Shattuck Labs(STTK) - 2022 Q3 - Quarterly Report

PART I - FINANCIAL INFORMATION This section presents the unaudited interim financial statements, management's discussion and analysis, market risk disclosures, and controls and procedures Item 1. Financial Statements (Unaudited) This section presents the unaudited interim financial statements, including balance sheets, statements of operations and comprehensive loss, statements of changes in stockholders' equity, and statements of cash flows, along with detailed notes explaining the company's organization, accounting policies, and financial position as of September 30, 2022 Balance Sheets The balance sheets provide a snapshot of the company's financial position, detailing assets, liabilities, and equity as of September 30, 2022, and December 31, 2021 Balance Sheets (in thousands) | Metric | Sep 30, 2022 (Unaudited) | Dec 31, 2021 | | :-------------------------------- | :----------------------------------- | :-------------------------- | | Cash and cash equivalents | $39,758 | $92,268 | | Investments | $145,356 | $176,536 | | Total current assets | $201,516 | $288,266 | | Total assets | $222,943 | $298,585 | | Total current liabilities | $19,139 | $24,586 | | Total liabilities | $23,525 | $26,799 | | Total stockholders' equity | $199,418 | $271,786 | Statements of Operations and Comprehensive Loss These statements detail the company's revenues, expenses, and net loss for the three and nine months ended September 30, 2022 and 2021 Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :-------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Collaboration revenue | $212 | $1,900 | $262 | $(61) | | Research and development | $18,862 | $15,137 | $61,012 | $40,356 | | General and administrative | $6,579 | $4,343 | $16,303 | $14,098 | | Loss from operations | $(25,229) | $(17,580) | $(77,053) | $(54,515) | | Net loss | $(24,635) | $(17,410) | $(76,534) | $(52,821) | | Net loss per share – basic and diluted | $(0.58) | $(0.41) | $(1.81) | $(1.26) | Statements of Changes in Stockholders' Equity This section outlines changes in the company's equity components, including additional paid-in capital and accumulated deficit, for the periods presented Statements of Changes in Stockholders' Equity (in thousands) | Metric | Balance at Dec 31, 2021 | Balance at Sep 30, 2022 | | :-------------------- | :---------------------- | :---------------------- | | Additional Paid-In Capital | $389,408 | $394,348 | | Accumulated Deficit | $(117,067) | $(193,601) | | Total Stockholders' Equity | $271,786 | $199,418 | - The accumulated deficit increased from $(117.1) million at December 31, 2021, to $(193.6) million at September 30, 2022, primarily due to net losses incurred during the period[19] Statements of Cash Flows These statements present the cash inflows and outflows from operating, investing, and financing activities for the nine months ended September 30, 2022 and 2021 Cash Flow Activity (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(70,657) | $(38,399) | | Net cash (used in) provided by investing activities | $17,976 | $(36,044) | | Net cash provided by financing activities | $171 | $1,639 | | Net decrease in cash and cash equivalents | $(52,510) | $(72,804) | | Cash and cash equivalents, end of period | $39,758 | $85,094 | Notes to the Unaudited Interim Financial Statements These notes provide detailed explanations of the company's accounting policies, financial instruments, and other significant financial information 1. Organization and Description of Business This section describes Shattuck Labs, Inc.'s formation, its focus on developing dual-sided fusion proteins, and its clinical-stage product candidates - Shattuck Labs, Inc. is a clinical-stage biopharmaceutical company incorporated in 2016, focused on developing dual-sided fusion proteins (Agonist Redirected Checkpoint ("ARC") and gamma delta T cell engager ("GADLEN") platforms) for oncology and inflammatory diseases[25] - The company has two clinical-stage product candidates, SL-172154 and SL-279252, and several compounds in preclinical development[25] Liquidity This section addresses the company's historical losses, accumulated deficit, and management's assessment of its ability to fund operations for the next twelve months - The Company has incurred losses and negative cash flows from operations since inception, with an accumulated deficit of $193.6 million as of September 30, 2022[26] - Management believes that the Company's cash and cash equivalents and investments of $185.1 million as of September 30, 2022, are sufficient to fund projected operations for at least the next twelve months[26] COVID-19 Pandemic This section discusses the disruptions caused by the COVID-19 pandemic