Dr. Laken brings over 25 years of leadership experience in research, development operations, scientific assessment and strategyWALTHAM, Mass., April 07, 2025 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of therapies for autoimmune diseases, today announced the appointment of Haley Laken, Ph.D., as Chief Scientific Officer (CSO). Dr. Laken brings signi ...

NEW YORK, March 25, 2025 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Zenas BioPharma, Inc. (NASDAQ: ZBIO) resulting from allegations that Zenas BioPharma may have issued materially misleading business information to the investing public. SO WHAT: If you purchased Zenas BioPharma securities you may be entitled to compensation without payment of any out of pocket fees or costs through a cont ...

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Zenas BioPharma, Inc. due to allegations of materially misleading business information issued to the investing public [1]. Group 1: Investigation Details - The investigation is focused on Zenas BioPharma, Inc. (NASDAQ: ZBIO) regarding possible misleading information that may have affected investors [1]. - Shareholders who purchased Zenas BioPharma securities may be entitled to compensation through a contingency fee arrangement, with no out-of-pocket fees or costs [2]. Group 2: Class Action Information - Rosen Law Firm is preparing a class action to seek recovery of investor losses related to Zenas BioPharma [2]. - Interested investors can join the prospective class action by submitting a form or contacting the firm directly [2]. Group 3: Rosen Law Firm's Credentials - Rosen Law Firm has a strong track record in securities class actions, having achieved the largest securities class action settlement against a Chinese company at the time [3]. - The firm has been ranked No. 1 for the number of securities class action settlements in 2017 and has consistently ranked in the top 4 since 2013, recovering hundreds of millions of dollars for investors [3]. - In 2019, the firm secured over $438 million for investors, showcasing its effectiveness in litigation [3].

–Dr. von Moltke brings over 30 years of deep drug development experience and a proven track record of clinical and regulatory success at both large and emerging global biopharmaceutical companies– WALTHAM, Mass., March 17, 2025 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of therapies for autoimmune diseases, today announced the appointment of Lisa vo ...

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]

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]