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137th Canton Fair Opens in Guangzhou

–       The new service robot zone becomes the hotspot for buyers

GUANGZHOU, China, April 15, 2025 /PRNewswire/ — On April 15, the 137th China Import and Export Fair (Canton Fair) officially opened in Guangzhou, drawing global attention as it kicked off one of the world’s largest trade events. Running from April 15 to May 5, the Fair is divided into three phases under the themes of “Advanced Manufacturing,” “Quality Home Life,” and “Better Life.” This edition features 55 exhibition sections and 172 product zones, with newly added zones dedicated to service robots and integrated housing solutions.

The 137th Canton Fair continues to embrace a hybrid model, with its online platform operating all year-round. Enhanced functionality, improved structure, and upgraded services on the digital platform aim to create new business opportunities and help stabilize and improve the quality of China’s foreign trade.

The Deputy Director of China Foreign Trade Centre, Zhang Sihong, welcomed international guests in his opening remarks, highlighting the Fair’s role as a long-standing bridge of global cooperation. “The Canton Fair once again opens its arms to friends from around the world. Here, this spectacular event, we come together to pursue shared success and mutual benefit,” Zhang said.

As of April 13, over 200,000 overseas buyers from 215 countries and regions had pre-registered to attend the fair.

On the opening day, Phase 1 of the Fair, themed “Advanced Manufacturing,” attracted tremendous foot traffic across its 520,000-square-meter exhibition space. A key highlight was the new Service Robots Zone in the Friendship Hall in Area D, where buyers gathered to film product displays of various robots, such as robotic dogs, industrial exoskeletons, and autonomous navigation robots.

From April 15 to 19, Phase 1 showcases the strength of China’s industrial innovation, featuring 11,304 exhibitors, including approximately 3,700 companies focused on electric vehicles, lithium batteries, solar cells, digital technologies, and intelligent manufacturing. The spotlight on advanced technologies and green solutions reflects China’s ongoing transformation into a high-tech manufacturing powerhouse.

With its expanding scale and evolving content, the Canton Fair remains a vital platform for connecting international markets and showcasing China’s industrial progress. As it enters its 137th session, the Fair continues to foster trade cooperation and inspire global partnerships, reaffirming its position as a cornerstone of international commerce.

To learn more about Canton Fair, please download the Canton Fair App at https://cief.cantonfair.org.cn/en/app/appintro.html.


 

First Phosphate Positioned to Power America’s Automated Manufacturing Revival with Secure, Domestic LFP Battery Material Supply Chain


Saguenay, Quebec – Newsfile Corp. – April 15, 2025 – First Phosphate Corp. (CSE: PHOS) (OTCQB: FRSPF) (FSE: KD0) (“First Phosphate” or the “Company”) highlights its strategic role in driving the onshoring of American manufacturing by supplying the domestic Lithium Iron Phosphate (LFP) battery materials essential to factory automation and robotics.

The resurgence of American manufacturing hinges on robotics, factory automation, and grid-scale energy storage—technologies powered by LFP batteries. These phosphate-based batteries are favored for their safety, longevity, scalability, and are rapidly becoming the global standard in industrial automation. This technological transition, fueled by national trade and security policies, is expected by many to ignite a new industrial revolution in the United States.

The demand for industrial automation is expected to reach USD $307.7 billion in 2030. About 60% of all occupations could automate at least 30% of their tasks and boost global productivity by 1.5% annually creating 6 million jobs (Convergix).

Yet, a critical vulnerability threatens this momentum: the LFP battery supply chain is heavily concentrated in China. Ongoing geopolitical tensions, including recently proposed U.S. tariffs of up to 125% on imports from China and potential Chinese export restrictions on LFP technology and rare earth materials, place America’s manufacturing future at risk.

First Phosphate provides a direct and domestic solution. The Company has been actively building a North American LFP ecosystem, vertically integrated from mine to battery-grade material, to ensure supply chain security, transparency, and sovereignty.

“America stands at the cusp of a manufacturing revival driven by AI, robotics, and energy storage,” said John Passalacqua, CEO of First Phosphate. “However, this future hinges on one critical factor: reliable, domestically sourced LFP battery material. First Phosphate reiterates its strategic role in supporting the future of American manufacturing and energy security.”

