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Wall Street Analysts See a 69.15% Upside in Fulcrum Therapeutics (FULC): Can the Stock Really Move This High?
Zacks Investment Research· 2024-05-15 14:56
Core Viewpoint - Fulcrum Therapeutics, Inc. (FULC) shows potential for significant upside, with a mean price target of $13.38 indicating a 69.2% increase from the current price of $7.91 [1] Price Targets and Analyst Consensus - The average price target consists of eight estimates ranging from a low of $5 to a high of $19, with a standard deviation of $5.13, indicating variability in analyst predictions [2] - The lowest estimate suggests a decline of 36.8%, while the highest indicates a potential upside of 140.2% [2] - A low standard deviation signifies greater agreement among analysts regarding price movement, which can be a starting point for further research [8] Earnings Estimates and Analyst Optimism - Analysts are optimistic about FULC's earnings prospects, as indicated by a trend of upward revisions in earnings estimates, which historically correlates with stock price movements [10] - Over the past 30 days, the Zacks Consensus Estimate for the current year has increased by 0.5%, with one estimate moving higher and no negative revisions [11] - FULC holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, suggesting strong potential for near-term upside [12]
Fulcrum Therapeutics(FULC) - 2024 Q1 - Quarterly Report
2024-05-13 11:15
Financial Performance - As of March 31, 2024, Fulcrum Therapeutics reported total assets of $232.6 million, a decrease from $257.7 million as of December 31, 2023, representing a decline of approximately 9.7%[17] - For the three months ended March 31, 2024, Fulcrum reported a net loss of $26.9 million, compared to a net loss of $24.8 million for the same period in 2023, reflecting an increase in loss of approximately 8.5%[19] - Total operating expenses for the first quarter of 2024 were $29.8 million, up from $28.2 million in the same quarter of 2023, marking an increase of about 5.6%[19] - The company had no collaboration revenue for the first quarter of 2024, a decrease from $295,000 in the same period of 2023[19] - As of March 31, 2024, the accumulated deficit stood at $536.5 million, up from $509.7 million at the end of 2023, indicating an increase of approximately 5.3%[17] - Fulcrum's total stockholders' equity decreased to $213.6 million as of March 31, 2024, from $235.2 million at the end of 2023, a decline of about 9.2%[17] - The company expects to incur substantial operating losses and negative operating cash flows for the foreseeable future due to ongoing research and development activities[151] - The net loss for the year ended December 31, 2023, was $97.3 million, and for the three months ended March 31, 2024, it was $26.9 million, with an accumulated deficit of $536.5 million as of March 31, 2024[167] Cash and Liquidity - The company had cash and cash equivalents of $39.9 million as of March 31, 2024, up from $25.6 million at the end of 2023, indicating a significant increase of 56.7%[17] - The Company expects its cash, cash equivalents, and marketable securities to be sufficient to fund operating expenses and capital expenditures for at least 12 months[34] - As of March 31, 2024, total cash equivalents and marketable securities amounted to $213.3 million, a decrease from $236.2 million as of December 31, 2023[40][43] - The company had cash, cash equivalents, and marketable securities totaling $213.3 million as of March 31, 2024, which, along with the expected $80.0 million payment, is projected to fund operations into 2027[175] - The company anticipates continued reliance on additional financing due to the lengthy and uncertain process of product development, which may not yield commercial success for several years[176] - The company may need to raise additional capital through equity offerings, debt financings, or collaboration arrangements, which could dilute existing stockholders' interests[155] Research and Development - Research and development expenses increased by $3.1 million from $16.7 million in Q1 2023 to $19.8 million in Q1 2024, primarily due to increased external research and development costs[140] - The company plans to continue clinical development of losmapimod and pociredir, advance clinical-stage candidates, and seek regulatory approvals for successful candidates[119] - The Phase 3 clinical trial of losmapimod for the treatment of FSHD completed enrollment in September 2023[174] - The FDA imposed a clinical hold on the IND application for pociredir, which was lifted in August 2023[173] - The company is still in the early stages of development for its product candidates and has not completed development of any product candidates[167] - The company has