On May 21, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the Phase III TALENTACE study, evaluating the efficacy and safety of Tecentriq (atezolizumab), Avastin (bevacizumab), and on-demand transarterial chemoembolization (TACE) in people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic treatment, met its primary endpoint with positive results (Press release, Chugai, MAY 21, 2025, View Source [SID1234653268]).

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The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of TACE-progression-free survival (TACE PFS*), and the other primary endpoint of overall survival (OS) is immature at the prespecified first interim analysis. Meanwhile, a clinically meaningful PFS by RECIST v1.1** was also observed. Detailed findings from this study will be presented at an upcoming academic congress.
*TACE PFS: Defined as the time from randomization to untreatable progression or TACE failure/refractoriness or death by any cause as determined by the investigator, and OS (overall survival), defined as time from randomization to death from any cause.
**RECIST v1.1: Response Evaluation Criteria in Solid Tumors guideline

Initiated in collaboration in China and Japan, the TALENTACE study aimed to assess whether combining Tecentriq and Avastin with TACE could improve outcomes for patients with unresectable HCC. This marks the Phase III study in Asia showing a TACE PFS benefit from cancer immunotherapy and target therapy in combination with TACE for unresectable HCC. The safety profiles of atezolizumab and bevacizumab were consistent with the well-established safety profile of each therapeutic agent and the underlying disease.

About the TALENTACE Study

TALENTACE study is a phase III, open-label, randomized study of on-demand transarterial chemoembolization (TACE) combined with Tecentriq + Avastin or on-demand transarterial chemoembolization (TACE) alone in patients with unresectable hepatocellular carcinoma who have not received prior systemic treatment. The TALENTACE study enrolled 342 patients in China and Japan who were randomized on a 1:1 ratio to receive TACE + Tecentriq/Avastin or TACE alone. TACE was performed on-demand. The co-primary endpoints are TACE PFS (TACE progression-free survival) and OS (overall survival). Secondary endpoints include PFS by RECIST v1.1 and others.

About Liver cancer

Liver cancer is the third leading cause of cancer-related death globally and one of the few cancers with rising mortality rates.1,2 More than 500,000 people are diagnosed with liver cancer every year, translating to one person being diagnosed every 50 seconds.1 Despite advances in treatment, only one in five people with liver cancer are alive five years post-diagnosis, and survival rates for advanced disease are even lower.

On May 21, 2025 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported clearance by the U.S. Food and Drug Administration (FDA) of its investigational new drug application (IND) for AVZO-023 (formerly ARTS-023), a potential best-in-class, novel cyclin-dependent kinase 4 (CDK4) selective inhibitor (Press release, Avenzo Therapeutics, MAY 21, 2025, View Source [SID1234653267]). Avenzo has also exercised its exclusive option for AVZO-023 from Allorion Therapeutics Inc., securing global (excluding Greater China) development, manufacturing, and commercialization rights.

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Under the IND, the company plans to initiate a Phase 1/2 first-in-human, open-label clinical study in the third quarter of this year. The Phase 1 portion will assess the safety, tolerability, and preliminary clinical activity of AVZO-023 as a single agent and in combination therapy with endocrine therapy and with AVZO-021, Avenzo’s potential best-in-class CDK2 inhibitor, in patients with advanced or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer and select other advanced solid tumors. AVZO-021 is currently being studied in HR+/HER2- metastatic breast cancer and other advanced solid tumors.

"The clearance of our IND for AVZO-023 represents an important milestone on our journey to transform cancer treatment," said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. "We believe AVZO-023 has the potential to be a best-in-class oncology therapy for patients with HR+/HER2- breast cancer and we look forward to initiating a Phase 1/2 clinical trial, and to studying the potential of AVZO-023 in combination with our potential best-in-class CDK2 selective inhibitor, AVZO-021."

Preclinical data for AVZO-023 were presented for the first time at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Conference in April 2025 and highlighted its sub-nanomolar potency against CDK4 while sparing other CDKs with high selectivity over CDK6, a key driver of hematologic toxicity. In addition, AVZO-023 demonstrated efficacy in in vivo xenograft models, both as a single agent and in combination with AVZO-021.

On May 21, 2025 AstraZeneca reported its ambition to eliminate cancer as a cause of death with new data across its diverse, industry-leading portfolio and pipeline at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, 30 May to 3 June 2025 (Press release, AstraZeneca, MAY 21, 2025, View Source [SID1234653255]).