First Phosphate Strategic Advantages

  • High-Purity Phosphate Resource
    The Company holds over 1,000 sq. km of rare, high-purity igneous phosphate claims in Quebec, capable of supporting over 350 GWh of LFP battery production annually. Its phosphate ore is amongst the purest in the world and is naturally low in deleterious elements and can be mined without solvents.
  • Advanced Processing
    First Phosphate’s high-purity phosphate ore can be fully and sustainably refined into battery-grade material without generating gypsum slag piles, a common byproduct when processing lower grade and lower yielding phosphate ores.
  • Full Vertical Integration
    The Company is uniquely positioned to manage the full value chain-from mining to phosphate processing to LFP cathode active material (CAM) production-ensuring supply traceability, quality control, and supply security.
  • Strategic Location & Infrastructure
    Located in the industrial hub of Saguenay-Lac-Saint-Jean, Quebec, operations benefit from a skilled workforce, regional airport, deep-sea port to global markets, and rail access to North American markets.
  • Strong Partnerships
    First Phosphate is co-developing its supply chain with major partners in the phosphate, iron and LFP battery supply chain, and has established collaborative agreements with local industrial and Indigenous communities.
  • Advanced Development Milestones
    Achievements include a NI 43-101 Technical Report, Preliminary Economic Assessment (PEA), and pilot plants for mineralogy/metallurgy, phosphoric acid, gypsum valorization, and iron powder. Phosphoric acid plant prefeasibility study completed as well as iron phosphate plant feasibility study. Upstream and downstream offtake agreements in place.

Phosphate-based LFP Batteries to Power Industrial Automation

To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/8917/248432_08dae2f564f7db79_001full.jpg

By securing a reliable domestic LFP battery supply chain, First Phosphate aims to empower North American manufacturers to reduce dependence on foreign materials and to lead the next generation of automated, robotic supply chains with confidence.

About First Phosphate Corp.

First Phosphate (CSE: PHOS) (OTCQB: FRSPF) (FSE: KD0) is a mineral development company dedicated to producing high-purity phosphate for the LFP battery industry. The Company is committed to sustainable extraction and purification with a low anticipated carbon footprint. Its vertically integrated model connects phosphate mining directly into the supply chains of North American battery producers. First Phosphate’s flagship project, the Bégin-Lamarche Property in Saguenay-Lac-Saint-Jean, Quebec, contains rare igneous anorthosite rock that yields high-purity phosphate with minimal impurities.

For additional information, please contact:

Bennett Kurtz
Chief Financial Officer
bennett@firstphosphate.com
+1 (416) 200-0657

Investor Relations: investor@firstphosphate.com
Media Relations: media@firstphosphate.com
www.FirstPhosphate.com

Follow First Phosphate:
Twitter
LinkedIn

Forward-Looking Information and Cautionary Statements

This news release contains certain statements and information that may be considered “forward-looking statements” and “forward-looking information” within the meaning of applicable securities laws. In some cases, but not necessarily in all cases, forward-looking statements and forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”, “is expected”, “an opportunity exists”, “is positioned”, “estimates”, “intends”, “assumes”, “anticipates” or “does not anticipate” or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “will” or “will be taken”, “occur” or “be achieved” and other similar expressions. In addition, statements in this news release that are not historical facts are forward-looking statements, including, among other things,: the Company’s planned exploration and production activities; the properties and composition of any extracted phosphate; the Company’s plans for vertical integration into North American supply chains and its ability to ensure supply chain security, transparency and sovereignty; the Company’s future plans relating to the design, build, operation and maintenance of the Bégin-Lamarche Phosphate Mine (and the the possibility of eventual economic extraction of minerals from the therefrom); the Company refining and processing phosphate, supplying LFP battery materials including LFP and CAM and managing the full value chain; the resurgence of American manufacturing and industrial revolution; the impacts of national trade, security, tariffs and export restrictions; LFP batteries becoming the global standard in industrial automation; and co-development with the Company supply chain with major partners.

