Wednesday, February 19, 2025

PIONEERING NEW STANDARDS IN HIGH BANDWIDTH CONNECTIVITY WITH CAVLI CQM200 5G NR CELLULAR IOT MODULE


The CQM200 5G NR Sub-6 IoT Module sets new benchmarks for data speeds and carrier aggregation, making it the ideal choice for high-bandwidth IoT solutions across Industry 4.0, smart cities, and beyond


SAN JOSE, Calif., Feb 19 (Bernama-GLOBE NEWSWIRE) -- Cavli Wireless, a leading innovator in IoT solutions, is thrilled to announce the unveiling of its flagship 5G NR Sub-6 CQM200 Cellular IoT Module. The CQM200 is engineered to meet the strict demands of high throughput connected applications, delivering high-speed 5G NR connectivity IoT-enabled applications. With this launch, Cavli continues to solidify its position as a trusted partner for OEMs developing next-generation automotive solutions.

The CQM200 module is engineered to provide superior 5G NR Sub-6 performance, adhering to 3GPP Release 17 standards. The CQM200 module measures 45 x 52 mm* and is offered in an LGA form factor. It offers exceptional download speeds of up to 3.7 Gbps and upload speeds of up to 2.5 Gbps, addressing the needs of high-throughput, data-heavy IoT applications. Built on the Qualcomm SDX72 chipset, the module integrates state-of-the-art components, including a Quad-Core Arm Cortex A55 processor and Qualcomm Hexagon DSP processor, to handle complex computing tasks with seamless efficiency.

A key feature of the CQM200 is its 3x Carrier Aggregation (3CA) capability. This allows the module to aggregate multiple carrier frequencies, optimizing the available radio spectrum for higher data speeds and better network reliability. With a 100MHz bandwidth, this module ensures continuous, high-quality connectivity, even under demanding conditions. Applications that require ultra-low latency even in areas of network congestion, like real-time industrial control systems, smart surveillance, or autonomous vehicles, benefit significantly from the CQM200’s speed and network resilience.

Equipped with global compatibility, the CQM200 supports eSIM technology and multi-constellation GNSS (L1+L5), facilitating worldwide deployments. Whether for asset tracking, real-time data analytics, or other location-based services, this module ensures seamless connectivity in even the most challenging environments. The inclusion of GNSS guarantees precise positioning, enabling accurate location-based services critical for modern IoT solutions. The CQM200 caters to a wide range of industries, delivering transformative solutions for IoT applications. In Industry 4.0, the module's high throughput and advanced processing capabilities facilitate real-time monitoring and predictive maintenance for industry floors with a multitude of machines that generate large volumes of data. This enables manufacturers to optimize operational costs and minimize downtime by employing Industrial gateways/routers powered by the module. For smart cities, the CQM200 supports intelligent infrastructure, such as smart surveillance solutions and public safety systems, ensuring more efficient and responsive urban environments. In the logistics and transportation sectors, the module’s GNSS capabilities and robust connectivity enable accurate real-time tracking, improving operational efficiency and ensuring the security of high-value assets.

The CQM200’s Hubble integration further enhances its capabilities by introducing remote diagnosis, monitoring, and debugging of the module along with Hubble Applet service, an advanced component of the Cavli Hubble IoT connectivity & modem management platform. This feature eliminates the necessity for physical intervention, simplifying the expansion of IoT solutions. Through strategic alliances with operators worldwide, Cavli has established a substantial presence, delivering unparalleled connectivity solutions that set new standards in service quality and cost-effectiveness.

John Mathew, the CEO and the Chief Technology Architect of Cavli Wireless, remarked, “The introduction of the CQM200 module marks a crucial moment for both Cavli and the IoT industry. With its 5G-NR Sub-6 capability, massive data throughput, and advanced processing power, the CQM200 is designed to address the increasingly complex demands of high-performance applications that require ultra-low latency connectivity along with seamless scalability for deployments across the world.”

By combining advanced features with seamless global connectivity, Cavli continues to set new standards for reliability, scalability, and innovation in cellular IoT. As the IoT landscape evolves, the CQM200 stands as a testament to Cavli’s vision of enabling future-ready connectivity solutions that empower industries and drive technological advancement. We encourage you to engage with our solution specialists to explore how CQM200 can enhance your upcoming project.

