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Shell completes acquisition of combined-cycle power plant in priority U.S. trading market

HOUSTON, Jan. 24, 2025 /PRNewswire/ — Shell Energy North America (US), L.P. (SENA), a subsidiary of Shell plc (Shell), has completed the previously announced 100% equity stake acquisition of RISEC Holdings, LLC (RISEC), which owns a 609-megawatt (MW) two-unit combined-cycle gas turbine power plant in Rhode Island, USA.

This acquisition maintains SENA’s position in the deregulated Independent System Operator New England (ISO New England) power market, securing long-term supply and capacity offtake for Shell. In the coming decades, power demand is expected to increase in the ISO New England market due to growing decarbonization efforts in sectors such as home heating and transportation.

The acquisition has been absorbed within Shell’s cash capital expenditure guidance, which remains unchanged.

Notes to editors

  • This acquisition allows Shell to continue an energy supply agreement that has been in place since 2019 and secure long-term energy offtake from the plant, maintaining Shell’s position in the ISO New England power market. The acquisition preserves SENA’s current operations and mitigates market risk by ensuring a reliable and stable power generation source.
  • RISEC’s two-unit combined-cycle gas turbine power plant has a maximum capacity of 609 MW and an average operating capacity of 594 MW. Serving the ISO New England market, the plant is located outside Providence, Rhode Island, and has been in operation since its completion in 2002.
  • Combined-cycle gas turbine power plants generate electricity via gas turbines, and capture waste heat to produce steam, which drives steam turbines for additional power: a process which enhances efficiency and reduces emissions compared to single-cycle power plants. Such plants provide reliable, flexible power, which balances the intermittency of renewable energy sources like wind and solar.
  • The acquisition is projected to generate an internal rate of return well in excess of the hurdle rate set for Shell’s Power business.
  • Prior to the transaction, the parent company of RISEC was 51% owned by funds managed by global investment firm Carlyle. Prior to the transaction, the remaining 49% owner of RISEC was EGCO RISEC II, LLC, a subsidiary of Electricity Generating Public Company Limited (EGCO), a Thai public limited company.
  • SENA is a full-service energy company providing energy solutions across all aspects of the market. SENA has been active in North American wholesale energy markets for over 25 years and is a market leader in wholesale and retail power, natural gas, and environmental products.

Cautionary note

The companies in which Shell plc directly and indirectly owns investments are separate legal entities. In this press release “Shell”, “Shell Group” and “Group” are sometimes used for convenience where references are made to Shell plc and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to Shell plc and its subsidiaries in general or to those who work for them. These terms are also used where no useful purpose is served by identifying the particular entity or entities. ”Subsidiaries”, “Shell subsidiaries” and “Shell companies” as used in this press release refer to entities over which Shell plc either directly or indirectly has control. The term “joint venture”, “joint operations”, “joint arrangements”, and “associates” may also be used to refer to a commercial arrangement in which Shell has a direct or indirect ownership interest with one or more parties.  The term “Shell interest” is used for convenience to indicate the direct and/or indirect ownership interest held by Shell in an entity or unincorporated joint arrangement, after exclusion of all third-party interest.

