2023 Q2 Form 10-Q Financial Statement

#000095017023022228 Filed on May 15, 2023

View on sec.gov

Income Statement

Concept 2023 Q2 2023 Q1 2022 Q1
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $6.026M $6.182M $4.218M
YoY Change 15.26% 46.56% 66.26%
% of Gross Profit
Research & Development $4.088M $13.42M $14.20M
YoY Change -69.0% -5.5% 119.48%
% of Gross Profit
Depreciation & Amortization $100.0K $436.0K $297.0K
YoY Change -75.0% 46.8% 120.0%
% of Gross Profit
Operating Expenses $16.50M $24.08M $18.41M
YoY Change -10.39% 30.76% 104.49%
Operating Profit -$16.50M -$24.08M -$18.41M
YoY Change -10.39% 30.76% 104.49%
Interest Expense $1.764M $1.581M $155.0K
YoY Change 452.98% 920.0% -152.72%
% of Operating Profit
Other Income/Expense, Net $1.364M $1.281M -$45.00K
YoY Change 1046.22% -2946.67% -84.69%
Pretax Income -$14.74M -$22.50M -$18.26M
YoY Change -18.56% 23.21% 96.35%
Income Tax
% Of Pretax Income
Net Earnings -$14.74M -$22.50M -$18.26M
YoY Change -18.56% 23.21% 96.35%
Net Earnings / Revenue
Basic Earnings Per Share -$0.35 -$0.54 -$0.45
Diluted Earnings Per Share -$0.35 -$0.54 -$445.6K
COMMON SHARES
Basic Shares Outstanding 42.17M 42.02M 41.46M
Diluted Shares Outstanding 42.17M 41.80M 40.98M

Balance Sheet

Concept 2023 Q2 2023 Q1 2022 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $152.3M $165.8M $225.5M
YoY Change -26.46% -26.47% 60.96%
Cash & Equivalents $18.40M $24.20M $22.80M
Short-Term Investments $133.9M $141.6M $202.7M
Other Short-Term Assets $1.328M $913.0K $797.0K
YoY Change 49.38% 14.55% 1089.55%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $156.2M $168.9M $228.4M
YoY Change -26.33% -26.07% 59.95%
LONG-TERM ASSETS
Property, Plant & Equipment $226.0K $2.584M $5.486M
YoY Change -96.06% -52.9% 163.37%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $111.0K $111.0K $111.0K
YoY Change 0.0% 0.0% 692.86%
Total Long-Term Assets $2.914M $3.747M $8.828M
YoY Change -67.18% -57.56% 320.98%
TOTAL ASSETS
Total Short-Term Assets $156.2M $168.9M $228.4M
Total Long-Term Assets $2.914M $3.747M $8.828M
Total Assets $159.1M $172.6M $237.2M
YoY Change -27.97% -27.25% 63.73%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $2.934M $3.384M $3.485M
YoY Change 41.4% -2.9% 353.19%
Accrued Expenses $6.349M $6.044M $3.840M
YoY Change 43.61% 57.4% 36.56%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $10.13M $10.18M $8.065M
YoY Change 38.23% 26.21% 125.22%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $11.00K $14.00K $3.151M
YoY Change -47.62% -99.56% 92.84%
Total Long-Term Liabilities $11.00K $14.00K $3.151M
YoY Change -47.62% -99.56% 92.84%
TOTAL LIABILITIES
Total Short-Term Liabilities $10.13M $10.18M $8.065M
Total Long-Term Liabilities $11.00K $14.00K $3.151M
Total Liabilities $10.69M $10.88M $11.22M
YoY Change 5.06% -3.03% 115.07%
SHAREHOLDERS EQUITY
Retained Earnings -$202.0M -$187.2M -$109.1M
YoY Change 58.81% 71.59% 108.6%
Common Stock $350.6M $349.3M $336.1M
YoY Change 3.4% 3.93% 5656.46%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $148.4M $161.7M $226.0M
YoY Change
Total Liabilities & Shareholders Equity $159.1M $172.6M $237.2M
YoY Change -27.97% -27.25% 63.73%

