continue as a going concern;

our regulatory plans to seek feedback from the FDA or European Medicines Agency (“EMA”) on\nthe design and execution of clinical studies;

our ability to enroll additional patients or establish or advance plans for further development, including\nthrough conversations with the FDA or EMA;

our ability to successfully manage our relationships with our licensors and third-party service providers;

our ability to maintain, protect and further develop our intellectual property rights;

our ability to fund our current operations with our cash on hand and our ability to raise additional capital\nas and when needed;

our future financial and operating results;

our intentions, expectations and beliefs regarding anticipated growth, market penetration and trends in\nour business;

the timing and success of our plan of commercialization;

our intellectual property position and strategy, and our ability to obtain, maintain and enforce intellectual\nproperty rights for our platform and development candidates;

our ability to identify additional product candidates with significant commercial potential;

our reliance on third-party manufacturing and supply vendors and contract research organizations, or CROs;

potential benefits of any future collaboration;

developments relating to our competitors and our industry;

the impact of general economic conditions, including inflation and the imposition of new or revised tariffs\nor other trade restrictions;

the impact of government laws and regulations; and

the use of proceeds from this offering.

The forward-looking\nstatements contained in this prospectus are based on current expectations and beliefs concerning future developments and their\npotential effects on the Company. There can be no assurance that future developments affecting us will be those that we have\nanticipated. These forward-looking statements involve a number of risks, uncertainties, some of which are beyond our control, or\nother assumptions that may cause actual results or performance to be materially different from those expressed or implied by these\nforward-looking statements. These risks and uncertainties include, but are not limited to, those factors described in the section\nentitled “Risk Factors” in this prospectus and in our periodic filings with the SEC. Our SEC\nfilings are available publicly on the SEC website at www.sec.gov.

Should one or more of these\nrisks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from\nthose projected in these forward-looking statements. Accordingly, forward-looking statements in this prospectus should not be relied upon\nas representing our views as of any subsequent date, and we undertake no obligation to update or revise any forward-looking statements,\nwhether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

USE OF PROCEEDS

We estimate that our net\nproceeds from this offering will be approximately $ (or approximately $ if\nthe underwriter exercises its over-allotment option in full), after deducting the underwriting discounts and commissions and estimated\noffering expenses payable by us and assuming no exercise of the purchase warrants offered hereby.

We expect to use the net proceeds\nfrom this offering for working capital and general corporate purposes. This represents our best estimate of the manner in which we will\nuse the net proceeds we receive from this offering based upon the current status of our business, but we have not reserved or allocated\namounts for specific purposes and we cannot specify with certainty how or when we will use any of the net proceeds. The amounts and timing\nof our actual use of the net proceeds from this offering will vary depending on numerous factors, including the factors described under\n“Risk Factors” located elsewhere in this prospectus or in the information incorporated by reference herein. As a result,\nour management will have broad discretion in the application of the net proceeds, and investors will be relying on our judgment regarding\nthe application of the net proceeds from this offering.

DESCRIPTION OF SECURITIES WE ARE OFFERING

The following summary of\nthe material terms of our capital stock is not intended to be a complete summary of the rights and preferences of such securities. We\nurge you to read our sixth amended and restated certificate of incorporation, as amended, or certificate of incorporation, and our amended\nand restated bylaws, or by-laws, each as amended from time to time, in their entirety for a complete\ndescription of the rights and preferences of our capital stock.

Common Stock

We are authorized to issue\n200,000,000 shares of common stock, par value of $0.000001 per share. As of June 30, 2026, there were 24,013,577 shares of common stock\nissued and outstanding.

Voting Rights. Holders\nof our common stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders, including the election\nof directors, and do not have cumulative voting rights. An election of directors by our stockholders will be determined by a plurality\nof the votes cast by the stockholders entitled to vote on the election. Subject to the supermajority votes for some matters, other matters\nshall be decided by the affirmative vote of our stockholders having a majority in voting power of the votes cast by the stockholders\npresent or represented and voting on such matter. Our certificate of incorporation also provides that our directors may be removed only\nfor cause and only by the affirmative vote of the holders of at least two-thirds in voting power of the outstanding shares of capital\nstock entitled to vote thereon. In addition, the affirmative vote of the holders of at least two-thirds in voting power of the outstanding\nshares of capital stock entitled to vote thereon is required to amend or repeal, or to adopt any provision inconsistent with, several\nof the provisions of our certificate of incorporation. See the subsection titled“-Certain Anti-Takeover Effects of Delaware Law” and “-Amendment of Charter Provisions” below.

Record Holders. As\nof June 30, 2026, our outstanding shares of common stock were held of record by 86 stockholders.

Dividends. Subject\nto preferences that may apply to any outstanding preferred stock, the holders of our common stock are entitled to receive dividends, if\nand when declared by our board of directors, out of funds legally available therefor.

Liquidation. In\nthe event of a liquidation, dissolution or winding up, our stockholders will be entitled to share ratably in all assets remaining available\nfor distribution to them after payment of liabilities and after provision is made for each class of stock, if any, having preference over\nthe common stock.

Rights, Preferences\nand Privileges. Holders of our common stock have no conversion, preemptive or other subscription rights, and there are no sinking\nfund or redemption provisions applicable to our common stock. The rights, preferences and privileges of the holders of our common stock\nare subject to, and may be adversely affected by, the rights of the holders of shares of any series of our preferred stock that we may\ndesignate and issue in the future.

Preferred Stock

Our certificate of incorporation\ngrants our board of directors the authority, without further stockholder authorization, to issue from time to time up to 10,000,000 shares\nof preferred stock in one or more series and to fix the terms, limitations, voting rights, relative rights and preferences and variations\nof each series. As of the date of this prospectus, we have not issued any shares of preferred stock. Although we have no present plans\nto issue any shares of preferred stock, the issuance of shares of preferred stock, or the issuance of rights to purchase such shares,\ncould decrease the amount of earnings and assets available for distribution to the holders of our common stock, could adversely affect\nthe rights and powers, including voting rights, of the common stock and could have the effect of delaying, deterring or preventing a change\nof control of our company or an unsolicited acquisition proposal.

Purchase Warrants Offered Hereby

The purchase warrants\nwill be issued under a warrant agency agreement between us and Broadridge Corporate Issuer Solutions, Inc., as warrant agent. The following\nsummary of certain terms and provisions of the purchase warrants that are being offered hereby is not complete and is subject to, and\nqualified in its entirety by, the provisions of the purchase warrants, a form of which has been filed with the SEC as an exhibit to the\nRegistration Statement on Form S-1 of which this prospectus is made part of. Prospective investors should carefully review the terms\nand provisions of the form of purchase warrant for a complete description of the terms and conditions of the purchase warrants.

Duration and Exercise\nPrice. Each warrant offered hereby will have an initial exercise price per share equal to $ . The purchase warrants will be immediately\nexercisable and will expire on the fifth anniversary of the original issuance date. The exercise price and number of shares of common\nstock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar\nevents affecting our common stock and the exercise price. The purchase warrants will be issued separately from the common stock and may\nbe transferred separately immediately thereafter. One warrant to purchase one share of our common stock will be issued for every shares\nof common stock purchased in this offering.

Exercisability.\nThe purchase warrants will be exercisable, at the option of each holder, in whole or in part, by delivering a duly executed exercise\nnotice accompanied by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of\na cashless exercise as discussed below). A holder (together with its affiliates) may not exercise any portion of the purchase warrant\nto the extent that the holder would own more than 4.99% of the outstanding common stock immediately after exercise, except that upon\nat least 61 days’ prior notice from the holder to us, the holder may increase the amount of ownership of outstanding stock after\nexercising the holder’s warrants up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect\nto the exercise, as such percentage ownership is determined in accordance with the terms of the purchase warrants. No fractional shares\nof common stock will be issued in connection with the exercise of a warrant.