Forward-looking Statements

This press release contains forward-looking statements (within the meaning of the U.S. Private Securities Litigation Reform Act of 1995) concerning the financial condition, results of operations and businesses of Shell. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements. Forward-looking statements are statements of future expectations that are based on management’s current expectations and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in these statements. Forward-looking statements include, among other things, statements concerning the potential exposure of Shell to market risks and statements expressing management’s expectations, beliefs, estimates, forecasts, projections and assumptions. These forward-looking statements are identified by their use of terms and phrases such as “aim”; “ambition”; ”anticipate”; ”believe”; “commit”; “commitment”; ”could”; ”estimate”; ”expect”; ”goals”; ”intend”; ”may”; “milestones”; ”objectives”; ”outlook”; ”plan”; ”probably”; ”project”; ”risks”; “schedule”; ”seek”; ”should”; ”target”; ”will”; “would” and similar terms and phrases. There are a number of factors that could affect the future operations of Shell and could cause those results to differ materially from those expressed in the forward-looking statements included in this press release including (without limitation): (a) price fluctuations in crude oil and natural gas; (b) changes in demand for Shell’s products; (c) currency fluctuations; (d) drilling and production results; (e) reserves estimates; (f) loss of market share and industry competition; (g) environmental and physical risks; (h) risks associated with the identification of suitable potential acquisition properties and targets, and successful negotiation and completion of such transactions; (i) the risk of doing business in developing countries and countries subject to international sanctions; (j) legislative, judicial, fiscal and regulatory developments including regulatory measures addressing climate change; (k) economic and financial market conditions in various countries and regions; (l) political risks, including the risks of expropriation and renegotiation of the terms of contracts with governmental entities, delays or advancements in the approval of projects and delays in the reimbursement for shared costs; (m) risks associated with the impact of pandemics, such as the COVID-19 (coronavirus) outbreak, regional conflicts, such as the Russia-Ukraine war, and a significant cybersecurity breach; and (n) changes in trading conditions. No assurance is provided that future dividend payments will match or exceed previous dividend payments. All forward-looking statements contained in this press release are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. Readers should not place undue reliance on forward-looking statements. Additional risk factors that may affect future results are contained in Shell plc’s Form 20-F for the year ended December 31, 2023 (available at www.shell.com/investors/news-and-filings/sec-filings.html and www.sec.gov). These risk factors also expressly qualify all forward-looking statements contained in this press release and should be considered by the reader.  Each forward-looking statement speaks only as of the date of this press release January 24, 2025. Neither Shell plc nor any of its subsidiaries undertake any obligation to publicly update or revise any forward-looking statement as a result of new information, future events or other information. In light of these risks, results could differ materially from those stated, implied or inferred from the forward-looking statements contained in this press release.

Shell’s Net Carbon Intensity

Also, in this press release we may refer to Shell’s “Net Carbon Intensity” (NCI), which includes Shell’s carbon emissions from the production of our energy products, our suppliers’ carbon emissions in supplying energy for that production and our customers’ carbon emissions associated with their use of the energy products we sell. Shell’s NCI also includes the emissions associated with the production and use of energy products produced by others which Shell purchases for resale. Shell only controls its own emissions. The use of the terms Shell’s “Net Carbon Intensity” or NCI are for convenience only and not intended to suggest these emissions are those of Shell plc or its subsidiaries.

Shell’s net-zero emissions target

Shell’s operating plan, outlook and budgets are forecasted for a ten-year period and are updated every year. They reflect the current economic environment and what we can reasonably expect to see over the next ten years. Accordingly, they reflect our Scope 1, Scope 2 and NCI targets over the next ten years. However, Shell’s operating plans cannot reflect our 2050 net-zero emissions target, as this target is currently outside our planning period. In the future, as society moves towards net-zero emissions, we expect Shell’s operating plans to reflect this movement. However, if society is not net zero in 2050, as of today, there would be significant risk that Shell may not meet this target.

Forward-looking non-GAAP measures

This press release may contain certain forward-looking non-GAAP measures such as cash capital expenditure and divestments. We are unable to provide a reconciliation of these forward-looking non-GAAP measures to the most comparable GAAP financial measures because certain information needed to reconcile those non-GAAP measures to the most comparable GAAP financial measures is dependent on future events some of which are outside the control of Shell, such as oil and gas prices, interest rates and exchange rates. Moreover, estimating such GAAP measures with the required precision necessary to provide a meaningful reconciliation is extremely difficult and could not be accomplished without unreasonable effort. Non-GAAP measures in respect of future periods which cannot be reconciled to the most comparable GAAP financial measure are calculated in a manner which is consistent with the accounting policies applied in Shell plc’s consolidated financial statements.

The contents of websites referred to in this press release do not form part of this press release.

We may have used certain terms, such as resources, in this press release that the United States Securities and Exchange Commission (SEC) strictly prohibits us from including in our filings with the SEC.  Investors are urged to consider closely the disclosure in our Form 20-F, File No 1-32575, available on the SEC website www.sec.gov.

Industrial legacy boosts tourism development in Shenyang

BEIJING, Jan. 24, 2025 /PRNewswire/ — A report from People’s Daily: “Every visit brought us new surprises,” said Han Zheng and his wife, who work in Beijing and have traveled to Shenyang, northeast China’s Liaoning province four times in a year.

“For the first trip, we visited the Shenyang Imperial Palace and Zhongjie Street. The second time, we explored the vibrant food scene at Caita Night Market and watched a basketball game. On the third trip, we came to experience the festive atmosphere of the Chinese New Year. And for the fourth, we visited Tiexi district to immerse ourselves in industrial culture,” Han told People’s Daily.

In recent years, with the improvement of the transportation infrastructure network, spontaneous trips to Shenyang have become a popular choice for many. In 2024, Shenyang welcomed over 200 million tourists for the first time, marking a historic breakthrough in tourism revenue.

