Market Newsdesk

March 18, 2025 8:34 am

Foresight Announces the Integration of NVIDIA Jetson Orin into its 3D Perception Systems

Foresight to equip autonomous drones and unmanned aerial vehicles with NVIDIA Jetson Orin platform for enhanced real-time perception, obstacle detection, and energy efficiency across diverse applications

NESS ZIONA, Israel, March 18, 2025 (GLOBE NEWSWIRE) — Foresight Autonomous Holdings Ltd. (Nasdaq and TASE: FRSX) (“Foresight” or the “Company”), a leading innovator in 3D perception systems, announces the integration of NVIDIA Jetson Orin computing platforms into its cutting-edge perception technologies.

The collaboration, previously announced on February 24, 2025, leverages NVIDIA Jetson Orin Nano and NVIDIA Jetson AGX Orin platforms to enhance the capabilities of Foresight’s 3D perception systems across various industries, with focus on autonomous drones and unmanned aerial vehicles (UAV).

The NVIDIA Jetson Orin platform provides Foresight’s vision systems with state-of-the-art computing power tailored to the unique requirements of autonomous drones and UAVs. The NVIDIA Jetson Orin Nano is optimized for compact, lightweight drones and UAVs, offering robust artificial intelligence (AI) performance and energy efficiency while minimizing weight and size. These platforms reduce power consumption while maintaining high performance, making them ideal for drones in large-scale or remote-area applications. For higher-performance needs, the NVIDIA Jetson AGX Orin delivers up to 275 trillion operations per second (TOPS), enabling real-time data processing, advanced obstacle detection, and precise terrain mapping in complex and dynamic environments.

By leveraging the advanced AI and graphics processing unit (GPU) capabilities of NVIDIA Jetson platforms, Foresight continues to revolutionize the field of autonomous drones and UAVs, delivering 3D perception solutions that set new benchmarks for performance, efficiency, and adaptability.

Foresight’s 3D perception systems, using both visible light and thermal long-wave infrared cameras, enable comprehensive environmental perception across diverse and challenging conditions, including low-light environments, heavy fog, and extreme weather scenarios. The technology offers unparalleled capabilities for applications that demand reliable and precise environmental understanding such as search and rescue missions and agriculture monitoring.

About Foresight

Foresight Autonomous Holdings Ltd. (Nasdaq and TASE: FRSX) is a technology company developing smart multi-spectral vision software solutions and cellular-based applications. Through the Company’s wholly owned subsidiaries, Foresight Automotive Ltd., Foresight Changzhou Automotive Ltd. and Eye-Net Mobile Ltd., Foresight develops both “in-line-of-sight” vision systems and “beyond-line-of-sight” accident-prevention solutions.

Foresight’s vision solutions include modules of automatic calibration and dense three-dimensional (3D) point cloud that can be applied to different markets such as automotive, defense, autonomous vehicles and heavy industrial equipment. Eye-Net Mobile’s cellular-based solution suite provides real-time pre-collision alerts to enhance road safety and situational awareness for all road users in the urban mobility environment by incorporating cutting-edge AI technology and advanced analytics.

For more information about Foresight and its wholly owned subsidiary, Foresight Automotive, visit www.foresightauto.com, follow @ForesightAuto1 on Twitter, or join Foresight Automotive on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, Foresight is using forward-looking statements in this press release when it discusses the benefits and advantages of NVIDIA Jetson Orin platforms, the benefits and advantages of Foresight’s products and technology, particularly with the integration of the NVIDIA Jetson Orin platforms and that this collaboration has significant potential for autonomous drone and UAVs. Because such statements deal with future events and are based on Foresight’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Foresight could differ materially from those described in or implied by the statements in this press release.

The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in Foresight’s annual report on Form 20-F for the fiscal year ended December 31, 2023 filed with the Securities and Exchange Commission (“SEC”) on March 27, 2024, and in any subsequent filings with the SEC. Except as otherwise required by law, Foresight undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Foresight is not responsible for the contents of third-party websites.

Investor Relations Contact:

Miri Segal-Scharia
CEO
MS-IR LLC
[email protected]
917-607-8654

March 18, 2025 8:34 am

StepStone Group Announces 2025 Partner and Managing Director Promotions

NEW YORK, March 18, 2025 (GLOBE NEWSWIRE) — StepStone Group Inc. (Nasdaq: STEP), a global private markets investment firm focused on providing customized investment solutions and advisory and data services, has named 10 new partners and 24 new managing directors.

