Financial Performance - As of December 31, 2024, the total assets of Zenas BioPharma, Inc. increased to $369.968 million from $68.180 million in 2023, representing a growth of approximately 442%[753] - Total revenue for 2024 was $5,000, a significant decrease of 90% compared to $50,000 in 2023[754] - The net loss attributable to common stockholders increased to $156,988 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 $156,831 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 $157.0 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 $319.742 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, a substantial increase from $56,943 at the end of 2023[759] - The Company experienced a net increase in cash of $262,889 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 $350.8 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 $23.258 million in 2023, reflecting a rise of approximately 146%[753] - The accumulated deficit expanded to $(387.391) million in 2024, up from $(230.403) million in 2023, marking an increase of about 68%[753] - Research and development expenses surged to $139,139 in 2024, up 132% from $60,033 in 2023[754] - Stock-based compensation expense rose to $10,821 in 2024, up from $3,495 in 2023, marking a 210% increase[759] - Total accrued expenses increased to $39.4 million as of December 31, 2024, up from $17.3 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 $17.00 per share, with net proceeds of $234.3 million after expenses[764] - Proceeds from the issuance of Series C convertible preferred stock amounted to $178,381 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 $25.4 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 $96.0 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 $75.5 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]
Zenas BioPharma, Inc.(ZBIO) - 2024 Q4 - Annual Report