|
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
|
|
|
|
(State or other jurisdiction of incorporation or organization)
|
(I.R.S. Employer Identification Number)
|
|
|
|
|
(Address of principal executive offices)
|
(Zip Code)
|
Title of Each Class
|
Trading Symbol(s)
|
Name of Each Exchange on
Which Registered
|
||
|
|
|
Large accelerated filer
|
☐ |
Accelerated filer
|
☐ |
|
☒ |
Smaller reporting company
|
|
Emerging growth company
|
Page
|
||
PART I—FINANCIAL INFORMATION
|
||
Item 1.
|
1
|
|
1
|
||
2
|
||
3
|
||
4
|
||
5
|
||
Item 2.
|
17
|
|
Item 3.
|
28
|
|
Item 4.
|
29
|
|
PART II—OTHER INFORMATION
|
||
Item 1.
|
30
|
|
Item 1A.
|
30
|
|
Item 2.
|
112 | |
Item 3.
|
112 | |
Item 4.
|
113 | |
Item 5.
|
113 | |
Item 6.
|
113 | |
• |
the ability of our ongoing and planned future preclinical studies and clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results;
|
• |
the timing, progress and results of ongoing and planned future preclinical studies and clinical trials for our current product candidates and other product candidates we may
develop, including statements regarding the timing of initiation and completion of preclinical studies or clinical trials and related preparatory work, the period during which the results of the preclinical studies or clinical trials will
become available, and our research and development programs;
|
• |
the timing, scope and likelihood of regulatory filings and approvals, including timing of investigational new drug applications (INDs) and final U.S. Food and Drug Administration
(FDA) approval of our current product candidates and any other future product candidates;
|
• |
the timing, scope or likelihood of foreign regulatory filings and approvals;
|
• |
our ability to develop and advance our current product candidates and programs into, and successfully complete, clinical trials;
|
• |
our manufacturing, commercialization, and marketing capabilities and strategy;
|
• |
our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and sales strategy;
|
• |
the need to hire additional personnel and our ability to attract and retain such personnel;
|
• |
the size of the market opportunity for our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting;
|
• |
our expectations regarding the approval and use of our product candidates in combination with other drugs;
|
• |
our competitive position and the success of competing therapies that are or may become available;
|
• |
our estimates of the number of patients that we will enroll in our clinical trials;
|
• |
the beneficial characteristics, and the potential safety, efficacy and therapeutic effects of our product candidates;
|
• |
our ability to obtain and maintain regulatory approval of our product candidates;
|
• |
our plans relating to the further development of our product candidates, including additional indications we may pursue;
|
• |
existing regulations and regulatory developments in the United States, Europe and other jurisdictions;
|
• |
our expectations regarding the impact of the COVID‑19 pandemic on our business;
|
• |
our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering our current product candidates and other future product candidates we may develop,
including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual
property rights;
|
• |
our continued reliance on third parties to conduct ongoing and planned future preclinical studies and clinical trials of our product candidates, and for the
manufacture of our product candidates for preclinical studies and clinical trials;
|
• |
our ability to obtain, and negotiate favorable terms of, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;
|
• |
the pricing and reimbursement of our current product candidates and other product candidates we may develop, if approved;
|
• |
the rate and degree of market acceptance and clinical utility of our current product candidates and other product candidates we may develop;
|
• |
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
|
• |
our financial performance;
|
• |
the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements;
|
• |
the impact of laws and regulations;
|
• |
our expectations regarding the period during which we will remain an emerging growth company (EGC) under the Jumpstart Our Business Startups Act of 2012 (JOBS Act); and
|
• |
our anticipated use of our existing resources.
|
March 31, 2022
|
December 31, 2021
|
|||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Cash at consolidated joint venture
|
||||||||
Short-term investments
|
|
|
||||||
Prepaid expenses and other current assets
|
|
|
||||||
Total current assets
|
|
|
||||||
Property and equipment, net
|
|
|
||||||
Right-of-use lease assets
|
||||||||
Long-term investments
|
|
|
||||||
Restricted cash |
||||||||
Deferred offering costs
|
||||||||
Other non-current assets |
||||||||
Total assets
|
$
|
|
$
|
|
||||
Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders’ Equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
|
$
|
|
||||
Accrued expenses
|
|
|
||||||
Current portion of operating lease liabilities | ||||||||
Total current liabilities
|
|
|||||||
Operating lease liabilities, long-term | ||||||||
Total liabilities
|
||||||||
Commitments and contingencies (See Note 12)
|
||||||||
Redeemable convertible noncontrolling interests | ||||||||
Stockholders’ equity:
|
||||||||
Preferred stock, $
|
|
|
||||||
Common stock, $
|
|
|
||||||
Additional paid-in capital
|
|
|
||||||
Accumulated other comprehensive loss
|
(
|
)
|
(
|
)
|
||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||
Total stockholders’ equity
|
|
|
||||||
Total liabilities, redeemable convertible noncontrolling interests and stockholders’ equity
|
$
|
|
$
|
|
Three Months Ended March 31,
|
||||||||
2022
|
2021
|
|||||||
Operating expenses:
|
||||||||
Research and development
|
$
|
|
$
|
|
||||
General and administrative
|
|
|
||||||
Total operating expenses
|
|
|
||||||
Loss from operations
|
(
|
)
|
(
|
)
|
||||
Other income, net
|
||||||||
Net loss | ( |
) | ( |
) | ||||
Net loss attributable to redeemable convertible noncontrolling interests
|
||||||||
Net loss attributable to Kinnate
|
$
|
(
|
)
|
$ | ( |
) | ||
Weighted-average shares outstanding, basic and diluted
|
||||||||
Net loss per share, basic and diluted
|
$ | ( |
) | $ | ( |
) | ||
Comprehensive loss: | ||||||||
Net loss | $ | ( |
) | $ | ( |
) | ||
Other comprehensive loss:
|
||||||||
Unrealized loss on investments
|
( |
) | ( |
) | ||||
Total comprehensive loss | ( |
) | ( |
) | ||||
Comprehensive loss attributable to redeemable convertible noncontrolling interests
|
|
|
||||||
Comprehensive loss attributable to Kinnate
|
$
|
(
|
)
|
$
|
(
|
)
|
Common Stock
|
Additional
Paid-in |
Accumulated Other Comprehensive
|
Accumulated
|
Total
Stockholders’ |
Redeemable Convertible Noncontrolling
|
|||||||||||||||||||||||
|
Shares
|
Amount
|
Capital
|
Loss
|
Deficit
|
Equity
|
Interests
|
|||||||||||||||||||||
|
||||||||||||||||||||||||||||
Balance at December 31, 2021
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
|
|||||||||||||
Stock-based compensation expense
|
-
|
|
|
|
|
|
|
|||||||||||||||||||||
Exercise of stock options
|
|
|
|
|
|
|
|
|||||||||||||||||||||
Net loss
|
-
|
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||||||||
Other comprehensive loss
|
-
|
|
|
(
|
)
|
|
(
|
)
|
|
|||||||||||||||||||
Balance at March 31, 2022
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
|
|||||||||||||
|
||||||||||||||||||||||||||||
Balance at December 31, 2020
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
|
|||||||||||||
Stock-based compensation expense
|
-
|
|
|
|
|
|
|
|||||||||||||||||||||
Net loss
|
-
|
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||||||||
Other comprehensive loss
|
-
|
|
|
(
|
)
|
|
(
|
)
|
|
|||||||||||||||||||
Balance at March 31, 2021
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
|
|
Three Months Ended March 31,
|
|||||||
|
2022
|
2021
|
||||||
Cash flows from operating activities:
|
||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Stock-based compensation expense
|
|
|
||||||
Depreciation
|
|
|
||||||
Amortization/accretion of investments
|
|
|
||||||
Loss on disposal of property and equipment
|
|
|
||||||
Changes in operating assets and liabilities:
|
||||||||
Prepaid expenses and other assets
|
(
|
)
|
|
|||||
Operating lease right-of-use assets and liabilities, net
|
|
|
||||||
Accounts payable and accrued expenses
|
|
|
||||||
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
Cash flows from investing activities:
|
||||||||
Purchases of short-term and long-term investments
|
(
|
)
|
(
|
)
|
||||
Sales and maturities of short-term and long-term investments
|
|
|
||||||
Purchases of property and equipment
|
(
|
)
|
(
|
)
|
||||
Net cash used in investing activities
|
(
|
)
|
(
|
)
|
||||
Cash flows from financing activities:
|
||||||||
Proceeds from stock option exercises
|
|
|
||||||
Net cash provided by financing activities
|
|
|
||||||
Net decrease in cash, cash equivalents and restricted cash
|
(
|
)
|
(
|
)
|
||||
Cash, cash equivalents and restricted cash at the beginning of the period
|
|
|
||||||
Cash, cash equivalents and restricted cash at the end of the period
|
$
|
|
$
|
|
||||
|
||||||||
Supplemental non-cash investing and financing activity:
|
||||||||
Purchases of property and equipment in accounts payable and accrued expenses
|
$
|
|
$
|
|
||||
Capitalized value of tenant improvement allowance
|
$
|
|
$
|
|
||||
Operating lease liabilities arising from obtaining right-of-use assets
|
$
|
|
$
|
|
Three Months Ended March 31,
|
||||||||
2022
|
2021
|
|||||||
Numerator
|
||||||||
Net loss attributable to Kinnate
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Denominator
|
||||||||
Weighted-average shares outstanding used in computing net loss per share, basic and diluted
|
|
|
||||||
Net loss per share, basic and diluted
|
$
|
(
|
)
|
$
|
(
|
)
|
Three Months Ended March 31,
|
||||||||
2022
|
2021
|
|||||||
Options to purchase common stock
|
|
|
March 31, 2022
|
December 31, 2021
|
|||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Cash at consolidated joint venture | ||||||||
Restricted cash, non-current
|
|
|
||||||
Total cash, cash equivalents and restricted cash reported in the Condensed Consolidated Statements of Cash Flows
|
$
|
|
$
|
|
March 31, 2022
|
December 31, 2021
|
|||||||
Furniture and fixtures
|
$
|
|
$
|
|
||||
Computers and equipment
|
|
|
||||||
Computer software
|
|
|
||||||
Leasehold improvements |
||||||||
Property and equipment
|
|
|
||||||
Less accumulated depreciation
|
(
|
)
|
(
|
)
|
||||
Property and equipment, net
|
$
|
|
$
|
|
March 31, 2022
|
December 31, 2021
|
|||||||
Accrued research and development
|
$
|
|
$
|
|
||||
Accrued compensation
|
|
|
||||||
Accrued legal fees
|
|
|
||||||
Other accruals
|
|
|
||||||
Total
|
$
|
|
$
|
|
March 31, 2022
|
||||||||||||||||||||
Maturity
in Years
|
Amortized
Cost
|
Unrealized
Gains
|
Unrealized
Losses
|
Estimated
Fair Value
|
||||||||||||||||
Corporate debt securities
|
less than
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
Commercial paper
|
less than
|
|
|
|
|
|||||||||||||||
U.S. Treasury securities |
less than |
( |
) | |||||||||||||||||
Asset-backed securities | less than |
( |
) | |||||||||||||||||
Short-term investments
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||||||||
Corporate debt securities
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
U.S. Treasury securities
|
|
|
|
(
|
)
|
|
||||||||||||||
Asset-backed securities
|
|
|
|
(
|
)
|
|
||||||||||||||
Long-term investments
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
December 31, 2021 |
||||||||||||||||||||
|
Maturity
in Years
|
Amortized
Cost
|
Unrealized
Gains
|
Unrealized
Losses
|
Estimated
Fair Value
|
|||||||||||||||
Corporate debt securities
|
less than |
$ | $ | $ | ( |
) | $ | |||||||||||||
U.S. Treasury securities | less than |
( |
) | |||||||||||||||||
Asset-backed securities
|
less than |
( |
) | |||||||||||||||||
Short-term investments
|
$ | $ | $ | ( |
) | $ | ||||||||||||||
U.S. Treasury securities | $ | $ | $ | ( |
) | $ | ||||||||||||||
Long-term investments
|
$ | $ | $ | ( |
) | $ |
Fair Value Measurements at March 31, 2022
|
||||||||||||||||
Level 1
|
Level 2
|
Level 3
|
Total
|
|||||||||||||
Money market funds
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Corporate debt securities
|
|
|
|
|
||||||||||||
Commercial paper
|
|
|
|
|
||||||||||||
U.S. Treasury securities
|
|
|
|
|
||||||||||||
Asset-backed securities
|
|
|
|
|
||||||||||||
Total cash equivalents and
investments
|
$
|
|
$
|
|
$
|
|
$
|
|
Fair Value Measurements at December 31, 2021
|
||||||||||||||||
Level 1
|
Level 2
|
Level 3
|
Total
|
|||||||||||||
Money market funds
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Corporate debt securities
|
|
|
|
|
||||||||||||
U.S. Treasury securities | ||||||||||||||||
Asset-backed securities
|
|
|
|
|
||||||||||||
Total cash equivalents and
investments
|
$
|
|
$
|
|
$
|
|
$
|
|
Options
|
Weighted-
Average
Exercise Price
|
Weighted-
Average
Remaining
Contractual
Term (in years)
|
Aggregate
Intrinsic
Value
(in thousands)
|
|||||||||||||
Outstanding at January 1, 2022
|
|
$
|
|
|
$
|
|
||||||||||
Granted
|
|
|
||||||||||||||
Exercised
|
(
|
)
|
|
|||||||||||||
Forfeited
|
(
|
)
|
|
|||||||||||||
Outstanding at March 31, 2022
|
|
$
|
|
|
$
|
|
||||||||||
Exercisable at March 31, 2022
|
|
$
|
|
|
$
|
|
|
Three Months Ended March 31,
|
||||||
|
2022
|
2021
|
|||||
|
|||||||
Expected term (in years)
|
|
|
|||||
Expected volatility
|
|
|
|
||||
Risk-free interest rate
|
|
|
|
||||
Expected dividend
|
|
|
|
|
Three Months Ended March 31,
|
|||||||
|
2022
|
2021
|
||||||
|
||||||||
Expected term (in years)
|
|
|
||||||
Expected volatility
|
|
|
||||||
Risk-free interest rate
|
|
|
||||||
Expected dividend
|
|
|
|
Three Months Ended March 31,
|
|||||||
|
2022
|
2021
|
||||||
Research and development
|
$
|
|
$
|
|
||||
General and administrative
|
|
|
||||||
Total stock-based compensation
|
$
|
|
$
|
|
|
March 31, 2022
|
May 13, 2021
|
||||||
Cash at consolidated joint venture
|
$
|
|
$
|
|
||||
Prepaid expenses and other current assets
|
|
|
||||||
Right-of-use lease assets
|
|
|
||||||
Other non-current assets
|
|
|
||||||
Accounts payable and accrued expenses
|
|
|
||||||
Operating lease liabilities
|
|
|
|
Operating Leases
|
|||
2022 remaining 9 months
|
$
|
|
||
2023
|
|
|||
2024
|
|
|||
2025
|
|
|||
2026
|
|
|||
Thereafter
|
|
|||
Total minimum lease payments
|
|
|||
Less: imputed interest
|
(
|
)
|
||
Total operating lease liabilities
|
|
|||
Less: current portion
|
(
|
)
|
||
Lease liability, net of current portion
|
$
|
|
Year Ending December 31,
|
Operating Leases
|
|||
2022
|
$
|
|
||
2023
|
|
|||
2024
|
|
|||
2025
|
|
|||
2026
|
|
|||
Thereafter
|
|
|||
Total mimium lease payments
|
$
|
|
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
|
• |
advance our RAF and FGFR programs through clinical development;
|
• |
advance the development of our other small molecule research programs, including our CDK12 inhibitor and next-generation programs for our product candidates;
|
• |
expand our pipeline of product candidates through our own product discovery and development efforts;
|
• |
seek to discover and develop additional product candidates;
|
• |
seek regulatory approvals for any product candidates that successfully complete clinical trials;
|
• |
establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates and related additional commercial manufacturing costs;
|
• |
implement operational, financial and management systems;
|
• |
attract, hire and retain additional clinical, scientific, management and administrative personnel;
|
• |
maintain, expand, protect and enforce our intellectual property portfolio, including patents, trade secrets and know how; and
|
• |
operate as a public company.
