|
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.
|
16
|
|
Item 3.
|
27
|
|
Item 4.
|
27
|
|
PART II—OTHER INFORMATION
|
||
Item 1.
|
28
|
|
Item 1A.
|
28
|
|
Item 2.
|
100
|
|
Item 3.
|
100
|
|
Item 4.
|
100
|
|
Item 5.
|
100
|
|
Item 6.
|
101
|
|
102 |
• |
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 approval by the U.S. Food and Drug Administration (FDA) 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 COVID, supply chain disruptions, inflation and other drivers of macroeconomic volatility 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 under the Jumpstart Our Business Startups Act of 2012 (JOBS Act); and
|
• |
our anticipated use of our existing resources.
|
March 31, 2023
|
December 31, 2022
|
|||||||
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 |
||||||||
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,
|
||||||||
2023
|
2022
|
|||||||
Operating expenses:
|
||||||||
Research and development
|
$
|
|
$
|
|
||||
General and administrative
|
|
|
||||||
Total operating expenses
|
|
|
||||||
Loss from operations
|
(
|
)
|
(
|
)
|
||||
Other income, net
|
||||||||
Net loss | $ |
( |
) | $ |
( |
) | ||
Weighted-average shares outstanding, basic and diluted
|
||||||||
Net loss per share, basic and diluted
|
$ | ( |
) | $ | ( |
) | ||
Comprehensive loss: | ||||||||
Net loss | $ | ( |
) | $ | ( |
) | ||
Other comprehensive loss:
|
||||||||
Unrealized gain (loss) on investments
|
( |
) | ||||||
Total comprehensive loss | $ |
( |
) | $ |
( |
) |
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, 2022
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
|
|||||||||||||
Stock-based compensation expense
|
-
|
|
|
|
|
|
|
|||||||||||||||||||||
Acquisition of redeemable convertible noncontrolling interests
|
( |
) | ||||||||||||||||||||||||||
Shares issued under equity incentive plans
|
||||||||||||||||||||||||||||
Net loss
|
-
|
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||||||||
Other comprehensive gain
|
-
|
|
|
|
|
|
|
|||||||||||||||||||||
Balance at March 31, 2023
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
|
|||||||||||||
|
||||||||||||||||||||||||||||
Balance at December 31, 2021
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
|
|||||||||||||
Stock-based compensation expense
|
-
|
|
|
|
|
|
|
|||||||||||||||||||||
Shares issued under equity incentive plans
|
||||||||||||||||||||||||||||
Net loss
|
-
|
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||||||||
Other comprehensive loss
|
-
|
|
|
(
|
)
|
|
(
|
)
|
|
|||||||||||||||||||
Balance at March 31, 2022
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
|
Three Months Ended March 31,
|
||||||||
2023
|
2022
|
|||||||
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
|
(
|
)
|
|
|||||
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 provided by (used in) investing activities
|
|
(
|
)
|
|||||
Cash flows from financing activities:
|
||||||||
Acquisition of redeemable convertible noncontrolling interests
|
(
|
)
|
|
|||||
Proceeds from issuance of common stock under equity incentive plans
|
|
|
||||||
Net cash (used in) provided by financing activities
|
(
|
)
|
|
|||||
Net increase (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:
|
||||||||
Acquisition of redeemable convertible noncontrolling interests
|
$
|
|
$
|
|
||||
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,
|
||||||||
2023
|
2022
|
|||||||
Numerator
|
||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
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,
|
||||||||
2023
|
2022
|
|||||||
Options to purchase common stock
|
|
|
||||||
Non-vested restricted stock units |
||||||||
Total
|
March 31, 2023
|
December 31, 2022
|
|||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Cash at consolidated joint venture | ||||||||
Restricted cash, non-current
|
|
|
||||||
Total cash, cash equivalents and restricted cash reported in the Consolidated Statements of Cash Flows
|
$
|
|
$
|
|
March 31, 2023
|
December 31, 2022
|
|||||||
Furniture and fixtures
|
$
|
|
$
|
|
||||
Computers and equipment
|
|
|
||||||
Computer software
|
|
|
||||||
Leasehold improvements |
||||||||
Property and equipment
|
|
|
||||||
Less accumulated depreciation
|
(
|
)
|
(
|
)
|
||||
Property and equipment, net
|
$
|
|
$
|
|
March 31, 2023
|
December 31, 2022
|
|||||||
Accrued research and development
|
$
|
|
$
|
|
||||
Accrued compensation
|
|
|
||||||
Accrued legal fees
|
|
|
||||||
Other accruals
|
|
|
||||||
Total
|
$
|
|
$
|
|
|
March 31, 2023
|
||||||||||||||||||
|
Maturity
|
Amortized
|
Unrealized
|
Unrealized
|
Estimated
|
||||||||||||||
|
in Years
|
Cost
|
Gains
|
Losses
|
Fair Value
|
||||||||||||||
Corporate debt securities
|
less than
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||||||
