|
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
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Page
|
||
PART I—FINANCIAL INFORMATION
|
||
Item 1.
|
1
|
|
1
|
||
2
|
||
3
|
||
4
|
||
5
|
||
Item 2.
|
16
|
|
Item 3.
|
27
|
|
Item 4.
|
28
|
|
PART II—OTHER INFORMATION
|
||
Item 1.
|
30
|
|
Item 1A.
|
30
|
|
Item 2.
|
112 | |
Item 3.
|
113 | |
Item 4.
|
113 | |
Item 5.
|
113 | |
Item 6.
|
113 | |
• |
the ability of our ongoing and planned future preclinical studies and ongoing and planned future 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 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 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 under the Jumpstart Our Business Startups Act of 2012 (JOBS
Act); and
|
• |
our anticipated use of our existing resources.
|
September 30, 2021
|
December 31, 2020
|
|||||||
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
|
|
|
||||||
Long-term investments
|
|
|
||||||
Restricted cash |
||||||||
Other non-current assets |
||||||||
Total assets
|
$
|
|
$
|
|
||||
Liabilities and Stockholders’ Equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
|
$
|
|
||||
Accrued expenses
|
|
|
||||||
Total current 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 and equity
|
$
|
|
$
|
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
2021
|
2020
|
2021
|
2020
|
|||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
General and administrative (includes related party amounts of $
|
|
|
|
|
||||||||||||
Total operating expenses
|
|
|
|
|
||||||||||||
Loss from operations
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
Other income:
|
||||||||||||||||
Interest income
|
|
|
|
|
||||||||||||
Other expense, net
|
(
|
)
|
|
(
|
)
|
|
||||||||||
Total 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 income (loss) on investments
|
|
|
(
|
)
|
|
|||||||||||
Total comprehensive loss
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
Comprehensive loss attributable to redeemable convertible noncontrolling interests
|
|
|
|
|
||||||||||||
Comprehensive loss attributable to Kinnate
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
Series A
Convertible Preferred Stock |
Series B
Convertible Preferred Stock |
Series C Convertible Preferred Stock |
Common Stock
|
Additional
Paid-in |
Accumulated
Other
Comprehensive
|
Accumulated
|
Total
Stockholders’
|
Redeemable
Convertible Noncontrolling
|
||||||||||||||||||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Shares | Amount |
Shares
|
Amount
|
Capital
|
Loss
|
Deficit
|
(Deficit) Equity
|
Interests
|
||||||||||||||||||||||||||||||||||||||||
Balance at December 31, 2020 | - |
$ | - | - |
$ | - | - | $ | - | $ | $ | $ | ( |
) | $ | ( |
) | $ | $ | |||||||||||||||||||||||||||||||||
Stock-based compensation expense
|
- |
- |
- |
- |
- | - | - | |||||||||||||||||||||||||||||||||||||||||||||
Net loss
|
- |
- |
- |
- |
- | - | - | ( |
) | ( |
) | |||||||||||||||||||||||||||||||||||||||||
Other comprehensive loss
|
- |
- |
- |
- |
- | - | - | ( |
) | ( |
) | |||||||||||||||||||||||||||||||||||||||||
Balance at March 31, 2021 | - | $ | - | - | $ | - | - | $ | - | $ | $ | $ | ( |
) | $ | ( |
) | $ | $ | |||||||||||||||||||||||||||||||||
Stock-based compensation expense
|
- | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||
Exercise of stock options
|
- | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||
Shares issued under employee stock purchase plan
|
- | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||
Contributions from redeemable convertible noncontrolling interest owners
|
- | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||
Issuance costs for Series A preferred stock to redeemable NCI
|
- | - | - | - | - | - | - | ( |
) | ( |
) | |||||||||||||||||||||||||||||||||||||||||
Net loss
|
- | - | - | - | - | - | - | ( |
) | ( |
) | |||||||||||||||||||||||||||||||||||||||||
Other comprehensive loss
|
- | - | - | - | - | - | - | ( |
) | ( |
) | |||||||||||||||||||||||||||||||||||||||||
Balance at June 30, 2021 | - | $ | - | - | $ | - | - | $ | - | $ | $ | $ | ( |
) | $ | ( |
) | $ | $ | |||||||||||||||||||||||||||||||||
Stock-based compensation expense
|
- | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||
Exercise of stock options
|
- | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||
