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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2022
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission File Number: 001-39593
Shattuck Labs, Inc.
(Exact name of registrant as specified in its charter)
Delaware
81-2575858
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification Number)
500 W. 5th Street, Suite 1200
Austin, TX 78701
(512) 900-4690
(Address of principal executive offices including zip code)
Former name, former address and former fiscal year, if changed since last report: N/A
Securities registered pursuant to Section 12(b) of the Exchange Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $0.0001 per shareSTTKThe Nasdaq Global Select Market
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
Accelerated filer
Non-accelerated filer
Smaller reporting company
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No ☒
As of August 1, 2022, the registrant had 42,382,013 shares of common stock, $0.0001 par value per share, outstanding.



SHATTUCK LABS, INC.
TABLE OF CONTENTS
Page
PART I1
Item 1.
1
1
2
3
5
6
18
Item 3.27
Item 4.27
PART II
27
Item 1.27
27
27
Item 3.27
Item 4.27
Item 5.27
28

29



CAUTIONARY NOTE ABOUT FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts, including statements concerning our plans, objectives, goals, strategies, future events, future revenues or performance, financing needs, plans or intentions relating to products and markets, and business trends and other information referred to under the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan,” or the negative of these terms, and similar expressions intended to identify forward-looking statements. Forward-looking statements are not historical facts and reflect our current views with respect to future events. Given the significant uncertainties, you should not place undue reliance on these forward-looking statements.
There are a number of risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this Quarterly Report on Form 10-Q. Such risks, uncertainties and other factors include, among others, the following:
the timing of the initiation, progress and expected results of our nonclinical studies, our clinical trials and our research and development programs;
the costs related to our nonclinical studies, our clinical trials and our research and development programs, and the impact of inflationary pressures on such costs;
our ability to retain the continued service of our key executives and to identify, hire and retain additional qualified professionals;
our ability to advance product candidates into, and successfully complete, nonclinical studies and clinical trials;
the timing or likelihood of regulatory filings and approvals;
the commercialization of our product candidates, if approved;
our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved;
the pricing, coverage, and reimbursement of our product candidates, if approved;
the implementation of our business model, strategic plans for our business and product candidates;
the scope of protection we are able to establish and maintain for intellectual property rights covering our technology platforms, including our ARC® and GADLEN product candidates and other product candidates, and the defense of such intellectual property rights;
our potential need to obtain additional licenses of third-party technology that may not be available to us or are available only on commercially unreasonable terms, and which may cause us to operate our business in a more costly or otherwise adverse manner that was not anticipated;
our ability to enter into strategic arrangements and/or collaborations and to realize the potential benefits of such arrangements;
our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;
our estimates regarding the market opportunity for our product candidates, if approved;
our estimates regarding expenses, capital requirements and needs for additional financing, and our ability to obtain additional capital;
our financial performance;



developments relating to our competitors and our industry, including competing product candidates and therapies; and
the ongoing COVID-19 pandemic and associated public health guidance measures.
There may be other factors that may cause our actual results to differ materially from the forward-looking statements expressed or implied in this Quarterly Report on Form 10-Q, including factors disclosed in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” You should evaluate all forward-looking statements made in this Quarterly Report on Form 10-Q in the context of these risks and uncertainties.
We caution you that the risks, uncertainties and other factors referred to above and elsewhere in this Quarterly Report on Form 10-Q may not contain all of the risks, uncertainties and other factors that may affect our future results and operations. Moreover, new risks will emerge from time to time. It is not possible for our management to predict all risks. In addition, we cannot assure you that we will realize the results, benefits or developments that we expect or anticipate or, even if substantially realized, that they will result in the consequences or affect us or our business in the way expected.
Any forward-looking statements contained in this Quarterly Report on Form 10-Q speak only as of the date hereof and not of any future date, and we expressly disclaim any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.




PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
SHATTUCK LABS, INC.
BALANCE SHEETS
(In thousands, except share and per share amounts)
June 30, 2022
December 31,
2021
(unaudited)
Assets
Current assets:
Cash and cash equivalents$37,870 $92,268 
Investments176,370 176,536 
Prepaid expenses and other current assets15,177 19,462 
Total current assets229,417 288,266 
Property and equipment, net18,759 9,938 
Other assets3,164 381 
Total assets$251,340 $298,585 
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable$5,674 $10,012 
Accrued expenses and other current liabilities18,571 14,574 
Total current liabilities24,245 24,586 
Non-current operating lease liabilities4,566  
Deferred rent 2,213 
Total liabilities28,811 26,799 
Commitments and contingencies (Note 5)
Stockholders’ equity:
Common stock, $0.0001 par value: 300,000,000 shares authorized; 42,382,013 shares issued and outstanding at June 30, 2022 and 42,338,898 shares issued and outstanding at December 31, 2021
5 5 
Additional paid-in capital392,598 389,408 
Accumulated other comprehensive loss(1,108)(560)
Accumulated deficit(168,966)(117,067)
Total stockholders’ equity222,529 271,786 
Total liabilities and stockholders’ equity$251,340 $298,585 
See accompanying notes to unaudited interim condensed financial statements
1


SHATTUCK LABS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands, except share and per share amounts)
 Three Months Ended June 30,Six Months Ended June 30,
 2022202120222021
Collaboration revenue$50 $(4,231)$50 $(1,961)
Operating expenses:
Research and development22,963 14,882 42,150 25,219 
General and administrative4,745 5,399 9,724 9,755 
Expense from operations27,708 20,281 51,874 34,974 
Loss from operations(27,658)(24,512)(51,824)(36,935)
Other income (expense):
Other287 914 (75)1,524 
Net loss$(27,371)$(23,598)$(51,899)$(35,411)
Unrealized loss on investments(581)(960)(548)(1,557)
Comprehensive loss$(27,952)$(24,558)$(52,447)$(36,968)
Net loss per share – basic and diluted$(0.65)$(0.56)$(1.22)$(0.85)
Weighted-average shares outstanding – basic and diluted42,380,454 41,906,268 42,369,102 41,840,555 
See accompanying notes to unaudited interim condensed financial statements
2


SHATTUCK LABS, INC.
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited)
(In thousands, except share amounts)
Six Months Ended June 30, 2022
Common StockAdditional Paid-In CapitalAccumulated Other Comprehensive Gain (Loss)Accumulated DeficitTotal Stockholders’ Equity
SharesAmount
Balance at December 31, 202142,338,898 $5 $389,408 $(560)$(117,067)$271,786 
Exercise of stock options and purchases pursuant to employee stock purchase plan39,616 — 134 — — 134 
Stock-based compensation expense— — 1,513 — — 1,513 
Unrealized gain on investments— — — 33 — 33 
Net loss— — — — (24,528)(24,528)
Balance at March 31, 202242,378,514 $5 $391,055 $(527)$(141,595)$248,938 
Exercise of stock options3,499 — 10 — — 10 
Stock-based compensation expense— — 1,533 — — 1,533 
Unrealized loss on investments— — — (581)— (581)
Net loss— — — — (27,371)(27,371)
Balance at June 30, 202242,382,013 $5 $392,598 $(1,108)$(168,966)$222,529 
See accompanying notes to unaudited interim condensed financial statements
3


SHATTUCK LABS, INC.
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (Continued)
(Unaudited)
(In thousands, except share amounts)
Six Months Ended June 30, 2021
Common StockAdditional Paid-In CapitalAccumulated Other Comprehensive LossAccumulated DeficitTotal Stockholders’ Equity
SharesAmount
Balance at December 31, 202041,767,431 $5 $382,012 $(63)$(72,093)$309,861 
Exercise of stock options13,543 — 31 — — 31 
Vesting of common stock previously subject to vesting requirements5,037 — — — — — 
Stock-based compensation expense— — 1,180 — — 1,180 
Unrealized loss on investments— — — (597)— (597)
Net loss— — — — (11,813)(11,813)
Balance at March 31, 202141,786,011 $5 $383,223 $(660)$(83,906)$298,662 
Exercise of stock options324,342 — 1,256 — — 1,256 
Vesting of common stock previously subject to vesting requirements5,037 — — — — — 
Stock-based compensation expense— — 1,727 — — 1,727 
Unrealized loss on investments— — — (960)— (960)
Net loss— — — — (23,598)(23,598)
Balance at June 30, 202142,115,390 $5 $386,206 $(1,620)$(107,504)$277,087 
See accompanying notes to unaudited interim condensed financial statements
4