Commercial paper
|
less than
|
|
|
(
|
)
|
|
|||||||||||||
U.S. Treasury securities
|
less than
|
|
|
(
|
)
|
|
|||||||||||||
U.S. Agency bonds
|
less than
|
|
|
|
|
||||||||||||||
Short-term investments
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
|
|||||||||||||||||||
Corporate debt securities
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||
U.S. Agency bonds
|
|
|
|
|
|
||||||||||||||
Asset-backed securities
|
|
|
|
(
|
)
|
|
|||||||||||||
Long-term investments
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
|
December 31, 2022
|
||||||||||||||||||
|
Maturity
|
Amortized
|
Unrealized
|
Unrealized
|
Estimated
|
||||||||||||||
|
in Years
|
Cost
|
Gains
|
Losses
|
Fair Value
|
||||||||||||||
Corporate debt securities
|
less than
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||||||
Commercial paper
|
less than
|
|
|
|
|
||||||||||||||
U.S. Treasury securities
|
less than
|
|
|
(
|
)
|
|
|||||||||||||
U.S. Agency bonds
|
less than
|
|
|
|
|
||||||||||||||
Short-term investments
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
|
|||||||||||||||||||
Corporate debt securities
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||||||
U.S. Agency bonds
|
|
|
|
(
|
)
|
|
|||||||||||||
Asset-backed securities
|
|
|
|
(
|
)
|
|
|||||||||||||
Long-term investments
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
|
March 31, 2023
|
|||||||||||||||||||||||||||||||||||
|
Less than 12 months
|
More than 12 months
|
Total
|
|||||||||||||||||||||||||||||||||
|
Unrealized
|
Unrealized
|
Unrealized
|
|||||||||||||||||||||||||||||||||
|
Count
|
Fair Value
|
Losses
|
Count
|
Fair Value
|
Losses
|
Count
|
Fair Value
|
Losses
|
|||||||||||||||||||||||||||
Corporate debt securities
|
|
$
|
|
$
|
(
|
)
|
|
$
|
|
$
|
|
|
$
|
|
$
|
(
|
)
|
|||||||||||||||||||
Commercial paper
|
|
|
(
|
)
|
|
|
|
|
|
(
|
)
|
|||||||||||||||||||||||||
U.S. Treasury securities
|
|
|
(
|
)
|
|
|
(
|
)
|
|
|
(
|
)
|
||||||||||||||||||||||||
U.S. Agency bonds
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
Asset-backed securities
|
|
|
(
|
)
|
|
|
|
|
|
(
|
)
|
|||||||||||||||||||||||||
|
|
$
|
|
$
|
(
|
)
|
|
$
|
|
$
|
(
|
)
|
|
$
|
|
$
|
(
|
)
|
|
December 31, 2022
|
|||||||||||||||||||||||||||||||||||
|
Less than 12 months
|
More than 12 months
|
Total
|
|||||||||||||||||||||||||||||||||
|
Unrealized
|
Unrealized
|
Unrealized
|
|||||||||||||||||||||||||||||||||
|
Count
|
Fair Value
|
Losses
|
Count
|
Fair Value
|
Losses
|
Count
|
Fair Value
|
Losses
|
|||||||||||||||||||||||||||
Corporate debt securities
|
|
$
|
|
$
|
(
|
)
|
|
$
|
|
$
|
|
|
$
|
|
$
|
(
|
)
|
|||||||||||||||||||
Commercial paper
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
U.S. Treasury securities
|
|
|
(
|
)
|
|
|
(
|
)
|
|
|
(
|
)
|
||||||||||||||||||||||||
U.S. Agency bonds
|
|
|
(
|
)
|
|
|
|
|
|
(
|
)
|
|||||||||||||||||||||||||
Asset-backed securities
|
|
|
(
|
)
|
|
|
|
|
|
(
|
)
|
|||||||||||||||||||||||||
|
|
$
|
|
$
|
(
|
)
|
|
$
|
|
$
|
(
|
)
|
|
$
|
|
$
|
(
|
)
|
Fair Value Measurements at March 31, 2023
|
||||||||||||||||
Level 1
|
Level 2
|
Level 3
|
Total
|
|||||||||||||
Money market funds
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Corporate debt securities
|
|
|
|
|
||||||||||||
Commercial paper
|
|
|
|
|
||||||||||||
U.S. Treasury securities
|
|
|
|
|
||||||||||||
U.S. Agency bonds |
||||||||||||||||
Asset-backed securities
|
|
|
|
|
||||||||||||
Total cash equivalents and
investments
|
$
|
|
$
|
|
$
|
|
$
|
|
Fair Value Measurements at December 31, 2022
|
||||||||||||||||
Level 1
|
Level 2
|
Level 3
|
Total
|
|||||||||||||
Money market funds
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Corporate debt securities
|
|
|
|
|
||||||||||||
Commercial paper |
||||||||||||||||
U.S. Treasury securities | ||||||||||||||||
U.S. Agency bonds |
||||||||||||||||
Asset-backed securities
|
|
|
|
|
||||||||||||
Total cash equivalents and
investments
|
$
|
|
$
|
|
$
|
|
$
|
|
Weighted- | ||||||||||||||||
Average | Aggregate | |||||||||||||||
Weighted- | Remaining | Intrinsic | ||||||||||||||
Average | Contractual | Value | ||||||||||||||
Options
|
Exercise Price
|
Term (in years)
|
(in thousands)
|
|||||||||||||
Outstanding at December 31, 2022
|
|
$
|
|
|
$
|
|
||||||||||
Granted
|
|
|
||||||||||||||
Exercised
|
(
|
)
|
|
|||||||||||||
Forfeited
|
(
|
)
|
|
|||||||||||||
Outstanding at March 31, 2023
|
|
$
|
|
|
$
|
|
||||||||||
Exercisable at March 31, 2023
|
|
$
|
|
|
$
|
|
|
Weighted-
|
Aggregate
|
||||||||||
|
Restricted
|
Average
|
Intrinsic
|
|||||||||
|
Stock Units
|
Grant Date
|
Value
|
|||||||||
|
Outstanding
|
Fair Value
|
(in thousands)
|
|||||||||
Outstanding at December 31, 2022
|
|
$
|
|
$
|
|
|||||||
Granted
|
|
|
||||||||||
Vested
|
( |