two product candidates in clinical development, with high risks of failure and no completed pivotal clinical trials[201] Collaboration and Revenue - The Company achieved a $2.5 million specified preclinical milestone under the MyoKardia Collaboration Agreement[68] - The Company received a non-refundable upfront payment of $10.0 million from MyoKardia as part of the collaboration agreement[67] - The Company recognized no collaboration revenue associated with the MyoKardia Collaboration Agreement for the three months ended March 31, 2024, compared to $0.3 million for the same period in 2023[81] - The company expects to recognize revenue from the Sanofi Agreement associated with the $80.0 million upfront payment and potential future milestones and royalties[125] - The company has entered into a collaboration and license agreement with Genzyme Corporation (Sanofi) to commercialize losmapimod outside the U.S., sharing global development costs[110] Stock and Equity - The Company has reserved 17,591,700 shares of common stock for future issuance as of March 31, 2024, an increase from 15,388,773 shares as of December 31, 2023[52] - The Company had outstanding stock options totaling 12,289,352 as of March 31, 2024, compared to 6,876,679 for the same period in 2023[99] - The total stock-based compensation expense for the three months ended March 31, 2024, was $3.916 million, compared to $4.253 million for the same period in 2023[62] - The aggregate intrinsic value of stock options outstanding at March 31, 2024, was $35.107 million[58] - The weighted average grant date fair value of stock options granted in the three months ended March 31, 2024, was $6.23 per share[59] Risks and Challenges - The company has incurred significant operating losses since inception and expects to continue incurring losses over the next several years[167] - Clinical trials are lengthy and expensive, with uncertain outcomes, and the company may face delays or additional costs[203][207] - Serious adverse events or unacceptable side effects during product candidate development may necessitate abandonment or limitation of certain candidates[213] - The commercial potential of the pociredir program may be materially and negatively impacted even if regulatory approval is received[215] - The company may need to conduct additional clinical trials or testing, which could increase development costs and delay marketing approvals[207][209] Legal and Regulatory - The company intends to defend against a class action lawsuit alleging misleading statements related to the FDA's clinical hold on pociredir[165] - The FDA placed the IND for pociredir on clinical hold in February 2023 due to concerns over hematological malignancies, which was lifted in August 2023[214] - Regulatory authorities have substantial discretion in the approval process, making it difficult to predict the time and cost of product candidate development[200]
Fulcrum Therapeutics(FULC) - 2024 Q1 - Quarterly Results
2024-05-13 11:05
Exhibit 99.1 Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for First Quarter 2024 ― Entered into a collaboration and ex-U.S. license agreement with Sanofi for the development and commercialization of losmapimod ― ― On track to report topline data for Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD) in the fourth quarter of 2024 ― ― Industry veteran, Patrick Horn M.D., Ph.D., appointed as chief medical of icer ― ― Conference call and webcast ...
Fulcrum Therapeutics Enters into a Collaboration and License Agreement with Sanofi for the Development and Commercialization of Losmapimod in Facioscapulohumeral Muscular Dystrophy
Newsfilter· 2024-05-13 10:00
― Sanofi receives exclusive rights to commercialize losmapimod in all territories outside the U.S.; Fulcrum retains full U.S. commercialization rights ― ― Fulcrum will receive an upfront payment of $80.0 million, and is eligible to receive $975.0 million in potential milestones, plus royalties on ex-U.S. product sales; parties will share future global development costs 50:50 ― ― Conference call and webcast scheduled for 8:00 a.m. ET today to discuss the collaboration and other recent corporate developments, ...
Fulcrum Therapeutics Announces Publication of Results from Phase 2b Clinical Trial of Losmapimod in Facioscapulohumeral muscular dystrophy (ReDUX4) in The Lancet Neurology
Newsfilter· 2024-05-08 12:00
― Phase 2b ReDUX4 clinical trial indicates improvements in functional, structural, and patient-reported outcomes; findings informed the design and choice of efficacy endpoints in the ongoing Phase 3 clinical trial― ― Topline data for the Phase 3 REACH clinical trial of losmapimod in FSHD expected during 4Q'24― CAMBRIDGE, Mass., May 08, 2024 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically def ...
