|
|
|
(State or other jurisdiction of incorporation)
|
(Commission File Number)
|
(IRS Employer Identification No.)
|
|
|
|
(Address of principal executive offices)
|
(Zip Code)
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
Title of each class
|
Trading
Symbol(s)
|
Name of each exchange
on which registered
|
||
|
|
Item 2.02
|
Results of Operations and Financial Condition.
|
Item 9.01 |
Financial Statements and Exhibits.
|
(d) |
Exhibits.
|
Exhibit
No.
|
Description
|
Press Release of Femasys Inc. dated August 8, 2024
|
|
104
|
Cover Page Interactive Data File (embedded within the Inline XBRL Document)
|
Femasys Inc.
|
||
By:
|
/s/ Kathy Lee-Sepsick
|
|
Names: Kathy Lee-Sepsick
|
||
Title: Chief Executive Officer
|
||
Date: August
8, 2024
|
• |
Company received European Union Medical Device Regulation (EU MDR) certification and CE Mark for four of its women’s health products,
providing regulatory approval to begin marketing in the European Union. Further, it serves as independent validation of Femasys’ commitment to the highest standards of quality and safety for its customers and their patients.
|
• |
Femasys completed the build-out of its initial commercial team in the U.S., which will be leading the Company’s marketing efforts. This milestone, together with the CE Mark approval for its product
portfolio, enables Femasys to concurrently identify strategic distribution partners to begin commercialization of its products in the European Union.
|
• |
CEO and Founder Kathy Lee-Sepsick met with the White House’s Gender Policy Council to discuss the Company’s reproductive health
products and the future of women’s health in the United States and the White House’s Office of Science and Technology Policy to discuss the Cancer Moonshot Initiative, as well as separately with Members of Congress to raise
awareness of the Company and our women’s healthcare initiatives.
|
• |
Research and development expenses increased by $448,703 to $1,975,875 in Q2 of 2024 from $1,527,172 in Q2 of 2023.
|
• |
Sales decreased by $99,030 to $221,484 in Q2 of 2024 from $320,514 in Q2 of 2023.
|
• |
Net loss was $4,684,574 or ($0.21) per basic and diluted share attributable to common stockholders, for the quarter ended June 30, 2024, compared to net loss of $2,893,508, or ($0.22) per basic and
diluted share attributable to common stockholders, for the quarter ended June 30, 2023.
|
• |
Cash and cash equivalents as of June 30, 2024 was $13.5 million and the Company had an accumulated deficit of $116.7 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.
|
• |
Research and development expenses increased by $681,995 to $3,746,606 for the first six months of 2024 from $3,064,611 for the first six months of 2023.
|
• |
Sales decreased by $121,874 to $492,624 for the first six months of 2024 from $614,498 for the first six months of 2023.
|
• |
Net loss was $8,284,084 or ($0.38) per basic and diluted share attributable to common stockholders, for the six month period ended June 30, 2024, compared to net loss of $5,839,765, or ($0.47) per
basic and diluted share attributable to common stockholders, for the same period ended June 30, 2023.
|
Assets
|
June 30,
2024
|
December 31,
2023
|
||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
13,525,898
|
21,716,077
|
|||||
Accounts receivable, net
|
92,535
|
98,906
|
||||||
Inventory, net
|
1,315,580
|
667,118
|
||||||
Prepaid and other current assets
|
997,623
|
695,879
|
||||||
Total current assets
|
15,931,636
|
23,177,980
|
||||||
Property and equipment, at cost:
|
||||||||
Leasehold improvements
|
1,212,417
|
1,212,417
|
||||||
Office equipment
|
47,308
|
47,308
|
||||||
Furniture and fixtures
|
429,933
|
414,303
|
||||||
Machinery and equipment
|
2,599,994
|
2,559,356
|
||||||
Construction in progress
|
651,157
|
423,077
|
||||||
4,940,809
|
4,656,461
|
|||||||
Less accumulated depreciation
|
(3,678,450
|
)
|
(3,545,422
|
)
|
||||
Net property and equipment
|
1,262,359
|
1,111,039
|
||||||
Long-term assets:
|
||||||||