These statements and other forward-looking information are based on assumptions and estimates that the Company believes are appropriate and reasonable in the circumstances, which may prove to be incorrect, include, but are not limited to, the various assumptions set forth herein and in the Company’s public disclosure record including the short form base prospectus dated June 5, 2024, as well as: there being no significant disruptions affecting the activities of the Company or inability to access required project inputs; permitting and development of the projects being consistent with the Company’s expectations; the accuracy of the current mineral resource estimates for the Company and results of metallurgical testing; certain price assumptions for P2O5 and Fe2O3; inflation and prices for Company project inputs being approximately consistent with anticipated levels; the Company’s relationship with First Nations and other Indigenous parties remaining consistent with the Company’s expectations; the Company’s relationship with other third party partners and suppliers remaining consistent with the Company’s expectations; and government relations and actions being consistent with Company expectations.

There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. There can be no assurance that any opportunity will be successful, commercially viable, completed on time or on budget, or will generate any meaningful revenues, savings or earnings, as the case may be, for the Company. In addition, the Company will incur costs in pursuing any particular opportunity, which may be significant. These factors and assumptions are not intended to represent a complete list of the factors and assumptions that could affect the Company and, though they should be considered carefully, should be considered in conjunction with the risk factors described in the Company’s other documents filed with the Canadian and United States securities authorities, including without limitation the “Risk Factors” section of the Company’s Management Discussion and Analysis dated January 29, 2025 and Annual Report on 20-F dated July 8, 2024, which are available on SEDAR at www.sedarplus.ca. Although the Company has attempted to identify factors that would cause actual actions, events or results to differ materially from those disclosed in the forward-looking information or information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. The Company does not undertake to update any forward-looking information, except in accordance with applicable securities laws.

The issuer is solely responsible for the content of this announcement.

NYSE Content Advisory: Pre-Market update + Bank of America beats earnings estimates

NEW YORK, April 15, 2025 /PRNewswire/ — The New York Stock Exchange (NYSE) provides a daily pre-market update directly from the NYSE Trading Floor. Access today’s NYSE Pre-market update for market insights before trading begins. 

 

NYSE Content Advisory: Pre-Market update + Bank of America beats earnings estimates

Kristen Scholer delivers the pre-market update on April 15th

  • Bank of America (NYSE: BAC) reported better than expected results this morning, raising share price pre-market.
  • General Motors (NYSE: GM) and Ford (NYSE: F) rose after President Trump’s comments around helping auto companies
  • Johnson & Johnson (NYSE: JNJ), Citigroup (NYSE: C), and PNC (NYSE: PNC) highlight upcoming earnings

Opening Bell
Caterpillar (NYSE: CAT) celebrates its 100th anniversary

Closing Bell
Axis Capital (NYSE: AXS) marks the two-year anniversary of Vincent Tizzio as President & CEO

Download the NYSE TV App and Subscribe Here 

 

Bank of America Reports First Quarter 2025 Financial Results

CHARLOTTE, N.C., April 15, 2025 /PRNewswire/ — Bank of America reported its first quarter 2025 financial results today. The news release, supplemental filing and investor presentation can be accessed at Bank of America’s Investor Relations website at https://investor.bankofamerica.com/quarterly-earnings.

Investor Conference Call information
Chief Executive Officer Brian Moynihan and Chief Financial Officer Alastair Borthwick will discuss the financial results in an investor conference call at 8:30 a.m. ET today. For a listen-only connection to the conference call, dial 1.877.200.4456 (U.S.) or 1.785.424.1732 (international), and the conference ID is 79795. Please dial in 10 minutes prior to the start of the call.

Investors can also listen to live audio of the conference call and view the presentation slides by visiting the “Events and Presentations” section of the company’s Investor Relations website.

Replay information for Investor Conference Call
Investors can access replays of the investor conference call by visiting the Investor Relations website or by calling 1.800.934.4850 (U.S.) or 1.402.220.1178 (international) from noon on April 15 through 11:59 p.m. ET on April 25. 

