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Share Name | Share Symbol | Market | Type |
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Femasys Inc | NASDAQ:FEMY | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.0251 | -2.41% | 1.015 | 1.00 | 1.05 | 1.05 | 1.00 | 1.05 | 78,685 | 21:44:50 |
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of principal executive offices)
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(Zip Code)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading
Symbol(s)
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Name of each exchange
on which registered
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Item 2.02 |
Results of Operations and Financial Condition.
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Item 5.02.
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Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements
of Certain Officers.
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Item 9.01 |
Financial Statements and Exhibits.
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Exhibit
No.
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Description
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Press Release of Femasys Inc. dated August 10, 2023
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL Document)
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Femasys Inc.
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By: |
/s/ Kathy Lee-Sepsick |
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Names: Kathy Lee-Sepsick
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Title: Chief Executive Officer
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• |
In August, Femasys announced the initiation of enrollment in a prospective multi-center pivotal trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent
Birth Control (the “FINALE” trial), to investigate the safety and efficacy of its investigational permanent birth control candidate, FemBloc. The robust trial is
designed to address the high unmet need that exists for women seeking permanent birth control for whom elective surgery remains the only option. It is intended to be a safer option for women and its cost is estimated to be
substantially less than the long-standing surgical alternative by eliminating the need for anesthesia, incisions, and permanent implants.
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• |
In July, Femasys announced that the United States Patent and Trademark Office (“USPTO”) issued a Notice of Allowance for U.S.
Patent Application 16/402,193 further strengthening Femasys’ intellectual property position and coverage for the Company’s therapeutic product candidate, FemBloc permanent birth control. Femasys expects the resulting patent, when issued,
will have an anticipated expiration in 2039 at the earliest.
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• |
In June, Femasys announced the approval of an Investigational Device Exemption (IDE) from the
United States Food and Drug Administration (FDA) to evaluate the safety and efficacy of FemBloc, a first-of-its-kind, non-surgical, non-implant, in-office solution for permanent birth control in the FINALE pivotal clinical trial. This prospective, multi-center, open-label, single-arm study design includes pregnancy rate as the primary endpoint. FemBloc
has the potential to offer women a convenient and reliable option for permanent birth control.
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• |
In June, Femasys announced the appointment of Mr. Keith J.
Kendall, former CEO of drug delivery company Aquestive Therapeutics and Mr. Alistair Milnes, COO
of biopharmeutical company Bicycle Therapeutics, to its board of directors. Messrs. Kendall and Milnes replaced
Mr. John Dyett and Mr. John Adams, both of whom have served as members of Femasys’ board of directors for over eight years. Mr. Kendall also replaced Mr. Dyett as Audit Committee Chair.
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• |
In April, May and June, respectively, Femasys received three product approvals for FemaSeed®, FemCerv®
and FemCath® from Health Canada, the Public Health Agency of Canada.
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• |
In April, Femasys raised $3.9 million in a registered direct offering priced at-the-market under Nasdaq rules. The offering closed on April 20, 2023. The proceeds from this
offering will be used for working capital and general corporate purposes and is expected to extend Femasys’ cash runway into the second quarter of 2024.
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• |
General and administrative expenses increased by $174,699 to
$1,356,637 for the three months ended June 30, 2023 compared to $1,181,938 for the same period in 2022. The increase was largely due to increased professional costs, compensation and related personnel costs, partially offset by decreased
facility and overhead costs.
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• |
Sales increased by $17,401 to $320,514 for the three months
ended June 30, 2023 compared to $303,113 for the same period in 2022. The $17,401 net increase was largely attributable to international sales of $58,045 for the three months ended June 30, 2023 as compared to no international sales for
the same period last year. U.S. sales decreased by $40,644, or 13.4%, for the three months ended June 30, 2023 as compared to the same period last year. U.S. units sold decreased by 13.0% for the three months ended June 30, 2023 as
compared to the same period last year.
