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, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39334 Biora Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 27-3950390 (State or other jurisdiction of ...

Biora Therapeutics, Inc. (NASDAQ:BIOR) Q4 2022 Earnings Conference Call March 30, 2023 4:30 PM ET Company Participants Chuck Padala – Managing Director-LifeSci Advisors Adi Mohanty – Chief Executive Officer Eric d'Esparbes – Chief Financial Officer Conference Call Participants Julian Harrison – BTIG Sahil Kazmi – B. Riley Securities Operator Thank you for standing by. This is the conference operator. Welcome to the Biora Therapeutics Fourth Quarter 2022 Financial Results Conference Call. As a reminder, all ...

Biora Therapeutics, Inc.业务及产品 - Biora Therapeutics, Inc.是一家生物技术公司，开发口服生物治疗药物，包括NAVICAPTM靶向口服递送平台和BIOJETTM全身口服递送平台[12] - NAVICAP靶向药物递送平台旨在提高炎症性肠道疾病（IBD）患者的治疗效果，最大限度地减少全身毒性[13] - NAVICAP靶向药物递送设备是一种临床阶段的单次使用可吞服设备，设计用于在肠道局部传递精确剂量的药物[19] - GITRACTM自主定位技术可自主识别胃肠道的解剖位置，提高设备在肠道的定位准确性[20] - Biora Therapeutics进行了三项临床研究，评估NAVICAP设备在人体中的功能[21] - BT-600（NAVICAP +托法替尼）和BT-001（NAVICAP +阿达木单抗变体）是Biora Therapeutics的两个主要项目，旨在提高溃疡性结肠炎（UC）患者的治疗效果[27] - BT-600是一种口服液体托法替尼制剂，通过NAVICAP递送，有望提高药物在结肠组织中的浓度，降低全身毒性[29] - BT-600的临床前研究结果表明，通过NAVICAP递送的托法替尼在结肠组织中的药物水平至少比口服托法替尼片剂高25倍[31] - BT-600在犬模型中的临床前研究表明无不良事件或安全信号[32] - BT-001是用于溃疡性结肠炎治疗的抗TNF-alpha单克隆抗体的液体制剂[33] - BT-001目前处于临床前阶段开发，使用我们开发和扩大到GMP级别材料的抗TNF-alpha抗体制剂[38] - BIOJET系统药物递送平台设计用于将大分子药物通过无针注射口径直接注射到小肠中，以实现最佳生物利用度[40] - BT-002是用于自身免疫疾病治疗的抗TNF-alpha单克隆抗体的液体制剂[51] - BT-200是用于2型糖尿病治疗的GLP-1受体激动剂的液体制剂[57] Biora Therapeutics, Inc.市场前景及竞争 - IBD治疗市场估计超过150亿美元，Biora Therapeutics的技术有望改善患者的治疗结果[16] - 生物技术药物市场估计超过2500亿美元，其中单克隆抗体市场超过1000亿美元[42] - 我们的解决方案是通过使用可进食胶囊进行系统性生物制剂的口服途径，以帮助提高患者依从性和降低静脉输液成本[45] - 目前IBD市场由多种治疗药物组成，包括品牌和仿制的小分子药物、生物制剂和生物类似物[66] - 我们的技术平台将通过口服途径实现治疗药物的定向传递，但将面临来自多家公司的竞争，这些公司的研发工作可能会导致新的药物问世[66] Biora Therapeutics, Inc.监管及合规 - FDA要求每个制造商初步确定是否需要新的510(k)清关或PMA申请[97] - FDASIA简化了de novo分类路径，允许制造商直接请求de novo分类[100] - PMA必须提交大量数据以证明设备的安全性和有效性[101] - FDA有180天审查PMA，但实际审查通常需要更长时间[102] - FDA可能要求PMA后市场监测以保护公共健康或提供额外的安全性和有效性数据[106] - 临床试验通常需要支持PMA，并有时需要支持510(k)预市场通知[107] - Breakthrough Devices计划旨在加速某些医疗设备的审查和发展[110] - 制造商必须遵守FDA的QSR，包括严格的设计、测试、生产控制等质量保证程序[113] - FDA可能对制造商进行定期或不定期的检查，以确定是否符合QSR要求[115] - 在设备商业化后，制造商可能会面临FDA的突击检查，以确定是否符合QSR要求[114] - 在美国，公司在上市前需要完成一系列步骤，包括实验室测试、动物研究、提交IND、临床试验、BLA或NDA提交和FDA批准[122] - 在美国进行人体临床试验前，公司必须生成广泛的临床前数据[123] - 临床试验包括对健康人群或患者进行药物管理，受到广泛监管，必须符合GCP要求[127] - 快速通道指定、优先审查、加速批准和突破性疗法指定不会改变批准标准，可能不会导致更快或更高效的审查[148] - 通过505(b)(2) NDAs获得FDA批准的替代途径允许依赖先前批准的药物产品的研究结果，但赞助商必须提交自己的产品特定数据以解决产品候选人与RLD之间的差异[151] - RLD专利要求在NDA中列出覆盖申请人产品的专利，任何提出ANDA的申请人必须向FDA保证专利已过期或无效，否则无法获得ANDA批准[152] - 制药厂商可以在新化学实体（NCE）获得NDA批准后获得五年的非专利排他性，期间FDA不接受任何寻求批准该药物的仿制版本的ANDA或505(b)(2)申请[154] - BPCIA为确定产品候选人与已获许可的生物制品（参考产品）是生物相似还是可互换设立了标准，并建立了提交、审查和许可生物相似产品候选人的BLA的程序[157] - 一旦药物或生物制品获得批准，FDA将对其及其制造商进行持续监管，如果未满足持续监管要求或在产品上市后出现安全问题，FDA可能随时撤销产品批准或采取限制或暂

