BIORA THERAPEUTICS


Associated tags: Therapy, Patient, GI, SAN, Pharmaceutical industry, Ulcerative colitis

Locations: EUROPE, AUSTRALIA, CHINA, MEXICO, JAPAN, ISRAEL, CANADA, SAN DIEGO, CA, US, UNITED STATES, MAD, COLON, PARK AVENUE, NEW YORK

Biora Therapeutics to Report First Quarter 2024 Financial Results and Provide Corporate Update

Retrieved on: 
Tuesday, May 7, 2024

SAN DIEGO, May 07, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc .

Key Points: 
  • SAN DIEGO, May 07, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc .
  • (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced it will report financial results and provide a corporate update for the first quarter ended March 31, 2024.
  • The company’s management will host a webcast and conference call on Wednesday, May 15, 2024, after the close of financial markets.

Biora Therapeutics to Present Clinical Data on Device Function of the NaviCap™ Oral Delivery Platform at Digestive Disease Week 2024

Retrieved on: 
Monday, May 6, 2024

Abstracts selected by the American Gastroenterological Association (AGA) for presentation at DDW will be available in a supplement to Gastroenterology.

Key Points: 
  • Abstracts selected by the American Gastroenterological Association (AGA) for presentation at DDW will be available in a supplement to Gastroenterology.
  • All information presented at DDW, including poster presentations, is embargoed until 12:01 AM Eastern on the day of the presentation.
  • The poster presentation will be made available on the Biora Therapeutics website following the meeting.

Biora Therapeutics Announces New Patent Covering its BioJet™ Liquid Jet Delivery Technology

Retrieved on: 
Monday, April 8, 2024

(Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced the issuance of a new patent related to the company’s BioJet™ platform for oral, systemic delivery of biotherapeutics, which uses an ingestible device designed to achieve systemic uptake through liquid jet delivery to the small intestine.

Key Points: 
  • (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced the issuance of a new patent related to the company’s BioJet™ platform for oral, systemic delivery of biotherapeutics, which uses an ingestible device designed to achieve systemic uptake through liquid jet delivery to the small intestine.
  • The United States Patent and Trademark Office (USPTO) has issued U.S. Patent No.
  • 11,938,295 entitled, “Ingestible Device for Delivery of Therapeutic Agent to the Gastrointestinal Tract.” The issued claims cover key jet parameters for liquid jet delivery of a drug to the gastrointestinal (GI) tract, including the stomach or small intestine.
  • “This latest patent further secures Biora’s broad and comprehensive ownership of liquid jet delivery to the GI tract.

Biora Therapeutics Achieves Positive Interim Results for Clinical Trial of BT-600, Advancing NaviCap™ Platform Development

Retrieved on: 
Thursday, April 4, 2024

SAN DIEGO, April 04, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today shared additional positive interim results from the single-ascending dose (SAD) clinical trial of BT-600, which is a drug-device combination consisting of the orally administered NaviCap™ device that delivers a proprietary liquid formulation of tofacitinib to the colon. BT-600 is being developed for the potential treatment of patients with ulcerative colitis (UC). The SAD portion of the phase 1 randomized, double-blind, placebo-controlled clinical trial tested the tolerability and pharmacokinetics of BT-600 at 5 mg and 10 mg doses of tofacitinib, compared to placebo, in healthy adult participants.

Key Points: 
  • BT-600 is being developed for the potential treatment of patients with ulcerative colitis (UC).
  • The SAD portion of the phase 1 randomized, double-blind, placebo-controlled clinical trial tested the tolerability and pharmacokinetics of BT-600 at 5 mg and 10 mg doses of tofacitinib, compared to placebo, in healthy adult participants.
  • We believe this could lead to better outcomes for patients suffering from UC.”
    According to the interim clinical data, all pharmacokinetic endpoints were met in all study participants.
  • The mean time to reach maximum concentration (Tmax) was 8–10 hours following administration of BT-600, versus 0.5-1.0 hours for conventional oral tofacitinib.

Biora Therapeutics Announces Closing of $6 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

Retrieved on: 
Wednesday, April 3, 2024

The gross proceeds of the offering of shares, before deducting placement agent’s fees and other offering expenses, were approximately $6,000,000.

Key Points: 
  • The gross proceeds of the offering of shares, before deducting placement agent’s fees and other offering expenses, were approximately $6,000,000.
  • H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.
  • The offering of the shares of common stock was made only by means of a prospectus, including a prospectus supplement, forming a part of an effective registration statement.
  • A prospectus supplement and accompanying prospectus relating to the offering of shares of common stock was filed with the SEC.

