ImmunityBio Announces FDA Submissions of Supplemental BLA for NMIBC Papillary Disease and for Expanded Access of ANKTIVA® to Treat Lymphopenia

On April 15, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported that it has completed multiple submissions to the FDA including an sBLA for BCG-unresponsive NMIBC in papillary disease and an EAP for ANKTIVA (nogapendekin alfa inbakicept-pmln) for the treatment of lymphopenia (Press release, ImmunityBio, APR 15, 2025, View Source [SID1234651934]).

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Supplemental Biologics License Application (sBLA):

In Q1, ImmunityBio completed the submission to the FDA of an sBLA for the use of ANKTIVA plus BCG in BCG-unresponsive NMIBC in the papillary indication. Subject to regulatory approvals, the addition of the papillary indication expands the patient population benefiting from this therapy beyond the currently approved indication of bladder carcinoma in situ (CIS) with or without papillary disease and allows more patients to avoid the high morbidity and mortality associated with radical cystectomy. The data submitted to the FDA included efficacy results demonstrating durable complete remissions in patients with BCG unresponsive NMIBC papillary disease. In 88% and 82% of subjects, the probability of avoiding surgical removal of the bladder was achieved for as long as 2 and 3 years respectively, following treatment with ANKTIVA plus BCG. The mortality and morbidity associated with a radical total cystectomy is high and this long-term bladder sparing therapy has the potential to provide a significant benefit and quality of life to patients suffering from BCG unresponsive papillary disease.

In a pivotal study published in NEJM Evidence, BCG plus ANKTIVA resulted in a disease-free survival (DFS) rate of 55% at 12 months, 51% at 18 months, and 48% at 24 months in participants with papillary NMIBC. In addition, patients receiving the novel treatment achieved a 93% avoidance of cystectomy (surgical removal of the bladder) with a median follow up of 20.7 months. This combination immunotherapy wherein ANKTIVA rescues BCG efficacy, currently approved in the BCG-unresponsive carcinoma in situ (CIS) indication, may provide an effective therapeutic option for papillary patients who did not respond to BCG alone and face the prospect of a radical cystectomy. 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.

Expanded Access Protocol for ANKTIVA in the Treatment of Lymphopenia:

The company also announced it has submitted to the FDA an EAP to make available ANKTIVA for the treatment of lymphopenia. Lymphopenia is the loss of natural killer cells and T cells, the very cells necessary to fight cancer. To date, no treatment exists to overcome lymphopenia which is induced by the cancer itself and by the standards of care including chemotherapy, radiation, steroids and checkpoint inhibitors. ImmunityBio received designation from the Agency for Regenerative Medicine Advanced Therapy (RMAT) for the indication of ANKTIVA to treat lymphopenia. The EAP, subject to authorization, would provide early access to patients and physicians desiring ANKTIVA in combination with standards of care.

Update of Product Revenue, Net Preliminary Results of Operations:

With the issuance of the permanent J-code (J9028) in January 2025, ImmunityBio has seen increased sales momentum supporting a trend of increases month-over-month as well as quarter-over-quarter, with March unit sales volume increasing 69% over February, and Q1 2025 unit sales exceeding unit sales achieved for all of FY 2024. ImmunityBio earned net product revenue of approximately $16.5 million during the three-month period ended March 31, 2025, which represented an increase of 129% over the $7.2 million of net revenue earned during the fourth quarter of 2024.

The amounts reported in this press release reflect the company’s preliminary estimates based solely upon information available to it as of the date of this press release, and the amounts reported are not a comprehensive statement of its financial results or position as of March 31, 2025. Any actual amounts that the company reports in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, will be subject to its financial closing procedures and any final adjustments that may be made prior to the time its financial results for the period ended March 31, 2025 are finalized. As a result, these preliminary estimates may differ materially from the actual results that will be reflected in the company’s consolidated financial statements for the quarter when they are completed and publicly disclosed.