Fulcrum Therapeutics to Host First Quarter 2024 Financial Results Conference Call and Webcast on Monday, May 13, 2024, at 8:00 a.m. ET
Newsfilter· 2024-05-06 12:00
CAMBRIDGE, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (the "Company") (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today announced that its first quarter 2024 financial results will be released on Monday, May 13, 2024 before the U.S. financial markets open. Management will host a conference call and webcast at 8:00 a.m. ET to discuss the results and provide an ...
Fulcrum Therapeutics Appoints Patrick Horn M.D., Ph.D., as Chief Medical Officer
Newsfilter· 2024-03-18 11:00
―Industry veteran with late-stage clinical development, medical affairs, and regulatory experience; well-positioned to advance losmapimod towards a potential regulatory submission and approval ― ― Interim Chief Medical Officer, Iain Fraser, MBChB, DPhil, will continue to serve on Fulcrum's executive leadership team as senior vice president (SVP) of early development ― CAMBRIDGE, Mass., March 18, 2024 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (NASDAQ:FULC), a clinical-stage biopharmaceutical ...
Fulcrum Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Newsfilter· 2024-03-08 21:30
CAMBRIDGE, Mass., March 08, 2024 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today announced that the company granted non-statutory stock options to two new employees. Fulcrum granted stock options to purchase shares of the company's common stock pursuant to the company's 2022 Inducement Stock Incentive Plan, as amended, or the plan, as ...
Fulcrum Therapeutics, Inc. (FULC) Reports Q4 Loss, Tops Revenue Estimates
Zacks Investment Research· 2024-02-27 14:11
Fulcrum Therapeutics, Inc. (FULC) came out with a quarterly loss of $0.40 per share versus the Zacks Consensus Estimate of a loss of $0.44. This compares to loss of $0.50 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 9.09%. A quarter ago, it was expected that this company would post a loss of $0.44 per share when it actually produced a loss of $0.39, delivering a surprise of 11.36%.Over the last four quarters, the company ha ...
Fulcrum Therapeutics(FULC) - 2023 Q4 - Annual Report
2024-02-26 16:00
Part I [Business](index=7&type=section&id=Item%201.%20Business) Fulcrum Therapeutics is a clinical-stage biopharmaceutical company developing small molecules for genetically defined rare diseases Clinical Pipeline Overview | Indication | Asset | Mechanism of Action | Preclinical | Phase 1 | Phase 2 | Phase 3 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **FSHD** | Losmapimod | DUX4 Reduction | | | | **✓** | | **SCD** | Pociredir | HbF Induction | | **✓** | | | - The company's primary focus is on developing small molecule therapies for rare genetic diseases with high unmet medical needs[20](index=20&type=chunk) - Losmapimod's Phase 3 REACH trial completed enrollment of **260 patients** in September 2023, with topline data anticipated in **Q4 2024**[20](index=20&type=chunk) - The FDA lifted a clinical hold on the IND for pociredir in August 2023, and the Phase 1b trial is being re-initiated at higher dose levels (12 mg and 20 mg) with revised criteria to target patients with higher disease severity[21](index=21&type=chunk)[79](index=79&type=chunk) [Losmapimod for FSHD](index=9&type=section&id=Losmapimod%20for%20FSHD) Losmapimod is being developed for Facioscapulohumeral Muscular Dystrophy (FSHD), a progressive muscle-wasting disease with no approved treatments - FSHD is a rare, progressive disease with no approved treatments, caused by the aberrant expression of the DUX4 gene in skeletal muscle[28](index=28&type=chunk)[31](index=31&type=chunk) - The pivotal Phase 3 REACH trial is a randomized, double-blind, placebo-controlled study evaluating a 15 mg twice-daily dose of losmapimod over 48 weeks, with the primary endpoint being the absolute change from baseline in Reachable Workspace (RWS)[51](index=51&type=chunk) - Previous Phase 2b (ReDUX4) trial data showed that while the primary biomarker endpoint was not met, losmapimod demonstrated **clinically relevant benefits** on functional measures like RWS and patient-reported outcomes compared to placebo at 48 weeks[37](index=37&type=chunk)[44](index=44&type=chunk) - Losmapimod has an extensive safety history, having been evaluated by its original developer, GSK, in nearly **3,500 subjects** across multiple non-muscle indications, where it was generally well-tolerated[36](index=36&type=chunk)[61](index=61&type=chunk) [Pociredir for SCD](index=17&type=section&id=Pociredir%20for%20SCD) Pociredir is an oral small molecule designed to treat Sickle Cell Disease (SCD) by inducing fetal hemoglobin (HbF) production - Pociredir aims to treat the root