Enliven Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Business Update Initial proof of concept data from Phase 1a trial evaluating ELVN-001 in adults with chronic myeloid leukemia (CML) is expected in the second quarter of 2024 IND application to evaluate ELVN-002 in combination with trastuzumab in patients with HER2+ metastatic breast cancer and colorectal cancer received U.S. FDA clearance Strong balance sheet, closing the year with $253 million in cash, cash equi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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: 001-39247 ENLIVEN THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) | Delaware | 81-1523849 | | --- | --- | | (S ...

BOULDER, Colo., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Enliven Therapeutics, Inc. (Enliven) (Nasdaq: ELVN), a clinical-stage precision oncology focused on the discovery and development of next-generation small molecule kinase inhibitors, today announced that management will participate in a panel discussion at TD Cowen’s 44th Annual Health Care Conference in Boston, MA, on Tuesday, March 5, 2024, at 12:50 p.m. ET. The panel will be webcast live and can be accessed by visiting the investor relations section of th ...

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 September 30, 2023 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: 001-39247 ENLIVEN THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) (State or other j ...

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Condensed Consolidated Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) Unaudited financial statements reflect significant asset growth and positive equity by June 30, 2023, driven by a February 2023 merger and financing, despite increased net loss and operating cash usage [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The company's financial position significantly improved due to increased assets and a shift to positive equity from a deficit | | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Total current assets** | $283,175 | $77,753 | | **Total assets** | $288,501 | $83,298 | | **Total current liabilities** | $9,147 | $9,715 | | **Total liabilities** | $9,507 | $10,374 | | **Total stockholders' equity (deficit)** | $278,994 | $(76,825) | *All figures in thousands* - The company's financial position strengthened significantly, with cash, cash equivalents, and marketable securities increasing to **$277.9 million** as of June 30, 2023, from **$75.5 million** at the end of 2022[15](index=15&type=chunk) - Stockholders' equity improved from a **deficit of $76.8 million** to a **positive equity of $279.0 million**, primarily due to the conversion of preferred stock and issuance of common stock related to the February 2023 merger and financing transaction[15](index=15&type=chunk)[20](index=20&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported increased operating expenses and a higher net loss for the six months ended June 30, 2023, driven by R&D and G&A costs | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2023** | **2022** | **2023** | **2022** | | **Research and development** | $15,183 | $7,937 | $27,063 | $14,996 | | **General and administrative** | $4,951 | $1,079 | $9,489 | $2,698 | | **Loss from operations** | $(20,134) | $(9,016) | $(36,552) | $(17,694) | | **Net loss** | $(16,721) | $(8,889) | $(31,445) | $(17,558) | | **Net loss per share, basic and diluted** | $(0.41) | $(2.86) | $(1.05) | $(5.87) | *All figures in thousands, except per share amounts* - Operating expenses for the six months ended June 30, 2023, **more than doubled** to **$36.6 million** from **$17.7 million** in the prior-year period, primarily due to increased research and development activities and higher general and administrative costs[17](index=17&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flows reflect increased operating cash usage, significant investing in marketable securities, and substantial cash inflow from financing activities | | Six Months Ended June 30, | | :--- | :--- | | | **2023** | **2022** | | **Net cash used in operating activities** | $(32,893) | $(17,485) | | **Net cash used in investing activities** | $(151,549) | $(497) | | **Net cash provided by financing activities** | $234,621 | $414 | | **Net increase (decrease) in cash** | $50,179 | $(17,568) | | **Cash at end of period** | $125,769 | $92,510 | *All figures in thousands* - Financing activities provided **$234.6 million** in cash during the first six months of 2023, primarily from a **$161.4 million** financing transaction and **$81.8 million** in cash acquired from the reverse recapitalization, net of transaction costs[23](index=23&type=chunk) - Investing activities used **$151.5 million**, mainly for the purchase of marketable securities, a **significant change** from the prior year which had minimal investing activities[23](index=23&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the February 2023 reverse recapitalization and financing, which significantly improved liquidity and increased stock-based compensation - On February 23, 2023, the company completed a merger with Former Enliven, which was accounted for as a reverse recapitalization[27](index=27&type=chunk)[28](index=28&type=chunk) - Concurrently with the merger, a financing transaction raised an aggregate of **$164.5 million** through the sale of common stock[31](index=31&type=chunk) - The company expects its