|
• |
expenses incurred in connection with the discovery, preclinical and clinical development of our product candidates, including under agreements with third parties, such as consultants and CROs;
|
• |
the cost of manufacturing compounds for use in our preclinical and clinical studies, including under agreements with third parties, such as consultants and contract manufacturing organizations (CMOs); and
|
• |
costs associated with consultants for chemistry, manufacturing and controls, development, regulatory, statistics and other
services, including expenses for technology and facilities.
|
• |
the timing and progress of preclinical and clinical development activities;
|
• |
the number and scope of preclinical and clinical programs we decide to pursue;
|
• |
our ability to maintain our current research and development programs and to establish new ones;
|
• |
establishing an appropriate safety profile with IND-enabling toxicology studies;
|
• |
successful patient enrollment in, and the initiation and completion of, clinical trials;
|
• |
per-subject trial costs;
|
• |
the number of clinical trials required
for regulatory approval;
|
• |
the countries in which the clinical trials
are conducted;
|
• |
the length of time required to enroll eligible subjects and initiate clinical trials;
|
• |
the number of subjects that participate in the clinical trials;
|
• |
the drop-out and discontinuation rate of subjects;
|
• |
potential additional safety monitoring requested by regulatory authorities;
|
• |
the duration of subject participation in the clinical trials and follow-up;
|
• |
the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to applicable regulatory authorities;
|
• |
the receipt of regulatory approvals from applicable regulatory authorities;
|
• |
the timing, receipt and terms of any marketing approvals and post-marketing approval commitments from applicable regulatory authorities;
|
• |
the extent to which we establish collaborations, strategic partnerships or other strategic arrangements with third parties, if any, and the performance of any such third party;
|
• |
obtaining and retaining research and development personnel;
|
• |
establishing commercial manufacturing capabilities or making arrangements with CMOs;
|
• |
development and timely delivery of commercial-grade drug formulations that can be used in our ongoing and planned future clinical trials and for commercial launch; and
|
• |
obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights.
|
Three Months Ended March 31,
|
Change
|
|||||||||||
2022
|
2021
|
|||||||||||
(in thousands)
|
||||||||||||
Operating expenses:
|
||||||||||||
Research and development
|
$
|
19,647
|
$
|
12,666
|
$
|
6,981
|
||||||
General and administrative
|
7,412
|
4,815
|
2,597
|
|||||||||
Total operating expenses
|
27,059
|
17,481
|
9,578
|
|||||||||
Loss from operations
|
(27,059
|
)
|
(17,481
|
)
|
(9,578
|
)
|
||||||
Other income, net
|
157
|
24
|
133
|
|||||||||
Net loss
|
(26,902
|
)
|
(17,457
|
)
|
(9,445
|
)
|
||||||
Net loss attributable to redeemable convertible noncontrolling interests
|
-
|
-
|
-
|
|||||||||
Net loss attributable to Kinnate
|
$
|
(26,902
|
)
|
$
|
(17,457
|
)
|
$
|
(9,445
|
)
|
Three Months Ended March 31,
|
Increase
(Decrease)
|
|||||||||||
2022
|
2021
|
|||||||||||
(in thousands)
|
||||||||||||
External expenses:
|
||||||||||||
RAF
|
$
|
5,354
|
$
|
4,604
|
$
|
750
|
||||||
FGFR
|
2,841
|
2,493
|
348
|
|||||||||
Other programs and other unallocated costs
|
4,017
|
2,012
|
2,005
|
|||||||||
Total external expenses
|
12,212
|
9,109
|
3,103
|
|||||||||
Internal expenses
|
7,435
|
3,557
|
3,878
|
|||||||||
Total research and development expenses
|
$
|
19,647
|
$
|
12,666
|
$
|
6,981
|
• |
advance our RAF and FGFR programs through clinical development;
|
• |
advance the development of our other small molecule research programs, including our CDK12 inhibitor;
|
• |
expand our pipeline of product candidates through our own product discovery and development efforts;
|
• |
seek to discover and develop additional product candidates;
|
• |
seek regulatory approvals for any product candidates that successfully complete clinical trials;
|
• |
establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates and related additional commercial manufacturing costs;
|
• |
implement operational, financial and management systems;
|
• |
attract, hire and retain additional clinical, scientific, management and administrative personnel;
|
• |
maintain, expand, protect and enforce our intellectual property portfolio, including patents, trade secrets and know how; and
|
• |
operate as a public company.
|
• |
the scope, timing, progress, results and costs of researching and developing our product candidates, and conducting preclinical studies and clinical trials;
|
• |
the scope, timing, progress, results and costs of researching and developing other product candidates that we may pursue;
|
• |
the costs, timing and outcome of regulatory review of our product candidates;
|
• |
the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;
|
• |
the costs of manufacturing commercial-grade products and sufficient inventory to support commercial launch;
|
• |
the revenue, if any, received from commercial sale of our products, should any of our product candidates receive marketing approval;
|
• |
the cost and timing of attracting, hiring and retaining skilled personnel to support our operations and continued growth;
|
• |
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
|
• |
our ability to establish and maintain collaborations, strategic partnerships or marketing, distribution, licensing or other strategic arrangements with third parties on favorable terms, if at all;
|
• |
the extent to which we acquire or in-license other product candidates and technologies, if any;
|
• |
the timing, receipt and amount of sales of, or milestone payments related to or royalties on, our current or future product candidates, if any; and
|
• |
the costs associated with operating as a public company.
|
Three Months Ended March 31,
|
||||||||
2022
|
2021
|
|||||||
(in thousands)
|
||||||||
Net cash used in operating activities
|
$
|
(21,087
|
)
|
$
|
(13,442
|
)
|
||
Net cash used in investing activities
|
(64,630
|
)
|
(169,631
|
)
|
||||
Net cash provided by financing activities
|
125
|
-
|
||||||
Net decrease in cash, cash equivalents and restricted cash
|
$
|
(85,592
|
)
|
$
|
(183,073
|
)
|
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk.
|
Item 4. |
Controls and Procedures.
|
Item 1. |
Legal Proceedings.
|
Item 1A. |
Risk Factors.
|
• |
We are early in our development efforts and have a limited operating history and no products approved for commercial sale.
|
• |
We have incurred significant net losses and expect to continue to incur significant net losses for the foreseeable future.
|
• |
Our ability to generate revenue and achieve profitability depends on our ability to achieve our objectives relating to discovery, development and commercialization of our product candidates.
|
• |
We will require substantial additional capital to finance our operations.
|
• |
We are substantially dependent on our RAF and FGFR programs.
|
• |
Our preclinical studies and clinical trials may fail to demonstrate the safety and efficacy of our product candidates.
|
• |
Our discovery and development activities are focused on the development of therapeutics in an evolving area of science.
|
• |
The outcome of testing and early clinical trials may not be predictive of the success of later clinical trials.
|
• |
In addition to our RAF and FGFR programs, our prospects depend in part upon discovering, developing and commercializing product candidates from our CDK12 and other research programs.
|
• |
Our approach to the discovery and development of product candidates is unproven.
|
• |
The regulatory approval processes of regulatory authorities are lengthy, time consuming and unpredictable.
|
• |
We have limited experience as a company in conducting clinical trials.
|
• |
We may not be able to file INDs on the timelines we expect.
|
• |
Our product candidates may cause significant adverse events, toxicities or other undesirable side effects.
|
• |
Data from our preclinical studies and clinical trials may change as more data become available and are subject to verification.
|
• |
We could experience delays or difficulties in the enrollment or maintenance of patients in clinical trials.
|
• |
The COVID-19 pandemic could adversely impact our business.
|
• |
We face substantial competition which may result in others discovering, developing or commercializing products before us.
|
• |
The manufacture of drugs is complex, and third-party manufacturers may encounter production difficulties.
|
• |
Our product candidates may not achieve adequate market acceptance among the medical community.
|
• |
The market opportunities for our product candidates may be limited to certain smaller patient subsets.
|
• |
Our product candidates may become subject to unfavorable third-party coverage and reimbursement practices.
|
• |
Our business entails a significant risk of product liability.
|
• |
We may be unable to obtain regulatory approval and be unable to commercialize our product candidates.
|
• |
We may develop our product candidates with other therapies, which would expose us to additional risks.
|
• |
We have never commercialized a product candidate as a company and currently lack the resources to do so on our own or with others.
|
• |
Regulatory authorities may not accept data from clinical trials conducted in locations outside of their jurisdiction.
|
• |
Obtaining regulatory approval in one jurisdiction does not mean we will be successful in other jurisdictions.
|
• |
Any product candidates that receive regulatory approval will be subject to post-marketing regulations.
|
• |
Regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses.
|
• |
Failure to obtain approval of a required companion diagnostic test, will prevent commercialization of the product candidate.
|
• |
Where appropriate, we plan to secure approval from regulatory authorities through accelerated registration pathways. If we are unsuccessful, we may be required to conduct additional preclinical studies or clinical trials.
|
• |
We may seek, but not obtain, Fast Track designation from the FDA for one or more of our product candidates.