on the company's operations, clinical trials, and supply chain - The COVID-19 pandemic has caused disruptions in the Company's ability to manufacture clinical trial materials, acquire raw materials, enroll and treat patients in clinical trials, and has led to slowdowns/shutdowns of laboratories and service providers[27] - The extent of the pandemic's future impact on the Company's results is uncertain and could have a material adverse effect on its business, results of operations, and financial condition[28] Global Economic Considerations This section outlines the potential impacts of global macroeconomic uncertainty, including inflation and geopolitical instability, on the company's future operations - The global macroeconomic environment is uncertain due to factors like COVID-19, trade disputes, supply chain weaknesses, geopolitical instability, rising interest rates, and inflationary pressures[29] - The Company is currently unable to quantify the potential effects of this economic instability on its future operations[29] 2. Basis of Presentation and Summary of Significant Accounting Policies This section details the principles underlying the financial statements and the key accounting policies applied by the company Basis of Presentation The unaudited interim financial statements are prepared in conformity with GAAP, including all necessary normal and recurring adjustments - The unaudited interim financial statements are prepared in conformity with GAAP and include all normal and recurring adjustments necessary for fair presentation[30][31] Use of Estimates Management's preparation of financial statements involves significant estimates and assumptions for revenue, R&D expenses, and stock-based awards - Preparation of financial statements requires management to make significant estimates and assumptions, including for revenue recognition, research and development expenses, and valuation of stock-based awards[32] Fair Value of Financial Instruments This section defines fair value and categorizes financial instruments into levels based on observability of inputs, noting short-term instruments approximate fair value - Fair value is defined as the price received or paid in an orderly transaction, classified into Level 1 (observable inputs), Level 2 (indirectly observable inputs), and Level 3 (unobservable inputs)[33] - The carrying amounts of the Company's financial instruments, such as investments and accounts payable, approximate fair value due to their short-term nature[34] Concentration of Risk The company's financial instruments are concentrated at two institutions, and it relies heavily on third-party CMOs and CROs for R&D activities - The Company's financial instruments (cash, cash equivalents, investments) are concentrated at two financial institutions, but the Company believes it is not subject to unusual credit risk[35] - Substantially all revenue was derived from a collaboration agreement with Takeda, which was mutually terminated in November 2021[36] - The Company is highly dependent on a limited number of third-party contract manufacturing organizations (CMOs) and contract research organizations (CROs) for its research and development activities[37][38] Cash and Cash Equivalents This section defines cash and cash equivalents as demand deposits and highly liquid investments with original maturities of 90 days or less - Cash and cash equivalents include demand deposits and highly liquid investments with original maturities of 90 days or less, primarily held in money market funds[39] Investments Investments primarily consist of highly-rated U.S. Treasury securities, classified as available-for-sale and carried at estimated fair value - Investments consist of highly-rated U.S. Treasury securities, classified as available-for-sale and carried at estimated fair value[40] - Unrealized gains or losses not related to credit impairments are recorded in accumulated other comprehensive income (loss); no credit impairments were recorded as of September 30, 2022[40] Deferred Offering Costs The company capitalizes legal, accounting, and other third-party fees directly associated with in-process equity financings as deferred offering costs - The Company capitalizes certain legal, accounting, and other third-party fees directly associated with in-process equity financings as deferred offering costs[41] Impairment of Long-Lived Assets The company recorded impairment losses for lab equipment no longer needed during the three and nine months ended September 30, 2022 - The Company recorded $0.4 million and $0.8 million in impairment losses for the three and nine months ended September 30, 2022, respectively, related to lab equipment no longer needed[42] Leases The company adopted ASC 