FEMY 8-K/A
Femasys Inc (FEMY)
8-K/A
2024-11-12
For: 2024-11-12
View Original
Added on
April 06, 2026
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K/A
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 12, 2024
(Exact name of registrant as specified in its charter)
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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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(770 ) 500-3910
(Registrant’s telephone number, including area code)
n/a
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instructions A.2. below):
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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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Securities registered pursuant to Section 12(b) of the Exchange Act:
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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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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new
or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Explanatory Note
This Amendment to Current Report on Form 8-K/A (this “Amendment”) amends the Current Report on Form 8-K filed by Femasys Inc. (the “Company”) on
November 12, 2024 (the “Original Form 8-K”). The Original Form 8-K inadvertently reported the "Date of Report (Date of earliest event reported)" on the cover page and the date referenced in the first sentence of the first paragraph under Item
2.02 as August 12, 2024, when both dates should have been reported as November 12, 2024. The sole purpose of this Amendment is to correct the incorrect dates. No other changes are being made to the Original Form 8-K by this Amendment.
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Item 2.02
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Results of Operations and Financial Condition.
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On November 12, 2024, Femasys Inc. (the “Company”) announced its financial results for the quarter ended September 30, 2024 and provided a corporate update. A copy of
the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section
18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or
otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in 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.
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Financial Statements and Exhibits.
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Exhibits.
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Exhibit
No.
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Description
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Press Release of Femasys Inc. dated November 12, 2024
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL Document)
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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Femasys Inc.
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By:
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/s/ Kathy Lee-Sepsick
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Names: Kathy Lee-Sepsick
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Title: Chief Executive Officer
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Date: November
12, 2024
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Exhibit 99.1
Femasys Announces Financial Results for Quarter Ended September 30, 2024, and Provides Corporate Update
-- Company accelerated commercialization with significant new partnerships both in the U.S. and Europe --
ATLANTA, November 12, 2024 -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible and innovative
therapeutic and diagnostic products, announces financial results for the quarter ended September 30, 2024 and provides a corporate update.
Corporate Highlights from 3Q 2024 to date
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Announced partnership with Boston IVF, prominent network of fertility centers, to offer FemaSeed®
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Announced the onboarding of the first infertility medical clinic customers to offer FemaSeed infertility treatment to patients in California and Florida
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Announced strategic distribution partnerships for CE-marked products, including FemaSeed and FemVue® in Spain, which are anticipated to generate over $1.3 million over the next year
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Received second order from Spain strategic distribution partners after successfully completing commercial FemaSeed infertility treatments
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Received 510(k) clearance from FDA for FemChec®, an innovative diagnostic solution for
fallopian tube check
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Received CE Mark certification and product approval from Health Canada, the Public Health Agency of Canada, for our compact, eco-friendly FemVue MINI for fallopian tube
assessment
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Announced issuance of U.S. patent covering FemBloc® device for female permanent birth control
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“We continue to achieve significant commercial milestones with regard to our FemaSeed first-line infertility treatment and its supporting FemVue product. Notably, in 3Q
we began commercialization of FemaSeed in the U.S., including a high-profile conglomerate, as well as in Europe with two partners in Spain. We look forward to collaborating with our expanding group of partners as we bring our next generation
advancements to women.” said Femasys’ CEO Kathy Lee-Sepsick.
Financial Results for Quarter Ended September 30, 2024
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Sales increased by $310,547, or 127.1%, to $554,908 in Q3 of 2024 from $244,361 in Q3 of 2023, due to increased sales of FemaSeed and FemVue. The Company recorded its first
FemaSeed U.S. and international sales for the three months ended September 30, 2024, and additional sales are expected in the 4th quarter of 2024.
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Research and development expenses increased by $230,411, or 11.1%, to $2,303,241 in Q3 of 2024 from $2,072,830 in Q3 of 2023.
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Net loss was $5,408,860, or ($0.24) per basic and diluted share attributable to common stockholders, for the quarter ended September 30, 2024, compared to net loss of $3,996,905, or ($0.26) per
basic and diluted share attributable to common stockholders, for the quarter ended September 30, 2023.
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Cash and cash equivalents as of September 30, 2024, was $7.6 million and the Company had an accumulated deficit of $122.1 million. 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 July 2025.
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Financial Results for Nine Months Ended September 30, 2024
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Sales increased by $188,673, or 22.0%, to $1,047,532 for the nine months of 2024, from $858,859 for the nine months of 2023 due to increased sales of FemaSeed and FemVue.
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R&D expenses increased by $912,406 or 17.8%, to $6,049,847 for the nine months of 2024, from $5,137,441 for the nine months of 2023.
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Net loss was $13,692,944, or ($0.62) per basic and diluted share attributable to common stockholders, for the nine-month period ended September 30, 2024, compared to net loss of $9,836,670, or
($0.74) per basic and diluted share attributable to common stockholders, for the same period ended September 30, 2023.
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For more information, please refer to the Company’s Form 10-Q filed November 12, 2024, which can be accessed on the SEC
website.
FEMASYS INC.
