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Mirum Pharmaceuticals to Present Data at Upcoming Medical Congresses

– 28-week data from Phase 2b VANTAGE PBC study highlighting improvements in itch and fatigue will be presented at EASL

– Data from Mirum studies presented at DDW, EASL, and ESPGHAN congresses

FOSTER CITY, Calif.–(BUSINESS WIRE)–
Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that it will present data at three upcoming medical congresses. Digestive Disease Week (DDW) will be held in San Diego, May 3-6, 2025. The European Association for the Study of the Liver (EASL) will take place May 7-10 in Amsterdam, the Netherlands. The 57^th European Society for Paediatric, Gastroenterology, Hepatology, and Nutrition (ESPGHAN) Annual Meeting will follow May 14-17 in Helsinki, Finland. Data from Mirum’s LIVMARLI and volixibat studies will be highlighted in oral and poster presentations during the congresses.

“We are excited to see the continued evidence generated by Mirum medicines and product candidates across a number of settings,” said Joanne Quan, MD, chief medical officer at Mirum. “In particular, we look forward to sharing updated data from the interim analysis of the VANTAGE study of volixibat in patients with pruritus due to PBC. We are encouraged by the positive results which show a meaningful decrease in pruritus that lasts for the duration of the placebo-controlled period.”

EASL – May 7-10, 2025

Abstract #OS-059 (Oral): Volixibat for the treatment of cholestatic pruritus in primary biliary cholangitis: an adaptive, randomized, placebo-controlled phase 2B trial (VANTAGE): 28-week interim analysis

Friday, May 9 from 8:30-8:45am CEST

Immune-mediated and Cholestatic Diseases Session, McIntyre Room

Presented by: Michael Heneghan, MD, MMedSc, FRCPI, King’s College, London, UK

New 28-week data were reported from the Phase 2 VANTAGE study evaluating volixibat in patients with cholestatic pruritus related to primary biliary cholangitis (PBC). Thirty-one patients with moderate-to-severe pruritus were randomized (20mg VLX=10, 80mg VLX=10, placebo=11). Data showed that volixibat led to early and significant reductions in PBC-associated cholestatic pruritus and were maintained throughout the duration of the study. Further, 70% of volixibat-treated patients had a ≥50% reduction in serum bile acid levels from baseline. Additionally, patients treated with volixibat experienced improvements in fatigue and sleep. No new safety signals were observed through 28 weeks of treatment. The most common treatment-emergent adverse event was diarrhea which was mild to moderate in severity and transient in nature.

Additional data will be shared following the formal presentation on May 9.

EASL Symposium

Wednesday, May 7 from 1:30-2:30pm CEST

Adult Cholestatic Liver Disease: Focusing on Clinical Outcomes and the Future of IBAT Inhibitors

An archive of the symposium will be available following the event.

DDW

Oral Presentations

Presentation 784: Volixibat for the Treatment of Cholestatic Pruritus in Primary Biliary Cholangitis: An Adaptive, Randomized, Placebo-controlled Phase 2B Trial (VANTAGE): Interim Results

Monday, May 5 from 2:15-2:30pm PT

Cholestatic Liver Disease session, Room 6C

Presented by Mitchell Schiffman, MD, Bon Secours Liver Institute, Virginia, USA

Presentation 1086: Comprehensive Analysis of Cholestasis Genetic Panel Results From 2016–2022 in Children and Young Adults: Insights into Diagnostic Yield

Tuesday, May 6 from 10:00-10:15am PT

Human and Experimental Cholestatic and Autoimmune Liver Diseases, Room 6F

Presented by Brett Hoskins, DO, Indiana University School of Medicine, Indiana, USA

Poster Presentations

Poster Su1756:Genetic Insights Into PFIC-associated Genes in Unexplained Chronic Cholestasis and Liver Disease: Frequency and Implications of Variant Combinations

Sunday, May 4 from 12:30-1:30pm PT

Pediatric Hepatology Session, DDW Poster Hall, C-E

Presented by Brett Hoskins, DO, Indiana University School of Medicine, Indiana, USA

Poster Mo1627: Improvements in Pruritus, Serum Bile Acids, and Total Bilirubin Following Treatment with Maralixibat in Patients with Primary Sclerosing Cholangitis

Monday, May 5 from 12:30-1:30pm PT

Human and Experimental Cholestatic and Autoimmune Liver Diseases, DDW Poster Hall C-E

Presented by Jessica Hochberg, MD, University of Miami Miller School of Medicine, Florida, USA

ESPGHAN – May 14-17, 2025

Oral presentations

Abstract 1066: Improvements in pruritus are associated with growth in patients with progressive familial intrahepatic cholestasis: Data from the MARCH-ON trial

Saturday, May 17 from 9:15-11:15am EEST

Nutrition and Hepatology Session, Hall 3G

Presented by Professor Richard Thompson, King’s College, London, UK

Abstract 1089: The relationship between serum bile acids and event-free survival following the use of maralixibat for progressive familial intrahepatic cholestasis (PFIC): Data from the MARCH/MARCH-ON trials

Saturday, May 17 from 1:10-2:40pm EEST

Hepatology Abstracts, Hall 3G

Presented by Professor Richard Thompson, King’s College, London, UK

Abstract 1110: Improvements in pruritus after maralixibat treatment are associated with improved health-related quality of life for patients with cholestatic liver disease

Saturday, May 17 from 1:10-2:40pm EEST

Hepatology Abstracts, Hall 3G

Presented by Dr. Emmanuel Gonzales, Hépatologie Pédiatrique, Hôpital Bicêtre, AP-HP. Université Paris-Saclay, Le Kremlin-Bicêtre, France

Abstract 1098: Bile acid subspecies are correlated with pruritus and bilirubin improvement in PFIC patients treated with maralixibat: Data from MARCH and MARCH-ON

Saturday, May 17 from 1:10-2:40pm EEST

Hepatology Abstracts, Hall 3G

Presented by Dr. Henkjan Verkade, University of Groningen, Beatrix Children’s Hospital and University Medical Center Groningen, Netherlands

Poster presentations

Abstract 1102: Greater improvements in bilirubin were observed in pruritus responders after maralixibat treatment in patients with PFIC: data from the MARCH/MARCH-ON trials

