UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________________________ FORM 10-Q ____________________________________________________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________to _________________ Commi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________________________ FORM 10-Q ____________________________________________________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________to _________________ Commission ...

公司产品及发展 - Carisma Therapeutics Inc.是一家临床阶段的细胞治疗公司，专注于利用其专有的巨噬细胞和单核细胞工程平台开发革命性的免疫疗法，以治疗癌症和其他严重疾病[13] - Carisma Therapeutics Inc.的首席产品候选药物CT-0508是第一个在人类临床试验中评估的CAR-M，旨在治疗过表达HER2的实体肿瘤[14] - CT-0508在多中心开放标签的第一阶段临床试验中表现出良好的制造可行性，高CAR表达率，存活率和纯度[14] - Carisma Therapeutics Inc.的第二个产品候选药物CT-0525也旨在治疗过表达HER2的实体肿瘤，目前处于临床前开发阶段[15] - CT-0525利用一种新颖的CAR-Monocyte疗法，通过直接工程化患者的单核细胞，而无需像CT-0508那样在体外分化成巨噬细胞，以加速制造过程[15] - Carisma Therapeutics Inc.预计在2023年下半年向美国食品和药物管理局提交CT-0525的IND，并在此后不久启动临床开发[16] - Carisma Therapeutics Inc.除了CT-0508和CT-0525外，还有一系列处于不同阶段的临床前开发的细胞疗法资产[17] - Carisma Therapeutics Inc.与ModernaTX Inc.建立了战略合作伙伴关系，以推进公司的体内CAR-M治疗[17] - Carisma Therapeutics Inc.于2023年3月7日与CTx Operations, Inc.完成了一项反向合并，从而完成了与Sesen Bio, Inc.的合并[18] 财务状况及风险 - 公司目前拥有1.39亿美元的现金、现金等价物和可交易证券[181] - 公司需要大量额外资金支持持续运营[176] - COVID-19大流行可能影响公司的临床试验和运营[189] - 公司在合并之前一直处于累计亏损状态，预计在可预见的未来仍将继续遭受重大亏损[201] - 公司拥有联邦、州和地方的净利润亏损(NOLs)分别为9420万美元、9420万美元和7430万美元，以及联邦研发税收抵免额度总计560万美元[201] - 公司的未来成功取决于新疗法方法的成功开发，目前的科学证据仍然初步和有限[205] - 公司的宏噬细胞工程平台可能无法按预期时间表或成本效率高的方式扩展产品线，这可能导致公司潜在价值下降并严重损害业务前景[207] - 公司的产品开发成本将增加，如果在进行前期研究或临床试验方面遇到延迟，或在获得营销批准方面遇到延迟[224] - 公司目前处于临床试验阶段，尚未获得任何产品的市场批准[242] - 临床试验结果可能会揭示不良副作用，导致试验暂停或终止[239] - 临床试验延迟可能导致开发成本增加，影响公司价值[236] - 公司可能会集中资源开发某一产品候选者或适应症，而错失更有利可图或更有成功可能性的产品候选者或适应症[244] - 公司的发现项目可能无法成功识别适用于治疗癌症或其他疾病的产品候选者[251] - 公众对基因医学，尤其是基因疗法的负面看法可能影响公司潜在产品的监管批准或需求[254] - 即使公司的产品候选者获得市场批准，也可能无法获得医生、患者、第三方支付者和医学界其他人士对其商业成功所必需的市场接受度[256]

HA RNE S S I NG THE PO W E R O F E NG I NE E RE D M A C RO PHA G E S Carisma Therapeutics Cautionary Note Regarding Forward-Looking Statements Regarding Carisma Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating ...

Maximizing Value for Sesen Bio Stockholders Forward-Looking Statements and Additional Disclaimers Forward-Looking Statements Any statements in this communication about future expectations, plans and prospects for SesenBio, Inc. (SesenBio), CARISMA Therapeutics Inc. (Carisma) or the combined company, SesenBio’s, Carisma’sor the combined company’s strategy or future operations, and other statements containing the words “anticipate,” “believe,” “contemplate,” “expect,” “intend,” “may,” “plan,” “predict,” “targ ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-36296 Sesen Bio, Inc. (Exact name of registrant as specified in its charter) Delaware 26-2025616 (State or other jurisdi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-36296 Sesen Bio, Inc. (Exact name of registrant as specified in its charter) Delaware 26-2025616 (State or othe ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-36296 Sesen Bio, Inc. (Exact name of registrant as specified in its charter) Delaware 26-2025616 (State or other jur ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-36296 Sesen Bio, Inc. (Exact name of registrant as specified in its charter) Delaware 26-2025616 (State or other ju ...

(Mark One) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒ Indicate by check mark whether the registrant (1) has filed all reports required to be file ...