| ☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
| ☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
Delaware
|
52-2386345
|
|
|
(State or other jurisdiction of
incorporation or organization)
|
(I.R.S. Employer
Identification No.)
|
|
|
Eddeva B920 Babraham Research Campus
Cambridge, United Kingdom
|
CB22 3AT
|
|
|
(Address of principal executive offices)
|
(Zip Code)
|
|
|
Title of Each Class
|
Trading
Symbol
|
Name of each exchange
on which registered |
||
|
Common Stock, $0.0001 par value per share
|
FSTX
|
The Nasdaq Stock Market
(Nasdaq Capital Market)
|
| Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
|
Non-accelerated
filer
|
☒ | Smaller reporting company | ☒ | |||
| Emerging growth company | ☒ | |||||
| • |
our ongoing and planned preclinical studies and clinical trials;
|
| • |
preclinical study data and clinical trial data and the timing of results of our ongoing clinical studies and/or trials;
|
| • |
our plans to seek and enter into clinical trial collaborations and other broader collaborations;
|
| • |
the direct and indirect impact of the
COVID-19
pandemic on our business operations and financial condition, including manufacturing, research and development costs, clinical trials, regulatory processes and employee expenses; and
|
| • |
our estimates regarding prospects, strategies, expenses, operating capital requirements, results of operations and needs for additional financing.
|
| • |
We are very early in our development efforts and our product candidates may not be successful in later stage clinical trials. Results obtained in our preclinical studies and clinical trials to date are not necessarily indicative of results to be obtained in future clinical trials. As a result, our product candidates may never be approved as marketable therapeutics.
|
| • |
We will need additional funding to complete the development of our product candidates and before we can expect to become profitable from the sales of our products, if approved. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
|
| • |
We rely, and expect to continue to rely, on third parties to conduct our clinical trials and to manufacture our product candidates for preclinical and clinical testing. These third parties may not perform satisfactorily, which could delay our product development activities.
|
| • |
If we are unable to adequately protect our proprietary technology or obtain and maintain issued patents which are sufficient to protect our product candidates, others could compete against us more directly, which would have a material adverse impact on our business, results of operations, financial condition and prospects.
|
| • |
We may not be able to retain key executives or to attract, retain and motivate key personnel. If we are unable to retain such key personnel, it could have a material adverse impact on our business and prospects.
|
| • |
Business interruptions resulting from the coronavirus disease
(“COVID-19”)
outbreak or similar public health crises could cause a disruption of the development of our product candidates and adversely impact our business.
|
|
Item 1.
|
Financial Statements.
|
|
June 30,
|
December 31
|
|||||||
|
2021
|
2020
|
|||||||
|
Unaudited
|
||||||||
|
Assets
|
||||||||
|
Current Assets:
|
||||||||
|
Cash and cash equivalents
|
$ | 81,648 | $ | 18,526 | ||||
|
Other receivables
|
72 | — | ||||||
|
Prepaid expenses and other current assets
|
3,439 | 3,976 | ||||||
|
Tax incentive receivable
|
160 | 3,563 | ||||||
|
|
|
|
|
|||||
|
Total current assets
|
85,319 | 26,065 | ||||||
|
Property and equipment, net
|
1,157 | 789 | ||||||
|
Right of use asset
|
3,758 | 2,782 | ||||||
|
Goodwill
|
15,009 | 14,926 | ||||||
|
In-process
research and development
|
19,249 | 18,986 | ||||||
|
Other long-term assets
|
482 | 61 | ||||||
|
|
|
|
|
|||||
|
Total assets
|
$ | 124,974 | $ | 63,609 | ||||
|
|
|
|
|
|||||
|
Liabilities and Stockholders’ Equity
|
||||||||
|
Current Liabilities:
|
||||||||
|
Accounts payable
|
$ | 2,427 | $ | 4,597 | ||||
|
Accrued expenses and other current liabilities
|
6,300 | 9,461 | ||||||
|
Contingent value rights
|
314 | 2,080 | ||||||
|
Lease obligations, current
|
912 | 539 | ||||||
|
Deferred revenue
|
— | 300 | ||||||
|
|
|
|
|
|||||
|
Total current liabilities
|
9,953 | 16,977 | ||||||
|
Long term Liabilities:
|
||||||||
|
Term debt
|
9,466 | — | ||||||
|
Lease obligations
|
3,197 | 2,622 | ||||||
|
Contingent value rights
|
2,789 | 440 | ||||||
|
Deferred tax liability
|
576 | 576 | ||||||
|
|
|
|
|
|||||
|
Total liabilities
|
25,981 | 20,615 | ||||||
|
Commitments and contingencies
|
||||||||
|
Stockholders’ equity:
|
||||||||
|
Preferred stock, $0.0001 par value; authorized, 10,000,000 shares at June 30, 2021 and December 31, 2020; no shares issued or outstanding at June 30, 2021 and December 31, 2020
|
— | — | ||||||
|
Common Stock, $0.0001 par value; authorized 200,000,000 shares at June 30, 2021 and December 31, 2020; 20,586,562 and 9,100,117 shares issued and outstanding at June 30, 2021 and December 31, 2020
|
2 | 1 | ||||||
|
Additional paid-in capital
|
172,895 | 91,238 | ||||||
|
Accumulated other comprehensive loss
|
(1,218 | ) | (1,077 | ) | ||||
|
Accumulated deficit
|
(72,686 | ) | (47,168 | ) | ||||
|
|
|
|
|
|||||
|
Total stockholders’ equity
|
98,993 | 42,994 | ||||||
|
|
|
|
|
|||||
|
Total liabilities and stockholders’ equity
|
$ | 124,974 | $ | 63,609 | ||||
|
|
|
|
|
|||||
|
For the Three Months Ended
June 30, |
For the Six Months Ended
June 30, |
|||||||||||||||
|
2021
|
2020
|
2021
|
2020