Friday, May 16 from 3:30-4:20pm EST

General Hepatology 02 Session, e-Poster Station 08

Presented by Professor Richard Thompson, King’s College, London, UK

Abstract 1094: Impact of long-term maralixibat treatment on concomitant medication use for the treatment of cholestatic pruritus in Alagille syndrome: Real-world experience in the United States

Friday, May 16 from 3:30-4:20pm EEST

General Hepatology 03 & Transplantation Session, e-Poster Station 09

Presented by Dr. Tony Tokman, Mirum Pharmaceuticals, Inc., Foster City, California USA

Abstract 1107: Clinical benefits of maralixibat for patients with Alagille syndrome are durable through 7 years of treatment: Data from the MERGE study

Friday, May 16 from 3:30-4:20pm EEST

General Hepatology Session 02, e-Poster Station 08

Presented by Dr. Emmanuel Gonzales, Hépatologie Pédiatrique, Hôpital Bicêtre, AP-HP. Université Paris-Saclay, Le Kremlin-Bicêtre, France

ESPGHAN Symposium

Thursday, May 15 from 12:45-1:45pm EEST

Hall 3C

Growing Knowledge and Evidence: Long-term impact of IBAT inhibition

Full presentations will be available within the Publications and Presentations section on Mirum’s website.

About Volixibat

Volixibat is an oral, minimally absorbed agent designed to selectively inhibit the ileal bile acid transporter (IBAT). Volixibat may offer a novel approach in the treatment of adult cholestatic diseases by blocking the recycling of bile acids, through inhibition of IBAT, thereby reducing bile acids systemically and in the liver. Volixibat is currently being evaluated in Phase 2b studies for primary sclerosing cholangitis (PSC) (VISTAS study), and primary biliary cholangitis (PBC) (VANTAGE study). In June, Mirum announced positive interim results from the Phase 2b VANTAGE study showing statistically significant improvement in pruritus as well as meaningful reductions in serum bile acids and improvements in fatigue for patients treated with volixibat. No new safety signals were observed, and the most common adverse event was diarrhea with all cases mild to moderate. Volixibat has been granted breakthrough therapy designation for the treatment of PBC.

About LIVMARLI® (maralixibat) oral solution and LIVMARLI® (maralixibat) tablets

LIVMARLI^® (maralixibat) is an orally administered, ileal bile acid transporter (IBAT) inhibitor approved by the U.S. Food and Drug Administration for two pediatric cholestatic liver diseases, in both liquid and tablet formulations. It is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) in the U.S. three months of age and older and in Europe for patients two months of age and older. It is also approved in the U.S. for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) 12 months of age and older and in Europe for the treatment of PFIC in patients three months of age and older. For more information for U.S. residents, please visit LIVMARLI.com.

LIVMARLI is currently being evaluated in the Phase 3 EXPAND study in additional settings of cholestatic pruritus. To learn more about ongoing clinical trials with LIVMARLI, please visit Mirum’s clinical trials section on the company’s website.

U.S. IMPORTANT SAFETY INFORMATION

Limitation of Use: LIVMARLI is not for use in PFIC type 2 patients who have a severe defect in the bile salt export pump (BSEP) protein.

LIVMARLI can cause side effects, including:

Liver injury. Changes in certain liver tests are common in patients with Alagille syndrome and PFIC but can worsen during treatment. These changes may be a sign of liver injury. In PFIC, this can be serious or may lead to liver transplant or death. Your healthcare provider should do blood tests and physical exams before starting and during treatment to check your liver function. Tell your healthcare provider right away if you get any signs or symptoms of liver problems, including nausea or vomiting, skin or the white part of the eye turns yellow, dark or brown urine, pain on the right side of the stomach (abdomen), bloating in your stomach area, loss of appetite or bleeding or bruising more easily than normal.

Stomach and intestinal (gastrointestinal) problems. LIVMARLI can cause stomach and intestinal problems, including diarrhea and stomach pain. Your healthcare provider may advise you to monitor for new or worsening stomach problems including stomach pain, diarrhea, blood in your stool or vomiting. Tell your healthcare provider right away if you have any of these symptoms more often or more severely than normal for you.

A condition called Fat Soluble Vitamin (FSV) Deficiency caused by low levels of certain vitamins (vitamin A, D, E, and K) stored in body fat is common in patients with Alagille syndrome and PFIC but may worsen during treatment. Your healthcare provider should do blood tests before starting and during treatment and may monitor for bone fractures and bleeding which have been reported as common side effects.

LIVMARLI is available in oral solution or tablet formulations and is taken by mouth 30 minutes before a meal. For Alagille syndrome, LIVMARLI is taken one time each day in the morning. For PFIC, LIVMARLI is taken two times each day. If you take the oral solution, use the oral dosing dispenser to measure your dose.

US Prescribing Information

EU SmPC

Canadian Product Monograph

About Mirum Pharmaceuticals, Inc.

Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Mirum has three approved medications: LIVMARLI® (maralixibat) oral solution/LIVMARLI® (maralixibat) tablets, CHOLBAM® (cholic acid) capsules, and CTEXLI™ (chenodiol) tablets.

LIVMARLI, an IBAT inhibitor, is approved for the treatment of two rare liver diseases affecting children and adults. It is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome in the U.S. (three months and older), in Europe (two months and older), and in other regions globally. It is also approved in the U.S. in cholestatic pruritus in PFIC patients 12 months of age and older; in Europe, it is approved for patients with PFIC three months of age and older. Mirum has initiated the Phase 3 EXPAND study, a label expansion opportunity for LIVMARLI in additional settings of cholestatic pruritus. CHOLBAM is FDA-approved for the treatment of bile acid synthesis disorders due to single enzyme deficiencies and adjunctive treatment of peroxisomal disorders in patients who show signs or symptoms of liver disease.

CTEXLI is FDA-approved for the treatment of cerebrotendinous xanthomatosis (CTX) in adults.

Mirum’s late-stage pipeline includes two investigational treatments for several rare diseases.