Update on ImmunityBio Platforms

Fireside chats with Dr. Patrick Soon-Shiong and the following Key Opinion Leaders (KOLs) discussing the science and current status of ImmunityBio platforms are expected to take place during the Investor Day program:

Dr. Christopher Pieczonka – Chief Executive Officer, Associated Medical Professionals of New York & Corporate Director of Clinical Research of US Urology Partners
Dr. Steven Finkelstein – National Director of Radiation Oncology, US Urology Partners. Director of the Center of Advanced Radiation Excellence (CARE) and Director Radiation Oncology Research
Dr. Mark Lanasa – Senior Vice President, Chief Medical Officer, Solid Tumors, BeiGene
Dr. Jennifer Buell – President & Chief Executive Officer, MiNK Therapeutics
Dr. Krishnansu Tewari – Gynecologic Oncology, Obstetrics & Gynecology at UC Irvine Health
Dr. David Kerr – Professor of Cancer Medicine Genetics and Genomics, University of Oxford
Dr. Timothy Henrich – Professor, School of Medicine UC San Francisco
Dr. Carlos Cordon-Cardo – Chairman for the Mount Sinai Health System Dept. of Pathology
The live stream can be found at:

View Source;tp_key=40dc7065b5

Participant Listening (Listen Only)

1-844-539-3703 or 1-412-652-1273

Baylink To Highlight New Preclinical Data At The American Association For Cancer Research (AACR) Annual Meeting

On April 15, 2025 Baylink Biosciences reported that new preclinical data from its portfolio will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 25-30, 2025, in Chicago, IL (Press release, Baylink Biosciences, APR 15, 2025, https://www.baylinkbio.com/post/lorem-ipsum-dolor-sit-amet-consectetur-adipiscing-elit [SID1234652049]). These data provide insights into the potential of Baylink’s innovative Antibody Drug Conjugate platform in treatment of cancers with high unmet medical need. Scientists at Baylink have invented a platform technology that enables the delivery of a variety of payloads including hydrophobic chemotherapy and protein degrader drugs at a high drug to antibody ratio while preserving stability and pharmacokinetic characteristics to enable application in ADC format. The innovative linker panel combined with Baylink’s proprietary payloads create a deep well of products, including dual payload ADC designs, and Degrader Antibody Conjugates (DAC) with potential application in cancer treatment.

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Preclinical data from Baylink’s most advanced candidate (BLB-101) will be presented. BLB-101 is an antibody drug conjugate designed to target Claudin 6/9 and deliver the topoisomerase 1 inhibitor, exatecan in a highly efficient manner with a drug to antibody ratio of 8. Claudin 6 (CLDN6) is a tight junction protein that is highly expressed in various human cancers, including ovarian cancer, endometrial cancer, and non-small cell lung cancer (NSCLC), but is absent in normal adult tissues. Claudin 9 (CLDN9), which shares high homology with CLDN6, exhibits a similar expression pattern—being nearly undetectable in normal tissues but upregulated in ovarian and endometrial cancers.

Data generated to support the rationale for Baylink’s innovative linker platform will also be presented. Baylink’s linker platform is designed to reduce non-specific uptake into healthy tissues and cells while enhancing potency by improving ADC’s homogeneity, stability, PK, and efficacy. The platform also has the ability to deliver ADCs with multiple payload classes.

"We are very pleased to share these results from Baylink’s innovative antibody drug conjugate platform. The data presented at this year’s AACR (Free AACR Whitepaper) meeting demonstrate the potential for Baylink’s technology to overcome critical challenges in the ADC field," said Alice Chen, PhD, Chief Scientific Officer and Founder of Baylink. "In addition to sharing details on our platform technology, we are presenting data for one of our lead products, BLB-101, a novel antibody targeting CLDN6/9, conjugated to our linker BL001 delivering exatecan. We believe BLB-101 offers the potential for best in class performance for CLDN6/9+ tumors such as ovarian, endometrial, and lung cancer."

