ATYR 8-K
aTYR PHARMA INC (ATYR)
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 obligations of the registrant under any of the following provisions:
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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 or Rule 12b-2 of the Securities Exchange Act of 1934.
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 August 7, 2026, aTyr Pharma, Inc. issued a press release announcing financial results for the quarter ended June 30, 2026. A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.
The information under this Item 2.02, including Exhibit 99.1 hereto is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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) |
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SIGNATURE
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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ATYR PHARMA, INC. |
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By: |
/s/ Jill M. Broadfoot |
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Jill M. Broadfoot |
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Chief Financial Officer |
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Date: August 7, 2026 |
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Exhibit 99.1
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Contact: |
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Ashlee Dunston |
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Sr. Director, Investor Relations and Public Affairs |
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aTyr Pharma Announces Second Quarter 2026 Results, Program Prioritization and Corporate Restructuring to Support Efzofitimod Program in ILD
Company awaiting comments from FDA by the end of August 2026 on protocol submitted for planned Phase 3 study of efzofitimod in patients with pulmonary sarcoidosis.
Workforce reduction of approximately 60% and program prioritization conserves capital and aligns resources on efzofitimod program in ILD.
Enrollment completed in Phase 2 EFZO-CONNECT™ study of efzofitimod in SSc-ILD; topline results expected in the first quarter of 2027.
Ended the second quarter 2026 with $58.9 million in cash, cash equivalents, restricted cash and investments; cash runway into late 2028 based on current operations.
SAN DIEGO – August 7, 2026 – aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced second quarter 2026 results and a corporate restructuring to prioritize its efzofitimod program in interstitial lung disease (ILD), including pulmonary sarcoidosis and systemic sclerosis (SSc)-related ILD (SSc-ILD).
The program prioritization aims to focus the Company’s resources on advancing its lead asset, efzofitimod, and targeted pipeline development to conserve capital in anticipation of receiving comments from the U.S. Food and Drug Administration (FDA) on the protocol for its planned Phase 3 study of efzofitimod in pulmonary sarcoidosis, a major form of ILD. The Company submitted the protocol in June 2026 and is expecting feedback from the FDA by the end of August 2026.
“We are proactively taking decisive, necessary action to focus our resources on our lead therapeutic candidate, efzofitimod, as we await feedback from the FDA on the protocol we submitted for our planned Phase 3 study in pulmonary sarcoidosis patients with restrictive lung disease. This approach positions aTyr to advance this planned Phase 3 study efficiently and continue completing the Phase 2 EFZO-CONNECT™ study in SSc-ILD,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “We remain confident in the potential of efzofitimod to become a meaningful therapy for patients with these forms of ILD, and these changes are essential to our ability to achieve that goal. We are deeply grateful to our dedicated team members for their
outstanding contributions, commitment, and perseverance, including those who have helped advance tRNA synthetase biology over the years.”
Program Prioritization and Corporate Restructuring
Second Quarter 2026 and Subsequent Period Highlights
Second Quarter 2026 Financial Highlights and Cash Position
About Efzofitimod
Efzofitimod is a novel biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. Efzofitimod is currently being investigated in the Phase 2 EFZO-CONNECT™ study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD, and aTyr recently submitted a protocol to the FDA for a global Phase 3 study of efzofitimod in patients with pulmonary sarcoidosis, a major form of ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.