Volixibat, an IBAT inhibitor, is being evaluated in two potentially registrational studies including the Phase 2 VISTAS study for primary sclerosing cholangitis (PSC) and Phase 2b VANTAGE study for primary biliary cholangitis. Volixibat has been granted Breakthrough Therapy Designation for the treatment of cholestatic pruritus in patients with PBC. Mirum is also planning for a Phase 2 study evaluating MRM-3379, a PDE4D inhibitor for the treatment of Fragile X syndrome, a rare genetic neurocognitive disorder.

To learn more about Mirum, visit mirumpharma.com and follow Mirum on Facebook, LinkedIn, Instagram and Twitter (X).

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the anticipated presentations of data from Mirum’s LIVMARLI and volixibat studies, including the VANTAGE study of volixibat in patients with pruritus due to PBC. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “will,” “could,” “can,” “would,” “potential,” “hope,” “opportunity,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Mirum’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Mirum’s business in general, the impact of macroeconomic and geopolitical developments, and the other risks described in Mirum’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission on February 26, 2025, and subsequent filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Mirum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250428020303/en/

Media Contact:

Erin Murphy

[email protected]

Investor Contact:

Andrew McKibben

[email protected]

KEYWORDS: Netherlands North America United States Finland Europe California

INDUSTRY KEYWORDS: Health Clinical Trials Research Pharmaceutical Science Biotechnology

MEDIA:

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Unmatched Long-Term Bladder Preservation for 36 Months in over 80 percent of Responders with ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC CIS and Papillary Disease Alone – Best in Disease and Best in Class with 5 Year Follow-Up

CIS with or without Papillary:

• Oral presentation from QUILT-3.032 study showed 71% complete response rate (N=100), with duration of response ranging up to more than 53 months, in BCG-unresponsive NMIBC CIS with or without papillary disease
• Probability of duration of complete response of at least 45 months in the FDA label population (N=77) is 51%, with median duration of complete response of 45.4 months
• Cystectomy avoidance rate in responders of 84% at 36 months
• Disease-specific overall survival rate of 99% at 36 months
• Longest follow-up of BCG-unresponsive CIS patients with unmatched more than 5 years data available (as of July 2024 data cutoff)

Papillary without CIS:

• Disease-free survival rate of 58% at 12 months (primary endpoint) and 52% at 24 months
• Cystectomy avoidance rate of 82% at 36 months—unmatched by any product in the field to date
• Disease-specific overall survival rate of 96% at 36 months
• Supplemental BLA submitted for FDA approval for this indication

CULVER CITY, Calif.–(BUSINESS WIRE)–
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced positive long-term results from its QUILT-3.032 study of ANKTIVA^® (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary disease. The findings were shared during an oral presentation at the American Urological Association Annual Meeting (AUA 2025) in Las Vegas, April 26-29.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250428844244/en/

AUA 2025 Presentation by Sam Chang, MD

At the 2025 AUA Annual Meeting, ImmunityBio presented updated clinical data highlighting the durability and impact of ANKTIVA in combination with BCG. The results demonstrated the longest duration of complete response and highest rate of cystectomy avoidance among therapies studied in BCG-unresponsive NMIBC, including both CIS with or without papillary disease and papillary-only disease without CIS.

The latest results from Cohort A (N=100) of the QUILT-3.032 study showed treatment with ANKTIVA plus BCG resulted in a complete response rate of 71% in patients with BCG-unresponsive NMIBC CIS with or without papillary tumors. Responses ranged up to more than 53 months, with 60% of responses having a duration of at least 12 months. Exceptional ongoing complete response data were presented for the FDA label population (N=77), which has a longer follow-up time of 29.3 months and showed a 51% probability of duration of complete response of at least 45 months. The rate of cystectomy avoidance in responders was 84.2% at 36 months, with disease-specific overall survival of 99% at 36 months.

In study Cohort B (N=80) of patients with BCG-unresponsive NMIBC papillary disease without CIS, ANKTIVA plus BCG demonstrated a 58.2% disease-free survival (DFS) rate at 12 months (primary endpoint), with a median DFS of 25.3 months. The cystectomy avoidance rate was 82% at 36 months, with a disease-specific overall survival rate of 96% at 36 months.

“While BCG is the commonly used first-line therapy for newly diagnosed high-risk non-muscle invasive bladder cancer, many patients will be refractory or relapse after an initial response and be diagnosed as BCG-unresponsive,” said QUILT-3.032 principal investigator and study presenter Sam S. Chang, M.D., Professor of Urology and Chief Surgical Officer of the Vanderbilt Ingram Cancer Center. “Our latest findings, including an 82% cystectomy avoidance rate, provide additional evidence that ANKTIVA has the ability to restore BCG activity and promote durable complete responses and, most importantly, help patients preserve their bladder for a prolonged duration from surgery in both CIS, as well as papillary without CIS disease.”

The latest findings from the QUILT-3.032 study also show that therapy with ANKTIVA plus BCG was well tolerated in both CIS and papillary NMIBC (N=180). Most treatment-related adverse events (TRAEs) were grade 1 or 2 and related to intravesical instillation consistent with BCG alone – dysuria, pollakiuria, hematuria and micturition urgency. TRAEs of grade 3 occurred at a rate of 3% (6 subjects out of 180). No grade 4 or 5 TRAEs were observed.

“We are pleased with these unmatched long-term follow up results which further illustrate ANKTIVA’s potential to improve outcomes and quality of life for patients with non-muscle invasive bladder cancer in both indications of CIS, as well as papillary disease without CIS,” said Dr. Patrick Soon-Shiong, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio. “The cystectomy avoidance rate of greater than 82% at 36 months in both BCG-unresponsive CIS with or without papillary disease and in BCG-unresponsive papillary without CIS disease is the highest percentage of bladder sparing and longest duration of complete response and disease-free status seen in this patient population to date, as confirmed by all the studies presented in the field at the AUA 2025 conference. We look forward to the national guidelines (NCCN) for BCG-unresponsive papillary disease without CIS to align with these long-term data of cystectomy avoidance and the data presented at AUA supporting Anktiva as the best in class and best in disease for this indication.”

Based on findings from the QUILT-3.032 study, ImmunityBio recently submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for use of ANKTIVA plus BCG in BCG-unresponsive NMIBC for the indication of papillary disease.

