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NEW YORK, Aug. 12, 2025 (GLOBE NEWSWIRE) — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer’s disease, Parkinson’s disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today reported financial results for its third quarter of fiscal 2025.

“Our development of non-invasive, targeted upstream compounds continues to advance, particularly in the context of Alzheimer’s disease,” said Christopher U. Missling, PhD, President and CEO of Anavex. “Clinical feedback highlights the importance of orally administered therapies that are both accessible and effective. At AAIC 2025, we presented open-label extension data for blarcamesine, which demonstrated continued clinically meaningful benefit in early-stage Alzheimer’s patients—further validating its therapeutic potential.”

Recent Highlights:

• On July 31, 2025, Anavex announced the latest findings for blarcamesine, an oral small molecule for the potential treatment of early Alzheimer’s disease. The data were presented by Marwan Noel Sabbagh, MD, Professor of Neurology, and Chairman of the Anavex Scientific Advisory Board at the 2025 Alzheimer’s Association International Conference (AAIC). Blarcamesine-treated patients continue to accrue benefit through up to 4 years, as measured by the prespecified clinical endpoints ADAS-Cog13 and ADCS-ADL, respectively. Further presentations at the AAIC 2025 Conference featured prespecified Precision Medicine Phase IIb/III 48-week ANAVEX®2-73-AD-004 double-blind (DB) clinical trial data on blarcamesine, confirming the upstream mechanism of blarcamesine, restoring impaired autophagy as an early event, preceding amyloid-beta and tau.
• July 27-31, 2025, Anavex was honored to be a part of the program at the 2025 Alzheimer’s Association International Conference (AAIC) in Toronto. The sharing of knowledge at these central events is important to help advance dementia science to better support the millions of individuals, families, and communities impacted by Alzheimer’s disease.
• In June 2025, a survey of Alzheimer’s Disease stakeholders from European Union (EU) Member States on ‘Current Unmet Needs in Alzheimer Care’ was conducted. There is a clear acknowledgment that oral therapies would ‘facilitate things’ for many countries and be ‘much more accessible’ for the respective healthcare systems, potentially requiring less extensive monitoring and complex administration compared to injectable monoclonal antibodies. This modality difference is seen as a key factor in potential broader market penetration.

Financial Highlights:

• Cash and cash equivalents of $101.2 million at June 30, 2025 compared to $132.2 million at year ended September 30, 2024. The Company anticipates at current adjusted cash utilization rates and ranges, an approximate cash runway of more than 3 years.
• Research and development expenses for the quarter of $10.0 million compared to $11.8 million for the comparable quarter of fiscal 2024.
• General and administrative expenses for the quarter of $4.5 million compared to $2.8 million for the comparable quarter of fiscal 2024.
• An increase in non-cash compensation charges, was offset by a decrease in overall cash operating expenses, as compared to the same quarter of fiscal 2024.
• Net loss for the quarter of $13.2 million, or $0.16 per share, compared to a net loss of $12.2 million, or $0.14 per share for the comparable quarter of fiscal 2024.

The financial information for the quarter ended June 30, 2025, should be read in conjunction with the Company’s consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com.

Webcast / Conference Call Information:

The live webcast of the conference call will be available on Anavex’s website at www.anavex.com.

The conference call can be also accessed by dialing 1 929 205 6099 for participants in the U.S. using the Meeting ID# 856 5033 5285 and reference passcode 014 352. A replay of the conference call will also be available on Anavex’s website for up to 30 days.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer’s disease, Parkinson’s disease, schizophrenia, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer’s disease, a Phase 2 proof-of-concept study in Parkinson’s disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson’s disease. We believe that ANAVEX®3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter,Facebook, Instagram, and LinkedIn.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

For Further Information:

Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: [email protected]

Investors:

Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: [email protected]

Momentum accelerates with $1.5 million in revenue for H1 2025 and an order backlog of $1.6 million as of June 30, bringing the combined total to $3.1 million — already approaching full-year 2024 revenue, as new sales continue to ramp in the second half of 2025