SHATTUCK LABS, INC.
STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
Six Months Ended
June 30,
20222021
Cash flows from operating activities:
Net loss$(51,899)$(35,411)
Adjustments to reconcile net loss to net cash used in operations:
Stock-based compensation3,046 2,907 
Net amortization of premium on investments1,396 2 
Depreciation1,134 557 
Impairment loss400  
Non-cash operating lease expense141  
Changes in operating assets and liabilities:
Prepaid expenses and other current assets4,285 (890)
Other assets13 18 
Accounts payable(4,522)(903)
Accrued expenses and other current liabilities3,539 3,974 
Non-current operating lease liabilities(337) 
Deferred revenue211 2,959 
Deferred rent 1,380 
Net cash used in operating activities(42,593)(25,407)
Cash flows from investing activities:
Purchase of property and equipment(10,171)(4,972)
Net change in investments(1,778)(42,312)
Net cash used in investing activities(11,949)(47,284)
Cash flows from financing activities:
Proceeds from the exercise of stock options and purchases pursuant to employee stock purchase plan144 1,287 
Net cash provided by financing activities144 1,287 
Net decrease in cash and cash equivalents(54,398)(71,404)
Cash and cash equivalents, beginning of period92,268 157,898 
Cash and cash equivalents, end of period$37,870 $86,494 
Supplemental disclosures of non-cash financial activities:
Operating lease liabilities recognized for operating right-of-use assets$5,447 $ 
Operating right-of-use assets exchanged for operating lease liabilities$2,945 $ 
Unpaid amounts related to purchases of property and equipment$184 $156 

See accompanying notes to unaudited interim condensed financial statements
5


SHATTUCK LABS, INC.
NOTES TO THE UNAUDITED INTERIM FINANCIAL STATEMENTS
1. Organization and Description of Business
Shattuck Labs, Inc. (the “Company”) was incorporated in 2016 in the State of Delaware and is a clinical-stage biopharmaceutical company developing dual-sided fusion proteins, including its Agonist Redirected Checkpoint (“ARC®”) and gamma delta T cell engager (“GADLEN”) platforms, as novel classes of biologic medicines capable of multifunctional activity with potential applications in oncology and inflammatory diseases. Using its proprietary technology, the Company is building a pipeline of therapeutics, initially focused on the treatment of solid tumors and hematologic malignancies. The Company has two clinical-stage product candidates, SL-172154 and SL-279252, and has several compounds in preclinical development.
Liquidity
The Company has incurred losses and negative cash flows from operations since inception and has an accumulated deficit of $169.0 million as of June 30, 2022. The Company anticipates incurring additional losses and negative cash flows from operations until such time, if ever, that it can generate significant sales of its product candidates currently in development, and is highly dependent on its ability to find additional sources of funding in the form of licensing of its technology, collaboration agreements and/or public and private debt and equity financings. Adequate additional funding may not be available to the Company on acceptable terms, or at all. The failure to raise funds as and when needed could have a negative impact on the Company’s financial condition and ability to pursue its clinical operations, research and development and commercialization of its product candidates. Management believes that the Company’s cash and cash equivalents and investments of $214.2 million as of June 30, 2022 are sufficient to fund projected operations of the Company for at least the next twelve months.
COVID-19 Pandemic
The COVID-19 pandemic has had, and is expected to continue to have, a broad adverse impact on the economies and financial markets of many countries, including the geographical areas in which the Company operates and conducts its business and in which the Company’s partners operate and conduct their business. The Company and its third-party vendors and consultants have experienced disruptions to their businesses as a result of the COVID-19 pandemic. Specifically, the outbreak has caused disruptions in its ability to manufacture clinical trial materials, including the acquisition of raw materials needed for such manufacturing, enrollment and treatment of patients in clinical trials, and slowdowns and shutdowns of the laboratories and other service providers that are being relied upon in the development of the Company’s product candidates.
The extent to which the COVID-19 pandemic or any other health epidemic may impact the Company’s results will depend on future developments, which are highly uncertain and cannot be predicted, including new information that may emerge concerning the severity of COVID-19 and the actions to mitigate its impact, among others. Accordingly, the COVID-19 pandemic could have a material and adverse effect on the Company’s business, results of operations and financial condition.
2. Basis of Presentation and Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited interim financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”).
Unaudited Interim Financial Statements
In the opinion of management, the accompanying interim financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position, its results of operations, statements of changes in stockholders’ equity and cash flows for the interim periods presented. Operating results for interim periods presented are not necessarily indicative of the results that may be expected for the year ending December 31, 2022. The interim financial statements presented herein do not contain all required disclosures under GAAP for annual financial statements. The accompanying unaudited interim financial statements should be read in
6


conjunction with the annual audited financial statements and related notes in our Annual Report on Form 10-K for the year ended December 31, 2021.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, revenue recognition, the accrual of research and development expenses, and the valuation of stock-based awards. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates, if any, are recorded in the period in which they become known and actual results could differ from management’s estimates. A change in the Company's estimates occurred in the second quarter of 2021, which impacted the Company's current period revenue recognition and related balance sheet accounts. See Note 7 to the Company's unaudited interim condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q for further information.
Fair Value of Financial Instruments
Fair value is defined as the price that would be received upon the sale of an asset or paid upon the transfer of a liability in an orderly transaction between market participants at the measurement date and in the principal or most advantageous market for that asset or liability. Fair value measurements are classified and disclosed in one of the following categories:
Level 1: Observable inputs such as quoted prices in active markets for identical assets the reporting entity has the ability to access as of the measurement date;
Level 2: Inputs, other than 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.
Fair value measurements are classified based on the lowest level of input that is significant to the measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment, which may affect the valuation of the assets and liabilities and their placement within the fair value hierarchy levels. The determination of the fair values stated below takes into account the market for its financial assets and liabilities, the associated credit risk and other factors as required. The Company considers active markets as those in which transactions for the assets or liabilities occur with sufficient frequency and volume to provide pricing information on an ongoing basis.
Management believes that the carrying amounts of the Company’s financial instruments, including investments and accounts payable, approximate fair value due to the short-term nature of those instruments.
Concentration of Risk
Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash, cash equivalents and investments. The Company maintains its cash and cash equivalents at two accredited financial institutions in amounts that exceed federally-insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company invests in only highly rated debt securities that management believes protects the Company from risk of default and impairment of value.
Substantially all of the Company’s revenue has been derived from its collaboration agreement with Millennium Pharmaceuticals, Inc., a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited (“Takeda”), which was mutually terminated pursuant to a termination agreement, dated November 8, 2021.
The Company is highly dependent on a limited number of third-party contract manufacturing organizations (“CMO”) to supply drug products for its research and development activities of its programs, including clinical trials and non-clinical studies. These programs could be adversely affected by a significant interruption in the supply of such drug products.
7