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• |
Sales and marketing expenses increased by $65,722 to
$128,899 for the three months ended June 30, 2023 compared to $63,177 for the same period in 2022. The increase is largely due to increased marketing costs to promote our commercial efforts.
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• |
Cost of sales increased by $8,116 to $110,469 for the three
months ended June 30, 2023 compared to $102,353 for the same period in 2022 mainly due to the increase in international sales which have lower gross margin. Gross margin percentage was 65.5% for the three months ended June 30, 2023 as
compared to 66.2% for the three months ended June 30, 2022.
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• |
Net loss was $2,893,508 or $0.22 per basic and diluted share attributable to common stockholders, primarily reflecting the factors noted above, for the three months ended June 30, 2023, compared to $2,634,101, or $0.22 per
basic and diluted share attributable to common stockholders, for the same period ended June 30, 2022.
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• |
Cash and cash equivalents as of June 30, 2023 and December
31, 2022, were $10,705,017 and $12,961,936, respectively. Based on our current operating plan, our existing cash and cash equivalents are expected to be sufficient to
fund our ongoing operations into the second quarter of 2024.
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• |
General and administrative expenses increased by $42,481 to
$2,671,774 for the six months ended June 30, 2023 compared to $2,629,293 for the same period in 2022. The increase was largely due to increased professional costs, partially offset by a decrease in facility and other overhead and
insurance costs.
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• |
Sales decreased by $10,020 to $614,498 for the six months
ended June 30, 2023 compared to $624,518 for the six months for the same period in 2022. The $10,020 decrease is entirely attributable to U.S. sales for the six months ended June 30, 2023 as compared to the same period last year;
international sales remained consistent with $58,045 for both the six month periods ended June 30, 2023 and 2022. U.S. units sold decreased by 3.6% for the six month periods ended June 30, 2023 as compared to the same period last year.
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• |
Sales and marketing expenses increased by $241,755 to
$373,795 for the six months ended June 30, 2023 compared to $132,040 for the same period in 2022 largely due to increased compensation and related personnel costs and marketing costs to promote our commercial efforts.
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Cost of sales decreased by $9,439 to $215,589 for the six
months ended June 30, 2023 compared to $225,028 for the same period in 2022. The decrease is largely due to prior investment in equipment and tooling, resulting in reduced labor in certain manufacturing processes, and reduced material
costs. Gross margin percentage was 64.9% for the six months ended June 30, 2023 as compared to 64.0% for the same period in 2022. Gross margins improved mainly due to manufacturing efficiencies.
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• |
Net loss was $5,839,765 or $0.47 per basic and diluted share attributable to common stockholders, primarily reflecting the factors noted above, for the six month period ended June 30, 2023, compared to $5,517,131, or $0.47
per basic and diluted share attributable to common stockholders, for the same period ended June 30, 2022.