About Cavli Wireless

Cavli Wireless is a cellular IoT module manufacturer that combines IoT connectivity and data management into one platform. Cavli designs and manufactures industrial-grade cellular IoT smart modules that improve equipment reliability and expedite application development processes. Cavli's smart cellular modules are equipped with global cellular connectivity through integrated eSIM functionality that provides users with affordable global data pricing, simplified device management, and centralized subscription management through the proprietary cloud-based platform Cavli Hubble.

CONTACT:

Abhinand Dinesh

Sr. Associate - Corporate Marketing

Cavli Wireless

abhinand.dinesh@cavliwireless.com

+91-9605750306

https://www.cavliwireless.com/


A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ae7d10e0-8540-4ba5-b71a-2231daad0206


SOURCE : Cavli Inc

Tuesday, February 18, 2025

ASEAN-JAPAN WOMEN ENTREPRENEURS’ SUMMIT IN KUALA LUMPUR EMPOWERS WOMEN IN BUSINESS, INNOVATION



KUALA LUMPUR, Feb 18 (Bernama) -- The ASEAN-Japan Centre (AJC), in collaboration with the ASEAN Youth Organization and with the support of the ASEAN Coordinating Committee for Micro, Small, and Medium Enterprises (ACCMSME) and Women Leadership Foundation Malaysia, successfully hosted the ASEAN-Japan Women Entrepreneurs’ Summit in Kuala Lumpur.

The summit emphasised the pivotal role of women entrepreneurs in driving economic innovation, sustainability, and inclusivity across the ASEAN-Japan region, aligning with Malaysia’s 2025 ASEAN Chairmanship, according to a statement.

The summit gathered over 100 women entrepreneurs, investors, business accelerators, and ecosystem enablers from across the ASEAN Member States and Japan. It provided a platform to discuss the challenges and opportunities faced by 60 million women entrepreneurs, particularly in scaling their contributions to economic and social growth.

MyDigital Corp Board Member, and BlueOnion Advisor and Regional Chief Executive Officer (CEO), Dato’ Munirah Looi delivered a keynote emphasising the importance of agility, resilience, customer experience, and employee engagement for adapting businesses, especially in response to economic disruptions like the COVID-19 pandemic.

Meanwhile, a key session titled “Harnessing AI and Digital Skills” explored how technology can drive the growth of women-led enterprises. Lennise Ng, CEO of Borong, highlighted that digitalisation must precede artificial intelligence (AI) adoption, stressing the need for stronger digital infrastructure. The speakers also called for government policies to make innovation more accessible for women entrepreneurs.

The session on “Strategic Access to Finance and Gender-Lens Investment” focused on the financial challenges women entrepreneurs face, such as understanding grants, securing the right investors, and the importance of women’s representation in investment firms.

The “Easing Women’s Burden: Innovations in the Care Economy” session showcased innovative solutions, such as Kiddocare in Malaysia, which uses digital platforms to connect families with care providers. The role of fathers in sharing caregiving responsibilities was also emphasised, with Better Dads Malaysia advocating for inclusive parenting.

The session on “Leveraging Sustainability for Growth and Impact” explored the significance of mentorship for women entrepreneurs. Capping off the summit, the “Closing the Gender Divide and Enabling Women-owned Enterprises to Scale” session highlighted the key resources needed for scaling women-owned businesses.

Speakers emphasised the importance of incorporating entrepreneurship education from an early age to change sociocultural narrative and foster empowerment.

The ASEAN-Japan Women Entrepreneurs’ Summit underscored the power of collaboration among businesses, investors, governments, and communities in empowering women-led MSMEs, paving the way for stronger economic integration and long-term growth in the region.

-- BERNAMA


Saturday, February 15, 2025

INAUGURAL SFA INTERNATIONAL SPORTING EVENTS CONCLUDES, WITH MORE THAN 35,000 SFA EXPO VISITORS AND OVER 40,000 RIYADH MARATHON PARTICIPANTS

 

Inaugural SFA International Sporting Events concludes, with more than 35,000 SFA Expo visitors and over 40,000 Riyadh Marathon participants (Photo: AETOSWire)


RIYADH, Saudi Arabia, Feb 13 (Bernama-BUSINESS WIRE) -- 
The Saudi Sports for All Federation (SFA) is celebrating the success of the inaugural 2025 SFA International Sporting Events, which combined the SFA Expo and the Riyadh Marathon. Held from February 5-7, 2025, the SFA Expo took place at the JAX District, while the Riyadh Marathon followed on February 8, 2025.