|
|||||||||||||
|
License revenue
|
$ | — | $ | 543 | $ | 2,917 | $ | 1,898 | ||||||||
|
Operating expenses:
|
||||||||||||||||
|
Research and development
|
8,437 | 2,093 | 15,704 | 5,493 | ||||||||||||
|
General and administrative
|
6,501 | 3,236 | 12,930 | 6,425 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Total operating expenses
|
14,938 | 5,329 | 28,634 | 11,918 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Loss from operations
|
(14,938 | ) | (4,786 | ) | (25,717 | ) | (10,020 | ) | ||||||||
|
Other
non-operating
(expense) income:
|
||||||||||||||||
|
Other income (expense)
|
(46 | ) | (143 | ) | 972 | (1,670 | ) | |||||||||
|
Change in fair value of convertible debt
|
— | (1,498 | ) | — | (1,884 | ) | ||||||||||
|
Change in fair value of conti
n
gent value rights
|
(583 | ) | — | (583 | ) | — | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Loss before income taxes
|
(15,567 | ) | (6,427 | ) | (25,328 | ) | (13,574 | ) | ||||||||
|
Income tax expense
|
(82 | ) | (35 | ) | (190 | ) | (47 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Net loss
|
$ | (15,649 | ) | $ | (6,462 | ) | $ | (25,518 | ) | $ | (13,621 | ) | ||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Net loss attributable to common stockholders
|
$ | (15,649 | ) | $ | (6,462 | ) | $ | (25,518 | ) | $ | (13,621 | ) | ||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Basic and diluted adjusted net loss per common shares
|
$ | (0.92 | ) | $ | (3.53 | ) | $ | (1.95 | ) | $ | (7.44 | ) | ||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Weighted-average number of shares outstanding, basic and diluted
|
17,022,417 | 1,830,075 | 13,083,230 | 1,829,993 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Other comprehensive loss:
|
||||||||||||||||
|
Net loss
|
$ | (15,649 | ) | $ | (6,462 | ) | $ | (25,518 | ) | $ | (13,621 | ) | ||||
|
Other comprehensive (loss) gain
|
||||||||||||||||
|
Foreign currency translation
|
324 | 387 | (141 | ) | 410 | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Total comprehensive loss
|
$ | (15,325 | ) | $ | (6,075 | ) | $ | (25,659 | ) | $ | (13,211 | ) | ||||
|
|
|
|
|
|
|
|
|
|||||||||
|
For the Six Months Ended June 30,
|
||||||||
|
2021
|
2020
|
|||||||
|
Cash flows from operating activities:
|
||||||||
|
Net loss
|
$ | (25,518 | ) | $ | (13,621 | ) | ||
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
|
Share based compensation expense
|
4,039 | 1,005 | ||||||
|
Foreign currency
(gain)
loss
|
(570 | ) | 1,478 | |||||
|
Loss
(
gain
)
on disposal of tangible fixed assets
|
(9 | ) | 6 | |||||
|
Depreciation
|
297 | 334 | ||||||
|
Non-cash
interest
|
82 | 532 | ||||||
|
Amortization of debt issuance costs
|
15 | — | ||||||
|
Fair value adjustments
|
583 | 1,884 | ||||||
|
Operating right of use asset
|
494 | 337 | ||||||
|
Changes in operating assets and liabilities:
|
||||||||
|
Other receivables
|
(72 | ) | — | |||||
|
Prepaid expenses and other current assets
|
593 | 905 | ||||||
|
Tax incentive receivable
|
3,493 | 5,909 | ||||||
|
Accounts payable
|
(2,231 | ) | 1,210 | |||||
|
Accrued expenses and other current liabilities
|
(3,278 | ) | (2,126 | ) | ||||
|
Deferred revenue
|
(308 | ) | (5 | ) | ||||
|
Operating lease liability
|
(520 | ) | (330 | ) | ||||
|
Other long term asset
|
(423 | ) | — | |||||
|
|
|
|
|
|||||
|
Net cash used in operating activities
|
(23,333 | ) | (2,482 | ) | ||||
|
|
|
|
|
|||||
|
Cash flows from investing activities:
|
||||||||
|
Purchase of property, plant and equipment
|
(658 | ) | (62 | ) | ||||
|
Proceeds from sale of property, plant and equipment
|
15 | — | ||||||
|
|
|
|
|
|||||
|
Net cash used in investing activities
|
(643 | ) | (62 | ) | ||||
|
|
|
|
|
|||||
|
Cash flows from financing activities:
|
||||||||
|
Proceeds from issuance of convertible notes
|
— | 500 | ||||||
|
Net proceeds from issuance of common stock
|
77,293 | — | ||||||
|
Net proceeds from term debt
|
9,845 | — | ||||||
|
Payment of debt issuance costs
|
(92 | ) | — | |||||
|
|
|
|
|
|||||
|
Net cash provided by financing activities
|
87,046 | 500 | ||||||
|
|
|
|
|
|||||
|
Net increase (decrease) in cash and cash equivalents
|
63,070 | (2,044 | ) | |||||
|
Effect of exchange rate changes on cash
|
52 | (201 | ) | |||||
|
Cash and cash equivalents at beginning of period
|
18,526 | 4,901 | ||||||
|
|
|
|
|
|||||
|
Cash and cash equivalents at end of period
|
$ | 81,648 | $ | 2,656 | ||||
|
|
|
|
|
|||||
|
Supplemental disclosure of cash flow information
|
||||||||
|
Cash paid for income taxes
|
$ | 36 | $ | 14 | ||||
|
Purchases of property and equipment included in accounts payable and accrued expenses
|
$ | 182 | $ | — | ||||
|
Cash paid for interest
|
$
|
115 |
$
|
— | ||||
|
Non-cash
investing and financing activities:
|
||||||||
|
Additions to ROU assets obtained from new operating lease liabilities
|
$ | 1,468 | $ | — | ||||
|
Issuance of warrants
|
$
|
326 |
$
|
— | ||||
|
Stockholders’ Equity
|
||||||||||||||||||||||||||||||||
|
For the Three Months Ended June 30, 2021
|
Common Shares
|
Capital in Excess
of par Value |
Accumulated Other
Comprehensive Loss |
Total Stockholders’
Equity |
||||||||||||||||||||||||||||
|
Number of
Shares |
Value
|
Accumulated
deficit |
||||||||||||||||||||||||||||||
|
Balance at March 31, 2021
|
9,100,320
|
$
|
1
|
|
$
|
93,418
|
$
|
(1,542
|
)
|
$
|
(57,037
|
)
|
$
|
34,840
|
||||||||||||||||||
|
Issuance of warrants in connection with term loan
|
— |
—
|
326 | — | — | 326 | ||||||||||||||||||||||||||
|
Issuance of common stock in connection with
at-the-market
|