Once a renowned industrial powerhouse in China, Shenyang has now evolved into a “cultural tourism hotspot” by implementing innovative strategies to develop new cultural tourism experiences and foster a seamless integration of culture and tourism.

In Tiexi district, there is a striking 26-meter-tall sculpture weighing 400 tons that depicts two workers holding a steel rod. It stands prominently on a square, with an old factory building featuring a sawtooth roof behind it. Despite its age, the building exudes a unique artistic vibe.

“This site was once a metal workshop of Shenyang Heavy Machinery Factory. After renovations, it became the 1905 Cultural and Creative Park, where visitors can watch plays, visit exhibitions, and browse creative markets,” said Wang Hui, head of the culture, tourism, broadcasting and television bureau of Tiexi district.

Rich industrial heritage is a defining cultural feature of Shenyang. “We have revitalized 700,000 square meters of industrial heritage areas, combining industrial history with cultural and lifestyle needs to create new cultural landmarks,” said Liu Kebin, head of the culture, tourism, broadcasting and television bureau of Shenyang.

A few kilometers from the 1905 Cultural and Creative Park is the original site of the Shenyang Hongmei MSG Factory. Young people are always seen lining up outside the factory’s raw materials warehouse, now a venue for music performances. The fermentation workshop has been converted into an art center, the union activity room into a taste museum, and the entire factory complex into the vibrant Hongmei Cultural and Creative Park.

In Shenyang, there’s more than the blend of “industrial charm” and “artistic flair.” Major cultural and sports events also add to the city’s appeal. From the 2023–2024 Chinese Basketball Association Finals to the inaugural China (Shenyang) Comedy Film Week, and to the 12th China Acrobatic Exhibition and the 2024 Shenyang Arts Festival, a series of high-profile events took place in the city in 2024.

“We actively cultivate signature events, continuously innovate tourism scenarios, enrich product offerings, and promote the integration of culture, sports, and tourism,” Liu said.

In the afternoon, young people would often flock to a “coffee alley” in Nanshichang sub-district, Heping district, a renowned photogenic spot for social media. At dusk, they head to a market by the Hunhe River to enjoy sunset and night views. After dark, they visit Laobeishi, a cultural landmark of Shenyang, to watch drone performance and experience traditional folk activities like ring toss game and sugar figurine blowing.

The warm, human-centered atmosphere adds to Shenyang’s charm. At 7 a.m., a long queue would form at a famous lyudagun (“donkey rolls”, which are glutinous rice rolls with sweet bean paste) stall in the Xiaoheyan morning market in Shenhe district. Known for affordable goods and friendly shopping environment, Shenyang’s morning markets have become a sensation on social media.

“We aim to embrace new tourism trends by integrating urban renewal projects, such as old neighborhood renovations and street upgrades, to create more youth-friendly blocks that combine scenery, culture, and modern flair,” said Wang Xinwei, secretary of the CPC Shenyang municipal committee.

To further enhance the tourist experience, Shenyang’s culture and tourism departments continuously refine services based on feedback from visitors and online users. From January to November 2024, the city saw a 38.2 percent year-on-year increase in the number of domestic tourists and a 46.0 percent rise in domestic tourism spending, achieving both acclaim and economic benefits.

U Power Announces Pricing of $5.0 Million Registered Direct Offering

SHANGHAI, Jan. 24, 2025 /PRNewswire/ — U Power Limited (Nasdaq: UCAR) (the “Company” or “U Power”), a vehicle sourcing services provider with a vision to becoming a comprehensive EV battery power solution provider in China, today announced that it has entered into a securities purchase agreement with certain institutional investors to sell 1,041,668 Class A ordinary shares (or pre-funded warrants in lieu thereof) of the Company in a registered direct offering. In a concurrent private placement, the Company also agreed to issue and sell to the investors warrants to purchase up to 1,562,502 Class A ordinary shares. The combined effective offering price for each Class A ordinary share and accompanying warrant is $4.80. The warrants are immediately exercisable, expire five years from issuance, and have an initial exercise price of $4.80 per share, which exercise price is subject to standard adjustments for dividends, splits and similar events and is also subject to adjustment for certain dilutive issuances (as defined in the form of warrant).

The gross proceeds to the Company from the registered direct offering and concurrent private placement are estimated to be approximately $5.0 million before deducting the placement agent’s fees and other estimated offering expenses payable by the Company.