 
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250212912259/en/ 


The SFA Expo attracted 35,359 visitors, with interactive sports zones, fitness classes, health exhibits, and engaging panel discussions, and a B2B lounge for industry professionals. The Primal Race functional fitness competition on February 7 was another major attraction.

The 2025 Riyadh Marathon saw 40,494 participants from 131 countries, an impressive jump from 20,000 runners in 2024. It was organized in partnership with the Ministry of Sport, the Saudi Arabian Olympic & Paralympic Committee, the Saudi Arabian Athletic Federation, and Amanat AlRiyadh.

Four races took place: the full marathon (42km), half marathon (21km), 10km race, and a family-friendly 4km run. A significant proportion of participants, 67%, were Saudi nationals, reflecting the growing enthusiasm for sports in the Kingdom. Also, 40% were female.

The top male and female finishers in the elite marathon categories received US$30,000 each, with additional prizes for second and third. Winners in the half marathon elite race also won cash prizes, with US$5,000 for first place.

Saudi Awwal Bank (SAB) was the presenting partner for the marathon, with ASICS, Tawuniya, Aquafina and Gatorade as strategic partners for both events. Medical support at the SFA Expo was provided by Dr. Sulaiman Al Habib Medical Services Group (HMG), with Ford, Calo, JP Morgan, Centrum, KAFD, Kayanee, and Joe & the Juice all marathon supporting partners. Official partners of the marathon included Kudu, MDLBEAST Radio, and BAE Systems, with Kayanee and Delta Sports the official partners of SFA Expo, and SPIMACO and Huawei official partners of both. JAX District was a venue partner for SFA Expo.

The SFA looks forward to building on this success in future editions, continuing to inspire the Kingdom’s residents and visitors to lead healthier, more active lives.

About the Saudi Sports for All Federation (SFA)

The Saudi Sports for All Federation (SFA), a proactive community sport and wellness organization founded to promote a healthy lifestyle in the Kingdom of Saudi Arabia, aims to provide access to opportunities for all members of society to practice physical activity. Partnering with government organizations, sports delivery bodies, sports federations, and the wider public and private sector to achieve its goals, the SFA focuses on increasing physical activity and health and wellness metrics across the country. Physical activity is achieved by advancing four strategic priorities: education; community and volunteering; fitness and wellbeing; and campaigns and promotion. The SFA does this by designing and deploying recreational sports programs tailored for women, men, youth, the elderly, and persons with disabilities across Saudi Arabia.

Source: AETOSWire

 
View source version on businesswire.com: https://www.businesswire.com/news/home/20250212912259/en/

Contact

Malek Abdelrahman
mabdelrahman@apcoworldwide.com 

Source : Saudi Sports for All Federation

--BERNAMA

Thursday, February 13, 2025

UNI-FUELS ACHIEVES INTERNATIONAL SUSTAINABILITY AND CARBON CERTIFICATIONS FOR SUSTAINABLE BIOFUELS



KUALA LUMPUR, Feb 13 (Bernama) -- Singapore-headquartered Uni-Fuels Holdings Limited (Uni-Fuels), a global marine fuel solutions provider, announced that its wholly owned subsidiary, Uni-Fuels Pte Ltd (Uni-Fuels Singapore), has received both ISCC EU and ISCC PLUS certifications.

The certifications were granted by the International Sustainability and Carbon Certification (ISCC), a globally recognised independent multi-stakeholder initiative and leading certification system supporting sustainable, fully traceable, deforestation-free, and climate-friendly supply chains.

“Achieving ISCC certifications demonstrates our commitment to supporting the global transition to cleaner fuels. With Proof of Sustainability documentation, we provide our customers with the assurance that the biofuels they rely on are responsibly produced and fully compliant with evolving regulations,” said Uni-Fuels Vice President, Operations, Tan Guan Kai in a statement.