979,843 |
—
|
9,115 |
—
|
—
|
9,115 | ||||||||||||||||||||||||||
|
Issuance of common stock in connection with public offering, net of issuance costs
|
10,439,347 |
|
1
|
|
68,177 | — | — | 68,178 | ||||||||||||||||||||||||
|
Equity adjustment from foreign currency translation
|
—
|
—
|
—
|
324 |
—
|
324 | ||||||||||||||||||||||||||
|
Stock option exercises
|
67,052 | — | — | — | — | — | ||||||||||||||||||||||||||
|
Share-based compensation
|
—
|
—
|
1,859 |
—
|
—
|
1,859 | ||||||||||||||||||||||||||
|
Net loss
|
— | — | — | — | (15,649 | ) | (15,649 | ) | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Balance at June 30, 2021
|
|
20,586,562
|
|
$
|
2
|
|
$
|
172,895
|
|
$
|
(1,218
|
)
|
$
|
(72,686
|
)
|
$
|
98,993
|
|
||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Stockholders’ Equity
|
||||||||||||||||||||||||||||||||
|
For the Three Months Ended June 30, 2020
|
Seed
preferred |
Series A
preferred |
Common Shares
|
Capital in Excess
of par Value |
Accumulated Other
Comprehensive Loss |
Total Stockholders’
Equity |
||||||||||||||||||||||||||
|
Number of
shares |
Number of
shares |
Number of
Shares |
Value
|
Accumulated
deficit |
||||||||||||||||||||||||||||
|
Balance at March 31, 2020
|
103,611
|
1,441,418
|
4,145,611
|
$
|
1
|
$
|
32,252
|
$
|
(1,611
|
)
|
$
|
(28,708
|
)
|
$
|
1,934
|
|||||||||||||||||
|
Issuance of common stock for services rendered
|
—
|
—
|
4,252 |
—
|
—
|
—
|
—
|
|||||||||||||||||||||||||
|
Issuance of common stock in connection with
at-the-market
|
—
|
—
|
162,274 |
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||
|
Equity adjustment from foreign currency translation
|
—
|
—
|
—
|
—
|
—
|
387 |
—
|
387 | ||||||||||||||||||||||||
|
Share-based compensation
|
—
|
—
|
—
|
—
|
471 |
—
|
—
|
471 | ||||||||||||||||||||||||
|
Net loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(6,462 | ) | (6,462 | ) | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
|
Balance at June 30, 2020
|
103,611
|
1,441,418
|
4,312,137
|
$
|
1
|
$
|
32,723
|
$
|
(1,224
|
)
|
$
|
(35,170
|
)
|
$
|
(3,670
|
)
|
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
|
Stockholders’ Equity
|
||||||||||||||||||||||||||||||||
|
For the Six Months Ended June 30, 2021
|
Common Shares
|
Capital in Excess
of par Value
|
Accumulated Other
Comprehensive Loss
|
Total Stockholders’
Equity
|
||||||||||||||||||||||||||||
|
Number of
Shares |
Value
|
Accumulated
deficit |
||||||||||||||||||||||||||||||
|
Balance at December 31, 2020
|
|
9,100,117
|
|
$
|
1
|
|
$
|
91,238
|
|
$
|
(1,077
|
)
|
$
|
(47,168
|
)
|
$
|
42,994
|
|
||||||||||||||
|
Issuance of warrants in connection with term loan
|
—
|
—
|
326 | — | — | 326 | ||||||||||||||||||||||||||
|
Issuance of common stock in connection with
at-the-market
offering, net of issuance costs
|
979,843 |
—
|
9,115 | — | — | 9,115 | ||||||||||||||||||||||||||
|
Issuance of common stock in connection with public offering, net of issuance costs
|
10,439,347 |
|
1
|
|
68,177 | — | — | 68,178 | ||||||||||||||||||||||||
|
Equity adjustment from foreign currency translation
|
— |
—
|
— | (141 | ) | — | (141 | ) | ||||||||||||||||||||||||
|
Stock option exercises
|
67,255 |
—
|
— | — | — | — | ||||||||||||||||||||||||||
|
Share-based compensation
|
— |
—
|
4,039 | — | — | 4,039 | ||||||||||||||||||||||||||
|
Net loss
|
— |
—
|
— | — | (25,518 | ) | (25,518 | ) | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Balance at June 30, 2021
|
|
20,586,562
|
|
$
|
2
|
|
$
|
172,895
|
|
$
|
(1,218
|
)
|
$
|
(72,686
|
)
|
$
|
98,993
|
|
||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Stockholders’ Equity
|
||||||||||||||||||||||||||||||||
|
For the Six Months Ended June 30, 2020
|
Seed
preferred |
Series A
preferred |
Common Shares
|
Capital in Excess
of par Value
|
Accumulated Other
Comprehensive Loss
|
Total Stockholders’
Equity
|
||||||||||||||||||||||||||
|
Number of
shares |
Number of
shares |
Number of
Shares |
Value
|
Accumulated
deficit |
||||||||||||||||||||||||||||
|
Balance at December 31, 2019
|
|
103,611
|
|
|
1,441,418
|
|
|
4,128,441
|
|
$
|
1
|
|
$
|
31,718
|
|
$
|
(1,634
|
)
|
$
|
(21,549
|
)
|
$
|
8,536
|
|
||||||||
|
Issuance of common stock for services rendered
|
— | — | 10,972 | — | — | — | — |
|
—
|
|
||||||||||||||||||||||
|
Issuance of common stock in connection with
at-the-market
offering, net of issuance costs
|
— | — | 172,724 | — | — | — | — | — | ||||||||||||||||||||||||
|
Equity adjustment from foreign currency translation
|
— | — | — | — | — | 410 | — | 410 | ||||||||||||||||||||||||
|
Share-based compensation
|
— | — | — | — | 1,005 | — | — | 1,005 | ||||||||||||||||||||||||
|
Net loss
|
— | — | — | — | — | — | (13,621 | ) | (13,621 | ) | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
|
Balance at June 30, 2020
|
|
103,611
|
|
|
1,441,418
|
|
|
4,312,137
|
|
$
|
1
|
|
$
|
32,723
|
|
$
|
(1,224
|
)
|
$
|
(35,170
|
)
|
$
|
(3,670
|
)
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
|
Estimated Useful Economic Life
|
||
| Leasehold property improvements, right of use assets | Lesser of lease term or useful life | |
| Laboratory equipment | 5 years | |
| Furniture and office equipment | 3 years |
|
(i)
|
the scope of the contract increases because of the addition of promised goods or services that are distinct; and
|
|
(ii)
|
the price of the contract increases by an amount of consideration that reflects standalone selling prices of the additional promised goods or services and any appropriate adjustments to that price to reflect the circumstances of the particular contract.