The offering is expected to close on or about January 27, 2025, subject to the satisfaction of customary closing conditions.

U Power has also agreed that certain existing Series A warrants to purchase up to an aggregate of approximately 100,000 Class A ordinary shares of the Company that were issued to such institutional investors on or around December 2023, at an exercise price of $120.00 per share, will be amended effective upon the closing of the offering so that the amended warrants will have an exercise price of $4.80 per share.

Maxim Group LLC is acting as the sole placement agent in connection with the offering.

The Class A ordinary shares are being offered pursuant to a shelf registration statement on Form F-3 (File No. 333-282901), which was declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on November 8, 2024. The offering of Class A ordinary shares will be made only by means of a prospectus supplement that forms a part of such registration statement. The warrants to be issued in the concurrent private placement and the Class A ordinary shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the sales of Class A ordinary shares will be filed by the Company with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 300 Park Avenue, New York, NY 10022, Attention: Syndicate Department, or via email at syndicate@maximgrp.com or telephone at (212) 895-3500.

About U Power Limited

U Power Limited is a vehicle sourcing services provider, with a vision to becoming an EV market player primarily focused on its proprietary battery-swapping technology, or UOTTA technology, which is an intelligent modular battery-swapping technology designed to provide a comprehensive battery power solution for EVs. Since its operation in 2013, the Company has established a vehicle sourcing network in China’s lower-tier cities. The Company has developed two types of battery-swapping stations for compatible EVs and is operating one manufacturing factory in Zibo City, Shandong Province, China. For more information, please visit the Company’s website: http://ir.upincar.com/.

Forward-Looking Statements

This press release contains “forward-looking statements.” Forward-looking statements reflect our current view about future events. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations and projections about future events that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. Investors can identify these forward-looking statements by words or phrases such as “may,” “will,” “could,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “is/are likely to,” “propose,” “potential,” “continue” or similar expressions. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in the Company’s registration statement and other filings with the SEC.

Contact

U Power Limited
Investor Relations Department
Email: ir@upincar.com

Robin Yang, Partner
ICR, LLC
Email: UPower.IR@icrinc.com
Phone: +1 (212) 475-0415

Nisun International Announces Preliminary 2024 Financial Guidance and Strategic Business Updates

Company Anticipates Return to Growth in 2025

SHANGHAI, Jan. 24, 2025 /PRNewswire/ — Nisun International Enterprise Development Group Co., Ltd (“Nisun International” or the “Company”) (Nasdaq: NISN), a technology and industry driven integrated supply chain solutions provider, today announced its preliminary revenue and earnings guidance for fiscal year 2024, along with key strategic decisions that position the Company for long-term growth and profitability.

PRELIMINARY 2024 FINANCIAL GUIDANCE

  • Revenue: The Company expects to report revenues in the range of USD 300 million to USD 350 million.
  • Net Income: The Company anticipates net income in the range of USD 11 million to USD 15 million.
  • EPS: The Company anticipates EPS in the range of USD 2.6 USD 3.6.
  • Annual Report: Nisun International expects to release its annual report before the end of April 2025.

“Our preliminary forecasts underscore the progress we are making in reshaping our business and highlight our commitment to enhancing shareholder value,” stated Xin Liu, Chief Executive Officer of Nisun International.

STRATEGIC REVIEW AND BUSINESS REALIGNMENT

Following a comprehensive review of all business segments, Nisun International has decided to reduce selected supply chain trading businesses characterized by low margins and high capital requirements. This move will enable the Company to better allocate resources and capital toward areas offering higher returns and sustainable growth.

FOCUS ON SUPPLY CHAIN FINANCING SOLUTIONS

Going forward, Nisun International will concentrate more on supply chain financing solutions that incorporate a financing component, such as accounts receivable (AR) factoring. These services offer higher margins and lower capital risk by leveraging a platform that arranges financing through third-party financial institutions rather than using Nisun International’s own capital.

“Our recalibration toward supply chain financing solutions is a direct response to market dynamics and our goal of delivering stronger, more sustainable results,” added Xin Liu. “We remain committed to innovation and operational excellence as we reposition our Company for the future.”

EXPANSION OF KFC BUSINESS ON COLLEGE CAMPUSES

Nisun International is also encouraged by the initial success of its KFC operations with its business partner on college campuses and plans to expand this business in the near term. The Company believes this initiative will serve as an additional growth driver, complementing its other core lines of business. For more details on the KFC business and its potential impact on Nisun International’s growth plans, please reference the Company’s upcoming filings and press releases.