cash, cash equivalents, and marketable securities of **$277.9 million** as of June 30, 2023, to be sufficient to fund operations for at least the next 12 months[35](index=35&type=chunk) - Stock-based compensation expense **increased significantly** to **$6.5 million** for the six months ended June 30, 2023, from **$1.4 million** in the same period of 2022[118](index=118&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's biopharmaceutical development, increased expenses, and improved liquidity from the February 2023 merger, ensuring a 12-month cash runway [Overview](index=25&type=section&id=Overview) Enliven Therapeutics is a clinical-stage biopharmaceutical company developing small molecule inhibitors for cancer - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule inhibitors for cancer, aiming to improve both survival and patient well-being[123](index=123&type=chunk) | Program | Target | Disease | Next Milestone | Milestone Expected | | :--- | :--- | :--- | :--- | :--- | | ELVN-001 | BCR-ABL | CML | Phase 1a Safety/Efficacy | 2024 | | ELVN-002 | HER2 & mutants | NSCLC, other solid tumors | Phase 1a Safety/Efficacy | 2024 | - As of June 30, 2023, the company had cash, cash equivalents, and marketable securities of **$277.9 million**, which is expected to fund operations for at least the next 12 months[126](index=126&type=chunk) - The company has incurred **significant losses** since inception, with an accumulated deficit of **$114.3 million** as of June 30, 2023, and expects operating losses to continue[127](index=127&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Results of operations highlight significant increases in R&D and G&A expenses, leading to a higher net loss | Expense Category | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | Change | | :--- | :--- | :--- | :--- | | Research and development | $27.1 million | $15.0 million | +$12.1 million | | General and administrative | $9.5 million | $2.7 million | +$6.8 million | - The **$12.1 million increase** in R&D expenses for the first half of 2023 was primarily driven by a **$5.5 million increase** in clinical trial expenses, along with higher contract manufacturing, preclinical, and personnel-related costs[151](index=151&type=chunk) - The **$6.8 million increase** in G&A expenses for the first half of 2023 was mainly due to higher professional services costs (**$2.1M**), stock-based compensation (**$1.9M**), and accelerated stock option vesting from the merger (**$1.3M**)[152](index=152&type=chunk) - Interest income **rose to $5.1 million** for the six months ended June 30, 2023, from **$136,000** in the prior-year period, due to higher interest rates and larger investment balances[153](index=153&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity and capital resources detail the company's cash position, primary funding sources, and future capital requirements - The company's primary sources of liquidity have been private placements of convertible preferred stock (**$140.5M**) and a common stock sale in a Financing Transaction (**$164.5M**) in February 2023[154](index=154&type=chunk) - On June 23, 2023, the company entered into an "at-the-market" (ATM) sales agreement allowing it to sell up to **$200.0 million** of its common stock[155](index=155&type=chunk) - Net cash used in operating activities **increased to $32.9 million** for the first six months of 2023, compared to **$17.5 million** for the same period in 2022, reflecting higher net loss and changes in operating assets and liabilities[163](index=163&type=chunk)[164](index=164&type=chunk)[165](index=165&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on short-term investments, with limited foreign currency exposure - The company's main market risk is interest rate sensitivity on its cash, cash equivalents, and marketable securities, primarily U.S. Treasury instruments[181](index=181&type=chunk) - Due to the short-term maturities of its investments, a hypothetical **100 basis point** change in interest rates is not expected to materially impact financial results[181](index=181&type=chunk) - The company has limited exposure to foreign currency exchange risk and does not currently engage in hedging activities[183](index=183&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2023, with no material changes to internal controls - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period, June 30, 2023[184](index=184&type=chunk) - No material changes to the company's internal control over financial reporting were identified during the quarter ended June 30, 2023[185](index=185&type=chunk) [PART II. OTHER INFORMATION](index=38&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, with a prior merger-related shareholder complaint dismissed - The company is not currently a party to any material litigation[188](index=188&type=chunk) - A shareholder complaint related to the merger was **voluntarily dismissed** by the plaintiff in January 2023 after supplemental disclosures were filed[89](index=89&type=chunk)[91](index=91&type=chunk)[92](index=92&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) This section details substantial risks including limited operating history, net losses, and dependence on lead product candidates - The company has a **limited operating history**, has incurred **significant net losses**, and its success is substantially dependent on its two lead product candidates, ELVN-001 and