|
| • |
Level 1 — Quoted prices in active markets for identical assets or liabilities.
|
| • |
Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
|
| • |
Level 3 — Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
|
|
Purchase Price Allocation
|
||||
|
Number of
full
common shares
|
4,449,559 | |||
|
Multiplied by fair value per share of common stock
|
$ | 4.84 | ||
|
|
|
|||
|
Purchase price
|
$ | 21,536 | ||
|
|
|
|||
|
Cash and cash equivalents
|
$ | 9,779 | ||
|
Marketable securities
|
5,000 | |||
|
Prepaid expenses and other assets
|
935 | |||
|
Operating lease right of use asset
|
2,784 | |||
|
Intangible assets
|
4,720 | |||
|
Goodwill
|
10,451 | |||
|
Accounts payable, accrued expenses and other liabilities
|
(5,453 | ) | ||
|
Contingent value rights
|
(2,520 | ) | ||
|
Liability and equity based warrants
|
(422 | ) | ||
|
Deferred tax liability
|
(576 | ) | ||
|
Operating lease liability
|
(3,162 | ) | ||
|
|
|
|||
|
Fair value of net assets acquired
|
$ | 21,536 | ||
|
|
|
|||
|
Net Loss Per Share
|
||||||||||||||||
|
For the Three Months Ended
June 30, |
For the Six Months Ended
June 30, |
|||||||||||||||
|
2021
|
2020
|
2021
|
2020
|
|||||||||||||
|
Net loss
|
$ | (15,649 | ) | $ | (6,462 | ) | $ | (25,518 | ) | $ | (13,621 | ) | ||||
|
Weighted average number shares outstanding, basic and diluted
|
17,022,417 | 1,830,075 | 13,083,230 | 1,829,993 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Net loss income per common, basic and diluted
|
$ | (0.92 | ) | $ | (3.53 | ) | $ | (1.95 | ) | $ | (7.44 | ) | ||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Potential Dilutive Shares
|
||||||||
|
For the Three and Six Months
Ended June 30, |
||||||||
|
2021
|
2020
|
|||||||
|
Convertible debt shares
|
— | 182,758 | ||||||
|
Common stock warrants
|
128,479 | — | ||||||
|
Stock options and RSUs
|
1,313,522 | 257,259 | ||||||
|
June 30,
|
December 31
|
|||||||
|
2021
|
2020
|
|||||||
|
Clinical Trial Costs
|
$ | 2,304 | $ | 3,394 | ||||
|
Severance
|
887 | 1,953 | ||||||
|
Compensation and
B
enefits
|
1,277 | 1,361 | ||||||
|
Professional
F
ees
|
1,518 | 1,593 | ||||||
|
Other
|
314 | 1,160 | ||||||
|
|
|
|
|
|||||
|
|
$ | 6,300 | $ | 9,461 | ||||
|
|
|
|
|
|||||
|
Term Debt
|
||||||||
|
June 30,
|
December 31,
|
|||||||
|
2021
|
2020
|
|||||||
|
Term Loan A and B due April 2025
|
$ | 5,000 | $ | — | ||||
|
Term Loan C and D due June 2025
|
5,000 | — | ||||||
|
|
|
|
|
|||||
|
Term debt
|
10,000 | — | ||||||
|
Less: Unamortized deferred issuance costs
|
(231 | ) | — | |||||
|
Less: Warrant discount and interest
|
(303 | ) | — | |||||
|
|
|
|
|
|||||
|
Total debt obligations- long term
|
$ | 9,466 | $ | — | ||||
|
|
|
|
|
|||||
|
Warrants
Outstanding |
||||
|
Outstanding at December 31, 2020
|
144,384 | |||
|
Exercises
|
(51,054 | ) | ||
|
Issued
|
42,236 | |||
|
Expired
|
(7,087 | ) | ||
|
|
|
|||
|
Outstanding at June 30, 2021
|
128,479 | |||
|
|
|
|||
|
|
|
Black-Scholes Option-Pricing
|
||
|
|
|
June 30,
2021 |
|
December 31
2020 |
|
Risk-free interest rate
|
0.78% | 0.17% – 0.42% | ||
|
Expected volatility
|
90.4% |
82.8%-98.3%
|
||
|
Expected dividend yield
|
0% | 0% | ||
|
Expected life (in years)
|
5.1 | 5.1 | ||
|
Stock Option Activity
|
|
|||||||||||||||
|
|
|
Number of
Shares |
|
|
Weighted Average
Exercise Price |
|
|
Weighted Average
Contractual Term |
|
|
Aggregate Intrinsic
Value |
|
||||
|
|
|
|
|
|
|
|
|
(in years)
|
|
|
(in thousands)
|
|
||||
|
Outstanding as of December 31, 2020
|
533,559 | $ | 3.33 | 9.30 | $ | 8,494 | ||||||||||
|
Granted
|
617,886 | 7.77 | 9.66 | 994 | ||||||||||||
|
Exercised
|
(3,670 | ) | 0.12 | 8.16 | 101 | |||||||||||
|
Forfeited
and expired
|
(19,212 | ) | 2.27 | 9.15 | 257 | |||||||||||
|
|
|
|||||||||||||||
|
Outstanding as of June 30, 2021
|
1,128,563 | 5.79 | 9.11 | 6,323 | ||||||||||||
|
|
|
|||||||||||||||
|
Options exercisable at June 30, 2021
|
150,671 | 8.35 | 7.37 | 1,739 | ||||||||||||
|
|
|
|||||||||||||||
|
RSU Activity
|
|
|||||||
|
|
|
Restricted
Stock Units |
|
|
Weighted-
Average Grant Date Fair Value |
|
||
|
Total nonvested units at December 31, 2020
|
69,749 | $ | 11.73 | |||||
|
Granted
|
310,385 | 8.57 | ||||||
|
Vested
|
(63,545 | ) | 8.57 | |||||
|
|
|
|
|
|||||
|
Total nonvested units at June 30, 2021
|
316,589 | $ | 9.31 | |||||
|
|
|
|
|
|||||
|
Share-Based Compensation
|
|
|||||||||||||||
|
|
|