842, recognizing Right-of-Use assets and corresponding lease liabilities for leases with terms longer than 12 months - The Company adopted ASC 842, Leases, effective January 1, 2022, recognizing Right-of-Use (ROU) assets and corresponding lease liabilities for leases with terms longer than 12 months[43][44] Commitments and Contingencies The company accrues estimated material losses if probable and estimable, and discloses reasonably possible losses in accordance with ASC 450-20 - The Company follows ASC 450-20 for contingencies, accruing estimated material losses if probable and estimable, and disclosing reasonably possible losses[45][46] Revenue Recognition Collaboration revenue is recognized using a five-step model, with methods varying for up-front license fees, milestone payments, and royalties - Collaboration revenue is recognized in accordance with ASC 606, Revenue from Contracts with Customers, using a five-step model to identify performance obligations, determine transaction price, and allocate it[48][52] - Revenue recognition methods vary for different types of consideration: up-front license fees (over time or at point in time), milestone payments (most-likely amount approach), and royalties (at later of sales occurrence or performance obligation satisfaction)[59][60][61] Research and Development Costs Research and development costs are expensed as incurred, including salaries, stock-based compensation, and third-party service provider fees - Research and development costs are expensed as incurred, including salaries, stock-based compensation, equipment, supplies, nonclinical studies, clinical trials, and manufacturing development activities[64] - Accruals for third-party service providers (CROs, CMOs) are based on estimates of services received and efforts expended, with adjustments made as actual costs become known[65] Net Loss Per Share Basic and diluted loss per share are identical due to the anti-dilutive effect of potentially dilutive securities when a net loss exists - Basic and diluted loss per share are the same because, when a net loss exists, potentially dilutive securities (stock options, unvested restricted stock) are excluded as their impact would be anti-dilutive[66][67] Potentially Dilutive Securities | Potentially Dilutive Securities | As of Sep 30, 2022 | As of Sep 30, 2021 | | :------------------------------ | :----------------- | :----------------- | | Stock options | 4,073,267 | 2,491,187 | | Unvested restricted stock | 295,977 | — | | Total | 4,369,244 | 2,491,187 | Other Comprehensive Income (Loss) Other comprehensive income (loss) comprises the net loss and unrealized gains and losses on investments - Other comprehensive income (loss) is comprised of the net loss and unrealized gains and losses on investments[69] Recently Adopted Accounting Pronouncements The company adopted ASC 842, Leases, effective January 1, 2022, requiring recognition of ROU assets and lease liabilities on the balance sheet - The Company adopted ASC 842, Leases, effective January 1, 2022, which requires lessees to record ROU assets and corresponding lease liabilities on the balance sheet for leases over 12 months[70] Balance Sheet Impact of ASC 842 Adoption (in thousands) | Balance Sheet Impact | Dec 31, 2021 | Effect of ASC 842 Adoption | Jan 1, 2022 | | :---------------------------------- | :----------- | :------------------------- | :---------- | | Other assets | $381 | $2,945 | $3,326 | | Accrued expenses and other current liabilities | $14,574 | $255 | $14,829 | | Non-current operating lease liabilities | — | $4,903 | $4,903 | | Deferred rent | $2,213 | $(2,213) | — | 3. Investments This section details the company's investments, primarily in U.S. government securities, and their fair value classification within the hierarchy Investments (in thousands) | Investment Type | Amortized Cost (Sep 30, 2022) | Gross Unrealized Loss (Sep 30, 2022) | Fair Value (Sep 30, 2022) | | :----------------------------- | :---------------------------- | :----------------------------------- | :------------------------ | | U.S. government securities | $146,690 | $(1,334) | $145,356 | | Total investments | $146,690 | $(1,334) | $145,356 | | | Amortized Cost (Dec 31, 2021) | Gross Unrealized Loss (Dec 31, 2021) | Fair Value (Dec 31, 2021) | | U.S. government securities | $177,096 | $(560) | $176,536 | | Total investments | $177,096 | $(560) | $176,536 | - The Company's investments are primarily in U.S. government securities, classified as Level 1 inputs within the fair value hierarchy, with an average maturity of 0.52 years as of September 30, 2022[73] 4. Accrued Expenses and Other Current Liabilities This section provides a breakdown of accrued expenses and other current liabilities, highlighting