| • |
employee-related expenses, including salaries, benefits, and stock-based compensation expense, for personnel engaged in research and development functions;
|
| • |
expenses incurred in connection with Disc’s research and development activities, including under agreements with third parties such as consultants, contractors and CROs;
|
| • |
costs related to contract development and manufacturing organizations, or CDMOs, that are primarily engaged to provide drug substance and product for Disc’s preclinical studies, clinical trials and research and
development programs, as well as investigative sites and consultants that conduct Disc’s clinical trials, preclinical studies and other scientific development services;
|
| • |
the costs of acquiring and manufacturing preclinical study and clinical trial materials, including manufacturing registration and validation batches;
|
| • |
costs related to compliance with quality and regulatory requirements; and
|
| • |
payments made under third-party licensing agreements.
|
| • |
the timing and progress of preclinical and clinical development activities;
|
| • |
the number and scope of preclinical and clinical programs Disc decides to pursue;
|
| • |
the ability to raise additional funds necessary to complete clinical development of and commercialize Disc’s product candidates;
|
| • |
Disc’s ability to establish new licensing or collaboration arrangements and the progress of the development efforts of third parties with whom Disc may enter into such arrangements;
|
| • |
Disc’s ability to maintain its current research and development programs and to establish new programs;
|
| • |
the successful initiation, enrollment and completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority;
|
| • |
the receipt and related terms of regulatory approvals from applicable regulatory authorities for any product candidates;
|
| • |
the availability of raw materials for use in production of Disc’s product candidates;
|
| • |
establishing agreements with third-party manufacturers for supply of product candidate components for Disc’s clinical trials;
|
| • |
Disc’s ability to obtain and maintain patents, trade secret protection and regulatory exclusivity, both in the United States and internationally;
|
| • |
Disc’s ability to protect its other rights in its intellectual property portfolio;
|
| • |
commercializing product candidates, if and when approved, whether alone or in collaboration with others; and
|
| • |
obtaining and maintaining third-party insurance coverage and adequate reimbursement for any approved products.
|
|
|
YEAR ENDED DECEMBER 31,
|
|||||||||||
|
|
2020
|
2021
|
CHANGE
|
|||||||||
|
Operating expenses:
|
||||||||||||
|
Research and development
|
$
|
18,020
|
$
|
25,170
|
$
|
7,150
|
||||||
|
General and administrative
|
2,956
|
5,763
|
2,807
|
|||||||||
|
Total operating expenses
|
20,976
|
30,933
|
9,957
|
|||||||||
|
Loss from operations
|
(20,976
|
)
|
(30,933
|
)
|
(9,957
|
)
|
||||||
|
Other income (expense), net:
|
||||||||||||
|
Interest income
|
40
|
14
|
(26
|
)
|
||||||||
|
Change in fair value of derivative liability
|
—
|
(5,050
|
)
|
(5,050
|
)
|
|||||||
|
Total other income (expense), net
|
40
|
(5,036
|
)
|
(5,076
|
)
|
|||||||
|
Net loss
|
$
|
(20,936
|
)
|
$
|
(35,969
|
)
|
$
|
(15,033
|
)
|
|||
|
|
YEAR ENDED DECEMBER 31,
|
|||||||||||
|
|
2020
|
2021
|
CHANGE
|
|||||||||
|
Bitopertin
|
$
|
—
|
$
|
8,354
|
$
|
8,354
|
||||||
|
DISC-0974
|
8,538
|
7,019
|
(1,519
|
)
|
||||||||
|
Other research programs and expenses
|
6,345
|
5,088
|
(1,257
|
)
|
||||||||
|
Personnel-related (including equity-based compensation)
|
3,137
|
4,709
|
1,572
|
|||||||||
|
Total research and development expenses
|
$
|
18,020
|
$
|
25,170
|
$
|
7,150
|
||||||
|
|
YEAR ENDED DECEMBER 31,
|
|||||||||||
|