For the Three Months Ended June 30,
|
|
|
For the Six Months ended June 30,
|
|
||||||||||
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
||||
|
Research and development expenses
|
$ | 531 | $ | 169 | $ | 944 | $ | 380 | ||||||||
|
General and administrative expenses
|
1,328 | 302 | 3,095 | 625 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| $ | 1,859 | $ | 471 | $ | 4,039 | $ | 1,005 | |||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
|
|
Deferred revenue
balance at January 1, 2021 |
|
|
Additions
|
|
|
Revenue
recognized |
|
|
Impact of exchange
rates |
|
|
Deferred revenue
balance at June 30, 2021 |
|
|||||
|
Deferred revenue
|
||||||||||||||||||||
|
Ares collaboration
|
$ | 37 | $ | — | $ | (37 | ) | $ | — | $ | — | |||||||||
|
Denali collaboration
|
263 | — | (117 | ) | (146 | ) | — | |||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
|
Total deferred revenue
|
$
|
300
|
|
$
|
—
|
|
$
|
(154
|
)
|
$
|
(146
|
)
|
$
|
—
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
|
Maturities of Operating Lease Liabilities
|
|
|||
|
Periods
|
|
|||
|
For the period July 1, 2021 to December 31, 2021
|
$ | 417 | ||
|
2022
|
843 | |||
|
2023
|
854 | |||
|
2024
|
474 | |||
|
2025
|
486 | |||
|
Thereafter
|
1,444 | |||
|
|
|
|||
|
Total lease payments
|
$ | 4,518 | ||
|
|
|
|||
|
Future Expected Cash Receipts From Sublease
|
||||
|
Period
|
||||
|
For the period July 1, 2021 to December 31, 2021
|
$ | 56 | ||
|
2022
|
462 | |||
|
2023
|
474 | |||
|
2024
|
486 | |||
|
2025
|
498 | |||
|
Thereafter
|
1,481 | |||
|
|
|
|||
|
Total sublease receipts
|
$ | 3,457 | ||
|
|
|
|||
|
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
|
| • |
expenses incurred under agreements with contract research organizations (“CROs”) as well as investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development services;
|
| • |
manufacturing
scale-up
expenses and the cost of acquiring and manufacturing preclinical and clinical trial materials;
|
| • |
expenses incurred for outsourced professional scientific development services;
|
| • |
costs for laboratory materials and supplies used to support our research activities;
|
| • |
allocated facilities costs, depreciation, and other expenses, which include rent and utilities;
|
| • |
up-front,
milestone and management fees for maintaining licenses under our third-party licensing agreements; and
|
| • |
compensation expense.
|
| • |
research and development support of our product candidates, including conducting future clinical trials of FS118, FS120, FS222 and SB 11285;
|
| • |
progressing the clinical development of FS118, FS120, FS222 and SB 11285;
|
| • |
establishing an appropriate safety profile with investigational new drug-enabling studies to advance our programs into clinical development;
|
| • |
identifying new product candidates to add to our development pipeline;
|
| • |
successful enrollment in, and the initiation and completion of clinical trials;
|
| • |
the timing, receipt and terms of any marketing approvals from applicable regulatory authorities;
|
| • |
commercializing the product candidates, if and when approved, whether alone or in collaboration with others;
|
| • |
establishing commercial manufacturing capabilities or making arrangements with third party manufacturers;
|
| • |
the development and timely delivery of commercial-grade drug formulations that can be used in our clinical trials;
|
| • |
addressing any competing technological and market developments, as well as any changes in governmental regulations;
|
| • |
negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter and performing our obligations under such arrangements;
|
| • |
maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and
know-how,
as well as obtaining and maintaining regulatory exclusivity for our product candidates;
|
| • |
continued acceptable safety profile of the drugs following approval; and
|
| • |
attracting, hiring, and retaining appropriately qualified personnel.
|
| • |
CROs in connection with performing research services on our behalf and clinical trials;
|
| • |
investigative sites or other providers in connection with clinical trials;
|
| • |
vendors in connection with preclinical and clinical development activities; and
|
| • |
vendors related to product manufacturing, development and distribution of preclinical and clinical supplies.