the impact of a litigation settlement Accrued Expenses and Other Current Liabilities (in thousands) | Accrued Expense | Sep 30, 2022 | Dec 31, 2021 | | :----------------------------- | :----------- | :----------- | | Research and development contract costs | $10,232 | $10,253 | | Compensation and related benefits | $3,176 | $3,320 | | Litigation settlement | $1,400 | — | | Other current liabilities | $1,295 | $1,001 | | Total accrued expenses and other current liabilities | $16,103 | $14,574 | - The increase in total accrued expenses and other current liabilities from $14.6 million to $16.1 million was primarily driven by a $1.4 million litigation settlement accrued as of September 30, 2022[74] 5. Commitments and Contingencies This section details the company's operating lease obligations, license agreement milestones, and the status of ongoing litigation Operating Leases This section outlines the company's operating lease assets and liabilities, along with associated rent expenses Operating Lease Balance Sheet Classification (in thousands) | Balance Sheet Classification | Sep 30, 2022 | | :---------------------------------------- | :----------- | | Other assets (ROU assets) | $2,717 | | Accrued expenses and other current liabilities | $679 | | Non-current operating lease liabilities | $4,386 | | Total liabilities | $5,065 | - The Company incurred rent expense of $0.2 million for the three months ended September 30, 2022, and $0.6 million for the nine months ended September 30, 2022[78] Heat License Agreement The company is obligated to make milestone and royalty payments under a license agreement with Heat Biologics Inc. upon achievement of specified conditions - The Company is required to make payments up to $20.6 million for development, regulatory, and commercial sales milestones, plus low single-digit royalties on net sales, under a license agreement with Heat Biologics Inc[80][81] - No liability has been recorded for these payments as the achievement of specified milestones is not probable as of the balance sheet date[81] Litigation This section details the consolidated class action lawsuits alleging misleading omissions and the subsequent $1.4 million settlement in principle - Putative class action lawsuits filed in early 2022 were consolidated, alleging misleading omissions regarding clinical trial results and the Takeda Collaboration Agreement[82] - A settlement in principle of $1.4 million was reached on November 2, 2022, and the amount was accrued in accrued expenses and other current liabilities as of September 30, 2022[82] Contractual Obligations Contractual obligations primarily arise from cancellable agreements with CMOs and CROs, which are not classified as long-term liabilities - Contractual obligations primarily stem from agreements with CMOs and CROs, which are cancellable upon written notice and thus not classified as long-term liabilities[83] 6. Stock-Based Compensation This section details the company's equity incentive and employee stock purchase plans, along with the associated stock-based compensation expense 2020 Equity Incentive Plan The 2020 Plan's share reserve automatically increased, with shares available for future grants and awards generally vesting over four years - The 2020 Plan's share reserve automatically increased by 1,693,555 shares on January 1, 2022, with 3,646,795 shares available for future grants as of September 30, 2022[84] - Awards generally vest over four years and have a term of 10 years, including 178,150 awards granted in 2022 with market-based vesting conditions[84] 2020 Employee Stock Purchase Plan The 2020 ESPP allows eligible employees to purchase common stock at a discount, with its share reserve also increasing automatically - The 2020 ESPP allows eligible employees to purchase common stock at 85% of the lower of the fair market value at the beginning or end of each offering period[85] - The share reserve increased by 423,388 shares on January 1, 2022; the Company issued 13,088 shares for $0.1 million in aggregate cash proceeds during the nine months ended September 30, 2022[86] Stock-Based Compensation Expense This section presents the stock-based compensation expense allocated to research and development and general and administrative categories Stock-Based Compensation Expense (in thousands) | Expense Category | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :------------------------------ | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Research and development | $950 | $620 | $2,672 | $1,542 | | General and administrative | $773 | $724 | $2,097 | $2,709 | | Total stock-based compensation | $1,723 | $1,344 | $4,769 | $4,251 | - Unrecognized compensation cost for options was $14.2 million as of September 30, 