Bank of America

Bank of America is one of the world’s leading financial institutions, serving individual consumers, small and middle-market businesses and large corporations with a full range of banking, investing, asset management and other financial and risk management products and services. The company provides unmatched convenience in the United States, serving approximately 69 million consumer and small business clients with 3,700 retail financial centers, approximately 15,000 ATMs (automated teller machines) and award-winning digital banking with approximately 58 million verified digital users. Bank of America is a global leader in wealth management, corporate and investment banking and trading across a broad range of asset classes, serving corporations, governments, institutions and individuals around the world. Bank of America offers industry-leading support to approximately 4 million small business households through a suite of innovative, easy-to-use online products and services. The company serves clients through operations across the United States, its territories and more than 35 countries. Bank of America Corporation stock is listed on the New York Stock Exchange (NYSE: BAC).

Investors May Contact:

Lee McEntire, Bank of America
Phone: 1.980.388.6780
lee.mcentire@bofa.com 

Jonathan Blum, Bank of America (Fixed Income)
Phone: 1.212.449.3112
jonathan.blum@bofa.com

Reporters May Contact:

Jocelyn Seidenfeld, Bank of America
Phone: 1.646.743.3356
jocelyn.seidenfeld@bofa.com 

XellSmart’s Allogeneic iPSC-derived Cell Therapies for Parkinson’s Disease and ALS Officially Approved by the U.S. FDA for Phase I Clinical Trials

SUZHOU, China, April 15, 2025 /PRNewswire/ — In January 2025 (U.S. time), the U.S. Food and Drug Administration (FDA) officially approved the Investigational New Drug (IND) application submitted by XellSmart Biopharmaceutical (Suzhou) Co., Ltd. for its universal allogeneic off-the-shelf iPS-derived dopaminergic neural progenitor cell therapy for the treatment of Parkinson’s disease (PD), the second most common neurodegenerative disease worldwide. Concurrently, the FDA also granted XellSmart a special exemption to support the clinical trial of XellSmart’s cell therapy for PD in the US.

The approval of XellSmart’s clinical trial, along with the special exemption granted, signifies the FDA’s recognition of XellSmart’s well-established clinical-grade iPSC-derived cell drug development, production, and quality control systems, as well as its completed preclinical safety and efficacy studies. This approval serves as a strong validation of the scientific rigor, professional expertise, and clinical value of XellSmart’s cell therapy for Parkinson’s disease.

Additionally, XellSmart’s allogeneic, off-the-shelf iPSC-derived dopaminergic neural progenitor cell injection (“XS-411 Injection”) has also been approved by China’s National Medical Products Administration (NMPA) to enter Phase I clinical trials. China has the largest population of Parkinson’s disease patients globally, with an estimated 5 million cases projected by 2030. The clinical trial approvals from both the U.S. FDA and China’s NMPA offer hope that XellSmart’s XS-411 could potentially benefit Parkinson’s disease patients not only in China and the U.S. but also worldwide.

Pioneering Achievements in XellSmart’s iPSC-Derived Cell Therapies to treat PD

In 2024, XellSmart successfully conducted a clinical study of GMP-grade iPSC-derived cell therapy for treating Parkinson’s disease patients in China. This study was officially approved by China’s National Health Commission, making XellSmart the first to complete an iPSC-derived cell therapy for Parkinson’s disease in China.

In the clinical study, GMP-grade XS411 cells were transplanted into the striatal putamen of multiple patients with moderate to moderate-to-severe Parkinson’s disease. To date, these patients have been followed for 6 to 12 months, with no adverse events related to XS411 reported. All treated patients showed significant improvements in key efficacy indicators, including increased ON time, reduced MDS-UPDRS scores, and enhancements in non-motor functions. These positive early-stage clinical results provide promising evidence supporting the continued development of XellSmart’s XS411 for Parkinson’s disease patients.

Pioneering Achievements in XellSmart’s FIC Cell Therapies to treat ALS

XellSmart has developed XS228, the world’s first-in-class, off-the-shelf, allogeneic, clinical-grade iPSC-derived cell therapy for ALS, which has been granted Orphan Drug Designation by the U.S. FDA. This designation provides market exclusivity, priority review, and special regulatory supports under the U.S. Orphan Drug Act.

In 2024, XellSmart received official approval from China’s National Health Commission to conduct a clinical study of XS228 for ALS in China, including the world’s first case of allogeneic, off-the-shelf iPSC-derived cell transplantation in an ALS patient. Clinical follow-up results showed that XS228 is safe and effectively slows disease progression compared to the current standard of care.