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More than 80 abstracts will feature 20 approved and potential new medicines from the Company including two plenary presentations, one special late-breaking oral abstract session and 19 additional oral presentations. Highlights include:

SERENA-6 Phase III trial of camizestrant in combination with widely approved cyclin-dependent kinase (CDK) 4/6 inhibitors in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation (Plenary #LBA4). Camizestrant is an investigational, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist. This is the first positive Phase III trial for a next-generation oral SERD in this 1st-line setting and the first positive Phase III trial for camizestrant.
MATTERHORN Phase III trial of perioperative Imfinzi (durvalumab) plus FLOT chemotherapy in patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers (Plenary #LBA5).
DESTINY-Breast09 Phase III trial of Enhertu (trastuzumab deruxtecan) in combination with pertuzumab in the 1st-line treatment of patients with HER2-positive metastatic breast cancer (Oral Abstract #LBA1008).
DESTINY-Gastric04 Phase III trial of Enhertu in patients with 2nd-line HER2-positive unresectable and/or metastatic gastric and GEJ cancers (#LBA4002).
NeoADAURA Phase III trial of neoadjuvant Tagrisso (osimertinib) with or without chemotherapy in resectable, early-stage EGFR-mutated non-small cell lung cancer (NSCLC) (Oral Abstract #8001).
TROPION-Lung02: Computational pathology biomarker analyses of the TROPION-Lung02 Phase Ib trial of Datroway (datopotamab deruxtecan) plus pembrolizumab with or without platinum chemotherapy as 1st-line treatment for patients with advanced NSCLC without actionable genomic alterations (Oral Abstract #8501).
KOMET Phase III trial of Koselugo (selumetinib) in adults with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas (Rapid Oral Abstract #3014).
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "Two key breast cancer presentations at ASCO (Free ASCO Whitepaper) will highlight the progress we are making with our innovative medicines and pipeline to change the treatment landscape. For camizestrant, SERENA-6 is the first pivotal Phase III trial to use circulating tumour DNA to inform a treatment switch, pioneering this technology in the first-line setting to delay disease progression in HR-positive, HER2-negative advanced breast cancer. In addition, DESTINY-Breast09 for Enhertu in combination with pertuzumab is the first trial in more than a decade to demonstrate superiority over first-line standard of care across a broad HER2-positive metastatic patient population."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "The MATTERHORN data for perioperative Imfinzi in gastric and gastroesophageal junction cancers are a further example of our successful strategy to move immunotherapy into early stages of cancer where cure is the treatment goal. This is the seventh consecutive year AstraZeneca medicines will be featured in an ASCO (Free ASCO Whitepaper) plenary session, an extraordinary milestone which underscores the strength of our industry-leading oncology portfolio and pipeline across many types of cancer."

AstraZeneca is collaborating with Daiichi Sankyo Company Limited to develop and commercialise Enhertu and Datroway, with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Koselugo (selumetinib), and with HUTCHMED to develop and commercialise Orpathys (savolitinib).

Key AstraZeneca presentations during ASCO (Free ASCO Whitepaper) 20251

Lead Author

Abstract Title

Presentation details (CDT)

Antibody drug conjugates

Shitara, K

Trastuzumab deruxtecan (T-DXd) vs ramucirumab (RAM) + paclitaxel (PTX) in second-line treatment of patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) unresectable/metastatic gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA): Primary analysis of the randomized, phase 3 DESTINY-Gastric04 study.

Abstract #LBA4002

Oral Abstract Session

31 May 2025

3:24pm

Tolaney, SM

Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2–positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09.

Abstract #LBA1008

Oral Abstract Session

2 June 2025

7:30am

Dent, R

Exploratory biomarker analysis of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) in HER2-low/-ultralow, hormone receptor-positive (HR+) metastatic breast cancer (mBC) in DESTINY-Breast06 (DB-06).

Abstract #1013

Oral Abstract Session

31 May 2025

3:23pm

Levy, BP

TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) as first-line (1L) therapy for advanced non-small cell lung cancer (aNSCLC).

Abstract #8501

Oral Abstract Session

1 June 2025

8:12am

Waqar, SN

First-line (1L) datopotamab deruxtecan (Dato-DXd) + rilvegostomig in advanced or metastatic non-small cell lung cancer (a/mNSCLC): Results from TROPION-Lung04 (cohort 5).

Abstract #8521

Poster Session

31 May 2025

1:30pm

Tumour drivers and resistance

Turner, NC

Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase 3, double-blind ctDNA-guided SERENA-6 trial.

Abstract #LBA4

Plenary Session

1 June 2025

2:41pm

Lu, S

Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET-amplification (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study.

Abstract #LBA8505

Oral Abstract Session

1 June 2025

9:48am

Levy, BP

Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO).