Cashless Exercise.\nIf, at the time a holder exercises its warrants, a registration statement registering the issuance of the shares of common stock underlying\nthe warrants under the Securities Act is not then effective or available and an exemption from registration under the Securities Act\nis not available for the issuance of such shares, then in lieu of making the cash payment otherwise contemplated to be made to us upon\nsuch exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole\nor in part) the net number of shares of common stock determined according to a formula set forth in the warrants.

Pre-Funded Warrants Offered Hereby

The pre-funded warrants\nwill be issued under a warrant agency agreement between us and Broadridge Corporate Issuer Solutions, Inc., as warrant agent. The following\nsummary of certain terms and provisions of the pre-funded warrants that are being offered hereby is not complete and is subject to, and\nqualified in its entirety by, the provisions of the pre-funded warrants, a form of which has been filed with the SEC as an exhibit to\nthe Registration Statement on Form S-1 of which this prospectus is made part of. Prospective investors should carefully review the terms\nand provisions of the form of pre-funded warrant for a complete description of the terms and conditions of the pre-funded warrants.

Duration and Exercise\nPrice. Each pre-funded warrant offered hereby will have an initial exercise price per share of common stock equal to $0.0001. The\npre-funded warrants will be immediately exercisable and will expire when exercised in full. The exercise price and number of shares of\ncommon stock issuable upon exercise is subject to appropriate adjustment in the event of share dividends, share splits, reorganizations\nor similar events affecting our shares of common stock.

Exercisability.\n The pre-funded warrants may only be exercised through a “cashless exercise” which\n will provide the holder with a net number of shares of common stock determined according\n to a formula set forth in the pre-funded warrants. The pre-funded warrants will be exercisable,\n at the option of each holder, in whole or in part, by delivering to us a duly executed exercise\n notice. A holder (together with its affiliates) may not exercise any portion of the pre-funded\n warrant to the extent that the holder would own more than 4.99% (or, at the election of the\n holder, 9.99%) of the outstanding shares of common stock immediately after exercise. However,\n upon notice from the holder to us, the holder may decrease or increase the holder’s\n beneficial ownership limitation, which may not exceed 9.99% of the number of outstanding\n shares of common stock immediately after giving effect to the exercise, as such percentage\n ownership is determined in accordance with the terms of the pre-funded warrants, provided\n that any increase in the beneficial ownership limitation will not take effect until 61 days\n following notice to us.

Other Warrants

As of June 30, 2026, there\nwere outstanding warrants to purchase an aggregate of 922,096 shares of our common stock at a weighted average exercise price of $7.87\nper share, including the Private Placement Warrants (as defined below).

Private Placement Warrants

Warrants to purchase of up to 666,497 shares of common stock were issued pursuant to a securities purchase agreement, dated June 25, 2025,\nwith certain institutional and accredited investors (the “Securities Purchase Agreement”) at an exercise price of $7.00 per\nshare of common stock, subject to adjustment as set forth in the warrants (the “Private Placement Warrants”). The Private\nPlacement Warrants are exercisable on a cash only basis at any time after the date of issuance and expire 20 days following the Milestone\nDate (as defined below) for additional proceeds to us of up to approximately $4.7 million if all Private Placement Warrants are exercised\nin full. The “Milestone Date” is the earliest to occur of (i) the FDA issuing Breakthrough Therapy designation for elraglusib\nand (ii) the date that the FDA provides written communication available to us of its determination as to whether we may pursue registration\nfor elraglusib using Phase 2 or Phase 3 clinical data.

Registration Rights

Certain holders of shares\nof our common stock are entitled to certain rights with respect to registration of such shares under the Securities Act under the investor\nrights agreement entered into in connection with the purchase of our preferred stock that converted into common stock upon our IPO.

We have entered into a registration\nrights agreement with B. Riley with respect to the resale of any shares sold under the Committed Equity Facility.

We have entered into a registration\nrights agreement with the parties to the Securities Purchase Agreement providing for the registration of the shares sold thereunder.

Certain Anti-Takeover Provisions of Delaware\nLaw

Some provisions of Delaware\nlaw, our certificate of incorporation and our amended and restated bylaws contain provisions that could make the following transactions\nmore difficult: an acquisition of us by means of a tender offer; an acquisition of us by means of a proxy contest or otherwise; or the\nremoval of our incumbent officers and directors. It is possible that these provisions could make it more difficult to accomplish or could\ndeter transactions that stockholders may otherwise consider to be in their best interest or in our best interests, including transactions\nthat provide for payment of a premium over the market price for our shares.

These provisions, summarized\nbelow, are intended to discourage coercive takeover practices and inadequate takeover bids. These provisions are also designed to encourage\npersons seeking to acquire control of us to first negotiate with our board of directors. We believe that the benefits of the increased\nprotection of our potential ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure\nus outweigh the disadvantages of discouraging these proposals because negotiation of these proposals could result in an improvement of\ntheir terms.

Undesignated Preferred\nStock. The ability of our board of directors, without action by the stockholders, to issue up to 10,000,000 shares of undesignated\npreferred stock with voting or other rights or preferences as designated by our board of directors could impede the success of any attempt\nto change control of us. These and other provisions may have the effect of deferring hostile takeovers or delaying changes in control\nor management of our company.

Stockholder Meetings.\nOur certificate of incorporation and our bylaws provide that a special meeting of stockholders may be called only by our board\nof directors, chairman of the board of directors, chief executive officer or president, or by a resolution adopted by a majority of our\nboard of directors.

Requirements for Advance\nNotification of Stockholder Nominations and Proposals. Our bylaws establish advance notice procedures with respect to stockholder\nproposals to be brought before a stockholder meeting and the nomination of candidates for election as directors, other than nominations\nmade by or at the direction of the board of directors or a committee of the board of directors.

Elimination of Stockholder\nAction by Written Consent. Our certificate of incorporation eliminates the right of stockholders to act by written consent without\na meeting.

Staggered Board of Directors.\nOur certificate of incorporation provides that our board of directors is divided into three classes. The directors in each class\nserve for a three-year term, with one class being elected each year by our stockholders. This system of electing directors may tend to\ndiscourage a third party from attempting to obtain control of us, because it generally makes it more difficult for stockholders to replace\na majority of the directors.

Removal of Directors.\nOur certificate of incorporation provides that no member of our board of directors may be removed from office except for cause\nand, in addition to any other vote required by law, upon the approval of not less than two thirds of the total voting power of all of\nour outstanding voting stock then entitled to vote in the election of directors.

Stockholders Not Entitled\nto Cumulative Voting. Our certificate of incorporation does not permit stockholders to cumulate their votes in the election of\ndirectors. Accordingly, the holders of a majority of the outstanding shares of our common stock entitled to vote in any election of directors\ncan elect all of the directors standing for election, if they choose, other than any directors that holders of our preferred stock may\nbe entitled to elect.

Delaware Anti-Takeover\nStatute. We are subject to Section 203 of the Delaware General Corporation Law, which prohibits persons deemed to be “interested\nstockholders” from engaging in a “business combination” with a publicly held Delaware corporation for three years following\nthe date these persons become interested stockholders unless the business combination is, or the transaction in which the person became\nan interested stockholder was, approved in a prescribed manner or another prescribed exception applies. Generally, an “interested\nstockholder” is a person who, together with affiliates and associates, owns, or within three years prior to the determination of\ninterested stockholder status did own, 15% or more of a corporation’s voting stock. Generally, a “business combination”\nincludes a merger, asset or stock sale, or other transaction resulting in a financial benefit to the interested stockholder. The existence\nof this provision may have an anti-takeover effect with respect to transactions not approved in advance by the board of directors.