OUTLOOK AND CONFIDENCE FOR 2025

With these strategic decisions and ongoing business successes, Nisun International is confident in its ability to return to growth in 2025. According to Xin Liu, “We are forging a bright path forward—committed to innovation, adaptability, and delivering value for our stakeholders.”

About Nisun International Enterprise Development Group Co., Ltd

Nisun International Enterprise Development Group Co., Ltd (NASDAQ: NISN) is a technology-driven, integrated supply chain solutions provider focused on transforming the corporate finance industry. Leveraging its industry experience, Nisun International is dedicated to providing professional supply chain solutions to Chinese and foreign enterprises and financial institutions. Through its subsidiaries, Nisun International provides users with professional solutions for technology supply chain management, technology asset routing, and digital transformation of tech and finance institutions, enabling the industry to strengthen and grow. At the same time, Nisun International continues to deepen the field of industry segmentation through industrial and financial integration. Focusing on industry-finance linkages, Nisun International aims to serve the upstream and downstream of the industrial supply chain while also assisting with supply-side sub-sector reform. For more information, please visit http://ir.nisun-international.com/

Cautionary Note Regarding Forward-Looking Statements

This press release contains information about Nisun International ‘s view of its future expectations, plans and prospects that constitute forward-looking statements. Actual results may differ materially from historical results or those indicated by these forward-looking statements as a result of a variety of factors including, but not limited to, risks and uncertainties associated with its ability to raise additional funding, its ability to maintain and grow its business, variability of operating results, its ability to maintain and enhance its brand, its development and introduction of new products and services, the successful integration of acquired companies, technologies and assets into its portfolio of products and services, marketing and other business development initiatives, competition in the industry, general government regulation, economic conditions, dependence on key personnel, the ability to attract, hire and retain personnel who possess the technical skills and experience necessary to meet the requirements of its clients, and its ability to protect its intellectual property. Nisun International encourages you to review other factors that may affect its future results in Nisun International ‘s registration statement and in its other filings with the Securities and Exchange Commission. Nisun International assumes no obligation to update or revise its forward-looking statements as a result of new information, future events or otherwise, except as expressly required by applicable law.

Crypto Markets Lukewarm on Trump’s Inauguration: Bybit and Block Scholes Report

DUBAI, UAE, Jan. 24, 2025 /PRNewswire/ — Bybit, the world’s second-largest cryptocurrency exchange by trading volume, released the latest weekly crypto derivatives report in collaboration with Block Scholes, recognizing crypto markets’ subdued bullish sentiment in an almost anti-climatic turn of events after Trump’s inauguration.

The 2025 presidential inauguration triggered a wild weekend of speculation with Trump family meme coins TRUMP and MELANIA, tilting derivative markets toward a bullish shift. However, the anticipated BTC-related executive orders failed to materialize, causing implied volatility to drop although realized volatility rose. Perpetual and options markets maintained high funding rates and a persistent bullish tilt, reflecting the complex speculative environment as crypto’s sunny expectations met political uncertainty.

Key Insights:

SOL’s Spotlight Moment: Trump’s issuance of “husband and wife” coins sparked an all-time high in Solana perpetual swaps, driven by traders anticipating crypto-friendly policies. The TRUMP meme coin’s launch on Solana DEXs elevated the network’s fee generation, symbolically positioning it above Ethereum competitors.

Sources: Bybit, Block Scholes
Sources: Bybit, Block Scholes

Derivatives Market Resilience: Perpetual swap funding rates remained neutral-to-bullish despite minimal crypto-positive inauguration announcements, with open interest showing stable positions. Derivatives markets viewed the event as just one of many potential catalyst opportunities.

BTC Options Speculation: Earlier anticipation of a potential strategic BTC reserve triggered significant short-tenor options positioning, resulting in robust call buying and the strongest at-the-money term structure inversion since the November 2024 election. While front-end volatility pricing has moderated, the strong skew toward out-of-the-money calls persists.

Access the full report, including detailed analysis of volatility trends, funding rates, and options market dynamics.

#Bybit / #TheCryptoArk /#BybitResearch

About Bybit

Bybit is the world’s second-largest cryptocurrency exchange by trading volume, serving a global community of over 60 million users. Founded in 2018, Bybit is redefining openness in the decentralized world by creating a simpler, open and equal ecosystem for everyone. With a strong focus on Web3, Bybit partners strategically with leading blockchain protocols to provide robust infrastructure and drive on-chain innovation. Renowned for its secure custody, diverse marketplaces, intuitive user experience, and advanced blockchain tools, Bybit bridges the gap between TradFi and DeFi, empowering builders, creators, and enthusiasts to unlock the full potential of Web3. Discover the future of decentralized finance at Bybit.com.