XellSmart’s off-the-shelf, allogeneic, clinical-grade iPSC-derived cell therapy (XS228) for ALS has been approved by the FDA to enter Phase I clinical trials, making it the first-in-class regenerative neural cell therapy for ALS.

These milestones position XellSmart as a global leader in advancing innovative iPSC-derived regenerative cell therapies for CNS diseases, including Parkinson’s disease and ALS.

Dr. Michael Lee (Xiang Li ), founder and CEO of XellSmart, stated:

April 11th marks World Parkinson’s Disease Day. We named our clinical-grade iPS-derived dopaminergic neural progenitor cell therapy “XellSmart-411 Injection” (XS-411) as a constant reminder to stay true to our mission and remain dedicated to our original aspiration.

XellSmart is committed to developing universal, off-the-shelf, allogeneic, clinical-grade iPSC-derived regenerative cell therapies to address CNS diseases with significant unmet clinical needs.

The FDA’s unconditional approval of the INDs for XellSmart’s XS411 and XS228 products, targeting Parkinson’s disease and ALS, paves the way for these therapies to advance into clinical trials in the United States and lays the foundation for future commercialization in the global market.

XellSmart remains firmly committed to providing allogeneic, off-the-shelf, iPSC-derived regenerative cell therapies to patients with CNS diseases worldwide.”

Funding and BD cooperation contact: BD@xellsmart.com 

About XellSmart

XellSmart is dedicated to developing universal, off-the-shelf, allogeneic, clinical-grade iPSC-derived cell therapies to address Parkinson’s disease and other CNS diseases that currently lack effective clinical solutions.

XellSmart has built a highly skilled, full-time team with extensive international expertise and established a portfolio of proprietary, cutting-edge technologies and platforms to drive sustained innovation in iPSC-derived cell therapies for CNS diseases.

XellSmart operates >5,000+ square meter facility comprising an advanced R&D center, GMP production facility, and quality control center. XellSmart has successfully achieved large-scale manufacturing of multiple GMP-grade iPSC-derived neural progenitor cell therapies.

XellSmart’s allogeneic iPSC-derived cell therapies, XS411 and XS228, targeting Parkinson’s disease and ALS, have been approved to enter Phase I clinical trials in both the United States and China.

To date, XellSmart has secured six rounds of financing from top-tier investors, including Frees Fund, Qiming Venture Partners, Lilly Asia Ventures, Sequoia China, and others, underscoring strong market confidence in its innovative therapies and growth potential.

Funding and BD cooperation contact: BD@xellsmart.com 

 

CIRQUE DU SOLEIL INTRODUCES NEW INTERACTIVE DIGITAL EXPERIENCE, OFFERING BACKSTAGE ACCESS TO FANS

Experience the world of KURIOS – Cabinet of Curiosities like never before with Parallel!, an interactive digital platform that lets viewers explore backstage, follow performers, and navigate the show for total immersion.

MONTREAL, April 15, 2025 /PRNewswire/ — Cirque du Soleil Entertainment Group (“Cirque du Soleil” or “the company”), in collaboration with Imagien, the company behind the interactive digital platform Parallel!, is excited to announce the launch of KURIOS – cabinet of Curiosities – In Parallel!. This groundbreaking digital format offers viewers behind-the-scenes access, parallel storylines, and a curated selection of stunning content, making them feel as if they were truly part of the show!

Cirque du Soleil Entertainment Group announces the launch of KURIOS - cabinet of Curiosities - In Parallel!
Cirque du Soleil Entertainment Group announces the launch of KURIOS – cabinet of Curiosities – In Parallel!

With this new format, friends and family can watch the show together while controlling their own experience and sharing the excitement in real time. By combining their TVs, phones, and tablets, fans unlock an interactive experience that transforms how they watch. It becomes a dynamic, social way to enjoy the show, where everyone can explore different aspects simultaneously.

