Tofacitinib Citrate

Testing in advanced animal model planned in Q4 for smaller, 00-size BioJet device with largest capacity of any ingestible injectable Company granted extension until December 9 to regain compliance with Nasdaq listing requirements for market value of securities SAN DIEGO, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, today provided a corporate update and reported financial results for the third quarter ended September 30, 2024. The company will not host a conference call. “We’ve made much faster progress than anticipated developing a smaller BioJet device that is highly desired by pharma companies,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “We recently presented initial animal data on our 00-size, clinical BioJet device. We were able to increase device capacity while decreasing overall size, giving BioJet the largest payload capacity of anything in the ingestible injectables category, and further increasing the number of drugs that can be delivered.” “The rapid development allowed us to reassess our partnering strategy, making the decision to shift from a co-development model to a focus on licensing the 00-size clinical BioJet device. We expect to pursue licensing agreements within multiple verticals in the near term, which we believe is preferable to a single co-development partner for a period of time. There has been tremendous interest from our pharma collaborators, both existing and new parties, and our capacity for testing various molecules during Q1 is starting to fill up. We continue to believe, based on our extensive engagement with many pharma companies, that BioJet is the category-leading technology for oral delivery of macromolecules. We look forward to testing in a more advanced animal model during Q4 and enabling progress into IND-enabling studies,” stated Mr. Mohanty. “Regarding our NaviCap platform, following a successful Phase 1 trial of BT-600, our team has concluded that the results may support proceeding to a larger clinical trial in ulcerative colitis patients, instead of the smaller Phase 1B trial we had been planning. We are working to facilitate the proper regulatory interactions to determine the next steps for this program,” continued Mr. Mohanty. “We are working with our noteholders and investors to potentially increase the company’s capitalization with the goal of maintaining our Nasdaq listing status after December 9. We appreciate the support of many of these investors as they have continued to provide funds to progress our programs, although their commitment cannot be guaranteed going forward. We are actively engaged with many parties regarding strategic alternatives and plan to provide a more detailed update soon,” stated Mr. Mohanty. Third Quarter 2024 and Recent Highlights NaviCap™ Targeted Oral Delivery Platform and BT-600 in ulcerative colitis Presented Phase 1 Clinical Trial Data at ACG 2024. Biora presented a summary of the Phase 1 clinical trial results for BT-600 at the American College of Gastroenterology Annual Meeting, receiving a Presidential Poster Award from ACG for high quality, novel research. The poster can be viewed on the company’s website. BioJet™ Systemic Oral Delivery Platform Preclinical Development Smaller, 00-Size BioJet Clinical Device. Biora recently announced a smaller version of the BioJet device based on market research indicating strong patient preference for a smaller, 00-size capsule. The smaller device uses the same core technology of internal, liquid jet injection that has been proven in over 30 animal studies to date. Payload capacity was increased while decreasing the overall size of the device from a 000-size capsule to a 00-size. The BioJet device now has a payload capacity of over 300 microliters, enabling delivery of upwards of 50 milligram doses, even for molecules that are difficult to concentrate, such as antibodies.The 00-size BioJet device is designed to be more easily tested in non-human primates. It has also been designed for compatibility with human clinical trial requirements and ease of automated manufacturing, including sterile fill and finish. Biora’s clinical and regulatory experience with the NaviCap platform informed this work and helped to streamline BioJet development.Biora has tested the trigger function of the 00-size device on the bench as well as in animals, achieving almost 100% device performance. The company is now conducting further animal studies to confirm complete device function with a test molecule. Other Matters Recent Financings. Biora partially drew down the facility put in place in August with its lead investors and complemented this funding source with approximately $4M in equity raises through registered direct and ATM program routes.Nasdaq Compliance. Biora received an extension to December 9 from Nasdaq to comply with the market value of securities requirement. No further extensions are available beyond that date. The company is in active negotiations with its lead investors to increase the company’s capitalization.Operating Expenses. Biora recently realigned its resources to focus on its BioJet program to ensure it can deliver in the short term the results needed by large pharma collaborators to progress