Author: Ravi Shankar

Median PFS was 21.5 months with the gedatolisib triplet and 11.5 months with the gedatolisib doublet versus 9.1 months with alpelisib + fulvestrant in patients who had no liver metastases 

ORR and median duration of response was 59% and 19.4 months for the gedatolisib triplet and 43% and 27.8 months for the gedatolisib doublet, respectively, compared to 33% and 7.5 months for alpelisib + fulvestrant

The discontinuation rate for gedatolisib due to treatment-emergent adverse events was 5% and 4% with the gedatolisib triplet and doublet, respectively, compared to 19% for alpelisib

MINNEAPOLIS, Oct. 24, 2026 (GLOBE NEWSWIRE) — Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced new subgroup analyses from the PIK3CA mutant (“MT”) cohort of the Phase 3 VIKTORIA-1 study evaluating gedatolisib in patients with HR+/HER2- locally advanced or metastatic breast cancer (“ABC”). These data were presented by Dr. Barbara Pistilli, Head of the Breast Cancer Unit, Gustave Roussy, at the European Society of Medical Oncology (ESMO) Congress 2026 today, Saturday, October 24, 2026, at 4:15 a.m. EST/10:15 a.m. CEST during a late breaking rapid oral presentation:

Presentation LBA 16: VIKTORIA-1: Updated results of a randomized, open-label, phase 3 study of gedatolisib (geda) + fulvestrant (fulv) ± palbociclib (palbo) vs standard of care in patients with HR+/HER2- advanced breast cancer (ABC) (Study 2)

Gedatolisib plus fulvestrant with palbociclib (“gedatolisib triplet”) or without palbociclib (“gedatolisib doublet”) significantly improved median progression-free survival (“PFS”) compared with alpelisib plus fulvestrant in HR+/HER2-, PIK3CA mutant ABC patients with and without liver metastases and those with or without visceral metastases:

Subgroup	Gedatolisib Triplet	Gedatolisib Doublet	Alpelisib + Fulvestrant
No Liver metastases, n	77	28	76
mPFS, mos. (95% CI)	21.5 (11.4-NR)	11.5 (9.2-NR)	9.1 (5.6-16.9)
HR (90% CI) vs. control	0.46 (0.30-0.72)	0.71 (0.41-1.25)
p-value	0.0016	0.1627
Liver Metastases, n	78	24	79
mPFS, mos. (95% CI)	9.1 (5.7-11.1)	11.1 (3.7-NR)	4.6 (3.7-5.6)
HR (90% CI) vs. control	0.47 (0.34-0.65)	0.38 (0.23-0.62)
p-value	<0.0001	0.0006
Subgroup	Gedatolisib Triplet	Gedatolisib Doublet	Alpelisib + Fulvestrant
No Visceral Metastases, n	38	13	37
mPFS, mos. (95% CI)	21.5 (9.6 – NR)	NR (1.6-NR)	9.2 (3.9-16.9)
HR (90% CI) vs. control	0.38 (0.21-0.73)	0.40 (0.15-1.1)
p-value	0.0059	0.0703
Visceral Metastases, n	117	39	118
mPFS, mos (95% CI)	9.8 (7.5-12.9)	11.3 (7.4-22.1)	5.6 (4.6-7.2)
HR (90% CI) vs. control	0.52 (0.39-0.70)	0.53 (0.35-0.79)
p-value	<0.0001	0.0042

* NR, not reached

In patients with evaluable disease, the gedatolisib-based regimens induced higher objective response rates (“ORR”) (confirmed and unconfirmed) and longer median durations of response in both the PIK3CA mutant and wild-type cohorts compared to the control:

Study 2 (PIK3CA Mutant Cohort)
Endpoint	Gedatolisib Triplet (n=133)	Gedatolisib Doublet (n=42)	Alpelisib + Fulvestrant (n=127)
Objective Response Rate, n (%)	78 (59%)	18 (43%)	42 (33%)
Median Duration of Response, mos. (95% CI)	19.4 (11.1-25.1)	27.8 (9.2-NR)	7.5 (5.6 – 16.6)
Study 1 (PIK3CA Wild-type Cohort)
	Gedatolisib Triplet (n=124)	Gedatolisib Doublet (n=113)	Fulvestrant (n=105)
Objective Response Rate, n (%)	48 (39%)	38 (34%)	1 (1%)
Median Duration of Response, mos. (95% CI)	19.2 (10.7-NR)	13.8 (9.4-NR)	Not evaluable

In the PIK3CA mutant cohort, the discontinuation rate of gedatolisib due to treatment-emergent adverse events (“TEAEs”) was 5% and 4% for the gedatolisib triplet and doublet, respectively, compared to a 19% discontinuation rate due to TEAEs for alpelisib. Grade 3 stomatitis with gedatolisib was transient. By the second cycle of treatment, less than 3% of patients had Grade 3 stomatitis, and all grade 3 events improved within 1-2 weeks. Discontinuations due to stomatitis for the gedatolisib triplet and gedatolisib doublet were minimal, 1% and 0%, respectively.

“The additional data from Study 2 of VIKTORIA-1 show consistent and significant clinical benefit for important sub-groups of breast cancer patients treated with gedatolisib regimens,” said Igor Gorbachevsky, Chief Medical Officer of Celcuity. “For patients who do not have liver metastases and received the gedatolisib triplet, the median progression-free survival was approximately 21 months, versus approximately 9 months for the alpelisib regimen. This is a particularly important result since patients with no liver metastases represent approximately 60%-70% of all patients treated in this setting.”

“Additionally, the median duration of response was over 19 months for the gedatolisib triplet in both the PIK3CA wild-type cohort, or Study 1, and the PIK3CA mutant cohort, or Study 2, compared to not evaluable for fulvestrant in the PIK3CA wild-type cohort and 7.5 months for alpelisib plus fulvestrant in the PIK3CA mutant cohort. To our knowledge, the gedatolisib triplet in each study demonstrated the longest median duration of response results ever reported for a therapeutic regimen used in the primary analysis for a Phase 3 trial in the second-line HR+/HER2- advanced breast cancer setting.”

VIKTORIA-1 PIK3CA Wild-Type Cohort Comparative Analysis

Dr. Sara Tolaney, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute, presented a comparative analysis of data for the gedatolisib regimens from the PIK3CA wild-type cohort of VIKTORIA-1 and other regimens evaluated in patients with HR+/HER2- advanced breast cancer.

Poster 1873P: Gedatolisib (Ged) vs Other Regimens Post-CDK4/6i and Endocrine Therapy (ET) in PIK3CA Wild-Type (WT) HR+/ HER2- Advanced Breast Cancer (aBC): A Network Meta-Analysis (NMA)

Eight studies were included in this network meta-analysis comparing progression-free survival outcomes in randomized controlled trials of systemic treatments evaluated among patients with HR+/HER2- advanced breast cancer with CDK4/6 inhibitor experience and PIK3CA wild-type tumors. This analysis found that the gedatolisib triplet and doublet each demonstrated statistically significant or numerically superior improvement in PFS and in progression-free survival rate at 6 months relative to the non-gedatolisib regimens evaluated. Of note, the analysis found that patients treated with the gedatolisib triplet and doublet were a statistically significant 2x and 1.5x more likely to survive without disease progression or death compared to imlunestrant plus abemaciclib, respectively.

