Keros Therapeutics(KROS) - 2022 Q4 - Annual Report

Part I Business Keros Therapeutics is a clinical-stage biopharmaceutical company developing novel treatments for hematological, pulmonary, and cardiovascular disorders by targeting the TGF-ß protein family, with three product candidates in or preparing for Phase 2 clinical development - The company focuses on discovering and developing treatments for hematological, pulmonary, and cardiovascular disorders by targeting the transforming growth factor-beta (TGF-ß) family of proteins[24] Product Candidate Pipeline Overview | Product Candidate | Indication | Development Stage | | :--- | :--- | :--- | | KER-050 | Myelodysplastic Syndromes (MDS) | Phase 2 | | | Myelofibrosis | Phase 2 | | KER-047 | Iron-Refractory Iron Deficiency Anemia (IRIDA) | Phase 2 | | | MDS / Myelofibrosis | Phase 2 (Planned) | | KER-012 | Pulmonary Arterial Hypertension (PAH) | Phase 2 (Planned) | | | Cardiovascular Disorders | Phase 2 (Biomarker Trial Planned) | - KER-050 is being developed for cytopenias in MDS and myelofibrosis, with 51.7% of evaluable MDS patients achieving an overall erythroid response and 50.0% of transfused patients achieving transfusion independence for at least eight weeks in a Phase 2 trial[25][71] - KER-047, an ALK2 inhibitor, is being developed for functional iron deficiency, with initial Phase 2 trial data in IRIDA patients showing decreased hepcidin and ferritin levels, suggesting iron redistribution[26][110] - KER-012 is being developed for PAH and cardiovascular disorders, with a Phase 1 trial completed and a Phase 2 trial in PAH patients planned for the first half of 2023[27] - The company has a license agreement with Hansoh for the development and commercialization of KER-050 in mainland China, Hong Kong, and Macau, for which it received a net $18.0 million upfront payment in 2022[186][188] Risk Factors The company faces significant risks including a limited operating history with consistent net losses, heavy reliance on its clinical-stage product candidates, and the need for substantial additional funding - The company has a limited operating history, has incurred net losses every year since inception, and anticipates continued net losses, with a net loss for 2022 of $104.7 million and an accumulated deficit of $228.4 million as of December 31, 2022[266] - Substantial additional funding is required to complete development and commercialization of product candidates, and failure to secure more capital could force delays or elimination of programs, though existing cash is expected to fund operations into the third quarter of 2025[269][270] - The business is heavily dependent on the success of its clinical-stage product candidates (KER-050, KER-047, KER-012), and failure to advance through clinical trials and obtain marketing approval would materially harm the business[277] - The company relies on third-party contract manufacturing organizations (CMOs) for product supply and contract research organizations (CROs) to conduct clinical trials, and inadequate performance by these third parties could stop or delay development and commercialization[416][424] - The company faces significant competition from large pharmaceutical and biotechnology companies with greater financial and technical resources, including Acceleron (Merck) and Bristol-Myers Squibb, developing therapies for similar indications[331][332] - Success depends on the ability to obtain and maintain patent protection, but the patenting process is difficult and costly, and the company may not be able to ensure protection for its proprietary rights and technology[365] Unresolved Staff Comments The company reports that it has no unresolved staff comments from the SEC - There are no unresolved staff comments[514] Properties The company's principal office is a leased 35,662 square foot office and laboratory space in Lexington, Massachusetts, with the lease terminating in February 2031 - The company's principal office is located at 1050 Waltham Street, Suite 302, Lexington, Massachusetts, consisting of approximately 35,662 square feet of leased office and laboratory space[515] Legal Proceedings The company is not currently a party to any material legal proceedings - As of the report date, the company is not a party to any material legal proceedings[517] Mine Safety Disclosures This item is not applicable to the company - Not applicable[518] Part II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock trades on Nasdaq under "KROS" since April 2020, with no dividends paid or anticipated, as earnings are retained for business operations - The company's common stock trades on the Nasdaq Global Market under the symbol "KROS" since April 8, 2020[520] - The company has never paid dividends and does not intend to pay them in the foreseeable future[522] Management's Discussion and Analysis of Financial Condition and Results of Operations Keros reported a net loss of $104.7 million in 2022, primarily due to increased R&D and G&A expenses, with $279.0 million in cash expected to fund operations into Q3 2025 Comparison of Results of Operations (in thousands) | | Year Ended December 31, 2022 | Year Ended December 31, 2021 | | :--- | :--- | :--- | | Total Revenue | $0 | $20,100 | | Research and Development Expenses | $87,265 | $55,143 | | General and Administrative Expenses | $27,525 | $21,330 | | Loss from Operations | ($114,790) | ($56,373) | | Net Loss | ($104,679) | ($58,744) | - The increase in R&D expenses by $32.1 million in 2022 was primarily due to higher costs for the two Phase 2 clinical trials of KER-050, increased preclinical pipeline activities, and a $14.4 million increase in personnel costs[567] - The company had $279.0 million in cash and cash equivalents as of December 31, 2022, which management expects will be sufficient to fund operations into the third quarter of 2025[540] - During 2022, the company raised gross proceeds of $121.4 million through its "at the market" (ATM) offering, selling 3,410,384 shares of common stock[534] - Net cash used in operating activities was $70.1 million for the year ended December 31, 2022, compared to $62.1 million in 2021[577][578] Quantitative and Qualitative Disclosures About Market Risk The company's primary market risk is interest rate sensitivity on its cash and cash equivalents, but due to conservative, short-term investments, no material impact from interest rate changes is anticipated - The company's market risk is primarily from interest rate sensitivity on its $279.0 million of cash and cash equivalents as of December 31, 2022[602] - The company does not expect its operating results or cash flows to be significantly affected by changes in market interest rates due to the short-term and conservative nature of its investments[602] Financial Statements and Supplementary Data This section presents the company's audited consolidated financial statements, including a net loss of $104.7 million for 2022 and an accumulated deficit of $228.4 million as of December 31, 2022 Consolidated Balance Sheet Highlights (in thousands) | | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $279,048 | $230,042 | | Total Assets | $306,781 | $255,251 | | Total Liabilities | $29,358 | $12,077 | | Accumulated Deficit | ($228,434) | ($123,755) | | Total Stockholders' Equity | $277,423 | $243,174 | Consolidated Statement of Operations Highlights (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | Total Revenue | $0 | $20,100 | | Total Operating Expenses | $114,790 | $76,473 | | Net Loss | ($104,679) | ($58,744) | | Net Loss Per Share | ($4.15) | ($2.52) | - As of December 31, 2022, the company had federal and state Net Operating Loss (NOL) carryforwards of $138.7 million and $137.8 million, respectively, which are subject to limitations under Section 382 of the Internal Revenue Code[747][749] Changes in and Disagreements With Accountants on Accounting and Financial Disclosure The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[605] Controls and Procedures Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2022 - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2022[607] - Management assessed internal control over financial reporting and concluded it was effective as of December 31, 2022, based on the COSO framework[610] - No changes in internal control over financial reporting occurred during the fourth quarter of 2022 that materially affected, or are reasonably likely to materially affect, internal controls[612] Other Information The company reports no other information for this item - None[614] Part III Directors, Executive Officers and Corporate Governance Information required by this item concerning directors, executive officers, and corporate governance will be incorporated by reference from the company's definitive Proxy Statement for its 2023 Annual Meeting of Stockholders - Information for this item is incorporated by reference from the registrant's 2023 Proxy Statement[617][618] Executive Compensation Information required by this item concerning executive compensation will be incorporated by reference from the company's definitive Proxy Statement for its 2023 Annual Meeting of Stockholders - Information for this item is incorporated by reference from the registrant's 2023 Proxy Statement[617][620] Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Information required by this item concerning security ownership will be incorporated by reference from the company's definitive Proxy Statement for its 2023 Annual Meeting of Stockholders - Information for this item is incorporated by reference from the registrant's 2023 Proxy Statement[617][621] Certain Relationships and Related Transactions, and Director Independence Information required by this item concerning related party transactions and director independence will be incorporated by reference from the company's definitive Proxy Statement for its 2023 Annual Meeting of Stockholders - Information for this item is incorporated by reference from the registrant's 2023 Proxy Statement[617][622] Principal Accountant Fees and Services Information required by this item concerning principal accountant fees and services will be incorporated by reference from the company's definitive Proxy Statement for its 2023 Annual Meeting of Stockholders - Information for this item is incorporated by reference from the registrant's 2023 Proxy Statement[617][623] Part IV Exhibits, Financial Statement Schedules This section lists the consolidated financial statements and exhibits filed as part of the Form 10-K, including corporate governance documents and certifications - This item lists the consolidated financial statements and exhibits filed with the Annual Report on Form 10-K[625][626] Form 10-K Summary This item is not applicable - Not applicable[629]