These certifications highlight the company’s commitment to sustainability and compliance with European Union (EU) regulations aimed at reducing greenhouse gas (GHG) emissions in the maritime industry.

The ISCC certifications ensure that the biofuels traded by Uni-Fuels Singapore meet the requirements of the EU’s Renewable Energy Directive (RED II), including the provision of Proof of Sustainability (PoS).

This important documentation ensures biofuels are sustainably sourced and produced, enabling full traceability from feedstock to final product.

As the maritime sector moves toward greater decarbonisation, it is essential for biofuel suppliers to demonstrate compliance with regulatory standards, including the EU Emissions Trading System (EU ETS) and FuelEU Maritime. The PoS documentation ensures biofuels can be counted toward emissions reduction targets, unlike fossil fuels.

The PoS framework, along with the ISCC EU and ISCC PLUS certifications, assures customers that the biofuels they rely on are sustainably sourced, traceable, and meet high sustainability standards. These certifications ensure regulatory compliance and enhance transparency, helping build trust in the biofuel sector.

-- BERNAMA

Saturday, February 8, 2025

AKWEL RECORDS 7.3 PCT REVENUE DROP IN 2024

KUALA LUMPUR, Feb 7 (Bernama) -- AKWEL posted a consolidated revenue of 989.0 million euros for fiscal year 2024, marking a 7.3 per cent decrease from 1.0664 billion euros, the previous year. (1 euro = RM4.59)

The last quarter of 2024 confirms the trend observed in the previous quarters, with revenue down 13.5 per cent to 231.2 million euros, according to a statement.

For the full year, revenues at constant scope and exchange rates fell by 7.0 per cent, despite a positive foreign exchange impact of 2.2 million euros.

The geographical revenue distribution highlights that France continues to perform significantly worse compared to the rest of the world.

AKWEL’s product lines also saw a general downturn, though Cooling (1.3 per cent) and Air ( 2.6 per cent) remained nearly stable, while Decontamination (24.4 per cent) experienced the largest decrease, given the winding down of Selective Catalytic Reduction (SCR) tanks production, scheduled to end in 2025.

The company’s consolidated net cash, excluding lease liabilities, amounted to 145 million euros on Dec 31, 2024, an increase of 4.5 million euros from Sept 30, with 10.8 million euros of investments made this quarter.

Despite this, the overall decline in activity is expected to result in a decrease of approximately two points in the current operating margin for the group.

Looking ahead, AKWEL anticipates a similar decline in activity for 2025, driven by the ongoing challenges in the global automotive market and the uncertainty surrounding the mix of electric, hybrid, and internal combustion engine vehicles.

AKWEL is a parts and systems manufacturer for the automotive and heavy-vehicle industry, and a specialist in fluid management, mechanisms and structural parts for electric vehicles.

-- BERNAMA

Friday, February 7, 2025

ZENAS BIOPHARMA ANNOUNCES KEY 2024 ACCOMPLISHMENTS AND 2025 BUSINESS OBJECTIVES TO SUPPORT THE GLOBAL DEVELOPMENT AND COMMERCIALIZATION OF THERAPIES FOR AUTOIMMUNE DISEASES

- Advancing Phase 2 and Phase 3 trials of obexelimab, a unique CD-19 x FcγRIIb inhibitor of B cell function-

-Topline results from Phase 2 Trial in Relapsing Multiple Sclerosis (MoonStone) expected in third quarter 2025-

-Topline results from pivotal Phase 3 Trial in Immunoglobulin G4-Related Disease (INDIGO) expected year-end 2025-

- Enrollment of Phase 2 Trial in Systemic Lupus Erythematosus (SunStone) expected to be completed in 2025-

- Out-licensed greater-China anti-IGF-1R Thyroid Eye Disease programs to Zai Lab -

WALTHAM, Mass., Feb 6 (Bernama-GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of therapies for autoimmune diseases, today announced its 2024 accomplishments, outlined its key business objectives for 2025 and announced preliminary unaudited cash balance as of year-end 2024.

“Based upon the progress achieved across all of our corporate goals and objectives during 2024, we enter 2025 with an opportunity to achieve major value-driving milestones with the anticipated results from our ongoing obexelimab Phase 2 and Phase 3 clinical trials,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. “We are extremely proud of the accomplishments of our dedicated team as we enter the year well-financed and able to focus on execution, and achievement of our key objectives for the year.”