licensing and partnering discussions. The company was able to reduce operating expenses and effective operating cash burn by about 40%, to less than $2.5 million per month on a going forward basis. Anticipated Milestones Biora anticipates sharing data from additional canine studies with the double-zero size BioJet device during Q4 2024.Biora plans to perform studies of the double-zero Biora device with its own molecules in non-human primates during Q4 2024.The company anticipates announcing an additional expanded collaboration agreement to test the double-zero BioJet device in primates during Q4 2024.Testing of collaborators’ molecules in primates is anticipated to begin in early 2025, with that round of testing completed during Q1 2025. Third Quarter 2024 Financial Results Comparison of Three Months Ended September 30, 2024 and June 30, 2024 Operating expenses were $16.3 million for the three months ended September 30, 2024, including $1.3 million in non-cash stock-based compensation expenses, compared to $16.1 million for the three months ended June 30, 2024, including $1.6 million in non-cash stock-based compensation expenses. Net loss was $18.4 million, including non-cash items of $4.0 million attributable to an extinguishment loss and the change in fair value of warrant and derivative liabilities, and a gain from discontinued operations of $3.8 million, while net loss per share was $5.04 for the three months ended September 30, 2024, compared to net income of $6.5 million, including non-cash items of $22.8 million attributable to the change in fair value of warrant and derivative liabilities, while diluted net loss per share was $0.35 for the three months ended June 30, 2024. Comparison of Three Months Ended September 30, 2024 and 2023 Operating expenses were $16.3 million for the three months ended September 30, 2024, including $1.3 million in non-cash stock-based compensation expenses, compared to $23.3 million for the three months ended September 30, 2023, including $10.5 million in non-cash stock-based compensation expenses, primarily attributable to a one-time charge of approximately $9.0 million related to vesting of employees' restricted stock units (RSUs) in 2023. Net loss was $18.4 million, net of non-cash items of $4.0 million attributable to the change in fair value of warrant and derivative liabilities, and a gain from discontinued operations of $3.8 million, while net loss per share was $5.04 for the three months ended September 30, 2024, compared to a net loss of $73.5 million, including non-cash items of $62.2 million attributable to an inducement loss of $53.2 million and a one-time stock-based compensation charge noted above, while net loss per share was $48.89 for the three months ended September 30, 2023. About Biora TherapeuticsBiora Therapeutics is a clinical-stage biotech company developing two smart pill-based therapeutics platforms: the NaviCap™ platform for colon-targeted treatment of IBD, designed to improve patient outcomes through treatment at the site of disease in the gastrointestinal tract, and the BioJet™ platform for oral delivery of large molecules, designed to replace injection with needle-free, oral delivery. For more information, visit bioratherapeutics.com or follow the company on LinkedIn or Twitter. Safe Harbor Statement or Forward-Looking StatementsThis 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 activities, and partnering and collaboration efforts with third parties, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “envision,” “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “anticipate,” “forward,” “believe,” “design,” “estimate,” “predict,” “projects,” “projecting,” “potential,” “plan,” “goal(s),” “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 FDA 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 need of and ability to raise sufficient capital to achieve our business objectives or continue our operations, our ability to maintain our listing on the Nasdaq Global Market or other Nasdaq market by regaining compliance by the December 9 deadline, the fact that delisting from the Nasdaq Global Market is a “fundamental change” under the indentures for our convertible notes triggering an obligation to offer to repurchase the convertible notes, the fact that we do not have cash sufficient to repurchase the notes if the noteholders accept such an offer, 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, 2023 filed with the Securities and Exchange Commission (SEC) and other subsequent documents, including Quarterly Reports on Form 10-Q, that we file with the SEC. 