Growth driven by


transition o


f


key


Tier-1


customers


in


to mass production


as


U.S.


sets policy


to


advance adoption of drones


,


defense manufacturers prepare for DoD Programs of Record,


continued conflicts in the Middle


East


and


increase


d European


defense spending

Selection


of


Mobilicom’s


cybersecure systems


in


to


the DoD’s prestigious


Blue UAS


Framework is


fast track


ing


additional


sales to


Tier-1


defense contractors

PALO ALTO, Calif., Aug. 12, 2025 (GLOBE NEWSWIRE) — Mobilicom Limited (Nasdaq: MOB, MOBBW), a provider of cybersecurity and robust solutions for drones and robotics, today announced financial results for the six months ended June 30, 2025, as well as recent business and operational highlights.

“During the first half of 2025, we saw a ramp up in order sas Tier-1 customers geared up for production for anticipated U.S. Department of Defense (DoD) programs of record, as evidenced by our most recent $1.4 million order and our $1.6 million backlog, which we expect to fulfill during the second half of the year,” stated Mobilicom CEO and Founder Oren Elkayam. “Our SkyHopper’s addition to the DoD BlueUAS Framework was a major achievement earlier this year and is very well timed with the broader drone-focused defense spending patterns emerging in the U.S., Europe, and Asia, all of which are fast tracking sales to DoD and allied militaries. Additionally, we expect to see accelerated adoption of our OS3cybersecurity software into AI-driven next-generation drones and robotics through key industry partnerships, several of we established during the first half of 2025.”

“We believe that Mobilicom remains very well positioned to continue to capture market share, supported by a strong balance sheet and narrowing burn rate,” Elkayam concluded.

H1
202
5
and
Recent Operational Highlights

• Recently secured a $1.4 million orders from a Tier-1 customer, one of the U.S.’s largest manufacturers of small-sized drones, for Mobilicom’s BlueUAS-listed SkyHopper PRO. Customer shifting into mass production to meet U.S. Department of Defense (DoD) demand
• Selected by one of the world’s largest loitering munitions manufacturers for Mobilicom’s cybersecure MCU-30 Mobile MESH product for integration into its latest perimeter protection drone fleets
• Secured initial production scale orders from a Tier-1 Asian conglomerate and manufacturer of robotics platforms that are sold to customers in the military and industrial markets
• Selected by U.S. DoD’s Defense Innovation Unit (DIU) added three Mobilicom SkyHopper products to the Blue UAS Framework, a prestigious short-list of approved products eligible for procurement by the DoD
• Entered a cooperation agreement with Palladyne AI to offer a bundled solution of Mobilicom’s OS3 cybersecurity with Palladyne AI’s Pilot autonomy software for UAVs and Palladyne’s IQ autonomy software for industrial robots and cobots
• Launched with ARK Electronics joint integrated cybersecure solution for drones and robotics platforms combining Mobilicom’s BlueUAS-listed SkyHopper PRO and advanced OS3 cybersecurity with ARK’s made-in-USA, BlueUAS listed, powered by NVIDIA
• Partnered with Aitech Systems to deliver aerospace and defense-grade solutions for next-generation autonomous AI-driven UAS platforms that combine Mobilicom’s OS3 with Aitech’s NVIDIA AI-driven autonomous computers
• Selected for a $390,000 innovation program to develop Enhanced Electronic Warfare communications systems that protect UAVs against advanced wideband jamming; Upon full development, the new innovation would be offered as an upgrade to further fortify Mobilicom’s ICE software suite when embedded on its SkyHopper family of products

