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Akero(AKRO) - 2024 Q4 - Annual Report
AKROAkero(AKRO)2025-02-28 12:30

Financial Performance - The company reported net losses of 252.1million,252.1 million, 151.8 million, and 112.0millionfortheyearsendedDecember31,2024,2023,and2022,respectively,withanaccumulateddeficitof112.0 million for the years ended December 31, 2024, 2023, and 2022, respectively, with an accumulated deficit of 826.2 million as of December 31, 2024[528]. - The net loss for the year ended December 31, 2024, was 252.1million,comparedtoanetlossof252.1 million, compared to a net loss of 151.8 million in 2023, reflecting a 66% increase in losses[545]. - The comprehensive loss for 2024 was 251,382,000,comparedto251,382,000, compared to 151,526,000 in 2023, representing a 65.9% increase[610]. - The company's accumulated deficit grew to 826,156,000in2024,comparedto826,156,000 in 2024, compared to 574,096,000 in 2023, an increase of 44.0%[608]. - The company has not generated any revenue since inception and does not expect to do so in the near future[533]. Capital and Funding - The company has raised capital through various means, including a 25.0millionequityinvestmentfromPfizer,Inc.in2022anda25.0 million equity investment from Pfizer, Inc. in 2022 and a 35.0 million term loan from Hercules Capital, Inc.[528]. - The company raised gross proceeds of 127.4millionin2023and127.4 million in 2023 and 80.3 million in 2024 through common stock offerings, with an additional 402.5millionraisedinJanuary2025[557].−Thecompanyraised402.5 million raised in January 2025[557]. - The company raised 344.84 million from a follow-on public offering in 2024, compared to 216.20millionin2023[617].−ThecompanyanticipatesrequiringadditionalfundingtocompletetheclinicaldevelopmentandcommercializationofEFX,pendingregulatoryapproval[625].−Thecompanyhasoutstandingborrowingsof216.20 million in 2023[617]. - The company anticipates requiring additional funding to complete the clinical development and commercialization of EFX, pending regulatory approval[625]. - The company has outstanding borrowings of 35.0 million under a loan agreement with Hercules, with the potential to borrow an additional 30.0millionuntilJune15,2025[569].ResearchandDevelopment−ThePhase3SYNCHRONYprogramconsistsofthreetrialsevaluatingEFXforpatientswithcompensatedcirrhosis(F4)andpre−cirrhoticMASH(F2−F3),withenrollmentforthetrialsbeginninginQ42023[525][526].−ThecompanyanticipatessignificantincreasesinresearchanddevelopmentexpensesasitadvancesEFXthroughlater−stageclinicaldevelopment[535].−Researchanddevelopmentexpensesroseto30.0 million until June 15, 2025[569]. Research and Development - The Phase 3 SYNCHRONY program consists of three trials evaluating EFX for patients with compensated cirrhosis (F4) and pre-cirrhotic MASH (F2-F3), with enrollment for the trials beginning in Q4 2023[525][526]. - The company anticipates significant increases in research and development expenses as it advances EFX through later-stage clinical development[535]. - Research and development expenses rose to 247.5 million in 2024, up from 141.8millionin2023,markinga75141.8 million in 2023, marking a 75% increase, primarily due to increased costs associated with the EFX program[546]. - The company expects substantial increases in research and development expenses to support ongoing clinical development activities for the EFX program[547]. - The company has entered into various agreements for research and development, with costs recorded as expenses as incurred[641]. Clinical Trials and Product Development - In the SYMMETRY Phase 2b trial, 39% of patients treated with 50mg EFX experienced reversal of cirrhosis at week 96, compared to 15% for the placebo group[522]. - In the HARMONY Phase 2b trial, response rates for ≥1 stage improvement in fibrosis at week 96 were 75% for the 50mg EFX group and 46% for the 28mg EFX group, compared to 24% for placebo[523]. - EFX has shown statistically significant fibrosis regression and MASH resolution in previous Phase 2b trials with over 300 patients treated for up to 96 weeks[619]. - The first