I-Mab Announces Intention to Undertake Strategic Transformation to Global Biotech Platform, to Pursue Hong Kong IPO, and Rebrand as NovaBridge Biosciences

On October 16, 2025 I-Mab (NASDAQ: IMAB) (I-Mab or the Company), is a global biotechnology platform company committed to accelerating access to innovative medicines for patients worldwide, reported its new business model, focused on its global capabilities built to accelerate access to innovative medicines and to enable broad strategic growth. The Company announced its intention to pursue a Hong Kong IPO through dual listing on NASDAQ and Hong Kong Stock Exchange (HKEX). The Company intends to operate under the new name of NovaBridge Biosciences.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company also announced the pending acquisition of VIS-101, a novel bifunctional biologic targeting VEGF-A and ANG2, and a more potent molecule that could potentially provide more durable treatment benefits for patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) than current standard of care. The pending acquisition will be made by a newly formed subsidiary, Visara, Inc. (Visara), a clinical-stage biopharmaceutical company focused on developing ophthalmic therapeutics for serious eye disorders, and is expected to be completed later this month.

In addition, the Company reaffirmed its previously announced givastomig investment plans as part of its new strategy.

Mr. Kyler Lei has been named Chief Financial Officer (CFO) of I-Mab, bringing significant expertise in the Hong Kong and global capital markets.

The Company sees a significant growth potential from the Asia Pacific originated biopharma innovations. Confidence in this opportunity comes from emerging trends showing that the Asia Pacific region has generated more than 30% of global biopharma assets under development, and has achieved more than $80B in deal value through collaborations with leading multi-national pharmaceutical organizations. In addition, the Asia Pacific biopharmaceutical ecosystem has become increasingly agile and efficient, with significantly lower clinical trial costs and faster patient enrollment than the global median, while maintaining high quality standards1.

"We believe we are entering a new era of rapid growth in the global biotech economy, driven by greater innovation capability in China and Asia and a resurgence of investment in high growth international markets across Asia. With our new business model, we are uniquely positioned to strategically create significant value for patients and investors," said Mr. Fu Wei, Executive Chairman of I-Mab. "Through the strategic insight of our expanded Board, backing by CBC Group,

Asia’s largest dedicated healthcare asset management firm, and our dual listing strategy, I-Mab is ideally placed to partner with leading global innovators to identify and accelerate high-value assets. The proposed dual listing on both NASDAQ and HKEX is a key element of our global growth strategy. This move will enable us to broaden and diversify our investor base, and enhance trading liquidity and access to capital, while strengthening our presence with key stakeholders in the rapidly growing Asian market."

"2025 has been a time of significant progress for I-Mab. Presentation of compelling Phase 1b givastomig combination data reinforced our confidence in its potential to be a best-in-class Claudin 18.2-directed therapy for gastric cancer and drove our plans to initiate a global randomized Phase 2 study, expected to begin in Q1 2026. In addition, the Company recently secured additional capital, and has attracted seasoned biotech executives to the Board of Directors and Scientific Advisory Board," said Sean Fu, PhD, Chief Executive Officer (CEO) of I-Mab. "With the strong foundation from our work on givastomig, and excellent progress this year, we are optimistic about moving forward with our new strategy. Our new global platform allows us to uphold our commitment to value creation by realizing the full potential of innovative medicines and improving the lives of patients."

The NovaBridge Business Model and Pipeline

The Company intends to partner with leading innovators to identify and accelerate high-value assets. Our model integrates rigorous asset selection, bespoke translational strategies, and efficient clinical execution. With the backing of CBC Group, we leverage deep local insights and global capabilities to develop the most promising drug candidates across a range of therapeutic categories.

The Company will utilize a "hub-and-spoke" model to create and advance specialized subsidiary companies (spokes) which maintain operational focus and agility. By focusing each spoke on a specific asset or therapeutic area, the Company can optimally manage risk and create value through potential partnering transactions.

