|
Delaware
(State or other jurisdiction of
incorporation or organization) |
| |
3841
(Primary Standard Industrial
Classification Code Number) |
| |
41-1983744
(I.R.S. Employer
Identification No.) |
|
|
Amy C. Seidel, Esq.
Ben A. Stacke, Esq. Faegre Drinker Biddle & Reath LLP 2200 Wells Fargo Center Minneapolis, MN 55402-1425 Telephone: (612) 766-7000 |
| |
Ilir Mujalovic, Esq.
Shearman & Sterling LLP 599 Lexington Avenue New York, NY 10022 (212) 848-4000 |
|
| Large accelerated filer ☐ | | | Accelerated filer ☐ | | | Smaller reporting company ☒ | | | Emerging growth company ☒ | |
| Non-accelerated filer ☒ | | | | | | | | | | |
Title of each class
of securities to be registered |
| | |
Proposed maximum
aggregate offering price(1)(2) |
| | |
Amount of
registration fee |
| |||
Common stock, par value $0.01 per share
|
| | |
$
|
| | | | $ | | |
| | | |
Per share
|
| |
Total
|
| ||||||
| Public offering price | | | | $ | | | | | $ | | | ||
| Underwriting discount(1) | | | | $ | | | | | $ | | | ||
| Proceeds, before expenses, to us | | | | $ | | | | | $ | | | |
| J.P. Morgan | | |
Piper Sandler
|
| |
William Blair
|
|
| | |
Page
|
| |||
| | | | 1 | | | |
| | | | 13 | | | |
| | | | 47 | | | |
| | | | 49 | | | |
| | | | 50 | | | |
| | | | 51 | | | |
| | | | 52 | | | |
| | | | 54 | | | |
| | | | 56 | | | |
| | | | 58 | | | |
| | | | 70 | | | |
| | | | 108 | | | |
| | | | 115 | | | |
| | | | 125 | | | |
| | | | 127 | | | |
| | | | 130 | | | |
| | | | 135 | | | |
| | | | 138 | | | |
| | | | 142 | | | |
| | | | 153 | | | |
| | | | 153 | | | |
| | | | 153 | | | |
| | | | F-1 | | |
| | |
Years ended December 31,
|
| |
Three months ended March 31,
|
| ||||||||||||||||||
| | |
2020
|
| |
2019
|
| |
2021
|
| |
2020
|
| ||||||||||||
| | |
(in thousands, except share and per share data)
|
| |||||||||||||||||||||
| | | | | | | | | | | | | | |
(unaudited)
|
| |||||||||
Consolidated Statements of Operations Data: | | | | | | ||||||||||||||||||||
Revenue:
|
| | | $ | 6,053 | | | | | $ | 6,257 | | | | | $ | | | | | $ | | | ||
Cost of goods sold
|
| | | | 1,440 | | | | | | 1,683 | | | | | | | | | | | | | | |
Gross profit
|
| | | | 4,613 | | | | | | 4,574 | | | | | | | | | | | | | | |
Operating expenses: | | | | | | | | | | | | | | | | | | | | | | | | | |
Research and development
|
| | | | 6,410 | | | | | | 8,662 | | | | | | | | | | | | | | |
Selling, general, and administrative
|
| | | | 9,717 | | | | | | 6,106 | | | | | | | | | | | | | | |
Total operating expenses
|
| | | | 16,127 | | | | | | 14,768 | | | | | | | | | | | | | | |
Loss from operations
|
| | | | (11,514) | | | | | | (10,194) | | | | | | | | | | | | | | |
Interest expense
|
| | | | (2,470) | | | | | | (1,720) | | | | | | | | | | | | | | |
Other expense, net
|
| | | | (40) | | | | | | (2,646) | | | | | | | | | | | | | | |
Loss before income taxes
|
| | | | (14,024) | | | | | | (14,560) | | | | | | | | | | | | | | |
Provision for income taxes
|
| | | | (85) | | | | | | (73) | | | | | | | | | | | | | | |
Net loss
|
| | | $ | (14,109) | | | | | $ | (14,633) | | | | | $ | | | | | $ | | | ||
Cumulative translation adjustment
|
| | | | (1) | | | | | | (6) | | | | | | | | | | | | | | |
Comprehensive loss
|
| | | $ | (14,110) | | | | | $ | (14,639) | | | | | | | | | | | | | | |
Net loss per share attributable to common stockholders, basic and diluted(1)
|
| | | $ | (0.94) | | | | | $ | (0.77) | | | | | $ | | | | | $ | | | ||
Weighted-average common shares used to compute net loss per share, basic and diluted(1)
|
| | | | 15,308,364 | | | | | | 19,085,104 | | | | | | | | | | | | | | |
Pro forma net loss per share attributable to common
stockholders, basic and diluted (unaudited)(1) |
| | | $ | | | | | | | | | | | $ | | | | | | | | | ||
Pro forma weighted-average common shares used to
compute net loss per share, basic and diluted (unaudited)(1) |
| | | | | | | | | | | | | | | | | | | | | | | | |
| | |
As of March 31, 2021
|
| |||||||||||||||
| | |
Actual
|
| |
Pro forma
|
| |
Pro forma as
adjusted(1) |
| |||||||||
| | |
(unaudited, in thousands)
|
| |||||||||||||||
Consolidated Balance Sheet Data: | | | | | | | | | | | | | | | | | | | |
Cash and cash equivalents
|
| | | $ | | | | | $ | | | | | $ | | | |||
Working capital(2)
|
| | | | | | | | | | | | | | | | | | |
Total assets
|
| | | | | | | | | | | | | | | | | | |
Long-term debt
|
| | | | | | | | | | | | | | | | | | |
Convertible preferred stock warrant liability
|
| | | | | | | | | | | | | | | | | | |
Redeemable convertible preferred stock
|
| | | | | | | | | | | | | | | | | | |
Total stockholders’ deficit
|
| | | | | | | | | | | | | | | | | | |
| | | |
As of March 31, 2021
|
| |||||||||||||||
| | | |
Actual
|
| |
Pro
Forma |
| |
Pro Forma As
Adjusted(1) |
| |||||||||
| | | |
(unaudited, in thousands, except share and
per share data) |
| |||||||||||||||
|
Cash and cash equivalents
|
| | | $ | | | | | $ | | | | | $ | | | |||
| Long-term debt | | | | | | | | | | | | | | | | | | | |
|
Convertible preferred stock, no par value; shares authorized,
shares issued and outstanding, actual; no shares authorized or issued and outstanding, pro forma and pro forma as adjusted |
| | | | | | | | | | | | | | | | | | |
|
Stockholders’ (deficit) equity:
Common stock, $0.01 par value; shares authorized, shares issued and outstanding, actual; shares authorized, pro forma and pro forma as adjusted; shares issued and outstanding, pro forma; shares issued and outstanding, pro forma as adjusted |
| | | | | | | | | | | | | | | | | | |
|
Additional paid-in capital, common stock
|
| | | | | | | | | | | | | | | | | | |
|
Accumulated deficit
|
| | | | | | | | | | | | | | | | | | |
|
Accumulated other comprehensive loss
|
| | | | | | | | | | | | | | | | | | |
|
Total stockholders’ deficit
|
| | | | | | | | | | | | | | | | | | |
|
Total capitalization
|
| | | $ | | | | | $ | | | | | $ | | | |
|
Assumed initial public offering price per share
|
| | | | | | | | | $ | | | |
|
Historical net tangible book value per share as of March 31, 2021
|
| | | $ | | | | | | | | | |
|
Pro forma increase in net tangible book value per share
|
| | | | | | | | | | | | |
|
Pro forma net tangible book value per share as of March 31, 2021
|
| | | | | | | | | | | | |
|
Increase in pro forma net tangible book value per share attributable
to new investors |
| | | | | | | | | | | | |
|
Pro forma as adjusted net tangible book value per share after this offering
|
| | | | | | | | | | | | |
|
Dilution per share to new investors participating in this offering
|
| | | | | | | | | $ | | | |
| | | |
Shares Purchased
|
| |