For more details about Bybit, please visit Bybit Press
For media inquiries, please contact: media@bybit.com
For updates, please follow: Bybit’s Communities and Social Media

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Clarity receives U.S. FDA Fast Track Designation for Cu-64 SAR-bisPSMA in biochemical recurrence of prostate cancer

SYDNEY, Jan. 24, 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 children and adults with cancer, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for 64Cu-SAR-bisPSMA for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions in patients with biochemical recurrence (BCR) of prostate cancer following definitive therapy.

This milestone builds on Clarity’s earlier receipt of an FTD for 64Cu-SAR-bisPSMA in patients with suspected metastasis of prostate cancer who are candidates for initial definitive therapy[1]. These 2 FTDs enable the Company to accelerate the development of its comprehensive diagnostic program with this product.

The FDA’s FTD is designed to expedite the development and regulatory review of novel drugs addressing serious conditions with significant unmet medical needs. For 64Cu-SAR-bisPSMA, it provides a number of product development advantages. The designation paves the way for a faster review process once Clarity submits its product approval applications. Additionally, it enables more frequent communication with the FDA, allowing for rapid resolution of queries during development. Furthermore, Clarity can submit completed sections of its application as they are ready, rather than waiting for the entire package to be finished before it can be lodged with the FDA. These benefits would reduce the review time needed to bring this innovative prostate cancer imaging agent to market, potentially improving diagnosis and treatment planning for patients sooner.

The FTD submission highlighted several advantages of 64Cu-SAR-bisPSMA over currently approved PSMA PET agents due to the bivalent structure of bisPSMA and the longer half-life of 64Cu (12.7 hours vs. <2 hours for 18F and 68Ga). These advantages include improved diagnostic performance, flexible imaging schedule and broader availability. The data for this FTD submission was primarily focused on the results of the Phase I/II COBRA study, which assessed the safety and diagnostic performance of 64Cu-SAR-bisPSMA in detecting prostate cancer in patients with BCR of their disease who had a negative or equivocal standard of care (SOC) scan at study entry. Advantages have been shown with same-day and next-day imaging, however, the standout was next-day 64Cu-SAR-bisPSMA PET imaging, showing localised disease in up to 80% of participants and detecting lesions as small as 2 mm. This compares favourably against the current SOC PSMA PET agents, with which the detection of lesions smaller than 5 mm is challenging. The number of lesions detected by 64Cu-SAR-bisPSMA on next-day imaging almost doubled compared to same-day imaging, and 64Cu-SAR-bisPSMA was also able to identify more lesions at much earlier timepoints compared to approved PSMA PET agents.

The COBRA trial paved the way for Clarity’s second diagnostic registrational trial, AMPLIFY, and an investigator-initiated trial (IIT) Co-PSMA, led by Prof Louise Emmett at St Vincent’s Hospital Sydney. The AMPLIFY trial will be a non-randomised, single-arm, open-label, multi-centre, Phase III diagnostic clinical trial of 64Cu-SAR-bisPSMA PET in approximately 220 participants with rising or detectable PSA after initial definitive treatment. As a pivotal trial, the final study results are intended to provide sufficient evidence to support an application to the FDA for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in prostate cancer in patients with BCR. The Co-PSMA IIT will aim to build on the evidence generated so far, evaluating the diagnostic performance of 64Cu-SAR-bisPSMA in comparison to SOC 68Ga-PSMA-11 for the detection of recurrent prostate cancer lesions with curative intent.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, “Receiving the second FTD for 64Cu-SAR-bisPSMA and well within the 60-day period following our application submission, reserved by the U.S. FDA for review, is yet another significant milestone in our bisPSMA program. This highlights the high unmet need for novel diagnostics in prostate cancer and the high quality of data we presented to the FDA.

“The market for first-generation diagnostic PSMA PET today is approximately US$2 billion (AU$3.2 billion) in the U.S. alone, with little differentiation between products. It is expected to further grow to US$3 billion (AU$4.75 billion) by 2029. The development pipeline of new products coming to market, outside of 64Cu-SAR-bisPSMA, also offers no differentiation from the existing offering, with some new entrants commercialising the unpatented 68Ga-PSMA-11 agent, which has been capitalised on by three separate groups already.  