Pipeline:


Givastomig, a potential best-in-class Claudin 18.2 X 4-1BB bispecific antibody, is in Phase 1b clinical trials for the potential treatment of gastric cancer and other Claudin 18.2-positive gastrointestinal malignancies. A global, randomized Phase 2 study is planned, with the enrollment of the first patient targeted in Q1 2026. Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

Ragistomig is an anti-PD-L1 X 4-1BB bispecific antibody. Built on Phase 1 clinical data, an ongoing Phase 1b study designed to expand the therapeutic index is expected to yield results in 2H 2026. The program is being jointly developed with ABL Bio.

Uliledlimab targets CD73, the rate-limiting enzyme critical for adenosine-driven immunosuppression in the tumor microenvironment. Progression free survival (PFS) data are expected in 2H 2026 from an ongoing randomized Phase 2 trial evaluating uliledlimab + toripalimab compared to pembrolizumab alone or toripalimab alone. I-Mab owns worldwide rights to uliledlimab outside of Greater China.
VIS-101, to be acquired by Visara, a newly formed I-Mab subsidiary, under the new business model, is a bifunctional biologic targeting VEGF-A and ANG2, currently in Phase 2 development


VIS-101 is a novel bifunctional biologic targeting VEGF-A and ANG-2, and a more potent molecule that could potentially provide more durable treatment benefits for patients with wet AMD, DME, and retinal vein occlusion (RVO) than current standard of care. VIS-101 has completed initial safety and dose-escalation studies in both the US and China, and is currently completing a randomized, dose-ranging Phase 2 study in China. VIS-101 is anticipated to be Phase 3-ready in 2026.

Acquisition will be completed by a newly formed subsidiary, Visara. Visara, a clinical-stage biopharmaceutical company focusing on the development of best-in-class ophthalmic therapeutics, will be launched with an approximately $37M capital infusion from I-Mab and the contribution of certain rights by AffaMed Therapeutics (HK) Limited. The capital contributions to Visara and its acquisition of VS-101 (collectively, the Transactions) are cross-conditioned, and are expected to close later this month. The Company has also signed a separate termsheet with Everest Medicines (HKEX 1952.HK) to potentially out-license greater China rights for VIS-101 and collaborate on global clinical development. Following completion of the Transactions, I-Mab will be the majority shareholder of Visara, and Visara will control global rights to VS-101.

Visara is led by Co-Founder and Executive Chairman Emmett T. Cunningham, Jr., MD, PhD, MPH. Dr. Cunningham has been a physician, innovator, entrepreneur, and investor for more than 25 years, formerly serving as Senior Managing Director at Blackstone Group L.P. and Managing Director at Clarus Ventures, LLC. Dr. Cunningham is also an internationally recognized specialist in infectious and inflammatory eye disease with over 450 co-authored publications.
"VIS-101 is anticipated to be second-in-class with best-in-class potential, based on bioengineered, superior target neutralizing capabilities," said Dr. Cunningham, Co-Founder and Executive Chairman of Visara. "Leveraging the speed, quality, and unique advantages of dedicated teams in North America and Asia, Visara will seek accelerated global clinical development and regulatory approvals."

Organizational Overview

The Company will build on the strength of the I-Mab Board, led by Mr. Fu Wei, Executive Chairman, including the expanded Scientific Advisory Board and new Research and Development Committee. The Executive Leadership Team will include Sean Fu, PhD, Chief Executive Officer; Phillip Dennis, MD, PhD, Chief Medical Officer; Kyler Lei, Chief Financial Officer; and Claire Xu, MD, PhD, Senior Vice President, Clinical Development.

Kyler Lei has been appointed as the Chief Financial Officer of I-Mab, effective October 16, 2025. Kyler is a global capital markets and investor relations professional with extensive experience in healthcare, equity research, corporate communications, corporate finance and strategy. Kyler will be primarily responsible for overseeing overall financial strategy and management, corporate finance and capital markets, corporate development and operations. Prior to joining I-Mab, Kyler served as Deputy General Manager and Head of Capital Markets at Sino Biopharmaceutical Limited (HKEX: 1177.HK).

"I am enthusiastic about starting on this new chapter with Kyler, and leveraging his expertise in global capital markets and financial strategy to make our new business model a resounding success," said Dr. Fu, CEO.

