Biora Therapeutics Provides Corporate Update and Reports Third Quarter 2024 Financial Results
Biora Therapeutics provided a Q3 2024 corporate update, highlighting progress on their BioJet device development. The company developed a smaller 00-size device with increased payload capacity, making it the largest in the ingestible injectables category. They shifted strategy from co-development to licensing focus. For NaviCap platform, successful Phase 1 trial of BT-600 may support proceeding directly to a larger clinical trial. Q3 operating expenses were $16.3M, with a net loss of $18.4M. The company received a Nasdaq compliance extension until December 9 and reduced monthly operating expenses by 40% to under $2.5M.
Biora Therapeutics ha fornito un aggiornamento aziendale per il terzo trimestre del 2024, evidenziando i progressi nello sviluppo del loro dispositivo BioJet. L'azienda ha sviluppato un dispositivo di dimensioni 00 più piccolo con una maggiore capacità di carico, rendendolo il più grande nella categoria degli iniettabili ingeribili. Hanno cambiato strategia passando da co-sviluppo a un focus sul licensing. Per la piattaforma NaviCap, il successo della fase 1 dello studio clinico di BT-600 potrebbe supportare il passaggio diretto a una sperimentazione clinica più ampia. Le spese operative del terzo trimestre sono state di 16,3 milioni di dollari, con una perdita netta di 18,4 milioni di dollari. L'azienda ha ricevuto un'estensione di conformità da Nasdaq fino al 9 dicembre e ha ridotto le spese operative mensili del 40%, portandole a meno di 2,5 milioni di dollari.
Biora Therapeutics ha proporcionado una actualización corporativa para el tercer trimestre de 2024, destacando los avances en el desarrollo de su dispositivo BioJet. La compañía ha desarrollado un dispositivo de tamaño 00 más pequeño con mayor capacidad de carga, lo que lo convierte en el más grande en la categoría de inyectables ingeribles. Han cambiado su estrategia de co-desarrollo a un enfoque en licencias. Para la plataforma NaviCap, el éxito del ensayo de fase 1 de BT-600 podría respaldar el paso directo a un ensayo clínico más grande. Los gastos operativos del tercer trimestre fueron de 16,3 millones de dólares, con una pérdida neta de 18,4 millones de dólares. La empresa recibió una extensión de cumplimiento de Nasdaq hasta el 9 de diciembre y redujo los gastos operativos mensuales en un 40%, llevándolos a menos de 2,5 millones de dólares.
비오라 테라퓨틱스는 2024년 3분기 기업 업데이트를 제공하며 바이오젯 장치 개발에 대한 진행 상황을 강조했습니다. 회사는 더 큰 적재 용량을 가진 00 사이즈의 더 작은 장치를 개발하여 섭취 가능한 주사제 카테고리에서 가장 큰 장치로 만들었습니다. 그들은 공동 개발에서 라이센스 중심으로 전략을 전환했습니다. NaviCap 플랫폼에 대한 BT-600의 성공적인 1상 시험은 대규모 임상 시험으로 직접 진행할 수 있도록 지원할 수 있습니다. 3분기 운영 비용은 1,630만 달러로, 순손실은 1,840만 달러였습니다. 회사는 12월 9일까지 Nasdaq 준수 연장을 받았으며, 월 운영 비용을 40% 줄여 250만 달러 이하로 조정했습니다.
Biora Therapeutics a fourni une mise à jour de l'entreprise pour le troisième trimestre 2024, mettant en évidence les progrès dans le développement de leur dispositif BioJet. L'entreprise a développé un dispositif de taille 00 plus petit avec une capacité de charge augmentée, ce qui en fait le plus grand de la catégorie des injectables ingérables. Ils ont changé de stratégie, passant du co-développement à un accent sur la licence. Pour la plateforme NaviCap, le succès de l'essai de phase 1 de BT-600 pourrait soutenir un passage direct à un essai clinique plus large. Les dépenses opérationnelles du troisième trimestre étaient de 16,3 millions de dollars, avec une perte nette de 18,4 millions de dollars. L'entreprise a reçu une extension de conformité Nasdaq jusqu'au 9 décembre et a réduit ses dépenses opérationnelles mensuelles de 40 %, à moins de 2,5 millions de dollars.
Biora Therapeutics hat ein Unternehmensupdate für das dritte Quartal 2024 bereitgestellt, in dem die Fortschritte bei der Entwicklung ihres BioJet-Geräts hervorgehoben werden. Das Unternehmen hat ein kleineres 00-Größengerät mit erhöhter Tragfähigkeit entwickelt, das es zum größten Gerät in der Kategorie der einnehmbaren Injektionsmittel macht. Sie haben ihre Strategie von der Co-Entwicklung auf den Fokus auf Lizenzen umgestellt. Für die NaviCap-Plattform könnte der erfolgreiche Phase-1-Test von BT-600 die direkte Fortsetzung zu einer größeren klinischen Studie unterstützen. Die Betriebskosten im dritten Quartal betrugen 16,3 Millionen Dollar, mit einem Nettoverlust von 18,4 Millionen Dollar. Das Unternehmen erhielt eine Nasdaq-Konformitätsverlängerung bis zum 9. Dezember und reduzierte die monatlichen Betriebskosten um 40 % auf unter 2,5 Millionen Dollar.
- Development of smaller BioJet device with largest payload capacity in its category
- Successful Phase 1 trial results for BT-600
- 40% reduction in operating expenses to under $2.5M monthly
- Operating expenses decreased from $23.3M in Q3 2023 to $16.3M in Q3 2024
- Q3 2024 net loss of $18.4M
- Risk of Nasdaq delisting after December 9 if market value requirements not met
- Uncertain future funding with no guaranteed investor commitment
- Operating expenses increased slightly from $16.1M in Q2 to $16.3M in Q3 2024
Insights
The Q3 2024 results reveal significant financial challenges. Operating expenses remained high at
Critical concerns include:
- Nasdaq compliance deadline of December 9 for market value requirements
- Dependence on lead investors for additional capitalization
- Shift from co-development to licensing strategy for BioJet device
The development of the smaller 00-size BioJet device represents a significant technical advancement. Key features include:
- Increased payload capacity of 300+ microliters
- Capability to deliver up to 50mg doses
- Improved compatibility with non-human primate testing
- Enhanced manufacturability for clinical trials
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
Net loss was
Comparison of Three Months Ended September 30, 2024 and 2023
Operating expenses were
Net loss was
About Biora Therapeutics
Biora 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 Statements
This 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 Contact
Chuck Padala
Managing Director, LifeSci Advisors
IR@bioratherapeutics.com
(646) 627-8390
Media Contact
Liz Robinson
CG life
lrobinson@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 30 2024 | |||||||
| 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 Ended September 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 | ||||||||
FAQ
What were Biora Therapeutics (BIOR) Q3 2024 financial results?
What is the deadline for Biora Therapeutics (BIOR) to meet Nasdaq compliance?
What progress did Biora Therapeutics (BIOR) make with their BioJet device in Q3 2024?
How much did Biora Therapeutics (BIOR) reduce their operating expenses?