“Being able to now fast-track the development of 64Cu-SAR-bisPSMA for patients with BCR as well as for patients prior to initial definitive therapy is incredibly exciting. The news is especially timely as we are actively preparing to commence recruitment for our second registrational trial, AMPLIFY, in the coming months. The designation will allow us to work closely with the FDA to facilitate the development process and accelerate the approval of what could become a best-in-class diagnostic.

“The dual targeting structure of bisPSMA enables increased uptake and retention of the product in the lesions, while the longer half-life of copper-64 provides greater flexibility with imaging scheduling, including next-day imaging (something that gallium-68 and fluorine-18 based products cannot support). When combined, these features make 64Cu-SAR-bisPSMA stand out from its competitors who are known to have issues with sensitivity. We have seen 2-3 times higher uptake in prostate cancer lesions and the identification of more lesions using 64Cu-SAR-bisPSMA compared to 68Ga-PSMA-11 in pre-prostatectomy patients in our PROPELLER study. The COBRA trial results showed great diagnostic performance in the BCR setting, with lesions identified by 64Cu-SAR-bisPSMA in the 2-mm range and visualised many months before SOC PSMA PET agents are able detect them.

“Not only are we developing a product that may have improved diagnostic performance compared to SOC PSMA PET agents, but the longer half-life of copper-64 also enables a longer shelf-life of 64Cu-SAR-bisPSMA than currently used diagnostic radiopharmaceuticals, allowing for centralised manufacture and wider distribution. These attributes have the potential to reduce disparities in prostate cancer care and ensure that most patients, regardless of geographic location, can benefit from the latest advances in diagnostic technology.

“This designation highlights the unique opportunity for 64Cu-SAR-bisPSMA in this very large market by addressing the limitations of the current-generation diagnostic radiopharmaceuticals and providing patients with prostate cancer with a more accurate diagnosis leading to more optimal treatment options. As such, we are fully committed to advancing the development of this best-in-class product to address the critical need for more accurate and accessible diagnostic tools in prostate cancer management.”

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.

64Cu-SAR-bisPSMA is an unregistered product. The safety and efficacy of 64Cu-SAR-bisPSMA has not been assessed by health authorities such as the U.S. FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that this product will become commercially available. Among 82 patients who received 64Cu-SAR-bisPSMA in PROPELLER and COBRA, 2 adverse reactions were reported in 2 participants (mild occasional metallic taste and moderate worsening of type II diabetes, both resolved)[2],[3].

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 U.S. 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] Clarity Pharmaceuticals. Clarity receives FDA Fast Track Designation for 64Cu-SAR-bisPSMA. https://www.claritypharmaceuticals.com/news/fast-track/ 

[2] Lengyelova et al.  64Cu-SAR-bisPSMA (PROPELLER) positron emission tomography (PET) imaging in patients with confirmed prostate cancer. ASCO, 2023.

[3] Nordquist et al. COBRA: Assessment of safety and efficacy of 64Cu-SAR-bisPSMA in patients with biochemical recurrence of prostate cancer following definitive therapy. EANM, 2024.

[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.

Akluer Celebrates 520 Dual-Sided Treadmill Milestone with Customer Appreciation Day

NEW YORK, Jan. 24, 2025 /PRNewswire/ — Akluer, the global leader in innovative fitness solutions, is excited to announce that its revolutionary 520 Dual-Sided Treadmill has sold over 5,000 units in its first month. To celebrate this achievement and thank our customers, Akluer will host a special discount event on January 28, 2025 to February 14, 2025. 

 

Akluer Dual-Sided Treadmill: The Top Health Gift Choice for 2025

Introducing the Akluer 520 Dual-Sided Treadmill

Akluer’s latest innovation is set to transform home fitness by integrating a treadmill and a foot massager into one stylish and space-saving device. The Akluer Treadmill is designed to cater to users of all ages and body types, making it an ideal addition to any household. Its multifunctional design not only saves space but also provides a seamless transition between high-intensity workouts and soothing relaxation sessions.

Akluer 520 Dual-Sided Treadmill (Original: $399.99, Special Discount: $139.99):

Fitness and Relaxation in One Space-Saving Device, combining fitness and relaxation in a versatile, modern design. Switch easily between running and foot massages, perfect for any home. The nature-inspired massage mimics cobblestone paths for a soothing experience. Four modes—Walking, Jogging, Massage, and Pet Walking—meet diverse needs. An 8-point shock absorption system protects knees and ankles, while a non-slip, 5-layer belt and double-layer frame ensure stability. Dual screens display speed, time, distance, calories, and massage settings. A 2.5HP motor supports up to 330 lbs, delivering stable, high-intensity performance. The Akluer Treadmill brings efficiency and comfort to every family.

