UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On May 15, 2024, Biora Therapeutics, Inc. (the "Company") issued a press release announcing its financial results for the first quarter ended March 31, 2024. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
As provided in General Instruction B.2 of Form 8-K, the information in this Item 2.02 and Exhibit 99.1 incorporated herein shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall such information or Exhibit 99.1 be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 |
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104 |
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Cover Page Interactive Data File (embedded with the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Biora Therapeutics, Inc. |
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Date: |
May 15, 2024 |
By: |
/s/ Aditya P. Mohanty |
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Aditya P. Mohanty |
Exhibit 99.1
Biora Therapeutics Provides Corporate Update and Reports
First Quarter 2024 Financial Results
Dosing of all patients in clinical trial of BT-600 has been successfully completed, with results anticipated in late Q2 2024
Clinical data on device function of the NaviCapTM platform to be presented at DDW on May 19
Partnering process for the BioJet oral delivery platform is progressing well
Management will host conference call and webcast today at 4:30 PM Eastern / 1:30 PM Pacific
SAN DIEGO, May 15, 2024 – Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today provided a corporate update and reported financial results for the first quarter ended March 31, 2024.
“We were gratified to see the excellent interim results from our clinical trial for BT-600, where we observed a pharmacokinetic profile consistent with drug delivery and absorption in the colon,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “We recently announced completion of the remaining portion of the trial, in which a cohort of 24 healthy participants received BT-600 at 5 mg and 10 mg doses of tofacitinib, or placebo, with once daily dosing for seven days. We are now awaiting the analysis of those results, and we anticipate sharing full study data in late June. Everything we have seen so far reinforces our belief that the NaviCapTM platform could optimize JAK inhibitor therapy in ulcerative colitis and lead to improved efficacy and reduced toxicity for patients.”
“We continue to progress our BioJet platform, with further animal studies in recent months that demonstrate advances in bioavailability and consistency with our own drug candidates and with collaborator molecules. We are currently running a partnering process for interested parties who see the potential for the BioJet platform and are eager to bring this technology to the clinic. Our goal is to confirm partner interest by mid-2024. We are encouraged by the engagement shown by some of our current collaborators, and we are also seeing strong interest from new companies,” continued Mr. Mohanty.
First Quarter 2024 and Recent Highlights
NaviCap™ Targeted Oral Delivery Platform and BT-600 in ulcerative colitis
BioJet™ Systemic Oral Delivery Platform preclinical development
Capital Markets
Anticipated Milestones
NaviCap™ Targeted Oral Delivery Platform and BT-600 in ulcerative colitis
BioJet™ Systemic Oral Delivery Platform development
First Quarter 2024 Financial Results
Comparison of Three Months Ended March 31, 2024 and December 31, 2023
Operating expenses were $16.1 million for the three months ended March 31, 2024, including $1.5 million in non-cash stock-based compensation expenses, compared to $13.3 million for the three months ended December 31, 2023 including $1.5 million in non-cash stock-based compensation expenses.
Net loss was $4.2 million, net of non-cash items of $13.9 million attributable to the change in fair value of warrant liabilities, while net loss per share was $0.14 for the three months ended March 31, 2024, compared to a net loss of $15.4 million, including non-cash charges of $6.4 million attributable to the convertible notes exchange and $3.0 million impairment on equity investments, while net loss per share was $0.62 for the three months ended December 31, 2023.
Comparison of Three Months Ended March 31, 2024 and 2023
Operating expenses were $16.1 million for the three months ended March 31, 2024, including $1.5 million in non-cash stock-based compensation expenses, compared to $15.5 million for the three months ended March 31, 2023, including $2.4 million in non-cash stock-based compensation expenses.
Net loss was $4.2 million, net of non-cash items of $13.9 million attributable to the change in fair value of warrant liabilities, while net loss per share was $0.14 for the three months ended March 31, 2024, compared to a net loss of $17.4 million and net loss per share of $1.59 for the three months ended March 31, 2023.
Conference Call and Webcast Information
Date: Wednesday, May 15, 2024
Time: 4:30 PM Eastern time / 1:30 PM Pacific time
Conference Call: Domestic 1-877-423-9813
International 1-201-689-8573
Conference ID 13746163
Call me for instant telephone access
Webcast: https://investors.bioratherapeutics.com/events-presentations
About Biora Therapeutics
Biora 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.
Biora 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.
