[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].

Imara Inc. (IMRA) Q4 2021 Earnings Conference Call March 15, 2022 8:30 AM ET Company Participants Rahul Ballal - President, Chief Executive Officer Mike Gray - Chief Financial Officer, Chief Operating Officer Ken Attie - Chief Medical Officer Conference Call Participants Yigal Nochomovitz - Citigroup Joseph Schwartz - SVB Securities Operator Ladies and gentlemen, thank you for standing by, and welcome to the Imara Inc. Q4 and 2021 earnings conference call and webcast. At this time, all participants are in ...

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, 2021 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 ...

Financial Data and Key Metrics Changes - Research and development expenses increased to $10.4 million in Q3 2021 from $9.5 million in Q3 2020, primarily due to clinical trial costs and personnel-related expenses [28] - General administrative expenses rose to $3.3 million in Q3 2021 compared to $3 million in Q3 2020, attributed to increased personnel and operating costs [29] - Net loss attributable to common stockholders was $13.6 million or $0.55 per share for Q3 2021, compared to a net loss of $12.4 million or $0.72 per share in Q3 2020 [29] - Cash, cash equivalents, and investments totaled $102.8 million as of September 30, 2021, up from $88.2 million as of December 31, 2020, providing sufficient funds for operations into Q1 2023 [30] Business Line Data and Key Metrics Changes - The Ardent Phase 2b clinical trial for sickle cell disease has completed patient enrollment, with interim data expected this quarter focusing on safety and biomarkers [6][7] - The Forte Phase 2b clinical trial for beta-thalassemia has also reached enrollment in both transfusion-dependent and non-transfusion-dependent cohorts, with interim data anticipated this quarter [13][14] Market Data and Key Metrics Changes - The Ardent study has enrolled approximately 115 subjects globally, including regions such as Europe, the U.S., the Middle East, and Africa [7] - The company plans to present updated safety and VOC data from the Phase 2a open-label extension trial at the American Society of Hematology annual meeting in December [8] Company Strategy and Development Direction - The company is expanding its development pipeline with a focus on tovinontrine for heart failure with preserved ejection fraction (HFpEF) and has initiated a new program, IMR-261, an oral Nrf2 activator [5][22] - IMARA aims to interact with the FDA regarding the HFpEF program and has appointed a new Vice President of Clinical Development to lead these efforts [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data readouts and the progress made in core programs, indicating a productive period for the company [26] - The company believes that tovinontrine may be a promising treatment option for patients with HFpEF based on independent literature and internal data [19] Other Important Information - IMR-261 is positioned as a clinic-ready asset with promising preclinical data in sickle cell disease and beta-thalassemia, with plans for clinical development in 2022 [25] - The company has made substantial progress in enabling the HFpEF program, with a focus on clinical trials and regulatory interactions [16] Q&A Session Summary Question: Will the company consider indications in kidney disease for the Nrf2 activator? - The company is currently focused on red blood cell disorders, particularly hemoglobinopathies, but acknowledges that Nrf2 activation is implicated in various diseases, including renal diseases [32] Question: What can be expected from the 12-month VOC data from the ongoing Phase 3 OLE study? - The 12-month data will provide a clearer annualized VOC rate for approximately 20 patients, minimizing the need for annualization from shorter data periods [38] Question: How did the company decide to advance IMR-261, and what challenges are anticipated? - The decision was based on existing literature and preclinical data showing significant efficacy in sickle cell models, with challenges primarily related to drug product manufacturing [41][44] Question: What doses are being tested for IMR-261, and what is the expected safety profile? - The company plans to test doses based on previous studies, with preclinical data indicating that the drug was well tolerated at higher doses [46][47] Question: What is the potential development pathway for IMR-261 given the available data? - The company is evaluating various clinical paths forward, leveraging existing data and previous INDs to expedite the development process [52]

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, 2021 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 ...