|
• |
A Breakthrough Therapy designation by the FDA may not lead to a faster review or approval process.
|
• |
We may not be able to obtain orphan drug designation or orphan drug exclusivity for one or more of our product candidates.
|
• |
We may face difficulties from changes to current regulations and future legislation.
|
• |
Our relationships with healthcare professionals, clinical investigators, CROs and third-party payors may be subject to reporting requirements and various laws.
|
• |
We must comply with regulations governing the use, processing and cross-border transfer of personal information.
|
• |
Our employees, service providers, suppliers and vendors may engage in misconduct or other improper activities.
|
• |
Our business activities may be subject to the U.S. Foreign Corrupt Practices Act (FCPA) and similar foreign laws, as well as U.S. and foreign export controls, trade sanctions, and import laws and regulations.
|
• |
If we fail to comply with California laws or Nasdaq rules governing the diversity of our board of directors, we could be exposed to financial penalties and suffer reputational harm.
|
• |
Our success is highly dependent on our ability to attract, hire and retain highly skilled executive officers and employees.
|
• |
We will need to grow the size and capabilities of our organization, and we may experience difficulties in managing growth.
|
• |
Our internal computer systems, or those of any of our service providers, may fail or suffer security or data privacy breaches or incidents.
|
• |
Many of our research and preclinical activities are conducted by third parties outside of the United States, including in China.
|
• |
Our operations are vulnerable to interruption by natural disasters, war, terrorist activity, pandemics and other events.
|
• |
If we are unable to establish sales or marketing capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be able to successfully sell or market our product candidates that obtain
regulatory approval.
|
• |
A variety of risks associated with marketing our product candidates internationally could adversely affect our business.
|
• |
Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
|
• |
Our success depends on our ability to protect our intellectual property and our proprietary technologies.
|
• |
The scope of our patent protection may not be sufficiently broad, or we could lose patent protection.
|
• |
Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
|
• |
Our commercial success depends on our operating without infringing the patents and other proprietary rights of third parties.
|
• |
We may not be successful in obtaining or maintaining rights to our future product candidates.
|
• |
We may be involved in lawsuits to protect or enforce our patents or our future licensors’ patents.
|
• |
The outcome of derivation proceedings may require us to cease using or attempt to license the related technology.
|
• |
Patent reform legislation may increase uncertainties and costs of prosecuting patent applications and enforcing issued patents.
|
• |
Changes in patent law could diminish the value of patents in general.
|
• |
We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
|
• |
Patent terms may be inadequate to protect our competitive position on our product candidates.
|
• |
If we do not obtain patent term extension for our product candidates, our business may be materially harmed.
|
• |
We may not be able to protect our intellectual property rights throughout the world.
|
• |
We rely on third parties to conduct our preclinical studies and clinical trials, and they may not perform satisfactorily.
|
• |
We contract with third parties for the manufacture of our product candidates for preclinical studies and clinical trials and expect to continue to do so for additional preclinical studies, clinical trials and ultimately for
commercialization.
|
• |
Our manufacturing process needs to comply with FDA regulations relating to the quality and reliability of such processes.
|
• |
If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
|
• |
If our manufacturers use hazardous materials in a manner that causes injury or violates law, we may be liable for damages.
|
• |
If we decide to establish collaborations, we may have to alter our development and commercialization plans.
|
• |
The market price of our common stock is volatile, which could result in substantial losses for investors.
|
• |
If securities analysts do not publish research or reports about our business, or if they publish adverse reports regarding us, our stock price and trading volume could decline.
|
• |
If our remediation of a material weakness that we identified in our internal control over financial reporting is not effective, we may not be able to accurately or timely report our financial condition or results of operations.
|
• |
Delaware law and provisions in our charter documents might prevent a change in control of our company or changes in our management, depressing the market price of our common stock.
|
• |
Our charter documents provide exclusive forums for disputes between us and our stockholders, limiting their ability to obtain a favorable judicial forum.
|
• |
successful and timely completion of clinical development of product candidates from our RAF and FGFR programs and preclinical and clinical development of product candidates from our CDK12 and other research
programs, and any other future programs;
|
• |
establishing and maintaining relationships with CROs and clinical sites for the clinical development of product candidates from our RAF and FGFR programs, our CDK12 and other research programs, and any other
future programs;
|
• |
timely receipt of marketing approvals from applicable regulatory authorities for any product candidates for which we successfully complete clinical development;
|
• |
developing an efficient and scalable manufacturing process for our product candidates, including obtaining finished products that are appropriately packaged for sale;
|
• |
establishing and maintaining commercially viable supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical
development and meet the market demand for our product candidates, if approved;
|
• |
successful commercial launch following any marketing approval, including the development of a commercial infrastructure, whether in-house or with one or more collaborators;
|
• |
a continued acceptable safety profile following any marketing approval of our product candidates;
|
• |
commercial acceptance of our product candidates by patients, the medical community and third-party payors;
|
• |
satisfying any required post-marketing approval commitments to applicable regulatory authorities;
|
• |
identifying, assessing and developing new product candidates;
|
• |
obtaining, maintaining and expanding patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally;
|
• |
defending against third-party interference or infringement claims, if any;
|
• |
entering into, on favorable terms, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;
|
• |
obtaining coverage and adequate reimbursement by third-party payors for our product candidates;
|
• |
addressing any competing therapies and technological and market developments; and
|
• |
attracting, hiring and retaining qualified personnel.
|
• |
approval of INDs for our planned clinical trials and future clinical trials;
|
• |
addressing any potential delays resulting from factors related to the COVID‑19 pandemic;
|
• |
successful initiation and completion of clinical trials;
|
• |
successful and timely patient selection and enrollment in and completion of clinical trials;
|
• |
maintaining and establishing relationships with CROs and clinical sites for the clinical development of our product candidates both in the United States and internationally;
|
• |
the frequency and severity of adverse events in clinical trials;
|
• |
demonstrating efficacy, safety and tolerability profiles that are satisfactory to the FDA, EMA or any other comparable foreign regulatory authority for marketing approval;
|
• |
the timely receipt of marketing approvals from applicable regulatory authorities;
|
• |
the timely identification, development and approval of companion diagnostic tests, if required;
|
• |
the extent of any required post-marketing approval commitments to applicable regulatory authorities;
|
• |
the maintenance of existing or the establishment of new supply arrangements with third-party drug product suppliers and manufacturers for clinical development and, if approved, commercialization of our
product candidates;
|
• |
obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally;
|
• |
the protection of our rights in our intellectual property portfolio;
|
• |
the successful launch of commercial sales following any marketing approval;
|
• |
a continued acceptable safety profile following any marketing approval;
|
• |
commercial acceptance by patients, the medical community and third-party payors; and
|
• |
our ability to compete with other therapies.
|
• |
failure of our product candidates in preclinical studies or clinical trials to demonstrate safety and efficacy;
|
• |
receipt of feedback from regulatory authorities that requires us to modify the design of our clinical trials;
|
• |
negative or inconclusive clinical trial results that may require us to conduct additional clinical trials or abandon certain research and/or drug development programs;
|
• |
the number of patients required for clinical trials being larger than anticipated, enrollment in these clinical trials being slower than anticipated or participants dropping out of these clinical trials at a
higher rate than anticipated;
|
• |
third-party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;
|
• |
the suspension or termination of our clinical trials for various reasons, including non-compliance with regulatory requirements or a finding that our product candidates have undesirable side effects or other
unexpected characteristics or risks;
|
• |
the cost of clinical trials of our product candidates being greater than anticipated;
|
• |
the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates being insufficient or inadequate; and
|
• |
regulators revising the requirements for approving our product candidates.
|
• |
generating sufficient data to support the initiation or continuation of preclinical studies and clinical trials;
|
• |
addressing any delays resulting from factors related to the COVID‑19 pandemic;
|
• |
obtaining regulatory permission to initiate clinical trials;
|
• |
contracting with the necessary parties to conduct clinical trials;
|
• |
successful enrollment of patients in, and the completion of, clinical trials on a timely basis;
|
• |
the timely manufacture of sufficient quantities of a product candidate for use in clinical trials; and
|
• |
adverse events in clinical trials.
|
• |
the FDA, EMA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials;
|
• |
the FDA, EMA or other comparable foreign regulatory authorities may determine that we have not demonstrated the safety and efficacy of our product candidates, or that they undesirable or unintended side
effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use;
|
• |
the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval;
|
• |
the FDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
|
• |
we may be unable to demonstrate to the FDA, EMA or other comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable;
|
• |
the FDA, EMA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we
contract for clinical and commercial supplies;
|
• |
the FDA, EMA or other comparable regulatory authorities may fail to approve companion diagnostic tests required for our product candidates; and
|
• |
the approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
|
• |
size and nature of the patient population;
|
• |
severity of the disease under investigation;
|
• |
availability and efficacy of approved drugs for the disease under investigation;
|
• |
patient eligibility criteria for the clinical trial in question as defined in the protocol, including biomarker-driven identification and/or certain highly-specific criteria related to stage of disease progression, which may limit the patient populations eligible for our
clinical trials to a greater extent than competing clinical trials for the same indication that do not have biomarker-driven patient eligibility criteria;
|
• |
perceived risks and benefits of the product candidate under study;
|
• |
clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new products that may be approved or other
product candidates being investigated for the indications we are investigating;
|
• |
clinicians’ willingness to screen their patients for biomarkers to indicate which patients may be eligible for enrollment in our clinical trials;
|
• |
patient referral practices of physicians;
|
• |
the ability to monitor patients adequately during and after treatment;
|
• |
proximity and availability of clinical trial sites for prospective patients; and
|
• |
the risk that patients enrolled in clinical trials will drop out of the clinical
trials before completion or, because they may be late-stage cancer patients, will not survive the full terms of the clinical trials.
|
• |
delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;
|
• |
delays or difficulties in enrolling and retaining patients in any clinical trials, particularly elderly subjects, who are at a higher risk of severe illness or death from COVID‑19;
|
• |
difficulties interpreting data from our clinical trials due to the possible effects of COVID‑19 on patients;
|
• |
diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of clinical
trials;
|
• |
interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others;
|
• |
interruption or delays in the operations of the FDA, EMA or other regulatory authorities, which may impact review and approval timelines;
|
• |
limitations in resources that would otherwise be focused on the conduct of our business, our preclinical studies or our clinical trials, including because of sickness or the desire to avoid contact with large
groups of people or as a result of government-imposed “shelter in place” or similar working restrictions;
|
• |
interruptions, difficulties or delays arising in our existing operations and company culture as a result of our employees
including those hired during the COVID‑19 pandemic, working from home or in a hybrid model;
|
• |
delays in receiving approval from regulatory authorities to initiate our clinical trials;
|
• |
delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials; interruptions in preclinical studies due to restricted or limited operations at the CROs conducting such
studies;
|
• |
interruption in global freight and shipping that may affect the transport of clinical trial materials, such as investigational drug product to be used in our clinical trials;
|
• |
changes in regulations as part of a response to the COVID‑19 pandemic which may require us to change the ways in which our clinical trials are to be conducted, or to discontinue the clinical trials
altogether, or which may result in unexpected costs;
|
• |
delays in necessary interactions with regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government or contractor
personnel; and
|
• |
refusal of the FDA, EMA or other regulatory authorities to accept data from clinical trials in affected geographies outside of their respective jurisdictions.
|
• |
the efficacy and safety profile as demonstrated in clinical trials compared to alternative treatments;
|
• |
the timing of market introduction of the product candidate as well as competitive products;
|
• |
the clinical indications for which a product candidate is approved;
|
• |
restrictions on the use of product candidates in the labeling approved by regulatory authorities, such as boxed warnings or contraindications in labeling, or a risk evaluation and mitigation strategy, if any,
which may not be required of alternative treatments and competitor products;
|
• |
the potential and perceived advantages of our product candidates over alternative treatments;
|
• |
the cost of treatment in relation to alternative treatments;
|
• |
the availability of coverage and adequate reimbursement by third-party payors, including government authorities;
|
• |
the availability of an approved product candidate for use as a combination therapy;
|
• |
relative convenience and ease of administration;
|
• |
the willingness of the target patient population to try new therapies and undergo required diagnostic screening to determine treatment eligibility and of physicians to prescribe these therapies and diagnostic
tests;
|
• |
the effectiveness of sales and marketing efforts;
|
• |
unfavorable publicity relating to our product candidates; and
|
• |
the approval of other new therapies for the same indications.