Partner and CEO Scott Hart said, “The momentum of the StepStone franchise is as strong as ever, which is a testament to the great talent we have attracted, cultivated, and promoted into leadership positions over the years. Congratulations to the newest class of partners and managing directors.”

2025 Partner Class

Christopher Bernadino joined StepStone in 2015 and is based in La Jolla. He serves as Global Head of Information Technology and Chief Information Security Officer.
Elizabeth Ferry joined StepStone in 2019 and is based in La Jolla. She serves as Head of Operational Due Diligence.
Anthony Giambrone joined StepStone in 2021 and is based in Baltimore. He is a member of the Venture Capital and Growth Equity team.
Remo Kämpf joined StepStone in 2016 and is based in Zurich. He is a member of the Private Debt team.
Laia Massague joined StepStone in 2017 and is based in London. She is a member of the Real Estate team.
Pooja Patel joined StepStone in 2014 and is based in London. She is a member of the Real Estate team.
Tim Rees joined StepStone in 2014 and is based in London. He is a member of the Infrastructure and Real Assets team.
Anja Ritchie joined StepStone in 2020 and is based in Frankfurt. She is a member of the Real Estate team.
Stephen West joined StepStone in 2021 and is based in Baltimore. He is a member of the Venture Capital and Growth Equity team.
Joey Wong Castillo joined StepStone in 2020 and is based in London. She serves as Head of Legal, Infrastructure and Real Assets.

New Managing Directors

Michael Bermel, Private Wealth, Charlotte
Elise Chanlatte, Fund Accounting, La Jolla
Jo-Anne Curchod, Corporate Finance and Accounting, Zurich
James Connolly, Operations, Dublin
Alec Darbyshire, Real Estate, San Francisco
Colin Donnelly, Real Estate, Chicago
Sean Doyle, Private Debt, Dublin
JD Hall, Venture Capital and Growth Equity, Baltimore
Patrick Hart, Product Management, La Jolla
Nichole Kim, Private Equity, New York
Daniel Krikorian, Private Equity, La Jolla
Gray Layden, Real Estate, San Francisco
Richard Lowe, Real Estate, London
Alex Morsy, Data and Software Engineering, La Jolla
Akhilan Nesaratnam, Private Equity, London
Simi Olusoga, Product Management, New York
Miriam Penney, Operational Due Diligence, Dublin
Selin Pinarci, Product Management, Zurich
Dylan Quesada, Product Management, New York
Veith Riebow, Business Development, Frankfurt
Jared Root, Private Debt, New York
Nicholas Russell, Portfolio Analytics and Reporting, La Jolla
Jonathan True, Private Equity, New York
Theodore Wong, Product Management, New York

About StepStone

StepStone Group Inc. (Nasdaq: STEP) is a global private markets investment firm focused on providing customized investment solutions and advisory and data services to its clients. As of December 31, 2024, StepStone was responsible for approximately $698 billion of total capital, including $179 billion of assets under management. StepStone’s clients include some of the world’s largest public and private defined benefit and defined contribution pension funds, sovereign wealth funds and insurance companies, as well as prominent endowments, foundations, family offices and private wealth clients, which include high-net-worth and mass affluent individuals. StepStone partners with its clients to develop and build private markets portfolios designed to meet their specific objectives across the private equity, infrastructure, private debt and real estate asset classes.

Contacts

Shareholder Relations:

Seth Weiss
[email protected]
+1 (212) 351-6106

Media:

Brian Ruby / Chris Gillick / Matt Lettiero, ICR
[email protected]
+1 (203) 682-8268

March 18, 2025 8:34 am

SCIENTURE announces the U.S. FDA Approval of its NDA for SCN-102, to be launched as ArbliTM, (losartan potassium) Oral Suspension, 10mg/mL. The global market for losartan potassium was approximately $1.5 billion in sales in 2024.

TAMPA, FL, March 18, 2025 (GLOBE NEWSWIRE) — –
SCIENTURE HOLDINGS, INC.
NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to market, and distributing novel specialty products to satisfy unmet market needs, is pleased to announce the U.S. Food and Drug Administration (FDA) has approved SCN-102, one of the products being developed by Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, Inc., with the brand name Arbli^TM (losartan potassium) Oral Suspension, 10 mg/mL. Arbli^TM is meant for the treatment of hypertension in patients greater than 6 years old, for the reduction of risk of stroke in patients with hypertension and left ventricular hypertrophy and for the treatment of diabetic nephropathy in certain patients with type 2 diabetes. Arbli^TM is the first and only FDA approved ready-to-use oral liquid losartan in the U.S. market.

