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Overview of Biora Therapeutics, Inc.
Biora Therapeutics, Inc. (Nasdaq: BIOR) is a clinical-stage biotechnology company that is revolutionizing therapeutic delivery through its innovative smart pill-based platforms. The company focuses on addressing critical unmet medical needs by enabling targeted and systemic delivery of therapeutics for chronic and complex diseases. Biora's two flagship platforms, the NaviCap™ and BioJet™, are designed to improve patient outcomes by offering precision delivery of drugs to the gastrointestinal (GI) tract and needle-free systemic delivery of large molecules, respectively.
Core Platforms and Technology
The NaviCap™ Targeted Oral Delivery Platform is engineered to treat inflammatory bowel disease (IBD), including conditions such as ulcerative colitis, by delivering therapeutic agents directly to the site of disease in the colon. Utilizing proprietary GItrac™ autolocation technology, the NaviCap device autonomously identifies targeted locations in the GI tract and releases a therapeutic payload. This approach increases drug concentration in affected tissues while minimizing systemic exposure, potentially improving efficacy and reducing side effects.
The BioJet™ Systemic Oral Delivery Platform is designed to replace traditional injections with an ingestible capsule that delivers liquid formulations of large molecules—such as peptides, proteins, and nucleic acids—directly into the small intestine. The device uses liquid jet injection technology to achieve systemic bioavailability comparable to subcutaneous injections. This needle-free delivery method simplifies drug administration and enhances patient adherence, particularly for chronic disease management.
Clinical Progress and Innovation
Biora has demonstrated significant progress in clinical development. The NaviCap platform has completed a Phase 1 trial for its BT-600 program, a drug-device combination for ulcerative colitis, showing successful targeted delivery to the colon with reduced systemic drug exposure. Similarly, the BioJet platform has shown promising preclinical results, achieving high oral bioavailability for various macromolecules in animal models. These advancements highlight the company's commitment to innovation and its potential to transform therapeutic delivery.
Market Position and Competitive Edge
Biora operates at the intersection of biotechnology and advanced drug delivery systems, targeting a rapidly growing market for precision medicine and chronic disease management. The company's competitive edge lies in its ability to address limitations of current treatments, such as the need for injections or systemic drug exposure. With an extensive patent portfolio comprising over 70 patent families, Biora secures its technological innovations and positions itself as a leader in the smart pill drug delivery space.
Challenges and Strategic Focus
As a clinical-stage company, Biora faces challenges such as regulatory approvals, financial sustainability, and competition from established pharmaceutical players. However, its strategic focus on partnerships and licensing agreements with large pharma companies positions it for long-term success. The company is actively engaged in collaborations to accelerate development and commercialization of its platforms.
Commitment to Patients and Future Outlook
Biora Therapeutics is dedicated to improving patient lives by reimagining how drugs are delivered. Through its innovative platforms, the company aims to enhance treatment outcomes, reduce patient burden, and expand therapeutic possibilities. With ongoing clinical trials and a robust pipeline, Biora is poised to make a significant impact in the fields of gastroenterology and chronic disease management.
Biora Therapeutics (Nasdaq: BIOR), a biotech company focused on reimagining therapeutic delivery, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024, in New York, NY.
Key details of Biora's involvement include:
- A company presentation on Wednesday, September 11, 2024, at 2:00 PM Eastern time
- One-on-one investor meetings
- A live webcast of the presentation available at a provided link
A replay of the presentation will be accessible on Biora's website after the conference concludes. This participation offers Biora an opportunity to showcase its innovations and engage with potential investors in the biotech sector.
Biora Therapeutics (Nasdaq: BIOR) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Successful completion of Phase 1 clinical trial for BT-600, demonstrating precise drug delivery to the colon with low systemic exposure.
2. Secured up to $16M funding from existing investors.
3. Active partnership discussions for BioJet™ platform with multiple large pharma companies.
4. Q2 2024 financial results: Operating expenses $16.1M, net income $6.5M, diluted net loss per share $0.04.
5. Anticipating Phase 1B clinical study initiation for BT-600 in ulcerative colitis patients by end of 2024.
6. Expecting to conclude at least one partnership agreement for BioJet platform in the near term.
Biora Therapeutics (Nasdaq: BIOR) has secured a $16 million multiple-draw facility from existing convertible notes holders. This funding is intended to serve as a bridge to anticipated pharmaceutical partnerships. The company's CFO, Eric d'Esparbes, expressed gratitude for the continued support of their noteholders, highlighting that this investment is expected to fund Biora through important milestones. The decision to provide additional funding was influenced by active interest from pharmaceutical collaborators in Biora's BioJet™ platform and recent promising clinical trial results from their NaviCap™ platform.