“Our goal was to create the best possible experience, recognizing the importance of testing the market and understanding how fans would embrace this new offering. The overwhelmingly positive response has reinforced our commitment to delivering a seamless, user-friendly experience that brings the magic of Cirque du Soleil into homes around the world. By seamlessly blending technology, storytelling, and real-time interaction, we are redefining how fans experience Cirque du Soleil—not just as spectators, but as active participants in our universe. With significant effort and innovation, we’ve ensured that audiences can enjoy it anytime, anywhere, with ease and excitement. And this is just the beginning of a deeper, more meaningful connection with our audience—every day of the year”, says Anne Belliveau, Chief Customer Experience Officer at Cirque du Soleil Entertainment Group.

Even before watching the main stage show, viewers can explore the venue in a whole new way. They can visit the VIP area, go backstage to see performers preparing, and witness the detailed work that brings the spectacle to life. Viewers can follow different characters, use an interactive map to navigate through locations, and explore multiple areas of the venue, offering them exclusive access like never before.

For the company, KURIOS – cabinet of Curiosities – In Parallel! marks a pivotal point in how they expand their reach globally and draw new fans to the brand. “It truly aligns with our commitment to bringing Cirque du Soleil into people’s daily lives and encouraging them to attend our Big Top shows when they come to their city” says Anne Belliveau. This new interactive experience in collaboration with Imagien perfectly embodies our vision of going beyond the stage by offering fans our beloved intellectual properties in various formats, available whenever they want” she adds.

The company is currently engaged in active discussions with Imagien to bring viewers more iconic shows from its portfolio in this format and to strengthen its presence in markets across the globe.

“We are proud to partner with Cirque du Soleil and provide the technology and platform behind this revolutionary interactive experience. We are looking forward to supporting Cirque du Soleil as they continue to grow and bring their iconic performances to audiences worldwide” says Danny Theis, CEO of Imagien.

KURIOS – cabinet of Curiosities – In Parallel! is now available for purchase in select markets at https://event.imagien.com/kurios

About Cirque du Soleil Entertainment Group 

Cirque du Soleil Entertainment Group is a world leader in live entertainment. Building on four decades of pushing the boundaries of the imagination, the artistic entertainment company brings its creative approach to a large variety of artistic forms such as live shows, multimedia productions, long-form content, music, immersive experiences, and special events. Since its creation in 1984, more than 400 million people have been inspired on 6 continents and 86 countries. The Canadian company now employs almost 4000 employees, including 1200 artists from more than 80 different nationalities. Along with its affiliates—Blue Man Group, VStar Entertainment Group, and The Works Entertainment—Cirque du Soleil Entertainment Group continues to expand its creative reach. For more information about Cirque du Soleil Entertainment Group, please visit http://www.cirquedusoleil.com.

About Imagien

Imagien, in partnership with world-class entertainment leaders, is transforming the industry by bringing live events into the home. Through its innovative platform and technology, Imagien enables rights holders to turn their live shows into immersive, interactive experiences for audiences at home. By collaborating with rights holders, producers, promoters, and the entertainment industry, Imagien is leading the future of in-home entertainment – delivering live performances to millions of people around the world – all from the comfort of their homes. For more information about Imagien, please visit imagien.com

SECuRE trial update: First patient treated in the Phase II Cohort Expansion

HIGHLIGHTS

  • The first of the planned 24 participants in the Cohort Expansion Phase (Phase II) of the SECuRE trial has been treated with their first dose of 8 GBq of 67Cu-SAR-bisPSMA.This follows the recent recommendation by the Safety Review Committee (SRC) after the successful completion of the Dose Escalation Phase to commence enrollment for the Cohort Expansion Phase at the 8 GBq dose level, with an increase of the number of cycles from up to 4 to up to 6.
  • This participant will be treated with the combination of 8 GBq of 67Cu-SAR-bisPSMA with enzalutamide (androgen receptor pathway inhibitor [ARPI]), as per the recent protocol amendment to include a subset of participants in the Cohort Expansion Phase to receive this combination.
  • Prior to the start of the Cohort Expansion Phase, Clarity rolled out its improved 67Cu-SAR-bisPSMA product formulation. The enhanced formulation offers room temperature stability, supply and scalability, which are essential for late-stage clinical trials and streamlined commercial-scale manufacture.