About HR+/HER2- Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.¹ More than two million breast cancer cases were diagnosed globally in 2022.¹ While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.² HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.²

About Celcuity

Celcuity is a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company’s first FDA-approved product is REVTORPYK™ (gedatolisib), pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM (PI3K/AKT/mTOR) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- locally advanced or metastatic breast cancer, supported FDA approval of REVTORPYK for use in patients without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of VIKTORIA-1 have been released. VIKTORIA-2 is an ongoing Phase 3 clinical trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib plus palbociclib plus fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib plus palbociclib plus letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of the Company’s clinical trials; the Company’s interpretation of clinical trial data; and the Company’s strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “confidence,” “encouraged,” “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management’s current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that the Company’s topline clinical results are based on an ongoing analysis of efficacy and safety data and such data may change following a more comprehensive review of the data related to the clinical trial; and the development of therapies and tools competitive with gedatolisib. In addition, all forward-looking statements are subject to other risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as such risks may be updated in its subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

References

1. Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;10.3322/caac.21660.
2. National Cancer Institute. Surveillance, Epidemiology and End Results Program (accessed July 2025). https://seer.cancer.gov/statfacts/html/breast-subtypes.html

Contacts

For Investors: 
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com   
(763) 392-0123
Jodi Sievers, jsievers@celcuity.com
(415) 494-9924

For Media:
Sam Brown LLC
Laura Morgan, lauramorgan@sambrown.com
(951) 333-9110

ORION CORPORATION
PRESS RELEASE
24 OCTOBER 2026 at 9.35 EEST
        

Darolutamide plus ADT and radiation therapy reduces risk of metastasis or death by 58% in prostate cancer patients at high risk of recurrence

• Interim analysis results from the Phase 3 trial DASL-HiCaP show a 58% reduction in the risk of metastasis or death in the combined primary endpoint of metastasis-free survival (MFS-CI) with darolutamide versus placebo, in addition to androgen deprivation therapy (ADT) and radiation therapy
• Four-year metastasis-free survival rate in trial reached 95% with darolutamide compared to 88% with placebo, alongside secondary endpoint improvements and a safety profile consistent with previous studies
• Results will be presented as a late-breaking abstract in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026

ESPOO, Finland, October 24, 2026 – New late-breaking data to be presented today at the European Society for Medical Oncology (ESMO) Congress 2026 will show that adding darolutamide, an androgen receptor inhibitor (ARi) initially discovered by Orion Pharma, to standard-of-care androgen deprivation therapy (ADT) and locoregional radiation therapy (RT), significantly improves metastasis-free survival based on conventional imaging (MFS-CI) in prostate cancer patients with high risk of recurrence compared to placebo. Darolutamide is currently not approved for this treatment setting. These data will be presented at Presidential Symposium I at the ESMO Congress 2026 (LBA4, Saturday 24 October, 16:30 CET).

At a median follow-up of 3.8 years, the interim analysis demonstrated a 58% reduction in the risk of metastasis or death with darolutamide plus ADT and RT compared with placebo plus ADT and RT (hazard ratio [HR] 0.42; 95% CI: 0.27–0.66; p=0.0001). The 4-year metastasis-free survival rate was 95% for patients receiving darolutamide compared with 88% for those receiving placebo.

Secondary endpoints also showed consistent positive trends with darolutamide, with a 53% reduction in the risk of prostate-specific antigen progression free survival (PSA-PFS; HR 0.47; 95% CI: 0.33–0.67), and a 4-year PSA-PFS rate of 91% versus 83% with placebo. Prostate cancer-specific survival (PCSS) and overall survival (OS) hazard ratios were 0.58 (95% CI: 0.17–1.97; 99% vs 99% at 4 years) and 0.88 (95% CI: 0.49–1.59; 97% vs 95% at 4 years), respectively, with follow-up ongoing.

The safety profile of darolutamide was consistent with its known tolerability, with adverse events being similar to the placebo group. Proportions of patients experiencing Grade ≥2 adverse events of special interest for darolutamide versus placebo were: fatigue/asthenia (14% vs 10%), hypertension (7% vs 9%), fractures (2% vs 3%), and cardiac events (3% vs 3%). Any Grade ≥3 adverse event occurred in 43% of patients in the darolutamide group versus 36% in the placebo group.

Follow-up of participants is continuing to provide further information on longer-term outcomes, including overall survival.

About the DASL-HiCaP trial (ANZUP1801)
The DASL-HiCaP trial is an investigator-initiated, randomized, placebo-controlled, Phase III trial (NCT04136353) evaluating darolutamide added to standard-of-care ADT and locoregional radiation therapy in prostate cancer patients at high risk of recurrence. DASL-HiCaP is conducted by the University of Sydney and ANZUP Clinical Trials Group and is the fourth Phase III trial for darolutamide. Following ARAMIS, ARASENS, and ARANOTE, which demonstrated darolutamide’s efficacy and safety in advanced prostate cancer, DASL-HiCaP represents the first Phase III study of darolutamide in early prostate cancer. A total of 1,106 participants across Australia, New Zealand, Canada, the United States, Ireland and the United Kingdom were randomized 1:1 to receive darolutamide (600 mg twice daily) or matching placebo for 96 weeks, combined with an LHRH analog for 96 weeks and RT to the prostate/prostate bed and pelvic lymph nodes. The primary endpoint was metastasis-free survival based on conventional imaging (MFS CI). Secondary endpoints included prostate-specific antigen progression free survival (PSA-PFS), prostate cancer-specific survival (PCSS), and overall survival (OS). The protocol specified an interim analysis after 87 MFS-CI events; follow-up is ongoing to evaluate long-term overall survival.

About Prostate Cancer
Prostate cancer is the second most common cancer and the fourth most common cause of cancer death in men worldwide. Over 1.5 million men are diagnosed with prostate cancer each year and almost 420,000 die from the disease worldwide. By 2040, prostate cancer diagnoses are projected to increase to 2.9 million.

Standard therapy for prostate cancer patients at high risk of recurrence combines radiation therapy with androgen deprivation therapy (ADT). However, despite this approach, a significant proportion of patients experience treatment failure, local recurrence, or distant metastases. Intensifying therapy early with an advanced androgen receptor inhibitor aims to improve long-term disease control and delay metastatic progression.

About darolutamide (Nubeqa™)
Darolutamide is an oral ARi with a unique chemical structure that binds with high affinity to the androgen receptor and exhibits a strong antagonistic effect against the androgen receptor inhibiting the receptor function and growth of prostate cancer cells. Additionally, preclinical models and neuroimaging data in healthy humans, support darolutamide’s low potential for blood-brain barrier penetration and low potential for clinically relevant drug drug interactions.

Darolutamide, under the brand name Nubeqa™ plus androgen deprivation therapy (ADT), is already approved in more than 85 markets around the world, including the US, EU and China. It is approved for the treatment of adult patients with mHSPC without docetaxel in 75 markets and with docetaxel in more than 85 countries, and for adult patients with nmCRPC at high risk of developing metastatic disease in more than 85 countries.

Darolutamide is developed jointly by Orion Pharma and Bayer.

A robust clinical development program is underway investigating darolutamide across various stages of prostate cancer. Current ongoing trials include the Phase III ARASTEP trial evaluating the efficacy of darolutamide plus ADT compared to ADT alone in hormone sensitive prostate cancer (HSPC), in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline.

Media contact:
Maddie Davidshofer, Lead, Scientific & Pipeline Communications
tel. +1 857 529 0169

Investor contact:
Tuukka Hirvonen, Head of Investor Relations
tel. +358 10 426 2721                                                 

Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 Espoo, Finland
http://www.orionpharma.com

Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals as well as active pharmaceutical ingredients, combining our trusted expertise with continuous innovation. We have an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by us are used to treat cancer, respiratory diseases and neurological diseases, among others. In 2025 our net sales amounted to EUR 1,890 million, and we employ about 4,000 professionals worldwide, dedicated to building well-being.

• IMA402 PRAME bispecific continues to demonstrate encouraging anti-tumor activity in multiple indications, alongside a favorable safety profile
• IMA402 achieved a cORR of 32%, 12.5 months median DOR and a 1-year OS rate of 91% in advanced melanoma patients with high PRAME expression
• Clinical profile of IMA402 reinforces development path across multiple solid tumor indications, including melanoma, gynecologic cancers and lung cancer, in earlier and later treatment lines, supported by Immatics’ innovative, rapid liquid biopsy-based PRAME testing
• IMA203CD8 PRAME cell therapy demonstrated deep and durable anti-tumor activity across multiple tumor types with a manageable safety profile, supporting its tumor-agnostic potential. At clinically relevant dose levels in patients with advanced, heavily pretreated gynecologic cancers, cORR was 55% with a median DOR of 8.4 months

Houston, Texas and Tuebingen, Germany, October 24, 2026 – Immatics N.V. (NASDAQ: IMTX, “Immatics” or the “Company”), the global leader in precision targeting of PRAME with multiple clinical-stage programs spanning cell therapies and bispecifics, today announced updated clinical trial data from its ongoing Phase 1b study with IMA402 PRAME bispecific and its Phase 1 study with IMA203CD8 PRAME cell therapy.