2022, to be recognized over an estimated weighted-average amortization period of 2.4 years[87] Restricted Stock Units This section summarizes the activity of restricted stock units, including grants and forfeitures, and the associated compensation recognized RSU Activity | RSU Activity | Awards (Nine Months Ended Sep 30, 2022) | | :------------- | :-------------------------------------- | | Granted | 318,153 | | Forfeited | (22,176) | | Balance at Sep 30, 2022 | 295,977 | - The Company recognized $0.4 million of stock-based compensation related to RSUs as of September 30, 2022[88] Fair Value of Stock Options and Shares Issued The Black-Scholes and Monte Carlo models are used to determine the fair value of stock options, based on various assumptions - The Black-Scholes option pricing model is used for stock options with service or performance conditions, while the Monte Carlo pricing model is used for options with market-based conditions[89] Stock Option Valuation Assumptions (Weighted-Average) | Assumption | 2020 Plan | 2020 ESPP | | :----------- | :--------------------------- | :--------------------------- | | Expected term - years | 6.08 | 0.50 | | Expected volatility | 82.30% | 82.90% | | Risk-free interest rate | 2.20% | 2.50% | | Expected dividends | — | — | 7. Collaboration Revenue Collaboration revenue is recognized using a cost-based input measure, with details on the terminated Takeda agreement and its financial impact - Collaboration revenue is recognized using a cost-based input measure, comparing actual costs incurred to budgeted costs[91] - The Collaboration Agreement with Takeda was mutually terminated in Q4 2021; a prior increase in expected program costs for SL-279252 in Q2 2021 resulted in a $4.2 million negative revenue adjustment and a $0.10 increase in 2021 basic and diluted loss per share[92] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides an overview of the company's business, operational highlights, and a detailed analysis of its financial performance for the three and nine months ended September 30, 2022, compared to the prior year; it also discusses liquidity, capital resources, critical accounting policies, and the company's status as an emerging growth and smaller reporting company Overview Shattuck Labs is a clinical-stage biotechnology company developing dual-sided fusion proteins for oncology and inflammatory diseases, with lead product candidates SL-172154 and SL-279252 - Shattuck Labs is a clinical-stage biotechnology company developing dual-sided fusion proteins through its Agonist Redirected Checkpoint (ARC®) and gamma delta T cell engager (GADLEN™) platforms for oncology and inflammatory diseases[95][98][99] - Lead product candidates include SL-172154 (inhibits CD47/SIRPα, activates CD40 for ovarian cancer, AML, HR-MDS) and SL-279252 (inhibits PD-1/PD-L1, activates OX40 for advanced solid tumors)[95][96] - Initial clinical data from Phase 1 trials for SL-172154 and SL-279252, announced in November 2021, demonstrated a differentiated safety profile and on-target immune activation[97] Overview of Operations Since inception, the company has focused on R&D, funded by various capital sources, and expects increased operating expenses due to clinical development - Since inception in 2016, the Company has focused on research and development, funded by its IPO ($213.5 million), preferred stock sales ($152.9 million), convertible notes ($10.5 million), and collaboration agreements ($82.3 million)[100] - The Company reported a net loss of $76.5 million for the nine months ended September 30, 2022, and an accumulated deficit of $193.6 million, expecting significant increases in operating expenses for clinical development, manufacturing, and public company operations[101][102][103] COVID-19 Pandemic The COVID-19 pandemic continues to cause delays in clinical trials, manufacturing, and patient enrollment, potentially leading to increased costs and adverse effects - The COVID-19 pandemic continues to cause delays in clinical trials (SL-172154 and SL-279252), manufacturing operations, raw material acquisition, patient enrollment, and performance from third-party vendors[103][104][105] - These disruptions could lead to increased costs and materially adverse effects on the business and financial condition, with the potential effects on future operations currently unquantifiable[105] Global Economic Considerations Global macroeconomic uncertainty, including inflation and geopolitical instability, could negatively affect the company's future operations, with unquantifiable potential effects - Global macroeconomic uncertainty, including pandemics, trade disputes, geopolitical instability, supply chain weaknesses, rising interest rates, and inflationary