Abstract #8513

Rapid Oral Abstract Session

2 June 2025

8:06am

Chaft JE

Neoadjuvant (neoadj) osimertinib (osi) ± chemotherapy (CT) vs CT alone in resectable (R) epidermal growth factor receptor-mutated (EGFRm) NSCLC: NeoADAURA.

Abstract #8001

Oral Abstract Session

2 June 2025

3:12pm

Immuno-oncology & bispecifics

Janjigian, YY

Event-free survival in MATTERHORN: a randomized, phase 3 study of durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin, and docetaxel chemotherapy (FLOT) in resectable gastric/gastroesophageal junction cancer (GC/GEJC).

Abstract #LBA5

Plenary Session

1 June 2025

3:13pm

Powles, T

Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA

Abstract #4503

Oral Abstract Session

1 June 2025

10:45am

Reck, M

Associations of post-surgical MRD status with neoadjuvant ctDNA dynamics, genomic mutations, and clinical outcomes in patients with resectable NSCLC (R-NSCLC) from the phase 3 AEGEAN trial.

Abstract #8009

Rapid Oral Abstract Session

1 June 2025

4:30pm

Barbie, DA

Clinical and molecular characteristics of early progressors (EPs) and long-term progression-free survivors (LTPs) from the phase 3 ADRIATIC trial of consolidation durvalumab (D) vs placebo (P) after concurrent chemoradiotherapy (cCRT) in limited-stage small-cell lung cancer (LS-SCLC).

Abstract #8014

Rapid Oral Abstract Session

1 June 2025

5:12pm

Mayadev, J

Ultrasensitive detection and tracking of circulating tumor DNA (ctDNA) and association with relapse and survival in locally advanced cervical cancer (LACC): Phase 3 CALLA trial analyses.

Abstract #5502

Oral Abstract Session

2 June 2025

8:48am

Westin, SN

Durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib as first-line treatment for endometrial cancer: Longitudinal changes in circulating tumor DNA.

Abstract #5512

Rapid Oral Abstract Session

3 June 2025

8:30am

Erinjeri, JP

Outcomes by baseline tumor burden using the 6-and-12 score in EMERALD-1: a phase 3 study of durvalumab (D) ± bevacizumab (B) with transarterial chemoembolization (TACE) in embolization-eligible unresectable hepatocellular carcinoma (uHCC).

Abstract #4083
Poster Session

31 May 2025

9:00am

Cascone, T

Neoadjuvant durvalumab (D) + chemotherapy (CT) + novel anticancer agents and adjuvant D ± novel agents in resectable non-small-cell lung cancer (NSCLC): Updated outcomes from NeoCOAST-2.

Abstract #8046

Poster Session

31 May 2025

1:30pm

Zhou, J

First-line rilvegostomig (rilve) plus chemotherapy (CTx) in advanced biliary tract cancer (BTC): Primary analysis of GEMINI-Hepatobiliary substudy 2 Cohort A.

Abstract #4080

Poster Session

31 May 2025

9:00am

Xu, R

ARTEMIDE-Gastric01: a phase 3 randomized study of rilvegostomig with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) as first-line (1L) treatment for locally advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer (GC/GEJC).

Abstract #TPS4204

Poster Session

31 May 2025

9:00am

Mathias, C

ARTEMIDE-Lung03: a phase 3, randomized, double-blind, multicenter, global study of rilvegostomig or pembrolizumab in combination with platinum-based chemotherapy as first-line treatment for patients with metastatic non-squamous non-small-cell lung cancer whose tumors express PD-L1.

Abstract #TPS8653

Poster Session

31 May 2025

1:30pm

Cell therapy

Yoo, C

RHEA-1: First-in-human (FIH) study of AZD9793, a first-in-class CD8-guided T cell-engager (TCE) for glypican-3-positive (GPC3+) advanced or metastatic hepatocellular carcinoma (HCC).

Abstract #TPS4215

Poster Session

31 May 2025

9:00am

Kim, TM

Safety and Efficacy of AZD0486, a CD19xCD3 T-cell Engager, in Relapsed or Refractory Diffuse Large B-cell Lymphoma.

Abstract #7046
Poster Session

1 June 2025

9:00am

Shadman, M

TITANium: An open-label, global multicenter Phase 1/2 study of AZD5492, a first-in-class subcutaneous CD8-guided tri-specific T-cell engager (TCE), in patients (pts) with relapsed or refractory (r/r) B-cell malignancies.

Abstract #TPS7091

Poster Session

1 June 2025

9:00am

Le Gouill, S

SOUNDTRACK-E: A Phase 1/2 Open-label Multicenter Study to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or Combination Therapy in Patients With Mature B-cell Malignancies.