The IMA402 data will be presented in a rapid oral presentation (1955RO) by Dirk Schadendorf, M.D., and the IMA203CD8 data were presented in an oral presentation (1946O) by Antonia Busse, M.D., at the 2026 Annual Meeting of the European Society for Medical Oncology (ESMO) in Madrid, Spain. In addition, exploratory analyses of the anzu-cel Phase 1b melanoma cohort will be presented in a poster (2128P) by Sapna Patel, M.D. The slides are available in the ‘Events & Presentations’ section of the Investor & Media page on the Company’s website.

“The data presented at ESMO further underscore the potential of IMA402 as an off-the-shelf treatment option for patients with solid cancers. This promising clinical profile reinforces our strategy as we continue to advance IMA402 across multiple cancer types and treatment lines, with combination approaches further expanding its reach,” said Cedrik Britten, M.D., Ph.D., Chief Medical Officer at Immatics. “In addition, as the IMA203CD8 PRAME cell therapy data continue to mature, we are increasingly encouraged by its broad potential for patients with advanced PRAME-positive cancers. Together with anzu-cel, IMA402 and IMA203CD8 give us three distinct and complementary approaches to target PRAME, with the potential to reach more patients across a broad range of cancers.”

Rapid Oral Presentation Summary – IMA402 PRAME TCR Bispecific Phase 1b Trial

Patient Population: Heavily pretreated patient population with a median of 3 prior lines of therapy
As of the data cutoff on June 1, 2026, 126 heavily pretreated patients across multiple tumor types, primarily melanoma and ovarian cancer, received at least one infusion of IMA402 during the dose escalation or dose expansion part of the ongoing trial (NCT05958121). Patients had received a median of 3 prior lines of systemic treatment, had a median target lesion sum of diameter of 7.4 cm and had a median of 4 tumor lesions. The efficacy population included 40 patients treated within the recommended Phase 2 dose (RP2D) range of 10 to 45 mg across varying levels of PRAME expression. Within this population, 31 patients exhibited high PRAME expression levels (PRAME-high)¹ in their tumors. Of these, all patients with PRAME-high melanoma had received prior systemic treatment with immune checkpoint inhibitors (ICI), with a median of 2 prior ICI regimens and all patients with PRAME-high ovarian cancer were previously treated with platinum-based chemotherapy.

Safety: Favorable tolerability profile as monotherapy and as combination therapy
IMA402 showed favorable tolerability across all doses. The most frequent treatment-related adverse events (TRAEs) were expected, transient lymphopenia and low-grade cytokine release syndrome (CRS), consistent with the mechanism of action. No cases of ICANS were reported. No IMA402-related Grade 5 events were reported. Tolerability was consistent across all evaluated doses, including the RP2D range, with no additive toxicity observed when combined with an ICI.

Anti-tumor Activity and Durability: 32% cORR in PRAME-high melanoma with promising durability and survival
IMA402 showed promising anti-tumor activity as monotherapy (n=36) or in combination with an immune checkpoint inhibitor (n=4) in the efficacy population at RP2D range. Treatment with IMA402 demonstrated 10 confirmed responses resulting in an overall confirmed objective response rate (cORR) of 25% (10/40) and a disease control rate (DCR) of 63% (25/40). This includes one confirmed complete response in melanoma. The longest ongoing response exceeded 2 years. In the PRAME-high population, cORR was 32% (10/31) across all indications and 32% (7/22) in patients with melanoma. The PRAME-high melanoma population further showed a median duration of response (mDOR) of 12.5 months (median follow-up, mFU, 16.8 months). Median overall survival (mOS) was not reached (mFU 8.8 months), with 91% of patients alive at 1 year (versus 60% of patients treated below RP2D range), indicating promising overall survival data irrespective of best response. Among 6 patients with PRAME-high ovarian cancer, 3 confirmed responses were reported.

^a Includes cutaneous melanoma and one patient with uveal melanoma. ^b Includes endometrial cancer (n=2), sqNSCLC (n=2), and synovial sarcoma (n=1); BOR, best overall response; BL, baseline; cCR, confirmed complete response; cORR, confirmed objective response rate; DCR, disease control rate; PD, progressive disease; (c)PR, (confirmed) partial response; SD, stable disease.

BOR, best overall response; BL, baseline; cCR, confirmed complete response; cORR, confirmed objective response rate; PD, progressive disease; (c)PR, (confirmed) partial response; SD, stable disease.

Next Development Steps for IMA402:
The promising clinical profile of IMA402 supports a development path across various solid tumors in earlier and later treatment lines. These include combination approaches with ICIs in melanoma and in gynecologic cancers as well as IMA402 in combination with the Company’s MAGEA4/8-directed bispecific, IMA401, in lung cancer with first data expected in 2027. Furthermore, the use of Immatics’ proprietary rapid, sensitive and reliable liquid biopsy-based PRAME testing enables precise patient selection and could support potential fast-to-market strategies, subject to regulatory approval, in PRAME-high melanoma and beyond.

Oral Presentation Summary – IMA203CD8 PRAME Cell Therapy Phase 1 Trial

Patient population: Heavily pretreated patient population with limited treatment options
As of the data cutoff on August 7, 2026, 98 heavily pretreated patients across multiple advanced solid tumor types expressing PRAME that had undergone a median of 3 prior systemic treatments were enrolled in the ongoing Phase 1 dose escalation/dose expansion trial (NCT03686124). Of these, 90 patients were evaluable for efficacy, including 27 with gynecologic cancers (ovarian and uterine cancer), 44 with melanoma, 12 with synovial sarcoma and 7 with other solid tumor types. All patients with ovarian cancer had received prior platinum-based therapy.

Safety: Treatment with IMA203CD8 was manageable
IMA203CD8 demonstrated a consistent and manageable safety profile across different solid tumor types and a wide dose range (median dose 1.81×10⁹ TCR T cells, range 0.44-12.50×10⁹). The most frequent treatment-emergent adverse events (TEAEs) were expected and included transient cytopenias associated with the lymphodepletion regimen and low-grade cytokine release syndrome (CRS), consistent with the mechanism of action. ICANS was infrequently observed, and no IMA203CD8-related Grade 5 events occurred. Maximum tolerated dose (MTD) was not reached with doses up to 12.5 billion IMA203CD8 cells.

Anti-tumor Activity and Durability: One-time infusion of IMA203CD8 PRAME cell therapy showed anti-tumor activity across multiple tumor types
Across all evaluated dose levels and tumor types, including lower dose levels not selected for further clinical development, a one-time infusion of IMA203CD8 demonstrated an ORR of 51% (46/90) and a cORR of 41% (36/87). The DCR was 82% (74/90) and 83% (71/86) of patients with evaluable target lesions experienced tumor reduction. Responses were observed across multiple solid tumors expressing PRAME, including ovarian cancer, uterine cancer, melanoma, synovial sarcoma, and others. Durable long-term responses were observed with ongoing responses for more than 2.5 years.

3 patients without any post-baseline scan not evaluable for assessment of tumor reduction, not depicted in the plot, but included in efficacy calculations. For patients achieving a (c)CR with <100% change from baseline, target lesions were lymph nodes that resolved to <10 mm per RECIST 1.1; BOR, best overall response; (c)CR, (confirmed) complete response; PD, progressive disease; (c)PR, (confirmed) partial response; SD, stable disease.