Dr. Fu added, "I would like to extend our gratitude to Joseph Skelton for his tremendous contributions in shaping I-Mab’s success. We wish him all the best in his future endeavors."

Business Update Webinar

The Company will review its new business model, strategic focus and upcoming milestones by webcast on Thursday, October 16, 2025, and Friday, October 17, 2025

Webcast and Conference Call Details:

In English:


Date: Thursday, October 16, 2025

Time: 5:00 PM ET

Dial-in number (US): 1-877-407-0784

Dial-in number (International): 1-201-689-8560

Webcast info: please click here
In Chinese:


Date: Friday, October 17, 2025

Time: 5:00 PM HKT/5:00 AM ET


Webcast info: please click here, and note Kyler Lei as the CLSA contact
A replay of the webinar will be accessible on the Events page of the Company website for 90 days.

(Press release, I-Mab Biopharma, OCT 16, 2025, View Source [SID1234656702])

EORTC’s presence at EANO 2025

On October 16, 2025 EORTC reported it will be prominently featured at the EANO 2025 conference, held in Prague from 16 to 19 October. Our team will present seven scientific abstracts, including two oral presentations and five posters, highlighting ongoing research in neuro-oncology.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In addition, EORTC projects will be featured in a joint session with the Brain Tumour Group (BTG), where six participants will present on clinical trial planning and current case studies, highlighting the collaborative efforts within EORTC to advance cancer research.

Further details can be found in the table below.

EORTC ABSTRACTS
AGE AND SEX AS RISK FACTORS FOR HEALTH-RELATED QUALITY OF LIFE OUTCOMES IN GLIOMA PATIENTS: POOLED ANALYSES OF CLINICAL TRIALS FROM THE CODAGLIO 2.0 DATABASE
Ogechukwu Edeh-Asogwa, Netherlands Friday, 17 October 10:35 – 10:45
Type: Oral session
Room: Forum Hall
FINAL CLINICAL AND MOLECULAR ANALYSIS OF THE EORTC RANDOMIZED PHASE III INTERGROUP CATNON TRIAL ON CONCURRENT AND ADJUVANT TEMOZOLOMIDE IN ANAPLASTIC GLIOMA WITHOUT 1P/19Q CODELETION
Martin Van Den Bent, Netherlands Saturday, 18 October 11:25 – 11:35
Type: Oral session
Room: Forum Hall
EANO, EORTC, EPTN and ESNR consensus-based definition for post-radiotherapy MRI abnormalities in the brain: preliminary findings from an interdisciplinary Delphi study
Maarten Lambrecht, Belgium Friday, 17 October 17:00 – 18:30
Type: Poster session
Room: Forum Hall Foyer 3
VORASIDENIB AS MAINTENANCE TREATMENT AFTER FIRST-LINE CHEMORADIOTHERAPY IN IDH-MUTANT GRADE 2 OR 3 ASTROCYTOMA: STUDY PROTOCOL FOR THE PLACEBO-CONTROLLED, TRIPLE-BLIND, RANDOMIZED PHASE III STUDY EORTC-2427 (VIGOR)
Marjolein Geurts, Netherlands Friday, 17 October 18:00 – 19:30
Type: Poster session
Room: Forum Hall Foyer 3
MGMT METHYLATION DURING THE PROGRESSION OF GLIOBLASTOMA
Bo Deng, Netherlands Saturday, 18 October 17:00 – 18:30
Type: Poster session
Room: Forum Hall Foyer 3
THE USE OF EORTC QLQ-C30 SUMMARY SCORE IN CANCER CLINICAL TRIALS AND ITS PERFORMANCE AS COMPARED WITH THE GLOBAL HEALTH / QUALITY OF LIFE SCALE: A COMPARATIVE ANALYSIS OF EFFECT SIZES
Josien Scheepens, Netherlands Saturday, 18 October 17:00-18:30
Type: Poster session
Room: Forum Hall Foyer 3
ASSOCIATION BETWEEN TEMOZOLOMIDE-RELATED HEMATOLOGICAL TOXICITY AND HRQOL SCORES IN GLIOBLASTOMA: A POOLED ANALYSIS OF THREE RANDOMIZED TRIALS
Clemens Seidel, Deutschland Sunday, 19 October 2025 12:00-12:45
Type: Poster session
Room: Forum Hall Foyer 3
SESSIONS
WHAT CAN A SUPPORTING AGENCY SUCH AS EORTC DO FOR YOU?
Michael Weller, Switzerland JOINT SESSION
Saturday, 18 October 08:00 – 08:14
South Hall 2
CLINICAL TRIAL MANAGEMENT: STEERING COMMITTEE, THE MEDICAL MONITOR AND THE DATA MONITORING COMMITTEE
Patrick Roth, Switzerland JOINT SESSION
Saturday, 18 October 08:14 – 08:28
South Hall 2
EORTC-2227 (LEGATO): LOMUSTINE WITH AND WITHOUT REIRRADIATION FOR FIRST PROGRESSION OF GLIOBLASTOMA: A RANDOMIZED PHASE III STUDY
Tomas Kazda, Czech Republic JOINT SESSION
Saturday, 18 October 08:28 – 08:36
South Hall 2
EORTC-2334 (LUMEN-1): 177LU-DOTATATE FOR RECURRENT MENINGIOMA: A RANDOMIZED PHASE II STUDY
Emeline Tabouret, France JOINT SESSION
Saturday, 18 October 08:36 – 08:44
South Hall 2
EORTC 2427 (VIGOR): VORASIDENIB AS MAINTENANCE TREATMENT AFTER FIRST-LINE CHEMORADIOTHERAPY IN IDH-MUTANT GRADE 2 OR 3 ASTROCYTOMA: A PLACEBO-CONTROLLED RANDOMIZED PHASE III STUDY
Marta Padovan, Italy JOINT SESSION
Saturday, 18 October 08:44 – 08:52
South Hall 2
EORTC-2013 (GLIO-RARE): OBSERVATIONAL STUDY FOR ASSESSING TREATMENT AND OUTCOME OF PATIENTS WITH PRIMARY BRAIN TUMOURS DIAGNOSED ACCORDING TO CIMPACT-NOW RECOMMENDATIONS AND THE 2021 WHO CLASSIFICATION
Maximilian Mair, Austria JOINT SESSION
Saturday, 18 October 08:52 – 09:00
South Hall 2

