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

GlobeNewswire03-27

All performance targets achieved in single-ascending dose (SAD) cohorts of BT-600 clinical trial Results demonstrated targeted drug delivery and absorption in the colon, with 3-4 times lower drug ...

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Results demonstrated targeted drug delivery and absorption in the colon, with 3-4 times lower drug levels in blood. Remainder of BT-600 clinical trial progressing well and on schedule. Management will host conference call and webcast today at 4:30 PM Eastern / 1:30 PM Pacific. SAN DIEGO, March 26, 2024  -- Biora Therapeutics, Inc. , the biotech company that is reimagining therapeutic delivery, today provided a corporate update andreported financial results for the fourth quarter and year ended December31, 2023.“We are thrilled by the results from the single ascending dose  portion of our clinical trial for BT-600. The data indicate exactly what we had hoped: NaviCap devices consistently delivered tofacitinib directly to the colon, resulting in systemic drug levels three to four times lower than conventional oral delivery. This demonstrates the NaviCap platform’s unique ability for targeted deli","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","BK4196":"保健护理服务","BIOR":"Biora Therapeutics, Inc.","LENZ":"Therapeutics"},"translate_title":"Biora Therapeutics提供公司更新并报告第四季度和2023年全年财务业绩","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"LENZ":1,"BIOR":0.9},"content_text":"All performance targets achieved in single-ascending dose (SAD) cohorts of BT-600 clinical trial\nResults demonstrated targeted drug delivery and absorption in the colon, with 3-4 times lower drug levels in blood\nRemainder of BT-600 clinical trial progressing well and on schedule\nManagement will host conference call and webcast today at 4:30 PM Eastern / 1:30 PM Pacific\nSAN 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.\n“We are thrilled by the results from the single ascending dose (SAD) portion of our clinical trial for BT-600. The data indicate exactly what we had hoped: NaviCap devices consistently delivered tofacitinib directly to the colon, resulting in systemic drug levels three to four times lower than conventional oral delivery. This demonstrates the NaviCap platform’s unique ability for targeted delivery to the colon, and is consistent with potentially higher drug levels in colon tissue at the site of the disease,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics.\n“We eagerly anticipate the conclusion of the multiple ascending dose (MAD) portion of the trial during the second quarter of 2024, which will provide additional insight into the performance of BT-600. We are working to create a new treatment paradigm that leads to better outcomes for patients suffering from ulcerative colitis, and we are encouraged by the data so far,” stated Mr. Mohanty.\n“Meanwhile, our BioJet platform is progressing well. We just completed animal studies with another collaborator molecule, and we remain focused on our planned goal of progressing to partnerships this year,” continued Mr. Mohanty.\nFourth Quarter and Full-Year 2023 and Recent Highlights\nNaviCap™ Targeted Oral Delivery Platform and BT-600 in ulcerative colitis \n\nCompletion of SAD Portion of Phase 1 Clinical Trial for BT-600. Results from the single-ascending dose (SAD) portion of the trial were consistent with desired performance targets: \n  \nNaviCap devices were well tolerated by study subjects in the SAD cohort.\nAll participants who received devices containing active drug showed systemic drug absorption, indicating that the NaviCap devices released and delivered drug as intended.\nMeasurable tofacitinib in blood was first observed at approximately six hours, with maximal concentrations at approximately eight hours post ingestion, which is indicative of drug delivery and absorption in the colon, as intended.\nPlasma levels of tofacitinib were approximately 3-4 times lower than what is observed with conventional oral tofacitinib at the same doses, which is a positive sign consistent with passage of drug through the colonic tissue and into systemic circulation.  \nDose-proportional pharmacokinetics were also observed, with consistently lower plasma drug concentrations with the 5 mg dose than the 10 mg dose.  \n \n\nBioJet™ Systemic Oral Delivery Platform preclinical development\n\nBioJet Research Collaborations. Biora has now successfully performed animal studies with peptides, antibodies, and nucleic acids, exceeding its performance target of 15% bioavailability compared to IV administration, and achieving 30-40% bioavailability with its most recent studies. The company recently completed animal studies with another large pharma research collaborator; final study data is anticipated during Q2.\n\nCapital Markets\n\nOptimization of Capital Structure. During 2023, Biora reduced its outstanding notes by more than $80 million, resulting in a 75% reduction in net debt. With an additional note exchange in March 2024, the company has brought in a total of $19.8 million in new investment through these transactions, demonstrating continued support from institutional investors.\nResolution of Legacy Matters. Biora recently monetized its investment in Enumera Molecular, Inc., generating $3 million in non-dilutive capital, and also reached an agreement in principle to resolve a legacy securities litigation matter. The company believes that remaining legacy issues will have minimal impact on Biora going forward.\n\nAnticipated Milestones\nNaviCap™ Targeted Oral Delivery Platform and BT-600 in ulcerative colitis\n\nConclusion of the Phase 1 clinical trial of BT-600 is anticipated. The company expects to receive final SAD/MAD data, including colon tissue biopsy results, during Q2 2024 and plans to present topline data from the trial shortly afterward.\nA clinical study in active ulcerative colitis patients is planned during the second half of 2024.\n\nBioJet™ Systemic Oral Delivery Platform development\n\nThe company expects data from a recently completed animal study with its newest large pharmaceutical collaborator during Q2.\nAn update on data from recent animal studies will be shared at the Next Gen Peptide Formulation & Delivery Summit in June 2024.\nBiora anticipates continued progress toward a partnership agreement for the BioJet platform.\n\n\n\n\nFourth Quarter and Full-Year 2023 Financial Results\n\n\n\nComparison of Three Months Ended December 31, 2023 and September 30, 2023\nOperating expenses were $13.3 million for the three months ended December 31, 2023, compared to $23.3 million for the three months ended September 30, 2023. The decrease was primarily attributable to a one-time stock-based compensation non-cash charge of approximately $9.0 million related to vesting of employees' restricted stock units (RSUs) in Q3 2023.\nNet loss was $15.4 million and net loss per share was $0.62 for the three months ended December 31, 2023, compared to a net loss of $73.5 million and net loss per share of $4.89 for the three months ended September 30, 2023. Q4 2023 includes non-cash charges of $6.4 million attributable to the December convertible notes exchange and $3.0 million impairment on equity investments. Q3 2023 includes non-cash charges to stock-based compensation expense of $9.0 million noted above and a non-cash charge of $53.2 million attributable to the convertible notes exchange implemented by the company in September 2023.\nNet gain from discontinued operations was $0.2 million and net gain per share was $0.01 for the three months ended December 31, 2023. There was no gain or loss from discontinued operations for the three months ended September 30, 2023.\nComparison of Three Months Ended December 31, 2023 and 2022\nOperating expenses were $13.3 million for the three months ended December 31, 2023, compared to $13.8 million for the three months ended December 31, 2022.\nNet loss was $15.4 million and net loss per share was $0.62 for the three months ended December 31, 2023, compared to a net loss of $13.7 million and net loss per share of $1.64 for the three months ended December 31, 2022.\nNet gain from discontinued operations was $0.2 million and net gain per share was $0.01 for the three months ended December 31, 2023 compared to net loss from discontinued operations of $0.3 million and net loss per share of $0.03 for the three months ended December 31, 2022.\nComparison of Full-Year Ended December 31, 2023 and 2022\nOperating expenses were $67.1 million for the year ended December 31, 2023, compared to $62.1 million for the year ended December 31, 2022.