| • |
Dov Elefant was appointed to chief financial officer (CFO). Mr. Elefant has 25 years of financial management experience at both public and private biopharmaceutical companies. Mr. Elefant brings a proven
record as a senior level global financial expert with financial reporting, fundraising, and mergers and acquisitions expertise.
|
| • |
Wendy Perrow joined as a new board member. Ms. Perrow brings decades of experience in the life sciences industry related to fundraising, global product launches and corporate strategy.
|
| • |
Edward G. Evantash, M.D., was appointed to chief medical officer (CMO). Dr. Evantash brings over two decades of industry experience in medical and clinical affairs, having previously served as CMO to Alydia
Health and vice president of medical affairs at Hologic, Inc., both medical technology companies focused on women’s healthcare.
|
| • |
Anne Morrissey was appointed to the company’s board of directors. Ms. Morrissey is currently president and CEO of AblaCare, and her previous experience includes serving as president and CEO of Alydia Health
and thereafter as an advisor until it was acquired by Merck in March 2021.
|
| • |
The Company completed an initial public offering in June 2021 with gross proceeds of approximately $34.45 million. On June18, 2021, the Company commenced trading on the Nasdaq Capital Market under the symbol
“FEMY.”
|
| • |
The Company announced that it expects to complete enrollment for its Stage 2 study of FemBloc in the third quarter of this year and file an investigational device exemption (IDE) for a pivotal trial to
support Premarket approval (PMA) in the first quarter of next year.
|
| • |
The first patient was treated with FemaSeed in the LOCAL de novo pivotal trial in July 2021. The trial is being conducted across centers in the United States and is
expected to enroll up to 792 patients who are diagnosed as infertile. The primary endpoints of the study are to determine effectiveness (clinical pregnancy rate) and safety over a period of seven weeks. The Company expects to have interim
data from this trial in the fourth quarter of this year and complete enrollment in the second quarter of next year.
|
| • |
Research and Development expenses decreased by $46,309, or 1.1%, to $4,084,304 for the year ended December 31, 2021 compared to the same period of 2020. The decrease was primarily due to a decrease in
compensation and related personnel costs and was partially offset by increased costs to support the Company’s clinical trials.
|
| • |
General and Administrative expenses increased by $1,717,959, or 67.5%, to $4,262,002 for the year ended December 31, 2021 compared to the same period of 2020. The increase was largely due to an increase of
$1,188,473 in professional costs associated with financing transactions and being a public company.
|
| • |
Sales of the Company’s FemVue® product, increased by $141,771, or 13.7%, to $1,179,689 for the year ended December 31, 2021. U.S. sales increased by 11.6% as compared to the same period last year
and were $1,005,612 in 2021 versus $900,751 in 2020 representing a 9.8% increase in units sold coupled with a slight increase in the average selling price. International sales increased by 26.9% in 2021 compared to the same period last year
and were $174,077 in 2021 as compared to $137,167 in 2020, representing an 8.5% increase in units sold with an increase in the average selling price due to the sales mix to our international distributors.
|
| • |
Primarily reflecting the factors noted above, net loss was $7,537,845, or $1.12 per basic and diluted share attributable to common stockholders, for the year ended December 31, 2021, compared to $6,914,992,
or $7.20 per basic and diluted share attributable to common stockholders, for the year ended December 31, 2020.
|
| • |
The cash and cash equivalents balance as of December 31, 2021 was $24,783,029. The Company expects, based on its current operating plan, that its existing cash and cash equivalents will be sufficient to fund
its operations at least 12 months from the date of the filing of the form 10-K.
|
|
Assets
|
December 31, 2021
|
December 31, 2020
|
|||||
|
Current assets:
|
|||||||
|
Cash and cash equivalents
|
$
|
24,783,029
|
3,322,226
|
||||
|
Accounts receivable, net
|
84,258
|
125,790
|
|||||
|
Inventory, net
|
208,270
|
131,378
|
|||||
|
Other current assets
|
555,853
|
284,115
|
|||||
|
Total current assets
|
25,631,410
|
3,863,509
|
|||||
|
Property and equipment, at cost:
|
|||||||
|
Leasehold improvements
|
1,155,332
|
1,155,332
|
|||||
|
Office equipment
|
99,344
|
64,145
|
|||||
|
Furniture and fixtures