cause of SCD by inducing HbF, which is known to mitigate clinical manifestations of the disease[73](index=73&type=chunk)[74](index=74&type=chunk) - Interim Phase 1b data from the 6 mg cohort showed up to **9.5% absolute HbF increases**, and data from the 12 mg cohort (prior to the hold) showed up to **10.0% absolute HbF increases** from baseline after 42 days[81](index=81&type=chunk)[82](index=82&type=chunk) - The FDA placed a full clinical hold on the pociredir IND in February 2023, citing hematological malignancies observed in toxicology studies, similar to other PRC2 inhibitors; the hold was lifted in August 2023[77](index=77&type=chunk)[78](index=78&type=chunk)[79](index=79&type=chunk) - The Phase 1b trial is being re-initiated with amended inclusion/exclusion criteria to target patients with higher disease severity, enrolling approximately 10 patients at the 12 mg dose and another 10 at the 20 mg dose[79](index=79&type=chunk)[85](index=85&type=chunk) [License Agreements and Collaborations](index=26&type=section&id=License%20Agreements%20and%20Collaborations) Fulcrum maintains several key strategic agreements for its pipeline, including in-licensing losmapimod and collaborating on new targets - Fulcrum in-licensed losmapimod from GSK, gaining exclusive worldwide rights, with the agreement including up to **$37.5 million** in development/regulatory milestones and up to **$60.0 million** in sales milestones, plus tiered royalties[99](index=99&type=chunk)[101](index=101&type=chunk) - The collaboration with MyoKardia (BMS) focuses on identifying targets for cardiomyopathies, for which Fulcrum received a **$10.0 million** upfront payment and is eligible for up to **$298.5 million** in milestones per target, plus tiered royalties[105](index=105&type=chunk)[108](index=108&type=chunk) - In July 2023, Fulcrum entered into an exclusive worldwide license agreement with CAMP4 for its Diamond Blackfan Anemia (DBA) program, with potential milestones totaling up to **$70.0 million**, plus royalties[110](index=110&type=chunk)[111](index=111&type=chunk) [Competition](index=30&type=section&id=Competition) The company faces competition from major pharmaceutical and biotechnology firms across its FSHD and SCD programs - For FSHD, there are no approved treatments, and key competitors in clinical development include **Roche**, **Avidity**, and **Arrowhead Pharmaceutical**[131](index=131&type=chunk)[132](index=132&type=chunk) - For SCD, pociredir competes with approved oral therapies (hydroxyurea, voxelotor, crizanlizumab, L-glutamine) and two recently approved gene therapies (**lovo-cel** and **exa-cel**)[133](index=133&type=chunk)[134](index=134&type=chunk) - Other SCD therapies in development include small molecules from **Novo Nordisk** (nDec) and **Agios** (mitapivat), and an HbS polymerization inhibitor from **Pfizer** (GBT-601)[137](index=137&type=chunk) [Government Regulation and Product Approvals](index=32&type=section&id=Government%20Regulation%20and%20Product%20Approvals) The company's operations are subject to extensive regulation by government authorities in the U.S. and other countries - The drug development and approval process in the U.S. requires successful completion of preclinical studies and three phases of human clinical trials before an NDA can be submitted to the FDA[141](index=141&type=chunk)[155](index=155&type=chunk) - The FDA has granted losmapimod **Orphan Drug** and **Fast Track** designations for FSHD, while pociredir has received **Orphan Drug** and **Fast Track** designations for SCD[39](index=39&type=chunk)[77](index=77&type=chunk) - In the EU, the approval process is managed by the EMA through a centralized procedure for rare diseases, leading to a single marketing authorization valid across the EU[216](index=216&type=chunk)[217](index=217&type=chunk)[215](index=215&type=chunk) - The company is subject to healthcare laws including the Anti-Kickback Statute, False Claims Act, and pricing regulations like the Inflation Reduction Act of 2022 (IRA), which could impact product pricing and reimbursement[200](index=200&type=chunk)[208](index=208&type=chunk) [Human Capital Management](index=56&type=section&id=Human%20Capital%20Management) The company emphasizes a patient-focused culture and is committed to diversity, equity, and inclusion to attract and retain talent - As of February 20, 2024, the company had **76 full-time employees**, with 26 holding M.D. or Ph.D. degrees and 47 engaged in R&D[248](index=248&type=chunk) - The company reports a diverse workforce, with women comprising approximately **55%** of full-time employees and non-white employees making up about **29%** of the U.S. workforce[251](index=251&type=chunk) [Risk Factors](index=58&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to