A linker platform for antibody drug conjugates (ADCs): expanding the therapeutic window

Poster number:7463

Session Date and Time: April 30, 2025, 9:00 AM – 12:00 PM

Preclinical evaluation of BLB-101, a topoisomerase-inhibitor-based anti-CLDN6/9 antibody-drug conjugate featuring a proprietary hydrophilic linker

Poster number:1578

Session Date and Time: April 28, 2025, 9:00 AM – 12:00 PM

Johnson & Johnson reports Q1 2025 results

On April 15, 2025 Johnson & Johnson (NYSE: JNJ) reported results for first-quarter 2025 (Press release, Johnson & Johnson, APR 15, 2025, View Source [SID1234651935]). "The power of Johnson & Johnson’s uniquely diversified portfolio was on full display this quarter, with strong operational sales growth reinforcing our confidence in 2025 guidance," said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. "During the quarter, we fortified our position as an innovation powerhouse with major advancements across our pipeline, including TREMFYA in IBD, RYBREVANT plus LAZCLUZE in non-small-cell lung cancer, and OTTAVA, our soft tissue surgical robotic system, and further enhanced our leading neuroscience portfolio with the completion of the Intra-Cellular Therapies acquisition."

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Overall financial results
Q1
($ in Millions, expect EPS)
2025
2024
% Change
Reported Sales

$21,893
$ 21,383
2.4%
Net Earnings
$10,999
$3,255
237.9%
EPS (diluted)
$4.54
$1.34
238.8%

Q1
Non-GAAP* ($ in Millions, except EPS)
2025
2024
% Change
Operational Sales1,2

4.2%
Adjusted Operational Sales1,3

3.3%
Adjusted Net Earnings1,4
$6,706
$6,580
1.9%
Adjusted EPS (diluted)1,4
$2.77
$2.71
2.2%
Free Cash Flow6,7
~$3,400
$2,850

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules

2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
4Excludes intangible amortization expense and special items
5Excludes COVID-19 Vaccine
6Non-GAAP measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings.
7First-quarter 2025 is estimated as of April 15, 2025
Note: values may have been rounded

Regional sales results
Q1

% Change

($ in Millions)
2025
2024
Reported
Operational1,2
Currency
Adjusted
Operational1,3
U.S.
$12,305
$11,620
5.9%
5.9

4.4
International
9,588
9,763
(1.8)
2.1
(3.9)
1.9
Worldwide
$21,893
$21,383
2.4%
4.2
(1.8)
3.3

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

Segment sales results
Q1

% Change

($ in Millions)
2025
2024
Reported
Operational1,2
Currency
Adjusted
Operational1,3
Innovative Medicine
$13,873
$13,562
2.3%
4.2
(1.9)
4.4
MedTech
8,020
7,821
2.5
4.1
(1.6)
1.3
Worldwide
$21,893
$21,383
2.4%
4.2
(1.8)
3.3

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

First-Quarter 2025 segment commentary:
Operational sales* reflected below excludes the impact of translational currency.
Innovative Medicine
Innovative Medicine worldwide operational sales grew 4.2%* driven primarily by DARZALEX, CARVYKTI, ERLEADA, and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and SIMPONI/SIMPONI ARIA in Immunology, SPRAVATO in Neuroscience, and XARELTO in Cardiovascular/Metabolism/Other. Growth was partially offset by an approximate (810) basis points impact from STELARA in Immunology.

MedTech
MedTech worldwide operational sales grew 4.1%*, with net acquisitions and divestitures positively impacting growth by 2.8%. Growth was driven primarily by Abiomed in Cardiovascular and wound closure products in General Surgery. Growth was partially offset by Spine, Sports & Other in Orthopaedics.

