CStone Pharmaceuticals Enters into Exclusive Commercialization Agreement with Arrotex for Sugemalimab across Australia and New Zealand

On June 25, 2026 CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, immunology, inflammation, and other key disease areas, reported that it has entered into an exclusive commercialization agreement with Arrotex Pharmaceuticals Pty Ltd ("Arrotex"), a core pharmaceutical commercialization platform of DBG Health ("DBG"), Australia’s largest diversified healthcare group, for the commercialization of sugemalimab in Australia and New Zealand.

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Under the terms of the agreement, CStone will receive an upfront payment from Arrotex and is eligible for additional regulatory and commercial milestone payments. CStone will supply sugemalimab to Arrotex and recognize a profit share arrangement.

Arrotex will hold exclusive commercialization rights for sugemalimab in Australia and New Zealand across all approved and future indications, including stage III and IV non-small cell lung cancer (NSCLC), gastric cancer (GC), esophageal squamous cell carcinoma (ESCC), and extranodal NK/T-cell lymphoma (ENKTL), subject to regulatory approval by Australia’s Therapeutic Goods Administration (TGA). Arrotex will be responsible for regulatory submissions and commercialization activities in the licensed territory.

Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated: "This agreement with Arrotex marks another milestone in the global commercialization of sugemalimab, successfully extending its commercialization reach into the Oceania region. Australia and New Zealand are well-established pharmaceutical markets with regulatory frameworks closely aligned with those of the EU and US. As the core commercialization platform of DBG, Arrotex’s commercialization infrastructure and established pharmacy network position is well placed to support the introduction of sugemalimab in these markets. Building on sugemalimab’s existing approvals in the EU and the UK for stage III and IV NSCLC, this collaboration provides a clear and efficient regulatory pathway for Australia and New Zealand. This milestone brings sugemalimab’s global commercial footprint to five strategic partnerships, covering over 60 countries and regions across Europe, the Middle East and Africa, Latin America, and Oceania."

Dennis Bastas, Chairman and Group Chief Executive Officer of DBG Health, the parent company of Arrotex Pharmaceuticals, said: "We are excited to be partnering with CStone to bring this innovative therapy to Australia and New Zealand. This partnership enables early commercial planning for CStone’s product while bringing together two organisations with a shared commitment to improving outcomes for people affected by cancer." Mr Bastas added, "Arrotex’s deep expertise in regulatory engagement, market access, and distribution across Australia and New Zealand – combined with CStone’s strong development capabilities – positions us well to accelerate access to this important new treatment for patients across multiple indications."

About Sugemalimab

The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.

The EC and MHRA have approved sugemalimab for two indications:

In combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations; and
Monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 expression on ≥1% of tumor cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based CRT.
The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications:

In combination with chemotherapy as first-line treatment of patients with metastatic squamous and non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and metastatic squamous NSCLC;
For the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based CRT;
For the treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
In combination with fluorouracil and platinum-based chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC; and
In combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression CPS ≥5.
ESMO Guidelines recommend sugemalimab [I, A] for:

In combination with platinum-doublet chemotherapy as first-line treatment for non-oncogene-addicted stage IV patients with squamous NSCLC, performance status (PS) 0-1, regardless of tumor PD-L1 status and without contraindications for immune checkpoint inhibitors (ICI);
In combination with platinum-based chemotherapy as first-line treatment for patients with non-squamous NSCLC, PS 0-1, regardless of tumor PD-L1 status and without contraindications for ICI; and
Consolidation therapy for up to 24 months in patients with stage III NSCLC, who are EGFR wild-type and lack ALK or ROS1 genomic aberrations, following concurrent or sequential chemoradiotherapy without disease progression.

(Press release, CStone Pharmaceauticals, JUN 25, 2026, View Source [SID1234668958])

Nuvation Bio Announces Proposed Convertible Senior Notes Offering

On June 25, 2026 Nuvation Bio Inc. ("Nuvation Bio") (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported its intent to offer, subject to market conditions and other factors, $200.0 million aggregate principal amount of Convertible Senior Notes due in 2032 (the "Notes") in an underwritten offering (the "Offering"). Nuvation Bio also intends to grant the underwriters of the Notes a right to purchase, exercisable within 30 days of the date of the prospectus supplement relating to the Offering, up to an additional $30.0 million aggregate principal amount of Notes, solely to cover over-allotments, if any.