SYDNEY, April 15, 2025 /PRNewswire/ — Clarity Pharmaceuticals (ASX: CU6) (“Clarity” or “Company”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce the treatment of the first participant with their first dose of 8 GBq of 67Cu-SAR-bisPSMA in the Cohort Expansion Phase of the SECuRE trial (NCT04868604)[1].

The dosing of this participant follows the recent successful completion of the Dose Escalation Phase (Phase I) of the trial and subsequent SRC recommendation to progress to the Cohort Expansion Phase (Phase II) at the 8 GBq dose level, with an increase in the total number of cycles from up to 4 to up to 6. This recommendation is based on the favourable safety profile and efficacy of 67Cu-SAR-bisPSMA observed to date[2].

This participant will be receiving the combination of 8 GBq of 67Cu-SAR-bisPSMA and enzalutamide (ARPI), allowed by a recent protocol amendment. This amendment incorporated an increase in the number of participants in this cohort from 14 to 24, in which a subset of participants will receive this combination therapy. These changes are aligned with the positive results from the Enza-p trial[3] and the ongoing discussions with and advice from key global medical experts in the field of prostate cancer, including the Company’s Clinical Advisory Board members, Prof Louise Emmett and Prof Oliver Sartor, as well as the SRC.

The recently amended SECuRE trial protocol will also focus on the evaluation of metastatic castration-resistant prostate cancer (mCRPC) participants in the pre-chemotherapy setting. This aligns with Clarity’s strategy of bringing 67Cu-SAR-bisPSMA to earlier stages of the disease and is based on its promising safety and efficacy data, especially in pre-chemotherapy participants treated in the SECuRE trial to date. In the Dose Escalation Phase, preliminary data showed that 92% of pre-chemotherapy participants (12/13) demonstrated prostate-specific antigen (PSA) drops greater than 35%, PSA reductions greater than 50% were reached in 61.5% (8/13) of participants, and reductions of 80% or more were achieved in 46.2% (6/13) of participants. These outstanding results were achieved despite many of the 13 pre-chemotherapy participants having considerable disease burden, being heavily pre-treated, and the majority of them only receiving a single dose of 67Cu-SAR-bisPSMA[2].

In preparation for the Cohort Expansion Phase, Clarity rolled out its improved 67Cu-SAR-bisPSMA product formulation. The enhanced formulation allows for room temperature stability, supply and scalability, which are essential for late-stage clinical trials and streamlined commercial-scale manufacture.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, “We are incredibly excited about the progress we’ve achieved in the SECuRE trial to date and look forward to continuing to generate promising data in the Cohort Expansion Phase.

“With the latest protocol amendments ensuring that we are utilising the most recent advances and knowledge in the radiopharmaceutical space, we continue to be driven by the highest standards of clinical trial management and research. At Clarity, we are committed to working with various key opinion leaders in the field and incorporating the most recent findings into our study design to maximise the probability of clinical trial success and positive patient outcomes. As a result, we are focused on bringing 67Cu-SAR-bisPSMA to earlier lines of prostate cancer therapy, especially in the pre-chemotherapy setting, where we have seen very promising safety and efficacy to date. We are also investigating the benefits of combination therapy, where SECuRE participants are being treated with 67Cu-SAR-bisPSMA and enzalutamide based on the results from Prof Emmett’s Enza-p trial and in consultation with global thought leaders in the prostate cancer space.

“We are committed to continuously improving our product and took the opportunity to advance our 67Cu-SAR-bisPSMA formulation prior to dosing our first patients in the Cohort Expansion Phase of the trial. The improvements also help us prepare for the large-scale manufacture in a potential Phase III trial and during commercialisation, allowing for room temperature stability with considerable advantages for supply and scalability. The ability to manufacture 67Cu-SAR-bisPSMA under room temperature reduces the likelihood of batch failures which lead to common supply issues and subsequent product shipment delays. Through the improvements in formulation, we hope that no patient is left waiting for their 67Cu-SAR-bisPSMA treatments.

“We thank our community, our team, Principal Investigators, members of the SRC, and especially the participants who have contributed to the SECuRE study so far. Armed with favourable safety and efficacy data from the Dose Escalation cohorts and with 3 US Food and Drug Administration (FDA) Fast Track Designations for the SAR-bisPSMA molecule, 1 for therapy and 2 for diagnostics, we are closer than ever to delivering on our ultimate goal of improving treatment outcomes for people with cancer.”

