SAN DIEGO, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, today announced the signing of financing agreements with its existing convertible notes holders. "We appreciate the continued commitment of our existing noteholders, who have agreed to an additional investment in Biora that we expect will fund us to important milestones, including anticipated partnering with large pharma," said Eric d'Esparbes, Chief Financial Officer o ...

SAN DIEGO, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, today announced it will report financial results and provide a corporate update for the second quarter ended June 30, 2024. Company management will host a webcast and conference call on Monday, August 12, 2024, after the close of financial markets. Conference Call and Webcast Information Date: Monday, August 12, 2024 Time: 4:30 PM Eastern time / 1:30 PM Pacific time Con ...

Pharmacokinetic and tissue data confirm NaviCap platform delivers topically through the entire colon, with lower systemic concentrations, as desired Data modeling suggests tofacitinib tissue concentrations greater than IC90 through at least 16 hours after dosing SAN DIEGO, July 18, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (NASDAQ:BIOR), the biotech company reimagining therapeutic delivery, presented supplemental data from the Phase 1 trial of BT-600 during the company's virtual KOL event on Wednesd ...

A replay will be available online following the event. About Bruce Sands, MD, MS Bruce Sands, MD, MS is the Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine at Mount Sinai, New York, NY. Dr. Sands was awarded his BA and MD from Boston University, and trained in internal medicine at the Hospital of the University of Pennsylvania. After completing GI fellowship at the Massachusetts General Hospital, he joined the faculty of Harvard Medical School and served as the Acting Chief of the ...

For more information, visit bioratherapeutics.com or follow the company on LinkedIn or Twitter. Biora Therapeutics expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. Media Contact media@bioratherapeutics.com Details of the presentation are as follows: Presentation Title: Empowering Peptide Self Administration with Needle-Free Smart Capsules Track: Pioneering Devices to Increase the Reach o ...

SAN DIEGO, May 20, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, presented a poster titled "Results of human device function studies for the NaviCap™ Targeted Oral Delivery Platform in healthy volunteers and patients with UC" at the Digestive Disease Week® conference in Washington DC, on Sunday, May 19, 2024. "In four separate clinical studies, we evaluated the functionality and safety of the NaviCap device in healthy particip ...

Financial Data and Key Metrics Changes - The net loss for the first quarter of 2024 was $4.2 million, which included noncash stock-based compensation expenses and gains from changes in warrant liabilities [26] - Operating expenses, excluding stock-based compensation, were $40.5 million, with a core operating cash burn of $11.5 million for the quarter [50][26] - The company reduced its convertible note balance to approximately $52 million by the end of the first quarter, reflecting strong institutional investor confidence [14] Business Line Data and Key Metrics Changes - The NaviCap platform's clinical trial for BT-600 in ulcerative colitis (UC) showed that all devices performed as intended and were well tolerated, with complete colonic coverage achieved [78][96] - The BioJet platform demonstrated an average bioavailability of over 20% for animals with detectable drug in blood, indicating progress in oral delivery of large molecules [82] Market Data and Key Metrics Changes - The company is actively engaging with potential partners for the BioJet platform, with strong interest from both current collaborators and new companies [4][36] - The anticipated clinical study with BT-600 in UC patients is expected to begin in the second half of 2024, indicating a strategic focus on expanding clinical applications [5] Company Strategy and Development Direction - The company aims to optimize tofacitinib therapy in UC by achieving higher drug exposure in colon tissue without high systemic exposure, addressing a significant unmet need in UC patients [80][96] - The focus for the BioJet platform is on progressing towards partnerships in 2024, with an emphasis on bringing the technology to clinical applications [88] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data from the BT-600 clinical trial, which is expected to provide insights into the efficacy of the NaviCap platform [88][52] - The company is focused on maximizing value and maintaining optionality in negotiations with potential partners, aiming for serious partnerships that lead to clinical trials [69] Other Important Information - The company has made significant progress in reducing its net debt, achieving a 75% reduction in 2023 alone, and continues to optimize its capital structure [86] - The NaviCap platform is designed to provide targeted delivery of therapeutics directly to the site of disease in the colon, which is crucial for treating UC effectively [96] Q&A Session Summary Question: What are the expectations for the BT-600 top line data? - Management indicated that confirmation of single ascending dose (SAD) data would be considered a success, as it supports colonic uptake and delivery [20] Question: What factors might influence the go/no-go decision for the adalimumab biosimilar program? - Management noted that they are encouraged by early data and are looking to take the BT-600 program further, which could inform the adalimumab program [64] Question: How is the company framing expectations for the UC study design? - Management stated that they are finalizing protocols and will make determinations based on the MAD data and expert consultations [52]

Common Stock, par value $0.001 per share BIOR The Nasdaq Global Market ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 For the transition period from to Delaware 27-3950390 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) Registrant's telephone number, including area code: (833) 727-2841 Indicate by check mark whether the registrant (1) has filed all reports required to ...