In 20 patients with gynecologic cancers (ovarian and uterine cancer) treated at clinically relevant dose levels (≥DL4c), IMA203CD8 demonstrated consistent anti-tumor activity with an ORR of 60% (12/20) and a cORR of 55% (11/20), a DCR of 70% (14/20) and tumor reduction in 68% (13/19) of patients. Early durability data showed a mDOR of 8.4 months (mFU 6.0 months), a mPFS of 5.8 months (mFU 8.1 months) and mOS not reached at 7.8 months mFU.

1 patient without any post-baseline scan not evaluable for assessment of tumor reduction, not depicted in plot, but included in efficacy calculations; those patients achieving a (c)CR with <100% changes from baseline, target lesions were lymph nodes that resolved to <10 mm per RECIST 1.1; BOR, best overall response; (c)CR, (confirmed) complete response; PD, progressive disease; (c)PR, (confirmed) partial response; SD, stable disease.

Next Development Steps for IMA203CD8:
Phase 1a dose escalation is complete. Immatics is currently enrolling patients with uterine cancer at clinically relevant doses to further expand the clinical dataset in this indication. In addition, a Phase 1/2 investigator-initiated trial (IIT) in patients with PRAME-positive pediatric cancers is planned to start in 1H 2027. The clinical activity of IMA203CD8 observed across tumor types with distinct biology and differing levels of PRAME expression, including ovarian cancer, uterine cancer, melanoma and synovial sarcoma, supports the broad applicability of IMA203CD8 across PRAME-positive cancers. The development approach for IMA203CD8 will leverage targeted cohorts of selected tumor types, such as ovarian cancer, uterine cancer, rare cancers and pediatric cancers to build the clinical evidence base for broader, tumor-agnostic application.

Poster Presentation Summary – Anzu-cel Phase 1b Melanoma Cohort
Additional exploratory analyses (data cutoff Sept 24, 2025) of anzu-cel (anzutresgene autoleucel, IMA203), presented in a poster (2128P) by Sapna Patel, M.D., demonstrated durable clinical benefit following a one-time treatment in a heavily pretreated population of patients with advanced melanoma. Durable clinical benefit was observed across patients with varied baseline clinical and treatment characteristics, with no single characteristic identified as a predictor of prolonged PFS. Exploratory analyses suggested that lower tumor burden, lower LDH, and a higher effector-to-target ratio may be associated with longer PFS. These findings further strengthen the clinical profile of anzu-cel, which is currently being evaluated in the Phase 3 SUPRAME trial in advanced melanoma.

About IMA402 PRAME Bispecific
IMA402 is a molecule from Immatics’ TCR bispecifics (TCER®) pipeline directed against an HLA-A*02:01-presented peptide derived from PRAME. IMA402 is currently being evaluated in a Phase 1b clinical trial in patients with solid tumors expressing PRAME. IMA402 is part of Immatics’ strategy to leverage the full clinical potential of targeting PRAME, one of the most promising targets for TCR-based therapies.

About IMA203CD8 PRAME Cell Therapy
IMA203CD8 is Immatics’ PRAME-directed TCR T-cell therapy engineered to recognize an intracellular PRAME-derived peptide presented by HLA-A*02:01 on the cell surface and initiate a potent and specific anti-tumor response. Co-transduction of CD8αβ with the PRAME TCR adds functional CD4+ T cells designed to boost anti-tumor activity. IMA203CD8 is currently being evaluated in a Phase 1b clinical trial in solid tumors expressing PRAME.

About Anzu-cel PRAME Cell Therapy
Anzu-cel (anzutresgene autoleucel; IMA203) is a PRAME-directed TCR T-cell therapy engineered to recognize an intracellular PRAME-derived peptide presented by HLA-A*02:01 on the cell surface and initiate a potent and specific anti-tumor response. Anzu-cel PRAME cell therapy is currently being evaluated in a registration-enabling randomized controlled Phase 3 trial, “SUPRAME,” in patients with unresectable or metastatic melanoma who have disease progression on or after treatment with at least one checkpoint inhibitor. In parallel, the Phase 1/2 clinical trial is ongoing with a focus on uveal melanoma.

About PRAME
PRAME is a tumor-associated target expressed in more than 50 cancers. Immatics’ PRAME franchise includes multiple product candidates, therapeutic modalities, indications and combination approaches: anzu-cel (anzutresgene autoleucel; IMA203) and IMA203CD8, both PRAME-directed cell therapies, and IMA402, a PRAME-directed bispecific. Combination approaches include IMA402 with immune checkpoint inhibitors, IMA402 with the MAGEA4/8-directed bispecific IMA401, and anzu-cel in combination with Moderna’s PRAME mRNA therapy designed to enhance the cell therapy response.

About Immatics
Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics.

Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates, you can also follow us on LinkedIn and Instagram.

Forward-Looking Statements
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or the Company’s future financial or operating performance. For example, statements concerning timing of data read-outs, the timing, outcome and design of clinical trials, the nature of clinical trials (including whether such clinical trials will be registration-enabling), the timing and outcomes of IND, CTA, BLA and other regulatory filings, the timing of commercial launches, estimated market opportunities, manufacturing timetables, capacity and success rates, the potential benefits of product candidates, the Company’s intended strategy, and other metrics are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “plan”, “target”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions and other risks, uncertainties and factors set forth in the Company’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission (SEC). Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification.

For more information, please contact:

Media
Trophic Communications
Phone: +49 151 74416179
immatics@trophic.eu

Immatics N.V.
Jordan Silverstein
Head of Strategy
Phone: +1 346 319-3325
InvestorRelations@immatics.com

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¹ Patients showed PRAME expression 3-fold higher than the PRAME qPCR threshold, based on an exploratory analysis in the efficacy population. More than 80% of patients with cut. melanoma are estimated to have PRAME-high expression based on Immatics and TCGA RNA seq data.

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• PDF Version

• ZW191 demonstrates compelling anti-tumor activity in heavily pretreated patients with platinum-resistant ovarian cancer across folate receptor alpha (FRα) expression levels
• Confirmed objective response rates (cORR) of 64.5% at the 6.4 mg/kg dose in patients with high-grade serous platinum-resistant ovarian cancer
• Median duration of response not yet reached at either dose level at median 7 months follow-up, with six-month progression-free survival rate of 61% in both groups
• Favorable tolerability profile, particularly at 6.4 mg/kg, supports continued clinical development in partnership or through a strategic collaboration
• Conference call with Zymeworks management on October 27 at 8:30 am Eastern Time (ET)

VANCOUVER, British Columbia, Oct. 24, 2026 (GLOBE NEWSWIRE) — Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets while developing a diverse pipeline of novel, multifunctional biotherapeutics, today presented new clinical data from the randomized dose-optimization portion of its ongoing Phase 1 study evaluating ZW191, a FRα-targeting antibody-drug conjugate (ADC), at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.

The presentation highlights compelling anti-tumor activity in heavily pretreated patients with platinum-resistant ovarian cancer (PROC), including patients with high-grade serous disease across all levels of FRα expression. The results demonstrate compelling response rates, durability and a favorable tolerability profile, particularly at the 6.4 mg/kg dose, further supporting the potential of ZW191 to address limitations of currently available FRα-targeted therapies and expand treatment opportunities for patients with ovarian cancer.

“We are highly encouraged by these results, which further demonstrate the differentiated clinical profile of ZW191 and its potential to deliver meaningful benefit to patients with platinum-resistant ovarian cancer,” said Sabeen Mekan, M.D., Senior Vice President and Chief Medical Officer, Zymeworks. “The robust response rates observed at both doses, including meaningful activity in patients with low or negative FRα expression, reinforce the potential of ZW191 to benefit a broader patient population. Importantly, the encouraging durability of responses and favorable tolerability profile, particularly at 6.4 mg/kg, provide valuable insights to guide dose selection and the next stage of clinical development.”