Biora Therapeutics (Nasdaq: BIOR), a biotech company focused on reimagining therapeutic delivery, has announced it will report its financial results for the second quarter of 2024, which ended on June 30. The company will also provide a corporate update during a webcast and conference call scheduled for Monday, August 12, 2024, after the financial markets close.
The conference call will take place at 4:30 PM Eastern time / 1:30 PM Pacific time. Interested parties can access the call using the following details:
- Domestic: 1-877-423-9813
- International: 1-201-689-8573
- Conference ID: 13747616
Biora Therapeutics (Nasdaq: BIOR), a biotech company focused on reimagining therapeutic delivery, has announced its participation in the Canaccord Genuity 44th Annual Growth Conference. The event is scheduled for August 13-15, 2024, in Boston, MA.
Key details of Biora's participation include:
- Company presentation on Tuesday, August 13, 2024, at 2:30 PM Eastern time
- One-on-one investor meetings
- Live webcast available at https://wsw.com/webcast/canaccord98/bior/2458676
- Replay of the presentation will be accessible on Biora's website after the conference
This participation provides an opportunity for Biora to showcase its innovations in therapeutic delivery to potential investors and industry professionals.
Biora Therapeutics (Nasdaq: BIOR) presented supplemental data from the Phase 1 trial of BT-600, an orally administered drug-device combination for ulcerative colitis treatment, at a virtual KOL event. The trial results demonstrated that BT-600, using Biora's NaviCap™ platform, successfully delivered tofacitinib directly to the colon, achieving higher tissue exposure and lower systemic concentrations compared to conventional oral administration.
Key findings include:
- Colon tissue drug levels above IC50 at 24 hours post-dosing
- Projected tissue levels above IC90 through at least 16 hours after 5 mg or 10 mg doses
- Pan-colonic delivery achieved with evidence of drug exposure in distal colon
- Lower systemic drug exposure, potentially reducing toxicity risks
- NaviCap devices were well-tolerated with no early release and >95% colon entry detection
These results support BT-600's potential to improve ulcerative colitis treatment efficacy and validate the NaviCap platform for targeted GI drug delivery.
Biora Therapeutics is set to host a virtual KOL event on July 17, 2024, to discuss its NaviCap™ Targeted Oral Delivery Platform and present Phase 1 clinical trial results for BT-600. The event will feature experts Bruce Sands and Brian Feagan, who will discuss the current treatment landscape for ulcerative colitis (UC) and the potential benefits of colonic drug delivery. The Phase 1 trial results indicate that BT-600, which uses the NaviCap device to deliver tofacitinib directly to the colon, effectively targets affected tissues in UC patients. The event will include a live Q&A session, and a replay will be available online.
Biora Therapeutics has announced positive results from its Phase 1 clinical trial for BT-600, a drug-device combination aimed at treating ulcerative colitis (UC). The NaviCap™ platform, which delivers tofacitinib directly to colonic tissue, met all trial objectives, demonstrating effective drug absorption in the colon, including the distal colon. This Phase 1 trial involved 48 healthy volunteers and showed that BT-600 was well tolerated. The results also indicated lower systemic drug exposure compared to conventional oral delivery methods. Following these successful outcomes, Biora plans to advance BT-600 into a Phase 1b clinical trial targeting UC patients. A virtual event featuring key opinion leaders will be held on July 17 to discuss these findings and future plans.
Biora Therapeutics (Nasdaq: BIOR) will present preclinical data on its BioJet™ Systemic Oral Delivery Platform at the Next Gen Peptide Formulation & Delivery Summit in Boston from June 18–20, 2024.
The presentation, titled 'Empowering Peptide Self-Administration with Needle-Free Smart Capsules,' will be delivered by Dr. Sharat Singh on June 19 from 2:15 to 2:45 PM Eastern time.
Additionally, Dr. Singh will join a panel discussion on peptide drug delivery innovations earlier the same day. Selections from the presentation will be available on Biora's website post-event.
Biora Therapeutics presented new clinical data on its NaviCap™ platform at the Digestive Disease Week 2024 conference. The studies demonstrated the device's ability to deliver therapeutics directly to the colon in varied gastrointestinal conditions and eating schedules. Conducted on 47 participants, including those with active ulcerative colitis (UC), the trials showed the device was well-tolerated, with no serious adverse events reported. The NaviCap uses GItrac™ technology to autonomously target locations in the GI tract, ensuring effective delivery. The findings suggest potential improvements in treating inflammatory bowel diseases.
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