|
|
Three Months Ended June 30,
|
||||||||||||
|
2021
|
2020
|
Change
|
||||||||||
|
(in thousands)
|
||||||||||||
|
Statements of Comprehensive Income
|
||||||||||||
|
License revenue
|
$ | — | $ | 543 | $ | (543 | ) | |||||
|
Operating expenses:
|
||||||||||||
|
Research and development
|
8,437 | 2,093 | 6,344 | |||||||||
|
General and administrative
|
6,501 | 3,236 | 3,265 | |||||||||
|
|
|
|
|
|
|
|||||||
|
Total operating expenses
|
$ | 14,938 | $ | 5,329 | $ | 9,609 | ||||||
|
|
|
|
|
|
|
|||||||
|
Loss from operations
|
|
(14,938
|
)
|
|
(4,786
|
)
|
|
(10,152
|
)
|
|||
|
Other non-operating income (expense):
|
||||||||||||
|
Other income (expense)
|
(46 | ) | (143 | ) | 97 | |||||||
|
Change in fair value of convertible notes
|
— | (1,498 | ) | 1,498 | ||||||||
|
Change in fair value of liability
|
(583 | ) | — | (583 | ) | |||||||
|
|
|
|
|
|
|
|||||||
|
Loss before income taxes
|
(15,567 | ) | (6,427 | ) | (9,140 | ) | ||||||
|
(Loss) benefit for income taxes
|
(82 | ) | (35 | ) | (47 | ) | ||||||
|
|
|
|
|
|
|
|||||||
|
Net loss
|
$ | (15,649 | ) | $ | (6,462 | ) | $ | (9,187 | ) | |||
|
|
|
|
|
|
|
|||||||
|
Six Months Ended June 30,
|
||||||||||||
|
2021
|
2020
|
Change
|
||||||||||
|
(in thousands)
|
||||||||||||
|
Statements of Comprehensive Income
|
||||||||||||
|
License revenue
|
$ | 2,917 | $ | 1,898 | $ | 1,019 | ||||||
|
Operating expenses:
|
||||||||||||
|
Research and development
|
15,704 | 5,493 | 10,211 | |||||||||
|
General and administrative
|
12,930 | 6,425 | 6,505 | |||||||||
|
|
|
|
|
|
|
|||||||
|
Total operating expenses
|
$ | 28,634 | $ | 11,918 | $ | 16,716 | ||||||
|
|
|
|
|
|
|
|||||||
|
Loss from operations
|
(25,717 | ) | (10,020 | ) | (15,697 | ) | ||||||
|
Other non-operating income (expense):
|
||||||||||||
|
Other income (expense)
|
972 | (1,670 | ) | 2,642 | ||||||||
|
Change in fair value of convertible notes
|
— | (1,884 | ) | 1,884 | ||||||||
|
Change in fair value of liability
|
(583 | ) | — | (583 | ) | |||||||
|
|
|
|
|
|
|
|||||||
|
Loss before income taxes
|
(25,328 | ) | (13,574 | ) | (11,754 | ) | ||||||
|
(Loss) benefit for income taxes
|
(190 | ) | (47 | ) | (143 | ) | ||||||
|
|
|
|
|
|
|
|||||||
|
Net loss
|
$ | (25,518 | ) | $ | (13,621 | ) | $ | (11,897 | ) | |||
|
|
|
|
|
|
|
|||||||
|
Summarized cash flow information
|
||||||||||||
|
Six Months Ended June 30,
|
||||||||||||
|
2021
|
2020
|
Change
|
||||||||||
|
(in thousands)
|
||||||||||||
|
Net cash used in operating activities
|
$ | (23,333 | ) | (2,482 | ) | $ | (20,851 | ) | ||||
|
Net cash used in investing activities
|
(643 | ) | (62 | ) | (581 | ) | ||||||
|
Net cash provided by financing activities
|
87,046 | 500 | 86,546 | |||||||||
|
Effect of exchange rate changes on cash
|
52 | (201 | ) | 253 | ||||||||
|
|
|
|
|
|
|
|||||||
|
Net increase in cash
|
$
|
63,122
|
|
$
|
(2,245
|
)
|
$
|
65,367
|
|
|||
|
|
|
|
|
|
|
|||||||
| • |
our ability to raise capital in light of the impacts of the ongoing global
COVID-19
pandemic on the global financial markets;
|
| • |
the scope, progress, results, and costs of drug discovery, preclinical development, laboratory testing, drug manufacturing and clinical trials for the product candidates we have developed or may develop;
|
| • |
our ability to enroll clinical trials in a timely manner and to quickly resolve any delays or clinical holds that may be imposed on our development programs, particularly in light of the global
COVID-19
pandemic;
|
| • |
the costs associated with our manufacturing process development and evaluation of third-party manufacturers and suppliers;
|
| • |
the costs, timing and outcome of regulatory review of our product candidates;
|
| • |
the costs of preparing and submitting marketing approvals for any of our product candidates that successfully complete clinical trials, and the costs of maintaining marketing authorization and related regulatory compliance for any products for which we obtain marketing approval;
|
| • |
the costs of preparing, filing, and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights, and defending intellectual property-related claims;
|
| • |
the costs of future activities, including product sales, medical affairs, marketing, manufacturing, and distribution, for any product candidates for which we receive marketing approval;
|
| • |
the terms of our current and any future license agreements and collaborations; and the extent to which we acquire or
in-license
other product candidates, technologies and intellectual property;
|
| • |
the success of our collaborations with Ares and Denali and other partners;
|
| • |
our ability to establish and maintain additional collaborations on favorable terms, if at all; and
|
| • |
the costs of operating as a public company.
|
|
Item 3.
|
Quantitative and Qualitative Disclosures About Market Risk.
|
|
Item 4.
|
Controls and Procedures.
|
|
Item 1.
|
Legal Proceedings.
|
|
Item 1A.
|
Risk Factors.
|
|
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds.
|
|
Item 3.
|
Defaults Upon Senior Securities
|
|
Item 4.
|
Mine Safety Disclosures.
|
|
Item 5.
|
Other Information.
|
|
Item 6.
|
Exhibits.
|
|
*
|
Filed herewith.
|
| ± |
Certain confidential portions of this Exhibit were omitted by means of marking such portions with brackets (“[***]”) because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.
|
|
F-star
Therapeutics, Inc.
|
||||||
| Date: August 13, 2021 | By: |
/s/ Eliot R. Forster
|
||||
|
Eliot R. Forster, Ph.D.
|
||||||
|
President and Chief Executive Officer
|
||||||
Exhibit 10.1
[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.]