Choice of Forum. Our\ncertificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery\nof the State of Delaware (the Court of Chancery) (or, in the event the Court of Chancery does not have jurisdiction, the federal district\ncourt for the District of Delaware or other state courts of the State of Delaware) will be the sole and exclusive forum for the following\ntypes of actions or proceedings under Delaware statutory or common law: (i) any derivative action or proceeding brought on our behalf;\n(ii) any action asserting a claim of breach of a fiduciary duty by any of our directors, officers or stockholders to us or our stockholders;\n(iii) any action asserting a claim against us arising pursuant to any provision of the Delaware General Corporation Law or our amended\nand restated certificate of incorporation or amended and restated bylaws; or (iv) any action asserting a claim governed by the internal\naffairs doctrine, in all cases to the fullest extent permitted by law. The provision would not apply to suits brought to enforce a duty\nor liability created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. Furthermore, our\ncertificate of incorporation also provides that unless we consent in writing to the selection of an alternative forum, the federal district\ncourts of the United States shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under\nthe Securities Act, including all causes of action asserted against any defendant to such complaint. For the avoidance of doubt, this\nprovision is intended to benefit and may be enforced by us, our officers and directors, the underwriters to any offering giving rise to\nsuch complaint, and any other professional entity whose profession gives authority to a statement made by that person or entity and who\nhas prepared or certified any part of the documents underlying the offering. In any case, stockholders will not be deemed to have waived\nour compliance with the federal securities laws and the rules and regulations thereunder. The enforceability of similar choice of forum\nprovisions in other companies’ certificates of incorporation has been challenged in legal proceedings, and it is possible that a\ncourt could find these types of provisions to be inapplicable or unenforceable. Our certificate of incorporation also provides that any\nperson or entity purchasing or otherwise acquiring any interest in shares of our capital stock will be deemed to have notice of and to\nhave consented to this choice of forum provision.

Amendment of Charter\nProvisions. The amendment of any of the above provisions, except for the provision making it possible for our board of directors\nto issue preferred stock, would require approval by holders of at least two thirds of the total voting power of all of our outstanding\nvoting stock.

The provisions of Delaware\nlaw, our certificate of incorporation and our bylaws could have the effect of discouraging others from attempting hostile takeovers and,\nas a consequence, they may also inhibit temporary fluctuations in the market price of our common stock that often result from actual or\nrumored hostile takeover attempts. These provisions may also have the effect of preventing changes in the composition of our board of\ndirectors and management. It is possible that these provisions could make it more difficult to accomplish transactions that stockholders\nmay otherwise deem to be in their best interests.

Transfer Agent

The transfer agent and registrar\nfor our common stock is Broadridge Corporate Issuer Solutions, LLC. The transfer agent’s address is 51 Mercedes Way, Edgewood, NY\n11717.

Listing

Our common stock is listed\non the Nasdaq Global Market under the trading symbol “ACTU.”

DILUTION

Our net tangible book\nvalue as of June 30, 2026 was approximately $0.99 million, or approximately $0.04 per share. Net tangible book value is determined by\nsubtracting our total liabilities from our total tangible assets, and net tangible book value per share is determined by dividing our\nnet tangible book value by the number of outstanding shares of our common stock. After giving effect to the sale of 40,000,000 shares\nof our common stock in this offering at the assumed public offering price of $0.50 per share, which was the last reported sale price\nof our common stock on the Nasdaq Global Market on October 15, 2026 (and assuming no sale of pre-funded warrants or exercise of purchase\nwarrants), and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us, our adjusted\nnet tangible book value as of June 30, 2026 would have been approximately $19.3 million, or approximately $0.30 per share. This represents\nan immediate increase in net tangible book value of approximately $0.26 per share to our existing stockholders and an immediate dilution\nin net tangible book value of approximately $0.20 per share to investors participating in this offering. The following table illustrates\nthis calculation on a per share basis:

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

Assumed public offering price per share of common stock			$	0.50
Net tangible book value per share as of June 30, 2026	$	0.04
Increase in net tangible book value per share attributable to investors participating in this offering		0.26
Adjusted net tangible book value per share after giving effect to this offering		0.30
Dilution per share to investors participating in this offering			$	0.20

If the underwriter exercises\nits option in full to purchase an additional 6,000,000 shares of common stock at the assumed public offering price of $0.50\nper share, our adjusted net tangible book value as of June 30, 2026, after giving effect to this offering, would have been approximately\n$0.32 per share, representing an increase in net tangible book value of approximately $0.28 per share to existing stockholders\nand immediate dilution in net tangible book value of approximately $0.18 per share to investors participating in this offering.

The number of shares of our\ncommon stock expected to be outstanding after this offering is based on 24,013,577 shares of common stock outstanding as of June 30, 2026,\nand excludes the following:

	·	2,755,836 shares of our common stock issuable upon the exercise of stock options outstanding as of June 30, 2026, at a weighted average exercise price of $5.14 per share;

	·	275,181 shares of our common stock issuable upon vesting of RSUs outstanding as of June 30, 2026;

	·	922,096 shares of common stock issuable upon the exercise of warrants outstanding as of June 30, 2026, at a weighted average exercise price of $7.87 per share;

	·	2,432,742 shares of common stock reserved for future issuance under our 2024 Plan as of June 30, 2026;

	·	3,364,407 shares of common stock issuable under the Committed Equity Facility with B. Riley;

	·	20,000,000\n additional shares of our common stock (23,000,000 additional shares if the underwriter exercises its over-allotment option\n in full) reserved for issuance upon exercise of purchase warrants offered hereby at an exercise price of $ per\n share;

	·	1,400,000 additional shares of our common stock (1,610,000 additional shares\n if the underwriter exercises its over-allotment option in full) reserved for issuance upon exercise of warrants, with an exercise\n price of $ per share, which will be issued to the underwriter at the close of this offering;

	·	3,000,000 additional shares of our common stock reserved for issuance upon exercise of warrants, with an exercise price of $ per share, which will be issued to the Bios Entities at the close of this offering; and

	·	700,000 additional shares of our common stock reserved for issuance upon exercise of warrants, with an exercise price of $ per share, which will be issued to the Kairos Entities at the close of this offering.

The above illustration of\ndilution per share to investors participating in this offering assumes no exercise of outstanding options or warrants to purchase our\ncommon stock (including the purchase warrants offered hereby) or vesting of RSUs. The exercise of outstanding options or warrants\nhaving an exercise or conversion price less than the assumed offering price would increase dilution to investors participating in this\noffering. In addition, we may choose to raise additional capital depending on market conditions, our capital requirements and strategic\nconsiderations, even if we believe we have sufficient funds for our current or future operating plans. To the extent that additional\ncapital is raised through our sale of equity or convertible debt securities, the issuance of these securities could result in further\ndilution to our stockholders.

UNDERWRITING

Newbridge Securities Corporation\n(“underwriter” or “Newbridge”) is acting as the underwriter of the offering. We have entered into an underwriting\nagreement, dated , 2026, with Newbridge. Subject to the terms and conditions\nof the underwriting agreement, we have agreed to sell to the underwriter named below and the underwriter named below has agreed to purchase,\nat the combined public offering price less the underwriting discounts and commissions set forth on the cover page of this prospectus,\nthe following number of shares of our common stock and warrants:

\n \n \n \n \n \n \n \n \n \n \n \n \n

Underwriter	Number of Shares	Number of Warrants
Newbridge Securities Corporation
Total

The underwriter is committed\nto purchasing all the shares of common stock and warrants offered by us other than those covered by the option to purchase additional\nshares and warrants described below, if they purchase any shares and warrants. The obligations of the underwriter may be\nterminated upon the occurrence of certain events specified in the underwriting agreement. Furthermore, pursuant to the underwriting agreement,\nthe underwriter’s obligations are subject to customary conditions, representations and warranties contained in the underwriting\nagreement, such as receipt by the underwriter of legal opinions, comfort letters and officer’s certificates.

We have agreed to indemnify\nthe underwriter against specified liabilities, including liabilities under the Securities Act, and to contribute to payments the underwriter\nmay be required to make in respect thereof.

The underwriter is offering\nthe common stock and warrants, subject to prior sale, when, as and if issued to and accepted by it, subject to approval of legal\nmatters by its counsel and other conditions specified in the underwriting agreement. The underwriter reserves the right to withdraw,\ncancel or modify offers to the public and to reject orders in whole or in part.