Condensed Balance Sheets
(unaudited)
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Assets
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September 30, 2024
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December 31, 2023
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Current assets:
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Cash and cash equivalents
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$
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7,611,210
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21,716,077
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Accounts receivable, net
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378,290
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98,906
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Inventory, net
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1,937,670
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667,118
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Prepaid and other current assets
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1,370,523
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695,879
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Total current assets
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11,297,693
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23,177,980
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Property and equipment, at cost:
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Leasehold improvements
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1,238,886
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1,212,417
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Office equipment
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67,231
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47,308
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Furniture and fixtures
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433,584
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414,303
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Machinery and equipment
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2,848,833
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2,559,356
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Construction in progress
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548,149
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423,077
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5,136,683
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4,656,461
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Less accumulated depreciation
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(3,748,393
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(3,545,422
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Net property and equipment
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1,388,290
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1,111,039
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Long-term assets:
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Lease right-of-use assets, net
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1,941,624
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2,380,225
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Intangible assets, net of accumulated amortization
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70,064
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—
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Other long-term assets
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887,410
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1,086,581
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Total long-term assets
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2,899,098
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3,466,806
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Total assets
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$
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15,585,081
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27,755,825
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(continued)
FEMASYS INC.
Condensed Balance Sheets
(unaudited)
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Liabilities and Stockholders’ Equity
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September 30, 2024
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December 31, 2023
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Current liabilities:
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Accounts payable
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$
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1,121,873
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1,137,823
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Accrued expenses
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1,127,645
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1,444,296
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Clinical holdback – current portion
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92,170
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65,300
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Lease liabilities – current portion
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525,752
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406,636
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Total current liabilities
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2,867,440
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3,054,055
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Long-term liabilities:
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Clinical holdback – long-term portion
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36,081
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54,935
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Convertible notes payable, net (including related parties)
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5,068,556
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4,258,179
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Lease liabilities – long-term portion
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1,643,217
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2,036,067
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Total long-term liabilities
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6,747,854
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6,349,181
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Total liabilities
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9,615,294
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9,403,236
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Commitments and contingencies
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Stockholders’ equity:
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Common stock, $.001 par, 200,000,000 authorized, 22,350,022 shares issued and 22,232,799 outstanding as of September 30, 2024; and
21,774,604 shares issued and 21,657,381 outstanding as of December 31, 2023
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22,350
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21,775
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Treasury stock, 117,223 common shares
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(60,000
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(60,000
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Warrants
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2,608,642
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2,787,137
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Additional paid-in-capital
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125,473,368
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123,985,306
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Accumulated deficit
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(122,074,573
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(108,381,629
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Total stockholders’ equity
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5,969,787
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18,352,589
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Total liabilities and stockholders' equity
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$
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15,585,081
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27,755,825
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FEMASYS INC.
Condensed Statements of Comprehensive Loss
(unaudited)
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Three Months Ended September 30,
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Nine Months Ended September 30,
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2024
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2023
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2024
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2023
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Sales
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$
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554,908
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244,361
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1,047,532
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858,859
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Cost of sales (excluding depreciation expense)
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190,839
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86,186
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352,496
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301,775
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Operating expenses:
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Research and development
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2,303,241
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2,072,830
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6,049,847
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5,137,441
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Sales and marketing
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1,572,189
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70,883
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2,847,866
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444,678
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General and administrative
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1,530,791
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1,970,408
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4,645,412
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4,642,182
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Depreciation and amortization
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76,288
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125,318
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215,144
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391,683
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Total operating expenses
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5,482,509
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4,239,439
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13,758,269
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10,615,984
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Loss from operations
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(5,118,440
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)
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(4,081,264
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)
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(13,063,233
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(10,058,900
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Other income (expense):
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Interest income
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124,028
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92,392
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532,850
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232,133
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Interest expense
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(413,290
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)
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(8,033
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(1,163,153
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(9,903
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Total other income (expense), net
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(289,262
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84,359
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(630,303
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)
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222,230
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Loss before income taxes
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(5,407,702
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)
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(3,996,905
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)
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(13,693,536
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)
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(9,836,670
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)
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Income tax expense (benefit)
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1,158
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—
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(592
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)
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—
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Net loss
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$
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(5,408,860
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)
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(3,996,905
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)
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(13,692,944
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)
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(9,836,670
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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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(5,408,860
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)
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(3,996,905
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)
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(13,692,944
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)
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(9,836,670
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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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(0.24
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)
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(0.26
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)
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(0.62
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)
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(0.74
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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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22,232,799
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15,093,147
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22,075,135
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13,369,462
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About Femasys
Femasys is a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative
therapeutic and diagnostic solutions, including a lead revolutionary product candidate and FDA-cleared products. FemaSeed® Intratubal Insemination, an innovative
infertility treatment designed to deliver sperm directly where conception occurs, is FDA-cleared and has received regulatory approval in Canada and Europe. FemBloc®
permanent birth control in late-stage clinical development is the first and only non-surgical, in-office, permanent birth control method intended to be a safer option for women at substantially less cost than the long-standing surgical
alternative. The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada, Europe, and other ex-U.S. territories, and which are commercial-ready due to its
in-house manufacturing capabilities. Its diagnostic products include FemVue® and FemVue®
Mini for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath®, an intrauterine catheter for selective fallopian tube evaluation,
and FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis. Learn more at www.femasys.com,
or follow us on X, Facebook and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be
identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “suggests,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not
all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and
could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ
include, among others: our ability to develop and advance our current product candidates and programs into, and successfully initiate, enroll and complete, clinical trials; the ability of our clinical trials to demonstrate safety and
effectiveness of our product candidates and other positive results; estimates regarding the total addressable market for our products and product candidates; our ability to commercialize our products and product candidates, our ability to
establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our
implementation thereof; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023, and other reports as filed with the SEC. Forward-looking
statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law.
Contacts:
Investors:
Matt Blazei
Media:
Kati Waldenburg