Arbli^TM is a novel proprietary formulation of losartan, a proven therapy for treating hypertension, which provides a tailored approach to patients that require or prefer an oral liquid option of losartan. Appropriate dosing is now easier, safe and effective, while providing the assurance of quality as an FDA-approved product. Arbli^TM provides a safe and convenient option to patients requiring a liquid formulation and addresses the intrinsic risks associated with potential inconsistencies in the process of crushing tablets to extemporaneously compound losartan prescriptions. Arbli^TM has two issued patents from the USPTO, which are also expected to be listed in the FDA Orangebook.

Losartan is classified as an angiotensin receptor blocker (ARB) for treating hypertension and is one of the highest prescribed molecules for this indication. Current products in the market containing losartan are available only as oral solids, which can be further compounded to a liquid formulation. Arbli^TM is the first liquid formulation of losartan on the market that does not require compounding and has reduced dosing volume and long-term shelf life at room temperature storage. IQVIA data (MAT December 2024) indicates a total annual sales of approximately $292 million and a prescription volume of 68 million (TRx) for losartan in the US market.

“The approval of Arbli^TM exemplifies our deep commitment to develop high value products that address unique and underserved patient needs. A significant number of patients can benefit from a safe and efficacious ready-to-use oral liquid formulation of losartan. We are excited with the approval of our first brand product which is part of our upcoming pipeline of novel specialty products,” remarked Shankar Hariharan, CEO of Scienture, LLC.

“We are pleased to bring to market, Arbli^TM, a transformative therapy option containing losartan, one of the most widely prescribed molecules in its class, to patients, caregivers and healthcare professionals (HCPs). We expect to commercially launch and make Arbli^TM available to patients in the U.S. in Q3 2025,” said Narasimhan Mani, President of Scienture, LLC.

“This announcement is extremely exciting and is a clear demonstration of the value Scienture, LLC brings to the combined company and its shareholders,” said Suren Ajjarapu, Chairman of the Board, Scienture Holdings, Inc.

About Arbli
^TM

Arbli^TM is the first and only oral liquid formulation of losartan approved by the U.S. FDA. Arbli™ comes in a 165 mL bottle as a peppermint flavored suspension that does not require refrigeration, and has been approved for a shelf life of 18 months from the date of manufacture when stored at room temperature, based on the data submitted in the NDA. Once the 24-months stability data is submitted to the FDA, the shelf-life of the product is expected to be extended to 24-months at room temperature.

INDICATION

Arbli^TM is an angiotensin II receptor blocker (ARB) indicated for:

Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy.
Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.

IMPORTANT SAFETY INFORMATION

Do not take Arbli^TMwhen pregnant. When pregnancy is detected, discontinue Arbli^TMas soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Arbli^TM can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
Do not co-administer Arbli^TM with aliskiren in patients with diabetes. Avoid use of aliskiren with Arbli^TM in patients with renal impairment (GFR <60 mL/min).
Do not administer Arbli^TM in patients with severe hepatic impairment. Arbli^TM has not been studied in patients with severe hepatic impairment.
The most common adverse reactions are (incidence ≥2% and greater than placebo): dizziness, upper respiratory infection, nasal congestion, and back pain.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Scienture at 1-833-754-4917.

Please see the full Prescribing Information for complete product information. For more information, talk to your healthcare provider.

About Hypertension

Hypertension (high blood pressure) is a cardiovascular condition, when the pressure in the blood vessels is too high (140/90 mmHg or higher). According to the CDC, hypertension, or high blood pressure, affects nearly half of adults in the United States, or 119.9 million people. Hypertension is defined as a systolic blood pressure of 140 mmHg or higher, and diastolic blood pressure of 90 mmHg or higher. Hypertension is a risk factor for stroke and heart disease, which are leading causes of death in the U.S. Factors that increase the risk of having high blood pressure include: older age, genetics, being overweight or obese, not being physically active, high-salt diet and drinking too much alcohol. Hypertension is clinically diagnosed if, when blood pressure is measured on two different days, the systolic blood pressure readings on both days is ≥140 mmHg and/or the diastolic blood pressure readings on both days is ≥ 90 mmHg.