(Press release, EORTC, OCT 16, 2025, View Source [SID1234656701])

Enterome receives FDA Fast Track designation in follicular lymphoma for lead OncoMimics™ immunotherapy EO2463

On October 16, 2025 Enterome, a clinical-stage company developing first-in-class OncoMimics immunotherapies to treat cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for follicular lymphoma in the low tumor burden "watch-and-wait" setting for its lead OncoMimics immunotherapy, EO2463. The decision highlights EO2463’s efficacy, excellent safety and tolerability as a first-in-class monotherapy in clinical testing to date in patients who currently do not normally receive any treatment as long as they do not show clinical symptoms, despite having been diagnosed with a cancer that progresses in the vast majority of cases.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The FDA’s decision is an important validation of the unique potential of Enterome’s OncoMimics program," said Pierre Belichard, CEO of Enterome. "It will expedite the clinical development and the regulatory pathways for EO2463, which is ready to enter registrational testing as early as next year after this Fast Track designation and a recent positive type-C meeting with the FDA."

The Fast Track designation provides increased opportunities for interaction with the FDA, rolling review and potential eligibility for priority review. EO2463 is ready for Phase 3 testing in watch-and-wait patients after showing marked efficacy as a monotherapy in interim data from the watch-and-wait population in the ongoing Phase 2 SIDNEY trial. The treatment was well tolerated, suggesting Enterome’s EO2463 immunotherapy may offer a safe and effective treatment option for patients in this setting, who have been diagnosed with a type of cancer they know is likely to progress, but show no troublesome symptoms and do not usually receive treatment.

Follicular Lymphoma (FL), one of several types of indolent Non-Hodgkin Lymphoma, is an incurable chronic condition with frequent relapses, characterized by slow progression and few symptoms, yet reduced life expectancy. It is usually diagnosed by the appearance of swollen lymph nodes, and the early stages of the disease can be characterized by a lack of troublesome symptoms such as night sweats, fever or weight loss. There is a widespread consensus among leading investigators of the need for a well-tolerated and effective monotherapy to stop or slow progression for watch-and-wait patients.