Papillary disease is estimated to be approximately 6-10 times more common than bladder cancer CIS, representing a large patient population that may benefit from ANKTIVA plus BCG.¹

About the QUILT-3.032 Study

QUILT-3.032 (NCT03022825) is a Phase II/III, open-label, single-arm, multicenter study of intravesical BCG plus ANKTIVA or ANKTIVA only in patients with BCG unresponsive high grade non-muscle invasive bladder cancer (NMIBC). All participants receive BCG plus ANKTIVA (Cohorts A and B) or ANKTIVA only (Cohort C) via a urinary catheter in the bladder for 6 consecutive weeks (initial induction treatment period). After the first disease assessment, eligible patients receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36. The study duration is 60 months.

Cohort A (N=100) includes patients with histologically-confirmed BCG-unresponsive NMIBC CIS with or without Ta/T1 papillary disease. The primary endpoint is biopsy-confirmed complete response (CR) rate at any time. Secondary endpoints include duration of CR, progression-free survival (PFS), time to cystectomy, safety and overall survival. Cohort B (N=80) enrolled participants with histologically-confirmed BCG-unresponsive high-grade Ta/T1 papillary NMIBC. The primary endpoint is disease-free rate at 12 months. Secondary endpoints include disease-free survival, PFS, time to cystectomy, safety and overall survival.

About ANKTIVA^®

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.

ANKTIVA is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.

ANKTIVA was approved by the FDA in 2024 with BCG for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer with CIS with or without papillary tumors. For more information, visit ImmunityBio.com (Founder’s Vision) and Anktiva.com.

About ImmunityBio

ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates natural killer cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit ImmunityBio.com (Founder’s Vision) and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.

References:

1. https://pmc.ncbi.nlm.nih.gov/articles/PMC10813486/

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding commercial launch activities and market access initiatives, the company’s submission of the sBLA for use of ANKTIVA plus BCG in BCG-unresponsive NMIBC for the indication of papillary disease and potential results therefrom as well as regulatory review process, decisions and timeline related thereto, NCCN guidelines, presentations at the AUA meeting, market data, clinical trial data and potential results to be drawn therefrom, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, potential future uses and applications of ANKTIVA and use in cancer vaccines and across multiple tumor types, and ImmunityBio’s approved product and investigational agents as compared to existing treatment options, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “is,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions.

Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding commercial launch execution, success and timing, (ii) risks and uncertainties regarding market access initiatives and timing, (iii) whether the FDA will accept the sBLA and other regulatory submissions for review and filing, (iv) uncertainties regarding the timeline of the FDA’s review of these submissions even if accepted for review and filing, (v) whether the FDA will ultimately approve the sBLA, or other submissions in a timely matter, or at all, of which there can be no assurance, (vi) risks and uncertainties regarding limited resources at the FDA and potential delays associated therewith, (vii) whether clinical trials will result in registrational pathways and the risks and uncertainties regarding the regulatory submission, filing, review and approval process, (viii) whether clinical trial data will be accepted by regulatory agencies, (ix) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (x) potential delays in product availability and regulatory approvals, (xi) ImmunityBio’s ability to retain and hire key personnel, (xii) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xiii) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xiv) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xv) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xvi) ImmunityBio’s ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 3, 2025, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at www.sec.gov. ImmunityBio cautions you not to place undue reliance on any forward looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law. 

View source version on businesswire.com: https://www.businesswire.com/news/home/20250428844244/en/

Investors

Hemanth Ramaprakash, PhD, MBA

ImmunityBio, Inc.

+1 858-746-9289

[email protected]

Media

Sarah Singleton

ImmunityBio, Inc.

+1 415-290-8045

[email protected]

KEYWORDS: United States North America California Nevada

INDUSTRY KEYWORDS: Research Infectious Diseases Genetics Clinical Trials Biotechnology General Health Pharmaceutical Health Science Oncology

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AUA 2025 Presentation by Sam Chang, MD

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Odyssey Marine Exploration Confirms Sufficient Operational Funding and Welcomes New Executive Order

TAMPA, Fla.–(BUSINESS WIRE)–
Odyssey Marine Exploration, Inc. (NASDAQ: OMEX), a U.S.-based leader in ocean exploration and sustainable mineral resource development, is pleased to see the issuance of a new Executive Order titled Unleashing America’s Offshore Critical Minerals and Resources. In addition, the company confirms that it currently has no specific plans to issue any securities under its universal shelf registration statement on Form S-3, which has been declared effective by the Securities and Exchange Commission (SEC) and provides Odyssey with the flexibility to access the capital markets in a timely manner. The specifics of any future offering, along with the prices and terms of any such securities offered by Odyssey, will be determined at the time of any such offering and will be described in detail in a prospectus supplement filed in connection with such offering. As previously announced, Odyssey currently anticipates that the proceeds from the Securities Purchase Agreement (SPA) executed by the company in December 2024, together with other prior funding arrangements, will continue to fund the company’s operations during 2025.

“This Executive Order is a milestone for U.S. resource strategy,” said Mark D. Gordon, CEO and Chairman of Odyssey Marine Exploration. “It validates what we have long known — that the seabed holds essential resources critical to our future and that it is not a question of if, but when, these resources must be responsibly explored and brought to market to meet growing global demand. The actions outlined in this Executive Order are a significant step forward, underscoring the growing global momentum toward securing critical minerals from the seafloor. With our expertise in deep-ocean exploration, Odyssey can capitalize on this opportunity and drive meaningful progress in advancing America’s offshore mineral strategy.”

The Executive Order prioritizes the rapid development of U.S. capabilities for the exploration, collection, and processing of seabed-derived critical minerals—essential to securing defense, clean energy, and advanced manufacturing inputs. With decades of proven leadership in ocean exploration and project development, Odyssey aligns with these national priorities through its active projects targeting battery metals (polymetallic nodules) and fertilizer-grade phosphates.

