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Biora Therapeutics | 8-K: Biora Therapeutics Provides Corporate Update and Reports Second Quarter 2024 Financial Results

Biora Therapeutics | 8-K: Biora Therapeutics Provides Corporate Update and Reports Second Quarter 2024 Financial Results

Biora Therapeutics | 8-K：Biora Therapeutics提供公司最新情况并报告2024年第二季度财务业绩
美股SEC公告 ·  2024/08/13 04:17

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Biora Therapeutics announced successful completion of Phase 1 clinical trial for BT-600, demonstrating precise drug delivery to the colon with limited systemic exposure. The trial met all objectives, showing first evidence of tofacitinib absorption at 6 hours and 3-4 times lower systemic exposure compared to conventional oral delivery. The company secured up to $16M in funding from existing investors based on these positive results.The NaviCap platform achieved pan-colonic delivery with drug concentrations above IC50 at all three tested locations, and modeling projects tissue levels at or above IC90 through 16 hours post-dosing. The devices were well-tolerated with no serious adverse events and >95% accuracy in colon entry detection. The company plans to initiate a Phase 1B study in active ulcerative colitis patients by late 2024.For Q2 2024, operating expenses were $16.1M, including $1.6M in non-cash stock compensation. The company reported net income of $6.5M, including $22.8M in non-cash items from changes in warrant and derivative liabilities. Biora is currently in active partnership discussions with multiple large pharma companies for its BioJet platform.
Biora Therapeutics announced successful completion of Phase 1 clinical trial for BT-600, demonstrating precise drug delivery to the colon with limited systemic exposure. The trial met all objectives, showing first evidence of tofacitinib absorption at 6 hours and 3-4 times lower systemic exposure compared to conventional oral delivery. The company secured up to $16M in funding from existing investors based on these positive results.The NaviCap platform achieved pan-colonic delivery with drug concentrations above IC50 at all three tested locations, and modeling projects tissue levels at or above IC90 through 16 hours post-dosing. The devices were well-tolerated with no serious adverse events and >95% accuracy in colon entry detection. The company plans to initiate a Phase 1B study in active ulcerative colitis patients by late 2024.For Q2 2024, operating expenses were $16.1M, including $1.6M in non-cash stock compensation. The company reported net income of $6.5M, including $22.8M in non-cash items from changes in warrant and derivative liabilities. Biora is currently in active partnership discussions with multiple large pharma companies for its BioJet platform.
Biora Therapeutics宣布成功完成Bt-600的第一阶段临床试验，证明了精准药物递送到结肠的能力，并且有限的全身暴露。该试验达到了所有目标，首次显示了托法替尼在6小时内的吸收证据，与传统口服给药相比，全身暴露降低了3-4倍。根据这些积极结果，公司获得了来自现有投资者的最高1600万美元的资金。NaviCap平台在所有三个测试位点达到了超出IC50的药物浓度，实现了全结肠递送，建模预测在给药后16小时内组织水平达到或超过IC90。这些设备耐受良好，没有严重的不良事件，并且结肠进入检测的准确率超过95%。公司计划在2024年底前启动针对活动性溃疡性结肠炎患者的第十阶段研究。在2024年第二季度，营业费用为1610万美元，其中包括160万美元的非现金股票补偿。公司报告的净利润为650万美元，其中包含从认股权证和衍生负债变动中产生的2280万美元的非现金项目。Biora目前正在与多家大型制药公司就其BioJet平台进行积极的合作讨论。
Biora Therapeutics宣布成功完成Bt-600的第一阶段临床试验，证明了精准药物递送到结肠的能力，并且有限的全身暴露。该试验达到了所有目标，首次显示了托法替尼在6小时内的吸收证据，与传统口服给药相比，全身暴露降低了3-4倍。根据这些积极结果，公司获得了来自现有投资者的最高1600万美元的资金。NaviCap平台在所有三个测试位点达到了超出IC50的药物浓度，实现了全结肠递送，建模预测在给药后16小时内组织水平达到或超过IC90。这些设备耐受良好，没有严重的不良事件，并且结肠进入检测的准确率超过95%。公司计划在2024年底前启动针对活动性溃疡性结肠炎患者的第十阶段研究。在2024年第二季度，营业费用为1610万美元，其中包括160万美元的非现金股票补偿。公司报告的净利润为650万美元，其中包含从认股权证和衍生负债变动中产生的2280万美元的非现金项目。Biora目前正在与多家大型制药公司就其BioJet平台进行积极的合作讨论。
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