Total Consideration
|
| | | | | | | ||||||
| | | |
Number
|
| |
Percent
|
| |
Amount
|
| |
Percent
|
| |
Average
Price Per Share |
| |||
|
Existing stockholders
|
| | | | | | | | | | | | | | | $ | | | |
|
Investors participating in this offering
|
| | | | | | | | | | | | | | | $ | | | |
|
Total
|
| | | | | | | | | | | | | | | | | | |
| | |
Years Ended December 31,
|
| |
Three Months Ended March 31,
|
| ||||||||||||||||||
| | |
2020
|
| |
2019
|
| |
2021
|
| |
2020
|
| ||||||||||||
| | |
(in thousands, except share and per share data)
|
| |||||||||||||||||||||
Consolidated Statements of Operations Data:
|
| | | | | | | | | | | | | |
(unaudited)
|
| |||||||||
Revenue:
|
| | | $ | 6,053 | | | | | $ | 6,257 | | | | | $ | | | | | $ | | | ||
Cost of goods sold
|
| | | | 1,440 | | | | | | 1,683 | | | | | | | | | | | | | | |
Gross profit
|
| | | | 4,613 | | | | | | 4,574 | | | | | | | | | | | | | | |
Operating expenses: | | | | | | | | | | | | | | | | | | | | | | | | | |
Research and development
|
| | | | 6,410 | | | | | | 8,662 | | | | | | | | | | | | | | |
Selling, general, and administrative
|
| | | | 9,717 | | | | | | 6,106 | | | | | | | | | | | | | | |
Total operating expenses
|
| | | | 16,127 | | | | | | 14,768 | | | | | | | | | | | | | | |
Loss from operations
|
| | | | (11,514) | | | | | | (10,194) | | | | | | | | | | | | | | |
Interest expense
|
| | | | (2,470) | | | | | | (1,720) | | | | | | | | | | | | | | |
Other expense, net
|
| | | | (40) | | | | | | (2,646) | | | | | | | | | | | | | | |
Loss before income taxes
|
| | | | (14,024) | | | | | | (14,560) | | | | | | | | | | | | | | |
Provision for income taxes
|
| | | | (85) | | | | | | (73) | | | | | | | | | | | | | | |
Net loss
|
| | | $ | (14,109) | | | | | $ | (14,633) | | | | | $ | | | | | $ | | | ||
Cumulative translation adjustment
|
| | | | (1) | | | | | | (6) | | | | | | | | | | | | | | |
Comprehensive loss
|
| | | $ | (14,110) | | | | | $ | (14,639) | | | | | $ | | | | | | $ | | | |
Net loss per share attributable to common stockholders, basic and diluted(1)
|
| | | $ | (0.94) | | | | | $ | (0.77) | | | | | $ | | | | | $ | | | ||
Weighted-average common shares used to compute net loss per share, basic and diluted(1)
|
| | | | 15,308,364 | | | | | | 19,085,104 | | | | | | | | | | | | | | |
Pro forma net loss per share attributable to common stockholders, basic and diluted (unaudited)(1)
|
| | | $ | | | | | | $ | | | | | | $ | | | | | $ | | | ||
Pro forma weighted-average common shares used to compute net loss per share, basic and diluted (unaudited)(1)
|
| | | | | | | | | | | | | | | | | | | | | | | | |
| | | |
As of December 31,
|
| | | | | | | |||||||||
| | | |
2020
|
| |
2019
|
| |
As of March 31,
2021 |
| |||||||||
| | | |
(in thousands)
|
| |||||||||||||||
| | | | | | | | | | | | | | | |
(unaudited)
|
| |||
| Consolidated Balance Sheet Data: | | | | | | | | | | | | | | | | | | | |
|
Cash and cash equivalents
|
| | | $ | 59,112 | | | | | $ | 25,741 | | | | | $ | | | |
|
Working capital(1)
|
| | | | 56,364 | | | | | | 20,293 | | | | | | | | |
|
Total assets
|
| | | | 64,777 | | | | | | 29,107 | | | | | | | | |
|
Long-term debt
|
| | | | 19,278 | | | | | | 18,992 | | | | | | | | |
|
Convertible preferred stock warrant liability
|
| | | | 3,911 | | | | | | 3,540 | | | | | | | | |
|
Redeemable convertible preferred stock
|
| | | | 329,983 | | | | | | 279,983 | | | | | | | | |
|
Total stockholders’ deficit
|
| | | | (293,238) | | | | | | (279,043) | | | | | | | | |
| | |
Year Ended December 31,
|
| |
Change
|
| ||||||||||||||||||
(in thousands)
|
| |
2020
|
| |
2019
|
| |
$
|
| |
%
|
| ||||||||||||
Revenue
|
| | | $ | 6,053 | | | | | $ | 6,257 | | | | | $ | (204) | | | | | | (3)% | | |
Cost of goods sold
|
| | | | 1,440 | | | | | | 1,683 | | | | | | (243) | | | | | | (14)% | | |
Gross profit
|
| | | | 4,613 | | | | | | 4,574 | | | | | | 39 | | | | | | 1% | | |
Gross margin
|
| | | | 76% | | | | | | 73% | | | | | | | | | | | | | | |
Operating Expenses: | | | | | | | | | | | | | | | | | | | | | | | | | |
Research and development
|
| | | | 6,410 | | | | | | 8,662 | | | | | | (2,252) | | | | | | (26)% | | |
Selling, general and administrative
|
| | | | 9,717 | | | | | | 6,106 | | | | | | 3,611 | | | | | | 59% | | |
Total operating expenses
|
| | | | 16,127 | | | | | | 14,768 | | | | | | 1,359 | | | | | | 9% | | |
Loss from operations
|
| | | | (11,514) | | | | | | (10,194) | | | | | | (1,320) | | | | | | 13% | | |
Interest expense
|
| | | | (2,470) | | | | | | (1,720) | | | | | | (750) | | | | | | 44% | | |
Other expense, net
|
| | | | (40) | | | | | | (2,646) | | | | | | 2,606 | | | | | | (98)% | | |
Loss before income taxes
|
| | | | (14,024) | | | | | | (14,560) | | | | | | 536 | | | | | | (4)% | | |
Provision for income taxes
|
| | | | (85) | | | | | | (73) | | | | | | (12) | | | | | | 16% | | |
Net loss
|
| | | $ | (14,109) | | | | | $ | (14,633) | | | | | $ | 524 | | | | | | (4)% | | |
| | |
Year Ended December 31,
|
| |||||||||
(in thousands)
|
| |
2020
|
| |
2019
|
| ||||||
Net cash (used in) provided by: | | | | | | | | | | | | | |
Operating activities
|
| | | $ | (16,096) | | | | | $ | (12,785) | | |
Investing activities
|
| | | | (311) | | | | | | (106) | | |
Financing activities
|
| | | | 49,783 | | | | | | 29,549 | | |
Effect of exchange rate changes on cash and cash equivalents
|
| | | | (5) | | | | | | (5) | | |
Net increase in cash
|
| | | $ | 33,371 | | | | | $ | 16,653 | | |
| | |
Payments due by period
|
| |||||||||||||||||||||||||||
(in thousands)
|
| |
Total
|
| |
Less
than 1 year |
| |
1 to 3
years |
| |
4 to 5
years |
| |
After
5 years |
| |||||||||||||||
Long-term debt(1)
|
| | | $ | 20,000 | | | | | $ | — | | | | | $ | 13,333 | | | | | $ | 6,667 | | | | | $ | — | | |
Operating lease(2)
|
| | | | 830 | | | | | | 231 | | | | | | 460 | | | | | | 139 | | | | | | | | |
Total
|
| | | $ | 20,830 | | | | | $ | 231 | | | | | $ | 13,793 | | | | | $ | 6,806 | | | | | $ | — | | |
Name
|
| |
Age
|
| |
Position(s)
|
| |||
Executive Officers | | | | | | | | | | |
Nadim Yared
|
| | | | 53 | | | | President and Chief Executive Officer | |
Jared Oasheim
|
| | | | 38 | | | | Chief Financial Officer | |
John Brintnall
|
| | | | 68 | | | | Chief Strategy Officer and Secretary | |
Dean Bruhn-Ding
|
| | | | 63 | | | |
Vice President of Regulatory Affairs and Quality Assurance
|
|
Liz Galle
|
| | | | 54 | | | | Vice President of Global Clinical Research | |
Paul Verrastro
|
| | | | 63 | | | | Chief Marketing Officer | |
Non-Employee Directors | | | | | | | | | | |
Ali Behbahani, M.D.
