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Zenas BioPharma, Inc.(ZBIO) - 2024 Q4 - Annual Report
ZBIOZenas BioPharma, Inc.(ZBIO)2025-03-11 10:15

Financial Performance - As of December 31, 2024, the total assets of Zenas BioPharma, Inc. increased to 369.968millionfrom369.968 million from 68.180 million in 2023, representing a growth of approximately 442%[753] - Total revenue for 2024 was 5,000,asignificantdecreaseof905,000, a significant decrease of 90% compared to 50,000 in 2023[754] - The net loss attributable to common stockholders increased to 156,988in2024,comparedtoalossof156,988 in 2024, compared to a loss of 37,124 in 2023, reflecting a 323% increase in losses[754] - The Company reported a comprehensive loss of 156,831in2024,comparedtoacomprehensivelossof156,831 in 2024, compared to a comprehensive loss of 37,046 in 2023[754] - The Company incurred significant operating losses and negative cash flows since inception, with expectations for continued losses in the foreseeable future[766] - The Company reported a net loss attributable to common stockholders for the years ended December 31, 2024, and 2023[821] - The Company incurred a segment net loss of 157.0millionin2024,comparedtoanetlossof157.0 million in 2024, compared to a net loss of 37.1 million in 2023, reflecting a 323% increase in losses[934] Cash and Liquidity - Cash and cash equivalents rose significantly to 319.742millionin2024,comparedto319.742 million in 2024, compared to 56.857 million in 2023, indicating a growth of about 463%[753] - Cash, cash equivalents, and restricted cash at the end of 2024 totaled 319,832,asubstantialincreasefrom319,832, a substantial increase from 56,943 at the end of 2023[759] - The Company experienced a net increase in cash of 262,889in2024,contrastingwithadecreaseof262,889 in 2024, contrasting with a decrease of 10,352 in 2023[759] - As of December 31, 2024, the Company had cash, cash equivalents, and short-term investments totaling 350.8million,expectedtofundoperationsforatleasttwelvemonths[768]ExpensesandLiabilities−Thetotalcurrentliabilitiesincreasedto350.8 million, expected to fund operations for at least twelve months[768] Expenses and Liabilities - The total current liabilities increased to 57.292 million in 2024 from 23.258millionin2023,reflectingariseofapproximately14623.258 million in 2023, reflecting a rise of approximately 146%[753] - The accumulated deficit expanded to (387.391) million in 2024, up from (230.403)millionin2023,markinganincreaseofabout68(230.403) million in 2023, marking an increase of about 68%[753] - Research and development expenses surged to 139,139 in 2024, up 132% from 60,033in2023[754]−Stock−basedcompensationexpenseroseto60,033 in 2023[754] - Stock-based compensation expense rose to 10,821 in 2024, up from 3,495in2023,markinga2103,495 in 2023, marking a 210% increase[759] - Total accrued expenses increased to 39.4 million as of December 31, 2024, up from 17.3millionin2023,primarilyduetoexternalresearchanddevelopmentexpenses[837]FinancingandCapitalStructure−ZenasBioPharmaanticipatessubstantialadditionalfinancingwillberequiredtoachieveitsgoals,withpotentialdilutiontostockholdersifcapitalisraised[12]−TheCompanycompleteditsIPOonSeptember16,2024,raising17.3 million in 2023, primarily due to external research and development expenses[837] Financing and Capital Structure - Zenas BioPharma anticipates substantial additional financing will be required to achieve its goals, with potential dilution to stockholders if capital is raised[12] - The Company completed its IPO on September 16, 2024, raising 258.7 million in gross proceeds from the sale of 15,220,588 shares at 17.00pershare,withnetproceedsof17.00 per share, with net proceeds of 234.3 million after expenses[764] - Proceeds from the issuance of Series C convertible preferred stock amounted to 178,381in2024,withnosuchproceedsreportedin2023[759]−TheconvertiblepreferredstockconvertedintocommonstockuponthecompletionoftheCompany′sIPOonSeptember16,2024[816]ResearchandDevelopment−TheCompanyisfocusedondevelopingimmunology−basedtherapiesforautoimmuneandrarediseases,withseveralproductcandidatesindevelopment[761]−TheCompanyhasasinglereportablesegmentdedicatedtotheresearchanddevelopmentofprecisionimmunology−basedtherapies[775]−DirectresearchanddevelopmentexpensesforObexelimabreached178,381 in 2024, with no such proceeds reported in 2023[759] - The convertible preferred stock converted into common stock upon the completion of the Company's IPO on September 16, 2024[816] Research and Development - The Company is focused on developing immunology-based therapies for autoimmune and rare diseases, with several product candidates in development[761] - The Company has a single reportable segment dedicated to the research and development of precision immunology-based therapies[775] - Direct research and development expenses for Obexelimab reached 94.6 million in 2024, compared to 25.4millionin2023,indicatinga27225.4 million in 2023, indicating a 272% increase[934] Agreements and Collaborations - The Company entered into a license agreement with Viridian Therapeutics, Inc. for exclusive rights to develop and commercialize certain antibody product candidates, with an initial consideration of 38,707 shares of common stock[873] - The Company entered into a license agreement with Zai Lab on January 24, 2025, receiving an upfront fee of 10.0 million and potential future milestones of up to 96.0million[937]−TheCompanyenteredintoanovationagreementwithTenacia,transferringitsrightsandobligationsundertheDianthusAgreements[852]TaxandDeferredAssets−TheeffectiveincometaxratefortheyearendedDecember31,2024,was(0.3)96.0 million[937] - The Company entered into a novation agreement with Tenacia, transferring its rights and obligations under the Dianthus Agreements[852] Tax and Deferred Assets - The effective income tax rate for the year ended December 31, 2024, was (0.3)%, a decrease from (0.8)% in 2023, primarily due to changes in income earned in the U.S.[912] - The valuation allowance against deferred tax assets increased by 50.5 million from December 31, 2023, to December 31, 2024, primarily due to additional net operating losses[914] - The Company had approximately 75.5millioninfederalnetoperatinglosscarryforwardsand75.5 million in federal net operating loss carryforwards and 65.0 million in state net operating loss carryforwards as of December 31, 2024[916] Market and Competition - Zenas BioPharma faces competition from established pharmaceutical and biotechnology companies that have made significant investments in novel treatments for immunological indications[12] - The complexity of manufacturing product candidates may lead to delays or difficulties in production, impacting clinical trial supply and marketing approval[12] Personnel and Management - The company is dependent on retaining key personnel and may face challenges in managing growth and expanding operations[12]