The analysis included efficacy and safety data from 80 patients with PROC randomized to receive ZW191 at 6.4 mg/kg (n=37) or 9.6 mg/kg (n=43) every three weeks, as of the September 10, 2026 data cutoff date. Patients were heavily pretreated, having received a median of four prior lines of therapy, with 45% receiving five or more prior lines. Median follow-up was seven months. FRα expression was assessed by immunohistochemistry and categorized as low/negative (0%–24%), intermediate (25%–74%) or high (75%–100%) based on the percentage of tumor cells with 2+ or 3+ staining intensity.

Key Findings

Among response-evaluable patients with high-grade serous PROC, ZW191 demonstrated a cORR of 64.5% at 6.4 mg/kg and 55.3% at 9.6 mg/kg, with disease control rates of 100% and 92.1%, respectively. These findings demonstrate compelling anti-tumor activity at both doses in a heavily pretreated patient population.

ZW191 demonstrated meaningful anti-tumor activity across FRα expression in patients with high-grade serous PROC. Confirmed objective response rates were 69.2% in patients with high FRα expression, 50.0% in patients with intermediate FRα expression and 55.0% in patients with low or negative FRα expression. These findings support the potential of ZW191 to show improved efficacy than existing FRα targeted therapies in FRα high population and meaningfully benefit patients with lower expression who may not be eligible for currently approved FRα targeting therapies.

Responses to ZW191 were deep and durable, with median duration of response not yet reached at either dose. Six-month progression-free survival (PFS) was 61% in both groups, while median PFS was 7.9 months at 6.4 mg/kg and 9.8 months at 9.6 mg/kg in patients with high-grade serous PROC. At the time of data cutoff, 45% of patients remained on treatment, and PFS data continue to mature, especially at 6.4 mg/kg.

ZW191 continued to demonstrate a favorable tolerability profile, particularly at 6.4 mg/kg. Grade 3 or higher treatment-related adverse events occurred in 22% of patients receiving 6.4 mg/kg compared with 44% at 9.6 mg/kg. Treatment-emergent adverse events leading to dose reductions occurred in 5% and 33% of patients, respectively, while discontinuations due to adverse events occurred in 14% and 19%. No deaths due to treatment-emergent adverse events were reported in either treatment group. The overall safety profile was manageable and supports continued clinical development.

“These results are particularly promising for patients with platinum-resistant ovarian cancer who have exhausted available treatment options,” said Jung-Yun Lee, M.D., Ph.D., Yonsei Cancer Center and Severance Hospital, Seoul, Republic of South Korea, and primary investigator who presented the results at ESMO 2026. “We observed substantial anti-tumor activity in patients who had received multiple prior therapies, including meaningful responses across high, intermediate and low or negative FRα expression levels. The encouraging durability of responses, together with the favorable safety profile observed at the lower dose, suggests ZW191 has the potential to become an important new treatment option for patients with this difficult-to-treat disease.”

The findings demonstrate encouraging anti-tumor activity across the 6.4 mg/kg and 9.6 mg/kg dose levels, with a more favorable tolerability profile at 6.4 mg/kg. These results will inform optimal dose selection for further clinical development.

ZW191’s differentiated profile, including its novel FRα-targeting antibody, proprietary topoisomerase I inhibitor payload, ZD06519, and high drug-to-antibody ratio, supports its potential to address key limitations of existing therapies and broaden the applicability of FRα-targeted treatment approaches.

The presentation will be available on Zymeworks’ website at www.zymeworks.com/publications/.

Investor Call Details

Zymeworks invites investors and the general public to view and listen to a live webcast of its conference call with investment analysts at 8:30 am ET on October 27, 2026.

Dial-in details and webcast link are available on Zymeworks’ website at https://ir.zymeworks.com/events-and-presentations. A webcast replay of the call will be available on the Zymeworks website within 24 hours following the conclusion of the live call and will be archived for a limited period.

About ZW191

ZW191 is an antibody-drug conjugate engineered to target a protein called folate receptor-⍺ found in ~75% of high-grade serous ovarian carcinomas,¹ over 50% of endometrial cancers^,2,3 and ~70% of lung adenocarcinomas⁴. ZW191’s differentiated design strongly supports its ability to internalize into FR⍺-expressing cells with the potential to release bystander active topoisomerase-1 inhibitor (ZD06519), a novel proprietary payload developed by Zymeworks to kill tumor cells.

The Company has engaged MTS Healthcare to evaluate strategic partnering opportunities to fund further development for ZW191 with the objective of maximizing long-term value.

About Zymeworks Inc.

Zymeworks is a global biotechnology company building a diversified portfolio of healthcare assets designed to generate durable cash flows while advancing innovative medicines for difficult-to-treat diseases. The Company’s asset and royalty aggregation strategy combines a growing portfolio of commercial and near-commercial assets, including YUPELRI® (revefenacin), with a differentiated internal research and development engine. Zymeworks’ portfolio also includes Ziihera® (zanidatamab-hrii), a HER2-targeted bispecific antibody discovered and developed by Zymeworks and commercialized through global partnerships with Jazz Pharmaceuticals and BeOne Medicines, and pasritamig, a clinical-stage multispecific antibody developed by Johnson & Johnson using Zymeworks’ proprietary antibody engineering technologies.

Zymeworks is advancing a diverse pipeline of novel biotherapeutics, leveraging its proprietary Azymetric™ platform and expertise in antibody-drug conjugates, multispecific antibodies and other next-generation antibody technologies. These capabilities, together with Zymeworks’ integrated drug development expertise, enable the Company to develop differentiated therapeutics and create value through both internal innovation and strategic partnerships.

For more information about Zymeworks, its portfolio and pipeline, visit www.zymeworks.com and follow @ZymeworksInc on X.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to the potential safety profile and therapeutic effects of ZW191; Zymeworks’ development of product candidates; status of studies and the related data; anticipated clinical data presentations; Zymeworks’ implementation of its long-term strategy; and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “continue”, “anticipate”, “potential”, “will”, “on track”, “progress”, “preserve”, “intend”, “could”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: any of Zymeworks’ or its partners’ product candidates, including ZW191, may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; Zymeworks may not achieve milestones or receive additional payments or royalties under its collaborations; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty around recent policy developments, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; the impact of global and regional geopolitical or public health developments on Zymeworks’ business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks’ behalf; zanidatamab may not be successfully commercialized; Zymeworks’ business strategy related to anticipated and potential future milestones and royalty streams and existing and potential new partnerships may not be successfully implemented; Zymeworks’ evolution of its business strategy may not deliver meaningful shareholder returns; Zymeworks may be unsuccessful in actively managing and/or aggregating revenue generating assets alongside its active R&D operations; ongoing and future clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates, including ZW191; Zymeworks’ assumptions and estimates regarding its financial condition, future financial performance and estimated cash runway may be incorrect; inability to maintain or enter into new partnerships or strategic collaborations; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at www.sec.gov and www.sedarplus.ca).

Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events.

Contacts:

Investor Inquiries:

Shrinal Inamdar
Vice President, Investor Relations
(604) 678-1388
ir@zymeworks.com   

Media Inquiries:

Diana Papove
Vice President, Corporate Communications
(604) 678-1388
media@zymeworks.com

—

¹ Köbel, M., Madore, J., Ramus, S. et al., Br J Cancer 111, 2297–2307 (2014).
² May B, Conway N, Truong T, Linhart S, et al. FRα, B7-H4, & HER2 Expression in Endometrial Cancer: Assessing the Promise of Antibody Drug Conjugate Therapies. Presented at: SGO 2025 Winter Meeting; January 30 – February 1, 2025; Whistler, British Columbia, Canada.
³ Senol S, Ceyran AB, Aydin A, Zemheri E, Ozkanli S, Kösemetin D, Sehitoglu I, Akalin I. Folate receptor α expression and significance in endometrioid endometrium carcinoma and endometrial hyperplasia. Int J Clin Exp Pathol. 2015 May 1;8(5):5633-41.
⁴ O’Shannessy DJ, et al., Oncotarget. 2012 Apr; 3(4):414-25.