About Scienture Holdings, Inc.

SCIENTURE HOLDINGS, INC. (NASDAQ: “SCNX”), through its wholly owned subsidiaries, Scienture, LLC and Integra Pharma Solutions, LLC, is a comprehensive pharmaceutical product company focused on providing enhanced value to patients, physicians and caregivers by offering novel specialty products to satisfy unmet market needs. Integra Pharma Solutions, LLC, is a licensed pharmaceutical wholesaler and sells brand, generic and non-drug products to healthcare markets including government organizations, hospitals, clinics and independent pharmacies nationwide. Scienture, LLC is a branded, specialty pharmaceutical company consisting of a highly experienced team of industry professionals who are passionate about developing and bringing to market unique specialty products that provide enhanced value to patients and healthcare systems. The assets in development at Scienture are across therapeutics areas, indications and cater to different market segments and channels. For more information please visit www.scienture.com.

Cautionary Statements Regarding Forward-Looking Statements

This press release contains certain statements that may be deemed to be “forward-looking statements” within the federal securities laws, including the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Statements that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements relate to future events or our future performance or future financial condition. These forward-looking statements are not historical facts, but rather are based on current expectations, estimates and projections about our company, our industry, our beliefs and our assumptions. Such forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including for the products we may launch and the success those products may have in the marketplace. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” or the negative of these terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are subject to a number of risks and uncertainties (some of which are beyond our control) that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. These risks include risks relating to agreements with third parties; our ability to raise funding in the future, as needed, and the terms of such funding, including potential dilution caused thereby; our ability to continue as a going concern; security interests under certain of our credit arrangements; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; claims relating to alleged violations of intellectual property rights of others; the outcome of any current legal proceedings or future legal proceedings that may be instituted against us; unanticipated difficulties or expenditures relating to our business plan; and those risks detailed in our most recent Annual Report on Form 10-K and subsequent reports filed with the SEC.

Forward-looking statements speak only as of the date they are made. Scienture Holdings, Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law.

Contact:

SCIENTURE HOLDINGS, INC.

6308 Benjamin Rd, Suite 708
Tampa, Florida 33634
Phone: (866) 468-6535
Email: [email protected]

March 18, 2025 8:34 am

TCBP Announces Outsourcing Initiatives, Reducing Burn Rate and Overhead

PR Newswire

The company is expected to reduce core operational burn by 55% when compared to 2024

EDINBURGH, Scotland
, March 18, 2025 /PRNewswire/ — TC BioPharm (Holdings) PLC (“TC BioPharm” or the “Company”) (NASDAQ: TCBP), a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today announced initiatives to outsource several functions, moving to a more decentralized model, resulting in reduction in its workforce and creating a leaner and more agile organization as part of the company’s strategic developmental plan.

The initiatives focus on moving to a CDMO model for production to accommodate larger production demand for future clinical trials, allowing TCB to review alternatives for new manufacturing facilities incorporating newly developed automated and other cell therapy production technologies. Additionally, the company is reviewing alternative approaches for testing and clinical needs, which align with a decentralized drug development model. This approach is expected to result in a workforce reduction of approximately 20 employees, focused largely within the company’s production and quality divisions and represents approximately half of the company’s total headcount. Separations will be substantially complete by the end of the second quarter 2025 and are expected to reduce the core operational burn rate by approximately 55% compared to 2024.  As a result of these steps, when compared to 2024, the Company estimates partial year 2025 savings to be approximately $2.1 million and annualized savings to be roughly $4.2 million.

“This decision to reduce staff is attributable to the company’s strategic shift in focus towards an outsourced production model and something that we believe will ultimately better position TC BioPharm for future clinical trial plans as well as advancements in new cell therapy manufacturing technologies,” said Bryan Kobel, CEO of TC BioPharm. “We are at a pivotal moment in our development as we expand into new indication verticals, prepare for ACHIEVE data review which will drive our next clinical pathway, and reduce the need for costly in-house expenses to provide a stronger foundation for future growth. I arrived at this decision knowing it will be difficult to say goodbye to colleagues who have been a significant part of TC BioPharm’s culture and accomplishments. I’m grateful to all those who have shared in our history and to those who will continue to usher in the next phase of TCBP.” 

About TC BioPharm (Holdings) PLC

TC BioPharm is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing gamma-delta T-cell therapies for cancer treatment with human efficacy data in acute myeloid leukemia. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue.