The Company is highly dependent on a limited number of contract research organizations (“CROs”) and third-party service providers to manage and support its clinical trials. These programs could be adversely affected by a significant disruption in services provided by these CROs and third parties.
Cash and Cash Equivalents
The Company considers all demand deposits with financial institutions and all highly liquid investments with original maturities of 90 days or less at the date of purchase to be cash and cash equivalents. Cash and cash equivalents consisted of $4.2 million held in operating accounts and $33.7 million held in money market funds as of June 30, 2022, and $14.6 million held in operating accounts and $77.7 million held in money market funds as of December 31, 2021.
Investments
The Company's investments consist of highly-rated U.S. Treasury securities and have been classified as available-for-sale and are carried at estimated fair value as determined based upon quoted market prices. Management determines the appropriate classification of its investment securities at the time of purchase. The Company may hold securities with stated maturities greater than one year. All available-for-sale securities are considered available to support current operations and are classified as current assets. Credit impairments for available-for-sale securities are recorded through an allowance rather than a direct write-down of the security and are recorded through a charge to the statements of operations. Unrealized gains or losses not related to credit impairments are recorded in accumulated other comprehensive income, a component of stockholders’ equity, until realized. The Company reviews available-for-sale debt securities for impairments related to credit losses and other factors each quarter. As of June 30, 2022, there were no impairments related to credit losses of investments.
Deferred Offering Costs
The Company capitalizes certain legal, accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of the equity financing, these costs will be recorded against gross proceeds.
Impairment of Long-Lived Assets
Long-lived assets are reviewed for indications of possible impairment whenever events or changes in circumstance indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by comparison of the carrying amounts to the future undiscounted cash flows attributable to these assets. An impairment loss is recognized to the extent an asset group is not recoverable and the carrying amount exceeds the projected discounted future cash flows arising from these assets. In the three and six months ended June 30, 2022, the Company recorded a $0.4 million impairment loss related to lab equipment that was determined to no longer be needed, and is included in the Company's research and development costs.
Leases
The Company determines if an arrangement is a lease at inception. Right-of-use (“ROU”) assets represent the Company's right to use an underlying asset for the lease term and lease liabilities represent the Company's obligation to make lease payments arising from the lease. The classification of the Company's leases as operating or finance leases, along with the initial measurement and recognition of the associated ROU assets and lease liabilities, are performed at the lease commencement date. The measurement of lease liabilities is based on the present value of future lease payments over the lease term. As the Company's leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of future lease payments. The ROU asset is based on the measurement of the lease liability and also includes any lease payments made prior to or on lease commencement and excludes lease incentives and initial direct costs incurred, as applicable. The lease terms may include options to extend or terminate the lease when it is reasonably certain the Company will exercise any such options. Rent expense for the Company's operating leases is recognized on a straight-line basis over the lease term. The Company has elected to not apply the recognition requirement of ASC Topic 842, Leases (“Topic 842”) to leases with a term of 12 months or less for all classes of assets.
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Revenue Recognition
Collaboration revenue is recognized in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). Arrangements with collaborators may include licenses to intellectual property, research and development services, manufacturing services for clinical and commercial supply and participation on joint steering committees. The Company evaluates the promised goods or services in the contract to determine which promises, or group of promises, represent performance obligations. In contemplation of whether a promised good or service meets the criteria required of a performance obligation, the Company considers the stage of development of the underlying intellectual property, the capabilities and expertise of the customer relative to the underlying intellectual property and whether the promised goods or services are integral to or dependent on other promises in the contract. When accounting for an arrangement that contains multiple performance obligations, the Company must develop judgmental assumptions, which may include market conditions, reimbursement rates for personnel costs, development timelines and probabilities of regulatory success, to determine the stand-alone selling price for each performance obligation identified in the contract.
Upon the amendment of an existing agreement, the Company evaluates whether the amendment represents a modification to an existing contract that would be recorded through a cumulative catch-up to revenue, or a separate contract. If it is determined that it is a separate contract, the Company will evaluate the necessary revenue recognition through the five-step process described below.
When the Company concludes that a contract should be accounted for as a combined performance obligation and recognized over time, the Company must then determine the period over which revenue should be recognized and the method by which to measure revenue. The Company generally recognizes revenue using a cost-based input method.
The Company recognizes collaboration revenue in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services when its customer or collaborator obtains control of promised goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the following five steps are performed:
i.identify the contract(s) with a customer;
ii.identify the performance obligations in the contract;
iii.determine the transaction price;
iv.allocate the transaction price to the performance obligations within the contract; and
v.recognize revenue when (or as) the entity satisfies a performance obligation.
The Company only applies the five-step model to contracts when it determines that it is probable it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer.
At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within the contract to determine whether each promised good or service is a performance obligation. The promised goods or services in the Company’s arrangements may consist of a license of, or options to license, the Company’s intellectual property and research, development and manufacturing services. The Company may provide options to additional items in such arrangements, which are accounted for as separate contracts when the customer elects to exercise such options, unless the option provides a material right to the customer. Performance obligations are promises in a contract to transfer a distinct good or service to the customer that (i) the customer can benefit from on its own or together with other readily available resources and (ii) are separately identifiable from other promises in the contract. Goods or services that are not individually distinct performance obligations are combined with other promised goods or services until such combined group of promises meet the requirements of a performance obligation.
The Company determines transaction price based on the amount of consideration the Company expects to receive for transferring the promised goods or services in the contract. Consideration may be fixed, variable or a combination of both. At contract inception for arrangements that include variable consideration, the Company estimates the probability and extent of consideration it expects to receive under the contract utilizing either the most-likely amount method or expected amount method, whichever best estimates the amount expected to be received.
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The Company then considers any constraints on the variable consideration and includes variable consideration in the transaction price to the extent it is deemed probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved.
The Company then allocates the transaction price to each performance obligation based on the relative standalone selling price and recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied. For performance obligations which consist of licenses and other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
The Company records amounts as accounts receivable when the right to consideration is deemed unconditional. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded as deferred revenue.
Amounts received prior to satisfying the revenue recognition criteria are recognized as deferred revenue in the Company’s accompanying balance sheet. Deferred revenues expected to be recognized as revenue within the 12 months following the balance sheet date are classified as a current liability. Deferred revenues not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as non-current liabilities.
The Company’s collaboration revenue arrangements may include the following:
Up-front License Fees: If a license is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
Milestone Payments: At the inception of an agreement that includes research and development milestone payments, the Company evaluates each milestone to determine when and how much of the milestone to include in the transaction price. The Company first estimates the amount of the milestone payment that the Company could receive using either the expected value or the most-likely amount approach. The Company primarily uses the most-likely amount approach as that approach is generally most predictive for milestone payments with a binary outcome. The Company then considers whether any portion of that estimated amount is subject to the variable consideration constraint (that is, whether it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty). The Company updates the estimate of variable consideration included in the transaction price at each reporting date which includes updating the assessment of the likely amount of consideration and the application of the constraint to reflect current facts and circumstances.
Royalties: For arrangements that include sales-based royalties, including milestone payments based on a level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
To date, the Company has not granted a development and commercialization license nor recognized any revenue related to sales-based royalties or milestone payments based on the level of sales.
Research and Development Services: The Company will record costs associated with development and process optimization activities as research and development expenses in the statements of operations and comprehensive loss consistent with ASC 730, Research and Development. The Company considered the guidance in ASC 808, Collaborative Agreements and will recognize the payments received from these agreements as revenue when the related costs are incurred.
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Research and Development Costs
Research and development costs are expensed as incurred, and include salaries, stock-based compensation and other personnel-related costs, equipment and supplies, depreciation, nonclinical studies, clinical trials and manufacturing development activities.
A substantial portion of the Company’s ongoing research and development activities are conducted by third-party service providers, including CROs and CMOs. The Company accrues for expenses resulting from obligations under agreements with CROs, CMOs and other outside service providers for which payment flows do not match the periods over which materials or services are provided to the Company. Accruals are recorded based on estimates of services received and efforts expended pursuant to agreements established with CROs, CMOs and other outside service providers. These estimates are typically based on contracted amounts applied to the proportion of work performed and determined through an evaluation of the progress or stage of completion of the services. In the event advance payments are made to a CRO, CMO or outside service provider, the payments will be recorded as a prepaid asset, which will be amortized as the contracted services are performed. As actual costs become known, the Company adjusts its accruals and prepaid assets accordingly. Inputs, such as the services performed, the number of patients enrolled or the study duration, may vary from the Company’s estimates, resulting in adjustments to research and development expense in future periods. The Company makes significant judgements and estimates in determining the accrual and/or prepaid balance in each reporting period and changes in these estimates may result in material changes to the Company’s accruals that could materially affect the Company’s results of operations.
Net Loss Per Share
Basic loss per share of common stock is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during each period. Diluted loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as redeemable convertible preferred stock or convertible notes (if any), stock options and unvested shares of restricted stock, which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive.
The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding as of June 30, 2022 and 2021, as they would be anti-dilutive:
As of June 30,
20222021
Stock options3,899,926 2,578,944 
Unvested restricted stock310,727 1,678 
4,210,653 2,580,622 
Other Comprehensive Income (Loss)
Other comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. Other comprehensive income (loss) is comprised of the net loss and unrealized gains and losses on investments.
Recently Adopted Accounting Pronouncements
In February 2016, the Financial Accounting Standards Board (“FASB”) issued Topic 842 which requires a lessee to record a right-of-use asset and a corresponding lease liability on the balance sheet for all leases with terms longer than 12 months. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The FASB deferred the effective date of this ASU until the annual periods beginning after December 15, 2021. The Company adopted this pronouncement effective January 1, 2022. See Note 5 to our financial statements found elsewhere in this Quarterly Report on Form 10-Q for the impact on the financial statements. No prior period amounts were adjusted and such prior period amounts continue to be reported in accordance with previous lease guidance, ASC Topic 840, Leases (“Topic 840”). The Company elected to use all of the available practical expedients permitted under the transition guidance within the new standard,
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which, among other things, allowed the Company to carry forward the historical lease classification of those leases in place as of January 1, 2022.
The following table summarizes the impact of the adoption of Topic 842 on the accompanying balance sheet as of January 1, 2022 (in thousands):
December 31, 2021Effect of the Adoption of Topic 842January 1, 2022
Other assets (1)$381 $2,945 $3,326 
Lease Liabilities:
Accrued expenses and other current liabilities (2)$14,574 $255 $14,829 
Non-current operating lease liabilities$ $4,903 $4,903 
Deferred Rent (3)$2,213 $(2,213)$ 
(1)Operating lease right-of-use assets are classified within other assets.
(2)Current operating lease liabilities are classified within accrued expenses and other current liabilities.
Current deferred rent was classified within accrued expenses as of December 31, 2021.
(3)Non-current deferred rent was classified within deferred rent as of December 31, 2021.
3. Investments
The following table represents the Company’s available for sale investments by major security type (amounts in thousands):
June 30, 2022
Less Than 12 Months12 Months or LongerTotal
Amortized
Cost
Gross Unrealized LossFair ValueAmortized
Cost
Gross Unrealized LossFair ValueAmortized
Cost
Gross Unrealized LossFair Value
Investments
U.S. government securities$158,810 $(981)$157,829 $18,668 $(127)$18,541 $177,478 $(1,108)$176,370 
Total investments$158,810 $(981)$157,829 $18,668 $(127)$18,541 $177,478 $(1,108)$176,370 
December 31, 2021
Less Than 12 Months12 Months or LongerTotal
Amortized
Cost
Gross Unrealized LossFair ValueAmortized
Cost
Gross Unrealized Gain ( Loss)Fair ValueAmortized
Cost
Gross Unrealized LossFair Value
Investments
U.S. government securities$177,096 $(560)$176,536 $ $ $ $177,096 $(560)$176,536 
Total investments$177,096 $(560)$176,536 $ $ $ $177,096 $(560)$176,536 
 