pressures, could negatively affect future operations[106] - The Company is currently unable to quantify the potential effects of this economic instability on its future operations[106] Collaboration Agreement - Takeda The collaboration agreement with Takeda was mutually terminated in November 2021, eliminating future milestone or royalty payments - The Collaboration Agreement with Millennium Pharmaceuticals, Inc. (Takeda), entered in 2017, was mutually terminated in November 2021[107] - Under the termination agreement, the Company is not required to satisfy remaining performance obligations and will not make or receive any future milestone or royalty payments from Takeda[107] Components of our Results of Operation This section analyzes the key components of the company's financial performance, including collaboration revenue, operating expenses, other income, and income taxes Collaboration Revenue Historically, revenue was primarily from the terminated Takeda agreement, with future collaboration revenue expected to fluctuate - The Company has no products approved for commercial sale and historically generated revenue primarily from the terminated Takeda Collaboration Agreement[108] - Future collaboration revenue from any new partners is expected to fluctuate[108] Operating Expense Operating expenses include research and development and general and administrative costs, which are expected to increase with clinical development Research and Development Expense R&D expenses cover clinical trials, nonclinical studies, manufacturing, and employee-related costs, and are projected to increase with pipeline advancement - Research and development expenses primarily include costs for clinical trials, nonclinical studies, manufacturing materials, process development, employee-related expenses, and fees to third-party service providers[109] Research and Development Expense (in thousands) | R&D Expense | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | SL-172154 | $7,338 | $3,963 | $27,080 | $11,153 | | Other pipeline candidates | $3,705 | $4,608 | $12,356 | $9,778 | | SL-279252 | $357 | $2,298 | $1,354 | $7,913 | | Internal costs | $7,462 | $4,268 | $20,222 | $11,512 | | Total R&D | $18,862 | $15,137 | $61,012 | $40,356 | - The Company expects R&D expenses to increase due to additional nonclinical studies, clinical trials (especially later-stage), regulatory approvals, and preclinical pipeline advancement[110] General and Administrative Expense G&A expenses include personnel, facility, legal, and accounting costs, expected to rise with R&D activities and public company operations - General and administrative expenses primarily consist of personnel expenses (salaries, benefits, stock-based compensation), corporate facility costs, and legal, accounting, and investor relations fees[112][114] - These expenses are expected to increase to support growing R&D activities and the costs associated with operating as a public company, including potential sales and marketing team build-out if product candidates are approved[114] Other Income Other income primarily consists of interest earned on cash, cash equivalents, and investments, along with investment fees and realized gains/losses - Other income consists of interest earned on cash, cash equivalents, and investments, as well as investment fees and realized gains/losses[115] Income Taxes The company has not recorded income tax benefits for NOLs or R&D tax credits due to a full valuation allowance against deferred tax assets - The Company has not recorded income tax benefits for net operating losses (NOLs) or research and development tax credits due to a full valuation allowance against deferred tax assets, as realization is not considered probable[116] Results of Operations (Comparison of the Three Months Ended September 30, 2022 and 2021) This section compares the company's financial performance for the three months ended September 30, 2022, against the same period in 2021, detailing changes in revenue, expenses, and net loss Results of Operations (Three Months Ended September 30, in thousands) | Metric | 2022 | 2021 | Change (Dollar) | Change (Percentage) | | :-------------------- | :----------- | :----------- | :-------------- | :------------------ | | Collaboration revenue | $212 | $1,900 | $(1,688) | (88.8)% | | Research and development | $18,862 | $15,137 | $3,725 | 24.6% | | General and administrative | $6,579 | $4,343 | $2,236 | 51.5% | | Loss from operations | $(25,229) | $(17,580) | $(7,649) | 43.5% | | Other income | $594 | $170 | $424 | 249.4% | | Net loss | $(24,635) | $(17,410) | $(7,225) | 41.5% | - Collaboration revenue decreased significantly due to the termination of the Takeda agreement, partially offset by a new collaboration