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The Notes will be general unsecured obligations of Nuvation Bio, with any interest payable semiannually in arrears and will mature on July 1, 2032, unless earlier converted, redeemed or repurchased. Upon conversion, Nuvation Bio will pay or deliver cash, shares of Nuvation Bio’s Class A common stock, par value $0.0001 per share ("Class A common stock"), or a combination of cash and shares of Class A common stock, at its election. The interest rate, initial conversion rate and other terms of the Notes will be determined at the time of pricing of the Offering.

Nuvation Bio expects to use the net proceeds from the Offering (i) to pay the cost of the capped call transactions described below, (ii) to repay in full all obligations under our senior secured loan agreement, and (iii) for general corporate purposes, which may include working capital, operating expenses, capital expenditures and general and administrative expenses.

In connection with the pricing of the Notes, Nuvation Bio expects to enter into capped call transactions with one or more of the underwriters or affiliates thereof and/or other financial institutions (the "Option Counterparties"). If the underwriters exercise their over-allotment option, Nuvation Bio expects to enter into additional capped call transactions. The capped call transactions will cover, subject to customary adjustments, the number of shares of Class A common stock initially underlying the Notes. The capped call transactions are expected generally to reduce the potential dilution to the Class A common stock upon any conversion of Notes and/or offset any cash payments Nuvation Bio is required to make in excess of the principal amount of converted Notes, as the case may be, with such reduction and/or offset subject to a cap.

In connection with establishing their initial hedges of the capped call transactions, Nuvation Bio expects the Option Counterparties or their respective affiliates will enter into various derivative transactions with respect to the Class A common stock concurrently with or shortly after the pricing of the Notes, including with certain investors in the Notes. This activity could increase (or reduce the size of any decrease in) the market price of the Class A common stock or the Notes at that time.

In addition, the Option Counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to the Class A common stock and/or purchasing or selling Class A common stock or other securities of Nuvation Bio in secondary market transactions following the pricing of the Notes and prior to the maturity of the Notes (and are likely to do so during the 40-trading day period beginning on the 41st scheduled trading day prior to the maturity date of the Notes, or, to the extent Nuvation Bio exercises the relevant election under the capped call transactions, following any repurchase, redemption or conversion of the Notes). This activity could also cause or avoid an increase or a decrease in the market price of the Class A common stock or the Notes which could affect a noteholder’s ability to convert the Notes and, to the extent the activity occurs during any observation period related to a conversion of Notes, it could affect the number of shares, if any, and value of the consideration that a noteholder will receive upon conversion of its Notes.

The Notes are being offered pursuant to a "shelf" registration statement on Form S-3 (File No. 333-285621), including a base prospectus, that was previously filed by Nuvation Bio and automatically became effective under the rules of the Securities and Exchange Commission (the "SEC") on March 6, 2025. A preliminary prospectus supplement relating to the Offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the Offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, by telephone at 877-821-7388 or by email at [email protected]; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions 1155 Long Island Avenue, Edgewood, NY 11717, by phone at 1-800-831-9146; Cantor Fitzgerald & Co. by mail at Attention: Capital Markets, 110 East 59th Street, New York, NY 10022 or by email at [email protected]; or RBC Capital Markets, LLC, Attn: Equity Capital Markets, 200 Vesey Street, 8th floor, New York, NY 10281, by telephone at 877-822-4089 or by email at [email protected]. Before investing in the Offering, you should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that Nuvation Bio has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus, which provide more information about Nuvation Bio and the Offering.

Jefferies LLC, Citigroup and Cantor Fitzgerald & Co. are acting as joint bookrunning managers for the Offering. RBC Capital Markets, LLC is acting as bookrunner for the Offering.