Odyssey’s Capabilities Aligned with the Executive Order:

• Proven Track Record in Deep-Sea Exploration: Over 30 years of experience in mineral identification, marine operations, environmental stewardship, and project advancement, including more than 24,000 hours of seabed mapping across 75,000+ km² at depths up to 6,000 meters. We apply these capabilities to advance our portfolio of critical mineral projects and provide specialized exploration and advisory services to governments and seabed license holders worldwide.
• Strong Government and Industry Partnerships: Collaborative relationships with sovereign governments, license holders, U.S. agencies, and academic institutions — aligning with the Executive Order’s call for allied cooperation and domestic capability building.
• Advanced Project Pipeline Across Strategic Jurisdictions: Active development of battery metal and phosphate projects targeting critical U.S. supply chain gaps in energy and food security.
• Proprietary Research: Odyssey’s 48-point global prospectivity program has analyzed over 100 countries’ exclusive economic zones resulting in identifying and ranking highly prospective subsea mineral targets around the world, including many in U.S. waters, which Odyssey will now prioritize. Our program is well aligned with the Executive Order’s seabed mapping and private-sector engagement directives.
• Expertise in Regulatory Navigation and Permitting: Deep experience managing complex international and U.S. regulatory frameworks, supporting the Executive Order’s goals for streamlined permitting under the Deep Seabed Hard Mineral Resources Act and OCS Lands Act.

On April 25, 2025, Odyssey took certain important steps to ensure the company’s flexibility to appropriately use its common stock to raise funds for business and financial purposes in the future and to comply with the Nasdaq Listing Rules.

• Universal Shelf Registration: Odyssey filed a prospectus as part of a registration statement with the Securities and Exchange Commission (SEC) using a “shelf” registration process. The prospectus, which provides that Odyssey may sell securities in one or more offerings up to a total dollar amount of $50 million, was a routine filing following the expiration of the company’s prior universal shelf registration.
• Reverse Stock Split: Odyssey’s annual report and proxy statement includes a proposal for a potential reverse stock split, which the company would implement only if necessary to regain compliance with the $1.00 minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2). This proposal is subject to approval by the company’s stockholders.
• Authorized Share Increase: The company’s annual report and proxy statement also includes a proposal to implement an increase in the number of shares of authorized common stock from 75 million shares to up to 150 million shares or such lesser number of shares of common stock as is determined necessary or desirable by the Board of Directors for the company’s business and financial purposes. This proposal is subject to approval by the company’s stockholders.

Odyssey’s current operational funding and the flexibility provided by the shelf registration ensure that Odyssey is well prepared for the opportunities that may result from the Executive Order. As one of the few U.S. public companies engaged in this industry, Odyssey is uniquely positioned to help lead the effort, leveraging our unmatched expertise in deep-ocean exploration, regulatory strategy, and strategic project development.

Odyssey will continue to work closely with U.S. and global agencies, policymakers, and allies to help shape a strong, secure, and responsible future for seabed mineral development while creating long-term value for stakeholders and partners.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of securities in any jurisdiction in which an offer, solicitation, or sale would be unlawful prior to registration and qualification under the securities law of such jurisdiction. Any offering of the securities covered by the shelf registration statement will be made solely by means of a prospectus and, if required, an accompanying prospectus supplement relating to that offering. A copy of the prospectus included in the shelf registration statement may be obtained on the SEC’s website at www.sec.gov or Odyssey’s investor relations website.

About Odyssey Marine Exploration

Odyssey Marine Exploration, Inc. (NASDAQ: OMEX) is a global leader in ocean exploration with over 30 years of experience. The company is committed to sustainable and responsible discovery, validation, and advancement of seafloor critical mineral projects, including polymetallic nodules for battery metals and subsea phosphate deposits for fertilizers. Offering comprehensive research, marine operations, and regulatory compliance support, Odyssey works with governments and seafloor rights holders worldwide. Odyssey develops its projects in collaboration with a global network of partners, academics, and industry professionals who share its commitment to environmentally sound solutions to obtain minerals that will address present and future global challenges. Learn more at www.odysseymarine.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250428818445/en/

Liz Shows

813-876-1776

[email protected]

KEYWORDS: United States North America Florida

INDUSTRY KEYWORDS: Natural Resources Maritime Transport Other Natural Resources Mining/Minerals

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Delcath Systems Announces FDA Clearance of IND Application for Phase 2 Clinical Trial of HEPZATO™ in Liver-Dominant Metastatic Breast Cancer

QUEENSBURY, N.Y.–(BUSINESS WIRE)–
Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the Company’s Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating HEPZATO™ in combination with standard of care (SOC) for liver-dominant metastatic breast cancer (mBC). With the FDA’s review complete, Delcath is now cleared to initiate patient enrollment in the U.S.

The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with SOC versus SOC alone in patients with liver-dominant HER2-negative mBC following the failure of previous treatments. The SOC options will be the physician’s choice of eribulin, vinorelbine or capecitabine. Approximately 90 patients will be enrolled in this randomized, controlled trial. The study will take place at more than 20 sites across the United States and Europe, with patient enrollment expected to begin in the fourth quarter of 2025. The trial’s primary endpoint, hepatic progression-free survival, is anticipated to be announced by the end of 2028, while results for overall survival, a secondary endpoint, are expected in 2029.

Company management estimates that approximately 7,000 patients annually in the United States are affected by HER2-negative metastatic breast cancer with liver metastases and are candidates for third line treatment. This population includes patients with a significant burden of liver metastases, which are likely to be the primary cause of mortality. By focusing on this demographic, Delcath intends to offer a novel therapeutic option to those patients with limited treatment alternatives.

“This randomized Phase 2 trial marks an important milestone as we expand the clinical investigation of HEPZATO into patients with liver-dominant metastatic breast cancer,” said Gerard Michel, Chief Executive Officer of Delcath Systems, Inc. “We are excited to bring new hope to patient populations in indications beyond metastatic uveal melanoma and to further demonstrate the potential of HEPZATO to address unmet needs in oncology. This study underscores our commitment to broadening the applications of HEPZATO and the underlying hepatic delivery system, positioning us as a platform technology that can offer directed treatment options for a variety of liver-dominant cancers.”

About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT

Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company’s proprietary products, HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure.

In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath’s proprietary Hepatic Delivery System (HDS). The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT.

In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver.