Confidential
| From: |
Denali Therapeutics Inc. |
161 Oyster Point Blvd.
South San Francisco
CA 94080
U.S.A.
BBB Holding Ltd
Hill House
1 Little New Street
London, United Kingdom
EC4A 3TR
| To: |
F-star Biotechnology Limited |
Eddeva B920
Babraham Research Campus
Cambridge, United Kingdom
CB22 3AT
Attn: Chief Executive Officer
F-star Biotechnologische Forschungs- und Entwicklungsges.m.b.h.
C/O - F-star Biotechnology Limited
Eddeva B920
Babraham Research Campus
Cambridge, United Kingdom
CB22 3AT
Attn: Chief Executive Officer
F-star Therapeutics Limited
Eddeva B920
Babraham Research Campus
Cambridge, United Kingdom
CB22 3AT
Attn: Chief Executive Officer
CC: alliances@f-star.com
June 30th, 2021
RE: Side Letter to License and Collaboration Agreement, the Amended and Restated Gamma License Agreement, the Support Services Agreement and the Share Purchase Agreement
Dear Sirs:
We refer to (a) the License and Collaboration Agreement between BBB Holding Ltd (f/k/a F-star Gamma Limited, “DBH”), F-star Biotechnologische Forschungs- und Entwicklungsges.m.b.h. (“F-star GmbH”), F-star Biotechnology Limited (“F-star Ltd”, together with F-star GmbH, “F-star”) and Denali Therapeutics Inc. (“Denali”), dated August 24, 2016 as amended by the letter agreement dated February 23, 2018 (“Patent Side Letter”), the letter agreement dated May 21, 2018 (“Buy-Out Side Letter”) and the amendment dated June 1, 2018 (together the “LCA”), (b) the Amended and Restated Gamma IP License Agreement between F-star Ltd and DBH dated August 24, 2016, as amended by the Patent Side Letter and Buy-Out Side Letter (the “GIPL”), (c) the Gamma Support Services Agreement between F-star Ltd. and DBH dated August 24, 2016 (“SSA”) as amended by Amendment No. 1 dated April 11, 2019 and (d) the Share Purchase Agreement between the Sellers, Shareholder Representative Services LLC (“SRS”) and Denali dated May 30, 2018 (“SPA”).
Capitalized terms in this letter have the meaning given to them in the LCA, GIPL, SSA and SPA unless otherwise stated.
By signing this letter, we, Denali and DBH, and by counter-signing, you, F-star and F-star Therapeutics, acknowledge and agree to the terms of this letter, which shall control notwithstanding any provision to the contrary in the LCA, GIPL, SSA or (as between Denali and F-star only) the SPA. For the avoidance of doubt, nothing in this letter shall vary or purport to vary the SPA and no right or obligation of a party arising under the LCA, GIPL or SSA shall be limited or restricted save to the extent expressly set out in this letter.
| 1. |
Acknowledgments and Confirmations. By signing this letter, we, Denali and DBH and by counter-signing, you, F-star and F-star Therapeutics, acknowledge and agree that: |
| a. |
all of the assets and business of F-star, including intellectual property rights, were assigned to F-star Therapeutics Limited, a company incorporated in England with registered number 11532458 and registered office at Eddeva B920, Babraham Research Campus, Cambridge, United Kingdom (“F-star Therapeutics”) on May 31, 2021 (“Novation Date”); |
| b. |
the rights and obligations of F-star arising under the LCA, GIPL, SSA, this letter and (as between Denali and F-star only) the SPA are to be deemed novated to F-star Therapeutics with effect from the Novation Date; |
| c. |
all rights and obligations of F-star arising under the LCA, GIPL, SSA, this letter and (as between Denali and F-star only) the SPA have been assumed by F-star Therapeutics with effect from the Novation Date; |
| d. |
this letter and any further notice served by a party to any F-star entity or F-star Therapeutics pursuant to any of the LCA, GIPL, SSA and (as between Denali and F-star only) the SPA does not need to be served on or copied to Cooley LLP; and |
| e. |
any further notice served on any F-star entity or F-star Therapeutics under the LCA, GIPL, SSA, this letter and (as between Denali and F-star only) the SPA shall be required to be sent to F-star Therapeutics only and marked for the attention of the Chief Executive Officer (and copied by email to alliances@f-star.com). |
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| 2. |
Denali Fcab Notice. The parties agree and acknowledge that this letter agreement serves as the Denali Fcab Notice with respect to [***]. |
| 3. |
Disbandment of JSC. In recognition of the winding down of collaboration activities related to the Fcab Discovery Plans for TfR and [***] under the LCA and SSA, the parties mutually agree to disband the JSC and Working Groups thereunder and, in accordance with Section 2.4 of the LCA, neither the JSC nor any Working Group shall have any further responsibility or authority under the LCA or the SSA. |
After the date hereof, contact between Denali and DBH on the one hand and F-star Therapeutics on the other hand shall be overseen by the Alliance Managers, and, notwithstanding Section 2.5 of the LCA, the Alliance Managers shall meet [***].