Financial Highlights for the
Six
Months Ended
June 30
, 202
5

• Revenues were $1.5 million for the six months ended June 30, 2025
• Confirmed order backlog of $1.6 million as of June 30, 2025, in addition to momentum in new orders expected to be received and fulfilled in the second half of 2025
• Gross margin remained consistently high at 55%, reflecting strong high-end IP-based technology and effective components and supply chain management
• Operating net cash burns continue to narrow to approximately $262,000 per month during the first half of the year as a result of continued efficiencies in operating expenses
• $7 million cash position as of June 30, 2025 and a low monthly burn rate affords Mobilicom a long cash runway to implement its strategic plans
• Clean balance sheet with no debt, no loans, no credit lines and no convertible debt
• EBITDA was $(1.9) million compared to $(1.5) million for the six months ended June 30, 2024

About
Mobilicom

Mobilicom is a leading provider of cybersecure robust solutions for the rapidly growing defense and commercial drones and robotics market. Mobilicom’s large portfolio of field-proven technologies includes cybersecurity, software, hardware, and professional services that power, connect, guide, and secure drones and robotics. Through deployments across the globe with over 50 customers, including the world’s largest drone manufacturers, Mobilicom’s end-to-end solutions are used in mission-critical functions.

For investors, please use https://ir.mobilicom.com/
For company, please use www.mobilicom.com

Forward Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. For example, the Company is using forward-looking statements when it discusses its expectations that its order backlog will be filled in the second half of the year and momentum in new orders, its beliefs with respect to drone-focused defense spending patterns emerging in the U.S., Europe, and Asia, allof which are fast tracking sales to the DoD and militaries, its expectation expect to see accelerated adoption of its OS3 cybersecurity software into AI-driven next-generation drones and robotics through key industry partnerships and its belief that it remains very well positioned to continue to capture market share. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Mobilicom Limited’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission.

Forward-looking statements contained in this announcement are made as of this date, and Mobilicom Limited undertakes no duty to update such information except as required under applicable law.

For more information on
Mobilicom
, please contact:

Liad Gelfer

Mobilicom Ltd
[email protected]

Use of Non-IFRS Financial Information

In addition to disclosing financial results calculated in accordance with the International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board, this release also contains non-IFRS financial measures, which Mobilicom believes are the principal indicators of the operating and financial performance of its business.

Management believes the non-IFRS financial measures provided are useful to investors’ understanding and assessment of Mobilicom’s ongoing core operations and prospects for the future, as the charges eliminated are not part of the day-to-day business or reflective of the core operational activities of the company. Management uses these non-IFRS financial measures as a basis for strategic decisions and evaluating the Company’s current performance. The presentation of these non-IFRS financial measures is not intended to be considered in isolation from, or as a substitute for, or superior to, operating loss and or net income (loss) or any other performance measures derived in accordance with IFRS or as an alternative to net cash provided by operating activities or any other measures of our cash flows or liquidity.

EBITDA is a non-IFRS financial measure that is defined as earnings before interest, taxes, depreciation, amortization, and other non-cash or one-time expenses.

* Less than $0.01 cents

FDA Accepted the Company’s Response to the CRL for CARDAMYST™ (etripamil) Nasal Spray; New PDUFA Target Date of December 13, 2025

Milestone Strengthens Balance Sheet to Fully Commercialize CARDAMYST if Approved

Public Offering Raised Total Gross Proceeds of up to $170 Million if all Warrants are Exercised

$75 Million Royalty Purchase Agreement Payment from RTW Extended Through End of 2025

MONTREAL and CHARLOTTE, N.C., Aug. 12, 2025 (GLOBE NEWSWIRE) — Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the second quarter ended June 30, 2025 and provided corporate and regulatory updates.

“With the FDA’s recent acceptance of our response to the CRL, our team is energized as we work toward the potential approval of CARDAMYST in its first indication, PSVT,” said Joe Oliveto, President and Chief Executive Officer of Milestone. “In parallel to our regulatory progress, we completed an equity financing in July with high-quality investors which strengthened our balance sheet and extended our operating runway. Our goal is to make CARDAMYST quickly available to PSVT patients, should the FDA grant approval this year.”