The Company’s investment instruments and cash and cash equivalents are classified using Level 1 inputs within the fair value hierarchy and are valued using quoted market prices, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency. Debt securities have an average maturity of 0.61 years as of June 30, 2022.
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4. Accrued Expenses and Other Current Liabilities
Accrued expenses consisted of the following (amounts in thousands):
June 30,
2022
December 31,
2021
Research and development contract costs$14,011 $10,253 
Compensation and related benefits2,109 3,320 
Other current liabilities2,451 1,001 
Total accrued expenses and other current liabilities$18,571 $14,574 
5. Commitments and Contingencies
Operating Leases
The Company leases certain office space, laboratory facilities, and equipment. These leases require monthly lease payments that may be subject to annual increases throughout the lease term. Certain of these leases also include renewal options at the election of the Company to renew or extend the lease. These optional periods have not been considered in the determination of the ROU assets or lease liabilities associated with these leases as the Company did not consider it reasonably certain it would exercise the options. The Company performed evaluations of its contracts and determined it has operating leases.
The following table summarizes the Company’s recognition of its operating leases (in thousands):
Balance Sheet Classification
June 30, 2022
Other assets$2,796 
Accrued expenses and other current liabilities$657 
Non-current operating lease liabilities4,566 
Total liabilities$5,223 
The following table summarizes the weighted-average remaining lease term and discount rates for the Company’s operating leases:
June 30, 2022
Lease term (years)6.0
Discount rate8.63 %
The Company incurred rent expense for its operating leases of $0.2 million during each of the three months ended June 30, 2022 and 2021, and $0.4 million and $0.3 million during the six months ended June 30, 2022 and 2021, respectively, included within operating expenses in the statements of operations and comprehensive loss. Cash paid for amounts included in the measurement of operating lease liabilities for the six months ended June 30, 2022 was $0.5 million and was included in net cash used in operating activities in the statement of cash flows.
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The maturities of the Company’s operating lease liabilities as of June 30, 2022 were as follows (in thousands):
2022 (excluding the six months ended June 30, 2022)
$534 
20231,089 
20241,120 
20251,152 
20261,093 
Thereafter1,722 
Total lease payments$6,710 
Less:
Imputed interest(1,487)
Total$5,223 
As of December 31, 2021, future annual minimum lease payments, as defined under the previous lease accounting guidance of Topic 840, due under non-cancelable operating leases at December 31 of each year are as follows (in thousands):
2022$986 
20231,089 
20241,120 
20251,152 
20261,093 
Thereafter1,722 
Total minimum lease payments$7,162 
Heat License Agreement
In connection with a license agreement with Heat Biologics Inc. (“Heat”), the Company is required to make payments of up to $20.6 million in aggregate for the achievement of specified development, regulatory and commercial sales milestones for certain licensed products. The Company is required to pay Heat a percentage of upfront fees or other non-royalty payments not tied to milestone events that it receives in connection with certain sublicenses of the licensed patents. The Company is also required to pay Heat a royalty on all of its worldwide net sales, those of its affiliates, and sublicenses of certain licensed patents in the low single digits. The Company has not recorded a liability for the aforementioned payments given the achievement of specified development, regulatory and commercial sales milestones for certain licensed products is not probable as of the balance sheet date.
Litigation
From time to time, the Company may become involved in various legal actions arising in the ordinary course of business. On January 31, 2022 and February 11, 2022, putative class action lawsuits were filed in the U.S. District Court for the Eastern District of New York against us and certain of the Company’s officers and directors. The cases were consolidated on June 2, 2022, and the plaintiffs filed an amended complaint on July 1, 2022. The amended complaint cites the volatility in the Company’s common stock and alleges that the defendants made or are responsible for misleading omissions regarding the Company’s clinical trial results and collaboration agreement with Takeda. The plaintiffs seek a ruling that the case may proceed as a class action, and seek unspecified damages and attorneys’ fees, expert fees and costs. The Company and the individual defendants deny any allegations of wrongdoing and intend to vigorously defend against these lawsuits.
Contractual Obligations
Contractual obligations represent future cash commitments and liabilities under agreements with third parties, and exclude contingent liabilities for which the Company cannot reasonably predict future payment. The Company’s contractual obligations result primarily from obligations for various CMOs and CROs, which include potential
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payments that may be required under its agreements. The contracts also contain variable costs and milestones that are hard to predict, as they are based on such things as patients enrolled and clinical trial sites. The timing of payments and actual amounts paid under CMO and CRO agreements may be different depending on the timing of receipt of goods or services or changes to agreed-upon terms or amounts for some obligations. Such agreements are cancellable upon written notice by the Company and, therefore, are not long-term liabilities.
6. Stock-Based Compensation
2020 Equity Incentive Plan
In September 2020, the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”) which, as of the adoption date, replaced the 2016 Stock Incentive Plan. Under the 2020 Plan, the share reserve automatically increases on January 1st of each year beginning in 2021 and ending with a final increase on January 1, 2030 in an amount equal to 4% of the Company’s outstanding common shares on December 31st of the preceding calendar year. The Board of Directors (the “Board”) may provide that there will be no increase in the share reserve for any such year or that the increase in the share reserve may be smaller than would otherwise occur. On January 1, 2022, the share reserve automatically increased by 1,693,555 shares. As of June 30, 2022, there were 3,806,098 shares available for future grants. The 2020 Plan permits the granting of options, stock appreciation rights, restricted stock, restricted stock units (“RSUs”), performance stock, and performance cash awards. The terms of the agreements under the 2020 Plan are determined by the Board. The Company’s awards generally vest over four years and have a term of 10 years. In January 2022, the Company granted 178,150 awards that vest based on the Company achieving a closing share price of equal to or greater than $18.00 for thirty consecutive trading days on or before the fourth anniversary of the grant date.
2020 Employee Stock Purchase Plan
The 2020 Employee Stock Purchase Plan (“2020 ESPP”) became effective in connection with the Company’s initial public offering (“IPO”). A total of 395,795 shares of common stock were reserved for issuance under the 2020 ESPP. Eligible employees may purchase shares of common stock under the 2020 ESPP at 85% of the lower of the fair market value of the Company’s common stock as of the first or the last day of each offering period. Employees are limited to contributing 15% of the employee’s eligible compensation and may not purchase more than $25,000 of stock during any calendar year or more than 600 shares during any one purchase period. The 2020 ESPP share reserve automatically increases on January 1st of each calendar year for ten years commencing on January 1, 2021, in an amount equal to 1% of the total number of shares of common stock outstanding on December 31st of the preceding calendar year. The Board may act prior to January 1st of a given year to provide that there will be no January 1st increase of the share reserve for such year or that the increase in the share reserve for such year will be a smaller number of shares of common stock than would otherwise occur pursuant to the preceding sentence. On January 1, 2022, the share reserve increased by 423,388 shares. The Company issued 5,227 shares of common stock for aggregate cash proceeds of $0.1 million during the three and six months ended June 30, 2022. There were no shares of common stock issued during the three and six months ended June 30, 2021.
The Company recorded stock-based compensation expense in the following expense categories of its accompanying unaudited interim statements of operations and comprehensive loss (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2022202120222021
Research and development$894 $508 $1,721 $921 
General and administrative639 1,219 1,325 1,986 
Total stock-based compensation$1,533 $1,727 $3,046 $2,907 
 