its financial condition, clinical development, third-party reliance, and intellectual property - The company has a history of significant losses (**$97.3 million in 2023**) and an accumulated deficit of **$509.7 million** as of December 31, 2023, and expects to incur losses for several more years[255](index=255&type=chunk) - **Substantial additional funding** is required to continue clinical trials and development programs, and failure to raise capital could force delays or elimination of programs[258](index=258&type=chunk) - Clinical drug development is uncertain, as highlighted by the FDA's clinical hold on pociredir from February to August 2023, which underscores the risk of delays and unforeseen challenges[288](index=288&type=chunk)[293](index=293&type=chunk) - The company relies on third-party contract manufacturing organizations (CMOs) for its product candidates, which poses risks related to supply, quality, and regulatory compliance[329](index=329&type=chunk) - The company's ability to protect its intellectual property is critical, as the composition of matter patents for losmapimod licensed from GSK have expired, increasing reliance on method-of-use patents[367](index=367&type=chunk)[373](index=373&type=chunk) [Unresolved Staff Comments](index=114&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - There are no unresolved staff comments[490](index=490&type=chunk) [Cybersecurity](index=114&type=section&id=Item%201C.%20Cybersecurity) The company has implemented a cybersecurity risk management process integrated into its enterprise risk management framework - The company's cybersecurity risk management is integrated into its overall enterprise risk management process and utilizes third-party security providers for testing and assessments[491](index=491&type=chunk)[492](index=492&type=chunk) - The audit committee has oversight responsibility for cybersecurity risks, with the Executive Director, IT & Operations leading the program[495](index=495&type=chunk)[497](index=497&type=chunk) [Properties](index=114&type=section&id=Item%202.%20Properties) The company's principal facility is leased office and laboratory space in Cambridge, Massachusetts - The company leases approximately **28,731 square feet** of office and lab space in Cambridge, MA, with the lease expiring in June 2028[499](index=499&type=chunk) [Legal Proceedings](index=114&type=section&id=Item%203.%20Legal%20Proceedings) The company is facing a class action lawsuit alleging violations of the Securities Exchange Act - A class action lawsuit was filed against the company and its officers related to the clinical hold on pociredir, alleging misleading statements about the drug's development[500](index=500&type=chunk) - The company filed a motion to dismiss the lawsuit in November 2023 and plans to defend against the litigation vigorously[500](index=500&type=chunk) [Mine Safety Disclosures](index=116&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - This item is not applicable[501](index=501&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=117&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock is traded on the Nasdaq Global Market, and it does not anticipate paying cash dividends - Common stock trades on the Nasdaq Global Market under the symbol **"FULC"**[503](index=503&type=chunk) - The company has never declared or paid cash dividends and does not intend to in the foreseeable future[505](index=505&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=118&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company's net loss decreased in 2023, and its cash position is expected to fund operations into 2026 Results of Operations (2023 vs. 2022) | (in thousands) | 2023 | 2022 | Change ($) | | :--- | :--- | :--- | :--- | | Collaboration revenue | $2,805 | $6,342 | $(3,537) | | Research and development | $71,801 | $76,782 | $(4,981) | | General and administrative | $41,668 | $41,694 | $(26) | | **Total operating expenses** | **$113,469** | **$118,903** | **$(5,434)** | | Loss from operations | $(110,664) | $(112,561) | $1,897 | | Other income, net | $13,329 | $2,690 | $10,639 | | **Net loss** | **$(97,335)** | **$(109,871)** | **$12,536** | - The decrease in R&D expenses was primarily driven by lower external costs for pociredir due to the clinical hold and a $5.0 million milestone payment to GSK in 2022 that did not recur, partially offset by higher costs for the advancing REACH trial[540](index=540&type=chunk) - As of December 31, 2023, the company had **$236.2 million** in cash, cash equivalents, and marketable securities, with a projected cash runway to fund operations into **2026**[517](index=517&type=chunk) - In January 2023, the company raised net proceeds of **$117.3 million** from a public