|
• |
the FDA, EMA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials;
|
• |
the FDA, EMA or other comparable foreign regulatory authorities may determine that we have not demonstrated the safety and efficacy of our product candidates, or that they have undesirable or unintended side
effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use;
|
• |
the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval;
|
• |
the FDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
|
• |
we may be unable to demonstrate to the FDA, EMA or other comparable foreign regulatory authorities that our product candidate’s risk-benefit ratio for its proposed indication is acceptable;
|
• |
the FDA, EMA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we
contract for clinical and commercial supplies; and
|
• |
the approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
|
• |
delays in or the rejection of product approvals;
|
• |
restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned clinical trials;
|
• |
restrictions on the products, manufacturers or manufacturing process;
|
• |
warning or untitled letters;
|
• |
civil and criminal penalties;
|
• |
injunctions;
|
• |
suspension or withdrawal of regulatory approvals;
|
• |
product seizures, detentions or import bans;
|
• |
voluntary or mandatory product recalls and publicity requirements;
|
• |
total or partial suspension of production;
|
• |
imposition of restrictions on operations, including costly new manufacturing requirements;
|
• |
revisions to the labeling, including limitation on approved uses or the addition of additional warnings, contraindications or other safety information, including boxed warnings;
|
• |
imposition of a REMS, which may include distribution or use restrictions; and
|
• |
requirements to conduct additional post-market clinical trials to assess the safety of products.
|
• |
the demand for our product candidates if we obtain regulatory approval;
|
• |
our ability to set a price that we believe is fair for our products;
|
• |
our ability to obtain coverage and reimbursement approval for a product;
|
• |
our ability to generate revenue and achieve or maintain profitability;
|
• |
the level of taxes that we are required to pay; and
|
• |
the availability of capital.
|
• |
the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or
rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which
payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to
have committed a violation. Violations are subject to civil and criminal fines and penalties for each violation, plus up to three times the remuneration involved, imprisonment, and exclusion from government healthcare programs. In addition,
the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act (FCA). There are a number of
statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, but the exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection;
|
• |
federal civil and criminal false claims laws, including the FCA, which can be enforced through civil “qui tam” or “whistleblower” actions, and civil monetary penalty laws, impose criminal and civil penalties
against individuals or entities for, among other things, knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid, or other federal health care programs that are false or fraudulent; knowingly
making or causing a false statement material to a false or fraudulent claim or an obligation to pay money to the federal government; or knowingly concealing or knowingly and improperly avoiding or decreasing such an obligation.
Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. The FCA also permits a private individual acting as
a “whistleblower” to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery. When an entity is determined to have violated the federal civil FCA, the government may impose
civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;
|
• |
HIPAA, which created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of
false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and
willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to
healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate it;
|
• |
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), and their respective implementing regulations, which impose requirements on certain covered
healthcare providers, health plans, and healthcare clearinghouses and their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information as well as their
covered subcontractors, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make
civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’
fees and costs associated with pursuing federal civil actions;
|
• |
the federal Physician Payments Sunshine Act, created under the ACA and its implementing regulations, which require applicable manufacturers of covered drugs, devices, biologicals or medical supplies for which payment is available under
Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to HHS information related to payments or other transfers of value made in the previous year to covered recipients, including
physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician healthcare professionals (such as physician assistants and nurse practitioners, among others) and teaching hospitals, as
well as ownership and investment interests held by physicians and their immediate family members; and
|
• |
analogous state and foreign laws and regulations, such as state and foreign anti-kickback, false claims, consumer protection and unfair competition laws which may apply to pharmaceutical business practices,
including but not limited to, research, distribution, sales and marketing arrangements as well as submitting claims involving healthcare items or services reimbursed by any third-party payor, including commercial insurers; state laws that
require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government that otherwise restricts payments that may be made to
healthcare providers and other potential referral sources; state laws that require drug manufacturers to file reports with states regarding pricing and marketing information, such as the tracking and reporting of gifts, compensations and
other remuneration and items of value provided to healthcare professionals and entities; state and local laws requiring the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security
of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
|
• |
identifying, recruiting, integrating, maintaining, retaining and motivating our current and additional employees;
|
• |
managing our internal development efforts effectively, including the preclinical, clinical, FDA, EMA and other comparable foreign regulatory authorities’ review process for our RAF and FGFR programs and our
other product candidates, while complying with any contractual obligations to contractors and other third parties;
|
• |
managing increasing operational and managerial complexity; and
|
• |
improving our operational, financial and management controls, reporting systems and procedures.
|
• |
differing regulatory requirements and reimbursement regimes in foreign countries, such as the lack of pathways for accelerated drug approval, may result in foreign regulatory approvals taking longer and being
more costly than obtaining approval in the United States;
|
• |
foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials or our interpretation of data from preclinical studies or clinical trials;
|
• |
approval policies or regulations of foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval;
|
• |
impact of the COVID‑19 pandemic on our ability to produce our product candidates and conduct clinical trials in foreign countries;
|
• |
unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;
|
• |
economic weakness, including inflation, or political instability in particular foreign economies and markets;
|
• |
compliance with legal requirements applicable to privacy, data protection, information security and other matters;
|
• |
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
|
• |
foreign taxes, including withholding of payroll taxes;
|
• |
foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;
|
• |
difficulties staffing and managing foreign operations;
|
• |
complexities associated with managing multiple payor reimbursement regimes and government payors in foreign countries;
|
• |
workforce uncertainty in countries where labor unrest is more common than in the United States;
|
• |
potential liability under the FCPA or comparable foreign regulations;
|
• |
challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United
States;
|
• |
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad (such as the ongoing conflict between Ukraine and Russia, including the sanctions imposed by
the United States, the European Union and others on Russia and other related parties); and
|
• |
business interruptions resulting from geo-political actions, including war and terrorism, trade policies, treaties and tariffs.
|
• |
the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process, the noncompliance with which
can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction;
|
• |
patent applications may not result in any patents being issued;
|
• |
patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage;
|
• |
our competitors, many of whom have substantially greater resources than we do and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that
will limit, interfere with or eliminate our ability to make, use and sell our potential product candidates;
|
• |
there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that
prove successful, as a matter of public policy regarding worldwide health concerns; and
|
• |
countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market
competing product candidates.
|
• |
others may be able to develop products that are similar to our product candidates but that are not covered by the claims of the patents that we own or license;
|
• |
we or our future licensors or collaborators might not have been the first to make the inventions covered by the issued patents or patent application that we own or license;
|
• |
we or our future licensors or collaborators might not have been the first to file patent applications covering certain of our inventions;
|
• |
others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;
|
• |
it is possible that the pending patent applications we own or license will not lead to issued patents;
|
• |
issued patents that we own or license may be held invalid or unenforceable, as a result of legal challenges by our competitors;
|
• |
our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for
sale in our major commercial markets;
|
• |
we may not develop additional proprietary technologies that are patentable;
|
• |
the patents of others may have an adverse effect on our business; and
|
• |
we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.
|
• |
result in costly litigation that may cause negative publicity;
|
• |
divert the time and attention of our technical personnel and management;
|
• |
cause development delays;
|
• |
prevent us from commercializing any of our product candidates until the asserted patent expires or is held finally invalid or not infringed in a court of law;
|
• |
require us to develop non-infringing technology, which may not be possible on a cost-effective basis;
|
• |
subject us to significant liability to third parties; or
|
• |
require us to enter into royalty or licensing agreements, which may not be available on commercially reasonable terms, or at all, or which might be non-exclusive, which could result in our competitors gaining
access to the same technology.
|
• |
the scope of rights granted under the license agreement and other interpretation-related issues;
|
• |
whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;
|
• |
our right to sublicense patents and other rights to third parties;
|
• |
our diligence obligations under the license agreement and what activities satisfy those diligence obligations;
|
• |
our right to transfer or assign the license;
|
• |
the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our future licensors and us and our partners; and
|
• |
the priority of invention of patented technology.
|
• |
the failure of the third party to manufacture our product candidates according to our schedule and specifications, or at all, including if our third-party contractors give greater priority to the supply of
other products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreements between us and them;
|
• |
the reduction or termination of production or deliveries by suppliers, or the raising or prices or renegotiation of terms;
|
• |
the termination or nonrenewal of arrangements or agreements by our third-party contractors at a time that is costly or inconvenient for us;
|
• |
the breach by the third-party contractors of our agreements with them;
|
• |
the failure of third-party contractors to comply with applicable regulatory requirements, including cGMPs;
|
• |
the breach by the third-party contractors of our agreements with them;
|
• |
the failure of the third party to manufacture our product candidates according to our specifications;
|
• |
the mislabeling of clinical supplies, potentially resulting in the wrong dose amounts being supplied or active drug or placebo not being properly identified;
|
• |
clinical supplies not being delivered to clinical sites on time, leading to clinical trial interruptions, or of drug supplies not being distributed to commercial vendors in a timely manner, resulting in lost
sales; and
|
• |
the misappropriation of our proprietary information, including our trade secrets and know-how.
|
• |
increased operating expenses and cash requirements;
|
• |
the assumption of additional indebtedness or contingent liabilities;
|
• |
the issuance of our equity securities;
|
• |
assimilation of operations, intellectual property, products and product candidates of an acquired company, including difficulties associated with integrating new personnel;
|
• |
the diversion of our management’s attention from our existing programs and initiatives in pursuing such a strategic merger or acquisition;
|
• |
retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships;
|
• |
risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products, product candidates and marketing approvals; and
|
• |
our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.
|
• |
collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations and may not perform their obligations as expected;
|
• |
collaborators may deemphasize or not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial
results, changes in the collaborators’ strategic focus, including as a result of a business combination or sale or disposition of a business unit or development function, or available funding or external factors such as an acquisition that
diverts resources or creates competing priorities;
|
• |
collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new
formulation of a product candidate for clinical testing;
|
• |
collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are
more likely;
|
• |
to be successfully developed or can be commercialized under terms that are more economically attractive than ours;
|
• |
a collaborator with marketing and distribution rights to multiple products may not commit sufficient resources to the marketing and distribution of our product relative to other products;
|
• |
we may grant exclusive rights to our collaborators that would prevent us from collaborating with others;
|
• |
collaborators may not properly obtain, maintain, defend or enforce our intellectual property rights or may use our proprietary information and intellectual property in such a way as to invite litigation or
other intellectual property related proceedings that could jeopardize or invalidate our proprietary information and intellectual property or expose us to potential litigation or other intellectual property related proceedings;
|
• |
disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or
arbitration that diverts management attention and resources;
|
• |
collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates;
|
• |
collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all;
|
• |
collaborators may not provide us with timely and accurate information regarding development progress and activities under the collaboration or may limit our ability to share such information, which could
adversely impact our ability to report progress to our investors and otherwise plan our own development of our product candidates;
|
• |
collaborators may own or co-own intellectual property covering our products or product candidates that result from our collaborating with them, and in such cases, we would not have the exclusive right to
develop or commercialize such intellectual property; and
|
• |
a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings.
|
• |
the timing and results of INDs, preclinical studies and clinical trials of our product candidates or those of our competitors;
|
• |
the success of competitive products or announcements by potential competitors of their product development efforts;
|
• |
regulatory actions with respect to our products or product candidates or our competitors’ products or product candidates;
|
• |
actual or anticipated changes in our growth rate relative to our competitors;
|
• |
regulatory or legal developments in the United States and other countries, including changes in leadership at various federal departments and agencies as well as new legislation, executive, and administrative
actions under the Biden administration;
|
• |
developments or disputes concerning patent applications, issued patents or other proprietary rights;
|
• |
the recruitment or departure of key personnel;
|
• |
announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, collaborations or capital commitments;
|
• |
actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;
|
• |
fluctuations in the valuation of companies perceived by investors to be comparable to us;
|
• |
market conditions in the pharmaceutical and biotechnology sector;
|
• |
changes in the structure of healthcare payment systems;
|
• |
share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;
|
• |
announcement or expectation of additional financing efforts;
|
• |
sales of our common stock by us, our insiders or our other stockholders;
|
• |
expiration of market stand-off or lock-up agreements;
|
• |
the impact of any natural disasters or public health emergencies, such as the COVID‑19 pandemic; and
|
• |
general economic, political, industry and market conditions and instability (such as those created by the ongoing conflict between Ukraine and Russia, including, without limitation, sanctions against Russia
imposed by the United States, the European Union and others).