SHANGHAI, China, Oct. 23, 2026 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the first patient dosing has been completed in a randomized, open-label, multicenter phase 3 clinical study of the company’s product, a recombinant humanized anti-CD20/CD3 bispecific antibody (code: JS203), in combination with chemotherapy compared to rituximab in combination with chemotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) (the JS203-003-III-DLBCL Study; NCT07808827). This study is the first registrational clinical study for JS203.

DLBCL is one of the most common types of non-Hodgkin lymphoma (NHL), accounting for approximately 40% of adult NHL cases in China. According to GLOBOCAN 2022 statistics, there are approximately 45,000 new cases of DLBCL in China each year, and the incidence rate shows a slow increasing trend. DLBCL is characterized by high aggressiveness and rapid progression. A retrospective study in an Asian population showed that, even after active treatment, patients with relapsed or refractory DLBCL had a median overall survival (mOS) of over one year and a 5-year survival rate of approximately 30%, which necessitates the exploration of more proactive and effective treatment options.

JS203 is a recombinant humanized anti-CD20/CD3 bispecific antibody self-developed by Junshi Biosciences. It consists of anti-CD20 segment and anti-CD3 segment. By associating and activating lymphoma cells (binding to CD20) and T cells (binding to CD3), JS203 can enable T cells to kill lymphoma cells effectively.

Results from a phase 1 clinical study showed that, for JS203 monotherapy at the recommended phase 2 dose (RP2D) administered with step-up dosing (SUD) to 30 mg for the treatment of patients with CD20-positive relapsed or refractory B-cell non-Hodgkin lymphoma, the objective response rate (ORR) reached 72.4%. Among patients with DLBCL, the ORR was 69.7%, and the complete response rate CRR was 39.4%, with persistent relief observed. Meanwhile, the overall safety profile was manageable, with a cytokine release syndrome (CRS) incidence rate of only 27.3% and no occurrence of immune effector cell-associated neurotoxicity syndrome (ICANS).

The JS203-003-III-DLBCL Study is a randomized, open-label, multicenter phase 3 clinical trial, with Professor Yuqin SONG of Beijing Cancer Hospital serving as the principal investigator. It aims to compare the efficacy and safety of JS203 in combination with chemotherapy compared to rituximab in combination with chemotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma. The study plans to enroll 282 subjects, with overall survival (OS) as its primary endpoint. This study is the first registrational clinical study for JS203.

The JS203-003-III-DLBCL study team commented: “Early clinical studies have shown encouraging efficacy and a favorable safety profile for JS203 in combination with chemotherapy in patients with R/R DLBCL, reinforcing our confidence in the ongoing Phase 3 study. We are committed to advancing the study with rigor and efficiency, with the aim of making a new treatment option available to patients as soon as possible.”

About JS203

JS203 is a recombinant humanized anti-CD20/CD3 bispecific antibody self-developed by Junshi Biosciences. CD20 is a B lymphocyte restricted differentiation antigen and one of the most successful targets for B-cell lymphoma treatment. CD3 is an important marker on the surface of T cells, and the main mechanism of T cell engaging bispecific antibodies is using CD3 as a mediator to activate T cells to specifically attack tumor cells. JS203 consists of anti-CD20 segment and anti-CD3 segment. By associating and activating lymphoma cells (binding to CD20) and T cells (binding to CD3), JS203 can enable T cells to kill lymphoma cells effectively. To date, a Phase 3 clinical study evaluating JS203 in combination with chemotherapy versus rituximab in combination with chemotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) is ongoing.

About Junshi Biosciences

Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. With our outstanding capacity for innovative drug discovery, strong biotechnology R&D capability, and large-scale production capacity, we have successfully developed a drug candidate portfolio with global competitiveness and a well-structured research pipeline, which covers therapeutic areas including cancer, autoimmune, metabolic, and infectious diseases. Our innovative field spans cutting-edge therapeutic modalities, including mAbs, small-molecule drugs, ADCs, bsAb/msAb, fusion proteins, nucleic acid drugs and vaccines. Five of the company’s products have received marketing authorizations in China and international markets, one of which is toripalimab, China’s domestically developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 50 countries and regions including China, the US, and Europe.

With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” The company currently employs more than 3,000 people worldwide. Headquartered in Shanghai, China, it has a business presence in multiple countries and regions around the world. For more information, please visit: http://www.junshipharma.com.

Junshi Biosciences Contact Information

IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-6105 8800

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800

WUHU, China, Oct. 23, 2026 (GLOBE NEWSWIRE) — During Chery International User Summit 2026, CHERY held a family parking challenge carnival at Squirrel Town. Centred on SIVP (Super Intelligent Valet Parking), it combined a parking workshop, scenario challenges and hands-on experiences, showing global guests how intelligent parking can save families time and effort.

A Parking Technology Class Introduces SIVP as the Latest Expression of “Technology. For Family”

At the parking workshop, CHERY presented three “For Family” pillars: “Space. For Family”, “Safety. For Family” and “Technology. For Family”. Guests had experienced the first two through vehicle experiences and a crash-test challenge; SIVP brought the third to life.

CHERY Brand Director Leo Liu counted the 27 sensors on the TIGGO7 together with users on site.

CHERY’s global user research found that parking and finding a space can affect a family’s mood. In supported, mapped car parks, SIVP offers two functions: One Tap Departure lets users select a pick-up point in the app and request the vehicle to travel there; One Step Home assists with parking after users get out. Users must follow app instructions, monitor the vehicle and surroundings, and remain ready to pause or take over.

SIVP uses AI Planner and an end-to-end large model to plan movements, avoid obstacles and respond to changing situations. It marks the first large-scale overseas application of such a model in production vehicles. Its 3R11V12U1L configuration—three millimetre-wave radars, 11 high-definition cameras, 12 ultrasonic sensors and one lidar—provides 360-degree sensing, helping detect obstacles in complex parking spaces and giving families greater peace of mind.

Timed Family Challenges Compare Parking and Vehicle Pick-up

Twelve guests drew lots to form four temporary families, each playing a father, mother and child. Timed challenges compared the SIVP and control groups.

The “Monday Morning Rush” recreated the pressure of getting children ready and leaving early. Each family had to complete a sequence of tasks, including preparing breakfast, tying a tie and helping their child through breakfast, before getting into the car together. The SIVP group could summon the vehicle to the door in advance using a phone, then get straight in once the tasks were finished, avoiding a detour to collect it. The “Easier Family Shopping Challenge” recreated a supermarket trip. The SIVP group could get out and head into the shop, using the app to initiate valet parking, then summon the vehicle back after shopping. The control group had to park manually and carry their purchases back to the car park to find their vehicle. The comparison showed clearly how much time and effort could be saved when parking and collecting a car.

Hands-On Experiences Across Multiple Models Bring Family Feedback into Focus

In the open experience area, guests could visit different zones offering Automatic Parking Assist (APA) demonstrations and SIVP experiences in challenging spaces, including bays at the end of dead-end parking aisles and extremely narrow bays. These activities showcased SIVP’s ability to handle complex parking scenarios. Afterwards, guests completed questionnaires about their experiences. Their feedback will inform ongoing improvements to SIVP, bringing intelligent parking technology closer to families’ actual mobility needs.

From technical explanations in the classroom and clear comparisons in the challenges to hands-on operation in the experience area, the carnival demonstrated CHERY’s understanding of families through the everyday act of parking. Parking need no longer be a burden on family outings, and every minute saved can be spent with loved ones. Through SIVP, “Technology. For Family” is becoming part of daily life for more families.

Contact: Belle Liu
Company Name: Chery Automobile Co., Ltd.
Website: https://www.cheryinternational.com
Email: liubingyu4@mychery.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/29725eca-145f-473a-80d5-56641cd6703d

• The 2026 iCAUR International User Summit opened on October 19 in Wuhu, China, under the theme “Classic Never Fades | Make It Yours.”
• The iCAUR V25 made its global debut and officially went on sale worldwide. Together with the V23 and V27, it rounds out the V-Series lineup, bringing the Future Classic Design concept to life across a comprehensive product portfolio.
• Three officially customized V-Series models will enter global markets. At the summit, 20 customized vehicles were showcased, highlighting the creativity of users from different communities and markets.