|
| | | | 45 | | | | Director | |
Mudit K. Jain, Ph.D.
|
| | | | 52 | | | | Director | |
John M. Nehra
|
| | | | 72 | | | | Director | |
Kirk Nielsen
|
| | | | 47 | | | | Director | |
Geoff Pardo
|
| | | | 49 | | | | Director | |
Joseph Slattery
|
| | | | 56 | | | | Director | |
Name and Principal Position
|
| |
Year
|
| |
Salary
($) |
| |
Option
Awards ($)(1) |
| |
Non-Equity
Incentive Plan Compensation ($)(2) |
| |
All
Other Compensation ($)(3) |
| |
Total
($) |
| ||||||||||||||||||
Nadim Yared
President and Chief Executive Officer |
| | | | 2020 | | | | | | 452,000 | | | | | | 344,735 | | | | | | 196,620 | | | | | | 13,259 | | | | | | 1,006,614 | | |
John Brintnall
Chief Strategy Officer |
| | | | 2020 | | | | | | 289,200 | | | | | | 98,435 | | | | | | 101,220 | | | | | | — | | | | | | 488,855 | | |
Dean Bruhn-Ding
Vice President of Regulatory Affairs and Quality Assurance |
| | | | 2020 | | | | | | 285,800 | | | | | | 65,620 | | | | | | 64,519 | | | | | | — | | | | | | 415,939 | | |
Name
|
| |
2020
Base Salary ($) |
| |
2021
Base Salary ($) |
| ||||||
Nadim Yared
|
| | | | 452,000 | | | | | | 452,000 | | |
John Brintnall
|
| | | | 289,200 | | | | | | 298,000 | | |
Dean Bruhn-Ding
|
| | | | 285,800 | | | | | | 295,000 | | |
Name
|
| |
Annual Target Incentive
Amount as a Percent of Base Salary |
|
Nadim Yared
|
| |
60%
|
|
John Brintnall
|
| |
50%
|
|
Dean Bruhn-Ding
|
| |
35%
|
|
Name
|
| |
Target
Percentage (% of Salary) |
| |
Target
Award Value ($) |
| |
Actual
Award Paid ($) |
| |
Paid
Award (% of Target) |
|
Nadim Yared
|
| |
60%
|
| |
271,200
|
| |
196,620
|
| |
72.50%
|
|
John Brintnall
|
| |
50%
|
| |
144,600
|
| |
101,220
|
| |
70.00%
|
|
Dean Bruhn-Ding
|
| |
35%
|
| |
100,030
|
| |
64,519
|
| |
64.50%
|
|
Option
|
| |
Nadim
Yared (# of shares) |
| |
John
Brintnall (# of shares) |
| |
Dean
Bruhn-Ding (# of share) |
| |||||||||
Grant A
|
| | | | 2,013,000 | | | | | | 573,700 | | | | | | 382,500 | | |
Grant B
|
| | | | 1,984,700 | | | | | | 565,700 | | | | | | 377,100 | | |
Grant C
|
| | | | 1,804,800 | | | | | | 514,400 | | | | | | 342,900 | | |
Grant D
|
| | | | 1,774,100 | | | | | | 509,600 | | | | | | 339,700 | | |
Total
|
| | | | 7,576,600 | | | | | | 2,163,400 | | | | | | 1,442,200 | | |
| | |
Option Awards
|
| |||||||||||||||||||||||||||
Name
|
| |
Vesting
Commencement Date |
| |
Number of
Securities Underlying Unexercised Options (#) Exercisable(1) |
| |
Number of
Securities Underlying Unexercised Options (#) Unexercisable(1) |
| |
Option
Exercise Price ($) |
| |
Option
Expiration Date |
| |||||||||||||||
Nadim Yared
|
| | | | 10/4/2006 | | | | | | 1,227,494 | | | | | | — | | | | | | 0.006 | | | | | | 8/6/2025 | | |
| | | | | 6/28/2007 | | | | | | 150,000 | | | | | | — | | | | | | 0.006 | | | | | | 8/6/2025 | | |
| | | | | 2/21/2008 | | | | | | 234,000 | | | | | | — | | | | | | 0.006 | | | | | | 8/6/2025 | | |
| | | | | 7/29/2009 | | | | | | 500,000 | | | | | | — | | | | | | 0.006 | | | | | | 8/6/2025 | | |
| | | | | 4/19/2011 | | | | | | 450,000 | | | | | | — | | | | | | 0.006 | | | | | | 8/6/2025 | | |
| | | | | 11/12/2013 | | | | | | 622,700 | | | | | | — | | | | | | 0.006 | | | | | | 11/11/2023 | | |
| | | | | 9/11/2014 | | | | | | 200,000 | | | | | | — | | | | | | 0.006 | | | | | | 9/10/2024 | | |
| | | | | 7/1/2015 | | | | | | 400,000 | | | | | | — | | | | | | 0.006 | | | | | | 6/30/2025 | | |
| | | | | —(2) | | | | | | 400,000(2) | | | | | | — | | | | | | 0.006 | | | | | | 6/30/2025 | | |
| | | | | 9/28/2016 | | | | | | 1,467,000 | | | | | | — | | | | | | 0.006 | | | | | | 9/27/2026 | | |
| | | | | 2/16/2018 | | | | | | 2,770,000(2) | | | | | | — | | | | | | 0.006 | | | | | | 2/15/2028 | | |
| | | | | 1/28/2019 | | | | | | 144,229 | | | | | | 156,771(3) | | | | | | 0.006 | | | | | | 2/15/2028 | | |
| | | | | 1/28/2019 | | | | | | — | | | | | | 2,729,000(4) | | | | | | 0.006 | | | | | | 2/15/2028 | | |
| | | | | 7/24/2019 | | | | | | 388,166 | | | | | | 707,834(3) | | | | | | 0.100 | | | | | | 7/23/2029 | | |
| | | | | 7/24/2019 | | | | | | — | | | | | | 2,071,000(4) | | | | | | 0.100 | | | | | | 7/23/2029 | | |
| | | | | 7/24/2019 | | | | | | — | | | | | | 333,000(4) | | | | | | 0.100 | | | | | | 7/23/2029 | | |
| | | | | 10/1/2020 | | | | | | — | | | | | | 2,013,000(5) | | | | | | 0.110 | | | | | | 9/30/2030 | | |
| | | | | 10/1/2020 | | | | | | — | | | | | | 1,984,700(6) | | | | | | 0.110 | | | | | | 9/30/2030 | | |
| | | | | 10/1/2020 | | | | | | — | | | | | | 1,804,800(7) | | | | | | 0.110 | | | | | | 9/30/2030 | | |
| | | | | 10/1/2020 | | | | | | — | | | | | | 1,774,100(4) | | | | | | 0.110 | | | | | | 9/30/2030 | | |
John Brintnall
|
| | | | 6/28/2007 | | | | | | 75,000 | | | | | | — | | | | | | 0.006 | | | | | | 8/6/2025 | | |
| | | | | 2/21/2008 | | | | | | 90,000 | | | | | | — | | | | | | 0.006 | | | | | | 8/6/2025 | | |
| | | | | 7/29/2009 | | | | | | 150,000 | | | | | | — | | | | | | 0.006 | | | | | | 8/6/2025 | | |
| | | | | 4/19/2011 | | | | | | 130,000 | | | | | | — | | | | | | 0.006 | | | | | | 8/6/2025 | | |
| | | | | 11/12/2013 | | | | | | 188,700 | | | | | | — | | | | | | 0.006 | | | | | | 11/11/2023 | | |
| | | | | 9/11/2014 | | | | | | 150,000 | | | | | | — | | | | | | 0.006 | | | | | | 9/10/2024 | | |
| | | | | 7/1/2015 | | | | | | 50,000 | | | | | | — | | | | | | 0.006 | | | | | | 6/30/2025 | | |
| | | | | 9/28/2016 | | | | | | 385,000 | | | | | | — | | | | | | 0.006 | | | | | | 9/27/2026 | | |
| | | | | 2/16/2018 | | | | | | 860,000(2) | | | | | | — | | | | | | 0.006 | | | | | | 2/15/2028 | | |
| | | | | 1/28/2019 | | | | | | 45,041 | | | | | | 48,959(3) | | | | | | 0.006 | | | | | | 2/15/2028 | | |
| | | | | 1/28/2019 | | | | | | — | | | | | | 846,000(4) | | | | | | 0.006 | | | | | | 2/15/2028 | | |
| | | | | 7/24/2019 | | | | | | 149,812 | | | | | | 273,188(3) | | | | | | 0.100 | | | | | | 7/23/2029 | | |
| | |
Option Awards
|
| |||||||||||||||||||||||||||
Name
|
| |
Vesting
Commencement Date |
| |
Number of
Securities Underlying Unexercised Options (#) Exercisable(1) |
| |
Number of
Securities Underlying Unexercised Options (#) Unexercisable(1) |
| |
Option
Exercise Price ($) |
| |
Option
Expiration Date |
| |||||||||||||||
| | | | | 7/24/2019 | | | | | | — | | | | | | 927,000(4) | | | | | | 0.100 | | | | | | 7/23/2029 | | |