agreement in Q2 2022[118] - The increase in R&D expenses was primarily driven by higher personnel costs, clinical costs, laboratory costs, and other operating expenses, partially offset by a decrease in manufacturing-related and pharmacology costs[119][120] - The rise in G&A expenses was mainly due to a $1.4 million litigation settlement and increased costs associated with being a public company[121] Results of Operations (Comparison of the Nine Months Ended September 30, 2022 and 2021) This section compares the company's financial performance for the nine months ended September 30, 2022, against the same period in 2021, detailing changes in revenue, expenses, and net loss Results of Operations (Nine Months Ended September 30, in thousands) | Metric | 2022 | 2021 | Change (Dollar) | Change (Percentage) | | :-------------------- | :----------- | :----------- | :-------------- | :------------------ | | Collaboration revenue | $262 | $(61) | $323 | 529.5% | | Research and development | $61,012 | $40,356 | $20,656 | 51.2% | | General and administrative | $16,303 | $14,098 | $2,205 | 15.6% | | Loss from operations | $(77,053) | $(54,515) | $(22,538) | 41.3% | | Other income | $519 | $1,694 | $(1,175) | (69.4)% | | Net loss | $(76,534) | $(52,821) | $(23,713) | 44.9% | - Collaboration revenue increased due to a one-time negative revenue adjustment in Q2 2021 and revenue from a new collaboration agreement in Q2 2022[124] - The substantial increase in R&D expenses was driven by higher manufacturing costs, increased headcount, expansion of manufacturing and clinical development capabilities, laboratory and facilities costs, clinical costs, and depreciation/impairment losses[125] - The increase in G&A expenses was primarily due to a $1.4 million litigation settlement and increased costs associated with being a public company[126] Liquidity and Capital Resources This section discusses the company's sources of liquidity, funding requirements, and cash flow activities, including its ability to fund future operations Capital Resources and Funding Requirements The company's liquidity sources include stock sales and collaboration agreements, with future funding dependent on R&D progress and commercialization activities - Primary liquidity sources include sales of preferred and common stock (including IPO) and collaboration agreements; as of September 30, 2022, the Company had an accumulated deficit of $193.6 million and $185.1 million in cash and cash equivalents and investments[127] - The Company entered into an 'at-the-market' (ATM) facility in July 2022, allowing it to sell up to $75.0 million of common stock, with no sales made as of September 30, 2022[128] - Future funding requirements are dependent on the scope and progress of R&D, manufacturing costs, intellectual property, and potential commercialization activities, necessitating additional capital through equity, debt, or collaborations[129][130] Cash Flows This section analyzes the company's cash flows from operating, investing, and financing activities, and assesses its ability to fund operations - Management believes that the Company's cash and cash equivalents and investments of $185.1 million as of September 30, 2022, are sufficient to fund projected operations into the second half of 2024[131] Cash Flow Activity (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(70,657) | $(38,399) | | Net cash (used in) provided by investing activities | $17,976 | $(36,044) | | Net cash provided by financing activities | $171 | $1,639 | | Net decrease in cash and cash equivalents | $(52,510) | $(72,804) | - Net cash used in operating activities increased due to higher net loss and changes in operating assets/liabilities, partially offset by noncash charges[133][135] - Net cash provided by investing activities shifted from usage due to net change in investments[133][135] Contractual Obligations and Other Commitments Further details on the company's contractual obligations and other commitments are provided in the notes to the financial statements - Further details on contractual obligations and other commitments are provided in Note 5 and Note 7 to the financial statements[138] Critical Accounting Policies This section highlights critical accounting policies requiring significant judgment, including revenue recognition, R&D expense accruals, and stock-based award valuation - Critical accounting policies requiring significant judgment and estimates include revenue recognition, accrual for research and development expenses, and valuation of stock-based awards[141] - The Company uses the Black-Scholes model for stock options with service/performance conditions and the Monte Carlo model for market-based conditions, with no material changes to these