WUHU, China, Oct. 23, 2026 (GLOBE NEWSWIRE) — The 2026 iCAUR International User Summit opened in Wuhu, China, on October 19, bringing together more than 500 user representatives from around the world, alongside partners and international media. Under the theme “Classic Never Fades | Make It Yours,” the five-day event brings together product experiences, vehicle customization, user stories and ecosystem activities, highlighting how iCAUR connects its design philosophy with the interests and creativity of users around the world.

The summit showcases the iCAUR V25, three officially customized V-Series models, and 20 customized vehicles. Visitors can also explore the iCAUR brand showroom, take part in a smart factory tour, and experience the V-Series through multi-scenario test drives. The event also marks the introduction of iCAUR’s first group of Brand Ambassadors and highlights the next phase of its global user engagement initiative, Club Connect. Through these activities, iCAUR brings together three key elements of its brand: Future Classic Design, customization and a growing network of users who help shape the brand’s development.

 [A Bustling Scene from 2026 iCAUR International User Summit]

Building a Global Brand Through Products and Local Connections

Since its launch, iCAUR has expanded into more than 40 countries and regions worldwide. The V23 has surpassed 100,000 units in cumulative global sales and received the Red Dot Design Award in 2026, while the V27 won the Best Interior Design Award in the Premium Car Category at the 2026 Torino Automotive Design Award (TADA).

These milestones mark an important stage in the brand’s international development. As iCAUR continues to expand into new markets, it is also working with local partners to strengthen sales and service networks and build lasting relationships with users.

At the summit, Ronna, CEO of iCAUR International, shared the brand’s view that entering a market is only the beginning. Long-term growth comes from understanding users, listening to their ideas and creating experiences that give them more ways to engage with the brand.

iCAUR V25 Expands the V-Series

The iCAUR V25 takes center stage at the summit, further expanding the V-Series alongside the V23 and V27. Built around the brand’s Future Classic Design philosophy, the V25 combines a distinctive boxy silhouette and classic round headlights with modern technology and capabilities for a range of driving scenarios.

 [iCAUR V25 Global Debut]

At the event, Dr. Su Jun, Vice President of Chery Automobile Co., Ltd., explained the thinking behind the V25 through three principles: restraint, capability and freedom.

The design retains the V-Series’ recognizable proportions and signature styling rather than following short-term trends. Its i-SWIFT Agile Handling Platform, Golden REEV powertrain and i-AWD system support a variety of driving conditions, from urban roads to more challenging terrain.

The V25 also leaves room for personalization, with more than 20 ecosystem interfaces. Other features include a 1.8-ton towing capacity, 6 kW vehicle-to-load (V2L) capability, 66.4% space efficiency, 41 storage spaces and a body made of 80% high-strength steel.

Together, the V23, V25 and V27 show how Future Classic Design can take different forms across the V-Series, combining a recognizable design identity with modern technology and opportunities for personal expression.

Three Officially Customized Models Showcase Different Personalities

Customization is a key highlight of the summit, with three officially customized V-Series models presented alongside 20 customized vehicles developed with users and partners.

Each of the three officially customized models reflects a different interest and lifestyle. The V23 Forge brings urban individuality to life with a muscular widebody stance and gloss-black accents, while retaining the V23’s playful character. The V25 Game Changer celebrates the freedom to play, combining the V25’s classic toughness with gaming-inspired details. The V27 Sun Roam draws inspiration from 1980s off-road vehicles and vintage cameras, pairing rugged proportions with carefully crafted details.

 [Three Officially Customized iCAUR Models on Display]

The three models are planned for introduction in global markets by early 2027, through KD production or dealer-installed packages, subject to local regulations and market conditions. Beyond the official builds, the 20 customized vehicles on display demonstrate how users and partners bring their own ideas to the V-Series. Visitors can explore different styles, learn about customization details and exchange ideas with the teams behind the vehicles.

 [Global User Creativity at 2026 iCAUR International User Summit]

Customization is already an important part of the iCAUR user experience. According to the brand, 50% of its users worldwide customize their vehicles. Their choices and ideas also provide inspiration for the brand’s future products and customization offerings.

Looking ahead, iCAUR plans to introduce dedicated customization spaces in its showrooms, giving customers more opportunities to explore personalization options. The brand also plans to present a customized classic vehicle alongside new models at future model launches, offering inspiration for different ways to make an iCAUR their own.

The brand is continuing to expand its customized vehicle lineup, develop accessories suited to local markets and establish quality and safety validation mechanisms for customization offerings. These efforts aim to make customization more accessible while safeguarding quality and safety.

Connecting Vehicles with Lifestyle Experiences

The iCAUR brand showroom brings together vehicle customization, classic lifestyle elements, and user co-creation, offering visitors a broader view of the brand beyond its vehicles.

 [iCAUR Brand Ecosystem Showroom]

Body accessories, outdoor equipment and lifestyle products demonstrate how the vehicle can connect with different interests and everyday activities. Music, travel, surfing and cycling elements reflect the varied ways users explore their interests and express their individuality.

The summit also includes a smart factory tour, giving participants a closer look at iCAUR’s manufacturing processes and quality management. During the event, the V-Series multi-scenario test-drive activities will give participants the opportunity to experience the V25 and V27 across different road conditions, including wavy roads, mud, uneven terrain, S-curves and other driving challenges. Activities involving smart ecosystem partner AiMOGA and green community initiatives are also scheduled as part of the five-day program.

Together, these experiences allow users and partners to explore the vehicles, understand the brand’s design approach and see how iCAUR connects its products with different lifestyles and interests.

From Official User Clubs to Global Club Connect

For iCAUR, the relationship with users continues well beyond vehicle delivery. The brand has established official user clubs in nine countries, bringing owners together to share experiences and connect through common interests.

[2026 iCAUR International User Summit Bird View]

In 2027, iCAUR plans to expand this approach through its global Club Connect initiative, bringing together more users across markets, encouraging the exchange of ideas, and using user feedback to inform future products and experiences.

 [CAUR’s First Group of Brand Ambassadors]

The summit also marks the introduction of iCAUR’s first group of Brand Ambassadors. These users are recognized for their creativity, passion, and contributions to the brand. Through Club Connect, iCAUR plans to continue selecting ambassadors who can share their experiences, contribute to brand activities, and inspire other users in their markets.

User participation also extends to customization. Ideas from users may inspire future officially customized models for global markets, creating further opportunities for users to contribute to how iCAUR products evolve.

As the brand continues its international expansion, iCAUR aims to reach more than 70 markets by 2027. Alongside market development, it will continue working with local partners to strengthen sales and service networks and to develop user engagement in different regions.

The 2026 iCAUR International User Summit brings these priorities together through iCAUR’s vehicles, customized builds, hands-on experiences, and growing network of user clubs and Brand Ambassadors.

Guided by “Classic Never Fades” and “Make It Yours,” iCAUR continues to develop its Future Classic Design philosophy while giving users more opportunities to express their individuality and contribute to the brand. For iCAUR, delivery is not the end of the story, but the starting point for what users can make of their iCAUR.

About iCAUR

Chery Group’s iCAUR is a new energy automotive brand driven by Future Classic Design and technology. Guided by its design philosophy, iCAUR combines classic design elements with modern aesthetics and technology to develop distinctive vehicles for urban mobility and outdoor exploration. With a focus on product innovation and customization, iCAUR offers diverse vehicle choices and personalization options, extending its brand experience through user services and a growing range of user engagements initiatives.

iCAUR’s product portfolio is supported by technologies including i-AWD intelligent electric all-wheel drive and the REEV Golden Range Extender, delivering performance and capability for a range of driving conditions. With a growing presence in more than 40 markets worldwide, iCAUR continues to expand its international business and user engagements, guided by its brand belief: Classic Never Fades.

