Financial Position - The company has approximately $350 million in cash, cash equivalents, and short-term investments as of December 31, 2024, expected to fund operations into Q4 2026[2] - The company completed an upsized Series C and IPO, raising approximately $458.7 million in gross proceeds to support obexelimab and growth strategy[5] Clinical Trials - Topline results from the Phase 2 MoonStone trial in Relapsing Multiple Sclerosis are anticipated in Q3 2025[1] - Topline results from the pivotal Phase 3 INDIGO trial in Immunoglobulin G4-Related Disease are expected by year-end 2025[1] - The Phase 3 INDIGO trial is the largest clinical trial ever conducted in patients with IgG4-RD, involving approximately 190 patients across 100 sites in 20 countries[14] - The Phase 2 SunStone trial in Systemic Lupus Erythematosus is expected to complete enrollment in 2025, with topline results projected in the first half of 2026[13] - Obexelimab has been evaluated in five completed clinical trials involving a total of 198 patients, demonstrating clinical activity and tolerability[4] - The primary endpoint of the Phase 2 MoonStone trial is the change in the cumulative number of gadolinium-enhancing lesions on MRI after 12 weeks[10] Strategic Partnerships - The company out-licensed its anti-IGF-1R Thyroid Eye Disease programs to Zai Lab, receiving an upfront fee and potential future milestone payments[5] Operational Risks - The Company relies on WuXi Biologics (Hong Kong) Limited for drug substance and drug product manufacturing, which is located in China[18] - The Company acknowledges risks related to operations of suppliers located outside the United States[18] Forward-Looking Statements - Forward-looking statements made by the Company are inherently uncertain and may prove incorrect[18] - The Company does not guarantee future events based on forward-looking statements due to potential risks and uncertainties[18] - Management cannot predict all emerging risks and uncertainties in the evolving environment[18] Research and Development Focus - The company aims to leverage obexelimab's unique mechanism of action to address the pathogenic role of B cells in chronic autoimmune diseases[15]

Core Insights - Zenas BioPharma is advancing its clinical trials for obexelimab, a CD-19 x FcγRIIb inhibitor, with significant milestones expected in 2025 [1][2][5] Group 1: Clinical Trials and Milestones - Topline results from the Phase 2 trial (MoonStone) in Relapsing Multiple Sclerosis (RMS) are anticipated in Q3 2025 [1][6] - The pivotal Phase 3 trial (INDIGO) in Immunoglobulin G4-Related Disease (IgG4-RD) is expected to report results by the end of 2025 [1][7] - Enrollment for the Phase 2 trial (SunStone) in Systemic Lupus Erythematosus (SLE) is projected to be completed in 2025 [1][12] Group 2: Financial Position - As of December 31, 2024, the company reported approximately $350 million in cash, cash equivalents, and short-term investments, which is expected to fund operations into Q4 2026 [2][3] Group 3: Recent Achievements - In 2024, Zenas completed enrollment for the Phase 3 INDIGO trial, initiated the Phase 2 MoonStone and SunStone trials, and provided initial data from the Phase 2 SApHiAre trial [3][4] - The company raised approximately $458.7 million through an upsized Series C and initial public offering to support its activities [3][4] Group 4: Mechanism of Action - Obexelimab is designed to inhibit B cell activity without depleting them, which may provide therapeutic benefits for various autoimmune diseases [5][11][16] - The drug has shown clinical proof of concept in previous trials, demonstrating safety and activity in patients [5][11] Group 5: Market Need and Competition - There are currently no approved therapies for IgG4-RD, indicating a high unmet medical need in this area [8][10] - The pathogenesis of IgG4-RD suggests that B cell-targeted therapies like obexelimab may offer significant benefits compared to existing treatments [10][11]

Financial Performance - Total revenue for the nine months ended September 30, 2024, was $50,000, 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 $35,608 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 $12.5 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 $38.606 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, a decrease of $50.0 million compared to $50.0 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 $14,376 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 $39,615 in the same period of 2023[13]. - General and administrative expenses for the three months ended September 30, 2024, were $7,454, compared to $5,024 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 $39.6 million in 2023, representing a $50.4 million increase[165]. - General and administrative expenses rose to $18.3 million for the nine months ended September 30, 2024, compared to $12.8 million in 2023, an increase of $5.5 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 $15.1 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 $411.1 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 $234.4 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 $178.4 million[72]. Accumulated Deficit - The accumulated deficit as of September 30, 2024, was $(334,786), compared to $(230,403) as of December 31, 2023[10]. - The balance of accumulated deficit increased to $230,403 as of December 31, 2023, from $212,377 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 $230.4 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 $12.0 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].