Forward-Looking Statements

This release contains forward-looking statements, including statements regarding the expected timeline for trial enrollment and data readouts, which are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, delays in regulatory review, site activation, patient enrollment, or unforeseen clinical trial results. For a detailed discussion of these and other risks, please refer to Delcath’s filings with the SEC.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250428793483/en/

Investor Relations: ICR Healthcare

[email protected]

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Science Biotechnology Research Pharmaceutical Oncology Health FDA Clinical Trials

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Bank of Marin Bancorp Reports First Quarter Financial Results

Improved Net Interest Margin, Loan Originations, and Deposit Flows

NOVATO, Calif.–(BUSINESS WIRE)–
Bank of Marin Bancorp, “Bancorp” (Nasdaq: BMRC), parent company of Bank of Marin, “Bank,” announced net income of $4.9 million for the first quarter of 2025, compared to net income of $6.0 million for the fourth quarter of 2024 and $2.9 million for the first quarter of the prior year. Diluted earnings per share was $0.30 for the first quarter, compared to $0.38 for the prior quarter and $0.18 for the first quarter of prior year, a 67% increase, year over year.

Concurrent with this release, Bancorp issued presentation slides providing supplemental information, some of which will be discussed during the first quarter 2025 earnings call. The earnings release and presentation slides are intended to be reviewed together and can be found online on Bank of Marin’s website at www.bankofmarin.com. under “Investor Relations.”

“Deposit growth was strong during the first quarter even as we made thoughtful reductions in deposit rates, which we believe is evidence of our acclaimed relationship banking model,” said Tim Myers, President and Chief Executive Officer. “Our commercial lending teams continue to gain traction and their originations were approximately five times higher than they were in the first quarter of 2024. These improved origination trends, which accelerated in March, have continued into April and we believe position us well for further margin expansion in the coming quarters.”

Bancorp also provided the following highlights for the first quarter of 2025:

• The first quarter tax-equivalent net interest margin improved 6 basis points over the preceding quarter to 2.86% from 2.80%, largely due to reductions in deposit rates. It improved 36 basis points over the first quarter of the prior year due to securities repositioning, the payoff of borrowings and the reduction of deposit costs.

• Return on average assets (“ROA”) was 0.53% for the first quarter of 2025, and return on average equity (“ROE”) was 4.52%, compared to 0.63% and 5.48% in the prior quarter, respectively. The efficiency ratio for the first quarter of 2025 increased to 76.44% from 65.53% last quarter, respectively due to the increase in non-interest expense, mainly in salaries and related benefits and charitable contributions, as discussed in greater detail below.

• The average cost of total deposits and of interest-bearing deposits decreased by 7 and 17 basis points, respectively, to 1.29% and 2.27%, in the first quarter of 2025, compared to the prior quarter. The decrease in cost of interest-bearing deposits due to strategic pricing adjustments contributed 7 basis points to the tax-equivalent net interest margin. limited rate-related outflows, and overall deposit growth demonstrating the Bank’s successful relationship banking model. Non-interest bearing deposits continued to make up a strong portion of total deposits at 43.2% as of March 31, 2025, compared to 43.5% last quarter.

• There was a $75 thousand provision for credit losses on loans in the first quarter of 2025 and no provision in the previous quarter. The allowance for credit losses was 1.44% of total loans at March 31, 2025 compared to 1.47% at December 31, 2024.

• Classified loans were 2.77% of total loans compared to 2.17% last quarter largely due to downgrades in one commercial relationship and one commercial real estate relationship during the quarter totaling $13.5 million.

• Non-accrual loans were 1.59% of total loans at quarter-end, down from 1.63% at December 31, 2024. The reduction in non-accrual balances included a $2.1 million non-owner occupied real estate loan sale that included a charge-off of $809 thousand.

• Total deposits of $3.302 billion as of March 31, 2025 were up $82.0 million compared to $3.220 billion as of December 31, 2024, mostly due to seasonal inflows and new deposit accounts added in the quarter.

• Capital was above well-capitalized regulatory thresholds with total risk-based capital ratios of 16.69% and 16.45% as of March 31, 2025 for Bancorp and the Bank, respectively, compared to 16.54% and 16.13% as of December 31, 2024. Bancorp’s tangible common equity to tangible assets (“TCE ratio”) was 9.82% as of March 31, 2025, and the Bank’s TCE ratio was 9.66%. The Bancorp’s TCE ratio net of after-tax unrealized losses on held-to-maturity securities as if the losses were realized¹ was 8.08% as of March 31, 2025.

• The Board of Directors declared a cash dividend of $0.25 per share on April 24, 2025, which represents the 80^th consecutive quarterly dividend paid by Bancorp. The dividend is payable on May 15, 2025, to shareholders of record at the close of business on May 8, 2025.

“The first quarter performance was negatively impacted by the proactive non-accrual note sale of a rapidly deteriorating acquired loan as well an increase in contributions expense from our annual grant program, the bulk of which has shifted from the second quarter into the first quarter,” said Dave Bonaccorso, Executive Vice President and Chief Financial Officer. “Salaries and related benefits expense increased from the prior quarter due to fourth quarter incentive compensation accrual adjustments and reductions and customary first quarter increases for items including payroll taxes and 401k matching. Excluding charitable contributions and salaries and related benefits, our first quarter non-interest expense declined almost 1% compared to the fourth quarter of 2024 and almost 3% compared to the first quarter of 2024. We expect that 2025 will be a year of prudent expense management with targeted investments in people and technology made to scale our growth.”

Loans and Credit Quality

Despite improved originations, loans decreased by $9.7 million for the first quarter of 2025 and totaled $2.074 billion as of March 31, 2025, compared to $2.083 billion as of December 31, 2024. Loan originations for the first quarter were $63.6 million ($47.4 million funded) including $50.2 million ($43.2 million funded) in commercial loans, which includes commercial and industrial, commercial real estate and construction. Funded commercial loans were more than five times those funded in the first quarter of prior year. The fourth quarter of 2024 included originations of $69.4 million ($47.1 million funded) and the first quarter of the prior year included total originations of $25.3 million ($12.4 million funded).