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. Investor ContactChuck PadalaManaging Director, LifeSci AdvisorsIR@bioratherapeutics.com(646) 627-8390 Media ContactLiz RobinsonCG lifelrobinson@cglife.com Biora Therapeutics, Inc.Condensed Consolidated Statements of Operations(Unaudited)(In thousands, except share and per share amounts) Three Months Ended September 30,2024 June 302024 Revenues $32 $318 Operating expenses: Research and development 5,610 7,704 Selling, general and administrative 10,649 8,400 Total operating expenses 16,259 16,104 Loss from operations (16,227) (15,786)Interest expense, net (2,016) (711)Gain on warrant liabilities 8,260 13,003 Other (expense) income, net (12,279) 9,892 (Loss) income before income taxes (22,262) 6,398 Income tax benefit (44) (67)(Loss) income from continuing operations (22,218) 6,465 Gain from discontinued operations 3,816 — Net (loss) income $(18,402) $6,465 Net (loss) gain per share from continuing operations: Basic $(6.08) $1.81 Diluted $(6.08) $(0.35)Net gain per share from discontinued operations: Basic $1.04 $— Diluted $1.04 $— Net (loss) gain per share: Basic $(5.04) $1.81 Diluted $(5.04) $(0.35)Weighted average shares outstanding: Basic 3,652,862 3,572,017 Diluted 3,652,862 7,421,597 Biora Therapeutics, Inc.Condensed Consolidated Statements of Operations(Unaudited)(In thousands, except share and per share amounts) Three Months EndedSeptember 30, 2024 2023 Revenues $32 $— Operating expenses: Research and development 5,610 10,547 Selling, general and administrative 10,649 12,774 Total operating expenses 16,259 23,321 Loss from operations (16,227) (23,321)Interest expense, net (2,016) (2,592)Gain on warrant liabilities 8,260 4,568 Other expense, net (12,279) (52,108)Loss before income taxes (22,262) (73,453)Income tax (benefit) expense (44) 1 Loss from continuing operations (22,218) (73,454)Gain from discontinued operations 3,816 — Net loss $(18,402) $(73,454)Net loss per share from continuing operations, basic and diluted $(6.08) $(48.89)Net gain per share from discontinued operations, basic and diluted $1.04 $— Net loss per share, basic and diluted $(5.04) $(48.89)Weighted average shares outstanding, basic and diluted 3,652,862 1,502,473 Biora Therapeutics, Inc.Condensed Consolidated Balance Sheets(Unaudited)(In thousands) September 30,2024 December 31,2023 (1) Assets Current assets: Cash, cash equivalents and restricted cash $3,196 $15,211 Income tax receivable 868 830 Prepaid expenses and other current assets 1,990 3,030 Total current assets 6,054 19,071 Property and equipment, net 1,175 1,156 Right-of-use assets 1,011 1,614 Other assets 193 3,302 Goodwill 6,072 6,072 Total assets $14,505 $31,215 Liabilities and Stockholders' Deficit Current liabilities: Accounts payable $6,916 $2,843 Accrued expenses and other current liabilities 21,404 17,319 Warrant liabilities 18,688 40,834 Convertible notes, net 4,527 — Senior secured convertible notes, net 14,344 — Related party senior secured convertible notes, net - current portion 19,721 1,976 Derivative liabilities 35,018 — Total current liabilities 120,618 62,972 Convertible notes, net — 9,966 Senior secured convertible notes, net — 14,591 Related party senior secured convertible notes, net — 19,179 Derivative liabilities — 22,899 Other long-term liabilities 516 3,029 Total liabilities $121,134 $132,636 Stockholders' deficit: Common stock 3 2 Additional paid-in capital 879,530 868,613 Accumulated deficit (967,084) (950,958)Treasury stock (19,078) (19,078)Total stockholders' deficit (106,629) (101,421)Total liabilities and stockholders' deficit $14,505 $31,215 (1) The condensed consolidated balance sheet data as of December 31, 2023 has been derived from the audited consolidated financial statements

GSK added Ojjaara to its portfolio through the acquisition of Sierra in 2022. Credit: Magda Wygralak via Shutterstock. Health Canada has granted approval for GlaxoSmithKline’s ( GSK ) Ojjaara (momelotinib) for treating myelofibrosis (MF) in adults with moderate-to-severe anaemia. The once-daily, oral treatment is indicated for use in patients with intermediate or high-risk primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF. This approval is based on the results from the global, randomised, multicentre, double-blind Phase III MOMENTUM trial of Ojjaara. The trial compared momelotinib with danazol in symptomatic and anaemic MF patients who had previously received treatment with an approved Janus kinase inhibitor. It assessed the safety and efficacy of momelotinib in addressing various aspects of the disease, including symptom relief, reduction in blood transfusions required for anaemia, and decrease in spleen enlargement. According to the trial’s findings, Ojjaara treatment offered improvements in total symptom score, transfusion independence, and splenic response rate. The approval in Canada is also backed by further data from a patient subset in the Phase III SIMPLIFY-1 trial, which demonstrated Ojjaara’s efficacy in treating MF patients with moderate-to-severe anaemia and related symptoms. In September last year, the US Food and Drug Administration approved Ojjaara for the same indication. Initially developed by Sierra Oncology , GSK added Ojjaara to its portfolio through the acquisition of Sierra in 2022. GSK Canada interim country medical director Michelle Horn said: “Treatment options for myelofibrosis-related anaemia have been limited. We are proud to offer this treatment alternative for Canadian patients to address this critical unmet need and other myelofibrosis symptoms. “With most myelofibrosis patients becoming anaemic over time, Ojjaara’s approval represents a significant milestone to improve the outcomes of these patients while also highlighting GSK’s commitment to making an impact in Canada’s haematology oncology space through innovative new treatments.”