\nNet loss was $124.1 million and net loss per share was $7.87 for the year ended December 31, 2023, compared to a net loss of $38.2 million and net loss per share of $5.00 for the year ended December 31, 2022. This includes non-cash charges to stock-based compensation expense of $9.0 million related to vesting of employees' restricted stock units (RSUs) in Q3 2023, a non-cash charge of $53.2 million attributable to the convertible notes exchange implemented by the company in September 2023, an extinguishment loss on the convertible notes exchange implemented by the company in December 2023, and an impairment loss on equity investments.\nNet gain from discontinued operations was $0.2 million and net gain per share was $0.01 for the year ended December 31, 2023, compared to net gain from discontinued operations of $10.7 million and net gain per share of $1.40 for the year ended December 31, 2022.\nConference Call and Webcast Information\n\n\n\nDate:\n     \nTuesday, March 26, 2024\n\n\nTime:\n \n4:30 PM Eastern time / 1:30 PM Pacific time\n\n\nConference Call:\n \nDomestic 1-877-423-9813 International 1-201-689-8573 Conference ID 13744533Call me for instant telephone access\n\n\nWebcast:\n \nhttps://investors.bioratherapeutics.com/events-presentations\n\n\n\nAbout Biora Therapeutics\nBiora 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, the company is developing therapies to improve patients’ lives.\nBiora is focused on development of two therapeutics platforms: the NaviCap™ targeted oral delivery platform, which is designed to improve outcomes for patients with inflammatory bowel disease through treatment at the site of disease in the gastrointestinal tract, and the BioJet™ systemic oral delivery platform, which is designed to replace injection for better management of chronic diseases through needle-free, oral delivery of large molecules.\nFor more information, visit bioratherapeutics.com or follow the company on LinkedIn or Twitter.\nSafe Harbor Statement or Forward-Looking Statements\nThis press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the progress and future expectations and goals of our research and development, preclinical, and clinical trial efforts including our phase 1 trial execution and data timelines, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “forward,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan,” “target,” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, our ability to innovate in the field of therapeutics, our ability to make future filings and initiate and execute clinical trials on expected timelines or at all, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, our expectations regarding allowed patents or intended grants to result in issued or granted patents, our expectations regarding opportunities with current or future pharmaceutical collaborators or partners, our ability to raise sufficient capital to achieve our business objectives, and those risks described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC and other subsequent documents, including Quarterly Reports, that we file with the SEC.\nBiora 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.\nInvestor ContactChuck PadalaManaging Director, LifeSci AdvisorsIR@bioratherapeutics.com(646) 627-8390\nMedia Contactmedia@bioratherapeutics.com\n\n\n\nBiora Therapeutics, Inc.Condensed Consolidated Statements of Operations(Unaudited)(In thousands, except share and per share amounts)\n\n\n \n\n\n \nThree Months Ended\n \n\n\n \nDecember 31,2023\n \n \nSeptember 30,2023\n \n\n\nRevenues\n$\n—\n \n \n$\n—\n \n\n\nOperating expenses:\n \n \n \n \n \n\n\nResearch and development\n \n6,118\n \n \n \n10,547\n \n\n\nSelling, general and administrative\n \n7,226\n \n \n \n12,774\n \n\n\nTotal operating expenses\n \n13,344\n \n \n \n23,321\n \n\n\nLoss from operations\n \n(13,344\n)\n \n \n(23,321\n)\n\n\nInterest expense, net\n \n(1,840\n)\n \n \n(2,592\n)\n\n\nGain on warrant liabilities\n \n12,733\n \n \n \n4,568\n \n\n\nOther expense, net\n \n(13,276\n)\n \n \n(52,108\n)\n\n\nLoss before income taxes\n \n(15,727\n)\n \n \n(73,453\n)\n\n\nIncome tax (benefit) expense\n \n(95\n)\n \n \n1\n \n\n\nLoss from continuing operations\n \n(15,632\n)\n \n \n(73,454\n)\n\n\nGain from discontinued operations\n \n219\n \n \n \n—\n \n\n\nNet loss\n$\n(15,413\n)\n \n$\n(73,454\n)\n\n\nNet loss per share from continuing operations, basic and diluted\n$\n(0.63\n)\n \n$\n(4.89\n)\n\n\nNet gain per share from discontinued operations, basic and diluted\n$\n0.01\n \n \n$\n—\n \n\n\nNet loss per share, basic and diluted\n$\n(0.62\n)\n \n$\n(4.89\n)\n\n\nWeighted average shares