Calidi Biotherapeutics(CLDI)
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Calidi Biotherapeutics(CLDI) - 2023 Q4 - Annual Report
2024-03-16 05:28
公司概况 - 公司是一家免疫肿瘤学公司,尚未从产品销售中产生任何收入[113] - 公司自成立以来一直专注于筹集资金和开发初始产品候选药物,累计亏损约9960万美元[114] - 公司预计未来将继续承担重大支出和运营亏损[114] - 公司的未来资本需求将取决于许多因素,包括产品发现、临床试验等方面的进展和成本[123] - 公司可能需要通过出售额外的普通股或其他证券或发行债务来筹集所需的现金[126] 产品候选人 - 公司产品候选人是经过改良的病毒[133] - 临床试验的延迟可能会影响产品候选人的商业前景[135] - 产品候选人的市场接受度取决于多个因素,包括临床试验中的效果[135] 竞争与监管 - 公司面临着来自其他公司的激烈竞争,包括大型制药公司和生物技术公司[138] - FDA和其他监管机构的审批过程漫长、耗时且不可预测[139] - FDA的突破性疗法认定并不一定会加快产品候选人的审批过程[140] COVID-19影响 - FDA在COVID-19大流行期间暂停了对国外制造设施和产品的大部分检查[143] - COVID-19大流行可能影响公司的临床试验、监管活动、制造和供应链,对业务和运营产生不利影响[166] - COVID-19大流行可能导致员工短缺、供应链中断、设施和生产暂停,对公司业务和运营产生直接和间接影响[166] 法律与法规 - 美国和许多外国司法管辖区已经或提出了影响医疗保健系统的立法和监管变化,可能阻止或延迟我们当前或任何未来产品候选人的上市批准[151] - 公司需遵守反腐败法和其他法律,否则可能面临严重后果[177] - 最近的税法变化可能对公司业务或财务状况产生不利影响[179] 风险与挑战 - 公司的持续亏损和需要额外资金的情况对公司作为持续经营实体的能力提出了重大质疑[172] - 公司可能需要削减临床和研发项目,以节省现金[174] - 公司可能面临产品责任风险,可能导致巨额赔偿和限制产品商业化[175]
Calidi Biotherapeutics to Highlight Novel Systemic Enveloped Oncolytic Virotherapy Platform Designed to Target All Tumor Sites at Upcoming Conference
Businesswire· 2024-02-12 20:00
Calidi Biotherapeutics介绍 - Calidi Biotherapeutics宣布将在Biocom Global Life Science Partnering & Investor Conference上介绍公司的系统包膜溶瘤病毒疗法平台的发展细节[1] - ImmunoNova项目利用工程化和包膜天花病毒,在靶向全身的晚期转移性疾病方面显示出潜在的前景[2] - Calidi的系统包膜溶瘤病毒疗法在改变肿瘤免疫微环境和消灭远程和多样性肿瘤方面表现出有效性[2] - Calidi的疗法通过激活免疫系统,最终消除肿瘤,为晚期实体肿瘤的癌症患者带来革命性的治疗前景[3]
Calidi Biotherapeutics(CLDI) - 2023 Q3 - Quarterly Report
2023-11-14 00:00
On October 27, 2022, the California Institute for Regenerative Medicine ("CIRM") approved Calidi's application for a CIRM grant for Calidi's continued development of the SNV1 program. CIRM awarded Calidi approximately $3.1 million of CIRM funding conditioned that Calidi co-fund approximately $0.8 million under the requirements of the CIRM application. On December 28, 2022, Calidi received the Notice of Award from CIRM for this grant and Calidi expects to be able to draw the funds over the next 18 months bas ...
Calidi Biotherapeutics(CLDI) - 2023 Q2 - Quarterly Report
2023-08-21 00:00
The Company established the initial fair value for the warrants on September 14, 2021, the date of the consummation of the Company's IPO. The Company used a lattice model and Monte Carlo simulation model to value the warrants. The Company allocated the proceeds received from (i) the sale of Units (which is inclusive of one share of Class A common stock and one-half of one Public Warrant), (ii) the sale of Private Placement Warrants, and (iii) the issuance of Class B common stock, first to the warrants based ...
Calidi Biotherapeutics(CLDI) - 2023 Q1 - Quarterly Report
2023-05-15 00:00
首次公开募股 - 公司于2021年9月14日完成首次公开募股,发行了23,000,000单位,募集约2.3亿美元[108] 财务状况 - 截至2023年3月31日,公司净亏损约220万美元,主要由运营成本、前期购买单位责任公允价值变动损失、未来利息责任公允价值变动损失和所得税准备等构成[112] 公司活动 - 公司自成立以来至2023年3月31日,活动主要集中在公司的形成、首次公开募股以及寻找业务组合候选公司[111] 业务合并 - 公司对于与Calidi的业务合并的前瞻性购买协议不承担购买义务,并决定不购买这些股票[127] 会计处理 - 公司根据美国通用会计准则对14,897,155份权证进行会计处理,将其作为权益类或负债类工具,并根据ASC 480和ASC 815的相关指导进行评估[129] - 公司根据ASC Topic 815对5,000,000份前瞻性购买单位进行会计处理,将其作为负债类工具按公允价值计量,并在后续报告日期记录公允价值变动[130]
Calidi Biotherapeutics(CLDI) - 2022 Q4 - Annual Report
2023-03-31 00:00
Title of each classTrading Symbol(s)Name of each exchange on which registered Units, each consisting of one share of Class A common stock, $0.0001 par value per share, and one-half of one redeemable warrant Shares of Class A common stock, par value $0.0001 per share FLAG NYSE American LLC FLAGW NYSE American LLC (Mark One) OR UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FLAGU NYSE American LLC Redeemable warrants included as part of the units, each whole warrant exercisable for on ...
Calidi Biotherapeutics(CLDI) - 2022 Q3 - Quarterly Report
2022-11-14 00:00
Table of Contents Title of each classTrading SymbolsName of each exchange on which registered Units, each consisting of one Class A common stock and one-half of one redeemable warrant FLAGU New York Stock Exchange Class A common stock, par value $0.0001 per share FLAG New York Stock Exchange Redeemable warrants, each whole warrant exercisable for one share of Class A common stock at an exercise price of $11.50 per share FLAGW New York Stock Exchange UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washingto ...
Calidi Biotherapeutics(CLDI) - 2022 Q2 - Quarterly Report
2022-08-10 00:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to to Commission File Number: 001-40789 FIRST LIGHT ACQUISITION GROUP, INC. (Exact name of registrant as specified in its charter) Delaware 86-2967193 (Sta ...
Calidi Biotherapeutics(CLDI) - 2022 Q1 - Quarterly Report
2022-05-11 00:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to to Commission File Number: 001-40789 FIRST LIGHT ACQUISITION GROUP, INC. (Exact name of registrant as specified in its charter) Delaware 86-2967193 (St ...
Calidi Biotherapeutics(CLDI) - 2021 Q4 - Annual Report
2022-03-31 00:00
Table of Contents Title of each classTrading Symbol(s) Name of each exchange on which registered Units, each consisting of one share of Class A common stock, $0.0001 par value, and one-half of one redeemable warrant FLAGU New York Stock Exchange Shares of Class A common stock, par value $0.0001 per share FLAG New York Stock Exchange Redeemable warrants included as part of the units, each whole warrant exercisable for one share of Class A common stock at an exercise price of $11.50 per share FLAGW New York S ...