The Company enters 2025 well-capitalized to deliver its key milestones with approximately $350 million in cash, cash equivalents, and short-term investments as of December 31, 2024, 1 which is expected to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2026.

2024 Accomplishments and Recent Achievements

During 2024, the Company achieved the following objectives and announced a recent business development transaction:
  • Completed enrollment of the Phase 3 INDIGO trial, a global Phase 3 registration-directed, randomized, double-blind placebo-controlled trial of obexelimab in patients with Immunoglobulin-G4 Related Disease (IgG4-RD), the largest clinical trial ever conducted in this patient population.
  • Initiated the Phase 2 MoonStone trial, a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab in patients with Relapsing Multiple Sclerosis (RMS).
  • Initiated the Phase 2 SunStone trial, a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab to reduce disease activity in patients with Systemic Lupus Erythematosus (SLE).
  • Provided initial data from the Phase 2 SApHiAre trial, a global, multicenter, open-label safety and dose confirmation run-in period (SRP) to evaluate the safety and activity of obexelimab in patients with warm Autoimmune Hemolytic Anemia (wAIHA). Obexelimab achieved clinical proof-of-mechanism by increasing hemoglobin levels and red blood cells, and decreasing LDH and total bilirubin levels. Obexelimab was well tolerated in the SRP.
  • Completed an upsized Series C and initial public offering, raising approximately $458.7 million in aggregate gross proceeds to fund its planned activities for obexelimab and the Company’s growth strategy.
  • Bolstered its leadership team with the appointments of Chief Commercial Officer, Orlando Oliveira, and Chief Legal Officer, Jeff Held.
  • Out-licensed ZB005, a human IgG4 monoclonal antibody designed to bind only to the active form of C1s, for which Zenas held the development and commercialization rights in China, Hong Kong, Macau and Taiwan (Greater China) through an exclusive license with Dianthus.
  • The Company recently out-licensed regional rights to its thyroid eye disease programs, including ZB001, an insulin-like growth factor-1 receptor (anti-IGF-1R) monoclonal antibody, to Zai Lab (Zai).  Zenas received an upfront fee and is eligible to receive milestone payments and royalties in the future, as consideration for an exclusive sublicense to Zai to develop and commercialize ZB001 and related programs in Greater China.
Anticipated 2025 Clinical Milestones for Obexelimab

Obexelimab is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique mechanism of action and self-administered, subcutaneous once-weekly injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Obexelimab has been evaluated in five completed clinical trials in a total of 198 patients who received obexelimab either as an intravenous infusion or as a subcutaneous injection. Obexelimab was well tolerated and demonstrated clinical activity across these five clinical trials, providing the Company an initial clinical proof of concept for obexelimab as a potent B cell inhibitor for the treatment of patients living with certain autoimmune diseases.

During 2025, the Company expects to achieve the following key clinical milestones:
  • Report the 12-week primary endpoint results in the third quarter of 2025 from the Phase 2 MoonStone trial in patients with RMS.
The role of B cells in the pathogenesis of multiple sclerosis including RMS has been demonstrated through the successful clinical development, approval and clinical use of anti-CD20 B cell targeting therapies of other companies, including OCREVUS® (ocrelizumab) and KESIMPTA® (ofatumumab), which selectively deplete CD20-expressing B cells. The Company believes obexelimab’s unique mechanism of action to potently inhibit but not deplete a broader B cell lineage than CD20, nonclinical data, and a subcutaneous injection regimen, supports its potential for the treatment of RMS.
  • Following an initial screening period, patients in the MoonStone trial are being randomized 2:1 to 250 mg of obexelimab or placebo administered as a subcutaneous injection every seven days for a 12-week treatment period.
  • The primary objective of this double-blinded portion of the trial will be to assess the change from baseline in the cumulative number of gadolinium (Gd) enhancing lesions identified on T1-weighted magnetic resonance imaging (MRI).
  • Upon completion of the 12-week period, patients will enter an open-label period where patients on placebo will receive obexelimab treatment for at least three months, and patients initially randomized to obexelimab will continue treatment.
  • Important secondary endpoints during this open-label period include using standardized assessments, novel 3D imaging and biomarkers, including serum neurofilament light chain (NfL), to evaluate the impact of obexelimab on disease progression.
More information on the Phase 2 MoonStone trial (NCT06564311) is available at clinicaltrials.gov
  • Report topline results year-end 2025 from the Phase 3 INDIGO trial in patients with IgG4-RD.
IgG4-RD is a chronic fibro-inflammatory disease that can affect virtually all organ systems, including the pancreas, biliary tract, salivary and lacrimal glands, lungs, and kidneys. Patients with IgG4-RD may present with a single organ involved but more frequently present with multiple organ involvement. As the disease progresses and patients experience new or worsening symptoms (i.e., flares), lesions develop in additional organs and the cellular inflammation characterizing early disease moves toward a more fibrotic stage, which can lead to major irreversible tissue damage and ultimately organ failure. We estimate that the currently diagnosed population of IgG4-RD patients in the U.S. is approximately 20,000, with comparable prevalence rates globally.