Full-year 2025 guidance:
Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.
($ in Billions, except EPS)
April 2025
January 2025
Adjusted Operational Sales1,2,5
Change vs. Prior Year / Mid-point
2.0% – 3.0% / 2.5%
2.0% – 3.0% / 2.5%
Operational Sales2,5 / Mid-point
Change vs. Prior Year / Mid-point
$91.6B – $92.4B / $92.0B
3.3% – 4.3% / 3.8%
$90.9B – $91.7B / $91.3B
2.5% – 3.5% / 3.0%
Estimated Reported Sales3,5/ Mid-point
Change vs. Prior Year / Mid-point
$91.0B – $91.8B / $91.4B
2.6% – 3.6% / 3.1%
$89.2B – $90.0B / $89.6B
0.5% – 1.5% / 1.0%
Adjusted Operational EPS (Diluted)2,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.50 – $10.70 / $10.60
5.2% – 7.2% / 6.2%
$10.75 – $10.95 / $10.85
7.7% – 9.7% / 8.7%
Adjusted EPS (Diluted)3,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.50 – $10.70 / $10.60
5.2% – 7.2% / 6.2%
$10.50 – $10.70 / $10.60
5.2% – 7.2% / 6.2%

1Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2Non-GAAP financial measure; excludes the impact of translational currency
3Calculated using Euro Average Rate: April 2025 = $1.10 and January 2025 = $1.04 (Illustrative purposes only)
4Non-GAAP financial measure; excludes intangible amortization expense and special items
5Excludes COVID-19 Vaccine
Note: percentages may have been rounded
Other modeling considerations will be provided on the webcast
Notable announcements in the quarter:
The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at News Releases, as well as Innovative Medicine News Center, MedTech News & Events, and www.factsabouttalc.com.

Regulatory
European Commission approves subcutaneous RYBREVANT (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer1
Press Release
European Commission approves Johnson & Johnson’s subcutaneous DARZALEX (daratumumab)-based quadruplet regimen for the treatment of patients with newly diagnosed multiple myeloma, regardless of transplant eligibility1
Press Release

U.S. FDA approves TREMFYA (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn’s disease
Press Release
Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough Therapy designation for the treatment of adults with moderate-to-severe Sjögren’s disease, has now received Fast Track designation
Press Release
Data Releases
Johnson & Johnson MedTech Announces Completion of First Cases with OTTAVA Robotic Surgical System1
Press Release
Icotrokinra results show 75% of adolescents with plaque psoriasis achieved completely clear skin and demonstrate favorable safety profile in a once daily pill1
Press Release
Johnson & Johnson highlights new data that showcase the strength of nipocalimab, demonstrating long-term sustained disease control in adults living with generalized myasthenia gravis (gMG)1
Press Release
TREMFYA (guselkumab) is the first and only IL-23 inhibitor to significantly reduce both the signs and symptoms and the progression of structural damage in adults living with active psoriatic arthritis1
Press Release
Johnson & Johnson MedTech to Highlight Latest Advancements in Heart Disease Treatment with Impella at ACC.25
Press Release
RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) outperforms osimertinib with a significant and unprecedented overall survival benefit in patients with EGFR-mutated non-small cell lung cancer
Press Release
New nipocalimab data and real-world research at AAN 2025 highlight positive Phase 3 results and commitment to people living with generalized myasthenia gravis (gMG)
Press Release
RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) significantly outperforms standard of care in first-line EGFR-mutated lung cancer with compelling new data at ELCC 2025
Press Release
Johnson & Johnson MedTech Showcases New Era of Digital Orthopaedics at AAOS 2025
Press Release
Icotrokinra meets primary endpoint of clinical response in ulcerative colitis study and shows potential to transform the treatment paradigm for patients
Press Release
Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis
Press Release
TREMFYA (guselkumab) subcutaneous (SC) induction data support potential to be the first and only in its class to offer the option of both intravenous and SC induction therapy in ulcerative colitis
Press Release
New nipocalimab data published in mAbs journal details differentiated molecular design, clinical profile and potential of nipocalimab to treat IgG-driven alloantibody and autoantibody diseases
Press Release
Findings from pivotal nipocalimab Phase 3 study in a broad antibody positive population of people living with generalized myasthenia gravis (gMG) published in The Lancet Neurology
Press Release