Second Quarter and Recent Program Updates

Etripamil for


p


atients with PSVT

• FDA accepted the Company’s response to the Complete Response Letter (CRL) for CARDAMYST™ (etripamil) Nasal Spray and set a new
  Prescription Drug User Fee Act (PDFUA) target date of December 13, 2025.  In June, Milestone submitted to the FDA its response to a CRL for CARDAMYST, its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT). On July 11, 2025, the Company announced the FDA accepted the response to issues raised in the CRL and assigned a new PDUFA target date of December 13, 2025. Milestone has maintained its launch infrastructure that was in place prior to the CRL and has restarted targeted pre-launch activities given the new potential approval date of CARDAMYST.

Etripamil for patients with atrial fibrillation with rapid ventricular rate (AFib-RVR)

• Phase 3 protocol of etripamil in AFib-RVR finalized. Milestone has finalized the Phase 3 study protocol following FDA’s review and obtained concurrence with the Agency to proceed. The Company has paused initiation of enrollment in the study to prioritize resources for the preparation of the expected launch of etripamil in PSVT.

Second Quarter and Recent Corporate Updates

• In July 2025, Milestone completed a public equity offering, raising total gross proceeds of up to $170 million, if all Series A and B warrants are exercised for cash, including immediate net proceeds of approximately $48.7 million. Milestone intends to use the proceeds from the underwritten public offering (the “Offering”), together with existing cash and cash equivalents, to fund the continued development and commercial launch of CARDAMYST in its lead indication of PSVT, as well as for working capital and other general corporate purposes. The Offering consisted of the sale and issuance of (i) 31,500,000 of its common shares (the “Shares”), accompanying Series A common warrants (the “Series A Common Warrants”) to purchase an aggregate of 31,500,000 common shares and accompanying Series B common warrants (the “Series B Common Warrants”) to purchase an aggregate of 31,500,000 common shares , at a combined public offering price of $1.50 per share and accompanying Series A Common Warrant and Series B Common Warrant and (ii) in lieu of common shares to certain investors that so choose, pre-funded warrants to purchase 3,502,335 common shares, accompanying Series A Common Warrants to purchase an aggregate of 3,502,335 common shares and accompanying Series B Common Warrants to purchase an aggregate of 3,502,335 common shares, at a combined public offering price of $1.499 per pre-funded warrant and accompanying Series A Common Warrant and Series B Common Warrant, which represented the combined public offering price for the Shares and accompanying common warrants less the $0.001 per share exercise price for each such pre-funded warrant. The net proceeds to the Company received from the Offering were approximately $48.7 million after deducting underwriting commissions and estimated offering expenses payable by the Company.
• Amended Royalty Agreement with RTW. Milestone extended the marketing approval deadline in its $75 million purchase and sale agreement (the “Royalty Purchase Agreement”) with existing shareholder, RTW Investments, LP, and certain of its affiliates (RTW) from September 30, 2025 to December 31, 2025. The proceeds from the Royalty Purchase Agreement are expected to fund the continued development and commercial launch of CARDAMYST in its lead indication of PSVT, following potential FDA approval and satisfaction of other customary closing conditions.