TC BioPharm is the leader in developing gamma-delta T cell therapies and the first company to conduct phase II/pivotal clinical studies in oncology. The Company is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line – Phase 2b/3 pivotal trial in the treatment of acute myeloid leukemia using the Company’s proprietary allogeneic CryoTC technology to provide frozen product to clinics worldwide.

Forward-Looking Statements for TC BioPharm

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report on Form 8-K that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the Company’s intent or ability to affect any budget savings or execute on any M&A or capital raising strategy. These statements are based on management’s current assumptions and are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. For other important factors that could cause actual results to differ materially from the forward-looking statements in this Current Report on Form 8-K, please see the risks and uncertainties identified under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, and our other reports filed with the SEC, all of which is available on the Company’s Investor Relations website at www.tcbiopharm.com and on the SEC website at www.sec.gov. All forward-looking statements reflect the Company’s beliefs and assumptions only as of the date of this Current Report on Form 8-K. The Company undertakes no obligation to update forward-looking statements to reflect future events or circumstances.

View original content to download multimedia:https://www.prnewswire.com/news-releases/tcbp-announces-outsourcing-initiatives-reducing-burn-rate-and-overhead-302403910.html

SOURCE TC BioPharm

March 18, 2025 8:34 am

Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough Therapy designation for the treatment of adults with moderate-to-severe Sjögren’s disease, has now received Fast Track designation

PR Newswire

Sjögren’s disease (SjD)
is a
prevalent, debilitating autoantibody disease with no FDA-approved advanced treatments

The Company is actively enrolling patients in the Phase 3 DAFFODIL study

This marks the fourth nipocalimab FDA Fast Track designation

SPRING HOUSE, Pa.
, March 18, 2025 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has granted investigational nipocalimab Fast Track designation (FTD) for the treatment of adult patients with moderate-to-severe Sjögren’s disease (SjD), having previously been granted Breakthrough Therapy designation (BTD) for the investigational therapy late last year. Currently, no advanced therapies are approved to treat this disease.

Building upon the BTD, which nipocalimab is the first and only therapeutic to receive for SjD, the U.S. FDA’s FTD is also designed to accelerate the delivery of new therapeutics to patients by facilitating the development and expediting the review of drugs that demonstrate the potential to treat serious conditions and help address unmet needs for serious or life-threatening conditions.

“This marks an additional important step forward in our efforts to bring meaningful advancements to people living with Sjögren’s disease, a serious and debilitating condition. We look forward to continuing to work closely with the FDA to advance the clinical development of nipocalimab and potentially provide a much-needed treatment option for this community,” said Katie Abouzahr, M.D., Vice President, Autoantibody Portfolio and Maternal Fetal Disease Area Leader, Johnson & Johnson Innovative Medicine.

There are no FDA-approved treatments that directly address the underlying causes of this complex disease, associated with serious health consequences including chronic dryness of moisture producing glands that may lead to systemic complications such as joint pain, fatigue and inflammation in multiple organ systems.^1,2,3 These systemic complications can lead to an increased risk of mortality and associated health conditions, including a 20 times greater risk of developing B-cell lymphomas when compared to the general population.^1,4

The Phase 2 DAHLIAS study, the results of which were presented last year, represented the first-ever positive results of an investigational FcRn blocker as a potential targeted therapy in SjD. The study achieved the primary endpoint in the 15 mg/kg Q2W nipocalimab group, showing a greater than 70% relative average improvement in systemic disease activity at Week 24 compared to placebo and IgG reductions of more than 77%.⁵ Trends of improvement were similarly observed across multiple secondary endpoints.⁵ Safety and tolerability were consistent with other nipocalimab clinical studies.⁵

ABOUT SJ
ÖGREN’S DISEASE

Sjögren’s disease (SjD) is one of the most prevalent autoantibody-driven diseases for which no therapies are currently approved that treat the underlying and systemic nature of the disease.¹ It is a chronic autoimmune disease that is estimated to impact approximately four million people worldwide and is nine times more common in women than men.^6,7 SjD is characterized by autoantibody production, chronic inflammation, and lymphocytic infiltration of exocrine glands. Most patients are affected by mucosal dryness (eyes, mouth, vagina), joint pain and fatigue.¹ More than 50% of SjD patients have a moderate to severe form of the condition, and disease burden can be as high as that of rheumatoid arthritis or systemic lupus erythematosus. It is usually associated with impaired quality of life and functional capacity.^6.8,9

