03/28/2024 | Press release | Distributed by Public on 03/28/2024 14:27
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Company announced positive topline data from pivotal trial for FDA-cleared FemaSeed® for the treatment of infertility
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Following FDA clearance of FemaSeed, the Company's revolutionary approach to artificial insemination, Femasys announced completion of enrollment in pivotal trial in support of commercial launch
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Activated enrollment for remaining clinical sites of initial phase of pivotal trial for FemBloc®, the Company's proprietary solution for permanent non-surgical birth control
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Appointed Richard Spector as Chief Commercial Officer and James Liu, M.D. as Chief Medical Officer
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Research and Development expenses increased by $1,394,946 to $7,208,701 in 2023 from $5,813,755 in 2022
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Salesdecreased by $134,248 to $1,071,970 in 2023 from $1,206,218 in 2022
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Net loss was $14,247,124 or $0.93 per basic and diluted share attributable to common stockholders, for the year ended December 31, 2023, compared to net loss of $11,394,170, or $0.96 per basic and diluted share attributable to common stockholders, for the year ended December 31, 2022
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Cash and cash equivalents as of December 31, 2023 was $21,716,077 and the Company had an accumulated deficit of $108,381,629. The Company expects, based on its current operating plan, that its existing cash and cash equivalents will be sufficient to fund its ongoing operations into the second half of 2025
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Assets
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December 31,
2023
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December 31,
2022
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Current assets:
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Cash and cash equivalents
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$
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21,716,077
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12,961,936
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Accounts receivable, net
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98,906
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77,470
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Inventory, net
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667,118
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436,723
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Prepaid and other current assets
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695,879
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655,362
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Total current assets
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23,177,980
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14,131,491
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Property and equipment, at cost:
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Leasehold improvements
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1,212,417
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1,195,637
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Office equipment
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47,308
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99,344
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Furniture and fixtures
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414,303
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419,303
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Machinery and equipment
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2,559,356
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2,572,243
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Construction in progress
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423,077
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413,843
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4,656,461
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4,700,370
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Less accumulated depreciation
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(3,545,422
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)
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(3,217,319
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)
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Net property and equipment
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1,111,039
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1,483,051
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Long-term assets:
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Lease right-of-use assets, net
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2,380,225
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319,557
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Intangible assets, net of accumulated amortization
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-
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3,294
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Other long-term assets
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1,086,581
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958,177
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Total long-term assets
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3,466,806
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1,281,028 |
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Total assets
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$
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27,755,825
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16,895,570 |
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(continued)
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Liabilities and Stockholders' Equity
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December 31,
2023
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December 31,
2022
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Current liabilities:
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Accounts payable
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$
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1,137,823
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510,758
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Accrued expenses
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1,444,296
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456,714
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Note payable
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-
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141,298
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Clinical holdback - current portion
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65,300
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45,206
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Lease liabilities - current portion
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406,636
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373,833
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Total current liabilities
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3,054,055
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1,527,809
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Long-term liabilities:
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Clinical holdback - long-term portion
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54,935
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96,658
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Convertible notes payable, net (including related parties)
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4,258,179
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-
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Lease liabilities - long-term portion
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2,036,067
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28,584
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Total long-term liabilities
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6,349,181
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125,242
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Total liabilities
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9,403,236
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1,653,051
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Commitments and contingencies
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Stockholders' equity:
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Common stock, $.001 par, 200,000,000 authorized, 21,774,604 shares issued and 21,657,381 outstanding as of December 31, 2023; and 11,986,927 shares issued and 11,869,704 outstanding as of December 31, 2022
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21,775
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11,987
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Treasury stock, 117,223 common shares
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(60,000
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)
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(60,000
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)
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Warrants
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2,787,137
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567,972
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Additional paid-in-capital
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123,985,306
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108,857,065
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Accumulated deficit
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(108,381,629
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)
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(94,134,505
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)
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Total stockholders' equity
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18,352,589
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15,242,519
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Total liabilities and stockholders' equity
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$
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27,755,825
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16,895,570
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December 31,
2023
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December 31,
2022
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Sales
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$
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1,071,970
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1,206,218
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Cost of sales (excluding depreciation expense)
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380,069
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441,938
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Operating expenses:
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Research and development
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7,208,701
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5,813,755
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Sales and marketing
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650,126
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558,852
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General and administrative
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6,858,008
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5,430,704
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Depreciation and amortization
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483,481
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561,233
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Total operating expenses
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15,200,316
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12,364,544
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Loss from operations
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(14,508,415
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)
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(11,600,264
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)
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Other income (expense):
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Interest income
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431,019
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228,164
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Interest expense
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(165,390
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)
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(13,464
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)
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Other expense
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-
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(2,306
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)
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Total other income
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265,629
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212,394
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Loss before income taxes
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(14,242,786
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)
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(11,387,870
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)
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Income tax expense
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4,338
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6,300
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Net loss
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$
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(14,247,124
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)
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(11,394,170
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)
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Net loss attributable to common stockholders, basic and diluted
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$
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(14,247,124
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)
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(11,394,170
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)
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Net loss per share attributable to common stockholders, basic and diluted
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$
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(0.93
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)
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(0.96
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)
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Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
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15,384,376
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11,815,019
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