About the SECuRE trial

The SECuRE trial (NCT04868604)[1] is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion involving approximately 54 participants in the US and Australia. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

About SAR-bisPSMA

SAR-bisPSMA derives its name from the word “bis”, which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA are unregistered products. The safety and efficacy of 67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that these products will become commercially available.

About Prostate Cancer

Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide[4]. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the US and around 35,770 deaths from the disease[5].

About Clarity Pharmaceuticals

Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancers in children and adults.

www.claritypharmaceuticals.com

For more information, please contact:

Clarity Pharmaceuticals

Dr Alan Taylor 

Catherine Strong

Executive Chairperson

Investor/Media Relations

ataylor@claritypharm.com

c.strong@morrowsodali.com 

+61 406 759 268

References

  1. ClinicalTrials.gov Identifier: NCT04868604, https://clinicaltrials.gov/ct2/show/NCT04868604
  2. Clarity Pharmaceuticals. SECuRE trial update: 92% of pre-chemo participants experience greater than 35% drop in PSA levels across all cohorts. Cohort Expansion Phase commences. https://www.claritypharmaceuticals.com/news/secure-update/
  3. Emmett L et al. ENZA-p Trial Investigators; Australian and New Zealand Urogenital and Prostate Cancer Trials Group. Overall survival and quality of life with [177Lu]Lu-PSMA-617 plus enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer (ENZA-p): secondary outcomes from a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2025 Mar;26(3):291-299. doi: 10.1016/S1470-2045(25)00009-9.
  4. Global Cancer Statistics 2022: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834
  5. American Cancer Society: Key Statistics for Prostate Cancer. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html

This announcement has been authorised for release by the Executive Chairperson.

Complete Genomics Names Four Winners of Spatial Xcellerator Grant Program

SAN JOSE, Calif., April 15, 2025 /PRNewswire/ — Complete Genomics, a leading innovator in genomic sequencing, today announced four winners from 30 applicants to its Spatial Xcellerator Grant Program. Winning projects address oncology, pediatric brain tumors, spinal cord injury and Alzheimer’s disease.

As the exclusive U.S. distributor of STOmics’ Stereo-seq technology for spatial transcriptomics, Complete Genomics launched the Spatial Xcellerator Grant Program and spatial certified service providers last year to promote advancements in spatial omics research.

“We designed the Spatial Xcellerator Grant Program to give scientists access to the most advanced spatial transcriptomics tools available,” said Rob Tarbox, vice president of product and marketing at Complete Genomics. “The creativity and scientific rigor of the winning projects illustrate the enormous potential of spatial omics to unlock new insights in areas like cancer, neurodegeneration and tissue regeneration. We’re proud to support work that will not only push the boundaries of spatial biology but also accelerate the impact of these discoveries on human health.”

Winners of the Spatial Xcellerator Grant Program:

  • Dorothee Günther, postdoctoral fellow, Icahn School of Medicine at Mount Sinai
  • Charles A. Ishak, assistant professor, The University of Texas MD Anderson Cancer Center
  • John Kramer, associate professor, Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia
  • Richard Lu, scientific director, Brain Tumor Center, Cincinnati Children’s

“Spatial transcriptomics provides an unprecedented ability to map gene expression directly within intact and damaged spinal cord tissue, revealing how distinct cell populations and molecular pathways interact at and around the injury site,” said John Kramer, associate professor in the Department of Anesthesiology, Pharmacology & Therapeutics at University of British Columbia, who led one of the winning projects. “By preserving spatial context, this approach enables researchers to pinpoint region-specific responses, uncover hidden cellular heterogeneity and ultimately gain deeper insights into the mechanisms underlying spinal cord injury and repair.”

About Complete Genomics

Complete Genomics is a pioneering life sciences company that provides novel, end to end DNA sequencing solutions. It has been at the forefront of high throughput cost-effective sequencing technology development since its inception in 2005. Our products have powered over 9,400 publications across a wide array of applications. To learn more, visit www.completegenomics.com.

* For Research Use Only. Not for use in diagnostic procedures.