outstanding, basic and diluted\n \n24,810,923\n \n \n \n15,024,726\n \n\n\n \n \n \n \n \n \n \n \n\n\n\n\n\n\nBiora Therapeutics, Inc.Condensed Consolidated Statements of Operations(Unaudited)(In thousands, except share and per share amounts)\n\n\n \n\n\n \nThree Months EndedDecember 31,\n \n \nYear Ended December 31,\n \n\n\n \n2023\n \n \n2022\n \n \n2023\n \n \n2022\n \n\n\n \n \n \n \n \n \n \n \n \n \n \n \n\n\nRevenues\n$\n—\n \n \n \n14\n \n \n$\n4\n \n \n$\n305\n \n\n\nOperating expenses:\n \n \n \n \n \n \n \n \n \n \n \n\n\nResearch and development\n \n6,118\n \n \n \n5,767\n \n \n \n29,838\n \n \n \n24,049\n \n\n\nSelling, general and administrative\n \n7,226\n \n \n \n8,023\n \n \n \n37,309\n \n \n \n38,037\n \n\n\nTotal operating expenses\n \n13,344\n \n \n \n13,790\n \n \n \n67,147\n \n \n \n62,086\n \n\n\nLoss from operations\n \n(13,344\n)\n \n \n(13,776\n)\n \n \n(67,143\n)\n \n \n(61,781\n)\n\n\nInterest expense, net\n \n(1,840\n)\n \n \n(2,685\n)\n \n \n(9,815\n)\n \n \n(10,990\n)\n\n\nGain on warrant liabilities\n \n12,733\n \n \n \n5,458\n \n \n \n18,004\n \n \n \n20,904\n \n\n\nOther (expense) income, net\n \n(13,276\n)\n \n \n(2,207\n)\n \n \n(65,470\n)\n \n \n2,617\n \n\n\nLoss before income taxes\n \n(15,727\n)\n \n \n(13,210\n)\n \n \n(124,424\n)\n \n \n(49,250\n)\n\n\nIncome tax (benefit) expense\n \n(95\n)\n \n \n259\n \n \n \n(90\n)\n \n \n(420\n)\n\n\nLoss from continuing operations\n \n(15,632\n)\n \n \n(13,469\n)\n \n \n(124,334\n)\n \n \n(48,830\n)\n\n\nGain (loss) from discontinued operations\n \n219\n \n \n \n(253\n)\n \n \n219\n \n \n \n10,673\n \n\n\nNet loss\n$\n(15,413\n)\n \n$\n(13,722\n)\n \n$\n(124,115\n)\n \n$\n(38,157\n)\n\n\nNet loss per share from continuing operations, basic and diluted\n$\n(0.63\n)\n \n$\n(1.61\n)\n \n$\n(7.88\n)\n \n$\n(6.40\n)\n\n\nNet gain (loss) per share from discontinued operations, basic and diluted\n$\n0.01\n \n \n$\n(0.03\n)\n \n$\n0.01\n \n \n$\n1.40\n \n\n\nNet loss per share, basic and diluted\n$\n(0.62\n)\n \n$\n(1.64\n)\n \n$\n(7.87\n)\n \n$\n(5.00\n)\n\n\nWeighted average shares outstanding, basic and diluted\n \n24,810,923\n \n \n \n8,349,844\n \n \n \n15,773,297\n \n \n \n7,635,107\n \n\n\n\n\n\n\nBiora Therapeutics, Inc.Condensed Consolidated Balance Sheets(Unaudited)(In thousands)\n\n\n \n\n\n \nDecember 31,\n \n\n\n \n2023\n \n \n2022\n \n\n\n \n \n \n \n \n \n\n\nAssets\n \n \n \n \n \n\n\nCurrent assets:\n \n \n \n \n \n\n\nCash, cash equivalents and restricted cash\n$\n15,211\n \n \n$\n30,486\n \n\n\nIncome tax receivable\n \n830\n \n \n \n828\n \n\n\nPrepaid expenses and other current assets\n \n3,030\n \n \n \n4,199\n \n\n\nCurrent assets of disposal group held for sale\n \n—\n \n \n \n2,603\n \n\n\nTotal current assets\n \n19,071\n \n \n \n38,116\n \n\n\nProperty and equipment, net\n \n1,156\n \n \n \n1,654\n \n\n\nRight-of-use assets\n \n1,614\n \n \n \n1,482\n \n\n\nOther assets\n \n3,302\n \n \n \n6,201\n \n\n\nGoodwill\n \n6,072\n \n \n \n6,072\n \n\n\nTotal assets\n$\n31,215\n \n \n$\n53,525\n \n\n\nLiabilities and Stockholders' Deficit\n \n \n \n \n \n\n\nCurrent liabilities:\n \n \n \n \n \n\n\nAccounts payable\n$\n2,843\n \n \n$\n3,606\n \n\n\nAccrued expenses and other current liabilities\n \n17,319\n \n \n \n16,161\n \n\n\nWarrant liabilities\n \n40,834\n \n \n \n3,538\n \n\n\nRelated party senior secured convertible notes, current portion\n \n1,976\n \n \n \n—\n \n\n\nTotal current liabilities\n \n62,972\n \n \n \n23,305\n \n\n\nConvertible notes, net\n \n9,966\n \n \n \n127,811\n \n\n\nSenior secured convertible notes, net\n \n14,591\n \n \n \n—\n \n\n\nRelated party senior secured convertible notes, net\n \n19,179\n \n \n \n—\n \n\n\nDerivative liabilities\n \n22,899\n \n \n \n—\n \n\n\nOther long-term liabilities\n \n3,029\n \n \n \n4,696\n \n\n\nTotal liabilities\n$\n132,636\n \n \n$\n155,812\n \n\n\nStockholders' deficit:\n \n \n \n \n \n\n\nCommon stock\n \n25\n \n \n \n8\n \n\n\nAdditional paid-in capital\n \n868,591\n \n \n \n743,626\n \n\n\nAccumulated deficit\n \n(950,958\n)\n \n \n(826,843\n)\n\n\nTreasury stock\n \n(19,079\n)\n \n \n(19,078\n)\n\n\nTotal stockholders' deficit\n \n(101,421\n)\n \n \n(102,287\n)\n\n\nTotal liabilities and stockholders' deficit\n$\n31,215\n \n \n$\n53,525","kind":null,"is_publish_news":null,"is_publish_highlight":null,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; 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