|
424,947
|
424,947
|
|||||
|
Machinery and equipment
|
2,261,793
|
2,242,088
|
|||||
|
Construction in progress
|
379,713
|
139,150
|
|||||
|
4,321,129
|
4,025,662
|
||||||
|
Less accumulated depreciation
|
(2,722,117
|
)
|
(2,197,868
|
)
|
|||
|
Net property and equipment
|
1,599,012
|
1,827,794
|
|||||
|
Long-term assets:
|
|||||||
|
Lease right-of-use assets, net
|
665,747
|
1,057,506
|
|||||
|
Intangible assets, net of accumulated amortization
|
25,093
|
65,069
|
|||||
|
Other long-term assets
|
655,418
|
792,440
|
|||||
|
Total long-term assets
|
1,346,258 |
1,915,015 |
|||||
|
Total assets
|
$ |
28,576,680 |
7,606,318 |
||||
|
Liabilities, Redeemable Preferred Stock and Stockholders’ Equity (Deficit)
|
December 31, 2021
|
December 31, 2020
|
|||||
|
Current liabilities:
|
|||||||
|
Accounts payable
|
$
|
445,522
|
674,333
|
||||
|
Accrued expenses
|
603,787
|
1,117,601
|
|||||
|
Clinical holdback - current portion
|
18,947
|
—
|
|||||
|
Note payable – current portion
|
181,123
|
630,010
|
|||||
|
Lease liabilities – current portion
|
406,674
|
434,072
|
|||||
|
Other – current
|
36,037
|
32,895
|
|||||
|
Total current liabilities
|
1,692,090
|
2,888,911
|
|||||
|
Long-term liabilities:
|
|||||||
|
Clinical holdback - long-term portion
|
149,791
|
164,972
|
|||||
|
Note payable – long-term portion
|
—
|
182,490
|
|||||
|
Lease liabilities – long-term portion
|
402,417
|
809,092
|
|||||
|
Other – long-term
|
—
|
32,895
|
|||||
|
Total long-term liabilities
|
552,208
|
1,189,449
|
|||||
|
Total liabilities
|
2,244,298
|
4,078,360
|
|||||
|
Commitments and contingencies
|
|||||||
|
Redeemable convertible preferred stock:
|
|||||||
|
Preferred stock, Series B, $.001 par, none authorized, issued and outstanding as of December 31,
2021; 13,344,349 shares authorized, issued
and outstanding as of December 31, 2020
|
—
|
10,748,873
|
|||||
|
Preferred stock, Series C, $.001 par, none authorized, issued and outstanding as of December 31,
2021; 42,491,484 shares authorized,
issued and outstanding as of December 31, 2020
|
—
|
44,594,813
|
|||||
|
Stockholders’ equity (deficit):
|
|||||||
|
Common stock, $.001 par, 200,000,000 authorized, 11,921,388 shares issued and 11,804,165
outstanding as of December 31, 2021;
and 95,583,558 authorized, 1,110,347 shares issued and 993,124 outstanding as of December 31, 2020
|
11,921
|
1,110 |
|||||
|
Treasury stock, 117,223 shares
|
(60,000
|
)
|
(60,000
|
)
|
|||
|
Preferred stock, Series A, $.001 par, none authorized, issued and outstanding as of December 31,
2021; 17,310,609 shares authorized,
and 17,210,609 shares issued and outstanding as of December 31, 2020
|
—
|
17,211
|
|||||
|
Warrants
|
702,492
|
702,492
|
|||||
|
Additional paid-in-capital
|
108,418,304
|
22,725,949
|
|||||
|
Accumulated other comprehensive loss, net of tax
|
—
|
—
|
|||||
|
Accumulated deficit
|
(82,740,335
|
)
|
(75,202,490
|
)
|
|||
|
Total stockholders’ equity (deficit)
|
26,332,382
|
(51,815,728
|
)
|
||||
|
Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)
|
$
|
28,576,680
|
7,606,318
|
||||
|
December 31, 2021
|
December 31, 2020
|
|||||||
|
Sales
|
$
|
1,179,689
|
1,037,918
|
|||||
|
Cost of sales
|
370,384
|
306,533
|
||||||
|
Gross margin
|
809,305
|
731,385
|
||||||
|
Operating expenses:
|
||||||||
|
Research and development
|
4,084,304
|
4,130,613
|
||||||
|
Sales and marketing
|
208,735
|
310,219
|
||||||
|
General and administrative
|
4,262,002
|
2,544,043
|
||||||
|
Depreciation and amortization
|
591,068
|
679,653
|
||||||
|
Total operating expenses
|
9,146,109
|
7,664,528
|
||||||
|
Loss from operations
|
(8,336,804
|
)
|
(6,933,143
|
)
|
||||
|
Other income (expense):
|
||||||||
|
Interest income, net
|
3,768
|
22,504
|
||||||
|
Other income
|
821,515
|
10,000
|
||||||
|
Interest expense
|
(19,226
|
)
|
(12,553
|
)
|
||||
|
Other expense
|
(3,098
|
)
|
—
|
|||||
|
Total other income
|
802,959
|
19,951
|
||||||
|
Loss before income taxes
|
(7,533,845
|
)
|
(6,913,192
|
)
|
||||
|
Income tax expense
|
4,000
|
1,800
|
||||||
|
Net loss
|
$
|
(7,537,845
|
)
|
(6,914,992
|
)
|
|||
|
Comprehensive loss:
|
||||||||
|
Net loss
|
$
|
(7,537,845
|
)
|
(6,914,992
|
)
|
|||
|
Change in fair value of available for sale investments
|
—
|
(20
|
)
|
|||||
|
Total comprehensive loss
|
$
|
(7,537,845
|
)
|
(6,915,012
|
)
|
|||
|
Net loss attributable to common stockholders, basic and diluted
|
$
|
(7,537,845
|
)
|
(6,914,992
|
)
|
|||
|
Net loss per share attributable to common stockholders, basic and diluted
|
$
|
(1.12
|
)
|
(7.20
|
)
|
|||
|
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
|
6,712,028
|
959,862
|
||||||