SRZN 8-K
Surrozen, Inc./DE (SRZN)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
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 9, 2025, Surrozen, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2025. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information set forth under this “Item 2.02. Results of Operations and Financial Condition” (including the exhibit referenced herein) shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference in any filing made by the Company pursuant to the Securities Act of 1933, as amended.
Item 9.01 Financial Statements and Exhibits.
(d) |
Exhibits |
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Exhibit No. |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within 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 hereunto duly authorized.
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SURROZEN, INC. |
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Date: |
May 9, 2025 |
By: |
/s/ Charles Williams |
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Name: Charles Williams |
Exhibit 99.1
Surrozen Reports First Quarter 2025 Financial Results and Provides Business Update
SOUTH SAN FRANCISCO, Calif., May 9, 2025 (GLOBE NEWSWIRE) -- Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN), a biotechnology company pioneering targeted therapeutics that selectively modulate the Wnt pathway for tissue repair and regeneration, with a focus on severe eye diseases, today announced financial results for the first quarter ended March 31, 2025, and provided a business update.
Business Highlights
Surrozen has pivoted its focus to its ophthalmology pipeline, leveraging its Wnt biology expertise and antibody technologies to develop novel treatments for severe eye diseases, including age-related macular degeneration (AMD) and diabetic retinopathy. The Company discontinued development of SZN-043 for the treatment of severe alcohol-associated hepatitis in the first quarter of 2025 due to insufficient clinical benefit in the Phase 1b trial.
The Company has redirected resources to advance its lead ophthalmology candidates SZN-8141 and SZN-8143 toward clinical studies. SZN-8141 combines Frizzled 4 (Fzd4) agonism with VEGF antagonism, while SZN-8143 adds IL-6 antagonism, offering potential differentiation from existing therapies. Surrozen expects to file an Investigational New Drug (IND) application and commence clinical studies for SZN-8141 in 2026. The Food and Drug Administration clearance of this IND application would trigger funding of the $98.6 million private placement tranche which is expected to fund operations through efficacy, safety and tolerability studies for SZN-8141 and SZN-8143. The Company continues its collaboration with Boehringer Ingelheim on SZN-413 for retinal vascular-associated diseases.
“We are thrilled about the opportunity to advance our novel ophthalmology pipeline which holds significant potential to address unmet needs in serious eye diseases,” said Craig Parker, President and Chief Executive Officer of Surrozen. “The strategic pivot to ophthalmology, supported by our recent $175 million financing, positions us to deliver innovative therapies that could transform patient outcomes in multiple severe and often disabling eye diseases. We remain committed to leveraging our proprietary Wnt pathway technologies to drive meaningful progress toward filing an Investigational New Drug application with the FDA for SZN-8141 while pre-clinically advancing multiple ophthalmology candidates.”
First Quarter 2025 Financial Highlights
- Cash Position: Cash and cash equivalents were $101.6 million as of March 31, 2025, compared to $34.6 million as of December 31, 2024, bolstered by $76.4 million in gross proceeds from the first closing of a $175 million private placement in March 2025.
- Research Service Revenue – Related Party: Research service revenue from a related party was $1.0 million for the quarter, compared to zero for the same period in 2024, driven by the collaboration with TCGFB, Inc. for TGF-β antibodies.
- Operating Expenses:
- Other Income and Expenses:
- Net Loss: Net loss was $27.0 million, or ($7.43) per share, compared to a net loss of $8.8 million, or ($4.24) per share, for the same period in 2024.
About Surrozen’s Ophthalmology Portfolio
About SZN-8141 for retinal diseases
SZN-8141 combines Frizzled 4 (Fzd4) agonism and Vascular Endothelial Growth Factor (VEGF) antagonism, which has the potential to provide benefits over treatment with single agents for Diabetic Macular Edema (DME) and neovascular Age-Related Macular Degeneration (wet AMD). The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF monotherapies. In addition, Fzd4 monotherapy has demonstrated proof of concept in DME in clinical trials. We believe SZN-8141 has the potential to treat multiple retinopathy indications and be differentiated from existing therapies. Data generated in preclinical models of retinopathy demonstrated that SZN-8141 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth.
About SZN-8143 for retinal diseases
SZN-8143 combines Fzd4 agonism, VEGF antagonism, and interleukin-6 (IL-6) antagonism which may have benefits over single agents for treatment of DME/wet AMD/uveitic macular edema (UME). The current standard of care for diabetic retinopathy (including DME), retinal vein occlusion and wet AMD is intravitreal administration of anti-VEGF monotherapies. In addition, Fzd4 monotherapy has demonstrated proof of concept in clinical trials for retinal disease. We believe SZN-8143 has the potential to treat multiple retinopathy indications and be differentiated from existing therapies. Data generated in preclinical models of retinopathy demonstrated that SZN-8143 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth.
About SZN-413 for Retinal Diseases
SZN-413 is a bi-specific antibody targeting Fzd4-mediated Wnt signaling designed using Surrozen’s SWAP™ technology. It is currently being developed for the treatment of retinal vascular-associated diseases. Data generated by Surrozen with SZN-413 in preclinical models of retinopathy demonstrated that SZN-413 could potently stimulate Wnt signaling in the eye, induce normal retinal vessel regrowth, suppress pathological vessel growth and reduce vascular leakage. This novel approach could thus potentially allow for regeneration of healthy eye tissue, not only halting retinopathy, but possibly allowing for a full reversal of the patient’s disease.