| | | | | 10/1/2020 | | | | | | — | | | | | | 573,700(5) | | | | | | 0.110 | | | | | | 9/30/2030 | | |
| | | | | 10/1/2020 | | | | | | — | | | | | | 565,700(6) | | | | | | 0.110 | | | | | | 9/30/2030 | | |
| | | | | 10/1/2020 | | | | | | — | | | | | | 514,400(7) | | | | | | 0.110 | | | | | | 9/30/2030 | | |
| | | | | 10/1/2020 | | | | | | — | | | | | | 509,600(4) | | | | | | 0.110 | | | | | | 9/30/2030 | | |
Dean Bruhn-Ding
|
| | | | 1/30/2006 | | | | | | 46,250 | | | | | | — | | | | | | 0.006 | | | | | | 8/6/2025 | | |
| | | | | 2/8/2007 | | | | | | 32,500 | | | | | | — | | | | | | 0.006 | | | | | | 8/6/2025 | | |
| | | | | 6/28/2007 | | | | | | 14,964 | | | | | | — | | | | | | 0.006 | | | | | | 8/6/2025 | | |
| | | | | 2/21/2008 | | | | | | 62,893 | | | | | | — | | | | | | 0.006 | | | | | | 8/6/2025 | | |
| | | | | 7/29/2009 | | | | | | 100,000 | | | | | | — | | | | | | 0.006 | | | | | | 8/6/2025 | | |
| | | | | 4/19/2011 | | | | | | 90,000 | | | | | | — | | | | | | 0.006 | | | | | | 8/6/2025 | | |
| | | | | 11/12/2013 | | | | | | 113,200 | | | | | | — | | | | | | 0.006 | | | | | | 11/11/2023 | | |
| | | | | 9/11/2014 | | | | | | 50,000 | | | | | | — | | | | | | 0.006 | | | | | | 9/10/2024 | | |
| | | | | 2/17/2015 | | | | | | 50,000 | | | | | | — | | | | | | 0.006 | | | | | | 2/16/2025 | | |
| | | | | 7/1/2015 | | | | | | 100,000 | | | | | | — | | | | | | 0.006 | | | | | | 6/30/2025 | | |
| | | | | 9/28/2016 | | | | | | 285,000 | | | | | | — | | | | | | 0.006 | | | | | | 9/27/2026 | | |
| | | | | 2/16/2018 | | | | | | 597,000(2) | | | | | | — | | | | | | 0.006 | | | | | | 2/15/2028 | | |
| | | | | 1/28/2019 | | | | | | 31,145 | | | | | | 33,855(3) | | | | | | 0.006 | | | | | | 2/15/2028 | | |
| | | | | 1/28/2019 | | | | | | — | | | | | | 588,000(4) | | | | | | 0.006 | | | | | | 2/15/2028 | | |
| | | | | 7/24/2019 | | | | | | 84,645 | | | | | | 154,355(3) | | | | | | 0.100 | | | | | | 7/23/2029 | | |
| | | | | 7/24/2019 | | | | | | — | | | | | | 525,000(4) | | | | | | 0.100 | | | | | | 7/23/2029 | | |
| | | | | 10/1/2020 | | | | | | — | | | | | | 382,500(5) | | | | | | 0.110 | | | | | | 9/30/2030 | | |
| | | | | 10/1/2020 | | | | | | — | | | | | | 377,100(6) | | | | | | 0.110 | | | | | | 9/30/2030 | | |
| | | | | 10/1/2020 | | | | | | — | | | | | | 342,900(7) | | | | | | 0.110 | | | | | | 9/30/2030 | | |
| | | | | 10/1/2020 | | | | | | — | | | | | | 339,700(4) | | | | | | 0.110 | | | | | | 9/30/2030 | | |
Name
|
| |
Fees earned
or paid in cash ($)(1) |
| |
Stock
Awards ($)(2) |
| |
Option
awards ($)(2)(3) |
| |
All Other
Compensation ($) |
| |
Total
($) |
| |||||||||||||||
Ali Behbahani
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Mudit Jain
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
V. Kadir Kadhiresan
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
John Nehra
|
| | | | 24,000 | | | | | | — | | | | | | 10,865 | | | | | | — | | | | | | 34,865 | | |
Kirk Nielsen
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Geoff Pardo
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Joseph Slattery
|
| | | | 37,000 | | | | | | — | | | | | | 22,952 | | | | | | — | | | | | | 59,952 | | |
| | |
Beneficial Ownership Prior to this Offering
|
| |
Beneficial Ownership
After this Offering |
| ||||||||||||||||||||||||
Name and Address of
Beneficial Owner |
| |
Number of
Outstanding Shares Beneficially Owned |
| |
Number of
Shares Exercisable Within 60 Days |
| |
Number of
Shares Beneficially Owned |
| |
Percentage
of Beneficial Ownership |
| |
Number of
Shares Beneficially Owned |
| |
Percentage
of Beneficial Ownership |
| ||||||||||||
5% and Greater Stockholders | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Johnson & Johnson Innovation – JJDC, Inc.(1)
|
| | | | 138,243,000 | | | | | | 24,201,686 | | | | | | 162,444,686 | | | | | | 31.8% | | | | | | | | |
New Enterprise Associates(2)
|
| | | | 82,887,104 | | | | | | — | | | | | | 82,887,104 | | | | | | 17.0% | | | | | | | | |
Coöperatieve Gilde Healthcare IV U.A.(3)
|
| | | | 61,458,493 | | | | | | 88,958 | | | | | | 61,547,451 | | | | | | 12.7% | | | | | | | | |
Vensana Capital I, L.P.(4)
|
| | | | 57,812,500 | | | | | | — | | | | | | 57,812,500 | | | | | | 11.9% | | | | | | | | |
Action Potential Venture Capital Limited(5)
|
| | | | 28,972,227 | | | | | | — | | | | | | 28,972,227 | | | | | | 6.0% | | | | | | | | |
Treo Ventures I, L.P.(6)
|
| | | | 28,125,000 | | | | | | 5,208 | | | | | | 28,130,208 | | | | | | 5.8% | | | | | | | | |
Named Executive Officers and Directors
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Nadim Yared(7)
|
| | | | 300,000 | | | | | | 10,291,024 | | | | | | 10,591,024 | | | | | | 2.1% | | | | | | | | |
| | |
Beneficial Ownership Prior to this Offering
|
| |
Beneficial Ownership
After this Offering |
| ||||||||||||||||||||||||
Name and Address of
Beneficial Owner |
| |
Number of
Outstanding Shares Beneficially Owned |
| |
Number of
Shares Exercisable Within 60 Days |
| |
Number of
Shares Beneficially Owned |
| |
Percentage
of Beneficial Ownership |
| |
Number of
Shares Beneficially Owned |
| |
Percentage
of Beneficial Ownership |
| ||||||||||||
Ali Behbahani(8)
|
| | | | — | | | | | | 126,458 | | | | | | 126,458 | | | | | | * | | | | | | | | |
Mudit K. Jain(6)
|
| | | | 28,125,000 | | | | | | 5,208 | | | | | | 28,130,208 | | | | | | 5.8% | | | | | | | | |
John M. Nehra(9)
|
| | | | 19,375 | | | | | | 382,443 | | | | | | 401,818 | | | | | | * | | | | | | | | |
Kirk Nielsen(10)
|
| | | | 57,812,500 | | | | | | 5,208 | | | | | | 57,817,708 | | | | | | 11.9% | | | | | | | | |
Geoff Pardo(11)
|
| | | | 61,458,493 | | | | | | 88,958 | | | | | | 61,547,451 | | | | | | 12.7% | | | | | | | | |
Joseph Slattery(12)
|
| | | | — | | | | | | 574,735 | | | | | | 574,735 | | | | | | * | | | | | | | | |
John Brintnall(13)
|
| | | | 693,175 | | | | | | 2,820,906 | | | | | | 3,514,081 | | | | | | * | | | | | | | | |
Dean Bruhn-Ding(14)
|
| | | | 223,393 | | | | | | 2,032,262 | | | | | | 2,255,655 | | | | | | * | | | | | | | | |
All directors and executive officers as
a group (12 persons)(15) |
| | | | 148,631,936 | | | | | | 17,772,060 | | | | | | 166,403,996 | | | | | | 33.0% | | | | | | | | |
Name
|
| |
Number of shares
|
|
J.P. Morgan Securities LLC
|
| | | |
Piper Sandler & Co.