Despite the growing recognition of IgG4-RD and advances in the understanding of its pathophysiology, there are no approved therapies for the treatment of this disease and there remains high unmet medical need. The current standard of care is treatment with glucocorticoids (GCs). Although GCs are initially effective, treatment with GCs can often result in various complications and co-morbidities. Most patients can relapse within 12 months of discontinuing GC treatment, and maintenance therapy with GCs has not been shown to prevent recurrence of disease.

The pathogenesis of IgG4-RD suggests that B cell-targeted therapies may provide therapeutic benefit. Although not approved by any regulatory authorities to treat IgG4-RD, certain B cell depleting agents (e.g., rituximab) are occasionally administered to patients with IgG4-RD. However, B cell depleting agents are often associated with infections, including serious opportunistic infections, and can compromise a patient’s ability to mount a response to vaccinations.

The reported evidence for the role of B cells in the pathogenesis of IgG4-RD, the observed effects of B cell targeting agents in previous trials in IgG4-RD, the data from our Phase 2 IgG4-RD trials with obexelimab, and its unique, non-depleting mechanism and once-weekly, subcutaneous injection regimen support its development in patients with IgG4-RD.
  • INDIGO is the largest clinical trial conducted in patients living with IgG4-RD and is designed to evaluate the safety and efficacy of obexelimab in approximately 190 patients with active IgG4-RD and being conducted at approximately 100 sites in 20 countries.
  • Following an initial screening period, patients were randomized 1:1 to 250 mg of obexelimab or placebo administered as a subcutaneous injection every seven days for 52 weeks, followed by an opportunity for eligible patients to continue in an open-label extension period where all patients will receive treatment with obexelimab.
  • The primary efficacy endpoint of INDIGO is the time to first IgG4-RD flare, as determined per protocol by the investigator and the adjudication committee.
  • Secondary endpoints include annualized flare rate, the proportion of patients achieving complete remission, and use and quantity of rescue medication, including GCs.
More information on the Phase 3 INDIGO trial (NCT05662241) is available at clinicaltrials.gov
  • Complete enrollment in 2025 in the Phase 2 SunStone trial in patients with SLE and report topline results in the first half of 2026.
The crucial role of B cells in SLE pathogenesis is well recognized, from producing autoantibodies to abnormal regulation of immune responses. Moreover, SLE is an autoimmune disease characterized by B cell dysfunction, the production of autoantibodies toward cellular and nuclear components, and multiorgan damage caused by immune complex deposition and inflammation within affected tissues. Current treatments are limited in number and modestly effective. Obexelimab has demonstrated clinical activity in a prior Phase 2 double-blind, randomized trial demonstrating proof-of-concept in the overall trial population and increased response in patients who maintained higher systemic exposure to obexelimab, and also in biomarker-defined subpopulations. Coupled with the safety data obtained to date, we believe these data provide support for the development of obexelimab in patients with SLE.
  • Patients with active SLE determined at screening by the investigator and adjudication committee are randomized 1:1 to obexelimab 250 mg or placebo administered as a subcutaneous injection every seven days for 24 weeks.
  • The 250 mg once-weekly subcutaneous injection dose has been selected to maximize the potential for clinical activity as higher systemic exposure (Ctrough) correlated with greater clinical activity in the prior Phase 2 trial in SLE.
  • The primary endpoint is the percentage of responders, defined by BILAG-based Composite Lupus Assessment, with a reduction of SLE disease activity at week 24.
  • Biomarker analysis is planned to be conducted in all patients, including baseline RNA expression profiles to immunophenotype patients and evaluation of their differential responses to treatment.
More information on the Phase 2 SunStone trial (NCT06559163) is available at clinicaltrials.gov

About Zenas BioPharma, Inc.