|
2020
|
2021
|
CHANGE
|
|||||||||
|
Legal, consulting and professional fees
|
$
|
1,581
|
$
|
2,661
|
$
|
1,080
|
||||||
|
Personnel-related (including equity-based compensation)
|
1,187
|
2,692
|
1,505
|
|||||||||
|
Other expenses
|
188
|
410
|
222
|
|||||||||
|
Total general and administrative expenses
|
$
|
2,956
|
$
|
5,763
|
$
|
2,807
|
||||||
|
|
NINE MONTHS ENDED
SEPTEMBER 30,
|
|||||||||||
|
|
2021
|
2022
|
CHANGE
|
|||||||||
|
Operating expenses:
|
||||||||||||
|
Research and development
|
$
|
19,511
|
$
|
23,421
|
$
|
3,910
|
||||||
|
General and administrative
|
4,012
|
9,033
|
5,021
|
|||||||||
|
Total operating expenses
|
23,523
|
32,454
|
8,931
|
|||||||||
|
Loss from operations
|
(23,523
|
)
|
(32,454
|
)
|
(8,931
|
)
|
||||||
|
Other income (expense), net:
|
||||||||||||
|
Interest income
|
5
|
321
|
316
|
|||||||||
|
Change in fair value of derivative liability
|
(3,600
|
)
|
(3,450
|
)
|
150
|
|||||||
|
Total other income (expense), net
|
(3,595
|
)
|
(3,129
|
)
|
466
|
|||||||
|
Net loss
|
$
|
(27,118
|
)
|
$
|
(35,583
|
)
|
$
|
(8,465
|
)
|
|||
|
|
NINE MONTHS ENDED
SEPTEMBER 30,
|
|||||||||||
|
|
2021
|
2022
|
CHANGE
|
|||||||||
|
Bitopertin
|
$
|
6,748
|
$
|
6,224
|
$
|
(524
|
)
|
|||||
|
DISC-0974
|
5,447
|
6,875
|
1,428
|
|||||||||
|
Other research programs and expenses
|
3,620
|
3,804
|
184
|
|||||||||
|
Personnel-related (including equity-based compensation)
|
3,696
|
6,518
|
2,822
|
|||||||||
|
Total research and development expenses
|
$
|
19,511
|
$
|
23,421
|
$
|
3,910
|
||||||
|
|
NINE MONTHS ENDED
SEPTEMBER 30,
|
|||||||||||
|
|
2021
|
2022
|
CHANGE
|
|||||||||
|
Legal, consulting and professional fees
|
$
|
2,034
|
$
|
4,631
|
$
|
2,597
|
||||||
|
Personnel-related (including equity-based compensation)
|
1,759
|
3,622
|
1,863
|
|||||||||
|
Other expenses
|
219
|
780
|
561
|
|||||||||
|
Total general and administrative expenses
|
$
|
4,012
|
$
|
9,033
|
$
|
5,021
|
||||||
|
|
YEAR ENDED
DECEMBER 31,
|
NINE MONTHS ENDED
SEPTEMBER 30,
|
||||||||||||||
|
|
2020
|
2021
|
2021
|
2022
|
||||||||||||
|
Net cash provided by (used in):
|
||||||||||||||||
|
Operating activities
|
$
|
(19,966
|
)
|
$
|
(27,534
|
)
|
$
|
(21,130
|
)
|
$
|
(32,587
|
)
|
||||
|
Investing activities
|
(77
|
)
|
(68
|
)
|
(5
|
)
|
(139
|
)
|
||||||||
|
Financing activities
|
34,980
|
89,929
|
89,933
|
163
|
||||||||||||
|
Net increase (decrease) in cash and cash equivalents and restricted cash
|
$
|
14,937
|
$
|
62,327
|
$
|
68,798
|
$
|
(32,563
|
)
|
|||||||
| • |
the initiation, progress, timing, costs and results of preclinical studies and clinical trials for Disc’s product candidates or any future product candidates Disc may develop;
|
| • |
the costs, timing and outcome of regulatory review of Disc’s product candidates;
|
| • |
changes in laws or regulations applicable to any product candidates Disc may develop, including but not limited to clinical trial requirements for approvals;
|
| • |
the cost and timing of obtaining materials to produce adequate product supply for any preclinical or clinical development of any product candidate Disc may develop;
|
| • |
the effect of competing technological and market developments;
|
| • |
Disc’s ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such arrangements;
|
| • |
the payment or receipt of milestones, royalties and other collaboration-based revenues, if any;
|
| • |
the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any product candidate Disc may develop for which Disc obtains marketing
approval;
|
| • |
the amount and timing of revenue, if any, received from commercial sales of Disc’s product candidates for which Disc receives marketing approval; and
|
| • |
the legal costs involved in prosecuting patent applications and enforcing patent claims and other intellectual property claims.