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The following table summarizes option activity under the 2020 Plan:
Options
Weighted
Average
Exercise
Price
Weighted Average
Remaining
Contract Life
(Years)
Balance at January 1, 20222,448,676 $10.968.08
Granted1,535,932 6.35
Exercised(37,888)3.24
Forfeited(46,794)14.16
Balance at June 30, 20223,899,926 $9.048.38
Vested and expected to vest June 30, 20223,832,595 $9.038.36
Exercisable at the end of the period1,502,876 $7.767.23
Options granted during the six months ended June 30, 2022 had a weighted-average grant-date fair value of $4.48. As of June 30, 2022, unrecognized compensation cost for options issued was $15.2 million, and will be recognized over an estimated weighted-average amortization period of 2.7 years. The aggregate intrinsic value of options exercised as of June 30, 2022 and 2021 was $3.9 million and $36.2 million, respectively. The aggregate intrinsic value of options outstanding and exercisable as of June 30, 2022 was $1.2 million.
Restricted Stock Units
The following table summarizes employee RSU activity for the six months ended June 30, 2022:
Awards
Weighted
Average
Grant Date Fair Value
Unvested RSUs as of December 31, 2021 $ 
Granted318,153 7.43 
Vested  
Forfeited(7,426)7.43 
Balance at June 30, 2022
310,727 $7.43 