ELVN-002[191](index=191&type=chunk) - Clinical development is **highly uncertain**, and positive results from early trials may not be predictive of success in later trials, which could prevent or delay regulatory approval[191](index=191&type=chunk)[206](index=206&type=chunk) - The company will need **substantial additional funding** to complete the development of its product candidates and may be forced to delay or cut programs if unable to raise capital[191](index=191&type=chunk)[449](index=449&type=chunk) - The company's success depends on its ability to obtain and maintain **intellectual property protection** for its technologies and product candidates[191](index=191&type=chunk)[368](index=368&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=97&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - There were no unregistered sales of equity securities in the reported period[479](index=479&type=chunk) [Other Information](index=97&type=section&id=Item%205.%20Other%20Information) CEO Sam Kintz and other executives adopted Rule 10b5-1 trading plans in Q2 2023 for orderly stock sales - CEO Sam Kintz adopted a Rule 10b5-1 trading plan on June 26, 2023, to sell up to **421,665 shares** over two years for asset diversification[483](index=483&type=chunk) - Other directors and executive officers also adopted Rule 10b5-1 plans during the second quarter of 2023[484](index=484&type=chunk)

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 March 31, 2023 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: 001-39247 ENLIVEN THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) (State or other juris ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 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 001-39247 IMARA INC. (Exact name of Registrant as specified in its charter) Delaware 81-1523849 (State or other jurisdiction of incorpora ...

Clinical Trials and Development - The company announced the discontinuation of the Ardent and Forte Phase 2b clinical trials for tovinontrine, impacting its development in sickle cell disease and ß-thalassemia [106]. - Research and development expenses decreased significantly to $0.2 million for the three months ended September 30, 2022, from $10.4 million for the same period in 2021, primarily due to the discontinuation of tovinontrine development [140]. - Research and development expenses decreased by approximately $8.8 million from $27.6 million in 2021 to $18.8 million in 2022, primarily due to a $7.9 million decrease in clinical materials and research costs [145]. Mergers and Acquisitions - An Asset Purchase Agreement was entered into with Cardurion Pharmaceuticals for the sale of tovinontrine, with an upfront cash payment of $34.75 million and potential future payments totaling up to $60 million based on clinical and regulatory milestones [110]. - The company is pursuing a merger with Enliven Therapeutics, where pre-merger stockholders are expected to own approximately 16% of the combined company, while Enliven stockholders will own about 84% [111]. - The merger is contingent upon the completion of the Asset Sale and requires stockholder approvals, with net cash requirements set between $75 million and $95 million [113]. - A contingent value rights agreement will be established for pre-merger stockholders, allowing potential payments based on future events related to the Asset Sale [111]. - The company has entered into a Merger Agreement with Enliven, subject to stockholder approval and customary closing conditions [171]. Financial Performance - The company incurred operating losses of $4.8 million and $31.0 million for the three and nine months ended September 30, 2022, respectively, compared to $13.7 million and $37.1 million for the same periods in 2021 [118]. - As of September 30, 2022, the company had an accumulated deficit of approximately $178.2 million [118]. - The company has not generated any revenue since inception and does not expect to do so in the near future [127]. - The company expects to continue incurring operating losses for the foreseeable future, with potential fluctuations based on strategic decisions [118]. - Net loss for the nine months ended September 30, 2022, was $30.7 million, an improvement from a net loss of $37.1 million in 2021 [144]. - Total operating expenses decreased from $37.1 million in 2021 to $31.0 million in 2022, resulting in a loss from operations of $31.0 million [144]. Cash and Funding - The company has raised $46.8 million from a public offering of 8,333,333 shares at a price of $6.00 per share in July 2021 [117]. - As of September 30, 2022, the company had $56.3 million in cash, cash equivalents, and investments as of September 30, 2022, which is expected to fund operations for at least twelve months [121]. - Net cash used in operating activities was $33.7 million for the nine months ended September 30, 2022, compared to $34.3 million in 2021 [153][155]. - Net cash provided by investing activities increased significantly to $34.7 million in 2022 from $12.9 million in 2021, primarily due to proceeds from maturities of short-term investments [156][157]. - The company anticipates needing substantial additional funding to support ongoing operations and develop a growth strategy [120]. Strategic Alternatives - The company has focused on strategic alternatives, including potential dissolution and liquidation if the Asset Sale or Merger does not close [107]. - If the Asset Sale or Merger