|
• |
the timing and cost of, and level of investment in, research and development activities relating to our programs, which will change from time to time;
|
• |
our ability to enroll patients in clinical trials and the timing of enrollment;
|
• |
the cost of manufacturing our current product candidates and any future product candidates, which may vary depending on FDA, EMA or other comparable foreign regulatory authority guidelines and requirements,
the quantity of production and the terms of our agreements with manufacturers;
|
• |
expenditures that we will or may incur to acquire or develop additional product candidates and technologies or other assets;
|
• |
the timing and outcomes of preclinical studies and clinical trials for product candidates from our RAF and FGFR programs, and any product candidates from our research programs, or competing product
candidates;
|
• |
the need to conduct unanticipated clinical trials or clinical trials that are larger or more complex than anticipated;
|
• |
competition from existing and potential future products that compete with our RAF or FGFR programs or any of our research programs, and changes in the competitive landscape of our industry, including
consolidation among our competitors or partners;
|
• |
any delays in regulatory review or approval of product candidates from our RAF or FGFR programs, or any of our research programs;
|
• |
the level of demand for any of our product candidates, if approved, which may fluctuate significantly and be difficult to predict;
|
• |
the risk/benefit profile, cost and reimbursement policies with respect to our product candidates, if approved, and existing and potential future products that compete with our RAF or FGFR programs, or any of
our research programs;
|
• |
our ability to commercialize product candidates from our RAF or FGFR programs, or any of our research programs, if approved, inside and outside of the United States, either independently or working with third
parties;
|
• |
our ability to establish and maintain collaborations, licensing or other arrangements;
|
• |
our ability to adequately support future growth;
|
• |
potential unforeseen business disruptions that increase our costs or expenses;
|
• |
future accounting pronouncements or changes in our accounting policies; and
|
• |
the changing and volatile global economic and political environment.
|
• |
being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” disclosure in our periodic reports;
|
• |
not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act;
|
• |
not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing
additional information about the audit and the financial statements;
|
• |
reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and
|
• |
exemptions from the requirements of holding nonbinding advisory stockholder votes on executive compensation and stockholder approval of any golden parachute payments not previously approved.
|
• |
establish a classified board of directors so that not all members of our board are elected at one time;
|
• |
permit only the board of directors to establish the number of directors and fill vacancies on the board;
|
• |
provide that directors may only be removed “for cause” and only with the approval of two-thirds of our stockholders;
|
• |
authorize the issuance of “blank check” preferred stock that our board could use to implement a stockholder rights plan (also known as a “poison pill”);
|
• |
eliminate the ability of our stockholders to call special meetings of stockholders;
|
• |
prohibit stockholder action by written consent, which requires all stockholder actions to be taken at a meeting of our stockholders;
|
• |
prohibit cumulative voting;
|
• |
authorize our board of directors to amend the bylaws;
|
• |
establish advance notice requirements for nominations for election to our board or for proposing matters that can be acted upon by stockholders at annual stockholder meetings; and
|
• |
require a super-majority vote of stockholders to amend some provisions described above.
|
• |
any derivative action or proceeding brought on our behalf;
|
• |
any action asserting a claim of breach of fiduciary duty;
|
• |
any action asserting a claim against us arising under the DGCL, our amended- and restated certificate of incorporation or our amended and restated bylaws; and
|
• |
any action asserting a claim against us that is governed by the internal-affairs doctrine.
|
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.
|
Exhibit
Number
|
Exhibit Description
|
Incorporated by Reference
|
||||||||
Form
|
File No.
|
Exhibit
|
Filing Date
|
|||||||
Sales Agreement, between the Company and SVB Leerink LLC, dated as of January 3, 2022
|
S-3ASR
|
333-261970
|
1.2
|
January 3, 2022
|
||||||
Certification of Principal Executive Officer 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.
|
||||||||||
Certification of Principal Financial Officer 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.
|
||||||||||
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
||||||||||
Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
||||||||||
101.INS
|
Inline XBRL Instance Document.
|
|||||||||
101.SCH
|
Inline XBRL Taxonomy Extension Schema Document.
|
|||||||||
101.CAL
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
|
|||||||||
101 DEF
|
Inline XBRL Taxonomy Extension Definition Linkbase Document.
|
|||||||||
101.LAB
|
Inline XBRL Taxonomy Extension Label Linkbase Document.
|
|||||||||
101.PRE
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
|
|||||||||
104
|
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101).
|
† |
The certifications attached as Exhibit 32.1 and Exhibit 32.2 that accompany this Quarterly Report on Form 10‑Q are deemed furnished and not filed with the Securities and Exchange Commission and are not to be incorporated by reference
into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10‑Q, irrespective of any general
incorporation language contained in such filing.
|
KINNATE BIOPHARMA INC.
|
||
May 12, 2022
|
By:
|
/s/ Nima Farzan
|
Nima Farzan
|
||
Chief Executive Officer and President
|
||
(Principal Executive Officer)
|
May 12, 2022
|
By:
|
/s/ Neha Krishnamohan
|
Neha Krishnamohan
|
||
Chief Financial Officer and Executive Vice
President, Corporate Development
|
||
(Principal Financial Officer)
|
1. |
I have reviewed this Quarterly Report on Form 10-Q of Kinnate Biopharma 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 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: May 12, 2022
|
By:
|
/s/ Nima Farzan |
Nima Farzan
|
||
President and Chief Executive Officer
|
1. |
I have reviewed this Quarterly Report on Form 10-Q of Kinnate Biopharma 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 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: May 12, 2022
|
By:
|
/s/ Neha Krishnamohan
|
Neha Krishnamohan | ||
Chief Financial Officer and Executive Vice President, Corporate Development |
(1) |
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
(2) |
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Date: May 12, 2022
|
By:
|
/s/ Nima Farzan
|
Nima Farzan
|
||
President and Chief Executive Officer
|
||
(Principal Executive Officer)
|
(1) |
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
(2) |
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Date: May 12, 2022
|
By:
|
/s/ Neha Krishnamohan
|
Neha Krishnamohan
|
||
Chief Financial Officer and Executive Vice President, Corporate Development
|
||
(Principal Financial and Accounting Officer)
|
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares |
Mar. 31, 2022 |
Dec. 31, 2021 |
---|---|---|
Stockholders' equity: | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 1,000,000,000 | 1,000,000,000 |
Common stock, shares issued (in shares) | 43,956,049 | 43,855,944 |
Common stock, shares outstanding (in shares) | 43,956,049 | 43,855,944 |
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Accumulated Other Comprehensive Loss [Member] |
Accumulated Deficit [Member] |
Redeemable Convertible Noncontrolling Interests [Member] |
Total |
---|---|---|---|---|---|---|
Balance at Dec. 31, 2020 | $ 4 | $ 446,601 | $ (9) | $ (53,329) | $ 0 | $ 393,267 |
Balance (in shares) at Dec. 31, 2020 | 43,477,439 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation expense | $ 0 | 2,793 | 0 | 0 | 0 | 2,793 |
Net loss | 0 | 0 | 0 | (17,457) | 0 | (17,457) |
Other comprehensive loss | 0 | 0 | (31) | 0 | 0 | (31) |
Balance at Mar. 31, 2021 | $ 4 | 449,394 | (40) | (70,786) | 0 | 378,572 |
Balance (in shares) at Mar. 31, 2021 | 43,477,439 | |||||
Balance at Dec. 31, 2021 | $ 4 | 463,089 | (524) | (143,092) | 35,000 | 319,477 |
Balance (in shares) at Dec. 31, 2021 | 43,855,944 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock-based compensation expense | $ 0 | 4,777 | 0 | 0 | 0 | 4,777 |
Exercise of stock options | $ 0 | 125 | 0 | 0 | 0 | 125 |
Exercise of stock options (in shares) | 100,105 | |||||
Net loss | $ 0 | 0 | 0 | (26,902) | 0 | (26,902) |
Other comprehensive loss | 0 | 0 | (1,656) | 0 | 0 | (1,656) |
Balance at Mar. 31, 2022 | $ 4 | $ 467,991 | $ (2,180) | $ (169,994) | $ 35,000 | $ 295,821 |
Balance (in shares) at Mar. 31, 2022 | 43,956,049 |
Organization and Basis of Presentation |
3 Months Ended |
---|---|
Mar. 31, 2022 | |
Organization and Basis of Presentation [Abstract] | |
Organization and Basis of Presentation |
1. Organization and Basis of Presentation
Organization and Nature of Operations
Kinnate Biopharma Inc. (Kinnate or the Company) was incorporated in the State of
Delaware in January 2018 and is headquartered in San Francisco, California. The Company is a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers.
Since its inception, the Company has devoted substantially all of its resources to
research and development activities, business planning, establishing and maintaining its intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations. It has incurred
losses and negative cash flows from operations since commencement of its operations. The Company had an accumulated deficit of $170.0
million and had cash and cash equivalents and short-term and long-term investments totaling $302.4 million as of March 31, 2022,
exclusive of $31.0 million at its consolidated joint venture discussed in the paragraph below. From its inception through March 31, 2022,
the Company has financed its operations primarily through issuances of common stock, including in the Company’s initial public offering (IPO), and private placements of convertible preferred stock.
In May 2021, the Company announced the closing of a Series A preferred stock
financing of a China joint venture, Kinnjiu Biopharma Inc. (Kinnjiu), to enable the potential development and commercialization of certain targeted oncology product candidates across Greater China (PRC, Hong Kong, Taiwan, and Macau). Contributions
from noncontrolling interest members totaled $35.0 million before issuance costs of $0.2 million. As of March 31, 2022, the Company held a 54.9%
equity interest in Kinnjiu.
As the Company continues to pursue its business plan, it expects to finance its
operations through the sale of equity, debt financings or other capital resources, which could include income from collaborations, strategic partnerships or marketing, distribution, licensing or other strategic arrangements with third parties, or
from grants. However, there can be no assurance that any additional financing or strategic transactions will be available to the Company on acceptable terms, if at all. If events or circumstances occur such that the Company does not obtain
additional funding, it may need to delay, reduce or eliminate its product development or future commercialization efforts, which could have a material adverse effect on the Company’s business, results of operations or financial condition. The
accompanying financial statements do not include any adjustments that might be necessary if the Company were unable to continue as a going concern. Management believes that it has sufficient working capital on hand to fund operations through at
least the next twelve months from the date this Quarterly Report on Form 10-Q is filed with the U.S. Securities and Exchange Commission (SEC).
Basis of Presentation
The Company’s condensed consolidated financial statements have been prepared in
accordance with U.S. generally accepted accounting principles (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of SEC Regulation S-X. Accordingly, since they are interim statements, the
accompanying condensed consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements.
The accompanying unaudited interim consolidated financial statements include all
known adjustments which, in the opinion of management, are necessary for a fair presentation of the results as required by GAAP. These adjustments consist primarily of normal recurring accruals and estimates that impact the carrying value of assets
and liabilities. The Condensed Consolidated Balance Sheet at December 31, 2021 has been derived from the audited financial statements at that date, but does not include all information and footnotes required by GAAP for complete financial
statements. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2021 included in the Company’s Annual Report on Form
10-K filed with the SEC on March 28, 2022.
The condensed consolidated financial statements include the
accounts of the Company’s variable interest entity (VIE), Kinnjiu, for which the Company is the primary beneficiary. All intercompany transactions and balances have been eliminated in consolidation.
The Company evaluates its ownership, contractual and other
interests in entities that are not wholly-owned to determine if these entities are VIEs, and, if so, whether the Company is the primary beneficiary of the VIE. In determining whether the Company is the primary beneficiary of a VIE and therefore
required to consolidate the VIE, the Company applies a qualitative approach that determines whether the Company has both (1) the power to direct the activities of the VIE that most significantly impact the VIE’s economic performance and (2) the
obligation to absorb losses of, or the rights to receive benefits from, the VIE that could potentially be significant to that VIE. As of March 31, 2022, the Company held a 54.9% equity interest in Kinnjiu. Based on the Company’s assessment, the Company concluded that Kinnjiu is a VIE and the Company is the primary beneficiary.
The Company will continuously assess whether it is the
primary beneficiary of a VIE, as changes to existing relationships or future transactions may result in the consolidation or deconsolidation of such VIE. During the periods presented, the Company has not provided any other financial or other
support to the Company’s VIE that it was not contractually required to provide.
Operating results presented in these unaudited condensed consolidated financial statements are not necessarily indicative of future results, particularly in light of the COVID-19 pandemic and its impact on domestic and global
economies. To limit the spread of the novel coronavirus that causes COVID-19, governments have taken various actions including the issuance of stay-at-home orders and physical distancing guidelines. Accordingly, businesses have adjusted,
reduced or suspended operating activities. Between March 2020 and June 2021, the Company’s employees worked almost exclusively from home. Since June 2021, the Company’s employees have been working in a hybrid model both in the Company’s
offices and also from home. Although some of the governmental orders and guidelines have terminated or are now less restrictive than when originally implemented, the Company continues to monitor and assess the spread of COVID-19 and may need
to further adjust its working model from time to time. The ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change, based, in part, on the length and severity of any additional restrictions and other limitations
that may be imposed on the Company’s business. As a result, research and development expenses and general and administrative expenses may vary significantly if there is an increased impact from the COVID-19
pandemic on the costs and timing associated with the conduct of the clinical activities and other related business activities.
|
Summary of Significant Accounting Policies |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Significant Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Significant Accounting Policies |
2. Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the
reporting period. Accounting estimates and management judgments reflected in the financial statements include: normal recurring accruals, including the accrual of research and development expenses; valuation of deferred tax assets; and stock-based
compensation. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may materially differ from these estimates and assumptions. Although the impact of the COVID-19
pandemic to the Company’s business and operating results presents additional uncertainty, the Company continues to use the best information available to update its critical accounting estimates.
