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Zenas BioPharma, Inc.(ZBIO) - 2024 Q3 - Quarterly Report
ZBIOZenas BioPharma, Inc.(ZBIO)2024-11-12 12:39

Financial Performance - Total revenue for the nine months ended September 30, 2024, was 50,000,withnocollaborationrevenuereportedforthethreemonthsendedSeptember30,2024[13].−NetlossforthethreemonthsendedSeptember30,2024,was50,000, with no collaboration revenue reported for the three months ended September 30, 2024[13]. - Net loss for the three months ended September 30, 2024, was 38,606, compared to a net income of 35,608forthesameperiodin2023[13].−FortheninemonthsendedSeptember30,2024,thecompanyreportedanetlossof35,608 for the same period in 2023[13]. - For the nine months ended September 30, 2024, the company reported a net loss of 104.4 million compared to a net loss of 12.5millionforthesameperiodin2023[28].−Thecompanyreportedacomprehensivelossof12.5 million for the same period in 2023[28]. - The company reported a comprehensive loss of 38,656 for the three months ended September 30, 2024[13]. - The company reported a net loss of 38.606millionforthethreemonthsendedSeptember30,2024,comparedtoanetincomeof38.606 million for the three months ended September 30, 2024, compared to a net income of 35.608 million for the same period in 2023[99]. - Total revenue for the nine months ended September 30, 2024, was 0,adecreaseof0, a decrease of 50.0 million compared to 50.0millionforthesameperiodin2023[164].OperatingExpenses−OperatingexpensesforthethreemonthsendedSeptember30,2024,were50.0 million for the same period in 2023[164]. Operating Expenses - Operating expenses for the three months ended September 30, 2024, were 40,984, compared to 14,376forthesameperiodin2023,reflectingasignificantincrease[13].−ResearchanddevelopmentexpensesfortheninemonthsendedSeptember30,2024,totaled14,376 for the same period in 2023, reflecting a significant increase[13]. - Research and development expenses for the nine months ended September 30, 2024, totaled 89,982, up from 39,615inthesameperiodof2023[13].−GeneralandadministrativeexpensesforthethreemonthsendedSeptember30,2024,were39,615 in the same period of 2023[13]. - General and administrative expenses for the three months ended September 30, 2024, were 7,454, compared to 5,024forthesameperiodin2023[13].−Researchanddevelopmentexpensesincreasedto5,024 for the same period in 2023[13]. - Research and development expenses increased to 90.0 million for the nine months ended September 30, 2024, up from 39.6millionin2023,representinga39.6 million in 2023, representing a 50.4 million increase[165]. - General and administrative expenses rose to 18.3millionfortheninemonthsendedSeptember30,2024,comparedto18.3 million for the nine months ended September 30, 2024, compared to 12.8 million in 2023, an increase of 5.5million[168].CashFlowandFinancing−Cashflowsfromoperatingactivitiesresultedinanetcashusedof5.5 million[168]. Cash Flow and Financing - Cash flows from operating activities resulted in a net cash used of 81.1 million for the nine months ended September 30, 2024, compared to 15.1millionforthesameperiodin2023[28].−Thecompanyexpectsitsexistingcashandinvestmentsof15.1 million for the same period in 2023[28]. - The company expects its existing cash and investments of 386.8 million as of September 30, 2024, to fund its operating expenses for at least the next twelve months[30]. - Net cash provided by financing activities was 411.1millionfortheninemonthsendedSeptember30,2024,significantlyupfrom411.1 million for the nine months ended September 30, 2024, significantly up from 20.1 million in 2023[176]. - The company anticipates requiring substantial additional financing to achieve its goals, which may lead to dilution for existing stockholders[6]. - The company may need to raise additional funds through equity offerings or collaborations, which could dilute existing stockholders' ownership interests[185]. Stock and Equity - The weighted-average common stock outstanding for the three months ended September 30, 2024, was 7,697,695 shares[13]. - The company completed its initial public offering (IPO) on September 16, 2024, raising approximately 234.4millioninnetproceedsfromthesaleof15,220,588sharesatapublicofferingpriceof234.4 million in net proceeds from the sale of 15,220,588 shares at a public offering price of 17.00 per share[26]. - Upon the IPO, all outstanding shares of the Company's Series Seed, Series A, Series B, and Series C Preferred Stock automatically converted into 24,978,715 shares of common stock[74]. - As of September 30, 2024, the Company had reserved 9,078,056 shares of common stock for the potential conversion of outstanding convertible preferred stock and exercise of stock options[87]. - The Company issued and sold 103,990,553 shares of Series C Preferred Stock in May 2023, raising total net cash proceeds of 178.4million[72].AccumulatedDeficit−TheaccumulateddeficitasofSeptember30,2024,was178.4 million[72]. Accumulated Deficit - The accumulated deficit as of September 30, 2024, was (334,786), compared to (230,403)asofDecember31,2023[10].−Thebalanceofaccumulateddeficitincreasedto(230,403) as of December 31, 2023[10]. - The balance of accumulated deficit increased to 230,403 as of December 31, 2023, from 212,377asofMarch31,2023,showingacontinuedtrendoflosses[17].−Thecompanyhadanaccumulateddeficitof212,377 as of March 31, 2023, showing a continued trend of losses[17]. - The company had an accumulated deficit of 334.8 million as of September 30, 2024, up from 230.4millionattheendof2023[28].DevelopmentandResearch−Thecompanyisdevelopingobexelimabforseveralautoimmunediseases,withongoingclinicaltrialsincludingaPhase3trialforIgG4−RDandPhase2trialsforMSandSLEinitiatedinQ32024[119].−Theincreaseinresearchanddevelopmentexpenseswasprimarilyduetoa230.4 million at the end of 2023[28]. Development and Research - The company is developing obexelimab for several autoimmune diseases, with ongoing clinical trials including a Phase 3 trial for IgG4-RD and Phase 2 trials for MS and SLE initiated in Q3 2024[119]. - The increase in research and development expenses was primarily due to a 20.0 million rise in costs related to the development of obexelimab, driven by a 12.0millionincreaseinclinicaltrialcostsanda12.0 million increase in clinical trial costs and a 7.6 million increase in manufacturing costs[157]. - The company expects research and development expenses to continue increasing as it advances clinical trials and expands its product portfolio[143]. - The successful development of product candidates remains highly uncertain, with numerous risks and uncertainties impacting timelines and costs[144]. Legal and Regulatory - The company is not currently involved in any legal proceedings that would have a material adverse effect on its business[201]. - The company expects to incur additional costs associated with being a public company, including audit, legal, and regulatory expenses, which were not present as a private entity[130]. Miscellaneous - The company qualifies as an "emerging growth company" and intends to rely on reduced disclosure requirements until December 31, 2029[191]. - The company does not currently engage in currency hedging activities, which may expose it to foreign currency exchange risks[196]. - Inflation has not had a material effect on the company's business or financial statements[197].