Biora Therapeutics, Inc. (NASDAQ:BIOR) Q3 2022 Results Conference Call November 14, 2022 4:30 PM ET Company Participants Alexandra Schuman - IR, LifeSci Advisors Adi Mohanty - Chief Executive Officer Eric d'Esparbes - Chief Financial Officer Conference Call Participants Joe Pantginis - H.C. Wainwright Julian Harrison - BTIG Mayank Mamtani - B. Riley Securities Operator Welcome to the Biora Therapeutics Third Quarter 2022 Earnings Call. As a reminder, all participants are in listen-only mode and the conferen ...

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 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: 001-39334 Biora Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 27-3950390 (State or other jurisdiction ...

CORPORATE PRESENTATION August 2022 FORWARD-LOOKING STATEMENTS This presentation contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical fact included in this presentation, including statements concerning our plans, objectives, goals, strategies, future events, plans or intentions relating to product candidates, es ...

Biora Therapeutics, Inc. (NASDAQ:BIOR) Q2 2022 Earnings Conference Call August 15, 2022 4:30 PM ET Company Participants Adi Mohanty – Chief Executive Officer Eric d’Esparbes – Chief Financial Officer Conference Call Participants Julian Harrison – BTIG Yuan Zhi – B. Riley Operator Greetings and welcome to the Biora Therapeutics Second Quarter 2022 Earnings Call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] ...

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 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: 001-39334 Biora Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 27-3950390 (State or other jurisdiction of i ...

CORPORATE PRESENTATION May 2022 FORWARD-LOOKING STATEMENTS This presentation contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this presentation, including statements concerning our plans, objectives, goals, strategies, future events, plans or intentions relating to product candidates, esti ...

Biora Therapeutics, Inc. (NASDAQ:BIOR) Q1 2022 Earnings Conference Call May 10, 2022 4:30 PM ET Company Participants Chuck Padala – Managing Director, LifeSci Advisors Adi Mohanty – Chief Executive Officer Eric d’Esparbes – Chief Financial Officer Conference Call Participants Julian Harrison – BTIG Sahil Kazmi – B. Riley Securities Operator Welcome to the Biora Therapeutics First Quarter 2022 Earnings Call. During the presentation, all participants will be in a listen-only mode. Afterwards, we’ll conduct a ...