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 anticipated milestones, 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 “anticipate,” “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 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 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, 2023 filed with the SEC and other subsequent documents, including Quarterly Reports, 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
media@bioratherapeutics.com
Biora Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except share and per share amounts)
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Three Months Ended |
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March 31, |
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December 31, |
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Revenues |
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$ |
542 |
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$ |
— |
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Operating expenses: |
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Research and development |
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7,005 |
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6,118 |
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Selling, general and administrative |
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9,053 |
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7,226 |
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Total operating expenses |
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16,058 |
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13,344 |
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Loss from operations |
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(15,516 |
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(13,344 |
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Interest expense, net |
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(2,757 |
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(1,840 |
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Gain on warrant liabilities |
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13,915 |
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12,733 |
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Other income (expense), net |
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217 |
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(13,276 |
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Loss before income taxes |
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(4,141 |
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(15,727 |
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Income tax expense (benefit) |
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48 |
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(95 |
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Loss from continuing operations |
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(4,189 |
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(15,632 |
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Gain from discontinued operations |
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— |
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219 |
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Net loss |
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$ |
(4,189 |
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$ |
(15,413 |
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Net loss per share from continuing operations, basic and diluted |
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$ |
(0.14 |
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$ |
(0.63 |
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Net gain per share from discontinued operations, basic and diluted |
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$ |
— |
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$ |
0.01 |
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Net loss per share, basic and diluted |
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$ |
(0.14 |
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$ |
(0.62 |
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Weighted average shares outstanding, basic and diluted |
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29,296,767 |
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24,810,923 |
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Biora Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except share and per share amounts)
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Three Months Ended |
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2024 |
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2023 |
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Revenues |
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$ |
542 |
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$ |
2 |
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Operating expenses: |
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Research and development |
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7,005 |
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7,190 |
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Selling, general and administrative |
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9,053 |
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8,356 |
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Total operating expenses |
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16,058 |
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15,546 |
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Loss from operations |
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(15,516 |
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(15,544 |
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Interest expense, net |
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(2,757 |
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(2,680 |
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Gain on warrant liabilities |
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13,915 |
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864 |
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Other income (expense), net |
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217 |
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(81 |
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Loss before income taxes |
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(4,141 |
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(17,441 |
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Income tax expense |
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48 |
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— |
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Net loss |
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$ |
(4,189 |
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$ |
(17,441 |
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Net loss per share, basic and diluted |
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$ |
(0.14 |
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$ |
(1.59 |
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Weighted average shares outstanding, basic and diluted |
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29,296,767 |
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10,970,583 |
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Biora Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
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March 31, |
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December 31, |
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(1) |
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Assets |
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Current assets: |
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Cash, cash equivalents and restricted cash |
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$ |
10,820 |
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$ |
15,211 |
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Income tax receivable |
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822 |
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830 |
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Prepaid expenses and other current assets |
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2,429 |
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3,030 |
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Total current assets |
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14,071 |
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19,071 |
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Property and equipment, net |
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1,136 |
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1,156 |
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Right-of-use assets |
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1,418 |
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1,614 |
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Other assets |
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293 |
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3,302 |
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Goodwill |
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6,072 |
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6,072 |
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Total assets |
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$ |
22,990 |
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$ |
31,215 |
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Liabilities and Stockholders' Deficit |
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Current liabilities: |
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Accounts payable |
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$ |
4,936 |
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$ |
2,843 |
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Accrued expenses and other current liabilities |
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16,984 |
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17,319 |
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Warrant liabilities |
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27,208 |
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40,834 |
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Related party senior secured convertible notes, current portion |
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1,976 |
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1,976 |
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Total current liabilities |
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51,104 |
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62,972 |
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Convertible notes, net |
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4,497 |
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9,966 |
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Senior secured convertible notes, net |
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18,709 |
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14,591 |
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Related party senior secured convertible notes, net |
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20,072 |
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19,179 |
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Derivative liabilities |
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26,210 |
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22,899 |
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Other long-term liabilities |
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2,583 |
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3,029 |
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Total liabilities |
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$ |
123,175 |
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$ |
132,636 |
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Stockholders' deficit: |
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Common stock |
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28 |
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25 |
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Additional paid-in capital |
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874,013 |
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868,591 |
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Accumulated deficit |
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(955,147 |
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(950,958 |
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Treasury stock |
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(19,079 |
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(19,079 |
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Total stockholders' deficit |
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(100,185 |
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(101,421 |
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Total liabilities and stockholders' deficit |
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$ |
22,990 |
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$ |
31,215 |
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(1) The condensed consolidated balance sheet data as of December 31, 2023 has been derived from the audited consolidated financial statements