|
| | | |
William Blair & Company, L.L.C.
|
| | | |
Canaccord Genuity LLC
|
| | | |
Total
|
| | | |
| | |
Without
option to purchase additional shares exercise |
| |
With full
option to purchase additional shares exercise |
| ||||||
Per Share
|
| | | $ | | | | | $ | | | ||
Total
|
| | | $ | | | | | $ | | | |
| | |
Page(s)
|
| |||
| | | | F-2 | | | |
Consolidated Financial Statements | | | | | | | |
| | | | F-3 | | | |
| | | | F-4 | | | |
| | | | F-5 | | | |
| | | | F-6 | | | |
| | | | F-7 – F-22 | | |
| | |
December 31,
|
| |||||||||
(in thousands, except share and per share amounts)
|
| |
2020
|
| |
2019
|
| ||||||
Assets | | | | | | | | | | | | | |
Current assets: | | | | | | | | | | | | | |
Cash and cash equivalents
|
| | | $ | 59,112 | | | | | $ | 25,741 | | |
Accounts receivable, net
|
| | | | 1,281 | | | | | | 719 | | |
Inventory
|
| | | | 3,343 | | | | | | 2,072 | | |
Prepaid expenses and other current assets
|
| | | | 605 | | | | | | 375 | | |
Total current assets
|
| | | | 64,341 | | | | | | 28,907 | | |
Property and equipment, net
|
| | | | 410 | | | | | | 174 | | |
Other non-current assets
|
| | | | 26 | | | | | | 26 | | |
Total assets
|
| | | $ | 64,777 | | | | | $ | 29,107 | | |
Liabilities and Stockholders’ Equity (Deficit) | | | | | | | | | | | | | |
Current liabilities: | | | | | | | | | | | | | |
Accounts payable
|
| | | $ | 483 | | | | | $ | 437 | | |
Accrued expenses
|
| | | | 3,583 | | | | | | 4,637 | | |
Warrant liability
|
| | | | 3,911 | | | | | | 3,540 | | |
Total current liabilities
|
| | | | 7,977 | | | | | | 8,614 | | |
Long-term debt
|
| | | | 19,278 | | | | | | 18,992 | | |
Other long-term liabilities
|
| | | | 777 | | | | | | 561 | | |
Total liabilities
|
| | | | 28,032 | | | | | | 28,167 | | |
Commitments and contingencies | | | | | | | | | | | | | |
Convertible preferred stock, no par value, 237,370,645 and 188,120,645
authorized as of December 31, 2020 and 2019, respectively; 223,541,754 and 161,041,754 shares issued and outstanding as of December 31, 2020 and 2019, respectively |
| | | | 329,983 | | | | | | 279,983 | | |
Stockholders’ equity (deficit): | | | | | | | | | | | | | |
Common stock, $.01 par value, 625,217,795 and 438,044,756 authorized as of December 31, 2020 and 2019, respectively; 14,253,564 and 19,138,493 shares issued and outstanding as of December 31, 2020 and 2019, respectively
|
| | | | 143 | | | | | | 192 | | |
Additional paid-in capital, common stock
|
| | | | 58,485 | | | | | | 58,521 | | |
Accumulated deficit
|
| | | | (351,676) | | | | | | (337,567) | | |
Accumulated other comprehensive loss
|
| | | | (190) | | | | | | (189) | | |
Total stockholders’ equity (deficit)
|
| | | | (293,238) | | | | | | (279,043) | | |
Total liabilities, convertible preferred stock, and stockholders’ equity (deficit)
|
| | | $ | 64,777 | | | | | $ | 29,107 | | |
| | |
Year ended
December 31, |
| |||||||||
| | |
2020
|
| |
2019
|
| ||||||
Revenue
|
| | | $ | 6,053 | | | | | $ | 6,257 | | |
Cost of goods sold
|
| | | | 1,440 | | | | | | 1,683 | | |
Gross profit
|
| | | | 4,613 | | | | | | 4,574 | | |
Operating expenses: | | | | | | | | | | | | | |
Research and development
|
| | | | 6,410 | | | | | | 8,662 | | |
Selling, general and administrative
|
| | | | 9,717 | | | | | | 6,106 | | |
Total operating expenses
|
| | | | 16,127 | | | | | | 14,768 | | |
Loss from operations
|
| | | | (11,514) | | | | | | (10,194) | | |
Interest expense
|
| | | | (2,470) | | | | | | (1,720) | | |
Other income (expense), net
|
| | | | (40) | | | | | | (2,646) | | |
Loss before income taxes
|
| | | | (14,024) | | | | | | (14,560) | | |
Provision for income taxes
|
| | | | (85) | | | | | | (73) | | |
Net loss
|
| | | | (14,109) | | | | | | (14,633) | | |
Cumulative translation adjustment
|
| | | | (1) | | | | | | (6) | | |
Comprehensive loss
|
| | | $ | (14,110) | | | | | $ | (14,639) | | |
Net loss per share, basic and diluted
|
| | | $ | (0.94) | | | | | $ | (0.77) | | |
Weighted-average common shares used to compute net loss per share, basic and diluted
|
| | | | 15,308,364 | | | | | | 19,085,104 | | |
| | |
Convertible
preferred stock |
| |
Common stock
|
| |
Additional
paid-in capital |
| |
Accumulated
deficit |
| |
Accumulated
other comprehensive loss |
| |
Total
stockholders’ (deficit) equity |
| ||||||||||||||||||||||||||||||
| | |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| ||||||||||||||||||||||||||||||||||||
Balances as of December 31,
2018 |
| | | | 130,166,754 | | | | | $ | 255,283 | | | | | | 18,921,785 | | | | | $ | 190 | | | | | $ | 58,469 | | | | | $ | (323,130) | | | | | $ | (183) | | | | | $ | (264,654) | | |
Adoption of ASC 606
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 196 | | | | | | — | | | | | | 196 | | |
Issuance of Series G
convertible preferred stock, net of issuance costs |
| | | | 30,875,000 | | | | | | 24,687 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Accretion of Series G issuance
costs |
| | | | — | | | | | | 13 | | | | | | — | | | | | | — | | | | | | (13) | | | | | | — | | | | | | — | | | | | | (13) | | |
Exercise of stock options
|
| | | | — | | | | | | — | | | | | | 216,708 | | | | | | 2 | | | | | | (1) | | | | | | — | | | | | | — | | | | | | 1 | | |
Employee stock compensation
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 66 | | | | | | — | | | | | | — | | | | | | 66 | | |
Net loss for the year ended December 31, 2019
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (14,633) | | | | | | — | | | | | | (14,633) | | |
Cumulative translation adjustment
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (6) | | | | | | (6) | | |
Balances as of December 31,
2019 |
| | | | 161,041,754 | | | | | $ | 279,983 | | | | | | 19,138,493 | | | | | $ | 192 | | | | | $ | 58,521 | | | | | $ | (337,567) | | | | | $ | (189) | | | | | $ | (279,043) | | |
Exercise of stock options
|
| | | | — | | | | | | — | | | | | | 6,875 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Employee stock compensation
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 132 | | | | | | — | | | | | | — | | | | | | 132 | | |
Issuance of Series G preferred
stock, net of costs |
| | | | 62,500,000 | | | | | | 49,783 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Accretion of Series G issuance
costs |
| | | | — | | | | | | 217 | | | | | | — | | | | | | — | | | | | | (217) | | | | | | — | | | | | | — | | | | | | (217) | | |