Cashflow Statement

Concept 2023 Q2 2023 Q1 2022 Q1
OPERATING ACTIVITIES
Net Income -$14.74M -$22.50M -$18.26M
YoY Change -18.56% 23.21% 96.35%
Depreciation, Depletion And Amortization $100.0K $436.0K $297.0K
YoY Change -75.0% 46.8% 120.0%
Cash From Operating Activities -$14.68M -$16.90M -$16.30M
YoY Change -15.05% 3.68% 80.17%
INVESTING ACTIVITIES
Capital Expenditures $221.0K $320.0K $1.341M
YoY Change -120.24% -76.14% 617.11%
Acquisitions
YoY Change
Other Investing Activities $9.140M $27.73M $21.77M
YoY Change -56.52% 27.39% 1334.94%
Cash From Investing Activities $8.919M $27.41M $20.43M
YoY Change -55.24% 34.19% 1435.86%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 137.0K 46.00K 30.00K
YoY Change 73.42% 53.33% 76.47%
NET CHANGE
Cash From Operating Activities -14.68M -16.90M -16.30M
Cash From Investing Activities 8.919M 27.41M 20.43M
Cash From Financing Activities 137.0K 46.00K 30.00K
Net Change In Cash -5.623M 10.55M 4.177M
YoY Change -306.2% 152.67% -154.25%
FREE CASH FLOW
Cash From Operating Activities -$14.68M -$16.90M -$16.30M
Capital Expenditures $221.0K $320.0K $1.341M
Free Cash Flow -$14.90M -$17.22M -$17.64M
YoY Change -7.96% -2.39% 91.04%