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas’ lead product candidate, obexelimab, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on LinkedIn.

Forward looking statements

This press release contains “forward-looking statements” which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning Zenas’s plans, objectives, expectations and intentions; the timing and results of ongoing and future clinical trials, including expectations on the timing of reporting INDIGO trial topline results, the 12-week primary endpoint data for the MoonStone trial and the anticipated timing of completing enrollment and reporting topline results for the SunStone trial; its growth strategy; the Company’s preliminary unaudited cash, cash equivalents and short-term investments as of December 31, 2024; and cash runway guidance. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies, many of which already have approved therapies in the Company’s current indications; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; risks related to the operations of the Company’s suppliers, many of which are located outside of the United States, including the Company’s current sole contract manufacturing organization for drug substance and drug product, WuXi Biologics (Hong Kong) Limited, which is located in China; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as well as other information we file with the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain, speak only as of the date of this press release and may prove incorrect. These statements are based upon information available to the Company as of the date of this press release and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that the Company has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, these forward-looking statements should not be relied upon as guarantees of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

The Zenas BioPharma word mark and logos are trademarks of Zenas BioPharma, Inc. or its affiliated companies. 

http://mrem.bernama.com/viewsm.php?idm=50286

SALIENCE LABS CLOSED SERIES A ROUND LED BY APPLIED VENTURES AND ICM HPQC FUND




Table

Image by Shabbir Bashar


Appointment of Dr. William Jeffrey to the Board and Bonnie Tomei as CFO


OXFORD, England, Feb 7 (Bernama-BUSINESS WIRE) -- Salience Labs Limited, a leader in photonic solutions targeting connectivity for AI datacenter infrastructure, today announced the successful close of $30 million in Series A financing led by ICM HPQC Fund and Applied Ventures, LLC, the venture capital arm of Applied Materials, Inc., to further the development of its optical switches for large scale AI connectivity. Applied Ventures and ICM HPQC Fund are joined by Strategic Investment Fund, Braavos, and continued participation from existing investors Oxford Sciences Enterprises, Cambridge Innovation Capital, and leaders from the global semiconductor industry including Silicon Catalyst and Jalal Bagherli.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250207290130/en/
 
“What our customers want is a photonic switch to connect their AI clusters that is compatible with existing infrastructure while delivering high bandwidth, low latency and significant power savings. The completion of this round will further our development and help us bring our product to customers to enable not just the savings, but large cluster connectivity,” said Vaysh Kewada, Co-founder and CEO of Salience Labs. “We are also excited to be working closely with our strategic investors who are industry leaders to advance our go-to market schedule.”

“Silicon photonics is a promising technology to deliver significant advancements in energy-efficient performance for AI data centers,” said Anand Kamannavar, Vice President and Global Head of Applied Ventures. “Salience's optical switch solution has the potential to enable a new generation of interconnect network architectures for faster and more efficient AI systems.”

“Salience Labs has done a tremendous job in developing a portfolio of innovative silicon photonics products that addresses critical needs in data center and AI infrastructure market,” said Dr. Jalal Bagherli, investor of Salience Labs and former CEO of Dialog Semiconductor that was acquired by Renesas. “Their customer focused approach in addition to the technology that are based on over a decade of research makes Salience Labs a clear leader to win in this enormous market.”

“Salience Lab’s optical switches will enable unprecedented bandwidth and scalability for the next generation of AI and high-performance data centers. By leveraging light, they will unlock the full capability of modern servers while decreasing power consumption and cost. ICM HPQC is excited to work with Vaysh and the Salience team as lead of the Series A raise,” said Dr. William Jeffrey, Chairman of the technical advisory committee on the ICM HPQC Fund and newly appointed Board Member of Salience Labs.