Repurchase of common stock
|
| | | | — | | | | | | — | | | | | | (4,891,804) | | | | | | (49) | | | | | | 49 | | | | | | — | | | | | | — | | | | | | — | | |
Net loss for the year ended December 31, 2020
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (14,109) | | | | | | — | | | | | | (14,109) | | |
Cumulative translation adjustment
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (1) | | | | | | (1) | | |
Balances as of December 31,
2020 |
| | | | 223,541,754 | | | | | $ | 329,983 | | | | | | 14,253,564 | | | | | $ | 143 | | | | | $ | 58,485 | | | | | $ | (351,676) | | | | | $ | (190) | | | | | $ | (293,238) | | |
| | |
Year ended
December 31, |
| |||||||||
| | |
2020
|
| |
2019
|
| ||||||
Cash flows from operating activities: | | | | | | | | | | | | | |
Net loss
|
| | | $ | (14,109) | | | | | $ | (14,633) | | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | | | | | | | | |
Stock-based compensation
|
| | | | 132 | | | | | | 66 | | |
Depreciation of property and equipment
|
| | | | 75 | | | | | | 56 | | |
Amortization of deferred financing costs and loan discount
|
| | | | 286 | | | | | | 195 | | |
Loss on debt extinguishment
|
| | | | — | | | | | | 261 | | |
Changes in allowance for doubtful accounts
|
| | | | — | | | | | | (27) | | |
Changes in fair value of convertible preferred stock warrants
|
| | | | 371 | | | | | | 2,632 | | |
Changes in operating assets and liabilities:
|
| | | | | | | | | | | | |
Accounts receivable
|
| | | | (562) | | | | | | (183) | | |
Inventory
|
| | | | (1,271) | | | | | | (216) | | |
Prepaid expenses and other current assets
|
| | | | (226) | | | | | | (94) | | |
Accounts payable
|
| | | | 46 | | | | | | (1,051) | | |
Accrued expenses
|
| | | | (838) | | | | | | 209 | | |
Net cash used in operating activities
|
| | | | (16,096) | | | | | | (12,785) | | |
Cash flows from investing activities: | | | | | | | | | | | | | |
Purchase of property and equipment
|
| | | | (311) | | | | | | (106) | | |
Net cash used in investing activities
|
| | | | (311) | | | | | | (106) | | |
Cash flows from financing activities: | | | | | | | | | | | | | |
Proceeds from issuance of Series G Preferred Stock, net of fees
|
| | | | 49,783 | | | | | | 24,688 | | |
Proceeds from long-term borrowings
|
| | | | — | | | | | | 20,000 | | |
Debt financing fees
|
| | | | — | | | | | | (479) | | |
Repayment on debt financing
|
| | | | — | | | | | | (14,661) | | |
Proceeds from the exercise of common stock options
|
| | | | — | | | | | | 1 | | |
Net cash provided by financing activities
|
| | | | 49,783 | | | | | | 29,549 | | |
Effect of currency exchange on cash and cash equivalents
|
| | | | (5) | | | | | | (5) | | |
Net change in cash and cash equivalents
|
| | | | 33,371 | | | | | | 16,653 | | |
Cash and cash equivalents at beginning of year
|
| | | | 25,741 | | | | | | 9,088 | | |
Cash and cash equivalents at end of year
|
| | | $ | 59,112 | | | | | $ | 25,741 | | |
Supplemental Information: | | | | | | | | | | | | | |
Cash paid for interest
|
| | | $ | 2,033 | | | | | $ | 1,215 | | |
Cash paid for income taxes
|
| | | $ | 10 | | | | | $ | 15 | | |
| | | | | | | | | | | | | |
| | |
December 31,
|
| |||||||||
(in thousands)
|
| |
2020
|
| |
2019
|
| ||||||
Raw material
|
| | | $ | 1,361 | | | | | $ | 671 | | |
Work-in-process
|
| | | | 321 | | | | | | 373 | | |
Finished goods
|
| | | | 1,661 | | | | | | 1,028 | | |
| | | | $ | 3,343 | | | | | $ | 2,072 | | |
| | |
December 31,
|
| |||||||||
(in thousands)
|
| |
2020
|
| |
2019
|
| ||||||
Office furniture and equipment
|
| | | $ | 189 | | | | | $ | 189 | | |
Lab equipment
|
| | | | 1,272 | | | | | | 1,207 | | |
Computer equipment and software
|
| | | | 516 | | | | | | 374 | | |
Leasehold improvements
|
| | | | 44 | | | | | | 29 | | |
Capital equipment in process
|
| | | | 89 | | | | | | — | | |
| | | | | 2,110 | | | | | | 1,799 | | |
Less: Accumulated depreciation and amortization
|
| | | | 1,700 | | | | | | 1,625 | | |
| | | | $ | 410 | | | | | $ | 174 | | |
| | |
December 31,
|
| |||||||||
(in thousands)
|
| |
2020
|
| |
2019
|
| ||||||
Clinical trial and other professional fees
|
| | | $ | 1,690 | | | | | $ | 3,073 | | |
Bonuses
|
| | | | 794 | | | | | | 677 | | |
Paid time off
|
| | | | 552 | | | | | | 413 | | |
Other
|
| | | | 547 | | | | | | 474 | | |
| | | | $ | 3,583 | | | | | $ | 4,637 | | |
(in thousands)
|
| | | | | ||||||||||||||||||||
Balance as of December 31, 2020
|
| |
Level 1
|
| |
Level 2
|
| |
Level 3
|
| |
Total
|
| ||||||||||||
Liabilities: | | | | | | | | | | | | | | | | | | | | | | | | | |
Convertible preferred stock warrant liability
|
| | | $ | — | | | | | $ | — | | | | | $ | 3,911 | | | | | $ | 3,911 | | |
Total liabilities
|
| | | $ | — | | | | | $ | — | | | | | $ | 3,991 | | | | | $ | 3,911 | | |
Balance as of December 31, 2019
|
| |
Level 1
|
| |
Level 2
|
| |
Level 3
|
| |
Total
|
| ||||||||||||
Liabilities: | | | | | | | | | | | | | | | | | | | | | | | | | |
Convertible preferred stock warrant liability
|
| | | $ | — | | | | | $ | — | | | | | $ | 3,540 | | | | | $ | 3,540 | | |
Total liabilities
|
| | | $ | — | | | | | $ | — | | | | | $ | 3,540 | | | | | $ | 3,540 | | |
| | |
December 31,
|
| |||
| | |
2020
|
| |
2019
|
|
Expected life in years
|
| |
1.3 – 8.8
|
| |
0.5 – 9.8
|
|
Expected volatility
|
| |
51.4% – 75.6%
|
| |
42.2% – 46.5%
|
|
Expected dividend yield
|
| |
0%
|
| |
0%
|
|
Risk-free interest rate
|
| |
0.10% – 0.93%
|
| |
1.60% – 1.92%
|
|
| | |
December 31,
|
| |||||||||
(in thousands)
|
| |
2020
|
| |
2019
|
| ||||||
Beginning of the period
|
| | | $ | 3,540 | | | | | $ | 303 | | |
Issued
|
| | | | — | | | | | | 605 | | |
Change in fair value
|
| | | | 371 | | | | | | 2,632 | | |
End of the period
|
| | | $ | 3,911 | | | | | $ | 3,540 | | |
|
Grant date
|
| | | | 9/30/2019 | | |
|
Number of shares available for purchase
|
| | | | 750,000 | | |
|
Expected life in years
|
| | | | 10.0 | | |
|
Expected volatility
|
| | | | 42.6% | | |
|
Expected dividend yield
|
| | | | 0% | | |
|
Risk-free interest rate
|
| | | | 1.68% | | |
|
Grant date fair value
|
| | | $ | 604,951 | | |
|
2021
|
| | | $ | — | | |
|
2022
|
| | | | 5,333 | | |
|
2023
|
| | | | 8,000 | | |
|
2024
|
| | | | 6,667 | | |
| | | | | | 20,000 | | |
|
Less: Unamortized debt costs and discounts
|
