Biora Therapeutics(BIOR) - 2024 Q1 - Quarterly Results

Corporate Update & Highlights Biora Therapeutics reported significant progress in Q1 2024, including successful BT-600 clinical trial dosing, BioJet platform advancements, and strengthened financial position - Dosing of all participants in the BT-600 Phase 1 clinical trial has been successfully completed, with results from the single-ascending dose (SAD) portion consistent with desired performance targets, showing devices were well tolerated and systemic drug absorption occurred[1][9][10] - BioJet platform demonstrated performance advances in consistency and bioavailability in additional animal studies for peptide (semaglutide) and antibody (adalimumab) candidates, exceeding its target of 15% bioavailability compared to IV administration[2][5] - The company secured $19.8 million in new investment since December 2023 through a third note exchange, reducing notes outstanding by over $80 million. Additionally, $31 million in capital was raised over the past four months from legacy asset monetization, equity proceeds, and a registered direct placement[11] Q1 2024 & Recent Highlights Biora Therapeutics reported significant progress in Q1 2024, including the successful completion of dosing for the BT-600 clinical trial with positive interim results, advancements in the BioJet platform's preclinical development, and successful capital market activities to strengthen its financial position NaviCap™ Targeted Oral Delivery Platform and BT-600 Clinical Trial Progress The NaviCap platform's BT-600 clinical trial successfully completed dosing, showing well-tolerated devices and systemic drug absorption in the colon - Dosing of all patients in the BT-600 clinical trial for ulcerative colitis has been successfully completed[1] - Interim results from the SAD portion showed NaviCap devices were well tolerated, with no safety signals, and all participants receiving active drug showed systemic drug absorption, confirming drug delivery in the colon[9][10] - Tofacitinib was present in fecal samples, and measurable in blood at approximately six to eight hours post-ingestion, indicating colon delivery and absorption. Plasma levels were 3-4 times lower than conventional oral tofacitinib, consistent with drug passage through colonic tissue, and dose-proportional pharmacokinetics were observed[4] BioJet™ Systemic Oral Delivery Platform Preclinical Development The BioJet platform demonstrated advanced performance in animal studies for peptide and antibody candidates, exceeding bioavailability targets - Additional animal studies demonstrated performance advances in consistency and bioavailability for the company's peptide candidate (semaglutide) and antibody candidate (adalimumab), as well as collaborator molecules[5] - The BioJet platform continues to exceed its performance target of 15% bioavailability compared to IV administration[5] - The partnering process for the BioJet oral delivery platform is progressing well, with a goal to confirm partner interest by mid-2024, showing strong engagement from current collaborators and new companies[1][2] Capital Markets & Financial Optimization Biora secured significant new investment and reduced outstanding notes through strategic capital market activities, strengthening its financial position - Biora secured a third note exchange during Q1, bringing total capital raised to $19.8 million in new investment since December 2023[11] - These transactions have resulted in more than an $80 million reduction in notes outstanding over the last three quarters, demonstrating continued support from institutional investors[11] - The company secured an additional $3 million from legacy asset monetization, $2.9 million from equity proceeds, and a $6 million registered direct placement (closed in early April), totaling $31 million in capital during the past four months[11] Anticipated Milestones Biora Therapeutics outlined key upcoming milestones for both its NaviCap and BioJet platforms, including data releases, conference presentations, and the initiation of new clinical studies and partnerships - Biora expects to receive final SAD/MAD data for BT-600 during Q2 2024 and plans to present topline data from the clinical trial toward the end of the second quarter[12] - Clinical data on the function of the NaviCap device across four different studies will be presented at the Digestive Disease Week (DDW) conference on May 19, 2024[12] - Initiation of a clinical study in active ulcerative colitis patients is anticipated during the second half of 2024[12] - An update on data from recent BioJet animal studies will be shared at the Next Gen Peptide Formulation & Delivery Summit in June 2024[13] - The company's progress is on track toward a pharma partnership for the BioJet platform in 2024[14] First Quarter 2024 Financial Results Overview Biora Therapeutics' Q1 2024 financial results show a significant reduction in net loss compared to previous periods, driven by non-cash gains and stable operating expenses Comparison of Three Months Ended March 31, 2024 and December 31, 2023 Biora Therapeutics reported a significant reduction in net loss for Q1 2024 compared to Q4 2023, primarily driven by a substantial non-cash gain on warrant liabilities, despite an increase in operating expenses Financial Comparison: Q1 2024 vs Q4 2023 | Metric | 3 Months Ended Mar 31, 2024 | 3 Months Ended Dec 31, 2023 | | :---------------- | :-------------------------- | :-------------------------- | | Operating expenses| $16.1 million | $13.3 million | | Net loss | $(4.2) million | $(15.4) million | | Net loss per share| $(0.14) | $(0.62) | - Net loss for Q1 2024 included $13.9 million in non-cash items attributable to the change in fair value of warrant liabilities, while Q4 2023 included $6.4 million in non-cash charges from convertible notes exchange and $3.0 million impairment on equity investments[18] Comparison of Three Months Ended March 31, 2024 and March 31, 2023 Year-over-year, Biora Therapeutics saw a substantial improvement in net loss and net loss per share in Q1 2024 compared to Q1 2023, with operating expenses remaining relatively stable Financial Comparison: Q1 2024 vs Q1 2023 | Metric | 3 Months Ended Mar 31, 2024 | 3 Months Ended Mar 31, 2023 | | :---------------- | :-------------------------- | :-------------------------- | | Operating