Product Launch
Shockwave Medical Launches Novel Forward Intravascular Lithotripsy Platform in U.S. to Transform Treatment of Difficult-to-Cross Calcified Lesions

Other
Johnson & Johnson Closes Landmark Intra-Cellular Therapies, Inc. Acquisition to Solidify Neuroscience Leadership1
Press Release
Johnson & Johnson to Return to Tort System to Defeat Meritless Talc Claims1
Press Release
Johnson & Johnson Increases U.S. Investment to More than $55 Billion Over the Next Four Years
Press Release
Johnson & Johnson Announces Darren Snellgrove as Vice President, Investor Relations
Press Release

1Subsequent to the quarter

Webcast information:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company’s website at events-and-presentations.

Lyell Immunopharma Receives Regenerative Medicine Advanced Therapy (RMAT) Designation for LYL314 for the Treatment of Relapsed and/or Refractory Large B-Cell Lymphoma

On April 15, 2025 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, reported that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to LYL314 (formerly IMPT-314) for the treatment of adult patients with relapsed and/or refractory large B-cell lymphoma after two or more prior lines of therapy (Press release, Lyell Immunopharma, APR 15, 2025, View Source [SID1234651936]). LYL314 is a next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to the approved CD19‑targeted CAR T-cell therapies for the treatment of aggressive large B-cell lymphoma (LBCL).

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RMAT designation provides all the benefits of the Fast Track and Breakthrough Therapy designation programs, including early interactions with the FDA. LYL314’s RMAT designation was granted based on promising early data from the ongoing Phase 1/2 clinical trial.

"The RMAT designation for LYL314, is based on promising clinical data from our ongoing Phase 1/2 trial and highlights the transformative potential of this next-generation CAR T-cell therapy to address the unmet needs of patients with aggressive large B-cell lymphoma," said Lynn Seely, M.D., president and chief executive officer of Lyell. "We believe that by targeting both CD19 and CD20 with equal potency and manufacturing with a process that enriches for more naïve and central memory CAR T cells, LYL314 has the potential to offer patients with aggressive B-cell lymphoma more complete responses and longer duration of response than first-generation CAR T-cell therapies that only target CD19. LYL314 has now received both Fast Track Designation and RMAT designation in the 3rd or later line setting and we look forward to working closely with the FDA as we continue to accelerate this promising CAR T-cell therapy into two pivotal programs for patients."

Initial data from the Phase 1/2 trial of LYL314 were presented at the American Society for Hematology 2024 Annual Meeting in December 2024, including data from 23 patients with relapsed or refractory LBCL in the 3rd or later line setting who received LYL314. The efficacy evaluable population consisted of 17 patients. The overall response rate was 94% (16/17) of patients, with 71% (12/17) of patients achieving a complete response by three months. The median follow up was 6.3 months (range 1.2 – 12.5 months) and 71% of patients were experiencing a response at last follow-up. In the safety evaluable population of 23 patients, no Grade 3 or greater cytokine release syndrome (CRS) was reported. Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in 13% (3/23) of patients with a median time to ICANS resolution of 5 days, and rapid improvement to Grade 2 or lower with standard therapy.

Additional clinical updates from the Phase 1/2 trial of LYL314 are planned for 2025. The company expects to present more mature data from the ongoing Phase 1/2 trial from patients being treated in the 3rd or later line setting and initial data from patients in the 2nd line setting in mid-2025 and to present more mature data from patients treated in the 2nd line setting in late 2025. Two pivotal programs for LBCL are planned, including one for patients treated in the 3rd or later line setting expected to be initiated in mid-2025 and another for patients treated in the 2nd line setting expected to be initiated by early 2026.

The RMAT designation is a program under the 21st Century Cures Act that is intended to expedite the development and review of regenerative medicine therapies for serious or life-threatening diseases or conditions. A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the regenerative medicine therapy has the potential to address unmet medical needs for such disease or condition.