| | | | (722) | | |
|
Long-term debt
|
| | | $ | 19,278 | | |
| | |
Authorized
|
| |
Issued and
Outstanding |
| |
Carrying Value
|
| |
Aggregate
Liquidation Preference |
| ||||||||||||
Series A-2
|
| | | | 2,454,686 | | | | | | 2,454,686 | | | | | $ | 4,909 | | | | | $ | 4,909 | | |
Series B-2
|
| | | | 2,963,069 | | | | | | 2,963,069 | | | | | | 7,526 | | | | | | 7,526 | | |
Series C-2
|
| | | | 4,308,394 | | | | | | 4,308,394 | | | | | | 13,141 | | | | | | 13,141 | | |
Series D-2
|
| | | | 8,631,967 | | | | | | 8,631,967 | | | | | | 53,518 | | | | | | 53,518 | | |
Series E-2
|
| | | | 12,114,211 | | | | | | 10,135,320 | | | | | | 76,826 | | | | | | 91,806 | | |
Series F-2
|
| | | | 29,773,318 | | | | | | 29,548,318 | | | | | | 41,663 | | | | | | 104,783 | | |
Series G
|
| | | | 177,125,000 | | | | | | 165,500,000 | | | | | | 132,400 | | | | | | 494,550 | | |
| | | | | 237,370,645 | | | | | | 223,541,754 | | | | | $ | 329,983 | | | | | $ | 770,233 | | |
| | |
Number
of Options |
| |
Weighted
Average Exercise Price |
| |
Aggregate
Intrinsic Value |
| |||||||||
| | | | | | | | | | | | | | |
(in thousands)
|
| |||
Balance as of December 31, 2019
|
| | | | 38,219,789 | | | | | $ | 0.04 | | | | | | | | |
Granted
|
| | | | 20,468,700 | | | | | | 0.11 | | | | | | | | |
Cancelled / Forfeited
|
| | | | (402,557) | | | | | | 0.11 | | | | | | | | |
Exercised
|
| | | | (6,875) | | | | | | 0.01 | | | | | | | | |
Balance as of December 31, 2020
|
| | | | 58,279,057 | | | | | $ | 0.07 | | | | | $ | 3,745 | | |
Options exercisable as of December 31, 2020
|
| | | | 22,855,772 | | | | | $ | 0.03 | | | | | $ | 2,442 | | |
| | |
December 31,
|
| |||
| | |
2020
|
| |
2019
|
|
Weighted average fair value of options granted
|
| |
$ 0.05
|
| |
$ 0.03
|
|
Expected term (in years) — non-officer employees
|
| |
2.7
|
| |
3.4
|
|
Expected term (in years) — officer employees
|
| |
3.0
|
| |
5.9
|
|
Expected volatility
|
| |
62.6%
|
| |
42.3% to 46.4%
|
|
Expected dividend yield
|
| |
0%
|
| |
0%
|
|
Risk-free interest rate
|
| |
0.16% to 0.18%
|
| |
1.61% to 2.50%
|
|
| | |
Year ended December 31,
|
| |||||||||
(in thousands)
|
| |
2020
|
| |
2019
|
| ||||||
Selling, general & administrative
|
| | | $ | 88 | | | | | $ | 42 | | |
Research & development
|
| | | | 43 | | | | | | 23 | | |
Cost of goods sold
|
| | | | 1 | | | | | | 1 | | |
| | | | $ | 132 | | | | | $ | 66 | | |
| | |
Year ended December 31,
|
| |||||||||
| | |
2020
|
| |
2019
|
| ||||||
Current: | | | | | | | | | | | | | |
Federal
|
| | | $ | — | | | | | $ | — | | |
State
|
| | | | — | | | | | | — | | |
Foreign
|
| | | | 85 | | | | | | 73 | | |
Total current
|
| | | | 85 | | | | | | 73 | | |
| | |
Year ended
December 31, |
| |||||||||
| | |
2020
|
| |
2019
|
| ||||||
Deferred: | | | | | | | | | | | | | |
Federal
|
| | | | — | | | | | | — | | |
State
|
| | | | — | | | | | | — | | |
Foreign
|
| | | | — | | | | | | — | | |
Total deferred
|
| | | | — | | | | | | — | | |
Total income tax expense
|
| | | $ | 85 | | | | | $ | 73 | | |
| | |
Year ended December 31,
|
| |||||||||
| | |
2020
|
| |
2019
|
| ||||||
U.S. statutory rate
|
| | | | 21.0% | | | | | | 21.0% | | |
Permanent differences
|
| | | | (0.5) | | | | | | (0.6) | | |
Research and development credit
|
| | | | 2.6 | | | | | | 4.2 | | |
Uncertain tax position
|
| | | | (0.5) | | | | | | (0.5) | | |
State taxes
|
| | | | 0.3 | | | | | | 0.2 | | |
Deferred rate change
|
| | | | (0.3) | | | | | | — | | |
Change in valuation allowance
|
| | | | (23.2) | | | | | | (24.8) | | |
Effective tax rate
|
| | | | (0.6)% | | | | | | (0.5)% | | |
| | |
December 31,
|
| |||||||||
| | |
2020
|
| |
2019
|
| ||||||
Deferred tax assets | | | | | | | | | | | | | |
Net operating loss carryforwards
|
| | | $ | 68,957 | | | | | $ | 65,970 | | |
Research and development credit carryforwards
|
| | | | 8,318 | | | | | | 7,960 | | |
IRC Section 59e election
|
| | | | 7,955 | | | | | | 7,909 | | |
Start-up costs
|
| | | | 1,198 | | | | | | 1,401 | | |
Non-qualified stock options
|
| | | | 136 | | | | | | 139 | | |
Property and equipment
|
| | | | 90 | | | | | | 102 | | |
Accrued vacation
|
| | | | 106 | | | | | | 71 | | |
Preferred stock warrants
|
| | | | 607 | | | | | | 530 | | |
Other
|
| | | | 67 | | | | | | 103 | | |
Total deferred tax assets
|
| | | | 87,434 | | | | | | 84,185 | | |
Valuation allowance
|
| | | | (87,434) | | | | | | (84,185) | | |
Net deferred tax assets
|
| | | $ | — | | | | | $ | — | | |
| | |
Year ended December 31,
|
| |||||||||
| | |
2020
|
| |
2019
|
| ||||||
Gross Unrecognized tax benefits at beginning of year
|
| | | $ | 1,757 | | | | | $ | 1,628 | | |
Gross increases: | | | | | | | | | | | | | |
Prior year tax positions
|
| | | | — | | | | | | 29 | | |
Current year tax positions
|
| | | | 83 | | | | | | 99 | | |
Gross decreases: | | | | | | | | | | | | | |
Prior year tax positions
|
| | | | — | | | | | | — | | |
| | | | $ | 1,840 | | | | | $ | 1,756 | | |
| | |
Year Ended December 31,
|
| |||||||||
| | |
2020
|
| |
2019
|
| ||||||
Numerator: | | | | | | | | | | | | | |
Net loss
|
| | | $ | (14,109) | | | | | $ | (14,633) | | |
Accretion of preferred stock to redemption value
|
| | | | (217) | | | | | | (13) | | |
Net loss attributable to common stockholders
|
| | | $ | (14,326) | | | | | $ | (14,646) | | |
Denominator: | | | | | | | | | | | | | |
Weighted average common shares outstanding — basic and diluted
|
| | | | 15,308,364 | | | | | | 19,085,104 | | |
Net loss per share attributable to common stockholders — basic and diluted
|
| | | $ | (0.94) | | | | | $ | (0.77) | | |
| | |
Year ended December 31,
|
| |||||||||
| | |
2020
|
| |
2019
|
| ||||||
Options to purchase common stock
|
| | | | 58,279,057 | | | | | | 38,219,789 | | |
Warrants to purchase redeemable convertible preferred stock (as converted to
common stock) |
| | | | 4,287,500 | | | | | | 4,287,500 | | |
Redeemable convertible preferred stock (as converted to common stock)
|
| | | | 471,791,754 | | | | | | 315,541,754 | | |
| | | | | 534,358,311 | | | | | | 358,049,043 | | |
|
December 31, 2021
|
| | | $ | 231 | | |
|
December 31, 2022
|
| | | | 227 | | |
|
December 31, 2023
|
| | | | 234 | | |
|
December 31, 2024
|
| | | | 138 | | |
| | | | | $ | 830 | | |
| | |
December 31,
|
| |||||||||
| | |
2020
|
| |
2019
|
| ||||||
Germany
|
| | | $ | 3,790 | | | | | $ | 4,186 | | |
U.S.