About aTyr
aTyr is a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans. aTyr’s discovery platform is focused on unlocking hidden therapeutic intervention points by uncovering signaling pathways driven by its
proprietary library of domains derived from all 20 tRNA synthetases. aTyr’s lead therapeutic candidate is efzofitimod, a novel biologic immunomodulator in clinical development for the treatment of interstitial lung disease, a group of immune-mediated disorders that can cause inflammation and progressive fibrosis, or scarring, of the lungs. For more information, please visit www.atyrpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are usually identified by the use of words such as “aims,” “anticipates,” “believes,” “can,” “designed,” “expects,” “hopes,” “intends,” “look toward,” “may,” “plans,” “potential,” “project,” “suggest,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include, among others, statements regarding the timelines and benefits with respect to our workforce reduction and program prioritization, including the resulting conservation of capital, reduction in operating expenses, ability to timely and efficiently advance our planned Phase 3 study of efzofitimod in pulmonary sarcoidosis and ability to complete the Phase 2 EFZO-CONNECT study in SSc-ILD; our new operating expense forecast and plans and the resulting cash runway sufficiency into late 2028 based on current operations; expected cash needs to develop efzofitimod in our planned Phase 3 study in pulmonary sarcoidosis and the means of raising such capital, including through equity or debt offerings, grant funding, collaborations, strategic partnerships and/or licensing arrangements; the potential therapeutic benefits and applications of efzofitimod; timelines and plans with respect to certain development activities and development goals, including the potential receipt of comments from the FDA by late August 2026 on a protocol submitted to the FDA in June 2026 for a Phase 3 study of efzofitimod in pulmonary sarcoidosis; the proposed design of our planned Phase 3 study of efzofitimod in pulmonary sarcoidosis, including the dosing regimen, enrollment expectations, targeted endpoints, and strategy to focus on a more limited patient population; our interpretation of the results of the Phase 3 EFZO-FIT™ study and the meaning of those interpretations for our planned Phase 3 study; and our expectation that we will report topline results from the Phase 2 EFZO-CONNECT™ study in the first quarter of 2027. These forward-looking statements also reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects, as reflected in or suggested by these forward-looking statements, are reasonable, we can give no assurance that the plans, intentions, expectations, strategies or prospects will be attained or achieved. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. Furthermore, actual results may differ materially from those described in these forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, uncertainty related to interactions with the FDA in general, risks related to our reliance on third-party partners and the potential that such partners may not perform as anticipated, the fact that NRP2 and tRNA synthetase biology is not fully understood, uncertainty regarding the ultimate long-term impact of evolving macroeconomic
and geopolitical conditions, the risks associated with targeting a more limited patient population in our planned Phase 3 study of efzofitimod in pulmonary sarcoidosis, the risk of delays in our clinical trials, risks associated with the discovery, development and regulation of our existing or future product candidates, including the uncertainty of related costs and regulatory filings and the risk that results from clinical trials or other studies may not support further development, the risk that we may cease or delay preclinical or clinical development activities for any of our existing or future product candidates for a variety of reasons (including difficulties or delays in patient enrollment in planned clinical trials), the fact that our collaboration agreements are subject to early termination, the risk that our assumptions and forecasts with respect to our workforce reduction and program prioritization may be materially inaccurate, the risk that our existing cash resources may be insufficient to fund our current operations for as long as anticipated due to changes in our operating plans, unanticipated expenses or other factors, and the risk that we may not be able to raise the additional funding required for our business and product development plans, as well as those risks set forth in our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and in our other SEC filings. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
ATYR PHARMA INC. |
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Condensed Consolidated Statements of Operations |
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(in thousands, except share and per share data) |
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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(unaudited) |
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Operating expenses: |
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Research and development |
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6,748 |
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15,384 |
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14,065 |
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27,198 |
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General and administrative |
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4,133 |
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4,929 |
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8,252 |
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8,888 |
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Total operating expenses |
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10,881 |
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20,313 |
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22,317 |
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36,086 |
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Loss from operations |
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(10,881 |
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(20,313 |
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(22,317 |
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(36,086 |
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Total other income (expense), net |
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571 |
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781 |
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1,215 |
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1,673 |
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Consolidated net loss |
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(10,310 |
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(19,532 |
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(21,102 |
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(34,413 |
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Net loss attributable to noncontrolling interest in Pangu BioPharma Limited |
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1 |
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1 |
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2 |
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2 |
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Net loss attributable to aTyr Pharma, Inc. |
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$ |
(10,309 |
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$ |
(19,531 |
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$ |
(21,100 |
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$ |
(34,411 |
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Net loss per share, basic and diluted |
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$ |
(0.11 |
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$ |
(0.22 |
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$ |
(0.22 |
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$ |
(0.39 |
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Shares used in computing net loss per share, basic and diluted |
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98,069,915 |
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90,120,235 |
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98,056,949 |
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88,312,722 |
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ATYR PHARMA INC. |
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Condensed Consolidated Balance Sheets |
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(in thousands) |
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June 30, |
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December 31, |
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2026 |
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2025 |
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(unaudited) |
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Cash, cash equivalents, restricted cash and available-for-sale investments |
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$ |
58,913 |
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$ |
80,922 |
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Other receivables |
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426 |
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873 |
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Property and equipment, net |
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4,127 |
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4,263 |
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Operating lease, right-of-use assets |
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5,353 |
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5,524 |
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Financing lease, right-of-use assets |
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298 |
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596 |
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Prepaid expenses and other assets |
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708 |
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825 |
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Total assets |
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$ |
69,825 |
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$ |
93,003 |
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Accounts payable and accrued expenses |
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$ |
9,932 |
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$ |
13,682 |
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Current portion of operating lease liability |
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946 |
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836 |
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Current portion of financing lease liability |
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518 |
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630 |
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Long-term operating lease liability, net of current portion |
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9,799 |
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10,308 |
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Long-term financing lease liability, net of current portion |
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36 |
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259 |
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Total stockholders’ equity |
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48,594 |
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67,288 |
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Total liabilities and stockholders’ equity |
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$ |
69,825 |
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$ |
93,003 |
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