EO2463 is an innovative, off-the-shelf OncoMimics active immunotherapy that combines four synthetic peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the B lymphocyte-specific lineage markers CD20, CD22, CD37, and CD268 (BAFF receptor). It also includes the helper peptide (CD4+ epitope) universal cancer peptide 2 (UCP2). The unique ability of EO2463 to selectively target multiple B cell markers enables the destruction of malignant B lymphocytes. By ensuring broad target coverage across malignant B cells, this novel approach aims to simultaneously improve safety and maximize efficacy, reducing the tumor cells’ capacity to develop immune-resistance mechanisms such as antigen escape.

OncoMimics are bacteria-derived peptide antigens that closely mimic tumor-associated antigens or lineage markers. These synthetically produced peptides are designed in silico using AI and machine learning to mine Enterome’s extensive proprietary database of 23 million commensal bacteria genes. Because these peptides are "non-self," they tap into pre-existing pools of effector-memory CD8 T cells primed by gut bacteria, enabling rapid, strong, and durable anti-tumor responses while avoiding the self-tolerance that limits many cancer immunotherapies. Each product combines multiple high-affinity peptides to broaden target coverage and mitigate tumor heterogeneity.

OncoMimics are easy to manufacture, store, distribute and administer as an "off-the-shelf" subcutaneous injection. In clinical testing to date they have been shown to be extremely well tolerated, especially compared to other potent immunotherapies.

(Press release, Enterome, OCT 16, 2025, View Source [SID1234656700])

Cycle Pharmaceuticals launches its first oncology product, PHYRAGO™ (dasatinib) tablets, in the US

On October 16, 2025 Cycle Pharmaceuticals reported the launch of PHYRAGO, its first oncology product in the US. PHYRAGO is launched in partnership with Handa Therapeutics, LLC, and will be exclusively available through specialty pharmacy Onco360 with a specialty distribution network from McKesson, Cencora, and Cardinal Health.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

PHYRAGO is a tyrosine kinase inhibitor indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), and pediatric patients 1 year of age and older with Ph+ CML in chronic phase, and newly diagnosed Ph+ ALL.1

PHYRAGO is bioequivalent to Sprycel (dasatinib) tablets,2 and has the unique clinical benefit of allowing patients to take proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RAs) concomitantly to help manage gastric acid disorders.1 To help patients with medication access, financial savings, and clinical support, Cycle Vita will be available to eligible* patients taking PHYRAGO.†

"We are honored to introduce PHYRAGO as a new treatment option for people living with Ph+ leukemia," said Steve Fuller, Chief Strategy Officer at Cycle Pharmaceuticals.

"We understand the daily challenges that come with managing Ph+ CML and Ph+ ALL, and our goal is to ease that burden, not just with an improved formulation of dasatinib, but through the individualized care and hands on support offered by our Cycle Vita program. By enabling more flexibility in co-medication and providing a dedicated support team, we’re committed to helping patients and their families navigate treatment with greater confidence and peace of mind."

Cycle Pharmaceuticals has been empowering patients with rare diseases through its products and support hub since 2017.

NITYR (nitisinone) Tablets in 2017
SAJAZIR (icatibant) Injection in 2021
JAVYGTOR (sapropterin dihydrochloride) Tablets for Oral Use and Powder for Oral Solution in 2022
TASCENSO ODT (fingolimod) in 2023
ORMALVI (dichlorphenamide) tablets in 2024
VENXXIVA (tiopronin) Delayed-Release Tablets in 2025
BAFIERTAM (monomethyl fumarate) Delayed-Release Capsules in 2025
HARLIKU (nitisinone) Tablets in 2025
Indications

PHYRAGO is a kinase inhibitor indicated for the treatment of:

Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance / intolerance to prior therapy including imatinib.
Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL) with resistance / intolerance to prior therapy.
Pediatric patients 1 year of age and older with Ph+ CML in chronic phase.
Pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.
Important Safety Information

Warnings and Precautions:

Myelosuppression and Bleeding Events: Severe thrombocytopenia, neutropenia and anemia may occur. Use caution if used concomitantly with medication that inhibits platelet function or anticoagulants. Monitor blood counts. Transfuse and interrupt PHYRAGO when indicated.