| 4. |
Status Reports. The parties mutually agree that Denali’s and DBH’s obligations under Sections 4.1, 4.7.2, 4.9 and 5.3 of the LCA and Sections 4.2 and 4.4.1 of the GIPL shall be limited to a written report in the form attached hereto as Appendix A which will be provided to F-star Therapeutics (with a copy being sent by email to alliances@f-star.com) [***]. For avoidance of doubt, the foregoing shall not limit Denali’s reporting obligations under Paragraph 2.8 of Schedule 5 to the SPA. |
Nothing in this paragraph shall restrict or limit a party’s obligation under Section 11.4 of the LCA, Section 9.3 of the GIPL and Section 7.3 of the SSA (to the extent applicable to such party) to provide to the other applicable party(ies) for its review and comment a proposed public disclosure by such party relating to the LCA, GIPL or SSA, as the case may be, where in the opinion of that disclosing entity’s counsel it is required by applicable law or the rules of a stock exchange on which its securities are listed to issue such public disclosure.
| 5. |
Transfer of Libraries.Denali agrees to deliver to F-star Therapeutics a copy of the two libraries known internally at Denali as [***], which library copies shall be provided to F-star Therapeutics in DNA form (and not in the form of a glycerol stock) within sixty (60) days after the date hereof. Following the date hereof, Denali and DBH’s obligations under Section 4.1 of the LCA and Section 4.3 of the GIPL shall be limited to providing F-star Therapeutics with [***]. |
| 6. |
Denali Materials. F-star and F-star Therapeutics agree to destroy or return to Denali (at Denali’s election provided always that such election shall be made by Denali within ninety (90) days of the date of this letter) all biological, chemical and other laboratory materials provided by Denali or DBH to F-star or F-star Therapeutics in connection with the LCA, SSA, or GIPL, including any Denali Fcabs, antigens and antibodies, and all subunits and derivatives thereof developed or generated by or on behalf of F-star or F-star Therapeutics, other than any Denali Libraries and Transferred Libraries provided by Denali to F-star or F-star Therapeutics. |
3
| 7. |
[***]. |
| 8. |
Denali Fcab-Specific IP. The parties hereby agree and acknowledge the following: |
| a. |
“Denali Fcab-Specific IP” means, subject to paragraph 8.b, (i) any Know-How to the extent pertaining to an Fcab that binds to TfR or CD98hc and (ii) any Patent that only includes claims that [***] (any such Patent, a “Denali Fcab-Specific Patent”). |
| b. |
For clarity, Denali Fcab-Specific Patents shall not include a Patent that includes a claim that covers the composition of matter, use, or method of identification, improvement, manufacture or other use of [***]. |
| c. |
As between the parties, Denali and/or DBH shall retain ownership of Denali Fcab-Specific IP and, for avoidance of doubt, neither Denali nor DBH or any of their Affiliates or (sub)licensees shall be obligated to assign any Denali Fcab-Specific IP to F-star or F-star Therapeutics. |
| d. |
Denali and/or DBH shall have the sole right to prosecute and maintain the Denali Fcab-Specific Patents, and shall keep F-star Therapeutics informed of the prosecution and maintenance thereof where Denali includes a claim in any such Patent that covers the composition of matter, use, or method of identification, improvement, manufacture or other use of [***], provided that Denali shall provide F-star Therapeutics with a patent status report regarding the Denali Fcab-Specific Patents every six months, such status report including a brief description of the claimed subject matter in each patent family, and Denali shall provide F-star Therapeutics with a copy of any claims in any Denali Fcab-Specific Patents prior [***]. For avoidance of doubt, the foregoing shall not limit Denali or DBH’s obligations under the LCA or GIPL with respect to the assignment, prosecution and maintenance of any Patent that is not a Denali Fcab-Specific Patent. |
| e. |
Nothing in this paragraph 8 shall oblige F-star or F-star Therapeutics to assign rights to Know-How or Patents to Denali or DBH that were developed, generated or invented by F-star or F-star Therapeutics on or prior to the date hereof. For clarity, the preceding sentence shall not limit any rights granted to Denali under the LCA or GIPL. |
Please acknowledge your acceptance of the terms of this letter by countersigning this letter below.
4
Sincerely,
|
/s/ Ryan Watts |
| Ryan Watts, CEO |
For and on behalf of Denali Therapeutics Inc. and BBB Holding Ltd
Agreed and Acknowledged by:
|
/s/ Eliot Forster |
|
Chief Executive Officer |
For and on behalf of F-star Biotechnology Limited, F-star Biotechnologische Forschungs -und Entwicklungsges.m.b.h. and F-star Therapeutics Limited
5
[***]
6
Exhibit 31.1
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Eliot R. Forster, certify that:
| 1. |
I have reviewed this Quarterly Report on Form 10-Q of F-star Therapeutics, Inc.; |
| 2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. |
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| (a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| (b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| (c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| (d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. |
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| (b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: August 13, 2021 | By: | /s/ Eliot R. Forster | ||||
| Eliot R. Forster, Ph.D. | ||||||
| President and Chief Executive Officer |
Exhibit 31.2
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Darlene Deptula-Hicks, certify that:
| 6. |
I have reviewed this Quarterly Report on Form 10-Q of F-star Therapeutics, Inc.; |
| 7. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 8. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 9. |
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| (a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| (b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| (c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| (d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 10. |
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| (b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: August 13, 2021 | By: | /s/ Darlene Deptula-Hicks | ||||
| Darlene Deptula-Hicks | ||||||
| Chief Financial Officer, Treasurer & Secretary |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of F-star Therapeutics, Inc. (the “Company”) on Form 10-Q for the period ending June 30, 2021, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
| (1) |
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
| (2) |
The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company. |
| Date: August 13, 2021 | By: | /s/ Eliot R. Forster | ||||
| Eliot R. Forster, Ph.D. | ||||||
| President and Chief Executive Officer |
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of F-star Therapeutics, Inc. (the “Company”) on Form 10-Q for the period ending June 30, 2021, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
| (1) |
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
| (2) |
The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company. |
| Date: August 13, 2021 | By: | /s/ Darlene Deptula-Hicks | ||||
| Darlene Deptula-Hicks | ||||||
| Chief Financial Officer, Treasurer & Secretary |