offering of its common stock[513](index=513&type=chunk)[544](index=544&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=131&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity related to its investment portfolio - The main market risk is interest rate sensitivity on its **$236.2 million** portfolio of cash, cash equivalents, and marketable securities[576](index=576&type=chunk) - The company has some exposure to foreign currency fluctuations from contracts with non-U.S. vendors but does not currently use hedging instruments[577](index=577&type=chunk) [Financial Statements and Supplementary Data](index=131&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section contains the company's audited consolidated financial statements for fiscal years 2023 and 2022 Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $25,563 | $35,098 | | Marketable securities | $210,658 | $167,823 | | **Total Assets** | **$257,694** | **$226,685** | | **Liabilities & Equity** | | | | Total current liabilities | $13,675 | $16,725 | | **Total Liabilities** | **$22,501** | **$27,743** | | **Total Stockholders' Equity** | **$235,193** | **$198,942** | Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Collaboration revenue | $2,805 | $6,342 | | Total operating expenses | $113,469 | $118,903 | | Loss from operations | $(110,664) | $(112,561) | | **Net loss** | **$(97,335)** | **$(109,871)** | | Net loss per share | $(1.59) | $(2.44) | [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=131&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants - There were no disagreements with accountants on accounting and financial disclosure[580](index=580&type=chunk) [Controls and Procedures](index=133&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective - Management concluded that the company's disclosure controls and procedures were **effective** as of December 31, 2023[582](index=582&type=chunk) - Management concluded that internal control over financial reporting was **effective** as of December 31, 2023[585](index=585&type=chunk) - The company is exempt from providing an auditor's attestation report on internal controls due to its status as an **emerging growth company**[586](index=586&type=chunk) [Other Information](index=134&type=section&id=Item%209B.%20Other%20Information) The company terminated its at-the-market (ATM) equity distribution agreement - The company terminated its May 2022 at-the-market (ATM) offering program, which had an aggregate offering price of up to **$50.0 million**, and no shares were sold under this agreement[589](index=589&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=135&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This information will be provided in the company's 2024 Definitive Proxy Statement - Information regarding directors, executive officers, and corporate governance is incorporated by reference from the forthcoming 2024 Proxy Statement[593](index=593&type=chunk) [Executive Compensation](index=135&type=section&id=Item%2011.%20Executive%20Compensation) This information will be provided in the company's 2024 Definitive Proxy Statement - Information regarding executive compensation is incorporated by reference from the forthcoming 2024 Proxy Statement[595](index=595&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=135&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This information will be provided in the company's 2024 Definitive Proxy Statement - Information regarding security ownership is incorporated by reference from the forthcoming 2024 Proxy Statement[596](index=596&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=135&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) This information will be provided in the company's 2024 Definitive Proxy Statement - Information regarding related transactions and director independence is incorporated by reference from the forthcoming 2024 Proxy Statement[597](index=597&type=chunk) [Principal Accountant Fees and Services](index=135&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) This information will be provided in the company's 2024 Definitive Proxy Statement - Information regarding principal accountant fees and services is incorporated by reference from the forthcoming 2024 Proxy Statement[598](index=598&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=136&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the consolidated financial statements and exhibits filed with the report - This item lists the financial statements and exhibits filed with the Form 10-K[600](index=600&type=chunk)[603](index=603&type=chunk) [Form 10-K Summary](index=136&type=section&id=Item%2016.%20Form%2010-K%20Summary) No Form 10-K summary is provided - This item is not applicable[604](index=604&type=chunk)