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CY2023Q1 us-gaap Nature Of Operations
NatureOfOperations
<p style="text-indent:0.0%;font-size:10.0pt;margin-top:12.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">1. Nature of Business and Liquidity</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">Talaris Therapeutics, Inc. (“Talaris” or the “Company”) is a cell therapy company developing an innovative method of allogeneic hematopoietic stem cell transplantation (“allo-HSCT”), called Facilitated Allo-HSCT Therapy. The Company maintains corporate offices in Boston, Massachusetts, a laboratory in Houston, Texas and its cell processing facility in Louisville, Kentucky.</span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">In February 2023, the Company announced the discontinuation of our FREEDOM-1 and FREEDOM-2 clinical trials evaluating FCR001’s ability to induce durable tolerance in living donor kidney transplant recipients. This decision was primarily attributable to the pace of enrollment and the associated timeline to critical milestones. In February 2023, the Company also announced a comprehensive review of strategic alternatives focused on maximizing shareholder value, including, but not limited to, an acquisition, merger, possible business combinations and/or a divestiture of the Company's cell therapy chemistry, manufacturing and controls ("CMC") capabilities. In March 2023, pending the outcome of the Company's review of strategic alternatives, the Company voluntarily paused enrollment in the FREEDOM-3 Phase 2 clinical trial evaluating FCR001's ability to induce tolerance in diffuse systemic scleroderma, a severe autoimmune disease, while continuing to evaluate patients for potential future enrollment.</span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:0.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="white-space:pre-wrap;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:0.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">In April 2023, the Company’s Board of Directors approved, and the Company announced a further reduction in force (the “April Reduction in Force”) that is expected to result in the termination of approximately </span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">80</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> additional employees, or approximately </span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">95</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">% of the Company’s remaining workforce. The Company estimates that the April Reduction in Force will be substantially completed by May 26, 2023.</span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:0.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="white-space:pre-wrap;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:0.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;font-style:italic;min-width:fit-content;">Initial Public Offering</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;font-style:italic;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">The Company completed an initial public offering (“IPO”) on May 11, 2021 in which the Company issued and sold </span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">8,825,000</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> shares of its common stock at a public offering price of $</span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">17.00</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> per share. The Company’s aggregate gross proceeds from the sale of shares in the IPO was $</span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">150.0</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> million before underwriting discounts and commissions and other expenses of approximately $</span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">12.9</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> million. Upon completion of the offering, the Company’s outstanding convertible preferred stock was automatically converted into shares of common stock and non-voting common stock. Following the IPO, there were </span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">no</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> shares of preferred stock outstanding. Prior to the IPO, on April 30, 2021, the Company’s board of directors and shareholders approved a </span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;"><span style="-sec-ix-hidden:F_568192b4-cab3-496f-b56e-2c58f81db4a1;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">one-for-5.35</span></span></span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> reverse share split of issued and outstanding common shares and incentive shares and a proportional adjustment to the existing conversion ratios for the Company’s convertible preferred stock.</span></p><p style="margin-left:4.533%;text-indent:0.0%;font-size:10.0pt;margin-top:18.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;font-style:italic;min-width:fit-content;">Liquidity and Going Concern</span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">The accompanying interim financial statements have been prepared assuming that the Company will continue as a going concern. Management has evaluated whether there are conditions and events that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the financial statements are issued. Since its inception, the Company has incurred net losses and negative cash flows from operations. During the three months ended March 31, 2023 and the year ended December 31, 2022, the Company incurred a net loss of </span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">$</span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">22.5</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> million</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> and $</span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">73.9</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> million, respectively, and used </span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">$</span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">16.9</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> million</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> and $</span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">60.9</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> million in cash for operations, respectively. In addition, as of </span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">March 31, 2023, the Company had an accumulated deficit of </span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">$</span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">187.2</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> million</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">. The Company expects to continue to generate operating losses and negative cash flows for the foreseeable future.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:0.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="white-space:pre-wrap;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:0.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">The Company currently expects the cash and cash equivalents of </span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">$</span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">24.2</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> million</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> and marketable securities of </span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">$</span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">141.6</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> million</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> as of March 31, 2023, will be sufficient to fund its operating expenses and capital requirements for more than twelve months from the date the financial statements are available to be issued. However, due to consideration of certain qualitative factors, including the discontinuation or pause of all clinical trials, CMC operations and research activities, as well as workforce reduction of all but a few custodial employees, the Company has concluded there is substantial doubt regarding the ability to continue as a going concern for more than twelve months from the date that the financial statements are available to be issued. These financial statements do not include any adjustments that might result from the outcome of this uncertainty.