This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

(Press release, Nuvation Bio, JUN 25, 2026, View Source [SID1234668957])

GRAIL Completes $110 Million Equity Financing With Samsung Entities

On June 25, 2026 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported the closing of its previously announced equity financing with Samsung affiliates including Samsung C&T Corporation.

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Pursuant to the definitive agreement, the Samsung entities invested $110 million in GRAIL through the purchase of shares of GRAIL common stock at a price of $70.05 per share, representing a long-term investment in support of GRAIL’s growth and international expansion objectives.

"This investment from the Samsung entities further strengthens our balance sheet and extends our cash runway as we advance key priorities, including securing regulatory approval and reimbursement for Galleri in the United States and expanding access to multi-cancer early detection internationally," said Aaron Freidin, Chief Financial Officer of GRAIL. "We are pleased to complete this financing and look forward to deepening our strategic collaboration with Samsung as we work to bring Galleri to patients in Asia."

As previously announced, GRAIL and Samsung C&T Corporation intend to collaborate to commercialize the Galleri multi-cancer early detection test in South Korea, with the potential to expand into additional Asian markets, including Japan and Singapore, subject to regulatory approvals and other conditions. Initial testing will continue to be performed at GRAIL’s clinical laboratory in Research Triangle Park, North Carolina.

"GRAIL is at a pivotal moment in its mission to transform early cancer detection. This investment in GRAIL, together with the strategic business collaboration, represents a significant milestone in advancing Samsung C&T’s vision expanding access to cancer early detection. We are excited to bring the benefits of innovative screening technologies to more people in South Korea and Asia, and believe this partnership will bring us one step closer to GRAIL and Samsung C&T’s shared goal of transforming cancer care through earlier detection," said Jaywoo Kim, Executive Vice President of Life Science Business at Samsung C&T.

Latham & Watkins LLP served as legal advisor and Morgan Stanley & Co. LLC served as financial advisor to GRAIL. Samsung was advised by Covington & Burling, BKL, and E&Y Han Young (Korea).

(Press release, Grail, JUN 25, 2026, View Source [SID1234668956])

Racura Oncology Doses First Patient in Phase 1 HARNESS-1 Trial of RC220 in EGFR-Mutant Non-Small Cell Lung Cancer

On June 25, 2026 Racura Oncology Limited (ASX: RAC), a clinical-stage biopharmaceutical company developing new small molecule based approaches to cancer treatment, reported that the first patient has been dosed with RC220 in HARNESS-1, a Phase 1a/b clinical trial evaluating RC220 in combination with osimertinib in patients with epidermal growth factor receptor-mutant (EGFR-mutant) non-small cell lung cancer (NSCLC). The first patient received RC220 at 50 mg/m2 by intravenous infusion. No adverse events were observed.

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HARNESS-1 is designed to test whether RC220, Racura’s proprietary formulation of (E,E)-bisantrene, can be safely combined with osimertinib (Tagrisso; AstraZeneca), a third-generation EGFR tyrosine kinase inhibitor (TKI) and standard-of-care therapy for EGFR-mutant NSCLC to delay or prevent TKI treatment resistance. Although EGFR TKIs have transformed outcomes for many patients with EGFR-driven lung cancer, acquired treatment resistance remains a central therapeutic challenge.

Daniel Tillett, Ph.D., Chief Executive Officer of Racura Oncology, said: "Dosing the first patient in HARNESS-1 is an important milestone for Racura and for the clinical development of RC220. The scientific rationale for this trial is grounded in the urgent need to address TKI therapeutic resistance in EGFR-mutant NSCLC. RC220 gives us the opportunity to explore whether targeting G4-DNA and RNA structures, including MYC-associated growth pathways, can delay EGFR TKI resistance arising and support a new therapeutic combination for patients treated with osimertinib. We are grateful to Associate Professor Surein Arulananda and the Monash Health team for enrolling and treating the first participant, and to the patients and families who make this research possible."