Net loss
|
- | - | - | - | - | - | - | ( |
) | ( |
) | |||||||||||||||||||||||||||||||||||||||||
Other comprehensive income
|
- | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2021 | - | $ | - | - | $ | - | - | $ | - | $ | $ | $ | ( |
) | $ | ( |
) | $ | $ | |||||||||||||||||||||||||||||||||
Balance at December 31, 2019
|
|
$
|
|
|
$
|
|
$ |
|
$
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
||||||||||||||||||||||||||||||
Issuance costs for Series B convertible preferred stock
|
-
|
|
-
|
(
|
)
|
- |
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense
|
-
|
-
|
-
|
-
|
- | - |
-
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
Exercise of stock options
|
-
|
-
|
-
|
-
|
- | - |
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
Net loss
|
-
|
|
-
|
|
- |
-
|
|
|
|
(
|
)
|
(
|
)
|
|
||||||||||||||||||||||||||||||||||||||
Balance at March 31, 2020
|
|
$
|
|
|
$
|
|
$ |
|
$
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
||||||||||||||||||||||||||||||
Stock-based compensation expense
|
-
|
-
|
-
|
-
|
- | - |
-
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
Exercise of stock options
|
-
|
-
|
-
|
-
|
- | - |
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
Net loss
|
-
|
|
-
|
|
- |
-
|
|
|
|
(
|
)
|
(
|
)
|
|
||||||||||||||||||||||||||||||||||||||
Balance at June 30, 2020
|
|
$
|
|
|
$
|
|
$ |
|
$
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
||||||||||||||||||||||||||||||
Issuance costs for Series C convertible
preferred stock
|
- | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense
|
- | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||
Exercise of stock options
|
- | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||
Shares acquired upon forfeiture | - | - | - | - | - | - | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||||||||||||||
Net loss | - | - | - | - | ( |
) | ( |
) | ||||||||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2020 | $ | $ | $ | $ | $ | $ | $ | ( |
) | $ | ( |
) | $ |
Nine Months Ended September 30,
|
||||||||
2021
|
2020
|
|||||||
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:
|
||||||||
Related party receivables, net
|
|
|
||||||
Prepaid expenses and other assets
|
(
|
)
|
(
|
)
|
||||
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:
|
||||||||
Issuance costs for Series B convertible preferred stock
|
|
(
|
)
|
|||||
Proceeds from issuance of Series C convertible preferred stock, net of issuance costs
|
||||||||
Payment of deferred offering costs
|
( |
) | ||||||
Contributions from redeemable convertible noncontrolling interest owners, net
|
||||||||
Proceeds (payments) upon stock option exercises, net of shares acquired upon forfeiture
|
|
(
|
)
|
|||||
Proceeds from issuance of common stock under employee stock purchase plan
|
||||||||
Net cash provided by financing activities
|
|
|
||||||
Net (decrease) increase 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: |
||||||||
Property and equipment included in accounts payable and accrued expenses
|
$ |
$ |
||||||
Deferred offering costs included in accounts payable and accrued expenses
|
$ |
$ |
Three Months Ended September 30, |
Nine Months Ended September 30,
|
|||||||||||||||
2021 |
2020 |
2021
|
2020
|
|||||||||||||
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 September 30, |
Nine Months Ended September 30,
|
|||||||||||||||
2021 |
2020 |
2021
|
2020
|
|||||||||||||
Options to purchase common stock
|
|
|
||||||||||||||
Convertible preferred stock
|
|
|
||||||||||||||
Total
|
|
|
September 30, 2021
|
December 31, 2020
|
|||||||
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
|
$
|
|
$
|
|
September 30, 2021
|
December 31, 2020
|
|||||||
Furniture and fixtures
|
$
|
|
$
|
|
||||
Computers and equipment
|
|
|
||||||
Computer software
|
|
|
||||||
Property and equipment
|
|
|
||||||
Less accumulated depreciation
|
(
|
)
|
(
|
)
|
||||
Property and equipment, net
|
$
|
|
$
|
|
September 30, 2021
|
December 31, 2020
|
|||||||
Accrued research and development
|
$
|
|
$
|
|
||||
Accrued compensation
|
|
|
||||||
Accrued legal fees
|
|
|
||||||
Other accruals
|
|
|
||||||
Total
|
$
|
|
$
|
|
September 30, 2021
|
|||||||||||||||||||
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
|
|
|
|
(
|
)
|
|