Abstract #TPS7083

Poster Session

1 June 2025

9:00am

Rare disease medicines

Chen, AP

Efficacy and safety of selumetinib in adults with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibroma (PN): Primary analysis of KOMET (NCT04924608), a Phase 3, international, randomized, placebo-controlled study.

Abstract #3014

Rapid Oral Abstract Session

2 June 2025

8:00am

On May 20, 2025 Theralase Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their formulations, intended for the safe and effective destruction of various cancers, bacteria and viruses, reported a corporate update outlining the Company’s strategic objectives (Press release, Theralase, MAY 20, 2025, View Source [SID1234653881]).

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1) Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") Registrational Clinical Study ("Study II")

Theralase has made steady progress on the completion of Study II by enrolling and providing the primary study procedure for 82 patients out of a target of 90 patients (91% enrollment).

According to the clinical study design, a patient is considered to have completed Study II, if they receive the study procedure (study drug activated by study device) and have been assessed by the Principal Investigator ("PI") for up to 15 months or they have been prematurely removed from the clinical study by the PI for failure to respond or failure to comply with the clinical study design.

According to this definition, 69 patients have completed Study II (with 13 patients on study with pending clinical data) resulting in the following interim clinical data in support of the Study II endpoints.

Primary Endpoint Performance (CR at any Point in Time)
# % Confidence Interval (95%)
Complete Response ("CR") 43/69 62.3% [43.7, 80.9]
Total Response (CR and IR) 48/69 69.6% [49.9, 89.2]
Secondary Endpoint Performance (Duration of CR) (15 months)
# % Confidence Interval (95%)
Complete Response ("CR") 18/43 41.9% [22.5, 61.2]
Tertiary Endpoint Performance (Safety) (15 months)
# %
Safety 69/69 100.0%
For 82 patients treated in Study II, there have been no Serious Adverse Events ("SAEs") directly related to the Study Drug or Study Device.

Outside of the defined endpoints of Study II, Theralase has demonstrated a duration of CR at extended time points, as follows:

Duration of CR
Time # % Confidence Interval (95%)
2 Years 10/43 23.3% [8.8, 37.7]
3 Years 9/43 20.9% [7.3, 34.6]
7 Years 1/43 2.3% [0.0, 6.9]
Note: Not all patients have been assessed at these extended time points. As more clinical data is collected, the duration of CR at 2 and 3 years may increase.

If approved by the regulatory authorities, the interim clinical data obtained could significantly benefit patients who are faced with a radical cystectomy (removal of their bladder), as the Theralase treatment provides a strong initial CR and an equally strong duration of that CR over time. It is made even more impressive by the fact that this clinical data was achieved with only one study procedure in the majority of cases.

Theralase is on track to complete enrollment in Study II by the summer of 2025.

This will allow the Company to report on 75 patients who have completed Study II in December 2025 and to report on all 90 patients by September 2026.

Upon follow-up of all patients, the Company plans to submit a New Drug Application ("NDA") to Health Canada and the FDA in 4Q2026, with a decision expected by the respective regulatory authorities on a marketing approval by 1Q2027.

As Theralase completes enrollment in Study II, it is actively searching for commercialization partners for international marketing and sales of Ruvidar.

To this end, Theralase is in various stages of initial and advanced discussions with international pharmaceutical companies for various geographical territories concerning:

Licensing of the light-activated Ruvidar for BCG-Unresponsive NMIBC CIS
Collaborative research focused on investigating light-activated Ruvidar in the treatment of NMIBC
Collaborative research focused on combining Ruvidar with other FDA approved drugs
In recent discussions with the FDA, the Company has decided that since Study II is 91% complete, that the best course of action is not to pursue Break Through Designation, but to complete Study II and submit the clinical data to the FDA in a formal NDA. At the end of the meeting, the FDA made a comment that they were impressed that the interim clinical data obtained to date was able to be achieved with only one clinical treatment, in the majority of cases.

Ruvidar has demonstrated 10 years shelf life, strongly supporting the stability of the molecule and the ability of clinics to store the small molecule for extended periods of time.

2) Glio Blastoma Multiforme ("GBM") Brain Cancer Treatment

Theralase has successfully completed pre-clinical research to develop Ruvidar for the destruction of GBM. The Company expects to complete Good Laboratory Practice ("GLP") toxicology in 4Q2025 to allow commencement of a Phase I/II adaptive clinical study in 1Q2026.