Akluer’s Commitment to Innovation

Akluer is a global leader in fitness technology, dedicated to transforming the way people engage with health and wellness. The Akluer 520 Dual-Sided Treadmill is the latest testament to the brand’s commitment to bringing cutting-edge fitness solutions to homes worldwide.

Pricing and Availability

Customers who purchase the 520 Dual-Sided Treadmill during this period will receive a $260 discount and enjoy a one-year warranty.

The Akluer 520 Dual-Sided Treadmill is now available for purchase at a special price of $139.99 on the Akluer website (www.akluer.com). For more information about Akluer and its innovative products, visit their official website.

Akluer continues to push the boundaries of fitness technology, making health and wellness accessible and enjoyable for everyone. The Akluer Treadmill is more than just a fitness device; it’s a lifestyle choice that combines efficiency, innovation, and relaxation.

Akluer website: www.akluer.com
Youtube: www.youtube.com/@akluer
Ins : www.instagram.com/akluer_offical/
TK: www.tiktok.com/@akluer
Pinterest: www.pinterest.com/Akluer_official/
FB page: www.facebook.com/Akluer
FB group: www.facebook.com/groups/akluer

Media Contact: Bo Li, finn.mertens@akluer.com 

Akluer Dual-Sided Treadmill: The Top Health Gift Choice for 2025
Akluer Dual-Sided Treadmill: The Top Health Gift Choice for 2025

Nuevocor Welcomes Andreas Wallnöfer as Chairman of the Board of Directors

SINGAPORE and PHILADELPHIA, Jan. 24, 2025 /PRNewswire/ — Nuevocor, an IND-stage biotechnology company dedicated to developing functional cures to treat cardiomyopathies with aberrant mechanobiology, today announces the appointment of Dr. Andreas Wallnöfer as Chairman of Nuevocor’s Board of Directors.   

Andreas Wallnöfer has over 25 years of experience in the pharmaceutical and biotech industry, including 12 years as a member of the F. Hoffmann-La Roche Pharma R&D Executive Leadership team and nearly a decade serving as a board member for several biotechnology companies. He has been a Partner at the Swiss venture capital firm BioMedPartners and later at Jeito Capital, a global leading European investment company based in Paris.

An accomplished investor, board member and operator, Andreas has played a pivotal role in successfully developing many innovative companies. He has contributed to numerous successful exits, including the recent acquisition of EyeBio by MSD for a total deal value of US$3 billion, achieved only three years after the company’s inception.

Prior to his career in venture capital, he was Head of Cardiovascular and Metabolism (CVM) R&D at Roche and a member of the Roche/Genentech Portfolio Committee. Andreas was part of several successful product developments and market introductions. Before the integration of Genentech (now a wholly owned member of the Roche Group), Andreas was Global Head of Clinical Research and Exploratory Development and led the R&D organization at multiple sites in Europe, the U.S., and Asia. He had a key role in the integration of the Roche and Genentech development organizations and, subsequently, led Roche’s Early Development Department.

“We are extremely pleased to welcome Andreas as Chairman of Nuevocor’s Board and look forward to benefiting from his experience in life-sciences investment as well as expertise in cardiovascular diseases,” said Dr. Yann Chong Tan, PhD, CEO and Co-Founder of Nuevocor. “Having moved several companies towards successful exits, Andreas’ experience will be a major asset to Nuevocor as we continue to grow and demonstrate the value of our therapeutic assets in treating cardiomyopathies.”

“Nuevocor is at the frontier of next generation gene therapy. Particularly as former Head of Cardiovascular Research and Development at Roche, it is very motivating to see how Nuevocor’s promising technology may sustainably benefit and improve the lives of patients with cardiomyopathies” said Dr. Andreas Wallnöfer.

About Nuevocor

Nuevocor is a biotechnology company that is pioneering an innovative pathway-centric approach to developing functional cures for heart conditions known as cardiomyopathies. By harnessing our PrOSIA mechanobiology platform, Nuevocor designs genetic medicines to target the biomechanical root cause of these diseases. Nuevocor’s approach surpasses the limitations of traditional gene therapy, which focuses on individual gene mutations, to treat defects within shared disease pathways across multiple genetic cardiomyopathies. This enables us to extend our impact to broader patient populations.