policies since the prior annual report[142][143] Recent Accounting Pronouncements Information regarding recent accounting pronouncements applicable to the financial statements is provided in Note 2 - Information regarding recent accounting pronouncements applicable to the financial statements can be found in Note 2[144] Emerging Growth Company and Smaller Reporting Company Status The company's status as an EGC and SRC allows for extended transition periods for new accounting standards and reduced disclosure requirements - The Company is an 'emerging growth company' (EGC) and 'smaller reporting company' (SRC), allowing it to use extended transition periods for new accounting standards and reduced disclosure requirements[145][147] - As an EGC, the Company can delay adoption of certain accounting standards and is exempt from auditor attestation on internal controls; as an SRC, it can present two years of audited financial statements and has reduced executive compensation disclosures[145][146][149] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Shattuck Labs, Inc. is exempt from providing quantitative and qualitative disclosures about market risk - The Company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[150] Item 4. Controls and Procedures This section details the management's evaluation of the effectiveness of disclosure controls and procedures and reports on any changes in internal control over financial reporting Evaluation of Disclosure Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of September 30, 2022 - Management, including the principal executive officer and principal financial officer, concluded that the Company's disclosure controls and procedures were effective at the reasonable assurance level as of September 30, 2022[151] Changes in Internal Control over Financial Reporting There were no material changes in the company's internal control over financial reporting during the third quarter of 2022 - There were no material changes in the Company's internal control over financial reporting during the third quarter of 2022[152] PART II - OTHER INFORMATION This section covers legal proceedings, risk factors, sales of equity securities, defaults, mine safety disclosures, other information, and exhibits Item 1. Legal Proceedings This section discloses ongoing legal proceedings, specifically a consolidated class action lawsuit, and confirms no other material legal actions - Putative class action lawsuits filed in January and February 2022 were consolidated in June 2022, alleging misleading omissions regarding clinical trial results and the Takeda collaboration agreement[154] - A settlement in principle of $1.4 million was reached on November 2, 2022, subject to a definitive agreement and court approval[154] - The Company is not a party to any other legal proceedings that would individually or collectively have a material adverse effect on its business[155] Item 1A. Risk Factors This section refers to the Annual Report on Form 10-K for general risk factors and provides an update on the potential impact of recent healthcare legislation, such as the Inflation Reduction Act of 2022, on drug pricing and reimbursement - The Company's business is subject to various risks, as described in Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2021[156] - New legislation, including the Inflation Reduction Act of 2022, may increase the difficulty and cost of obtaining marketing approval and commercializing drug candidates, potentially affecting pricing and reimbursement[157][158] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section states that there were no unregistered sales of equity securities or use of proceeds to report - None[159] Item 3. Defaults Upon Senior Securities This section states that there were no defaults upon senior securities to report - None[160] Item 4. Mine Safety Disclosures This section states that there were no mine safety disclosures to report - None[160] Item 5. Other Information This section states that there is no other information to report - None[161] Item 6. Exhibits This section lists all exhibits filed or furnished as part of this Quarterly Report on Form 10-Q, including corporate documents, agreements, and certifications - The exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, Form of common stock certificate, Investors' Rights Agreement, Sales Agreement, and various certifications (principal executive officer, principal financial officer) and XBRL documents[164] Signatures This section contains the signatures of the Company's authorized officers, confirming the due filing of the report - The report was signed on November 9, 2022, by Dr. Taylor Schreiber, Chief Executive Officer, and Andrew R. Neill, Chief Financial Officer[169]