ABOUT DAHLIAS

DAHLIAS (NCT04968912) is a Phase 2 multicenter, randomized, placebo-controlled double-blind study to evaluate the effects of nipocalimab in participants with primary Sjögren’s disease. DAHLIAS is a Phase 2 dose-ranging study for adults with moderately-to-severely active primary SjD who were seropositive for anti-Ro60 and/or anti-Ro52 IgG antibodies. 163 adults aged 18-75 were randomized 1:1:1 to receive intravenous nipocalimab at 5 or 15 mg/kg or placebo every 2 weeks through Week 22 and received protocol-permitted background standard of care. Safety assessments were conducted through Week 30. The primary endpoint was change in baseline in the ClinESSDAI (Clinical European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index) Score at Week 24. ClinESSDAI is a systemic diseases activity index designed to measure disease activity in patients with primary SjD based on 11 domains including: constitutional, lymphadenopathy, glandular, articular, cutaneous, respiratory, renal, muscular, peripheral nervous system, central nervous system, and hematological.

ABOUT NIPOCALIMAB

Nipocalimab is an investigational monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies potentially without impact on other immune functions. This includes autoantibodies and alloantibodies that underlie multiple conditions across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Fetal diseases mediated by maternal alloantibodies and Rheumatic diseases.^{5,10,11,12,13,14,15,16.17}Blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the fetus.¹⁸^,19

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:

U.S. FDA Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021 and fetal neonatal alloimmune thrombocytopenia (FNAIT) in March 2024 and Sjögren’s disease (SjD) in March 2025
U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023
U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for Sjögren’s disease in November 2024
U.S. FDA granted Priority Review in gMG in Q4 2024
EU EMA Orphan medicinal product designation for HDFN in October 2019

ABOUT JOHNSON & JOHNSON

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

Learn more at https://www.jnj.com/ or at https://innovativemedicine.jnj.com/

Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.

CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at

www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

REFERENCES

Huang H, Xie W, Geng Y, Fan Y, Zhang Z. Mortality in patients with primary Sjögren’s syndrome: a systematic review and meta-analysis. Rheumatology (Oxford). 2021 Sep 1;60(9):4029-4038. doi: 10.1093/rheumatology/keab364. PMID: 33878179.

Sjogren’s Disease Foundation. Understanding Sjogrens – Treatment. Available at: https://sjogrens.org/. Last accessed: March 2025.

Mayo Clinic. Sjogren’s syndrome. Available at: https://www.mayoclinic.org/diseases-conditions/sjogrens-syndrome/symptoms-causes/syc-20353216. Last accessed: March 2025.

⁴

Brito-Zeron, P., Flores-Chavez, A., Horvath, Fanny I., Rasmussen, A., et al. Mortality risk factors in primary Sjogren syndrome: a real-world, retrospective, cohort study. eClinicalMedicine. July, 4, 2023. DOI: https://doi.org/10.1016/j.eclinm.2023.102062

⁵

ClinicalTrials.gov Identifier: NCT04968912 Available at: https://clinicaltrials.gov/study/NCT04968912. Last accessed: March 2025.

⁶

Nat Rev Rheumatol 20, 158–169 (2024). https://doi.org/10.1038/s41584-023-01057-6

⁷

Beydon, M., McCoy, S., Nguyen, Y. et al. Epidemiology of Sjögren syndrome.

⁸

Carsons SE, Patel BC. Sjogren Syndrome. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK431049/

⁹

Hackett KL, et al. Arthritis Care Res (Hoboken). 2012;64(11):1760-1764.

¹⁰

ClinicalTrials.gov Identifier: NCT04951622. Available at: https://clinicaltrials.gov/ct2/show/NCT04951622. Last accessed: March 2025

¹¹

ClinicalTrials.gov. NCT03842189. Available at: https://clinicaltrials.gov/ct2/show/NCT03842189. Last accessed: March 2025

¹²

ClinicalTrials.gov Identifier: NCT05327114. Available at: https://www.clinicaltrials.gov/study/NCT05327114. Last accessed: March 2025

¹³

ClinicalTrials.gov Identifier: NCT04119050. Available at: https://clinicaltrials.gov/study/NCT04119050. Last accessed: March 2025

¹⁴

ClinicalTrials.gov Identifier: NCT05379634. Available at: https://clinicaltrials.gov/study/NCT05379634 Last accessed: March 2025.