</span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:0.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="white-space:pre-wrap;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:0.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">The Company does not currently expect to progress any product candidate through clinical trials or commercial approval and it does not currently expect to generate any revenue from product sales. The Company does expect to devote substantial time and resources to exploring strategic alternatives that the board of directors believes will maximize stockholder value. Despite devoting significant efforts to identify and evaluate potential strategic alternatives, there can be no assurance that this strategic review process will result in the Company pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. The Company has not set a timetable for completion of this strategic review process, and the board of directors has not approved a</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p><p style="text-indent:0.0%;font-size:10.0pt;margin-top:0.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:left;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">definitive course of action. Additionally, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated or lead to increased stockholder value, or that the Company will make any additional cash distributions to stockholders.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p>
CY2021Q2 us-gaap Preferred Stock Shares Outstanding
PreferredStockSharesOutstanding
0
CY2023Q1 us-gaap Net Income Loss
NetIncomeLoss
-22500000
CY2022 us-gaap Net Income Loss
NetIncomeLoss
-73900000
CY2023Q1 us-gaap Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
-16900000
CY2022 us-gaap Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
-60900000
CY2023Q1 us-gaap Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
-187200000
CY2023Q1 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
24200000
CY2023Q1 us-gaap Marketable Securities
MarketableSecurities
141600000
CY2023Q1 us-gaap Use Of Estimates
UseOfEstimates
<p style="margin-left:4.533%;text-indent:0.0%;font-size:10.0pt;margin-top:18.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;font-style:italic;min-width:fit-content;">Use of Estimates</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;font-style:italic;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">The preparation of financial statements in conformity with U.S. GAAP requires management to make judgments, assumptions, and estimates that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of financial statements, and the reported amounts of income and expense during the reporting period. The most significant estimates relate to the determination of the fair value of stock option grants and estimates related to the amount of prepaid and accrued research and development expenses as of the balance sheet date. Management evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors, including the current economic environment, and makes adjustments when the facts and circumstances dictate. These estimates are based on information available as of the date of the financial statements; therefore, actual results could differ from those estimates.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p>
CY2023Q1 us-gaap Impairment Of Long Lived Assets Held For Use
ImpairmentOfLongLivedAssetsHeldForUse
2700000
CY2022 us-gaap Impairment Of Long Lived Assets Held For Use
ImpairmentOfLongLivedAssetsHeldForUse
200000
CY2023Q1 us-gaap Concentration Risk Credit Risk
ConcentrationRiskCreditRisk
<p style="margin-left:4.533%;text-indent:0.0%;font-size:10.0pt;margin-top:18.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;font-style:italic;min-width:fit-content;">Concentration of Credit Risk</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:bold;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;font-style:italic;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:6.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">Financial </span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash and cash equivalents. The Company’s investment policy includes guidelines regarding the quality of the financial institutions and financial</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p><p style="text-indent:0.0%;font-size:10.0pt;margin-top:6.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">instruments </span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">and defines allowable investments that it believes minimizes the exposure to concentration of credit risk. The Company may invest in money market funds (minimum of $</span><span style="font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">1</span><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> billion in assets), U.S. Treasury securities, corporate debt, bank debt, U.S. government-related agency securities, other sovereign debt, municipal debt and commercial paper. These deposits may exceed federally insured limits. The Company has not experienced any losses historically in these accounts and believes that it is not exposed to significant credit risk as its deposits are held at financial institutions that management believes to be of high credit quality.</span><span style="color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p><p style="text-indent:0.0%;font-size:10.0pt;margin-top:0.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="white-space:pre-wrap;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10.0pt;margin-top:0.0pt;font-family:Times New Roman;margin-bottom:0.0pt;text-align:justify;"><span style="background-color:rgba(0,0,0,0);color:rgba(0,0,0,1);white-space:pre-wrap;font-weight:normal;font-size:10.0pt;font-family:&quot;Times New Roman&quot;, serif;min-width:fit-content;">On March 10, 2023, Silicon Valley Bank (“SVB”) was closed by the California Department of Financial Protection and Innovation, and the Federal Deposit Insurance Corporation (“FDIC”) was appointed as receiver. On March 27, 2023, SVB was acquired by First-Citizen BancShares, Inc ("First-Citizen"). Similarly, on May 1, 2023, First Republic Bank (“FRB”) was closed by the California Department of Financial Protection and Innovation and the FDIC was appointed as receiver. JPMorgan Chase Bank, National Association (N.A.) acquired all of FRB’s deposit accounts and substantially all of its assets. The Company historically did not and currently does not have banking relationships with SVB or FRB.</span></p>
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Dividend Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate
0
CY2022Q1 us-gaap Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
3400000
CY2022Q1 us-gaap Operating Lease Liability
OperatingLeaseLiability
3500000
CY2023Q1 us-gaap Available For Sale Debt Securities Amortized Cost Basis
AvailableForSaleDebtSecuritiesAmortizedCostBasis
141888000
CY2023Q1 us-gaap Available For Sale Debt Securities Accumulated Gross Unrealized Gain Before Tax
AvailableForSaleDebtSecuritiesAccumulatedGrossUnrealizedGainBeforeTax
6000
CY2023Q1 us-gaap Available For Sale Debt Securities Accumulated Gross Unrealized Loss Before Tax
AvailableForSaleDebtSecuritiesAccumulatedGrossUnrealizedLossBeforeTax
305000
CY2023Q1 us-gaap Available For Sale Securities Debt Securities
AvailableForSaleSecuritiesDebtSecurities
141589000