Fluid Retention: Fluid retention, including pleural effusions. Manage with supportive care and/or dose modification.

Cardiovascular Toxicity: Monitor for signs or symptoms and treat appropriately.

Pulmonary Arterial Hypertension (PAH): PHYRAGO may increase the risk of developing PAH which may be reversible on discontinuation. Consider baseline risk and evaluate patients for signs and symptoms of PAH during treatment. Stop PHYRAGO if PAH is confirmed.

QT Prolongation: Use PHYRAGO with caution in patients who have / may develop prolongation of the QT interval.

Severe Dermatologic Reactions: Severe mucocutaneous dermatologic reactions have been reported.

Tumor Lysis Syndrome: Tumor lysis syndrome has been reported. Maintain hydration and correct uric acid levels prior to initiating treatment.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential, of potential risk to fetus and to use effective contraception.

Effects on Growth and Development in Pediatric Patients: Epiphyses delayed fusion, osteopenia, growth retardation, and gynecomastia have been reported. Monitor bone growth and development.

Hepatotoxicity: Assess liver function before treatment, monthly thereafter or as clinically indicated. Monitor liver function when combined with chemotherapy.

Adverse Reactions:

Common adverse reactions in adults include myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain.

Common adverse reactions in pediatric patients include mucositis, febrile neutropenia, pyrexia, diarrhea, nausea, vomiting, musculoskeletal pain, abdominal pain, cough, headache, rash, fatigue, constipation, arrhythmia, hypertension, edema, infections (bacterial, viral and fungal), hypotension, decreased appetite, hypersensitivity, dyspnea, epistaxis, peripheral neuropathy, and altered state of consciousness.

Postmarketing Experience:

Post approval adverse reactions:

Hepatitis B virus reactivation, atrial fibrillation/atrial flutter, interstitial lung disease, chylothorax, Stevens-Johnson syndrome, nephrotic syndrome, thrombotic microangiopathy, hepatotoxicity.

Drug Interactions:

Strong CYP3A4 Inhibitors and Strong CYP3A4 Inducers: Dose reduction may be necessary.

Antacids: Avoid concomitant use.

Use in Specific Populations:

Pregnancy: PHYRAGO can cause fetal harm. Advise a pregnant woman of the potential risk to a fetus.

Contraception: Should be used during treatment and for 30 days after the last dose.

Lactation: Breastfeeding is not recommended during treatment and for 2 weeks after the last dose.

Pediatric Use: There is no data in children under 1 year of age. Adverse reactions associated with bone growth and development were reported and should be monitored closely. Refer to the full USPI for pediatric patients with difficulty swallowing tablets.

Geriatric Use: Patients over 65 and older may experience: fatigue, pleural effusion, diarrhea, dyspnea, cough, lower gastrointestinal hemorrhage, appetite disturbance, abdominal distention, dizziness, pericardial effusion, congestive heart failure, hypertension, pulmonary Cinzia, and weight decrease. Monitor closely.

For more detailed information, please refer to the full Prescribing Information at phyrago.com/PI/.

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals at
1-844-784-1807, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

US-DAS-2500114 | October 2025

(Press release, Cycle Pharmaceuticals, OCT 16, 2025, View Source [SID1234656699])

Cellectis Hosts R&D Day Today Showcasing Pipeline Progress and Long-Term Value Drivers

On October 16, 2025 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, reported to host a R&D Day in New York City. The Company’s leadership team and key opinion leaders will present the full Phase 1 dataset and outline the pivotal Phase 2 trial design and commercial opportunity for lasme-cel in r/r B-ALL.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of the Event:

Date: Today, October 16, 2025
Time: 08:30 – 10:30 a.m. ET
Format: In-person and live webcast
Webcast: Join live via View Source

A replay will be available after the event on the Cellectis website.

(Press release, Cellectis, OCT 16, 2025, View Source [SID1234656698])