The Company recognized $0.2 million of stock-based compensation as of June 30, 2022. The fair values of RSUs are based on the fair value of the Company's common stock on the date of the grant.
Fair Value of Stock Options and Shares Issued
The Company accounts for stock-based compensation by measuring and recognizing as compensation expense the fair value of all share-based payment awards made to employees, including employee stock options and restricted stock awards. The Company uses the Black-Scholes option pricing model to estimate the fair value of employee stock options that only have service or performance conditions. The Company uses the Monte Carlo pricing model to estimate the fair value of options that have market-based conditions. The inputs to both pricing models require a number of management estimates such as the expected term, volatility, risk-free interest rate and dividend yield. The fair value of stock options was determined using the methods and assumptions discussed below.
The expected term of employee stock options with service-based vesting is determined using the “simplified” method, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the option due to the Company’s lack of sufficient historical data.
The expected stock price volatility assumption is based on the historical volatilities of the common stock of a peer group of publicly traded companies as well as the historical volatility of the Company's common stock since the Company began trading subsequent to the IPO in October 2020 over the period corresponding to the expected life as of the grant date. The historical volatility data was computed using the daily closing prices during the equivalent period of the calculated expected term of the stock-based awards. The Company
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will continue to apply this process until a sufficient amount of historical information regarding the volatility of the Company's stock price becomes available, or until circumstances change, such that the identified entities are no longer comparable companies. In the latter case, other suitable, similar entities whose share prices are publicly available would be utilized in the calculation.
The risk-free interest rate is based on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the expected term.
The expected dividend yield is 0% because the Company has not historically paid, and does not expect, for the foreseeable future, to pay dividends on its common stock.
Prior to the Company’s IPO, the Board periodically estimated the fair value of the Company’s common stock considering, among other things, contemporaneous valuations of its common stock prepared by an unrelated third-party valuation firm. Subsequent to the Company’s IPO, options are issued with a strike price no less than the market price on date of grant.
The grant-date fair value of options granted under the Company’s 2020 Plan were estimated throughout the year using the following weighted-average assumptions:
2020 Plan
Expected term - years6.08
Expected volatility82.0%
Risk-free interest rate2.0%
Expected dividends
The grant-date fair value of shares issued under the Company’s 2020 ESPP were estimated throughout the year using the Black-Scholes option-pricing model using the following weighted-average assumptions:
2020 ESPP
Expected term - years0.49
Expected volatility81.8%
Risk-free interest rate2.0%
Expected dividends
7. Collaboration Revenue
The Company recognizes revenue for the allocated up-front payments using a cost-based input measure. In applying the cost-based input method of revenue recognition, the Company uses actual costs incurred relative to budgeted costs expected to be incurred.
Collaboration Agreement - Takeda
In the second quarter of 2021, in connection with the Company’s modifications to the SL-279252 clinical development plan and its intention to expand the dose escalation portion of its ongoing Phase 1 clinical trial, the estimated total costs related to the SL-279252 development program increased. The increase in expected total cost of the development program required to satisfy a specific performance obligation in the August 2017 Collaboration Agreement with Takeda (the “Collaboration Agreement”), or the denominator in the cost-based input method, resulted in a cumulative-effect adjustment under ASC 250, Change in Accounting Estimates. Actual consideration received and total revenue expected to be recognized in accordance with the development of SL-279252 under the Collaboration Agreement remained unchanged. The Company recognized revenue related to the reimbursable costs as they were incurred. The effects of this change in the Company's estimates were a $4.2 million increase in 2021 net loss and a $0.10 increase in 2021 basic and diluted loss per share. The Collaboration Agreement was mutually terminated pursuant to a termination agreement dated November 8, 2021 (the “Termination Agreement”). The remaining deferred revenue was recognized as revenue in the fourth quarter of 2021.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed financial statements and related notes appearing in this Quarterly Report on Form 10-Q, as well as the audited financial statements, notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2021. This discussion and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the “Risk Factors” section of our Annual Report on Form 10-K. You should carefully read the “Cautionary Note About Forward-Looking Statements” of this Quarterly Report on Form 10-Q and the “Risk Factors” section of our Annual Report on Form 10-K to gain an understanding of the important factors that could cause actual results to differ materially from the results described below.
Overview
We are an innovative clinical-stage biotechnology company pioneering the development of dual-sided fusion proteins as an entirely new class of biologic medicine. We have created a novel approach to immune modulation by designing biologics with structural characteristics that may not be achievable by existing therapeutic modalities, including monoclonal or bispecific antibodies. Compounds derived from our proprietary Agonist Redirected Checkpoint, or ARC®, platform simultaneously inhibit checkpoint molecules and activate costimulatory molecules with a single therapeutic.
Our lead product candidate, SL-172154, is designed to simultaneously inhibit the CD47/SIRPα macrophage checkpoint interaction and activate the CD40 costimulatory receptor to induce an antitumor immune response. Coupling CD40 activation with CD47 inhibition differentiates SL-172154 from all other clinical-stage CD47/SIRPα inhibitors in development, and in our published preclinical studies, SL-172154 resulted in superior antitumor immunity as compared to certain CD47/SIRPα inhibitors. We are pursuing a broad clinical development strategy in both hematologic and solid tumors, with multiple ongoing clinical trials. SL-172154 is in an ongoing Phase 1 clinical trial for the treatment of patients with ovarian cancer. We are also evaluating SL-172154 in an ongoing Phase 1 clinical trial for the treatment of patients with certain hematologic malignancies, including acute myeloid leukemia, or AML, and higher-risk myelodysplastic syndromes, or HR-MDS. We believe our clinical development plan may provide both first-in-class and best-in-class development opportunities for SL-172154.
Our second product candidate, SL-279252, is designed to simultaneously inhibit the PD-1/PD-L1 interaction and activate the OX40 costimulatory receptor and is in an ongoing Phase 1 clinical trial in patients with advanced solid tumors.
In November 2021, at the 36th annual meeting of the Society for Immunotherapy of Cancer, or the SITC Meeting, we announced initial clinical data from our ongoing Phase 1 clinical trials for SL-172154 in ovarian cancer and for SL-279252 in advanced solid tumors and lymphoma. We believe that these data generated in human cancer patients have demonstrated that the unique protein engineering and physical properties of the ARC platform have led to a differentiated profile in terms of safety and on-target immune activation as compared to monoclonal or bispecific antibodies.
In addition to our clinical-stage ARC product candidates, we possess a deep pipeline of preclinical immuno-oncology candidates. As an example, SL-9258, an ARC compound in preclinical development, is designed to inhibit the TIGIT/PVR checkpoint interaction while simultaneously activating HVEM and LTβ costimulatory receptors.
Furthermore, our expertise in dual-sided fusion proteins has led to the development of a second novel platform technology. We call this our gamma delta T cell engager, or GADLEN, platform.
We plan to nominate a third clinical product candidate from our preclinical pipeline in 2022. Longer-term, we are pursuing additional disease areas, including autoimmune diseases, where our dual-sided fusion protein platforms may provide advantages over current treatment modalities.
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Overview of Operations
Since our inception in 2016, we have devoted substantially all of our resources to conducting research and development activities, including undertaking nonclinical studies of our product candidates, conducting clinical trials of our most advanced product candidates, manufacturing our product candidates, developing and perfecting our intellectual property rights, organizing and staffing our company, business planning and raising capital. We do not have any products approved for sale, and we have not generated any revenue from product sales. We have funded our operations as of the filing date of this Quarterly Report on Form 10-Q through the net proceeds from our initial public offering of approximately $213.5 million, the sale of redeemable convertible preferred stock for approximately $152.9 million, the issuance of convertible notes for approximately $10.5 million and payments received pursuant to our collaboration agreements for approximately $82.3 million.
For the six months ended June 30, 2022 and 2021, our net loss was $51.9 million and $35.4 million, respectively. We have not been profitable since inception, and as of June 30, 2022, we had an accumulated deficit of $169.0 million and $214.2 million in cash and cash equivalents and investments. We expect to continue to incur significant expenses and increasing operating losses in the near term. We expect our expenses will increase substantially in connection with our ongoing activities, as we:
continue to advance the nonclinical and clinical development of our clinical-stage product candidates, SL-172154;
initiate nonclinical studies and clinical trials for additional product candidates that we may identify in the future;
manufacture sufficient quantities of bulk drug substance and drug product to support our ongoing and planned nonclinical studies and clinical trials;
continue our process development efforts for our current and future product candidates;
expand our operational, financial, and management systems;
increase personnel and infrastructure to support our clinical development, research and manufacturing efforts;
build out and expand our in-house process development and manufacturing capabilities;
continue to develop, perfect, and defend our intellectual property portfolio;
incur additional legal, accounting, or other expenses in operating our business, including the additional costs associated with operating as a public company and expenses incurred in connection with ongoing and future litigation, if any.
We do not expect to generate significant product revenue unless and until we successfully complete development and obtain regulatory and marketing approval of, and begin to sell, one or more of our product candidates, which we expect will take several years. We expect to spend a significant amount in development and marketing costs prior to such time. We may never succeed in achieving regulatory and marketing approval for our product candidates. We may obtain unexpected results from our nonclinical and clinical trials. We may elect to discontinue, delay, or modify nonclinical and clinical trials of our product candidates. We may be adversely affected by inflationary pressures and the macroeconomic environment, which are beyond our control. A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. Accordingly, until such time as we can generate significant product revenue, if ever, we expect to continue to seek private or public equity and debt financing to meet our capital requirements. There can be no assurance that such funding may be available to us on acceptable terms, or at all, or that we will be able to commercialize our product candidates. In addition, we may not be profitable even if we commercialize any of our product candidates.
COVID-19 Pandemic
As a result of the COVID-19 pandemic, we have experienced, and expect to continue to experience, delays in our SL-172154 and SL-279252 clinical trials. Our manufacturing operations have been impacted, including delays with certain third-party manufacturers and difficulties in obtaining raw materials needed to manufacture material for