Leases
The
Company determines if an arrangement is or contains a lease at inception. For leases with a term greater than one year, right-of-use
assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses its incremental borrowing rate
which represents an estimated rate of interest that the Company would have to pay to borrow equivalent funds on a collateralized basis at the lease commencement date. Leases are classified as finance or operating, with classification affecting
the pattern and classification of expense recognition in the Condensed Consolidated Statement of Operations and Comprehensive Loss. The Company’s leases often include options to extend or terminate the lease. These options are included in the
lease term when it is reasonably certain that the Company will exercise that option. As of March 31, 2022, it is not reasonably certain that these options will be exercised and they are not included within the lease term.
Redeemable Convertible Noncontrolling Interests
The shares third parties own in Kinnjiu represent an interest in the equity the
Company does not control. The redeemable convertible noncontrolling interests attributable to other owners has been classified in temporary equity on the Condensed Consolidated Balance Sheets as the preferred stock is redeemable by the
noncontrolling interests.
Since the preferred stock held at Kinnjiu does not represent a residual equity
interest, net losses of Kinnjiu are not allocated to the preferred shares. As a result, the balance of the preferred stock classified as a redeemable convertible noncontrolling interest equals its carrying value.
Net Loss Per Share
Basic net loss per common share is calculated by dividing the net loss attributable
to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration of potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common
stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, the Company’s common stock options are considered to be
potentially dilutive securities. As the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for those periods.
The following table sets forth the computation of the basic and diluted net loss per
share (in thousands, except share and per share amounts):
The following outstanding shares of potentially dilutive
securities were excluded from the computation of diluted net loss per share for the periods presented because including them would have been anti-dilutive:
Recently Adopted Accounting Pronouncements
From time
to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) under its accounting standard codifications (ASC) or other standard setting bodies and adopted by the Company as of the specified effective date,
unless otherwise discussed below.
In
February 2016, the FASB issued Accounting Standard Update (ASU) No. 2016-02, Leases (Topic 842) (ASC 842), which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both parties to a contract (i.e.,
lessees and lessors). The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether the lease is effectively a financed purchase by the lessee. This
classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease
liability for all leases with a term of greater than 12 months regardless of their classification. ASC 842 provides a lessee with an option to not account for leases with a term of 12 month or less as leases in the scope of the new standard. ASC
842 supersedes the previous leases standard, ASC 840 Leases. For public business entities, this ASU is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years, and should be applied through a
modified retrospective transition approach for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. Early adoption is permitted. As amended by ASU No. 2020-05, for all
other entities, this ASU is effective for fiscal years beginning after December 15, 2021 and interim periods within fiscal years beginning after December 15, 2022. As a result of the Company having elected the extended transition period for
complying with new or revised accounting standards pursuant to Section 107(b) of the JOBS Act, ASU No. 2016-02 is effective for the Company for the year ended December 31, 2022, and all interim periods within. In July 2018, the FASB issued
supplemental adoption guidance and clarification to ASC 842 within ASU No. 2018-10, Codification Improvements to Topic 842, Leases and ASU No. 2018-11, Leases (Topic 842): Targeted Improvements. ASU No. 2018-11 provides another transition method
in addition to the existing modified retrospective transition method by allowing entities to initially apply the new leasing standard at the adoption date and recognize a cumulative-effect adjustment to the opening balance of accumulated deficit
in the period of adoption. On January 1, 2022, the Company adopted ASC 842 using the modified retrospective approach. Accordingly, prior period financial information and disclosures have not been adjusted and continue to be reported in accordance
with the Company’s historical accounting under the previous lease standard. In addition, the Company elected the package of practical expedients available for existing contracts, which allowed it to carry forward historical assessments of lease
identification, lease classification, and initial direct costs. As a result of adopting ASC 842, the Company recognized right-of-use assets and lease liabilities of $3.7 million and $4.2 million, respectively, on January 1, 2021, which are
related to the Company’s facility operating leases. The difference between the right-of-use assets and lease liabilities is primarily attributed to unamortized lease incentives. There was no adjustment to the opening balance of accumulated
deficit as a result of the adoption of ASC 842.
Recently Issued Accounting Pronouncements Not Yet Adopted
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326) (ASC
326): Measurement of Credit Losses on Financial Instruments, which introduced the expected credit losses methodology for the measurement of credit losses on financial assets measured at amortized cost basis, replacing the previous incurred loss
methodology. The amendments in ASU No. 2016-13 added Topic 326, Financial Instruments—Credit Losses, made several consequential amendments to the Codification. ASU No. 2016-13 also modified the accounting for available-for-sale debt securities,
which must be individually assessed for credit losses when fair value is less than the amortized cost basis, in accordance with Subtopic 326-30, Financial Instruments— Credit Losses—Available-for-Sale Debt Securities. The guidance is effective for
public business entities for annual periods beginning after December 15, 2019, including interim periods within those years. For all other entities, the standard is effective for annual periods beginning after December 15, 2022 and interim periods,
therein. Early adoption is permitted. Since the Company has elected to use the extended transition period under the JOBS Act available to EGCs, the ASU is effective for the Company for fiscal years beginning after December 15, 2022. The Company
does not expect the adoption to have a material impact on its financial statements.
In December 2019, the FASB issued ASU No. 2019-12, Income Taxes—Simplifying the Accounting
for Income Taxes (ASU No. 2019-12). Among other items, the amendments in ASU No. 2019-12 simplify the accounting treatment of tax law changes and year-to-date losses in interim periods. An entity generally recognizes the effects of a change in
tax law in the period of enactment; however, there is an exception for tax laws with delayed effective dates. Under current guidance, an entity may not adjust its annual effective tax rate for a tax law change until the period in which the law is
effective. This exception was removed under ASU No. 2019-12, thereby providing that all effects of a tax law change are recognized in the period of enactment, including adjustment of the estimated annual effective tax rate. Regarding year-to-date
losses in interim periods, an entity is required to estimate its annual effective tax rate for the full fiscal year at the end of each interim period and use that rate to calculate its income taxes on a year-to-date basis. However, current
guidance provides an exception that when a loss in an interim period exceeds the anticipated loss for the year, the income tax benefit is limited to the amount that would be recognized if the year-to-date loss were the anticipated loss for the
full year. ASU No. 2019-12 removes this exception and provides that, in this situation, an entity would compute its income tax benefit at each interim period based on its estimated annual effective tax rate. ASU No. 2019-12 is effective for
fiscal years beginning after December 15, 2020, including interim periods within those annual periods. Early adoption is permitted. For EGCs, the standard is effective for fiscal years beginning after December 15, 2021, and for interim periods
beginning after December 15, 2022. The Company does not expect the ASU to have a material impact on its financial statements and related disclosures.
|
Cash, cash equivalents and restricted cash |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||
Cash, cash equivalents and restricted cash [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
Cash, cash equivalents and restricted cash |
3. Cash, cash equivalents and restricted cash
The following table
provides a reconciliation of the components of cash, cash equivalents and restricted cash reported in the Condensed Consolidated Statements of Cash Flows (in thousands):
The cash at the consolidated joint venture represents cash held at Kinnjiu and the use of such cash is limited to the operations of
Kinnjiu (see Note 11). The restricted cash balance relates to the Company’s office lease in San Diego, California (see Note 12).
|
Property and Equipment, Net |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property and Equipment, Net [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property and Equipment, Net |
4. Property and Equipment, Net
Property and equipment, net consisted of the following (in thousands):
|
Accrued Expenses |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Expenses [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Expenses |
5. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
|
Investments |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments |
6. Investments
The Company has invested its excess cash in marketable securities as of March 31,
2022 and December 31, 2021. The following is a summary by significant investment category (in thousands):
At March 31, 2022 and December 31, 2021, the Company held
securities in a total unrealized loss position of $2.2 million and $0.5 million, respectively. The Company generally does not intend to sell any investments prior to recovery of their amortized cost basis for any investment in an unrealized
loss position. Further, such investments are invested in high grade securities. As such, the Company has classified these losses as temporary in nature.
The Company has determined that there were no material declines in fair value of its investments due to credit-related factors as of March 31, 2022 and December 31, 2021.
|
Fair Value Measurements |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements |
7. Fair Value Measurements
The accounting guidance defines fair value, establishes a consistent framework for
measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an exit price, representing the amount that would be received to
sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an
asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
Level 1: Observable inputs such as quoted prices in active markets;
Level 2: Inputs, other than the quoted prices in active markets, that are
observable either directly or indirectly; and
Level 3: Unobservable inputs in which there is little or no market data, which
require the reporting entity to develop its own assumptions.
The carrying amounts of the Company’s prepaid expenses and other current assets,
accounts payable and accrued expenses are generally considered to be representative of their fair value because of the short-term nature of these instruments. The Company’s investments, which may include money market funds and available-for-sale
investment securities consisting of high-quality, marketable debt instruments of corporations and the U.S. government are measured at fair value in accordance with the fair value hierarchy.
The following tables present the hierarchy for assets measured at fair value on a
recurring basis (in thousands):
Money market funds are classified as cash and cash equivalents
in the Company’s balance sheets at March 31, 2022 and December 31, 2021.
|
Stockholders' Equity |
3 Months Ended |
---|---|
Mar. 31, 2022 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity |
8. Stockholders’ Equity
Under its Amended and Restated Articles of Incorporation dated December 7, 2020, the
Company had a total of 1,200,000,000 shares of capital stock authorized for issuance, consisting of 1,000,000,000 shares of common stock, par value of $0.0001
per share, and 200,000,000 shares of preferred stock, par value of $0.0001 per share.
|
Equity Incentive Plans and Stock-Based Compensation |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity Incentive Plans and Stock-Based Compensation [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity Incentive Plans and Stock-Based Compensation |
9. Equity Incentive Plans and Stock-Based Compensation
2020 Equity Incentive Plan
In December 2020, the Company adopted the 2020 Equity Incentive Plan (2020 Plan),
which replaced the 2018 Equity Incentive Plan (2018 Plan). The 2020 Plan allows the Company to issue options for shares of its common stock, among other award types, up to a total of 5,218,000 shares (Option Pool), subject to appropriate adjustments for stock splits, combinations and other similar events for issuance pursuant to awards made under the 2020
Plan. As of March 31, 2022, 2,221,150 shares of common stock remained available for future grants under the 2020 Plan.
The options that are granted under the 2020 and 2018 Plans are exercisable at
various dates as determined upon grant and terminate within 10 years of the date of grant, unless the optionee owns 10% or more of the common shares at which point the expiration period is 5 years, or upon the employee’s termination (whereupon the terminated employee has thirty days after termination to exercise vested options from the date of termination). The vesting period generally occurs over
to four years unless there is a specific performance vesting trigger at which time those shares will vest when the performance
trigger is probable to occur.
Stock option activity, is as follows:
All exercisable options are vested and all outstanding options
are vested or expected to vest. Total intrinsic value of options exercised during the three months ended March 31, 2022 was $0.8
million. No options were exercised during the three months ended March 31, 2021.
2020 Employee Stock Purchase Plan
The 2020 Employee Stock Purchase Plan (ESPP) permits eligible
employees who elect to participate in an offering under the ESPP to have up to 15% of their eligible earnings withheld, subject to
certain limitations, to purchase shares of common stock pursuant to the ESPP. The price of common stock purchased under the ESPP is equal to 85%
of the lower of the fair market value of the common stock at the commencement date of each offering period or the relevant date of purchase. Each offering period is six months, with new offering periods commencing every six months on or about the dates of May 15 and
November 15 of each year. A total of 435,000 shares of common stock were initially reserved for issuance under the ESPP.
Kinnjiu Equity Incentive
Plan
In
May 2021, Kinnjiu adopted the 2021 Equity Incentive Plan (2021 Plan), which allows for the issuance of options for shares of common stock and share appreciation rights, among other award types, up to a total of 9,000,000 shares subject to appropriate adjustments for stock splits, combinations and other similar events for issuance pursuant to awards made under
the 2021 Plan. As of March 31, 2022, 2,882,500 shares of common stock remained available for future grants under the 2021 Plan.