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Assets
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June 30,
2023
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December 31,
2022
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||||||
Current assets:
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||||||||
Cash and cash equivalents
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$
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10,705,017
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12,961,936
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|||||
Accounts receivable, net
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155,746
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77,470
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Inventory, net
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581,474
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436,723
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Other current assets
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587,828
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655,362
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Total current assets
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12,030,065
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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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1,195,637
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1,195,637
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Office equipment
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99,344
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99,344
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Furniture and fixtures
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419,303
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419,303
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Machinery and equipment
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2,628,509
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2,572,243
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Construction in progress
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384,888
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413,843
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4,727,681
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4,700,370
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Less accumulated depreciation
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(3,472,349
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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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1,255,332
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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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162,006
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319,557
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Intangible assets, net of accumulated amortization
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970
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3,294
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Other long-term assets
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865,588
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958,177
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Total long-term assets
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1,028,564
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1,281,028
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Total assets
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$
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14,313,961
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16,895,570
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Liabilities and Stockholders’ Equity
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June 30,
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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546,877
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510,758
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Accrued expenses
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536,830
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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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88,738
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45,206
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Lease liabilities – current portion
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209,098
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373,833
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Total current liabilities
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1,381,543
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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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56,245
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96,658
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Lease liabilities – long-term portion
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—
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28,584
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Total long-term liabilities
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56,245
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125,242
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Total liabilities
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1,437,788
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1,653,051
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Commitments and contingencies Stockholders’ equity:
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||||||||
Common stock, $.001 par, 200,000,000 authorized, 15,190,376 shares issued
and 15,073,153 outstanding as of June 30, 2023; and 11,986,927 shares issued and 11,869,704 outstanding as of December 31, 2022
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15,190
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11,987
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Treasury stock, 117,223 shares
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(60,000
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)
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(60,000
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)
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Warrants
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1,918,103
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567,972
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Additional paid-in-capital
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110,977,150
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108,857,065
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Accumulated deficit
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(99,974,270
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)
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(94,134,505
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)
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Total stockholders’ equity
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12,876,173
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15,242,519
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Total liabilities and stockholders' equity
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$
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14,313,961
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16,895,570
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Three Months Ended June 30,
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Six Months Ended June 30,
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|||||||||||||||
2023
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2022
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2023
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2022
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$
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320,514
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303,113
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614,498
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624,518
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Sales
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110,469
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102,353
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215,589
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225,028
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Cost of sales
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210,045
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200,760
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398,909
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399,490
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Gross margin
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||||||||||||||||
Operating expenses:
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1,527,172
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1,472,924
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3,064,611
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2,893,987
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Research and development
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128,899
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63,177
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373,795
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132,040
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Sales and marketing
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1,356,637
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1,181,938
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2,671,774
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2,629,293
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||||||||||||
General and administrative
|
133,299
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142,684
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266,365
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286,883
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Depreciation and amortization
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3,146,007
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2,860,723
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6,376,545
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5,942,203
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Total operating expenses
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(2,935,962
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)
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(2,659,963
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)
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(5,977,636
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)
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(5,542,713
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)
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Loss from operations
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||||||||||||||||
Other income (expense):
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||||||||||||||||
Interest income
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42,652
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26,745
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139,741
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29,199
|
||||||||||||
Interest expense
|
(198
|
)
|
(883
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)
|
(1,870
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)
|
(3,617
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)
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Other income (expense), net
|
42,454
|
25,862
|
137,871
|
25,582
|
||||||||||||
Net loss
|
$
|
(2,893,508
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)
|
(2,634,101
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)
|
(5,839,765
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)
|
(5,517,131
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)
|
|||||||
Net loss attributable to common stockholders, basic and diluted
|
$
|
(2,893,508
|
)
|
(2,634,101
|
)
|
(5,839,765
|
)
|
(5,517,131
|
)
|
|||||||
Net loss per share attributable to common stockholders, basic and diluted
|
$
|
(0.22
|
)
|
(0.22
|
)
|
(0.47
|
)
|
(0.47
|
)
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|||||||
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
|
13,107,590
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11,812,988
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12,493,334
|
11,808,601
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Document and Entity Information |
Aug. 10, 2023 |
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Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | Aug. 10, 2023 |
Entity File Number | 001-40492 |
Entity Registrant Name | Femasys Inc. |
Entity Central Index Key | 0001339005 |
Entity Incorporation, State or Country Code | DE |
Entity Tax Identification Number | 11-3713499 |
Entity Address, Address Line One | 3950 Johns Creek Court |
Entity Address, Address Line Two | Suite 100 |
Entity Address, City or Town | Suwanee |
Entity Address, State or Province | GA |
Entity Address, Postal Zip Code | 30024 |
City Area Code | 770 |
Local Phone Number | 500-3910 |
Title of 12(b) Security | Common Stock, par value $0.001 per share |
Trading Symbol | FEMY |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | true |
Entity Ex Transition Period | true |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
1 Year Femasys Chart |
1 Month Femasys Chart |
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