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our clinical trials. Additionally, we have experienced, and expect to continue to experience, delays in enrolling patients, missed treatments for enrolled patients, and performance delays from certain third-party vendors supporting the SL-172154 and SL-279252 clinical trials, although the significance of any future delays is difficult to predict.
Certain of our research and development activities, including the conduct of nonclinical studies, have been delayed and may be further delayed due to the impact of the COVID-19 pandemic. The COVID-19 pandemic or local outbreaks associated with the COVID-19 pandemic could result in difficulty manufacturing our product candidates, securing clinical trial site locations, contract research organizations, or CROs, and/or trial monitors and other critical vendors and consultants supporting our clinical trials. In addition, outbreaks or the perception of an outbreak near a clinical trial site location could impact our ability to enroll patients or to complete all scheduled physician visits for currently enrolled patients. These situations, or others associated with COVID-19 pandemic, could cause delays in our clinical trial plans and could increase expected costs, all of which could have a material and adverse effect on our business and its financial condition. At the current time, we are unable to quantify the potential effects of the COVID-19 pandemic on our future operations.
Collaboration Agreement - Takeda
On August 8, 2017, we entered into a Collaboration Agreement with Millennium Pharmaceuticals, Inc., or Takeda, a wholly owned subsidiary of Takeda Pharmaceutical Company, Ltd., or the Collaboration Agreement. The Collaboration Agreement was mutually terminated pursuant to the termination agreement, or the Termination Agreement, dated November 8, 2021. Under the terms of the Termination Agreement, we are not required to satisfy any remaining performance obligations, we will not make any payments to or receive any future milestone or royalty payments from Takeda, and all options to license and rights of first negotiation held by Takeda under the Collaboration Agreement were terminated.
Components of our Results of Operation
Collaboration Revenue
We have no products approved for commercial sale, and we have not generated any revenue from commercial product sales. Our total revenue to date has been primarily generated from our Collaboration Agreement with Takeda, which was terminated in November 2021. We expect that any collaboration revenue we may generate from any future collaboration partners will fluctuate from period to period.
Operating Expense
Research and Development Expense
Our research and development expenses consist primarily of costs incurred in connection with the discovery and development of our product candidates. These expenses include:
expenses incurred to conduct our clinical trials and nonclinical studies;
costs of manufacturing clinical trial and nonclinical study materials, including the costs of raw materials required for manufacturing;
process development activities to optimize manufacturing processes;
employee-related expenses, including salaries, benefits, and stock-based compensation;
fees paid to third parties who assist with research and development activities;
expenses relating to regulatory activities, including filing fees paid to regulatory agencies;
laboratory materials and supplies used to support our research activities; and
allocated expenses for facility-related costs.
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The following table summarizes our research and development expenses by product candidate:
Three Months Ended June 30,
Six Months Ended June 30,
(in thousands)2022202120222021
(unaudited)(unaudited)
SL-172154$11,560 $5,228 $19,742 $7,189 
SL-279252265 2,678 997 5,614 
Other pipeline candidates4,103 3,161 8,651 5,171 
Internal costs, including personnel related benefits, facilities and depreciation7,035 3,815 12,760 7,245 
$22,963 $14,882 $42,150 $25,219 
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials, including increased demand for clinical
trial material. We expect our research and development expenses to increase for the remainder of this year. Over the next several years, while it is difficult for us to predict with certainty, we expect increasing year-over-year operating expense in the event that we conduct additional nonclinical studies and clinical trials (beyond our currently planned clinical trials), including later-stage clinical trials, for our current and future product candidates, pursue regulatory approval of our product candidates, or advance our preclinical pipeline. For SL-279252, we have not planned additional clinical trial-related expense beyond our ongoing Phase 1 clinical trial in advanced solid tumors and lymphoma. Should we choose to advance SL-279252 into later-stage clinical development, we would expect significantly increased operating expense and significantly increased capital requirements over the next several years.
The process of conducting the necessary nonclinical and clinical research to obtain regulatory approval is costly and time consuming. The actual probability of success for our product candidates may be affected by a variety of factors including:
the safety and efficacy of our product candidates;
early clinical data for our product candidates;
investment in our clinical programs;
competition;
manufacturing capability; and
commercial viability.
We may never succeed in achieving regulatory approval for any of our product candidates due to the uncertainties discussed above. We are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of our product candidates, if ever.
General and Administrative Expense
General and administrative expense consists primarily of personnel expenses, including salaries, benefits, and stock-based compensation expense, for employees and consultants in executive, finance, accounting, legal, information technology, business development and human resource functions. General and administrative expense also includes corporate facility costs, including rent, utilities, depreciation, and maintenance, not otherwise included in research and development expense, as well as legal fees related to intellectual property, corporate, and litigation matters and fees for accounting and tax services.
We expect that our general and administrative expense will increase in the future to support our growing research and development activities and as a result of the increased costs of operating as a public company. These increases will likely include increased costs related to the hiring of additional personnel and fees to outside consultants, lawyers, and accountants, among other expenses. Additionally, we anticipate increased costs associated
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with being a public company, including expenses related to services associated with maintaining compliance with the requirements of Nasdaq and the Securities and Exchange Commission, or SEC, insurance, and investor relations costs. If any of our current or future product candidates obtains regulatory approval, we expect that we would incur significantly increased expenses associated with building a sales and marketing team.
Other Income
Other income consists of interest earned on our cash, cash equivalents and investments, which consists of amounts held in a money market fund and at various times in government and corporate obligations as well as investment fees and realized gain or losses on investments (if any).
Income Taxes
Since our inception, we have not recorded any income tax benefits for the net operating losses, or NOLs, we have incurred or for our research and development tax credits, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our NOLs and tax credits will not be realized. Our NOLs and tax credit carryforwards will begin to expire in 2036. We have recorded a full valuation allowance against our deferred tax assets at each balance sheet date.
Results of Operations
Comparison of the Three Months Ended June 30, 2022 and 2021
The following table sets forth our results of operations for the three months ended June 30, 2022 and 2021.
Three Months Ended June 30,
Change
(in thousands)20222021DollarPercentage
(unaudited)
Collaboration revenue$50 $(4,231)$4,281 101.2 %
Operating expenses:
Research and development22,963 14,882 8,081 54.3 %
General and administrative4,745 5,399 (654)(12.1)%
Loss from operations(27,658)(24,512)(3,146)12.8 %
Other income (expense):
Other287 914 (627)(68.6)%
Net loss$(27,371)$(23,598)$(3,773)16.0 %
Collaboration Revenue
Collaboration revenue increased by $4.3 million, or 101.2%, to $0.1 million for the three months ended June 30, 2022 from $(4.2) million for the three months ended June 30, 2021. In the second quarter of 2021, in connection with our modifications to the SL-279252 clinical development plan and our intention to expand the dose escalation portion of the ongoing Phase 1 clinical trial, the expected program costs related to the SL-279252 development program increased. The increase in the expected total cost of the development program, or the denominator in the cost-based input method, resulted in a one-time negative revenue adjustment, recognized in the second quarter of 2021. We subsequently ceased work with Takeda under the Collaboration Agreement, which was mutually terminated in the fourth quarter of 2021. In the second quarter of 2022, we executed a collaboration agreement with another third party, and we have recognized $0.1 million of revenue for work performed pursuant to this agreement. We expect to recognize less than $1.0 million of total revenue associated with this collaboration agreement.
Research and Development Expense
Research and development expenses increased by $8.1 million, or 54.3%, to $23.0 million for the three months ended June 30, 2022 from $14.9 million for the three months ended June 30, 2021. The increase was primarily due to an increase of $2.1 million in personnel costs related to the expansion of our in-house manufacturing and clinical development capabilities, an increase of $2.0 million in manufacturing-related expense, including process development costs and manufacturing of clinical trial materials, an increase of $1.8 million in
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laboratory costs, an increase of $0.9 million in clinical costs, including clinical site and contract research organization costs, and an increase of $0.7 million in other operating expenses, which consist primarily of an impairment loss.
General and Administrative Expense
General and administrative expenses decreased by $0.7 million, or (12.1)%, to $4.7 million for the three months ended June 30, 2022 from $5.4 million for the three months ended June 30, 2021. The decrease was primarily as a result of expense associated with an executive severance agreement, executed in the second quarter of 2021.
Results of Operations
Comparison of the Six Months Ended June 30, 2022 and 2021
The following table sets forth our results of operations for the six months ended June 30, 2022 and 2021.
Six Months Ended June 30,
Change
(in thousands)20222021DollarPercentage
(unaudited)
Collaboration revenue$50 $(1,961)$2,011 102.5 %
Operating expenses:
Research and development42,150 25,219 16,931 67.1 %
General and administrative9,724 9,755 (31)(0.3)%
Loss from operations(51,824)(36,935)(14,889)40.3 %
Other income (expense):
Other(75)1,524 (1,599)(104.9)%
Net loss$(51,899)$(35,411)$(16,488)46.6 %
Collaboration Revenue
Collaboration revenue increased by $2.0 million, or 102.5%, to $0.1 million for the six months ended June 30, 2022 from $(2.0) million for the six months ended June 30, 2021. In the second quarter of 2021, in connection with our modifications to the SL-279252 clinical development plan and our intention to expand the dose escalation portion of the ongoing Phase 1 clinical trial, the expected program costs related to the SL-279252 development program increased. The increase in the expected total cost of the development program, or the denominator in the cost-based input method, resulted in a one-time negative revenue adjustment, recognized in the second quarter of 2021. We subsequently ceased work with Takeda under the Collaboration Agreement, which was mutually terminated in the fourth quarter of 2021. In the second quarter of 2022, we executed a collaboration agreement with another third party and we have recognized $0.1 million of revenue for work performed pursuant to this agreement. We expect to recognize less than $1.0 million of total revenue associated with this collaboration agreement.
Research and Development Expense
Research and development expenses increased by $16.9 million, or 67.1%, to $42.2 million for the six months ended June 30, 2022 from $25.2 million for the six months ended June 30, 2021. The increase was primarily due to an increase of $7.4 million in manufacturing costs, an increase of $4.0 million as a result of an increase in headcount and expansion of our manufacturing and clinical development capabilities, an increase of $2.0 million in laboratory and facilities related costs, an increase of $1.7 million in clinical, pharmacology and preclinical pipeline costs, an increase of $0.5 million in depreciation and an increase of $0.4 million in other operating expenses primarily related to an impairment loss recognized in the second quarter of 2022.