The underwriter proposes\nto offer the common stock and warrants offered by us to the public at the combined public offering price per two shares of common stock\nand accompanying purchase warrant set forth on the cover of this prospectus. In addition, the underwriter may offer some of the common\nstock and warrants to other securities dealers at such combined price less a concession of $ per two shares\nof common stock and accompanying purchase warrant. After this offering, the combined public offering price and concession to dealers\nmay be changed.

Discounts and Commissions.\nThe following table shows the combined public offering price, underwriting discount, and proceeds, before expenses, to us. The\ninformation assumes either no exercise or full exercise by the underwriter of its over-allotment option.

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

Total

Per Two Shares and Accompanying\n Warrant

Without Over-

Allotment

With Over-

Allotment

Combined public offering price

Underwriting discount (7%) to be paid by us:

Proceeds, before expenses, to us

In addition, we have also\nagreed to pay all fees, disbursements and expenses (including but not limited to all representations) in connection with this offering,\nincluding, without limitation, our legal and accounting fees and disbursements, the costs of preparing, printing and delivering registration\nstatements, prospectuses, and prospectus supplements and amendments, post-effective amendments and supplements thereto. In particular,\nwe have agreed to pay at each of the closings of this offering (including the offering of shares sold through the exercise of the over-allotment\noption, if any), to the extent not paid at earlier closings of this offering, all expenses incident to the performance of our obligations\nunder our engagement letter with the underwriter, including, but not limited to: (1) all filing fees and communication expenses relating\nto the registration of the shares of common stock to be sold in this offering (including the over-allotment shares) with the SEC; (2)\nall Public Offering System filing fees associated with the review of this offering by FINRA; (3) all fees and expenses relating to the\nlisting of the securities on the Nasdaq Stock Market; (4) all fees, expenses and disbursements relating to the registration, qualification\nor exemption of the offered common stock under the securities laws of such foreign jurisdictions as the Company and the underwriter together\ndetermine; (5) the costs of all mailing and printing of the offering documents (including, without limitation, the underwriting agreement,\nand, if appropriate, any agreement among underwriters, selected dealers’ agreement, underwriter’s questionnaire and power\nof attorney), registration statements, prospectuses and prospectus supplements, and all amendments, supplements and exhibits thereto\nand as many preliminary and final prospectuses as the underwriter may reasonably deem necessary; (6) the costs of preparing, printing\nand delivering certificates representing the securities; (7) fees and expenses of the transfer agent for the securities; and (8) stock\ntransfer and/or stamp taxes, if any, payable upon the transfer of securities from the Company to the underwriter.

Additionally, we will reimburse\nthe underwriter for its reasonable accountable expenses including actual accountable road show expenses for this offering; reasonable\nfees of the underwriter’s counsel up to an amount of $125,000 (which maximum shall apply solely to such fees and disbursements of\ncounsel and not to other fees and expenses); and background checks of our officers and directors.

We\n have paid a $25,000 expense advance to be credited against the accountable expenses actually\n incurred by the underwriter, which includes the reasonable fees of underwriter’s counsel,\n which will be returned to us to the extent such out-of-pocket accountable expenses are not\n actually incurred in accordance with FINRA Rule 5110(g)(4)(A). In no event will we be required\n to reimburse the underwriter for its expenses in excess of $125,000 (not including any costs\n related to the indemnification of our officers and directors).

We estimate that the total\nexpenses of the offering, excluding underwriting discount, will be approximately $268,516.

Over-Allotment Option

We have granted the underwriter\nan over-allotment option. This option, which is exercisable for up to 45 days after the closing of this offering, permits the underwriter\nto purchase up to [•] additional shares of common stock and warrants to purchase an additional shares of common stock, representing\n15% of the common stock and warrants sold in the offering, solely to cover over-allotments, if any. If the underwriter exercises\nall or part of this option, it will purchase shares of common stock and warrants covered by the option at the combined public\noffering price per two shares of common stock and accompanying- purchase warrant that appears on the cover page of this prospectus,\nless the underwriting discount.

Lock-Up Agreements

We, on behalf of ourselves\nand any successor entity, have agreed that, without the prior written consent of the underwriter, we will not, for a period of 120 days\nafter the closing of this offering, (i) offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option\nor contract to sell, grant any option, right or warrant to purchase, lend, or otherwise transfer or dispose of, directly or indirectly,\nany shares of our capital stock or any securities convertible into or exercisable or exchangeable for shares of our capital stock, subject\nto customary exceptions for exercises or conversion of outstanding derivative securities and equity grants approved by our compensation\ncommittee; (ii) file or cause to be filed any registration statement with the SEC relating to the offering of any shares of our capital\nstock or any securities convertible into or exercisable or exchangeable for shares of our capital stock other than a Form S-8; (iii) complete\nany offering of our debt securities, other than entering into a line of credit with a traditional bank or (iv) enter into any swap or\nother arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of our capital stock,\nwhether any such transaction described in clause (i), (ii), (iii) or (iv) above is to be settled by delivery of shares of our capital\nstock or such other securities, in cash or otherwise.

In addition, we and all of\nour directors and executive officers, other than Aaron Fletcher, Ph.D. and Todd Thomson, each of whom serves on our board of directors,\nhave agreed that, for a period of 120 days after the closing date of this offering, subject to certain limited exceptions, not to directly\nor indirectly, without the prior written consent of the underwriter, (a) offer, sell, or otherwise transfer or dispose of, directly or\nindirectly, any shares of capital stock of the Company or any securities convertible into or exercisable or exchangeable for shares of\ncapital stock of the Company; or (b) file or cause to be filed any registration statement with the SEC relating to the offering of any\nshares of capital stock of the Company or any securities convertible into or exercisable or exchangeable for shares of capital stock\nof the Company. The prior sentence will not apply to (i) the shares to be sold pursuant to the underwriting agreement, (ii) any shares\nof common stock issued upon the exercise of an option or other security outstanding on the date of the offering, (iii) such issuances\nof options or grants of restricted stock or other equity-based awards under an existing Company equity incentive plan, as amended, and\nthe issuance of shares issuable upon exercise of any such equity-based awards, (iv) the filing of registration statements on Form S-8,\n(v) the issuance of securities to affiliates and subsidiaries of the Company, and, (vi) the issuance of securities in connection with\nmergers, acquisitions, joint ventures, licensing arrangements or any other similar non-capital raising transactions. Further, the Bios\nEntities, Kairos Entities and their managing persons, Dr. Fletcher and Mr. Thomson, respectively, have agreed, subject to certain limited\nexceptions, not to sell, transfer or dispose of, directly or indirectly, any shares of our capital stock or securities convertible into\nor exercisable or exchangeable for our capital stock beneficially owned by them for a period of two years following the close of this\noffering.

The underwriter, in its sole\ndiscretion, may release the common stock and other securities subject to the lock-up agreements described above in whole or in part at\nany time. When determining whether or not to release common stock and other securities from lock-up agreements, the underwriter will consider,\namong other factors, the holder’s reasons for requesting the release, the number of shares of common stock and other securities\nfor which the release is being requested and market conditions at the time.