Stock-Based Compensation Expense
The Company estimated the fair value of stock
options using the Black-Scholes valuation model. The Company accounts for any forfeitures of options when they occur. Previously recognized compensation expense for an award is reversed in the period that the award is forfeited. The
fair value of stock options was estimated using the following assumptions:
The weighted-average grant-date fair value of options granted
was $7.32 and $25.80 for
the three months ended March 31, 2022 and 2021, respectively.
The assumptions used for the three months ended March 31, 2022
and 2021 under the ESPP were as follows:
Stock-based compensation expense related to the Company’s
stock options and ESPP totaled the following (in thousands):
As of March 31, 2022, there was approximately $53.8 million of total unrecognized stock-based compensation expense related to nonvested stock-based compensation arrangements, which is expected to be
recognized over a weighted-average period of approximately 2.76 years.
As of March 31, 2022, there was approximately $0.1 million of total unrecognized stock-based compensation expense related to the ESPP.
|
Related Party Transactions |
3 Months Ended |
---|---|
Mar. 31, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transactions |
10. Related Party Transactions
Series A Preferred Stock Financing of Kinnjiu
In connection with the Series A preferred stock
financing of Kinnjiu, contributions from noncontrolling interest members totaled $35.0 million. Such noncontrolling interest members
are also investors or affiliates of investors in the Company and have representatives that serve on both the Company’s board of directors and the board of directors of Kinnjiu.
|
Variable Interest Entity |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Variable Interest Entity [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Variable Interest Entity |
11. Variable Interest Entity
As disclosed above, in May 2021, the Company announced the closing of a Series A preferred stock financing of Kinnjiu to enable the potential development
and commercialization of certain targeted oncology product candidates across Greater China. Contributions from noncontrolling interest members totaled $35.0
million before issuance costs of $0.2 million. As of March 31, 2022, the Company held a 54.9% equity interest in Kinnjiu. As the Company determined it was the primary beneficiary of this VIE, the VIE has been consolidated in the Company’s condensed consolidated
financial statements.
The
Company provides certain general and administrative and research and development services to Kinnjiu pursuant to intercompany agreements; however, the Company does not provide any financial support and has no obligation to fund operations of Kinnjiu.
The following table summarizes the fair value of Kinnjiu as of May 13, 2021 recorded upon initial consolidation in the Company’s Condensed Consolidated
Balance Sheets and the carrying amount of such assets and liabilities as of March 31, 2022, excluding intercompany balances (in thousands):
|
Commitments and Contingencies |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies |
12. Commitments and Contingencies
Litigation
The Company,
from time to time, is involved in legal proceedings, regulatory actions, claims and litigation arising in the ordinary course of business. The Company was not a defendant in any lawsuit for the three months ended March 31, 2022 and 2021 that, in
the opinion of Company’s management, is likely to have a material adverse effect on the Company’s business.
Operating Leases
In June
2021, the Company entered into an agreement to lease 8,088 rentable square feet of office space (SD Permanent Space) located in San
Diego, California (SD Lease) for a period of five years and four months expiring on July 31, 2027. Additionally, the Company has an
option to extend the SD Lease for an additional five years at the end of the initial term. The SD Lease commenced in March 2022.
In
connection with the execution of the SD Lease, the Company provided a standby letter of credit for $0.4 million in lieu of a security
deposit, which is classified as restricted cash on the Condensed Consolidated Balance Sheets. So long as the Company is not in default under the SD Lease, this amount will decrease after each of years three and four of the SD Lease term to $0.3 million.
In
August 2021, the Company entered into an agreement to lease 5,698 rentable square feet of office space located in San Francisco,
California (SF Lease). The SF Lease commenced in January 2022 and expires on June 30, 2026. The Company has an option to extend the SF Lease for an additional three years at the end of the initial term.
The
operating lease right-of-use assets and liabilities on the Company’s Condensed Consolidated Balance Sheet related to these facility leases. The right-of-use lease assets were $4.0 million as of March 31, 2022. Operating lease liabilities were $4.6 million
as of March 31, 2022, including $0.5 million classified as a current liability.
Our facility leases require us to pay property taxes, insurance and common area
maintenance. While these payments are not included as part of our lease liabilities, they are recognized as variable lease cost in the period they are incurred.
Operating
lease costs under operating leases for the three months ended March 31, 2022 was approximately $0.1 million. The weighted-average
discount rate used was 7.0%. The weighted-average remaining lease term for operating leases was 4.8 years.
Future lease payments of
operating lease liabilities as of March 31, 2022 were as follows (in thousands):
Under ASC 840, Future minimum lease payments
under non-cancelable operating leases as of December 31, 2021 were as follows (in thousands):
|
Organization and Basis of Presentation (Policies) |
3 Months Ended |
---|---|
Mar. 31, 2022 | |
Organization and Basis of Presentation [Abstract] | |
Organization and Nature of Operations |
Organization and Nature of Operations
Kinnate Biopharma Inc. (Kinnate or the Company) was incorporated in the State of
Delaware in January 2018 and is headquartered in San Francisco, California. The Company is a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers.
Since its inception, the Company has devoted substantially all of its resources to
research and development activities, business planning, establishing and maintaining its intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations. It has incurred
losses and negative cash flows from operations since commencement of its operations. The Company had an accumulated deficit of $170.0
million and had cash and cash equivalents and short-term and long-term investments totaling $302.4 million as of March 31, 2022,
exclusive of $31.0 million at its consolidated joint venture discussed in the paragraph below. From its inception through March 31, 2022,
the Company has financed its operations primarily through issuances of common stock, including in the Company’s initial public offering (IPO), and private placements of convertible preferred stock.
In May 2021, the Company announced the closing of a Series A preferred stock
financing of a China joint venture, Kinnjiu Biopharma Inc. (Kinnjiu), to enable the potential development and commercialization of certain targeted oncology product candidates across Greater China (PRC, Hong Kong, Taiwan, and Macau). Contributions
from noncontrolling interest members totaled $35.0 million before issuance costs of $0.2 million. As of March 31, 2022, the Company held a 54.9%
equity interest in Kinnjiu.
As the Company continues to pursue its business plan, it expects to finance its
operations through the sale of equity, debt financings or other capital resources, which could include income from collaborations, strategic partnerships or marketing, distribution, licensing or other strategic arrangements with third parties, or
from grants. However, there can be no assurance that any additional financing or strategic transactions will be available to the Company on acceptable terms, if at all. If events or circumstances occur such that the Company does not obtain
additional funding, it may need to delay, reduce or eliminate its product development or future commercialization efforts, which could have a material adverse effect on the Company’s business, results of operations or financial condition. The
accompanying financial statements do not include any adjustments that might be necessary if the Company were unable to continue as a going concern. Management believes that it has sufficient working capital on hand to fund operations through at
least the next twelve months from the date this Quarterly Report on Form 10-Q is filed with the U.S. Securities and Exchange Commission (SEC).
|
Basis of Presentation |
Basis of Presentation
The Company’s condensed consolidated financial statements have been prepared in
accordance with U.S. generally accepted accounting principles (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of SEC Regulation S-X. Accordingly, since they are interim statements, the
accompanying condensed consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements.
The accompanying unaudited interim consolidated financial statements include all
known adjustments which, in the opinion of management, are necessary for a fair presentation of the results as required by GAAP. These adjustments consist primarily of normal recurring accruals and estimates that impact the carrying value of assets
and liabilities. The Condensed Consolidated Balance Sheet at December 31, 2021 has been derived from the audited financial statements at that date, but does not include all information and footnotes required by GAAP for complete financial
statements. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2021 included in the Company’s Annual Report on Form
10-K filed with the SEC on March 28, 2022.
The condensed consolidated financial statements include the
accounts of the Company’s variable interest entity (VIE), Kinnjiu, for which the Company is the primary beneficiary. All intercompany transactions and balances have been eliminated in consolidation.
The Company evaluates its ownership, contractual and other
interests in entities that are not wholly-owned to determine if these entities are VIEs, and, if so, whether the Company is the primary beneficiary of the VIE. In determining whether the Company is the primary beneficiary of a VIE and therefore
required to consolidate the VIE, the Company applies a qualitative approach that determines whether the Company has both (1) the power to direct the activities of the VIE that most significantly impact the VIE’s economic performance and (2) the
obligation to absorb losses of, or the rights to receive benefits from, the VIE that could potentially be significant to that VIE. As of March 31, 2022, the Company held a 54.9% equity interest in Kinnjiu. Based on the Company’s assessment, the Company concluded that Kinnjiu is a VIE and the Company is the primary beneficiary.
The Company will continuously assess whether it is the
primary beneficiary of a VIE, as changes to existing relationships or future transactions may result in the consolidation or deconsolidation of such VIE. During the periods presented, the Company has not provided any other financial or other
support to the Company’s VIE that it was not contractually required to provide.
Operating results presented in these unaudited condensed consolidated financial statements are not necessarily indicative of future results, particularly in light of the COVID-19 pandemic and its impact on domestic and global
economies. To limit the spread of the novel coronavirus that causes COVID-19, governments have taken various actions including the issuance of stay-at-home orders and physical distancing guidelines. Accordingly, businesses have adjusted,
reduced or suspended operating activities. Between March 2020 and June 2021, the Company’s employees worked almost exclusively from home. Since June 2021, the Company’s employees have been working in a hybrid model both in the Company’s
offices and also from home. Although some of the governmental orders and guidelines have terminated or are now less restrictive than when originally implemented, the Company continues to monitor and assess the spread of COVID-19 and may need
to further adjust its working model from time to time. The ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change, based, in part, on the length and severity of any additional restrictions and other limitations
that may be imposed on the Company’s business. As a result, research and development expenses and general and administrative expenses may vary significantly if there is an increased impact from the COVID-19
pandemic on the costs and timing associated with the conduct of the clinical activities and other related business activities.
|
Summary of Significant Accounting Policies (Policies) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Significant Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Use of Estimates |
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the
reporting period. Accounting estimates and management judgments reflected in the financial statements include: normal recurring accruals, including the accrual of research and development expenses; valuation of deferred tax assets; and stock-based
compensation. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may materially differ from these estimates and assumptions. Although the impact of the COVID-19
pandemic to the Company’s business and operating results presents additional uncertainty, the Company continues to use the best information available to update its critical accounting estimates.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Leases |
Leases
The
Company determines if an arrangement is or contains a lease at inception. For leases with a term greater than one year, right-of-use
assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses its incremental borrowing rate
which represents an estimated rate of interest that the Company would have to pay to borrow equivalent funds on a collateralized basis at the lease commencement date. Leases are classified as finance or operating, with classification affecting
the pattern and classification of expense recognition in the Condensed Consolidated Statement of Operations and Comprehensive Loss. The Company’s leases often include options to extend or terminate the lease. These options are included in the
lease term when it is reasonably certain that the Company will exercise that option. As of March 31, 2022, it is not reasonably certain that these options will be exercised and they are not included within the lease term.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Redeemable Convertible Noncontrolling Interests |
Redeemable Convertible Noncontrolling Interests
The shares third parties own in Kinnjiu represent an interest in the equity the
Company does not control. The redeemable convertible noncontrolling interests attributable to other owners has been classified in temporary equity on the Condensed Consolidated Balance Sheets as the preferred stock is redeemable by the
noncontrolling interests.
Since the preferred stock held at Kinnjiu does not represent a residual equity
interest, net losses of Kinnjiu are not allocated to the preferred shares. As a result, the balance of the preferred stock classified as a redeemable convertible noncontrolling interest equals its carrying value.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss Per Share |
Net Loss Per Share
Basic net loss per common share is calculated by dividing the net loss attributable
to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration of potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common
stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, the Company’s common stock options are considered to be
potentially dilutive securities. As the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for those periods.
The following table sets forth the computation of the basic and diluted net loss per
share (in thousands, except share and per share amounts):
The following outstanding shares of potentially dilutive
securities were excluded from the computation of diluted net loss per share for the periods presented because including them would have been anti-dilutive:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Recently Adopted Accounting Pronouncements and Recently Issued Accounting Pronouncements Not Yet Adopted |
Recently Adopted Accounting Pronouncements
From time
to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) under its accounting standard codifications (ASC) or other standard setting bodies and adopted by the Company as of the specified effective date,
unless otherwise discussed below.