Appointment of Dr. William Jeffrey as new Board Member

In conjunction with the closing of the Series A financing, Salience Labs is appointing Dr. Jeffrey to the Board of Directors, where he joins Jack Edmondson, Chief Investment Officer of Oxford Sciences Enterprises, and Daniel Armbrust, co-founder of Silicon Catalyst, CEO of the SEMATECH semiconductor consortium and appointee to the Industrial Advisory Committee, which advises the Department of Commerce on the R&D strategy for the CHIPS Act.

Dr. Jeffrey is an astronomer with a career spanning the Executive Office of the President of the United States, to leading HRL (known for its groundbreaking innovations such as the invention of the laser, integrated circuits and liquid crystal displays), to being the Director of the National Institute of Standards and Technology, an institution boasting three Nobel prize laureates and ties to a dozen more, and he served as the CEO of SRI International. Dr. Jeffrey earned a Bachelor of Science in physics from the Massachusetts Institute of Technology and a Ph.D. in astronomy from Harvard University.

Appointment of Bonnie Tomei as Chief Financial Officer

Salience Labs is also announcing its appointment of Bonnie Tomei, a certified public accountant and an industry veteran located in Silicon Valley, California, as Chief Financial Officer.

“With over 20 years of experience including initial public offerings, de-SPAC and a strong business operations background, Ms. Tomei will be a key member of the executive team to realize our strategic and operational objectives, including expanding to the U.S. to serve our key customers,” said Ms. Kewada.

About Salience Labs

Salience Labs Limited is a leader in photonic solutions targeting connectivity for AI datacenter infrastructure. Founded in 2021 and backed by over a decade of research from the University of Oxford in the UK and University of Münster in Germany, Salience’s innovative developments in photonic switching technology enable high-speed, ultra-low latency networking fabrics that remove infrastructure bottlenecks for AI workloads. Learn more at http://www.saliencelabs.ai

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Contact

Bonnie Tomei
bonnie.tomei@saliencelabs.ai
+1 669 212-1089


Source : Salience Labs

Wednesday, February 5, 2025

INGREDION REPORTS STRONG Q4 FY2024, SETS STRONG 2025 OUTLOOK



KUALA LUMPUR, Feb 5 (Bernama) -- Ingredion Incorporated, a global provider of ingredient solutions, reported a net sales of US$1.8 billion for the fourth quarter (Q4) ended Dec 31, 2024 (FY2024) from US$1.921 billion, down six per cent for the same period previous year. (US$1=RM4.42)

In a statement, Ingredion said the decrease were driven by price mix, including the pass-through of lower corn cost, lost net sales from the sale of its South Korea business and foreign exchange impacts, partially offset by Texture and Healthful Solutions (T&HS) volumes.

Its reported and adjusted earnings per share (EPS) showed notable improvement year-over-year. Full-year 2024 adjusted EPS increased US$10.65 from US$9.42 in 2023, and cash from operations reaching US$1.436 billion, benefitting from a US$400 million improvement in working capital as corn costs declined.

Additionally, Ingredion returned US$426 million to shareholders in 2024 through dividends and share repurchases.

The company also highlighted significant contributions from its T&HS segment and strong performance in its Food and Industrial Ingredients (F&II) segments across the United States (US), Canada, and Latin America (LATAM).

Additionally, the company is investing more than US$100 million into its flagship Indianapolis facility to improve reliability and operating efficiency.

The T&HS business delivered double digit sales volume growth in the fourth quarter amid a backdrop of continued food inflation and changing consumer buying behaviour. The company’s strategic initiatives, such as the reorganisation and the establishment of the Global T&HS segment, contributed to its solid performance.

Meanwhile, the F&II US/Canada segment recorded significant operating income growth, benefitting from multi-year customer contract renewals that helped offset inflationary impacts. LATAM segment saw strong performance in Mexico and Andean regions despite weaker sweetener demand.

Looking ahead to 2025, Ingredion expects continued growth, with a projected increase in reported and adjusted EPS, estimated to range between US$10.75 and US$11.55, reflecting expectations of continued financial growth.

The company plans to enhance customer collaborations, invest in operational efficiencies, and allocate capital towards organic growth investments, while continuing to return value to shareholders through dividends and share repurchases.

-- BERNAMA