Underwriter’s Warrants

We\n have agreed to issue to the underwriter or its designees warrants to purchase up to a total\n of 3.5% of the shares of common stock and pre-funded warrants sold in this offering (including\n the shares and pre-funded warrants sold through the exercise of the over-allotment option,\n if any). The registration statement of which this prospectus forms a part registers for sale\n the Underwriter’s Warrants and the shares of our common stock issuable upon exercise\n of the Underwriter’s Warrants. The warrants are exercisable at $ per share (125% of\n the public offering price per share) for five (5) years from the commencement of sales of\n this offering in compliance with FINRA Rule 5110(g)(8)(A). The Underwriter’s Warrants\n have been deemed compensation by FINRA and are therefore subject to a 180-day lock-up pursuant\n to FINRA Rule 5110(e). The underwriter (or its permitted assignees under the Rule) will not\n sell, transfer, assign, pledge, or hypothecate these warrants or the shares of common stock\n underlying these warrants, nor will it engage in any hedging, short sale, derivative, put,\n or call transaction that would result in the effective economic disposition of the warrants\n or the underlying securities for a period of 180 days from the commencement of sales of the\n offering. The warrants may be exercised as to all, or a lesser number of shares of common\n stock and will provide for cashless exercise for the underlying shares. The Underwriter’s\n Warrants will provide for registration rights upon request, in certain cases. The sole demand\n registration right provided, if any, will not be greater than five years from the commencement\n of sales of the public offering in compliance with FINRA Rule 5110(g)(8)(C). The piggyback\n registration rights provided, if any, will not be greater than seven years from the commencement\n of sales of the public offering in compliance with FINRA Rule 5110(g)(8)(D). The Underwriter’s\n Warrants will have anti-dilution terms that are consistent with FINRA Rule 5110(g)(8)(E)\n and (F). We will bear all fees and expenses attendant to registering the securities issuable\n on exercise of the warrants other than underwriting commissions incurred and payable by the\n holders, if any. The exercise price and number of shares issuable upon exercise of the Underwriter’s\n Warrants may be adjusted in certain circumstances including in the event of a stock dividend,\n extraordinary cash dividend or our recapitalization, reorganization, merger or consolidation.\n However, the warrant exercise price or underlying shares will not be adjusted for issuances\n of shares of common stock at a price below the warrant exercise price.

Stabilization

In accordance with Regulation\nM under the Exchange Act, the underwriter may engage in activities that stabilize, maintain or otherwise affect the price of our common\nstock, including short sales and purchases to cover positions created by short positions, stabilizing transactions, syndicate covering\ntransactions, penalty bids and passive market making.

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

	·	Short positions involve\nsales by the underwriters of shares in excess of the number of shares the underwriters are obligated to purchase, which creates a syndicate\nshort position. The short position may be either a covered short position or a naked short position. In a covered short position, the\nnumber of shares involved in the sales made by the underwriters in excess of the number of shares they are obligated to purchase is not\ngreater than the number of shares that they may purchase by exercising their option to purchase additional shares. In a naked short position,\nthe number of shares involved is greater than the number of shares in their option to purchase additional shares. The underwriters may\nclose out any short position by either exercising its option to purchase additional shares or purchasing shares in the open market.

	·	Stabilizing transactions\npermit bids to purchase the underlying security as long as the stabilizing bids do not exceed a specific maximum price.

	·	Syndicate covering transactions\ninvolve purchases of our common stock in the open market after the distribution has been completed to cover syndicate short positions.\nIn determining the source of shares to close out the short position, the underwriters will consider, among other things, the price of\nshares available for purchase in the open market as compared to the price at which they may purchase shares through the underwriters’\noption to purchase additional shares. If the underwriters sell more shares than could be covered by the underwriters’ option to\npurchase additional shares, thereby creating a naked short position, the position can only be closed out by buying shares in the open\nmarket. A naked short position is more likely to be created if the underwriters are concerned that there could be downward pressure on\nthe price of the shares in the open market after pricing that could adversely affect investors who purchase in the offering.

	·	Penalty bids permit the\nunderwriters to reclaim a selling concession from a syndicate member when the common stock originally sold by the syndicate member is\npurchased in a stabilizing or syndicate covering transaction to cover syndicate short positions.

	·	In passive market making,\nmarket makers in our common stock who are underwriters or prospective underwriters may, subject to limitations, make bids for or purchase\nshares of our common stock until the time, if any, at which a stabilizing bid is made.

These activities may have\nthe effect of raising or maintaining the market price of our common stock or preventing or retarding a decline in the market price of\nour common stock. As a result of these activities, the price of our common stock may be higher than the price that might otherwise exist\nin the open market. These transactions may be effected on the Nasdaq Stock Market or otherwise and, if commenced, may be discontinued\nat any time.

Neither we nor the underwriter\nmake any representation or prediction as to the direction or magnitude of any effect that the transactions described above may have on\nthe price of our common stock. In addition, neither we nor the underwriter make any representation that the underwriter will engage in\nthese stabilizing transactions or that any transaction, once commenced, will not be discontinued without notice.

Offering Price Determination

The public offering price\nwas negotiated between the underwriter and us. In determining the public offering price of our common stock, the underwriter considered:

\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n

	·	the history and prospects for the industry in\nwhich we compete;

	·	our financial information;

	·	the ability of our management and our business\npotential and earning prospects;

	·	the prevailing securities markets at the time\nof this offering; and

	·	the recent market prices of, and the demand for,\npublicly traded shares of generally comparable companies, as well as the recent market price of our common stock.

Indemnification

We have agreed to indemnify\nthe underwriter, its affiliates and each person controlling the underwriter against any losses, claims, damages, judgments, assessments,\ncosts, and other liabilities, as the same are incurred (including the reasonable fees and expenses of counsel), relating to or arising\nout of the offering, undertaken in good faith.

Discretionary Accounts

The underwriter has informed\nus that it does not expect to make sales to accounts over which it exercises discretionary authority in excess of 5% of the shares of\nour common stock being offered in this offering.

Passive Market Making

In connection with this offering,\nthe underwriter and selling group members may engage in passive market making transactions in our securities on the Nasdaq Stock Market\nin accordance with Rule 103 of Regulation M under the Exchange Act, during a period before the commencement of offers or sales of the\nshares and extending through the completion of the distribution. A passive market maker must display its bid at a price not in excess\nof the highest independent bid of that security. However, if all independent bids are lowered below the passive market maker’s bid,\nthen that bid must then be lowered when specified purchase limits are exceeded.

Other Relationships

From time to time, the underwriter\nand/or its affiliates have provided, and may in the future provide, various investment banking and other financial services for us for\nwhich services it has received and, may in the future receive, customary fees. Except for the services provided in connection with this\noffering and other than as described below, the underwriter has not provided any investment banking or other financial services during\nthe 180-day period preceding the date of this prospectus.

An affiliate of Newbridge\nSecurities Corporation, the underwriter in this offering, has previously acted as a placement agent for Bios Partners, in raising capital\nfor Bios Fund III, NT and QP, LP and related special purpose vehicle funds Bios Actuate Co-Invest II, LP, Bios ONL Co-Invest I, LP and\nBios SIRPant Co-Invest I, LP (collectively, Bios Fund III Entities), managed by Bios Partners, LP, the largest shareholder of our Company.\nThe Bios Fund III Entities collectively own 5,006,131 shares of Actuate on an as converted and basis. Pursuant to the terms of that engagement,\nthe affiliate of Newbridge currently receives between 40.0% and 50.0% of the management fee and 20.0% of the final carried interest generated\nby the capital raised by Newbridge for Bios Fund III Entities, which includes amounts resulting from the management fee and returns generated\nby Bios Fund III Entities’ holdings in our Company. In 2026, as of the date of this prospectus, the affiliate of Newbridge was\npaid a management fee of approximately $350,296.

In addition, Newbridge\nserved as placement agent for approximately $7.1 million of the Company’s Series C financing between August 2022 and June 2023.\nIn connection with the engagement, Newbridge received an 8.5% cash fee of approximately $0.6 million, a reimbursement of $30,000 of expenses\nand a 2.0% warrant fee consisting of 18,223 Series C Warrants.

Offer Restrictions Outside the United States

Other than in the United States,\nno action has been taken by us or the underwriter that would permit a public offering of the securities offered by this prospectus in\nany jurisdiction where action for that purpose is required. The securities offered by this prospectus may not be offered or sold, directly\nor indirectly, nor may this prospectus or any other offering material or advertisements in connection with the offer and sale of any such\nsecurities be distributed or published in any jurisdiction, except under circumstances that will result in compliance with the applicable\nrules and regulations of that jurisdiction. Persons who come into possession of this prospectus are advised to inform themselves about\nand to observe any restrictions relating to the offering and the distribution of this prospectus. This prospectus does not constitute\nan offer to sell or a solicitation of an offer to buy any securities offered by this prospectus in any jurisdiction in which such an offer\nor a solicitation is unlawful.