Biora Therapeutics Announces $6 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

Retrieved on: 
Monday, April 1, 2024

(Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced that it has entered into definitive agreements for the purchase and sale of 5,454,548 shares of the Company’s common stock at an offering price of $1.10 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules.

Key Points: 
  • (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced that it has entered into definitive agreements for the purchase and sale of 5,454,548 shares of the Company’s common stock at an offering price of $1.10 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules.
  • In addition, in a concurrent private placement, the Company will issue unregistered warrants to purchase up to 5,454,548 shares of common stock.
  • The closing of the offering is expected to occur on or about April 3, 2024, subject to the satisfaction of customary closing conditions.
  • The gross proceeds to Biora from this offering are expected to be approximately $6 million, before deducting the placement agent’s fees and other offering expenses.

Biora Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2023 Financial Results

Retrieved on: 
Tuesday, March 26, 2024

SAN DIEGO, March 26, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today provided a corporate update and reported financial results for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • Results demonstrated targeted drug delivery and absorption in the colon, with 3-4 times lower drug levels in blood
    SAN DIEGO, March 26, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today provided a corporate update and reported financial results for the fourth quarter and year ended December 31, 2023.
  • “We are thrilled by the results from the single ascending dose (SAD) portion of our clinical trial for BT-600.
  • During 2023, Biora reduced its outstanding notes by more than $80 million, resulting in a 75% reduction in net debt.
  • Comparison of Full-Year Ended December 31, 2023 and 2022
    Operating expenses were $67.1 million for the year ended December 31, 2023, compared to $62.1 million for the year ended December 31, 2022.

Biora Therapeutics to Report Fourth Quarter and Full Year 2023 Financial Results and Provide Corporate Update

Retrieved on: 
Monday, March 18, 2024

SAN DIEGO, March 18, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc .

Key Points: 
  • SAN DIEGO, March 18, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc .
  • (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced it will report financial results and provide a corporate update for the fourth quarter and full year ended December 31, 2023.
  • The company’s management will host a webcast and conference call on Tuesday, March 26, 2024, after the close of financial markets.

Biora Therapeutics Further Reduces Net Debt and Monetizes Legacy Asset

Retrieved on: 
Monday, March 11, 2024

SAN DIEGO, March 11, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced an agreement with institutional investor Context Capital to invest $2.8 million in new capital alongside a convertible note exchange, and announced the monetization of its investment in privately held Enumera Molecular, Inc. (“Enumera”) in a separate transaction that results in $3 million of nondilutive funding for Biora.

Key Points: 
  • By monetizing our interest in Enumera, which is related to our legacy business, we are also bringing in additional funding to complement our shareholders’ capital investment,” said Eric d’Esparbes, Chief Financial Officer of Biora Therapeutics.
  • “We continue to make substantive progress toward optimizing the capital structure of Biora, and developing our therapeutics programs, which are progressing well.
  • In May 2022, Biora contributed legacy assets related to its single-molecule detection platform to Enumera in exchange for a minority ownership stake in Enumera.
  • On March 8, 2024, Biora sold its minority stake to Enumera investors for $3 million.

Biora Therapeutics Announces Successful Completion of Single-Ascending Dose (SAD) Cohorts of Phase 1 Clinical Study of BT-600

Retrieved on: 
Monday, February 26, 2024

SAN DIEGO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced completion of the single-ascending dose (SAD) cohorts for its phase 1, first-in-human clinical study of BT-600 in healthy adult volunteers. BT-600 is a drug-device combination consisting of the orally administered NaviCap™ device which delivers a unique, liquid formulation of tofacitinib to the colon for the potential treatment of moderate to severe ulcerative colitis.

Key Points: 
  • (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced completion of the single-ascending dose (SAD) cohorts for its phase 1, first-in-human clinical study of BT-600 in healthy adult volunteers.
  • “Completion of the SAD cohorts of the clinical study is an exciting step advancing clinical development for BT-600, and we are pleased with the execution of the study and its progress so far,” said Ariella Kelman, MD, Chief Medical Officer of Biora Therapeutics.
  • The study, which is being conducted in the United States, consists of two parts.
  • The first is a single-dose ascending cohort comprised of 24 participants receiving BT-600 with tofacitinib at 5 mg and 10 mg doses or placebo.