clinical milestone payment of 7.5 million was made to Amgen in December 2023, related to the Phase 3 SYNCHRONY program[576]. - The company is focused on developing treatments for metabolic diseases, particularly metabolic dysfunction-associated steatohepatitis (MASH)[619]. Operating Expenses - For the year ended December 31, 2024, total operating expenses increased to 285.4millionfrom285.4 million from 172.9 million in 2023, representing a 65% increase[545]. - Cash used in operating activities for 2024 was 230.1million,significantlyhigherthan230.1 million, significantly higher than 145.4 million in 2023, indicating increased operational expenditures[560]. - General and administrative expenses increased to 37.9millionin2024from37.9 million in 2024 from 31.1 million in 2023, a rise of 22% due to higher stock-based compensation and staffing costs[548]. - Stock-based compensation expense was 29.7millionfortheyearendedDecember31,2024,comparedto29.7 million for the year ended December 31, 2024, compared to 21.5 million in 2023, showing an increase in compensation costs[583]. Liquidity and Assets - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling 797.8million,withanadditional797.8 million, with an additional 402.5 million raised from a public offering in January 2025[532]. - Cash, cash equivalents, and marketable securities totaled 797.8millionasofDecember31,2024,providingastrongliquiditypositionforfutureoperations[558].−Totalcurrentassetsincreasedto797.8 million as of December 31, 2024, providing a strong liquidity position for future operations[558]. - Total current assets increased to 770,380,000 as of December 31, 2024, up from 559,962,000in2023,representinga37.5559,962,000 in 2023, representing a 37.5% increase[608]. - Cash and cash equivalents increased to 340,238,000 in 2024 from 234,207,000in2023,reflectinga45.2234,207,000 in 2023, reflecting a 45.2% growth[608]. - The total fair value of short-term and long-term marketable securities was 771,683 as of December 31, 2024, up from 541,965in2023[667].StockandEquity−Theweighted−averagenumberofsharesusedincomputingnetlosspercommonshareincreasedto67,136,772in2024from52,568,159in2023,ariseof27.7541,965 in 2023[667]. Stock and Equity - The weighted-average number of shares used in computing net loss per common share increased to 67,136,772 in 2024 from 52,568,159 in 2023, a rise of 27.7%[610]. - The company issued 12.65 million shares in a follow-on offering in 2024, contributing to an increase in total shares outstanding to 72.38 million[617]. - The company has reserved 577,089 options under the 2018 Stock Option and Grant Plan and 6,983,360 options under the 2019 Stock Option and Incentive Plan as of December 31, 2024[697]. - The total intrinsic value of stock options outstanding as of December 31, 2024, was 46,487,000, up from 35,133,000attheendof2023[710].−Stock−basedcompensationclassifiedwithinresearchanddevelopmentexpensefor2024was35,133,000 at the end of 2023[710]. - Stock-based compensation classified within research and development expense for 2024 was 11,294,000, compared to 7,579,000in2023[717].DebtandLiabilities−TheCompanyhasaLoanPayableunderaLoanAgreementwithHerculesCapital,withamendmentsmadeonJune7,2023,andFebruary28,2024[648].−Thetotalprincipaloutstandingloanpayableis7,579,000 in 2023[717]. Debt and Liabilities - The Company has a Loan Payable under a Loan Agreement with Hercules Capital, with amendments made on June 7, 2023, and February 28, 2024[648]. - The total principal outstanding loan payable is 35,000,000, with an end of term charge of 2,048,000,leadingtoatotalof2,048,000, leading to a total of 37,048,000 including the end of term charge[681]. - The Company reported accrued external research and development expenses of 28,925asofDecember31,2024,comparedto28,925 as of December 31, 2024, compared to 10,041 in 2023[670]. - The Term Loan bears interest at a variable rate of at least 7.65% and matures on March 1, 2027[673]. - The company has a contingent liability to issue warrants for up to an additional 211,137 shares of common stock under the Loan Agreement as of December 31, 2024[681].