Loan payoffs were $25.5 million for the first quarter of 2025, compared to $36.7 million for the fourth quarter of 2024 and $21.8 million in the first quarter of the prior year. The decrease quarter over quarter was mostly within the commercial sector. Payoffs included $7.6 million in residential real estate loans. In addition, $31.8 million of loan amortization from scheduled repayments, including a net decrease of $9.5 million in credit line utilization, predominantly construction, contributed to the decline in loan balances for the quarter ended March 31, 2025.

Accruing loans past due 30 to 89 days totaled $6.0 million as of March 31, 2025, compared to $2.2 million as of December 31, 2024. Within the additions were two commercial loan maturities totaling $4.4 million that have since been approved to extend.

Non-accrual loans totaled $32.9 million, or 1.59% of the loan portfolio, at March 31, 2025, compared to $33.9 million, or 1.63% at December 31, 2024. The $1.0 million decrease resulted from the sale of one $2.1 million commercial real estate loan related to the $809 thousand charge-off discussed below, net paydowns of $370 thousand, one payoff of $100 thousand and two charged off loans totaling $16 thousand, partially offset by the addition of four loans totaling $1.7 million. Of the total non-accrual loans as of March 31, 2025, approximately 57% were paying as agreed, 90% were real estate secured, and all are being closely managed and monitored.

The Bank continues to uphold its conservative underwriting standards. In response to current market conditions, we continue to closely monitor our portfolio for signs of potential weakness to ensure proactive risk management and actively work towards a resolution on our classified loans. Classified loans increased by $12.3 million to $57.4 million as of March 31, 2025, from $45.1 million as of December 31, 2024. The increase was largely due to downgrades of one $7.1 million commercial relationship and two non-owner occupied real estate relationships totaling $7.2 million, partially offset by the sale of a $2.1 million non-owner occupied real estate loan.

Loans designated special mention, which are not considered adversely classified, decreased by $20.0 million to $88.9 million as of March 31, 2025, from $108.9 million as of December 31, 2024. The decrease was largely due to $14.2 million in downgrades to substandard risk rating and contractual paydowns and payoffs totaling $6.0 million.

There were $825 thousand in net charge-offs for the first quarter of 2025, including the $809 thousand charge-off of an acquired commercial non-owner occupied real estate loan the Bank had previously reserved $449 thousand for as of December 31, 2024. There was an additional decline in the financial condition of the borrower and guarantor and the value of the collateral during the first quarter that led to the Bank proactively selling the note in March rather than pursuing the additional costly steps of liquidating after foreclosure. It had been on non-accrual since late 2023. This compared to net charge-offs of $19 thousand for the fourth quarter of 2024.

There was a $75 thousand provision for credit losses on loans in the first quarter of 2025 and no provision in the fourth quarter of 2024. Modest deterioration in economic forecast, effects from the noted charge-offs, and the pooled and individual total loan balance declines this quarter contributed to the provision. The ratio of allowance for credit losses to total loans was 1.44% at March 31, 2025, compared to 1.47% at December 31, 2024. There was no provision for credit losses on unfunded loan commitments in the first quarter of 2025 or in the fourth quarter of 2024.

Cash, Cash Equivalents and Restricted Cash

Total cash, cash equivalents and restricted cash were $259.9 million at March 31, 2025, an increase of $122.6 million compared to $137.3 million at December 31, 2024 largely due to the $82.0 million growth in deposits and the paydowns of investment securities and loans.

Investments

The investment securities portfolio totaled $1.241 billion at March 31, 2025, a decrease of $26.1 million from December 31, 2024. The decrease was primarily the result of principal repayments and maturities totaling $63.0 million, offset by $33.6 million available-for-sale securities purchases and a $3.3 million improvement in unrealized losses on available for sale securities. Both the available-for-sale and held-to-maturity portfolios are eligible for pledging to FHLB or the Federal Reserve as collateral for borrowing. The portfolios are comprised of high credit quality investments with average effective durations of 3.27 on available-for-sale securities and 5.61 on held-to-maturity securities. Both portfolios generate cash flows monthly from interest, principal amortization and payoffs, which supports the Bank’s liquidity. Those cash flows totaled $72.8 million and $22.2 million in the first and fourth quarters of 2025 and 2024, respectively.

Deposits

Deposits increased $82.0 million to $3.302 billion at March 31, 2025, compared to $3.220 billion at December 31, 2024. Non-interest bearing deposits made up 43.2% of total deposits at March 31, 2025, compared to 43.5% at December 31, 2024. The Bank’s competitive and balanced approach to relationship management and focused outreach to customers seeking alternative options for banking solutions generated over 1,000 new accounts during the first quarter, 44% of which were new relationships (excluding new reciprocal accounts).

Borrowings and Liquidity

At March 31, 2025, the Bank had no outstanding borrowings, consistent with December 31, 2024. While available as a liquidity source, we have not utilized brokered deposits. Net available funding sources, including unrestricted cash, unencumbered available-for-sale securities and total available borrowing capacity totaled $1.917 billion, or 58% of total deposits and 203% of estimated uninsured and/or uncollateralized deposits as of March 31, 2025.

The following table details the components of our contingent liquidity sources as of March 31, 2025.

Capital Resources

The total risk-based capital ratio for Bancorp was 16.69% at March 31, 2025, compared to 16.54% at December 31, 2024. The increase was largely due to a $3.3 million improvement in unrealized losses on available for sale securities. The total risk-based capital ratio for the Bank was 16.45% at March 31, 2025, compared to 16.13% at December 31, 2024.

Bancorp’s tangible common equity to tangible assets (“TCE ratio”) was 9.82% at March 31, 2025, compared to 9.93% at December 31, 2024. The TCE ratio decreased slightly quarter over quarter due mainly to the increase in tangible total assets. The capital plan and point-in-time capital stress tests indicate that Bank of Marin and Bancorp capital ratios will remain above regulatory well-capitalized and internal policy minimums throughout a five-year forecast horizon and across stress scenarios such as additional unrealized losses on the investment portfolio, additional deposit growth or decline, loan credit quality deterioration, and potential share repurchases.