Electronic Distribution

A prospectus in electronic\nformat may be made available on the websites maintained by the underwriter or selling group members, if any, participating in the offering.\nThe underwriter may allocate a number of shares to the underwriter and selling group members, if any, for sale to their online brokerage\naccount holders. Any such allocations for online distributions will be made by the underwriter on the same basis as other allocations.

Listing

Our common stock is listed\non the Nasdaq Global Market under the symbol “ACTU.”

LEGAL MATTERS

The\nvalidity of the securities offered by this prospectus has been passed upon for us by Greenberg Traurig, LLP, Irvine, California.\nLucosky Brookman, LLP, Woodbridge, New Jersey, is acting as counsel for the underwriter in connection with this offering.

EXPERTS

The\nconsolidated financial statements incorporated in this prospectus by reference to the Annual Report on Form 10-K for the year ended December\n31, 2025 have been so incorporated in reliance on the report of Crowe LLP, independent registered public accounting firm, given on the\nauthority of said firm as experts in auditing and accounting.

INCORPORATION\nBY REFERENCE

The SEC\nallows us to “incorporate by reference” information into this prospectus, which means that we can disclose important information\nto you by referring to those documents. We hereby “incorporate by reference” the documents listed below, which means that\nwe are disclosing important information to you by referring you to those documents. The Registration Statement, including the exhibits,\ncan be read at the SEC website referred to below under “Where You Can Find More Information.” The information that\nwe file later with the SEC will automatically update and in some cases supersede this information. Specifically, we incorporate by reference\nthe following documents or information filed with the SEC (other than, in each case, documents or information deemed to have been furnished\nand not filed in accordance with SEC rules):

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

	·	our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on March 26, 2026;

	·	our Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2026 and June 30, 2026, filed with the SEC on May 14, 2026 and August 14, 2026, respectively;

	·	our Definitive Proxy Statement on Schedule 14A, filed with the Commission on April 6, 2026; and

	·	our Current Reports on Form 8-K, filed with the SEC on May 6, 2026, May 22, 2026 and July 17, 2026.

In\naddition, all documents subsequently filed by us pursuant to Sections 13(a), 13(c), 14, or 15(d) of the Exchange Act (not including any\ninformation furnished under Item 2.02, 7.01, or 9.01 of Form 8-K or any other information that is identified as “furnished”\nrather than filed, which information is not incorporated by reference herein) after the initial filing date of the registration statement\nof which this prospectus is a part and prior to the effectiveness of the registration statement, as well as subsequent to the effectiveness\nof such registration statement and prior to the filing of a post-effective amendment which indicates that all securities offered have\nbeen sold or which deregisters all securities then remaining unsold, shall be deemed to be incorporated by reference in the registration\nstatement, of which this prospectus forms a part, and to be a part hereof from the date of filing of such documents.

Any\nstatement contained in a document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded\nfor purposes of the registration statement, of which this prospectus forms a part, to the extent that a statement contained herein, or\nin any other subsequently filed document that also is deemed to be incorporated by reference herein, modifies or supersedes such statement.\nAny statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of the registration\nstatement, of which this prospectus forms a part.

We\nwill provide without charge to each person, including any beneficial owner, to whom a prospectus is delivered, upon written or oral request\nof that person, a copy of any and all of the reports or documents that have been incorporated by reference in this prospectus but not\ndelivered with this prospectus. Please direct requests to us at the following address:

Actuate Therapeutics,\nInc.

1751 River\nRun, Suite 400

Fort Worth,\nTexas 76107

(817) 887-8455

You may also access these\nfilings on our website at www.actuatetherapeutics.com. Except for the specific incorporated\ndocuments listed above, no information available on or through our website shall be deemed to be incorporated in this prospectus or the\nregistration statement of which it forms a part.

WHERE YOU CAN FIND MORE INFORMATION

This\nprospectus is part of a registration statement we filed with the SEC and does not contain all the information set forth or incorporated\nby reference in the registration statement. Whenever a reference is made in this prospectus to any of our contracts, agreements, or other\ndocuments, the reference may not be complete and you should refer to the exhibits that are a part of the registration statement or the\nexhibits to the reports or other documents incorporated by reference into this prospectus for a copy of such contract, agreement, or other\ndocument. Because we are subject to the information and reporting requirements of the Exchange Act, we file annual, quarterly, and current\nreports, proxy statements, and other information with the SEC. The SEC maintains an Internet site that contains reports, proxy and information\nstatements, and other information regarding issuers that file electronically with the SEC. Our SEC filings are available to the public\nover the Internet on the SEC’s website at http://www.sec.gov.

$\"\"$

40,000,000 Shares of Common Stock

Warrants to Purchase 20,000,000 Shares of Common\nStock

20,000,000 Shares of Common Stock Underlying\nthe Purchase Warrants

Pre-Funded Warrants to Purchase 40,000,000 Shares\nof Common Stock

40,000,000 Shares of Common Stock Underlying\nthe Pre-Funded Warrants

\n \n \n \n \n \n \n

PRELIMINARY PROSPECTUS\n

Newbridge Securities Corporation

, 2026

PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13. Other Expenses\nof Issuance and Distribution

The\nfollowing table sets forth the estimated expenses to be borne by the registrant in connection with the issuance and distribution of the\nsecurities being registered hereby.

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

Item	Amount to be paid
SEC registration fee	$	3,067
FINRA filing fee		9,503
Accounting fees and expenses		40,000
Legal fees and expenses		200,000
Miscellaneous fees and expenses		15,946
Total	$	268,516

Item 14. Indemnification of Directors and Officers.

The following summary is qualified\nin its entirety by reference to the complete Delaware General Corporation Law, or the DGCL, our sixth amended and restated certificate\nof incorporation, or certificate of incorporation, and our amended and restated bylaws, or bylaws.

Section 145 of the DGCL\nprovides, generally, that a corporation shall have the power to indemnify any person who was or is a party or is threatened to be made\na party to any threatened, pending or completed action, suit or proceeding (except actions by or in the right of the corporation) by reason\nof the fact that such person is or was a director, officer, employee or agent of the corporation against all expenses, judgments, fines\nand amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding if such\nperson acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the corporation\nand, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful. A corporation\nmay similarly indemnify such person for expenses actually and reasonably incurred by such person in connection with the defense or settlement\nof any action or suit by or in the right of the corporation, provided that such person acted in good faith and in a manner he or she reasonably\nbelieved to be in or not opposed to the best interests of the corporation, and, in the case of claims, issues and matters as to which\nsuch person shall have been adjudged liable to the corporation, provided that a court shall have determined, upon application, that, despite\nthe adjudication of liability but in view of all of the circumstances of the case, such person is fairly and reasonably entitled to indemnity\nfor such expenses which such court shall deem proper.

Section 102(b)(7) of\nthe DGCL provides, generally, that our certificate of incorporation may contain a provision eliminating or limiting the personal liability\nof a director to the corporation or its shareholders for monetary damages for breach of fiduciary duty as a director, provided that such\nprovision may not eliminate or limit the liability of (i) a director or officer for any breach of the director’s duty of loyalty\nto the corporation or its shareholders, (ii) a director for acts or omissions not in good faith or which involve intentional misconduct\nor a knowing violation of law, (iii) a director under section 174 of the DGCL, or (iv) a director for any transaction from which\nthe director derived an improper personal benefit. No such provision may eliminate or limit the liability of a director for any act or\nomission occurring prior to the date when such provision became effective.