Second Quarter 2025 Financial Results  

• As of June 30, 2025, Milestone had cash, cash equivalents, and short-term investments of $43.4 million, compared to $69.7 million as of December 31, 2024. Subsequent to the end of the quarter, the company raised net proceeds of approximately $48.7 million from the Offering, as described above.
• There was no revenue for the second quarter ended June 30, 2025 or for the second quarter of 2024.
• Research and development expense for the second quarter of 2025 was $3.7 million, compared with $2.8 million for the prior year period. For the six months ended June 30, 2025, research and development expense was $8.6 million compared with $6.5 million for the same period in 2024. The increase was primarily due to higher consulting and outside service costs that were partially offset by lower personnel-related costs.
• General and administrative expense for the second quarter of 2025 was $3.8 million, compared with $5.0 million for the prior year period. For the six months ended June 30, 2025, general and administrative expense was $8.9 million, compared with the $9.0 million for the prior year period.  The decrease between the quarters is primarily due to a decrease in legal fees, professional fees, and personnel costs.
• Commercial expense for the second quarter of 2025 was $5.1 million, compared with $1.8 million for the prior year period. For the six months ended June 30, 2025, commercial expense was $15.5 million compared with $4.7 million for the prior year period. These increases are a result of additional personnel costs, professional costs and other operational expenses related to preparation for the launch of CARDAMYST. As a result of the CRL, Milestone temporarily paused the ramping of operational expenditures related to launch, but has maintained the capability to launch quickly, pending approval of CARDAMYST by the FDA.
• For the second quarter of 2025, net loss was $13.0 million, compared to $9.4 million for the prior year period. For the six months ended June 30, 2025, Milestone’s net loss was $33.7 million, compared to $19.7 million in the prior year period.

For further details on the Company’s financials, refer to the Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC.

About Etripamil

Etripamil is Milestone’s lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly symptomatic episodes of PSVT and AFib-RVR. It is designed as a self-administered rapid response therapy for patients thereby bypassing the need for immediate medical oversight. If approved, etripamil is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable, self-administered treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST™, the conditionally approved brand name for etripamil nasal spray, is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT and Phase 2 trial for the treatment of patients with AFib-RVR.

About Milestone Pharmaceuticals

Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone’s lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “continue,” “could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,” “may,” “pending,” “plan,” “potential,” “progress,” “will”, “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding: the outcomes of future interactions with the FDA, including the potential approval of the NDA for CARDAMYST for PSVT; Milestone’s ability to receive additional cash proceeds from the warrants issued in the Offering; Milestone’s ability to receive the $75.0 million royalty payment under the Royalty Purchase Agreement on the timeline provided, or at all; Milestone’s expected operating runway; CARDAMYST’s potential as a novel treatment option to help patients with PSVT; Milestone’s ability to make CARDAMYST quickly available to PSVT patients following FDA approval, if received; the success of Milestone’s launch infrastructure; the timing of patient enrollment in the Phase 3 study of etripamil for AFib-RVR; and other statements not related to historical facts. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether our future interactions with the FDA will have satisfactory outcomes; whether and when, if at all, our NDA for etripamil will be approved by the FDA; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, international tariffs, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone’s filings with the U.S. Securities and Exchange Commission (SEC), including in its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended June 30, 2025, in each case under the caption “Risk Factors,” as such discussions may be updated from time to time by subsequent filings Milestone may make with the SEC. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact: 

Investor Relations 
Kevin Gardner, [email protected] 

– Topline results from pivotal Phase 3 INDIGO trial in Immunoglobulin G4-Related Disease expected around year-end 2025 –

– Completed enrollment of Phase 2 MoonStone trial in Relapsing Multiple Sclerosis; results expected early in the fourth quarter 2025 –

– Enrollment of Phase 2 SunStone trial in Systemic Lupus Erythematosus expected to be completed by year-end 2025; topline results expected mid-2026 –

– Cash, cash equivalents and investments of $274.9 million as of June 30, 2025, expected to provide cash runway into the fourth quarter of 2026 –

WALTHAM, Mass., Aug. 12, 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 transformative therapies for autoimmune diseases, today reported financial results for the second quarter ended June 30, 2025, and provided recent corporate updates.

“We are very pleased with the rapid advancement of our broad obexelimab development program, including the completion of enrollment for the Phase 2 MoonStone trial in patients with Relapsing Multiple Sclerosis this past quarter. We look forward to reporting the results from the primary analysis of the trial, and importantly, the topline results from the Phase 3 INDIGO trial of obexelimab in patients with IgG4-RD,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. “Given the differentiated profile of obexelimab, along with our extensive development capabilities and commercialization experience, we are well positioned to execute on the significant opportunity ahead to potentially impact the lives of patients living with autoimmune diseases worldwide.”