Earnings

Net Interest Income

Net interest income totaled $24.9 million for the first quarter of 2025, a $284 thousand decrease from the prior quarter related to the decrease of $36.3 million in average earning assets including a $8.0 million decrease in average loan balances over the quarter, reducing interest income by $1.2 million. This was significantly offset by the reduction of interest expense of $1.0 million despite average interest-bearing deposit growth of $7.2 million over the quarter. Average money market balances increased by 2.20% and average time deposits decreased by 11.31% while the average cost of those deposits decreased by 17 and 31 basis points, respectively, due to relationship-focused rate management, contributing to the reduced costs.

The tax-equivalent net interest margin was 2.86% for the first quarter of 2025, compared to 2.80% for the prior quarter. Lower cost of funds, as referenced above, contributed 7 basis points, while lower average interest-earning deposit balances with banks and the December fed funds rate cut of 25 basis points, reducing the earning power on those deposits, reduced the margin by 5 basis points. Minor changes in the loan and investment mix contributed to the margin by 2 basis points each, resulting in the 6 basis point margin expansion.

Non-Interest Income

Non-interest income was $2.9 million for the first quarter of 2025, compared to $2.8 million for the prior quarter. The increase from the prior quarter was primarily attributed to a $71 thousand death benefit received on bank owned life insurance.

Non-Interest Expense

Non-interest expense totaled $21.3 million for the first quarter of 2025, compared to $18.3 million for the prior quarter, an increase of $2.9 million. Salaries and related benefits increased $2.6 million, due to various factors, both in prior and current quarter. Last quarter, incentive, stock-based compensation and profit sharing accrual adjustments reduced expenses. In the first quarter of 2025, there was an increase to the 401(k) contribution matching associated with the usual reset, lower deferred loan origination costs, bonus accruals based on budget, stock-based compensation grants and increased salary costs due to new talent acquisition. In order to better serve the timing needs of our non-profit communities, the bulk of our charitable contributions were pulled forward into the first quarter from the second quarter. In the first quarter, we incurred $403 thousand of contributions expense which compares to $30 thousand in the fourth quarter of 2024 and $12 thousand in the first quarter of 2024.

Statement Regarding use of Non-GAAP Financial Measures

Financial results are presented in accordance with GAAP and with reference to certain non-GAAP financial measures. Management believes that, given industry turmoil that largely began in the first quarter of 2023, the presentation of Bancorp’s non-GAAP TCE ratio reflecting the after tax impact of unrealized losses on held-to-maturity securities provides useful supplemental information to investors because it reflects the level of capital remaining after a hypothetical liquidation of the entire securities portfolio. In addition, management believes that providing selected financial measures excluding the loss on sale of securities discussed above is useful to investors as the strategic short-term loss taken for long-term profitability makes the operational performance difficult to compare to other periods. Because there are limits to the usefulness of this or any other non-GAAP measure to investors, Bancorp encourages readers to consider its annual and quarterly consolidated financial statements and notes related thereto for their entirety, as filed with the Securities and Exchange Commission, and not to rely on any single financial measure. A reconciliation of the GAAP financial measures to comparable non-GAAP financial measures is presented below.

Reconciliation of GAAP and Non-GAAP Financial Measures

Share Repurchase Program

On July 21, 2023, the Board of Directors approved the adoption of Bancorp’s share repurchase program for up to $25.0 million and expiring on July 31, 2025. There were no repurchases in the first quarter of 2025 or in the fourth quarter of 2024.

Earnings Call and Webcast Information

Bank of Marin Bancorp (Nasdaq: BMRC) will present its first quarter financial results call via webcast on Monday, April 28, 2025 at 8:30 a.m. PT/11:30 a.m. ET. Investors can listen to the webcast online through Bank of Marin’s website at www.bankofmarin.com. under “Investor Relations.” To listen to the live call, please go to the website at least 15 minutes early to register, download and install any necessary audio software. For those who cannot listen to the live broadcast, a replay will be available at the same website location shortly after the call. Closed captioning will be available during the live webcast, as well as on the webcast replay.

About Bank of Marin Bancorp

Founded in 1990 and headquartered in Novato, Bank of Marin is the wholly owned subsidiary of Bank of Marin Bancorp (Nasdaq: BMRC). A leading business and community bank with assets of $3.8 billion, Bank of Marin provides commercial and personal banking, specialty lending, and wealth management and trust services throughout its network of 27 branches and eight commercial banking offices serving Northern California. Specializing in providing legendary service to its customers and investing in its local communities, Bank of Marin has consistently been ranked one of the “Top Corporate Philanthropists” by San Francisco Business Times since 2003, was inducted into NorthBay Biz’s “Best of” Hall of Fame in 2024, and ranked top 10 in Sacramento Business Journal’s Corporate Direct Giving List for philanthropic efforts in 2023. Bank of Marin Bancorp is included in the Russell 2000 Small-Cap Index and Nasdaq ABA Community Bank Index. For more information, visit www.bankofmarin.com.

Forward-Looking Statements

This release may contain certain forward-looking statements that are based on management’s current expectations regarding economic, legislative, and regulatory issues that may impact Bancorp’s earnings in future periods. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts. They often include the words “believe,” “expect,” “intend,” “estimate” or words of similar meaning, or future or conditional verbs such as “will,” “would,” “should,” “could” or “may.” Factors that could cause future results to vary materially from current management expectations include, but are not limited to, general economic conditions and the economic uncertainty in the United States and abroad, including economic or other disruptions to financial markets caused by the Trump administration’s approach to tariffs and trade, acts of terrorism, war or other conflicts, impacts from inflation, supply chain disruptions, changes in interest rates (including the actions taken by the Federal Reserve to control inflation), California’s unemployment rate, deposit flows, real estate values, and expected future cash flows on loans and securities; the impact of adverse developments at other banks, including bank failures, that impact general sentiment regarding the stability and liquidity of banks; costs or effects of acquisitions; competition; changes in accounting principles, policies or guidelines; changes in legislation or regulation; natural disasters (such as wildfires and earthquakes in our area); adverse weather conditions; interruptions of utility service in our markets for sustained periods; and other economic, competitive, governmental, regulatory and technological factors (including external fraud and cybersecurity threats) affecting our operations, pricing, products and services; and successful integration of acquisitions. These and other important factors are detailed in various securities law filings made periodically by Bancorp, copies of which are available from Bancorp without charge. Bancorp undertakes no obligation to release publicly the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.