II-1

Our certificate of incorporation\nprovides that we will indemnify each person who was or is a party or is threatened to be made a party or is involved in any threatened,\npending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or\nin the right of us) by reason of the fact that he or she is or was, or has agreed to become, our director or officer, or is or was serving,\nor has agreed to serve, at our request as a director, officer, partner, employee or trustee of, or in a similar capacity with, another\ncorporation, partnership, joint venture, trust or other enterprise (including any employee benefit plan) (all such persons being referred\nto as an “Indemnitee”), or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses\n(including attorneys’ fees), liabilities, losses, judgments, fines (including excise taxes and penalties arising from the Employee\nRetirement Income Security Act of 1974), and amounts paid in settlement actually and reasonably incurred in connection with such action,\nsuit or proceeding and any appeal therefrom, if such Indemnitee acted in good faith and in a manner he or she reasonably believed to be\nin, or not opposed to, our best interests, and, with respect to any criminal action or proceeding, he or she had no reasonable cause to\nbelieve his or her conduct was unlawful. Our certificate of incorporation also provides that we will indemnify any Indemnitee who was\nor is a party to an action or suit by or in the right of us to procure a judgment in our favor by reason of the fact that the Indemnitee\nis or was, or has agreed to become, our director or officer, or is or was serving, or has agreed to serve, at our request as a director,\nofficer, trustee, partner, managing member, fiduciary, employee or agent of any other corporation, limited liability company, partnership,\njoint venture, trust or other enterprise, or by reason of any action alleged to have been taken or omitted in such capacity, against all\nexpenses (including attorneys’ fees) and, to the extent permitted by law, amounts paid in settlement actually and reasonably incurred\nin connection with such action, suit or proceeding, and any appeal therefrom, if the Indemnitee acted in good faith and in a manner he\nor she reasonably believed to be in, or not opposed to, our best interests, except that no indemnification shall be made with respect\nto any claim, issue or matter as to which such person shall have been adjudged to be liable to us, unless a court determines that, despite\nsuch adjudication but in view of all of the circumstances, he or she is entitled to indemnification of such expenses. Notwithstanding\nthe foregoing, to the extent that any Indemnitee has been successful, on the merits or otherwise, he or she will be indemnified by us\nagainst all expenses (including attorneys’ fees) actually and reasonably incurred by him or her or on his or her behalf in connection\ntherewith. If we do not assume the defense, expenses must be advanced to an Indemnitee under certain circumstances.

Our board of directors has\napproved a form of indemnification agreement that has been executed by each of our directors and executive officers. In general, these\nagreements provide that we will indemnify the director or executive officer to the fullest extent permitted by law for claims arising\nin his or her capacity as a director or executive officer of our company or in connection with their service at our request for another\ncorporation or entity. The indemnification agreements also provide for procedures that will apply in the event that a director or executive\nofficer makes a claim for indemnification and establish certain presumptions that are favorable to the director or executive officer.

Additionally, we maintain\na general liability insurance policy that covers certain liabilities of our directors and officers arising out of claims based on acts\nor omissions in their capacities as directors or officers.

Item 15. Recent Sales of Unregistered Securities.

In February, March and May\n2024, we issued and sold to a certain accredited investor convertible promissory notes, with principal amounts of $3.0 million, $1.5 million\nand $1.0 million, respectively. In connection with the closing of our initial public offering (“IPO”) on August 14, 2024,\nwe issued to the noteholders 884,427 shares of our common stock upon the conversion of the convertible promissory notes, including accrued\ninterest thereon, at a conversion price of $6.40 per share, representing 80% of the IPO price of $8.00 per share.

In\nAugust 2024, in connection with the IPO, we issued to the underwriters, Titan Partners Group LLC, a division of American Capital Partners,\nLLC, and Newbridge Securities Corporation, warrants to purchase up to 161,000 shares of common stock, representing 5% of the shares of\ncommon stock issued under the IPO, at an exercise price of $10.00 per share, representing 125% of the IPO price. The warrants became exercisable\non February 8, 2025 and expire on August 12, 2027. The warrants can only be exercised on a cash basis through November 11, 2025 and only\non a cashless basis on November 12, 2025 and thereafter.

II-2

In March 2025, we entered\ninto a common stock purchase agreement with B. Riley (the “Purchase Agreement”), pursuant to which we have the right to sell\nto B. Riley up to 3,904,374 shares of common stock, subject to certain limitations and the satisfaction of specified conditions in the\nPurchase Agreement, from time to time over the 36-month period beginning on the Commencement Date (as defined in the Purchase Agreement).\nAs of June 30, 2026, we have sold an aggregate of 539,967 shares of our common stock to B. Riley for proceeds of $3,800,465, net of discounts\nand offering costs.

In June 2025, we entered into\nthe Securities Purchase Agreement for the private placement of an aggregate of (i) 666,497 shares of common stock, at a purchase price\nof $7.00 per share, and (ii) warrants to purchase up to an aggregate of 666,497 shares of common stock, with an exercise price of $7.00\nper share, for aggregate gross proceeds of approximately $4.7 million, and additional gross proceeds of up to approximately $4.7 million\nif all warrants are exercised in full.

The securities in the above\ntransactions were offered and sold pursuant to Section 4(a)(2) of the Securities Act and Rule 506 thereunder, as transactions not involving\na public offering. The recipients of the securities in each of these transactions represented their intentions to acquire the securities\nfor investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends were placed\nupon the certificates and warrants issued in these transactions. All recipients had adequate access, through their relationships with\nus, to information about our Company. The sales of these securities were made without any general solicitation or advertising. There was\nno sales commission paid in connection with any of the transactions.

Item 16. Exhibits and Financial Statement Schedules.

(a) Exhibits

The exhibits to the registration\nstatement are listed in the Exhibit Index attached hereto and incorporated by reference herein.

(b) Financial\nStatement Schedules

No financial statement schedules\nare provided because the information called for is not required or is shown either in financial statements or the related notes.

Exhibit Index

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

Exhibit Number		Description of Document

1.1*		Form of Underwriting Agreement between the Registrant and Newbridge Securities Corporation
3.1		Sixth\n Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Registrant’s Current Report on\n Form 8-K as filed on August 14, 2024)
3.2		Amended\n and Restated Bylaws of the Registrant (incorporated by reference to Registrant’s Current Report on Form\n 8-K as filed on August 14, 2024)
4.1		Form\n of Common Stock Certificate of the Registrant (incorporated by reference to Registrant’s Registration Statement on Form\n S-1/A, filed with the SEC on June 11, 2024)
4.2		Fourth Amended and Restated Investors’ Rights Agreement by and between the Registrant and certain of its stockholders, dated November 30, 2022 (incorporated by reference to Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024)
4.3		Form of Representative Warrant issued to Underwriter under IPO (incorporated by reference to Registrant’s Registration Statement on Form S-1/A, filed with the SEC on June 11, 2024)
4.4		Form of Second Amended and Restated Warrant issued to holders of Convertible Redeemable Preferred Stock (incorporated by reference to Registrant’s Registration Statement on Form S-1/A, filed with the SEC on June 11, 2024)
4.5		Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934 (incorporated by reference to Registrant’s Annual Report on Form 10-K, filed with the SEC on March 13, 2025)