does not close, the company may pursue dissolution and liquidation as a strategic alternative [119]. - The company expects operating expenses to decrease significantly following the decision to discontinue the development of tovinontrine and implement workforce reductions [160]. - Future capital requirements will depend on the results of ongoing strategic evaluations, including potential asset sales or mergers [162]. Regulatory and Compliance - The company is classified as an "emerging growth company" (EGC) under the JOBS Act, allowing for delayed adoption of certain accounting standards [175]. - The company can present only two years of audited financial statements and related Management's Discussion and Analysis in registration statements [176]. - The company will remain an EGC until the earliest of December 31, 2025, or until total annual gross revenues exceed $1.07 billion [177]. - Interest income is sensitive to changes in interest rates, but a 10% change would not materially affect the fair market value of the investment portfolio due to short-term maturities [179]. - The company is not currently exposed to significant market risk from foreign currency exchange rates, but may contract with foreign vendors in the future [180].

Financial Performance - The company has incurred significant operating losses since inception, with losses from operations of $11.5 million and $26.2 million for the three and six months ended June 30, 2022, respectively, compared to $13.2 million and $23.4 million for the same periods in 2021 [96]. - As of June 30, 2022, the company had an accumulated deficit of approximately $173.6 million and expects to continue incurring operating losses for the foreseeable future [96]. - Net loss for the six months ended June 30, 2022, was $26.1 million, compared to a net loss of $23.4 million for the same period in 2021 [124]. - Total operating expenses for the six months ended June 30, 2022, were $26.2 million, an increase of $2.7 million compared to $23.4 million for the same period in 2021 [124]. Cash and Investments - The company had $60.3 million in cash, cash equivalents, and investments as of June 30, 2022, which is expected to fund operating expenses for at least twelve months [101]. - As of June 30, 2022, the company had $60.3 million in cash, cash equivalents, and investments [132]. - The company has cash, cash equivalents, and investments totaling $60.3 million as of June 30, 2022 [157]. Research and Development - Research and development expenses for the three months ended June 30, 2022, totaled $7.4 million, a decrease from $10.1 million for the same period in 2021 [111]. - The company expects research and development expenses to decrease significantly beginning in the third quarter of 2022 due to the discontinuation of certain trials [108]. - Research and development expenses decreased by approximately $2.7 million from $10.1 million in Q2 2021 to $7.4 million in Q2 2022, primarily due to a $3.2 million decrease related to the discontinued development of tovinontrine [120]. Workforce and Operational Changes - The company decided to discontinue the development of tovinontrine and implemented a reduction in workforce to reduce operating expenses [92]. - The company expects operating expenses to decrease significantly starting in Q3 2022 following the decision to discontinue tovinontrine development and reduce workforce [140]. Revenue Generation - The company has not generated any revenue since inception and does not expect to do so in the near future [107]. - The company has not yet commercialized or generated revenue from any product candidate, relying on funding through stock issuances [128]. Stock Issuance and Financing - The company has issued and sold 231,291 shares of common stock under a sales agreement, resulting in net proceeds of $1.4 million as of June 30, 2022 [94]. - The company completed a public offering of 8,333,333 shares at a price of $6.00 per share, resulting in net proceeds of $46.8 million [95]. Other Financial Information - Net cash used in operating activities for the six months ended June 30, 2022, was $29.5 million, primarily due to a net loss of $26.1 million [133]. - Total other income, net for Q2 2022 was $72, compared to $8 in Q2 2021, primarily from interest earned on cash and investments [119]. Accounting and Regulatory Matters - The company is classified as an "emerging growth company" (EGC) under the JOBS Act, allowing it to delay the adoption of certain accounting standards [152]. - The company may remain an EGC until it reaches total annual gross revenues of $1.07 billion or more [155]. - The company has elected to take advantage of certain exemptions and reduced reporting requirements under the JOBS Act [153]. - There were no material changes to the company's critical accounting policies during the three and six months ended June 30, 2022 [150]. Contingent Liabilities - The company has not included contingent payments related to its license agreement with Lundbeck on its consolidated balance sheets [148]. - The company is subject to certain agreements that require payments upon achievement of development, regulatory, or commercial milestones, which are contingent and not considered contractual obligations [148]. - The company may incur termination fees or wind-down costs upon termination of agreements with contract research organizations, but these costs are generally not fixed or estimable [149].