General and Administrative Expense
General and administrative expenses remained relatively unchanged for the six months ended June 30, 2022 as compared to the six months ended June 30, 2021.
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Liquidity and Capital Resources
Since our inception, our primary sources of liquidity have been generated by sales of our preferred stock and common stock, including our initial public offering, or IPO, and through our Collaboration Agreement with Takeda. As of June 30, 2022, we had an accumulated deficit of $169.0 million and $214.2 million of cash and cash equivalents and investments.
Capital Resources and Funding Requirements
Our primary uses of cash and cash equivalents and investments are to fund our operations, which consist primarily of research and development expenditures related to our programs, product development costs, research expenses, administrative support, capital expenditures related to bringing in-house certain process development and manufacturing capabilities and working capital requirements. We anticipate incurring additional net losses and negative cash flows from operations in the near future until such time, if ever, that we can generate significant sales of our product candidates currently in development. Our future funding requirements will depend on many factors, including:
the scope, timing, progress and results of discovery, nonclinical development, laboratory testing and clinical trials for our product candidates;
the costs of process development and scale up of a commercially ready manufacturing process to support registrational clinical trials;
the costs of manufacturing our product candidates for clinical trials and in preparation for marketing approval and commercialization;
the extent to which we enter into collaborations or other arrangements with additional third parties in order to further develop our product candidates;
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending other intellectual property-related claims;
the costs and fees associated with the discovery, acquisition or in-license of additional product candidates or technologies;
the costs of future commercialization activities, if any, including establishing sales, marketing, manufacturing, distribution and storage capabilities, for any of our product candidates for which we receive marketing approval; and
revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval.
Until we obtain regulatory approval to market our product candidates, if ever, we cannot generate revenues from sales of our products. Even if we are able to sell our products, we may not generate a sufficient amount of product revenues to finance our cash requirements. Accordingly, it will be necessary for us to seek to raise additional capital through equity offerings and/or debt financings or from other potential sources of liquidity, which may include new collaborations, licensing or other commercial agreements for one or more of our development programs or patent portfolios. There can be no assurance that such funding may be available to us on acceptable terms, or at all. The issuance of equity securities may result in dilution to stockholders and the issuance of debt securities may have rights, preferences and privileges senior to those of our common stock and the terms of any such debt securities could impose significant restrictions on our operations. The failure to raise funds as and when needed could have a negative impact on our financial condition and ability to pursue our business strategies. Additionally, if additional funding is not secured when required, we may need to delay or curtail our operations until such funding is received, which would have a material and adverse impact on our business prospects and results of operations.
We believe that our cash and cash equivalents and investments as of June 30, 2022 are sufficient to fund projected operations into the second half of 2024.
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Cash Flows
The following table shows a summary of our cash flows for the periods indicated:
Six Months Ended June 30,
(in thousands)20222021
(unaudited)
Net cash used in operating activities$(42,593)$(25,407)
Net cash used in investing activities(11,949)(47,284)
Net cash provided by financing activities144 1,287 
Net decrease in cash and cash equivalents$(54,398)$(71,404)
Net Cash Used in Operating Activities
During the six months ended June 30, 2022, net cash used in operating activities was $42.6 million and primarily reflected our net loss of $51.9 million and a $3.2 million net change in our operating assets and liabilities, offset by noncash charges of $3.0 million in stock-based compensation, $2.7 million in depreciation expense, amortization of investments and non-cash operating lease expense and $0.4 million in impairment loss. We expect our operating activities expenses to increase as we continue to conduct our clinical trials and nonclinical studies, incur costs of manufacturing clinical trial and nonclinical study materials and continue process development activities to optimize our manufacturing processes.
During the six months ended June 30, 2021, net cash used in operating activities was $25.4 million and primarily reflected our net loss of $35.4 million and a $6.5 million net change in our operating assets and liabilities, partially offset by noncash charges of $2.9 million in stock-based compensation and $0.6 million in depreciation expense.
Net Cash Used in Investing Activities
During the six months ended June 30, 2022, net cash used in investing activities was $11.9 million, of which $10.1 million was used to purchase property and equipment, primarily attributable to our continued efforts to bring in-house certain process development, manufacturing and laboratory capabilities and $1.8 million represents the net change in investments.
During the six months ended June 30, 2021, net cash used in investing activities was $47.3 million, of which $42.3 million represents the net change in investments and $5.0 million was used to purchase property and equipment.
Net Cash Provided by Financing Activities
During the six months ended June 30, 2022, net cash provided by financing activities was $0.1 million and was primarily from the exercise of stock options and purchases pursuant to our employee stock purchase plan.
During the six months ended June 30, 2021, net cash provided by financing activities was $1.3 million and was primarily from the exercise of stock options.
Contractual Obligations and Other Commitments
See Note 7 to our financial statements found elsewhere in this Quarterly Report on Form 10-Q for additional disclosures. There have been no other material changes from the Contractual Obligations and Other Commitments disclosed in Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2021.
Critical Accounting Policies
Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in
the United States of America, or GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to revenue recognition, the accrual for research and development expenses, and the valuation of stock-based awards. We base our estimates on historical experience, known trends and events, and various other
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factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Our critical accounting policies are those policies which require the most significant judgments and estimates in the preparation of our financial statements. We believe that the assumptions and estimates associated with our most critical accounting policies are those relating to revenue, accrued research and development costs and stock-based compensation.
In January 2022, we granted stock options that vest upon achievement of certain market-based conditions. We use the Monte Carlo pricing model to estimate the fair value of options that have market-based conditions. The inputs to the Monte Carlo pricing models require a number of management estimates such as the expected term, volatility, risk-free interest rate and dividend yield.
There have been no other material changes in our critical accounting policies and estimates as compared to the critical accounting policies and estimates disclosed in Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2021.
Recent Accounting Pronouncements
See Note 2 to our financial statements found elsewhere in this Quarterly Report on Form 10-Q for a description of recent accounting pronouncements applicable to our financial statements.
Emerging Growth Company and Smaller Reporting Company Status
We are an emerging growth company as defined in the JOBS Act. Under the JOBS Act, an emerging growth company can take advantage of the extended transition period for complying with new or revised accounting standards and delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this exemption from complying with new or revised accounting standards and, therefore, will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.
We have evaluated the benefits of relying on other exemptions and reduced reporting requirements under the JOBS Act. Subject to certain conditions, as an emerging growth company, we may rely on certain of these exemptions, including without limitation exemptions to the requirements for (1) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (2) complying 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, known as the auditor discussion and analysis. We will remain an emerging growth company until the earlier of (a) the last day of the fiscal year (i) following the fifth anniversary of the completion of our initial public offering, (ii) in which we have total annual gross revenues of at least $1.07 billion or (iii) in which we are deemed to be a “large accelerated filer” under the rules of the SEC, which means the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30th, or (b) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.
We are also a “smaller reporting company” as defined under the Exchange Act. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250.0 million or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company, as defined by Rule 12b-2 under the Securities and Exchange Act of 1934 and in Item 10(f)(1) of Regulation S-K, and are not required to provide the information under this item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and our principal financial officer, evaluated, as of the end of the period covered by this Quarterly Report on Form 10-Q, the effectiveness of our disclosure controls and procedures. Based on this evaluation of our disclosure controls and procedures as of June 30, 2022, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures as of such date are effective at the reasonable assurance level. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act are recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the second quarter of the year ending December 31, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
On January 31, 2022 and February 11, 2022, putative class action lawsuits were filed in the U.S. District Court for the Eastern District of New York against us and certain of the Company’s officers and directors. The cases were consolidated on June 2, 2022, and the plaintiffs filed an amended complaint on July 1, 2022. The amended complaint cites the volatility in the Company’s common stock and alleges that the defendants made or are responsible for misleading omissions regarding the Company’s clinical trial results and collaboration agreement with Takeda. The plaintiffs seek a ruling that the case may proceed as a class action, and seek unspecified damages and attorneys’ fees, expert fees and costs. The Company and the individual defendants deny any allegations of wrongdoing and intend to vigorously defend against these lawsuits.
Item 1A. Risk Factors
Our business is subject to various risks, including those described in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2021. There have been no material changes from the risk factors disclosed in Item 1A of our Annual Report on Form 10-K.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
None.
Item 5. Other Information
None.
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Item 6. Exhibits
The exhibits filed or furnished as part of this Quarterly Report on Form 10-Q are set forth below.
Exhibit
Number
Description of Exhibit
  
3.1
3.2
4.1
4.2
31.1*
31.2*
32.1* (1)
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
101.LAB*Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE*Inline XBRL Taxonomy Extension Presentation Linkbase Document
104*The cover page for this report, formatted in Inline XBRL (included in Exhibit 101)
______________
*    Filed herewith
(1)    The certifications on Exhibit 32 hereto are deemed not “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section. Such certifications will not be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Shattuck Labs, Inc.
 
Date: August 11, 2022By:
/s/ Dr. Taylor Schreiber
 
Dr. Taylor Schreiber
Chief Executive Officer
(principal executive officer)
Date: August 11, 2022By:
/s/ Andrew R. Neill
Andrew R. Neill
Chief Financial Officer
(principal financial and accounting officer)

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