expenses| $16.1 million | $15.5 million | | Net loss | $(4.2) million | $(17.4) million | | Net loss per share| $(0.14) | $(1.59) | - Non-cash stock-based compensation expenses were $1.5 million in Q1 2024, down from $2.4 million in Q1 2023[19] Condensed Consolidated Financial Statements The condensed consolidated financial statements provide an unaudited overview of Biora Therapeutics' operations and financial position for Q1 2024 and comparative periods Condensed Consolidated Statements of Operations The unaudited condensed consolidated statements of operations detail Biora Therapeutics' financial performance, showing revenues, operating expenses, and net loss for the three months ended March 31, 2024, compared to both the previous quarter and the prior year's quarter Condensed Consolidated Statements of Operations (Unaudited, in thousands, except per share amounts) | Metric | 3 Months Ended Mar 31, 2024 | 3 Months Ended Dec 31, 2023 | 3 Months Ended Mar 31, 2023 | | :----------------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Revenues | $542 | $0 | $2 | | Research and development | $7,005 | $6,118 | $7,190 | | Selling, general and administrative | $9,053 | $7,226 | $8,356 | | Total operating expenses | $16,058 | $13,344 | $15,546 | | Loss from operations | $(15,516) | $(13,344) | $(15,544) | | Interest expense, net | $(2,757) | $(1,840) | $(2,680) | | Gain on warrant liabilities | $13,915 | $12,733 | $864 | | Other income (expense), net | $217 | $(13,276) | $(81) | | Loss before income taxes | $(4,141) | $(15,727) | $(17,441) | | Income tax expense (benefit) | $48 | $(95) | $0 | | Net loss | $(4,189) | $(15,413) | $(17,441) | | Net loss per share, basic and diluted | $(0.14) | $(0.62) | $(1.59) | | Weighted average shares outstanding | 29,296,767 | 24,810,923 | 10,970,583 | Condensed Consolidated Balance Sheets The unaudited condensed consolidated balance sheets provide a snapshot of Biora Therapeutics' financial position as of March 31, 2024, compared to December 31, 2023, detailing assets, liabilities, and stockholders' deficit Condensed Consolidated Balance Sheets (Unaudited, in thousands) | Metric | March 31, 2024 | December 31, 2023 | | :-------------------------------------- | :------------- | :---------------- | | Assets | | | | Cash, cash equivalents and restricted cash | $10,820 | $15,211 | | Total current assets | $14,071 | $19,071 | | Total assets | $22,990 | $31,215 | | Liabilities | | | | Accounts payable | $4,936 | $2,843 | | Accrued expenses and other current liabilities | $16,984 | $17,319 | | Warrant liabilities | $27,208 | $40,834 | | Total current liabilities | $51,104 | $62,972 | | Total liabilities | $123,175 | $132,636 | | Stockholders' Deficit | | | | Total stockholders' deficit | $(100,185) | $(101,421) | About Biora Therapeutics Biora Therapeutics is a biotech company focused on revolutionizing therapeutic delivery through two innovative smart pill platforms: NaviCap™ for targeted gastrointestinal delivery in inflammatory bowel disease and BioJet™ for systemic, needle-free oral delivery of large molecules for chronic diseases Company Overview and Platforms Biora Therapeutics is a biotech company focused on revolutionizing therapeutic delivery through two innovative smart pill platforms: NaviCap™ for targeted gastrointestinal delivery in inflammatory bowel disease and BioJet™ for systemic, needle-free oral delivery of large molecules for chronic diseases - Biora Therapeutics is reimagining therapeutic delivery by creating innovative smart pills designed for targeted drug delivery to the GI tract and systemic, needle-free delivery of biotherapeutics[21] - The company focuses on two platforms: the NaviCap™ targeted oral delivery platform, aimed at improving outcomes for inflammatory bowel disease patients, and the BioJet™ systemic oral delivery platform, designed to replace injections for chronic diseases through oral delivery of large molecules[22] Safe Harbor Statement This section serves as a disclaimer for forward-looking statements within the press release, emphasizing that such statements are subject to substantial risks and uncertainties that could cause actual results to differ materially from projections. Biora Therapeutics disclaims any obligation to update these statements Forward-Looking Statements Disclaimer This section serves as a disclaimer for forward-looking statements within the press release, emphasizing that such statements are subject to substantial risks and uncertainties that could cause actual results to differ materially from projections. Biora Therapeutics disclaims any obligation to update these statements - The press release contains "forward-looking statements" subject to substantial risks and uncertainties, based on estimates and assumptions, reflecting plans, estimates, and expectations as of the date of the release[24] - These statements involve known and unknown risks, uncertainties, and other factors that could cause actual results to differ materially, including those related to innovation, FDA filings, clinical trials, regulatory approval, partnerships, and capital raising[24] - Biora Therapeutics expressly disclaims any obligation to update any forward-looking statements, except as required by law[24] Conference Call and Webcast Information This section provides details for the conference call and webcast hosted by Biora Therapeutics to discuss the corporate update and financial results for the first quarter ended March 31, 2024 Event Details Details for the conference call and webcast hosted by Biora Therapeutics to discuss the corporate update and financial results for the first quarter ended March 31, 2024 - Date: Wednesday, May 15, 2024[15] - Time: 4:30 PM Eastern time / 1:30 PM Pacific time[15] - Conference Call Access: Domestic 1-877-423-9813, International 1-201-689-8573, Conference ID 13746163[15] - Webcast Link: **https://investors.bioratherapeutics.com/events-presentations**[15](index=15&type=chunk) Contact Information This section provides contact details for investor relations and media inquiries for Biora Therapeutics Investor and Media Contacts Contact details for investor relations and media inquiries for Biora Therapeutics - Investor Contact: Chuck Padala, Managing Director, LifeSci Advisors, at IR@bioratherapeutics.com or (646) 627-8390[25] - Media Contact: media@bioratherapeutics.com[25]