Financial Performance - The company has incurred operating losses of $14.7 million and $10.3 million for the three months ended March 31, 2022 and 2021, respectively, with an accumulated deficit of approximately $162.1 million as of March 31, 2022[104]. - The net loss for Q1 2022 was $14.6 million, compared to a net loss of $10.3 million in Q1 2021, reflecting an increase of approximately 42%[126]. - Cash used in operating activities was $17.2 million in Q1 2022, compared to $13.0 million in Q1 2021, indicating a 32% increase[134]. - The company has not yet commercialized any product candidates and has incurred significant losses since inception[131]. Revenue Generation - The company has not generated any revenue since its inception and does not expect to generate revenue from product sales in the near future[113]. - Future funding requirements will depend on various factors, including the outcome of strategic transactions and product development efforts[141]. Cash and Funding - As of March 31, 2022, the company had $72.9 million in cash, cash equivalents, and investments, which is expected to fund operations for at least twelve months[107]. - The company expects existing cash resources to fund operations for at least twelve months from the filing date of the report[140]. - The company has funded its operations primarily through the sale of common stock and convertible preferred stock since its inception in 2016[101]. Research and Development - Research and development expenses increased from $7.1 million in Q1 2021 to $11.2 million in Q1 2022, a rise of approximately 57%[127]. - The increase in research and development expenses was primarily due to a $3.5 million rise in costs related to clinical materials and trials for tovinontrine[127]. - Research and development expenses are expected to decrease significantly beginning in the second half of 2022 due to the discontinuation of tovinontrine development[114]. Operational Changes - The company decided to discontinue the development of tovinontrine in sickle cell disease and β-thalassemia based on interim analysis results, leading to a reduction in workforce to cut operating expenses[94]. - The company anticipates a significant decrease in general and administrative expenses starting in the second half of 2022 due to workforce reduction[124]. - General and administrative expenses rose from $3.2 million in Q1 2021 to $3.5 million in Q1 2022, an increase of about 9%[129]. Clinical Trials and Results - The median annualized vaso-occlusive crisis (VOC) rate was 1.89 VOCs per year in the high dose tovinontrine group compared to 2.02 VOCs per year in the placebo group, indicating a treatment difference of 0.13 VOCs per year, or 6.4%[97]. - In the Forte trial, no meaningful benefit was observed in transfusion burden in either tovinontrine group when compared to placebo[100]. Market and Risk Factors - The COVID-19 pandemic has not significantly impacted the company's financial condition as of the reporting date, but future impacts remain uncertain[110]. - The company is not currently exposed to significant market risk related to foreign currency exchange rates, but may contract with foreign vendors in the future[159]. - Interest income is sensitive to changes in interest rates, but a 10% change would not materially affect the fair market value of the investment portfolio due to short-term maturities[158]. Agreements and Obligations - The company has made cash payments totaling $1.8 million to Lundbeck under a license agreement, with future milestone payments aggregating up to $23.5 million upon achieving specified milestones[112]. - The company has agreements with third parties that require payments upon achieving certain development, regulatory, or commercial milestones, but these are not included in the consolidated balance sheets[148]. - The company is party to agreements with contract research organizations for clinical trials, which are generally cancellable with notice[151]. - The company has not included contingent payments related to certain agreements on its consolidated balance sheets[150]. Accounting and Compliance - The company is an "emerging growth company" (EGC) and can delay the adoption of certain accounting standards until they apply to private companies[154]. - The company may remain an EGC until the earliest of December 31, 2025, or if total annual gross revenues exceed $1.07 billion[156]. - There were no material changes to the company's critical accounting policies during the three months ended March 31, 2022[152].