¹⁵

ClinicalTrials.gov Identifier: NCT05912517. Available at: https://www.clinicaltrials.gov/study/NCT05912517. Last accessed: March 2025

¹⁶

ClinicalTrials.gov Identifier: NCT06028438. Available at: https://clinicaltrials.gov/study/NCT06028438. Last accessed: March 2025

¹⁷

ClinicalTrials.gov Identifier: NCT04882878. Available at: https://clinicaltrials.gov/study/NCT04882878. Last accessed: March 2025.

¹⁸

Lobato G, Soncini CS. Relationship between obstetric history and Rh(D) alloimmunization severity. Arch Gynecol Obstet. 2008 Mar;277(3):245-8. DOI: 10.1007/s00404-007-0446-x.

¹⁹

Roy S, Nanovskaya T, Patrikeeva S, et al. M281, an anti-FcRn antibody, inhibits IgG transfer in a human ex vivo placental perfusion model. Am J Obstet Gynecol. 2019;220(5):498 e491-498 e499.

Media contact:

Bridget Kimmel

[email protected]

Investor contact:

Lauren Johnson

[email protected]

View original content to download multimedia:https://www.prnewswire.com/news-releases/nipocalimab-the-first-and-only-investigational-treatment-to-be-granted-us-fda-breakthrough-therapy-designation-for-the-treatment-of-adults-with-moderate-to-severe-sjogrens-disease-has-now-received-fast-track-designation-302404447.html

SOURCE Johnson & Johnson

March 18, 2025 8:34 am

Bakkt Reschedules Release of Fourth Quarter and Full Year 2024 Earnings Results and Conference Call

Bakkt Reschedules Release of Fourth Quarter and Full Year 2024 Earnings Results and Conference Call

ALPHARETTA, Ga.–(BUSINESS WIRE)–
Bakkt Holdings, Inc. (NYSE: BKKT) today announced that it has changed the date for its previously announced earnings conference call. The company will now host a conference call at 5:00 P.M. ET on Wednesday, March 19, 2025, to review the results for the quarter and full year.

Investors and analysts interested in participating in the earnings conference call are invited to join at https://events.q4inc.com/attendee/258383643 or dial in at (833) 470-1428 or (404) 975-4839, and reference participant access code 796835 approximately ten minutes prior to the start of the call.

The conference call will be webcast live and archived on the investor relations section of Bakkt’s corporate website under the ‘Events & Presentations’ section, along with any related earnings materials.

About Bakkt

Founded in 2018, Bakkt builds solutions that enable our clients to grow with the crypto economy. Through institutional-grade custody, trading, and onramp capabilities, our clients leverage technology that’s built for sustainable, long-term involvement in crypto.

Bakkt is headquartered in Alpharetta, GA. For more information, visit: https://www.bakkt.com/ | X – @Bakkt | LinkedIn.

Bakkt-C

View source version on businesswire.com: https://www.businesswire.com/news/home/20250318817576/en/

Investor Relations

[email protected]

Media

[email protected]

KEYWORDS: United States North America New York Georgia

INDUSTRY KEYWORDS: Cryptocurrency Professional Services Finance

MEDIA:

March 18, 2025 8:34 am

Data and Safety Monitoring Board Reviews Cohort 1 Safety Data and Approves Dosing Cohort 2 in the Clinical Trial of OCU200—a Novel Fusion Protein for Diabetic Macular Edema

OCU200 has a very favorable safety and tolerability profile
No serious adverse events related to the study drug have been reported
Dosing of the second cohort has been approved

MALVERN, Pa., March 18, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the Data and Safety Monitoring Board (DSMB) for the OCU200 clinical trial recently convened and reviewed safety data following dosing of the first cohort in the dose-escalation portion of the Phase 1 study and approved continuation of dosing in the second cohort. OCU200 is a novel fusion protein consisting of two human proteins, tumstatin and transferrin, with the potential to treat diabetic macular edema (DME).

“OCU200 is given intravitreally,” said Peter Chang, MD, FACS, Co-President and Partner of the Massachusetts Eye Research and Surgery Institution (MERSI). “No serious adverse events related to OCU200 have been reported to date.”

The OCU200 Phase 1 clinical trial is a multicenter, open-label, dose-escalation study to assess drug safety via intravitreal injection in three cohorts: low dose (0.025 mg), medium dose (0.05 mg), and high dose (0.1 mg). All subjects will receive two doses six weeks apart, and patients will be followed for up to 6 months.