Financial Performance - The net loss for Q3 2024 was $38.6 million, compared to a net income of $35.6 million in Q3 2023, which was influenced by collaboration revenue from Bristol-Myers Squibb[13]. - Research and development (R&D) expenses for Q3 2024 were $33.5 million, a significant increase from $9.4 million in Q3 2023, primarily due to higher costs associated with obexelimab[11]. - General and administrative (G&A) expenses totaled $7.5 million in Q3 2024, up from $5.0 million in Q3 2023, driven by increased personnel and operational costs[12]. - Total operating expenses for Q3 2024 were $41.0 million, compared to $14.4 million in Q3 2023, reflecting the company's investment in growth and clinical trials[17]. Clinical Development - The company achieved targeted enrollment for the Phase 3 INDIGO trial, the largest clinical trial for Immunoglobulin G4-Related Disease (IgG4-RD), with topline results expected by the end of 2025[2][4]. - The company initiated the Phase 2 MoonStone trial for obexelimab in Relapsing Multiple Sclerosis, with primary endpoint results anticipated by Q3 2025[5]. Funding and Growth Strategy - Zenas BioPharma completed its initial public offering, raising approximately $258.7 million in gross proceeds to fund the clinical development of obexelimab and support its growth strategy[1][8]. - As of September 30, 2024, the company's cash balance was $386.8 million, including net proceeds of $234.4 million from the IPO, expected to fund operations into Q4 2026[14]. Leadership Changes - The company appointed Orlando Oliveira as Chief Commercial Officer and Jeff Held as Chief Legal Officer to strengthen its leadership team[9]. Licensing and Partnerships - Zenas BioPharma out-licensed ZB005, a human IgG4 monoclonal antibody, for a non-refundable upfront payment and potential milestone payments[10].

Core Insights - Zenas BioPharma completed its initial public offering, raising $258.7 million to support the clinical development of its lead product candidate, obexelimab, and its growth strategy [1][7] - The company has achieved targeted enrollment for the Phase 3 INDIGO trial, which is the largest clinical trial for Immunoglobulin G4-Related Disease (IgG4-RD), with topline results expected by the end of 2025 [2][4] Clinical Development - Obexelimab is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, designed to inhibit the activity of B cells involved in autoimmune diseases without depleting them [3][14] - The Phase 2 MoonStone trial has been initiated to evaluate obexelimab's efficacy and safety in patients with Relapsing Multiple Sclerosis (RMS), with primary endpoint results expected by Q3 2025 [5] - The Phase 2 SunStone trial is also underway to assess obexelimab in patients with Systemic Lupus Erythematosus (SLE), with topline results anticipated in the first half of 2026 [6] - Enrollment continues in the Phase 2 SApHiAre trial for warm Autoimmune Hemolytic Anemia (wAIHA), with initial data expected later this year [7] Financial Performance - For Q3 2024, research and development expenses were $33.5 million, a significant increase from $9.4 million in Q3 2023, primarily due to costs associated with obexelimab's clinical development [10] - General and administrative expenses rose to $7.5 million from $5.0 million in the same period last year, attributed to increased personnel and operational costs [11] - The net loss for Q3 2024 was $38.6 million, compared to a net income of $35.6 million in Q3 2023, which was influenced by collaboration revenue from Bristol-Myers Squibb [12][16] Cash Position - As of September 30, 2024, the company's cash balance was $386.8 million, including net proceeds of $234.4 million from the IPO, expected to fund operations into Q4 2026 [13][17]

Core Insights - Zenas BioPharma has completed targeted enrollment for the Phase 3 INDIGO trial, the largest clinical trial for patients with IgG4-RD, and expects topline results by the end of 2025 [1][2] Company Overview - Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing and commercializing immunology-based therapies [9] - The company's lead product candidate, obexelimab, is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb to inhibit B cell activity without depleting them [9] INDIGO Trial Details - The Phase 3 INDIGO trial is a global, double-blind, placebo-controlled study involving approximately 190 patients across 100 sites in 20 countries [3] - Patients are randomized to receive either 250 mg of obexelimab or placebo weekly for 52 weeks, followed by an open-label extension period [3] - The primary efficacy endpoint is the time to first IgG4-RD flare, with secondary endpoints including annualized flare rate and complete remission rates [4] Obexelimab Clinical Background - Obexelimab has been evaluated in five completed clinical trials with a total of 198 patients, demonstrating good tolerance and clinical activity [5] - The drug is currently being tested in multiple Phase 2 and Phase 3 trials for various autoimmune diseases, including IgG4-RD, Multiple Sclerosis, and Systemic Lupus Erythematosus [5] IgG4-RD Overview - IgG4-RD is a chronic fibro-inflammatory disease affecting multiple organ systems, with an estimated 20,000 diagnosed patients in the U.S. [6] - There are currently no approved therapies for IgG4-RD, and the standard treatment involves glucocorticoids, which can lead to complications and relapses [7] Therapeutic Landscape - B cell-targeted therapies are suggested to provide benefits for IgG4-RD, although existing agents like rituximab are not approved for this indication and carry risks of infections [8]

Company Overview - Zenas BioPharma, Inc. is a clinical-stage global biopharmaceutical company focused on developing and commercializing transformative immunology-based therapies for patients with autoimmune diseases [2] - The company's lead product candidate, obexelimab, is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb to inhibit the activity of B cells implicated in autoimmune diseases without depleting them [2] Upcoming Events - Zenas will participate in several healthcare investor conferences, including: - Guggenheim's Inaugural Healthcare Innovation Conference on November 12, 2024, in Boston, MA - Jefferies London Healthcare Conference on November 19, 2024, with a presentation scheduled from 4:00 p.m. to 4:25 p.m. [1] - Citi's 2024 Global Healthcare Conference on December 3, 2024, with a presentation from 9:30 a.m. to 10:10 a.m. ET in Miami, FL [1] - Evercore ISI HealthCONx Conference on December 4, 2024, with a presentation from 1:20 p.m. to 1:40 p.m. ET in Coral Gables, FL [1] - Live webcasts and archived replays of the presentations will be available on the Zenas BioPharma website [1]