About Surrozen
Surrozen is a biotechnology company developing tissue-specific antibodies to selectively modulate the Wnt pathway, with a current focus on ophthalmology. Its proprietary technologies aim to harness the body’s biological repair mechanisms to treat severe diseases. For more information, visit www.surrozen.com.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws. Forward-looking statements generally are accompanied by words such as “will,” “plan,” “intend,” “potential,” “expect,” “could,” or the negative of these words and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding Surrozen’s discovery, research and development activities, in particular its development plans for its product candidates (including anticipated clinical development plans and timelines, the availability of data, the potential for such product candidates to be used to treat human disease or address unmet needs in serious eye diseases, as well as the potential benefits and potential differentiation from existing therapies of such product candidates), expectations regarding timing of an IND application and commencement of clinical studies for SZN-8141, triggering the funding of the second private placement tranche, expectations of the second private placement trance to fund operations through efficacy, safety and tolerability studies for SZN-8141 and SZN-8143, and the Company’s partnership with Boehringer Ingelheim. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management of Surrozen and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Surrozen. These forward-looking statements are subject to a number of risks and uncertainties, including the initiation, cost, timing, progress and results of research and development activities, preclinical and clinical trials with respect to its product candidates and potential future drug candidates; the Company’s ability to fund its preclinical and clinical trials and development efforts, whether with existing funds or through additional fundraising; Surrozen’s ability to identify, develop and commercialize drug candidates; Surrozen’s ability to successfully complete preclinical and clinical studies for its product candidates; the effects that arise from volatility in global economic, political, regulatory and market conditions; and all other factors discussed in Surrozen’s Annual Report on Form 10-K for the year ended December
31, 2024 filed, and Surrozen’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 to be filed with the Securities and Exchange Commission (“SEC”) under the heading “Risk Factors,” and other documents Surrozen has filed, or will file, with the SEC. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Surrozen presently does not know, or that Surrozen currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Surrozen’s expectations, plans, or forecasts of future events and views as of the date of this press release. Surrozen anticipates that subsequent events and developments will cause its assessments to change. However, while Surrozen may elect to update these forward-looking statements at some point in the future, Surrozen specifically disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Surrozen’s assessments of any date after the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.
Investor/Media Contact:
Email: [email protected]
SURROZEN, INC.
Unaudited Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
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Three Months Ended |
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March 31, |
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2025 |
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2024 |
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Research service revenue – related party |
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$ |
983 |
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$ |
— |
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Operating expenses: |
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Research and development |
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6,558 |
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5,247 |
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General and administrative |
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3,976 |
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3,883 |
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Total operating expenses |
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10,534 |
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9,130 |
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Loss from operations |
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(9,551 |
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(9,130 |
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Interest income |
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296 |
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385 |
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Loss on amendment and cancellation of warrants |
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(2,073 |
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— |
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Loss on execution of the 2025 PIPE |
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(71,084 |
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— |
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Gain on change in fair value of tranche liability |
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16,340 |
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— |
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Gain on settlement of tranche liability |
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1,117 |
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— |
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Other income (expense), net |
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37,985 |
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(85 |
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Net loss |
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$ |
(26,970 |
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$ |
(8,830 |
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Net loss per share attributable to common |
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$ |
(7.43 |
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$ |
(4.24 |
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Weighted-average shares used in computing net |
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3,628 |
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2,083 |
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SURROZEN, INC.
Condensed Consolidated Balance Sheets
(In thousands)
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March 31, |
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December 31, |
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2025 |
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2024(1) |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
101,645 |
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$ |
34,565 |
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Accounts receivable |
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2,130 |
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2,039 |
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Accounts receivable – related party |
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502 |
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502 |
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Prepaid expenses and other current assets |
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1,734 |
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1,826 |
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Total current assets |
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106,011 |
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38,932 |
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Property and equipment, net |
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295 |
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562 |
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Operating lease right-of-use assets |
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7,350 |
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7,801 |
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Restricted cash |
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688 |
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688 |
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Warrant asset |
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384 |
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153 |
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Other assets |
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101 |
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331 |
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Total assets |
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$ |
114,829 |
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$ |
48,467 |
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Liabilities and stockholders’ equity (deficit) |
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Current liabilities: |
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Accounts payable |
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$ |
302 |
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$ |
306 |
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Accrued and other liabilities |
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9,090 |
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5,180 |
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Lease liabilities, current portion |
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1,190 |
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1,829 |
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Total current liabilities |
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10,582 |
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7,315 |
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Lease liabilities, noncurrent portion |
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6,778 |
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6,640 |
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Tranche liability |
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42,423 |
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— |
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Warrant liabilities |
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49,372 |
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55,892 |
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Total liabilities |
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109,155 |
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69,847 |
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Stockholders’ equity (deficit): |
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Preferred stock |
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— |
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— |
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Common stock |
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1 |
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— |
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Additional paid-in-capital |
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317,902 |
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263,879 |
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Accumulated deficit |
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(312,229 |
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(285,259 |
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Total stockholders’ equity (deficit) |
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5,674 |
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(21,380 |
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Total liabilities and stockholders’ equity (deficit) |
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$ |
114,829 |
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$ |
48,467 |
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(1) Derived from the audited consolidated financial statements, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.