Serena Wang

Email: wangjieyun2@mychery.com

Website: iCAUR GLOBAL WEB

Photos accompanying this announcement are available at 

https://www.globenewswire.com/NewsRoom/AttachmentNg/89cfa0a8-a584-4046-9b3b-c828e06f96aa

https://www.globenewswire.com/NewsRoom/AttachmentNg/a5f97723-243a-46e4-9f0c-2333661b692f

https://www.globenewswire.com/NewsRoom/AttachmentNg/aa8c1b50-1872-4901-80ac-b1fa0964252c

https://www.globenewswire.com/NewsRoom/AttachmentNg/23245027-98b8-4ebf-b3b3-dbe68455f71a

https://www.globenewswire.com/NewsRoom/AttachmentNg/1f2d2df7-63f4-4a03-8752-24a6e5bbb691

https://www.globenewswire.com/NewsRoom/AttachmentNg/006a0fd4-92d5-4413-a8fc-eeceacb12074

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ALISO VIEJO, Calif., Oct. 23, 2026 (GLOBE NEWSWIRE) — RxSight, Inc. (NASDAQ: RXST) today announced that on October 23, 2026, RxSight granted inducement stock options to purchase a total of 236,456 shares of RxSight’s common stock to two new non-executive officer employees in connection with the commencement of their employment with RxSight. RxSight also agreed to grant inducement restricted stock units (RSUs) covering a total of 637,449 shares of RxSight’s common stock to the same employees in connection with the commencement of their employment with RxSight, which RSUs are anticipated to be granted on or about November 3, 2026.

Each inducement stock option has an exercise price of $5.02 per share, which is equal to the closing price of a share of RxSight common stock on the grant date, and shall vest as follows, subject to continuing service: 25% of the shares subject to such inducement stock option shall vest on the one year anniversary of October 23, 2026, and one forty-eighth (1/48th) of the shares subject to such inducement stock option shall vest monthly thereafter.

Each inducement RSU award shall vest as follows, subject to continuing service: one-sixth of the shares subject to the inducement RSU award shall vest on the first trading day on or after each of February 28, 2027, August 31, 2027, February 29, 2028, August 31, 2028, February 28, 2029, and August 31, 2029.

Each inducement award is subject to the terms of the RxSight, Inc. 2026 Inducement Equity Incentive Plan and related forms of agreements, and were granted as inducements material to these employees to enter into employment with RxSight in accordance with Nasdaq Listing Rule 5635(c)(4).

About RxSight, Inc.

RxSight, Inc. is an ophthalmic medical device company dedicated to providing high-quality customized vision to patients following cataract surgery. The Light Adjustable Lens™ system, comprised of the RxSight Light Adjustable Lens™ products (LAL™ and LAL+™), RxSight Light Delivery Device™ (LDD™), and accessories, is the first and only commercially available intraocular lens (IOL) technology that can be adjusted after surgery, enabling doctors to customize and deliver high-quality vision to patients after cataract surgery. Additional information about RxSight can be found at www.rxsight.com.

Light Adjustable Lens™, LAL™, LAL+™, Light Delivery Device™ and LDD™ are trademarks of RxSight, Inc.

Investor Relations Contact:
Oliver Moravcevic
VP, Investor Relations
omoravcevic@rxsight.com

VANCOUVER, British Columbia, Oct. 23, 2026 (GLOBE NEWSWIRE) — Mirasol Resources Ltd. (TSX-V: MRZ) (OTCPK: MRZLF) (the “Company” or “Mirasol”) announced today that the Board of Directors has approved the grant of 3,878,750 incentive stock options (“Options”) to employees, officers, directors and consultants of the Company.

The Options entitle the holders to purchase the equivalent number of common shares of the Company at a price of $0.30 per common share for a period of five years from the date of grant. The options will vest as follows: 40% on the date of grant, followed by an additional 30% on each of the six and twelve month anniversaries of the date of grant.

All grants of Options are subject to the Company’s Stock Option Plan which was approved by shareholders at Mirasol’s annual and special meeting of shareholders on October 7, 2026.

For further information, contact:

Tim Heenan, President & CEO
or
Troy Shultz, Vice President Investor Relations

Tel: +1 (604) 602-9989
Email: contact@mirasolresources.com
Website: www.mirasolresources.com

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

New Location Marks 8th Store in California

Scottsdale, AZ, Oct. 23, 2026 (GLOBE NEWSWIRE) — Black Rock Coffee Bar, the Oregon-born boutique coffee chain celebrated for its specialty coffees, teas, smoothies, and signature Fuel® energy drinks, is growing its footprint in California with the opening of a new store in Rancho Cucamonga. 

The store, located at 11370 Fourth St, will officially open its doors on Sunday, October 25th. This opening marks Black Rock’s eighth California location and reinforces the brand’s steady expansion across the state. Guests can enjoy the following specials during opening week: 

• Sunday, October 25th: $2 Medium Drinks 

• Monday, October 26th: BOGO Drinks 

• Tuesday, October 27th: 50% Off a Drink w/ Food Purchase 

• Wednesday, October 28th: Signature Grand Opening Sticker with a Purchase 

• Thursday, October 29th: Free T-shirt with a Purchase 

• Friday, October 30th: $2 Off Any Size Drink 

“California has been an important part of Black Rock’s growth, and we’re excited to expand in the state,” said Mark Davis, CEO of Black Rock Coffee Bar. “We look forward to becoming part of the Rancho Cucamonga community and creating a welcoming place for guests to enjoy their favorite drinks and fuel their day!” 

 

Guests can also take advantage of the Black Rock Rewards app, where every purchase—whether in-store, online, or through the app—earns “bolts” that can be redeemed for free beverages. Recent menu additions, like Black Rock’s protein-packed Egg Bites, are also included in the program. 

 

Black Rock Coffee Bar is beloved for its handcrafted beverages, including the Caramel Blondie, a sweet and creamy signature blend; the Mexican Mocha, a spicy twist with hints of vanilla, almond, and cinnamon; and the Jackhammer, a vanilla mocha with an extra double shot; as well as its in-house developed Fuel energy drink, customizable with over 20 fruit flavors.  These can be enjoyed alongside sweet and savory food items, including the recently launched Grilled Cheese and Pumpkin Blondie Cake Pop. For an extra kick of protein, guests can add Black Rock’s new Protein Cold Foam, Protein Boosted Milk or Protein Boost to their drinks. 

 

In addition to Black Rock menu staples, guests can enjoy limited-time offerings like the Pumpkin Spiced Latte, Pumpkin Blondie, and Pumpkin Spice Cookie Latte with Cookie Butter Cold Foam. The brand’s Fall Remix seasonal drinks are also now available, featuring the Caramel Apple Butter Shaken Espresso, Cinnamon Bun Latte, and Spellbound Berry Fuel, offering a mix of nostalgic and refreshing flavors.  

 

For more information, visit https://br.coffee/ and follow @blackrockcoffeebar on Facebook and Instagram, and @blackrockcoffeeofficial on TikTok for updates on new locations, promotions, and seasonal offerings. 

 

About Black Rock Coffee Bar  

Black Rock Coffee Bar is a national boutique coffee shop that is known for its premium roasted coffees, teas, smoothies and flavorful Fuel® energy drinks. Founded as a family owned and operated business in Oregon in 2008, Black Rock Coffee Bar has grown to over 200 retail locations in seven states. The Black Rock culture prides itself on not only being a positive force for the communities it serves, but also the team members that fuel their locations day in and day out. An important aspect of their team mission is to recognize those that go above and beyond by displaying the 4G’s of Black Rock – grit, growth, gratitude, and grace. For more information, visit https://br.coffee/. 

 

Attachments

• Black Rock Coffee Bar
• Black Rock Coffee Bar

CONTACT: Audrey Arbogast
Black Rock Coffee Bar
audrey.arbogast@havasred.com