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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提供公司最新情況並報告2024年第二季度財務業績
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宣佈成功完成Bt-600的第一階段臨牀試驗，證明了精準藥物遞送到結腸的能力，並且有限的全身暴露。該試驗達到了所有目標，首次顯示了託法替尼在6小時內的吸收證據，與傳統口服給藥相比，全身暴露降低了3-4倍。根據這些積極結果，公司獲得了來自現有投資者的最高1600萬美元的資金。NaviCap平台在所有三個測試位點達到了超出IC50的藥物濃度，實現了全結腸遞送，建模預測在給藥後16小時內組織水平達到或超過IC90。這些設備耐受良好，沒有嚴重的不良事件，並且結腸進入檢測的準確率超過95%。公司計劃在2024年底前啓動針對活動性潰瘍性結腸炎患者的第十階段研究。在2024年第二季度，營業費用爲1610萬美元，其中包括160萬美元的非現金股票補償。公司報告的凈利潤爲650萬美元，其中包含從認股權證和衍生負債變動中產生的2280萬美元的非現金項目。Biora目前正在與多家大型製藥公司就其BioJet平台進行積極的合作討論。
Biora Therapeutics宣佈成功完成Bt-600的第一階段臨牀試驗，證明了精準藥物遞送到結腸的能力，並且有限的全身暴露。該試驗達到了所有目標，首次顯示了託法替尼在6小時內的吸收證據，與傳統口服給藥相比，全身暴露降低了3-4倍。根據這些積極結果，公司獲得了來自現有投資者的最高1600萬美元的資金。NaviCap平台在所有三個測試位點達到了超出IC50的藥物濃度，實現了全結腸遞送，建模預測在給藥後16小時內組織水平達到或超過IC90。這些設備耐受良好，沒有嚴重的不良事件，並且結腸進入檢測的準確率超過95%。公司計劃在2024年底前啓動針對活動性潰瘍性結腸炎患者的第十階段研究。在2024年第二季度，營業費用爲1610萬美元，其中包括160萬美元的非現金股票補償。公司報告的凈利潤爲650萬美元，其中包含從認股權證和衍生負債變動中產生的2280萬美元的非現金項目。Biora目前正在與多家大型製藥公司就其BioJet平台進行積極的合作討論。
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