[Corporate Update & Highlights](index=1&type=section&id=Corporate%20Update%20%26%20Highlights) 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](index=1&type=chunk)[9](index=9&type=chunk)[10](index=10&type=chunk) - 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](index=2&type=chunk)[5](index=5&type=chunk) - 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](index=11&type=chunk) [Q1 2024 & Recent Highlights](index=1&type=section&id=Q1%202024%20%26%20Recent%20Highlights) 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](index=1&type=section&id=NaviCap%E2%84%A2%20Targeted%20Oral%20Delivery%20Platform%20and%20BT-600%20Clinical%20Trial%20Progress) 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](index=1&type=chunk) - 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](index=9&type=chunk)[10](index=10&type=chunk) - 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](index=4&type=chunk) [BioJet™ Systemic Oral Delivery Platform Preclinical Development](index=1&type=section&id=BioJet%E2%84%A2%20Systemic%20Oral%20Delivery%20Platform%20Preclinical%20Development) 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](index=5&type=chunk) - The BioJet platform continues to exceed its performance target of **15% bioavailability** compared to IV administration[5](index=5&type=chunk) - 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](index=1&type=chunk)[2](index=2&type=chunk) [Capital Markets & Financial Optimization](index=2&type=section&id=Capital%20Markets%20%26%20Financial%20Optimization) 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](index=11&type=chunk) - 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](index=11&type=chunk) - 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](index=11&type=chunk) [Anticipated Milestones](index=2&type=section&id=Anticipated%20Milestones) 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](index=12&type=chunk) - 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](index=12&type=chunk) - Initiation of a clinical study in active ulcerative colitis patients is anticipated during the second half of 2024[12](index=12&type=chunk) - An update on data from recent BioJet animal studies will be shared at the Next Gen Peptide Formulation & Delivery Summit in **June 2024**[13](index=13&type=chunk) - The company's progress is on track toward a pharma partnership for the BioJet platform in **2024**[14](index=14&type=chunk) [First Quarter 2024 Financial Results Overview](index=1&type=section&id=First%20Quarter%202024%20Financial%20Results%20Overview) 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](index=3&type=section&id=Comparison%20of%20Three%20Months%20Ended%20March%2031%2C%202024%20and%20December%2031%2C%202023) 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](index=18&type=chunk) [Comparison of Three Months Ended March 31, 2024 and March 31, 2023](index=3&type=section&id=Comparison%20of%20Three%20Months%20Ended%20March%2031%2C%202024%20and%20March%2031%2C%202023) 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](index=19&type=chunk) [Condensed Consolidated Financial Statements](index=5&type=section&id=Condensed%20Consolidated%20Financial%20Statements) 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](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=3&type=section&id=About%20Biora%20Therapeutics) 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](index=3&type=section&id=Company%20Overview%20and%20Platforms) 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](index=21&type=chunk) - 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](index=22&type=chunk) [Safe Harbor Statement](index=4&type=section&id=Safe%20Harbor%20Statement) 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](index=4&type=section&id=Forward-Looking%20Statements%20Disclaimer) 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](index=24&type=chunk) - 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](index=24&type=chunk) - Biora Therapeutics expressly disclaims any obligation to update any forward-looking statements, except as required by law[24](index=24&type=chunk) [Conference Call and Webcast Information](index=3&type=section&id=Conference%20Call%20and%20Webcast%20Information) 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](index=3&type=section&id=Event%20Details) 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](index=15&type=chunk) - Time: **4:30 PM Eastern time / 1:30 PM Pacific time**[15](index=15&type=chunk) - Conference Call Access: Domestic **1-877-423-9813**, International **1-201-689-8573**, Conference ID **13746163**[15](index=15&type=chunk) - Webcast Link: **https://investors.bioratherapeutics.com/events-presentations**[15](index=15&type=chunk) [Contact Information](index=4&type=section&id=Contact%20Information) This section provides contact details for investor relations and media inquiries for Biora Therapeutics [Investor and Media Contacts](index=4&type=section&id=Investor%20and%20Media%20Contacts) 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](index=25&type=chunk) - Media Contact: **media@bioratherapeutics.com**[25](index=25&type=chunk)

SAN DIEGO, May 06, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (NASDAQ:BIOR), the biotech company that is reimagining therapeutic delivery, today announced that it will present clinical data on device function of the NaviCap™ Targeted Oral Delivery Platform at Digestive Disease Week® (DDW), which will take place both virtually and in-person May 18-21, 2024 in Washington, DC. Details of the presentations are as follows: Abstract Title:Results of Human Device Function Studies for the NaviCap™ Targeted O ...