|
| | | | 1,733 | | | | | | 1,004 | | |
Other countries
|
| | | | 530 | | | | | | 1,067 | | |
| | | | $ | 6,053 | | | | | $ | 6,257 | | |
| J.P. Morgan | | |
Piper Sandler
|
| |
William Blair
|
|
Item
|
| |
Amount to
be paid |
| |||
SEC registration fee
|
| | | $ | * | | |
FINRA filing fee
|
| | | | * | | |
Exchange listing fee
|
| | | | * | | |
Printing and engraving expenses
|
| | | | * | | |
Legal fees and expenses
|
| | | | * | | |
Accounting fees and expenses
|
| | | | * | | |
Transfer agent fees and expenses
|
| | | | * | | |
Miscellaneous expenses
|
| | | | * | | |
Total
|
| | | $ | * | | |
Exhibit
Number |
| |
Exhibit Description
|
| |||
| | 1.1* | | | | Form of Underwriting Agreement. | |
| | 3.1* | | | | Twelfth Amended and Restated Certificate of Incorporation, as currently in effect. | |
| | 3.2* | | | | Form of Amended and Restated Certificate of Incorporation to be in effect upon the closing of this offering. | |
| | 3.3* | | | | Bylaws, as currently in effect. | |
| | 3.4* | | | | Form of Amended and Restated Bylaws to be in effect upon the closing of this offering. | |
| | 4.1 | | | | Reference is made to exhibits 3.1 through 3.4. | |
| | 4.2* | | | | Form of Common Stock Certificate. | |
| | 4.3* | | | | Warrant to Purchase Stock, dated as of September 12, 2014, issued by the Company to Life Science Loans, LLC. | |
| | 4.4* | | | |
Warrant to Purchase Stock, dated as of September 12, 2014, issued by the Company to Silicon Valley
Bank. |
|
| | 4.5* | | | | Warrant to Purchase Stock, dated as of July 21, 2015, issued by the Company to Life Science Loans, LLC. | |
| | 4.6* | | | |
Warrant to Purchase Stock, dated as of July 21, 2015, issued by the Company to Silicon Valley Bank.
|
|
| | 4.7* | | | |
Warrant to Purchase Stock, dated as of May 31, 2016, issued by the Company to Oxford Finance LLC.
|
|
| | 4.8* | | | |
Warrant to Purchase Stock, dated as of May 31, 2016, issued by the Company to Oxford Finance LLC.
|
|
| | 4.9* | | | |
Warrant to Purchase Stock, dated as of May 31, 2016, issued by the Company to Oxford Finance LLC.
|
|
| | 4.10* | | | |
Warrant to Purchase Stock, dated as of May 31, 2016, issued by the Company to Oxford Finance LLC.
|
|
Exhibit
Number |
| |
Exhibit Description
|
| |||
| | 4.11* | | | |
Warrant to Purchase Series E-2 Convertible Preferred Stock, dated as of September 28, 2018, issued
by the Company to Biosense Webster, Inc. |
|
| | 4.12* | | | | Warrant to Purchase Series G Convertible Preferred Stock, dated as of September 28, 2018, issued by the Company to Biosense Webster, Inc. | |
| | 4.13* | | | | Warrant to Purchase Shares of Series G Preferred Stock (Loan A), dated as of September 30, 2019, issued by the Company to Horizon Technology Finance Corporation, as assigned to Horizon Credit II LLC on February 6, 2020. | |
| | 4.14* | | | | Warrant to Purchase Shares of Series G Preferred Stock (Loan B), dated as of September 30, 2019, issued by the Company to Horizon Technology Finance Corporation, as assigned to Horizon Credit II LLC on February 6, 2020. | |
| | 4.15* | | | | Warrant to Purchase Shares of Series G Preferred Stock (Loan C), dated as of September 30, 2019, issued by the Company to Horizon Technology Finance Corporation, as assigned to Horizon Funding Trust 2019-1 on February 18, 2020. | |
| | 4.16* | | | | Warrant to Purchase Shares of Series G Preferred Stock (Loan D), dated as of September 30, 2019, issued by the Company to Horizon Technology Finance Corporation as assigned to Horizon Funding Trust 2019-1 on February 18, 2020. | |
| | 5.1* | | | | Opinion of Faegre Drinker Biddle & Reath LLP. | |
| | 10.1* | | | |
Lease, dated October 13, 2008, by and between the Company and Duke Realty Limited Partnership.
|
|
| | 10.2* | | | | First Lease Amendment, dated November 30, 2010, by and between the Company and Duke Realty Limited Partnership. | |
| | 10.3* | | | | Second Lease Amendment, dated October 22, 2012, by and between the Company and Duke Realty Limited Partnership. | |
| | 10.4* | | | | Lease Amending Agreement No. 3, dated May 20, 2016, by and between the Company and AX CROSSTOWN VI L.P. | |
| | 10.5* | | | | Lease Amending Agreement No. 4, dated May 18, 2020, by and between the Company and AX CROSSTOWN VI L.P. | |
| | 10.6* | | | | Eighth Amended and Restated Voting Agreement, dated July 1, 2020, by and among the Company and the holders listed therein. | |
| | 10.7* | | | | Eighth Amended and Restated Investors’ Rights Agreement, dated July 1, 2020, by and among the Company and the holders listed therein. | |
| | 10.8#* | | | | 2001 Stock Incentive Plan, as amended and restated. | |
| | 10.9#* | | | | Sales Bonus Plan (adopted and effective July 1, 2020). | |
| | 10.10#* | | | | Executive Bonus Plan. | |
| | 10.11#* | | | | Form of 2021 Equity Incentive Plan. | |
| | 10.12* | | | | Venture Loan and Security Agreement, dated as of September 30, 2019, by and among Horizon Technology Finance Corporation, as a lender and collateral agent, and the Company, as borrower. | |
| | 21.1* | | | | List of Subsidiaries. | |
| | 23.1* | | | | Consent of Grant Thornton LLP, independent registered public accounting firm. | |
| | 23.2* | | | | Consent of Faegre Drinker Biddle & Reath LLP (included in Exhibit 5.1). | |
| | 24.1* | | | | Powers of Attorney (included on signature page). | |
| CVRx, INC. | | |||
| By: | | |
|
|
| | | |
Name: Nadim Yared
Its: President and Chief Executive Officer |
|
|
Signature
|
| |
Title
|
| |
Date
|
|
|
Nadim Yared
|
| |
President and Chief Executive Officer
(Principal Executive Officer) |
| | | |
|
Jared Oasheim
|
| |
Chief Financial Officer
(Principal Financial and Accounting Officer) |
| | | |
|
Ali Behbahani, M.D.
|
| |
Director
|
| | | |
|
Mudit K. Jain, Ph.D.
|
| |
Director
|
| | | |
|
John M. Nehra
|
| |
Director
|
| | | |
|
Kirk Nielsen
|
| |
Director
|
| | | |
|
Geoff Pardo
|
| |
Director
|
| | | |
|
Joseph Slattery
|
| |
Director
|
| | | |