Lease right-of-use assets, net
|
2,081,054
|
2,380,225
|
||||||
Intangible assets, net of accumulated amortization
|
44,317
|
—
|
||||||
Other long-term assets
|
957,078
|
1,086,581
|
||||||
Total long-term assets
|
3,082,449
|
3,466,806
|
||||||
Total assets
|
$
|
20,276,444
|
27,755,825
|
Liabilities and Stockholders’ Equity
|
June 30,
2024
|
December 31, 2023
|
||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
951,510
|
1,137,823
|
|||||
Accrued expenses
|
886,352
|
1,444,296
|
||||||
Clinical holdback – current portion
|
92,397
|
65,300
|
||||||
Lease liabilities – current portion
|
533,734
|
406,636
|
||||||
Total current liabilities
|
2,463,993
|
3,054,055
|
||||||
Long-term liabilities:
|
||||||||
Clinical holdback – long-term portion
|
32,706
|
54,935
|
||||||
Convertible notes payable, net (including related parties)
|
4,758,017
|
4,258,179
|
||||||
Lease liabilities – long-term portion
|
1,771,487
|
2,036,067
|
||||||
Total long-term liabilities
|
6,562,210
|
6,349,181
|
||||||
Total liabilities
|
9,026,203
|
9,403,236
|
||||||
Commitments and contingencies
|
||||||||
Stockholders’ equity:
|
||||||||
Common stock, $.001 par, 200,000,000 authorized, 22,350,022 shares issued and 22,232,799 outstanding as of June 30, 2024; and 21,774,604 shares issued and 21,657,381 outstanding as of December 31, 2023
|
22,350
|
21,775
|
||||||
Treasury stock, 117,223 common shares
|
(60,000
|
)
|
(60,000
|
)
|
||||
Warrants
|
2,608,642
|
2,787,137
|
||||||
Additional paid-in-capital
|
125,344,962
|
123,985,306
|
||||||
Accumulated deficit
|
(116,665,713
|
)
|
(108,381,629
|
)
|
||||
Total stockholders’ equity
|
11,250,241
|
18,352,589
|
||||||
Total liabilities and stockholders' equity
|
$
|
20,276,444
|
27,755,825
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2024
|
2023
|
2024
|
2023
|
|||||||||||||
Sales
|
$
|
221,484
|
320,514
|
492,624
|
614,498
|
|||||||||||
Cost of sales (excluding depreciation expense)
|
73,125
|
110,469
|
161,657
|
215,589
|
||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
1,975,875
|
1,527,172
|
3,746,606
|
3,064,611
|
||||||||||||
Sales and marketing
|
975,190
|
128,899
|
1,275,677
|
373,795
|
||||||||||||
General and administrative
|
1,611,817
|
1,356,637
|
3,114,621
|
2,671,774
|
||||||||||||
Depreciation and amortization
|
67,628
|
133,299
|
138,856
|
266,365
|
||||||||||||
Total operating expenses
|
4,630,510
|
3,146,007
|
8,275,760
|
6,376,545
|
||||||||||||
Loss from operations
|
(4,482,151
|
)
|
(2,935,962
|
)
|
(7,944,793
|
)
|
(5,977,636
|
)
|
||||||||
Other income (expense):
|
||||||||||||||||
Interest income
|
184,138
|
42,652
|
408,822
|
139,741
|
||||||||||||
Interest expense
|
(388,311
|
)
|
(198
|
)
|
(749,863
|
)
|
(1,870
|
)
|
||||||||
Total other income (expense), net
|
(204,173
|
)
|
42,454
|
(341,041
|
)
|
137,871
|
||||||||||
Loss before income taxes
|
(4,686,324
|
)
|
(2,893,508
|
)
|
(8,285,834
|
)
|
(5,839,765
|
)
|
||||||||
Income tax benefit
|
(1,750
|
)
|
—
|
(1,750
|
)
|
—
|
||||||||||
Net loss
|
$
|
(4,684,574
|
)
|
(2,893,508
|
)
|
(8,284,084
|
)
|
(5,839,765
|
)
|
|||||||
Net loss attributable to common stockholders, basic and diluted
|
$
|
(4,684,574
|
)
|
(2,893,508
|
)
|
(8,284,084
|
)
|
(5,839,765
|
)
|
|||||||
Net loss per share attributable to common stockholders, basic and diluted
|
$
|
(0.21
|
)
|
(0.22
|
)
|
(0.38
|
)
|
(0.47
|
)
|
|||||||
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
|
22,215,516
|
13,107,590
|
21,995,436
|
12,493,334
|
Document and Entity Information |
Aug. 08, 2024 |
---|---|
Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | Aug. 08, 2024 |
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 $0.001 per share |
Trading Symbol | FEMY |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | true |
Entity Ex Transition Period | true |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
OM:11RHY_U=3_ 102P,$%
M @
^Y0)["HZ:HS3?$AK+ F::EU=J9&]Y-'MT5#VZ6AI\Z>71K=
M&MT:W7=#MT]#QZ%^:&MT:W1K=.\9NL%N^S[U;-6G4DF&[MVG-:3;*V!P]&L]
MXB5)\[@8<_*\FR;R0JUC0J,&E6@