Scientific Rationale

EGFR-mutant NSCLC is a molecularly stratified lung adenocarcinoma subtype driven by constitutive EGFR kinase signaling and initial sensitivity to EGFR inhibition. However, responses to EGFR tyrosine kinase inhibitors, including osimertinib, are typically limited by acquired resistance, arising through heterogeneous mechanisms such as secondary EGFR alterations, bypass receptor tyrosine kinase activation, MAPK/PI3K pathway reactivation, oncogenic fusions, lineage plasticity, epithelial-to-mesenchymal transition and histologic transformation.

RC220 is being developed to target the non-canonical G-quadruplex DNA and RNA structures enriched in oncogenic regulatory regions, including promoters, untranslated regions and highly transcribed loci. Stabilization of these structures can disrupt transcriptional and post-transcriptional control networks that sustain malignant proliferation, including silencing the c-MYC-regulated growth and survival pathways.

HARNESS-1 is designed to evaluate the safety and tolerability of RC220 with continued osimertinib-mediated EGFR suppression, while generating pharmacokinetic, pharmacodynamic, molecular response and translational biomarker data.

HARNESS-1 Trial Design

HARNESS-1 is a multi-center Phase 1a/b clinical study in patients with EGFR-mutant NSCLC receiving osimertinib. The study includes an observational screening stage using ctDNA to help identify eligible patients and characterize tumor molecular status before treatment.

The Phase 1a dose-escalation stage will evaluate RC220 administered by intravenous infusion on Day 1 of each 21-day cycle in combination with standard-of-care maintenance osimertinib. The first three dose levels will use single-patient cohorts at 50 mg/m2, 100 mg/m2 and 150 mg/m2, before progressing to larger cohorts to identify the maximum tolerated dose and an appropriate dose for further study. Between 12 and 40 patients are expected to participate in the dose-escalation stage.

Following review of available safety and pharmacokinetic data, the study is expected to advance into a double-blind, randomized Phase 1b expansion stage. In this dose expansion stage, 40 patients will receive one of two RC220 dose levels in combination with osimertinib. Patients will be monitored for safety, pharmacokinetics and early signals of clinical activity, including progression-free survival, overall survival, ctDNA dynamics and changes in cancer-specific mutations.

The first patient was treated by Principal Investigator Associate Professor Surein Arulananda and his team at Monash Health in Clayton, Victoria. Additional clinical trial sites are expected to open in the coming months to support patient recruitment and study progress.

Clinical Trial Information

Further details about HARNESS-1, including open and recruiting sites, are available through the Australian and New Zealand Clinical Trial Registry at www.anzctr.org.au under trial code ACTRN12626000325303. Clinical trial inquiries may be directed to Racura Oncology at [email protected].

About RC220 & (E,E)-bisantrene

RC220 is a proprietary formulation of (E,E)-bisantrene designed to overcome drug solubility issues that prevent safe peripheral intravenous infusion. (E,E)-bisantrene, is a clinical validated small molecule anticancer agent that primarily functions via G4-DNA and RNA binding, leading to potent transcriptional silencing of the important cancer growth regulator c-MYC.

(Press release, Racura Oncology, JUN 25, 2026, View Source [SID1234668955])

Phio Pharmaceuticals Announces “How siRNA Therapy can Change the Course of Cancer Treatment” in a Fireside Chat with Force Family Office on Monday, June 29, 2026

On June 25, 2026 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported that Mr. Robert Bitterman, CEO and Chairman of the Board, Phio Pharmaceuticals will participate in a fireside chat with Harvey Briggs, Chief Communications Officer, Force Family Office. Joining them will be James Cardia, Ph.D., who will explore siRNA therapy and skin cancer treatments.

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"We are excited to take part in this fireside chat with Force Family Office," said Robert Bitterman, CEO and Chairman of Phio Pharmaceuticals. "Dr. Jim Cardia will discuss the future direction of siRNA oncology and highlight how our INTASYL siRNA program represents a differentiated and innovative approach to immuno-oncology."

DATE: Monday June 29, 2026

TIME: 12 PM EDT

REGISTRATION LINK: PHIO Pharma – Force Family Office

(Press release, Phio Pharmaceuticals, JUN 25, 2026, View Source [SID1234668954])