II-3

4.6		Form of Warrant, dated June 25, 2025, by and among Registrant and each of the purchasers party thereto under the Securities Purchase Agreement (incorporated by reference to Registrant’s Current Report on Form 8-K as filed on June 26, 2025)
4.7*		Form of Pre-Funded Common Stock Purchase Warrant
4.8*		Form of Purchase Warrant offered in October 2026 public offering
4.9*		Form of Underwriter’s Warrant
4.10*		Form of Warrant Agency Agreement between the Registrant and Broadridge Corporate Issuer Solutions, LLC, as warrant agent
5.1*		Opinion of Greenberg Traurig, LLP
\n 10.1±		Exclusive License Agreement with Equity, dated April 6, 2015, as amended, between The Board of Trustees of the University of Illinois and the Registrant (incorporated by reference to Registrant’s Registration Statement on Form S-1/A, filed with the SEC on July 16, 2024)
\n 10.2± \n		License Agreement, dated March 31, 2015, as amended, between Northwestern University and the Registrant (incorporated by reference to Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024)
\n 10.3+ \n		Actuate Therapeutics, Inc. 2015 Equity Incentive Plan, as amended, and form of grant agreements thereunder (incorporated by reference to Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024)
\n 10.4+ \n		Actuate Therapeutics, Inc. 2024 Equity Incentive Plan (incorporated by reference to Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024)
\n 10.5+		Form of Stock Option Agreement under the Actuate Therapeutics, Inc. 2024 Stock Incentive Plan (incorporated by reference to Registrant’s Registration Statement on Form S-1/A, filed with the SEC on June 11, 2024)
\n 10.6+		Form of Restricted Stock Unit Agreement under the Actuate Therapeutics, Inc. 2024 Stock Incentive Plan (incorporated by reference to Registrant’s Registration Statement on Form S-1/A, filed with the SEC on June 11, 2024)
\n 10.7+		Non-Employee Director Compensation Policy (incorporated by reference to Registrant’s Registration Statement on Form S-1/A, filed with the SEC on June 21, 2024)
\n 10.8+		Employment Agreement, effective April 15, 2015 and as amended on each of February 5, 2016, September 28, 2017, September 23, 2018, January 29, 2019, August 1, 2022, January 27, 2023 December 12, 2023 and May 9, 2024, between Daniel Schmitt, and the Registrant (incorporated by reference to Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024)
\n 10.9+		Employment Agreement, effective June 1, 2022, between Andrew P. Mazar, Ph.D. and the Registrant (incorporated by reference to Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024)
\n 10.10+		Employment Agreement, effective June 1, 2024, between Paul Lytle, and the Registrant (incorporated by reference to Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024)
10.11		Form of Indemnification Agreement for Directors and Officers (incorporated by reference to Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024)
10.12+		Tenth Amendment to Employment Agreement by and between Daniel Schmitt and the Registrant dated March 11, 2025 (incorporated by reference to Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 15, 2025)
10.13+		First Amendment to Employment Agreement by and between Andrew P. Mazar, Ph.D. and the Registrant dated March 11, 2025 (incorporated by reference to Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 15, 2025)
10.14+		First Amendment to Employment Agreement by and between Paul Lytle and the Registrant dated March 11, 2025 (incorporated by reference to Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 15, 2025)
10.15		Securities Purchase Agreement, dated March 27, 2025, by and between Registrant and B. Riley Principal Capital II, LLC (incorporated by reference to Registrant’s Current Report on Form 8-K as filed on March 28, 2025)
10.16		Registration Rights Agreement, dated March 27, 2025, by and between Registrant and B. Riley Principal Capital II, LLC (incorporated by reference to Registrant’s Current Report on Form 8-K as filed on March 28, 2025)
10.17		Form of Securities Purchase Agreement, dated June 25, 2025, by and among Registrant and each of the purchasers party thereto (incorporated by reference to Registrant’s Current Report on Form 8-K as filed on June 26, 2025)
10.18		Form of Registration Rights Agreement, dated June 25, 2025, by and among Registrant and each of the purchasers party thereto (incorporated by reference to Registrant’s Current Report on Form 8-K as filed on June 26, 2025)
10.19		At the Market Issuance Sales Agreement dated as of November 28, 2025 between Registrant, on the one hand, and B. Riley Securities, Inc. and Craig-Hallum Capital Group LLC, on the other (incorporated by reference to Registrant’s Current Report on Form 8-K as filed on November 28, 2025)
10.20**		Letter\n Agreement, dated as of October 2, 2026, by and between the Registrant and Bios Partners, L.P.
10.21**		Letter\n Agreement, dated as of October 2, 2026, by and between the Registrant and Kairos Venture Investments, LLC
19.1		Insider Trading Policy (incorporated by reference to Registrant’s Annual Report on Form 10-K, filed with the SEC on March 13, 2025)

II-4

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

21.1		Subsidiaries\n of the Registrant (incorporated by reference to Registrant’s Annual Report on Form 10-K,\nfiled with the SEC on March 26, 2026)
23.1*		Consent of Crowe LLP, Independent Registered Public Accounting Firm
23.2*		Consent of Greenberg Traurig, LLP (included within the opinion filed as Exhibit 5.1)
24.1**		Power\n of Attorney (previously included on the signature page to the Registration Statement filed on October 6, 2026)
101.INS		Inline XBRL Instance Document
101.SCH		Inline XBRL Taxonomy Extension Schema Document
101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB		Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document
101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document
107*		Filing Fee Table

_____________________

\n \n \n \n \n \n \n \n \n \n \n \n \n

*	Filed herewith.
**	Previously filed
+	Indicates management contract or compensatory plan.
\n ± \n \n \n	\n Certain portions of this exhibit have been\nomitted pursuant to Item 601(b)(10) of Regulation S-K on the basis that they are not material and would likely cause competitive harm\nto the registrant if disclosed.

Item 17. Undertakings

The\nundersigned registrant hereby undertakes:

(1)

To file, during any period in which offers or sales are being made,\na post-effective amendment to this registration statement:

To include any prospectus required by Section 10(a)(3) of the Securities\nAct of 1933, as amended;

ii.

To reflect in the prospectus any facts or events arising after the\neffective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate,\nrepresent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase\nor decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered)\nand any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with\nthe SEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum\naggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement;\nand

iii.

To include any material information with respect to the plan of\ndistribution not previously disclosed in the registration statement or any material change to such information in the registration statement.

provided, however,\nthat paragraphs (1)(i), (ii) and (iii) above do not apply if the information required to be included in a post-effective\namendment by those paragraphs is contained in reports filed with or furnished to the SEC by the registrant pursuant to section 13\nor section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement or is contained\nin a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.

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(2)

That, for the purpose of determining any liability under the Securities\nAct, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein,\nand the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

(3)

To remove from registration by means of a post-effective amendment\nany of the securities being registered which remain unsold at the termination of the offering.

(4)

That, for the purpose of determining liability under the Securities\nAct of 1933 to any purchaser, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering,\nother than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to\nbe part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no\nstatement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated\nor deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as\nto a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration\nstatement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first\nuse.

(5)

The undersigned registrant hereby undertakes that, for purposes\nof determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to Section\n13(a) or 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report\npursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall\nbe deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time\nshall be deemed to be the initial bona fide offering thereof.

(6)

Insofar as indemnification for liabilities arising under the Securities\nAct may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise,\nthe registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities\nAct and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by\nthe registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of\nany action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered,\nthe registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate\njurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed\nby the final adjudication of such issue.

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SIGNATURES

Pursuant to the requirements\nof the Securities Act, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing\non Form S-1 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized,\nin the City of Fort Worth, Texas on this October 19, 2026.

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

	ACTUATE THERAPEUTICS, INC.

	By:	/s/ Daniel M. Schmitt
		Daniel M. Schmitt
		President and Chief Executive Officer

Pursuant to the requirements\nof the Securities Act of 1933, as amended, this Registration Statement has been signed by the following persons on behalf of the registrant\nand in the capacities and on the dates indicated.

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

Name	Position	Date

/s/ Daniel M. Schmitt	President, Chief Executive Officer and Director	October 19, 2026
Daniel M. Schmitt	(principal executive officer)

/s/ Paul Lytle	Chief Financial Officer	October 19, 2026
Paul Lytle	(principal financial and accounting officer)

*	Director and Chairperson	October 19, 2026
Aaron G.L. Fletcher, Ph.D.

*	Director	October 19, 2026
Martin H. Huber, M.D.

*	Director	October 19, 2026
Jason Keyes

*	Director	October 19, 2026
Amy Ronneberg

*	Director	October 19, 2026
Roger Sawhney, M.D.

	Director	October 19, 2026
Todd Thomson

*	Director	October 19, 2026
Daniel Zabrowski, Ph.D.

\n\n\n

*	By: /s/ Daniel M. Schmitt
	Daniel M. Schmitt, Attorney-in Fact

II-7

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