Recent corporate highlights

Obexelimab, a CD-19 x FcγRIIb inhibitor of B cell function

• Immunoglobulin G4-Related Disease (IgG4-RD): Advanced the Phase 3 INDIGO trial, a global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab in patients with IgG4-RD. INDIGO is the largest clinical trial conducted in patients living with IgG4-RD to date. Target enrollment of the INDIGO trial concluded in November 2024, and Zenas expects to report topline results around year-end 2025.

• Relapsing Multiple Sclerosis (RMS): Completed enrollment of the Phase 2 MoonStone trial, a multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab in patients with RMS. Zenas expects to report results from this trial, including the 12-week primary endpoint results, early in the fourth quarter of 2025.

• Systemic Lupus Erythematosus (SLE): Continued enrollment of the Phase 2 SunStone trial, a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of obexelimab in patients with SLE. Zenas expects to complete enrollment of the Phase 2 SunStone trial by year-end 2025 and report topline results in mid-2026.

Second quarter 2025 financial results

• As of June 30, 2025, the Company’s cash, cash equivalents and investments were $274.9 million. The Company expects that its cash, cash equivalents and investments, as of June 30, 2025, will fund its operating expenses and capital expenditure requirements into the fourth quarter of 2026.
• Research and development (R&D) expenses were $43.0 million for the quarter ended June 30, 2025, compared to $33.8 million for the quarter ended June 30, 2024. The increase of $9.2 million in R&D expenses primarily relates to an increase in costs related to the clinical development of obexelimab and an increase in personnel costs partially offset by a decrease in costs related to our partnered programs.
• General and administrative (G&A) expenses were $12.1 million for the quarter ended June 30, 2025, compared to $5.9 million for the quarter ended June 30, 2024. The increase of $6.2 million in G&A expenses was due to an increase in personnel costs, including stock-based compensation expense, pre-commercialization activities including hiring and other expenses associated with operating as a public company.
• Net loss was $52.2 million for the quarter ended June 30, 2025, compared to net loss of $38.0 million for the quarter ended June 30, 2024.

About Obexelimab
Obexelimab is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease.

Obexelimab has been evaluated in five completed clinical trials in a total of 198 subjects who received obexelimab either as an intravenous infusion or as a subcutaneous injection. Obexelimab was well tolerated and demonstrated pharmacologic activity across these five clinical trials, providing the Company an initial clinical proof of concept for obexelimab as a potent B cell inhibitor for the treatment of patients living with certain autoimmune diseases. Currently, Zenas is conducting multiple Phase 2 and Phase 3 trials of obexelimab in several autoimmune diseases including Immunoglobulin G4-Related Disease, Relapsing Multiple Sclerosis and Systemic Lupus Erythematosus.

About Zenas BioPharma, Inc.
Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas’ lead product candidate, obexelimab, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on LinkedIn.

Forward looking statements
This press release contains “forward-looking statements” which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning the timing and results of ongoing and future clinical trials, including expectations on the timing of reporting INDIGO trial topline results, results of the 12-week primary endpoint analysis for the MoonStone trial and the anticipated timing of completing enrollment and reporting topline results for the SunStone trial; the ability to potentially impact the treatment of autoimmune diseases; its growth strategy; and cash runway guidance. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies, many of which already have approved therapies in the Company’s current indications; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; significant political, trade, regulatory developments, including changes in relations between the U.S. and China; risks related to the operations of the Company’s suppliers, many of which are located outside of the United States, including the Company’s current sole contract manufacturing organization for drug substance and drug product, WuXi Biologics (Hong Kong) Limited, which is located in China; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as well as other information we file with the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain, speak only as of the date of this press release and may prove incorrect. These statements are based upon information available to the Company as of the date of this press release and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that the Company has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, these forward-looking statements should not be relied upon as guarantees of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

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Investor and Media Contact:
Argot Partners
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