|
|
|
Payments Due by Period
|
|||||||||||||||||||
|
|
Total
|
Less Than
1 Year
|
1 to 3
Years
|
3 to 5
Years
|
More Than
5 Years
|
|||||||||||||||
|
Operating lease commitments(1)
|
$
|
1,577
|
$
|
371
|
$
|
770
|
$
|
436
|
$
|
—
|
||||||||||
|
Total
|
$
|
1,577
|
$
|
371
|
$
|
770
|
$
|
436
|
$
|
—
|
||||||||||
| (1) |
Amounts reflect payments due for Disc’s leased office space in Watertown, Massachusetts as of September 30, 2022. The lease term began in November 2021 and will end in November 2026.
|
| • |
vendors in connection with preclinical development activities;
|
| • |
CROs and investigative sites in connection with preclinical studies and clinical trials; and
|
| • |
CDMOs in connection with the production of preclinical study and clinical trial materials.
|
|
Grant Date
|
Number of
Shares Subject
to Option
|
Per Share
Exercise Price
of Options
|
Per Share Fair
Value of
Common
Stock on
Grant Date
|
Per Share
Estimated Fair
Value of
Options
on Grant
Date(1)
|
||||||||||||
|
March 11, 2020
|
2,868,382
|
$
|
0.11
|
$
|
0.11
|
$
|
0.06
|
|||||||||
|
August 11, 2020
|
989,097
|
$
|
0.29
|
$
|
0.29
|
$
|
0.16
|
|||||||||
|
September 15, 2020
|
123,637
|
$
|
0.29
|
$
|
0.29
|
$
|
0.16
|
|||||||||
|
October 23, 2020
|
1,692,775
|
$
|
0.29
|
$
|
0.29
|
$
|
0.16
|
|||||||||
|
November 27, 2020
|
256,468
|
$
|
0.29
|
$
|
0.29
|
$
|
0.16
|
|||||||||
|
February 12, 2021
|
705,287
|
$
|
0.29
|
$
|
0.29
|
$
|
0.16
|
|||||||||
|
March 18, 2021
|
89,000
|
$
|
0.29
|
$
|
0.29
|
$
|
0.16
|
|||||||||
|
April 26, 2021
|
192,350
|
$
|
0.29
|
$
|
0.29
|
$
|
0.16
|
|||||||||
|
September 10, 2021
|
1,003,926
|
$
|
1.08
|
$
|
1.08
|
$
|
0.62
|
|||||||||
|
September 14, 2021
|
4,112,590
|
$
|
1.08
|
$
|
1.08
|
$
|
0.62
|
|||||||||
|
December 1, 2021
|
665,000
|
$
|
1.58
|
$
|
1.58
|
$
|
0.89
|
|||||||||
|
February 7, 2022
|
1,356,149
|
$
|
1.61
|
$
|
1.61
|
$
|
0.86
|
|||||||||
|
April 6, 2022
|
335,000
|
$
|
1.61
|
$
|
1.61
|
$
|
0.87
|
|||||||||
|
July 11, 2022
|
518,200
|
$
|
1.00
|
$
|
1.00
|
$
|
0.54
|
|||||||||
|
November 4, 2022
|
640,000
|
$
|
2.19
|
$
|
2.19
|
$
|
1.24
|
|||||||||
| (1) |
The per share estimated fair value of options reflects the fair value of options as estimated at the date of grant using the Black-Scholes option-pricing model.
|