CY2022Q4 us-gaap Available For Sale Debt Securities Amortized Cost Basis
AvailableForSaleDebtSecuritiesAmortizedCostBasis
168333000
CY2022Q4 us-gaap Available For Sale Debt Securities Accumulated Gross Unrealized Gain Before Tax
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19000
CY2022Q4 us-gaap Available For Sale Debt Securities Accumulated Gross Unrealized Loss Before Tax
AvailableForSaleDebtSecuritiesAccumulatedGrossUnrealizedLossBeforeTax
740000
CY2022Q4 us-gaap Available For Sale Securities Debt Securities
AvailableForSaleSecuritiesDebtSecurities
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CY2023Q1 us-gaap Debt Securities Available For Sale Unrealized Loss Position
DebtSecuritiesAvailableForSaleUnrealizedLossPosition
125000000.0
CY2023Q1 us-gaap Debt Securities Available For Sale Allowance For Credit Loss
DebtSecuritiesAvailableForSaleAllowanceForCreditLoss
0
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PrepaidInsurance
325000
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PrepaidInsurance
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4180000
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PropertyPlantAndEquipmentNet
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CY2023Q1 us-gaap Depreciation
Depreciation
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CY2022Q1 us-gaap Depreciation
Depreciation
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2700000
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OperatingLeaseWeightedAverageDiscountRatePercent
0.069
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CompensationAndBenefitCostsCurrent
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CY2023Q1 tals Professional Fees Consulting And Other Current
ProfessionalFeesConsultingAndOtherCurrent
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CY2023Q1 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
6044000
CY2022Q4 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
6665000
CY2023Q1 tals Number Of Active Lease Agreements
NumberOfActiveLeaseAgreements
4
CY2023Q1 us-gaap Lessee Operating Lease Option To Extend
LesseeOperatingLeaseOptionToExtend
three additional one-year
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CY2023Q1 us-gaap Lessee Operating Lease Liability Payments Due Next Twelve Months
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411000
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LesseeOperatingLeaseLiabilityPaymentsDue
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CY2023Q1 tals Annual Maintenance Fee Pursuant To Ulrf License Agreement
AnnualMaintenanceFeePursuantToUlrfLicenseAgreement
100000
CY2022Q1 tals Annual Maintenance Fee Pursuant To License Agreement
AnnualMaintenanceFeePursuantToLicenseAgreement
100000
CY2021Q2 us-gaap Preferred Stock Shares Authorized
PreferredStockSharesAuthorized
10000000
CY2021Q2 us-gaap Preferred Stock Par Or Stated Value Per Share
PreferredStockParOrStatedValuePerShare
0.0001
CY2023Q1 us-gaap Preferred Stock Shares Outstanding
PreferredStockSharesOutstanding
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CY2022Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
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ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
6.92
CY2022 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Outstanding Weighted Average Remaining Contractual Term2
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P8Y5M4D
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ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue
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CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Gross
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross
1000000
CY2023Q1 us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Grants In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice
1.73
CY2023Q1 us-gaap Stock Issued During Period Shares Stock Options Exercised
StockIssuedDuringPeriodSharesStockOptionsExercised
49040
CY2023Q1 us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Exercises In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExercisesInPeriodWeightedAverageExercisePrice
0.94
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Expirations In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExpirationsInPeriod
25912
CY2023Q1 us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Expirations In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExpirationsInPeriodWeightedAverageExercisePrice
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CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod
602281
CY2023Q1 us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Forfeitures In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsForfeituresInPeriodWeightedAverageExercisePrice
7.06
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
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CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
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SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2
P8Y4M28D
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue
593000
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Number
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2567969
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice
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CY2023Q1 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Exercisable Weighted Average Remaining Contractual Term1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsExercisableWeightedAverageRemainingContractualTerm1
P7Y8M19D
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Weighted Average Grant Date Fair Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue
1.28
CY2022Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Weighted Average Grant Date Fair Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue
6.49
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercises In Period Total Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisesInPeriodTotalIntrinsicValue
47000
CY2022Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercises In Period Total Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisesInPeriodTotalIntrinsicValue
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CY2023Q1 us-gaap Employee Service Share Based Compensation Nonvested Awards Total Compensation Cost Not Yet Recognized
EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognized
16000000.0
CY2023Q1 us-gaap Employee Service Share Based Compensation Nonvested Awards Total Compensation Cost Not Yet Recognized Period For Recognition1
EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedPeriodForRecognition1
P2Y4M24D
CY2023Q1 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
3659000
CY2022Q1 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
2197000
CY2023Q1 us-gaap Net Income Loss
NetIncomeLoss
-22497000
CY2022Q1 us-gaap Net Income Loss
NetIncomeLoss
-18259000
CY2023Q1 us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-0.54
CY2023Q1 us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
-0.54
CY2022Q1 us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-0.45
CY2022Q1 us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
-0.45
CY2023Q1 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
41796830
CY2023Q1 us-gaap Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
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CY2022Q1 us-gaap Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
40980213
CY2022Q1 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
40980213
CY2023Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
9658346
CY2022Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
7255584
CY2023Q1 us-gaap Defined Contribution Plan Cost Recognized
DefinedContributionPlanCostRecognized
200000
CY2022Q1 us-gaap Defined Contribution Plan Cost Recognized
DefinedContributionPlanCostRecognized
100000

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