RMAT designation provides all Breakthrough Therapy designation features, including early interactions to discuss any potential surrogate or intermediate endpoints. RMATs may be eligible for accelerated approval based on previously agreed-upon surrogate or intermediate endpoints that are reasonably likely to predict long-term clinical benefit.

About LYL314

LYL314 is a next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to the approved CD19‑targeted CAR therapies for the treatment of LBCL. LYL314 is designed as a true CD19/CD20 "OR" logic-gated CAR targeting either CD19 or CD20 with full potency, and the cell therapy product is manufactured with a process that enriches for CD62L+ cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity.

In addition to RMAT, LYL314 has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of relapsed and/or refractory LBCL in the 3rd or later line setting.

Mural Oncology Announces Plans to Explore Strategic Alternatives

On April 15, 2025 Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company, reported that following review of data from its phase 2 ARTISTRY-6 trial in melanoma and previously announced results from the phase 3 ARTISTRY-7 trial in platinum-resistant ovarian cancer, the company is discontinuing all clinical development of nemvaleukin alfa and plans to immediately commence the exploration of strategic alternatives focused on maximizing shareholder value (Press release, Mural Oncology, APR 15, 2025, View Source [SID1234651944]). Mural has engaged Lucid Capital Markets, LLC to act as its financial advisor in connection with the exploration of strategic alternatives. The company had approximately $144.4 million of cash, cash equivalents, and marketable securities as of December 31, 2024. In conjunction with today’s announcement, Mural plans to reduce its workforce by approximately 90%.

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ARTISTRY-6, cohort 2 is a phase 2, single-arm trial evaluating nemvaleukin as a monotherapy in 92 patients with mucosal melanoma with a minimum follow-up of at least six months. A review of the topline data from this cohort showed that the primary endpoint was not achieved. Mural also conducted a review of preliminary data from ARTISTRY-6, cohort 3, evaluating less-frequent intravenous dosing of nemvaleukin in patients with cutaneous melanoma, and did not observe a level of activity that warranted continuation. Based on the totality of these data, together with the interim overall survival results from ARTISTRY-7 as announced on March 25, 2025, Mural will discontinue all clinical development of nemvaleukin.

Mural plans to explore potential strategic alternatives including, but not limited to, an offer for or other acquisition of the company, merger, business combination, or other transaction. While the company has not set a timetable for completion of this process, further updates and developments will be disclosed as appropriate or where necessary under regulatory requirements. There can be no assurance that the exploration of strategic alternatives will result in the company pursuing a transaction or that any acquisition or other transaction involving the company will be completed, nor as to the terms on which any acquisition or other transaction will occur, if at all.

The company confirms that, as at the date of this announcement, it is not in receipt of any approaches and not in active discussions with any potential offeror.

Irish Takeover Rules Considerations

Mural is subject to the Irish Takeover Panel Act, 1997, Irish Takeover Rules 2022 (the "Irish Takeover Rules"), which have certain implications on some of the strategic alternatives to be explored by the company. As the exploration of strategic alternatives is expected to include consideration of potential offers for the company, following the publication of this announcement Mural is now considered to be in an "offer period" as defined in the Irish Takeover Rules and the dealing disclosure requirements of Rule 8 of the Irish Takeover Rules as summarized below will apply.

The Irish Takeover Panel has granted a dispensation from the requirements of Rules 2.4(b) and 2.4(c) of the Irish Takeover Rules such that any potential offeror will not be required to be publicly identified as a result of this announcement for so long as the strategic evaluation is ongoing. Such parties should nonetheless be mindful of their obligations under the Irish Takeover Rules, including in particular with respect to confidentiality under Rule 2.1 and the circumstances in which an announcement may be required under Rule 2.2. If a potential offeror has any doubts about its obligations pursuant to the Irish Takeover Rules, it should contact its financial adviser(s) and, where applicable, it should also consult with the Irish Takeover Panel.

This is an announcement under Rule 2.4 of the Irish Takeover Rules and is not an announcement of a firm intention by any party to make an offer under Rule 2.7 of the Irish Takeover Rules.