3) Non-Small Cell Lung Cancer ("NSCLC") Treatment

Theralase has finished conducting pre-clinical research to develop Ruvidar for the destruction of NSCLC. Mice treated with x-ray activated Rutherrin in a Lewis Lung Cancer ("LLC1") orthotopic model have demonstrated up to a 4-fold slower tumour progression, based on the Magnetic Resonance Imaging assessment of tumour volumes.

4) Muscle Invasive Bladder Cancer ("MIBC") Treatment

Theralase is conducting pre-clinical research to develop Ruvidar for the destruction of MIBC as an intravenous treatment for patients that are inflicted with this disease. The Company expects to complete GLP toxicology in 4Q2025 to allow commencement of a Phase I/II adaptive clinical study in 1Q2026.

5) Leukemia, Lymphoma and Myeloma Treatment

Theralase is conducting pre-clinical research to develop Ruvidar for the destruction of Leukemia, Lymphoma and Myeloma as an extracorporeal treatment for patients that are inflicted with these diseases. Theralase plans to develop this technology in 2026.

6) Herpes Simplex Virus ("HSV-1") Topical Treatment for Cold Sore Lesions

Theralase is conducting pre-clinical research to develop Ruvidar for the inactivation of HSV-1 as a topical treatment for the billions of patients worldwide that are inflicted with cold sores on an annual basis. The Company is using its internal research laboratory to develop the topical formulation to be used in preclinical and clinical evaluation.

The Company expects to complete GLP toxicology in 4Q2025 to allow commencement of a Phase I/II adaptive clinical study in 1Q2026.

The research, which demonstrated that RuvidarTM was effective at inactivating both enveloped and non-enveloped viruses, alone and when light activated was accepted in a peer-reviewed publication, Heliyon, and can be reviewed at View Source

7) Cross Listing to a US Exchange

The Company has raised $CAN 6.3 million over the last 2 years in support of it research and development programs. It is currently investigating the use of a full-service investment bank in the United States to advise on potential financings and US listing opportunities. Information on any future financings will be released once available in accordance with applicable securities laws.

2025/2026: Potentially Transformative Years
Theralase is positioning itself to deliver on a series of significant clinical and corporate milestones in 2025; including:

Completing Study II and submitting an NDA to Health Canada and the FDA
Commencing Phase I/II adaptive clinical studies in: GBM, NSCLC, MIBC, HSV and Leukemia
Evaluating strategic financing and listing opportunities in the US market
These efforts should collectively support long-term shareholder value and reinforce Theralase’s leadership in light / radiation-activated drug therapy for the destruction of various cancers and viruses.

About Study II:
Study II utilizes the therapeutic dose of the patented study drug (Ruvidar) (0.70 mg/cm2) activated by the proprietary study device (TLC-3200 Medical Laser System). Study II is focused on enrolling and treating approximately 90 BCG-Unresponsive NMIBC CIS patients in 12 clinical study sites located in Canada and the United States.

About Ruvidar:
Ruvidar(TLD-1433) is a small molecule, able to be activated by light, radiation, sound and/or other drugs, intended for the safe and effective destruction of various cancers, bacteria and viruses.

On May 20, 2025 4SC AG ("4SC") (Frankfurt Stock Exchange, Prime Standard: VSC; ISIN: DE000A3E5C40) reported to have received a Negative Opinion on the Company’s Market Authorization Application for Resminostat (Kinselby) for the treatment of patients with advanced stage cutaneous T-cell lymphoma (CTCL) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) (Press release, 4SC, MAY 20, 2025, https://www.pressetext.com/news/20250523025 [SID1234653364]).

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Following an Oral Explanation on 20 May 2025, and the CHMP’s review of the data on quality, safety and efficacy for Resminostat (Kinselby) in the treatment of patients with advanced stage mycosis fungoides (MF) and Sézary syndrome (SS) that have achieved at least stable disease with at least one prior systemic therapy or Total Skin Electron Beam therapy (TSEB) – the CHMP considers by consensus that the efficacy of the above-mentioned medicinal product is not sufficiently demonstrated, and therefore, recommends the refusal of the granting of the marketing authorization for Resminostat (Kinselby).

As already communicated on 20 May 2025, 4SC will thus cease all efforts to develop and commercialize Resminostat (Kinselby). Currently, 4SC has at least a 12-month cash runway to finance the Company’s projected expenses as the Management and Supervisory Boards consider all options for the Company, including liquidation.

Jason Loveridge, Ph.D., CEO of 4SC, commented: "We had hoped that the long wait for a maintenance treatment to help manage CTCL would soon be over. We are therefore deeply disappointed with this outcome as it is a further setback for people living with this rare and incurable disease."