In
February 2016, the FASB issued Accounting Standard Update (ASU) No. 2016-02, Leases (Topic 842) (ASC 842), which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both parties to a contract (i.e.,
lessees and lessors). The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether the lease is effectively a financed purchase by the lessee. This
classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease
liability for all leases with a term of greater than 12 months regardless of their classification. ASC 842 provides a lessee with an option to not account for leases with a term of 12 month or less as leases in the scope of the new standard. ASC
842 supersedes the previous leases standard, ASC 840 Leases. For public business entities, this ASU is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years, and should be applied through a
modified retrospective transition approach for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. Early adoption is permitted. As amended by ASU No. 2020-05, for all
other entities, this ASU is effective for fiscal years beginning after December 15, 2021 and interim periods within fiscal years beginning after December 15, 2022. As a result of the Company having elected the extended transition period for
complying with new or revised accounting standards pursuant to Section 107(b) of the JOBS Act, ASU No. 2016-02 is effective for the Company for the year ended December 31, 2022, and all interim periods within. In July 2018, the FASB issued
supplemental adoption guidance and clarification to ASC 842 within ASU No. 2018-10, Codification Improvements to Topic 842, Leases and ASU No. 2018-11, Leases (Topic 842): Targeted Improvements. ASU No. 2018-11 provides another transition method
in addition to the existing modified retrospective transition method by allowing entities to initially apply the new leasing standard at the adoption date and recognize a cumulative-effect adjustment to the opening balance of accumulated deficit
in the period of adoption. On January 1, 2022, the Company adopted ASC 842 using the modified retrospective approach. Accordingly, prior period financial information and disclosures have not been adjusted and continue to be reported in accordance
with the Company’s historical accounting under the previous lease standard. In addition, the Company elected the package of practical expedients available for existing contracts, which allowed it to carry forward historical assessments of lease
identification, lease classification, and initial direct costs. As a result of adopting ASC 842, the Company recognized right-of-use assets and lease liabilities of $3.7 million and $4.2 million, respectively, on January 1, 2021, which are
related to the Company’s facility operating leases. The difference between the right-of-use assets and lease liabilities is primarily attributed to unamortized lease incentives. There was no adjustment to the opening balance of accumulated
deficit as a result of the adoption of ASC 842.
Recently Issued Accounting Pronouncements Not Yet Adopted
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326) (ASC
326): Measurement of Credit Losses on Financial Instruments, which introduced the expected credit losses methodology for the measurement of credit losses on financial assets measured at amortized cost basis, replacing the previous incurred loss
methodology. The amendments in ASU No. 2016-13 added Topic 326, Financial Instruments—Credit Losses, made several consequential amendments to the Codification. ASU No. 2016-13 also modified the accounting for available-for-sale debt securities,
which must be individually assessed for credit losses when fair value is less than the amortized cost basis, in accordance with Subtopic 326-30, Financial Instruments— Credit Losses—Available-for-Sale Debt Securities. The guidance is effective for
public business entities for annual periods beginning after December 15, 2019, including interim periods within those years. For all other entities, the standard is effective for annual periods beginning after December 15, 2022 and interim periods,
therein. Early adoption is permitted. Since the Company has elected to use the extended transition period under the JOBS Act available to EGCs, the ASU is effective for the Company for fiscal years beginning after December 15, 2022. The Company
does not expect the adoption to have a material impact on its financial statements.
In December 2019, the FASB issued ASU No. 2019-12, Income Taxes—Simplifying the Accounting
for Income Taxes (ASU No. 2019-12). Among other items, the amendments in ASU No. 2019-12 simplify the accounting treatment of tax law changes and year-to-date losses in interim periods. An entity generally recognizes the effects of a change in
tax law in the period of enactment; however, there is an exception for tax laws with delayed effective dates. Under current guidance, an entity may not adjust its annual effective tax rate for a tax law change until the period in which the law is
effective. This exception was removed under ASU No. 2019-12, thereby providing that all effects of a tax law change are recognized in the period of enactment, including adjustment of the estimated annual effective tax rate. Regarding year-to-date
losses in interim periods, an entity is required to estimate its annual effective tax rate for the full fiscal year at the end of each interim period and use that rate to calculate its income taxes on a year-to-date basis. However, current
guidance provides an exception that when a loss in an interim period exceeds the anticipated loss for the year, the income tax benefit is limited to the amount that would be recognized if the year-to-date loss were the anticipated loss for the
full year. ASU No. 2019-12 removes this exception and provides that, in this situation, an entity would compute its income tax benefit at each interim period based on its estimated annual effective tax rate. ASU No. 2019-12 is effective for
fiscal years beginning after December 15, 2020, including interim periods within those annual periods. Early adoption is permitted. For EGCs, the standard is effective for fiscal years beginning after December 15, 2021, and for interim periods
beginning after December 15, 2022. The Company does not expect the ASU to have a material impact on its financial statements and related disclosures.
|
Summary of Significant Accounting Policies (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Significant Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Basic and Diluted Net Loss Per Share |
The following table sets forth the computation of the basic and diluted net loss per
share (in thousands, except share and per share amounts):
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dilutive Securities Excluded from Computation of Diluted Net Loss Per Share |
The following outstanding shares of potentially dilutive
securities were excluded from the computation of diluted net loss per share for the periods presented because including them would have been anti-dilutive:
|
Cash, cash equivalents and restricted cash (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||
Cash, cash equivalents and restricted cash [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
Components of cash, cash equivalents and restricted cash |
The following table
provides a reconciliation of the components of cash, cash equivalents and restricted cash reported in the Condensed Consolidated Statements of Cash Flows (in thousands):
|
Property and Equipment, Net (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property and Equipment, Net [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property and Equipment, Net |
Property and equipment, net consisted of the following (in thousands):
|
Accrued Expenses (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Expenses [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Expenses |
Accrued expenses consisted of the following (in thousands):
|
Investments (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments by Type and Classes of Security |
The Company has invested its excess cash in marketable securities as of March 31,
2022 and December 31, 2021. The following is a summary by significant investment category (in thousands):
|
Fair Value Measurements (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Major Categories of Assets Measured at Fair Value on a Recurring Basis |
The following tables present the hierarchy for assets measured at fair value on a
recurring basis (in thousands):
|
Equity Incentive Plans and Stock-Based Compensation (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock Option Activity |
Stock option activity, is as follows:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation Expense |
Stock-based compensation expense related to the Company’s
stock options and ESPP totaled the following (in thousands):
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock Options [Member] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value of Stock Assumptions | The
fair value of stock options was estimated using the following assumptions:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Employee Stock Purchase Plan [Member] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value of Stock Assumptions |
The assumptions used for the three months ended March 31, 2022
and 2021 under the ESPP were as follows:
|
Variable Interest Entity (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Variable Interest Entity [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Carrying Amount of Assets and Liabilities |
The following table summarizes the fair value of Kinnjiu as of May 13, 2021 recorded upon initial consolidation in the Company’s Condensed Consolidated
Balance Sheets and the carrying amount of such assets and liabilities as of March 31, 2022, excluding intercompany balances (in thousands):
|
Commitments and Contingencies (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Future Lease Payments of Operating Lease Liabilities |
Future lease payments of
operating lease liabilities as of March 31, 2022 were as follows (in thousands):
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Future Minimum Lease Payments Under Non-Cancelable Operating Leases |
Under ASC 840, Future minimum lease payments
under non-cancelable operating leases as of December 31, 2021 were as follows (in thousands):
|
Organization and Basis of Presentation (Details) - USD ($) $ in Thousands |
1 Months Ended | 3 Months Ended | |
---|---|---|---|
May 31, 2021 |
Mar. 31, 2022 |
Dec. 31, 2021 |
|
Organization and Nature of Operations [Abstract] | |||
Accumulated deficit | $ (169,994) | $ (143,092) | |
Cash and cash equivalents and short-term and long-term investments | 302,400 | ||
Contributions from redeemable convertible noncontrolling interest owners, net | $ 35,000 | 35,000 | |
Contributions from noncontrolling interest owners, issuance cost | $ 200 | 200 | |
China Joint Venture [Member] | |||
Organization and Nature of Operations [Abstract] | |||
Cash and cash equivalents and short-term and long-term investments | $ 31,000 | ||
Equity interest held in joint venture | 54.90% |
Summary of Significant Accounting Policies, Leases (Details) |
Mar. 31, 2022 |
---|---|
Leases [Abstract] | |
Lease term | 1 year |
Summary of Significant Accounting Policies, Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2022 |
Mar. 31, 2021 |
|
Numerator [Abstract] | ||
Net loss attributable to Kinnate | $ (26,902) | $ (17,457) |
Denominator [Abstract] | ||
Weighted-average shares outstanding used in computing net loss per share, basic (in shares) | 43,882,920 | 43,477,439 |
Weighted-average shares outstanding used in computing net loss per share, diluted (in shares) | 43,882,920 | 43,477,439 |
Net loss per share, basic (in dollars per share) | $ (0.61) | $ (0.40) |
Net loss per share, diluted (in dollars per share) | $ (0.61) | $ (0.40) |
Options to Purchase Common Stock [Member] | ||
Dilutive Securities Excluded from Computation of Diluted Net Loss Per Share [Abstract] | ||
Dilutive securities excluded from computation of diluted net loss per share (in shares) | 9,235,652 | 7,261,364 |
Cash, cash equivalents and restricted cash (Details) - USD ($) $ in Thousands |
Mar. 31, 2022 |
Dec. 31, 2021 |
Mar. 31, 2021 |
Dec. 31, 2020 |
---|---|---|---|---|
Cash, cash equivalents and restricted cash [Abstract] | ||||
Cash and cash equivalents | $ 33,099 | $ 116,096 | ||
Cash at consolidated joint venture | 30,998 | 33,593 | ||
Restricted cash, non-current | 371 | 371 | ||
Total cash, cash equivalents and restricted cash reported in the Condensed Consolidated Statements of Cash Flows | $ 64,468 | $ 150,060 | $ 182,389 | $ 365,462 |
Property and Equipment, Net (Details) - USD ($) $ in Thousands |
Mar. 31, 2022 |
Dec. 31, 2021 |
---|---|---|
Property and Equipment [Abstract] | ||
Property and equipment | $ 3,408 | $ 1,093 |
Less accumulated depreciation | (195) | (137) |
Property and equipment, net | 3,213 | 956 |
Furniture and Fixtures [Member] | ||
Property and Equipment [Abstract] | ||
Property and equipment | 606 | 5 |
Computers and Equipment [Member] | ||
Property and Equipment [Abstract] | ||
Property and equipment | 432 | 381 |
Computer Software [Member] | ||
Property and Equipment [Abstract] | ||
Property and equipment | 69 | 69 |
Leasehold Improvements [Member] | ||
Property and Equipment [Abstract] | ||
Property and equipment | $ 2,301 | $ 638 |
Accrued Expenses (Details) - USD ($) $ in Thousands |
Mar. 31, 2022 |
Dec. 31, 2021 |
---|---|---|
Accrued Expenses [Abstract] | ||
Accrued research and development | $ 6,237 | $ 4,842 |
Accrued compensation | 1,403 | 3,344 |
Accrued legal fees | 478 | 425 |
Other accruals | 665 | 628 |
Total | $ 8,783 | $ 9,239 |
Stockholders' Equity (Details) - $ / shares |
Mar. 31, 2022 |
Dec. 31, 2021 |
Dec. 07, 2020 |
---|---|---|---|
Stockholders' Equity [Abstract] | |||
Capital shares authorized (in shares) | 1,200,000,000 | ||
Common stock, shares authorized (in shares) | 1,000,000,000 | 1,000,000,000 | 1,000,000,000 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 200,000,000 | 200,000,000 | 200,000,000 |
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Equity Incentive Plans and Stock-Based Compensation, Employee Stock Purchase Plan (Details) - 2020 Employee Stock Purchase Plan [Member] |
3 Months Ended |
---|---|
Mar. 31, 2022
shares
| |
Employee Stock Purchase Plan [Abstract] | |
Percentage of purchase date | 85.00% |
Offering period | 6 months |
New offering period | 6 months |
Common stock reserved for future issuance (in shares) | 435,000 |
Maximum [Member] | |
Employee Stock Purchase Plan [Abstract] | |
Percentage of offering date | 15.00% |
Equity Incentive Plans and Stock-Based Compensation, Kinnjiu Equity Incentive Plan (Details) - 2021 Equity Incentive Plan [Member] - Maximum [Member] |
Mar. 31, 2022
shares
|
---|---|
Kinnjiu Equity Incentive Plan [Abstract] | |
Number of shares of common stock options authorized to issue (in shares) | 9,000,000 |
Common stock remained available for issuance of shares (in shares) | 2,882,500 |
Related Party Transactions (Details) - USD ($) $ in Millions |
1 Months Ended | 3 Months Ended |
---|---|---|
May 31, 2021 |
Mar. 31, 2022 |
|
Related Party Transactions [Abstract] | ||
Contributions from redeemable convertible noncontrolling interest owners, net | $ 35.0 | $ 35.0 |