“It is encouraging that we have successfully completed dosing in the low dose cohort for OCU200, a novel biologic that has a very favorable safety and tolerability profile,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “There remains a considerable unmet medical need for the 30% to 40% of DME patients who do not respond to current anti-VEGF therapies. OCU200 holds the promise of potentially benefiting all DME, diabetic retinopathy (DR), and wet age-related macular degeneration (wet AMD) patients.”

Approximately 12 million people in the United States and 130 million people worldwide are affected by DME, DR, or wet AMD. Patients affected by them share common symptoms, such as blurriness in vision and progressive vision loss, as the diseases progress. The formation of fragile and leaky new blood vessels leads to fluid accumulation in and around the retina, causing damage to vision.

OCU200 has the potential to change the treatment landscape for DME, DR, and wet AMD with its unique mechanism of action, binding the active component—tumstatin—to integrin receptors on active endothelial cells that play a crucial role in disease pathogenesis.

OCU200 brings an innovative biologic candidate to Ocugen’s ophthalmology portfolio targeting blindness diseases. The Company intends to complete the Phase 1 OCU200 clinical trial in the second half of 2025 and to provide preliminary safety and efficacy updates throughout the year.

About OCU200

OCU200 is a recombinant fusion protein that consists of two parts connected by a linker: tumstatin, the active component, acts as an anti-inflammatory, anti-VEGF agent by binding to integrin receptors; and transferrin, which targets the drug to the choroid and retina by binding transferrin receptors on endothelial cells. These features will potentially enable OCU200 to reduce the vascular permeability, inflammation, and neovascularization that drive the pathophysiology of DME, DR, and wet AMD at a significantly lower dose compared to currently approved therapies.

About Ocugen, Inc.

Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements

This
press
release
contains
forward-looking
statements
within
the
meaning
of
The
Private
Securities
Litigation
Reform
Act
of
1995,
including,
but
not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines,
which
are
subject
to
risks
and
uncertainties.
We
may,
in
some
cases,
use
terms
such
as
“predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,”
or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including,
but
not
limited
to,
the
risks
that
preliminary,
interim
and
top-line
clinical
trial
results
may
not
be
indicative
of,
and
may
differ
from,
final
clinical data;
the ability of OCU200 to perform in humans in a manner consistent with nonclinical or preclinical study data;
that
unfavorable
new
clinical
trial
data
may
emerge
in
ongoing
clinical
trials
or
through
further
analyses
of
existing
clinical
trial
data;
that
earlier non-clinical
and
clinical
data
and
testing
of
may
not
be
predictive
of
the
results
or
success
of
later
clinical
trials;
and
that
that
clinical
trial
data
are subject to differing interpretations and assessments, including by regulatory authorities.
These
and
other
risks
and
uncertainties
are
more
fully described
in
our
periodic
filings
with
the
Securities
and
Exchange
Commission
(SEC),
including
the
risk
factors
described
in
the
section
entitled
“Risk Factors”
in
the
quarterly
and
annual
reports
that
we
file
with
the
SEC.
Any
forward-looking
statements
that
we
make
in
this
press
release
speak
only
as of
the
date
of
this
press
release.
Except
as
required
by
law,
we
assume
no
obligation
to
update
forward-looking
statements
contained
in
this
press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:

Tiffany Hamilton
AVP, Head of Communications
[email protected]

March 18, 2025 8:34 am

Cango Inc. Joins Bitwise Bitcoin Standard Corporations ETF

PR Newswire

SHANGHAI
, March 18, 2025 /PRNewswire/ — Cango Inc. (NYSE: CANG) (“Cango” or the “Company”), a leading Bitcoin mining company with an automotive transaction service in China, today announced that it has been included in the Bitwise Bitcoin Standard Corporations ETF (NYSE Arca: OWNB), launched by Bitwise Asset Management on March 11, 2025. The exchange-traded fund (ETF) tracks the Bitwise Bitcoin Standard Index, providing investors with exposure to forward-looking publicly traded corporations holding a minimum of 1,000 Bitcoins on their balance sheets.

“We are proud to be included in the recently launched Bitwise Bitcoin Standard Corporations ETF. Our inclusion highlights the industry’s acknowledgement of our strategic pivot to Bitcoin mining and significant achievements in such a short time,” said Mr. Jiayuan Lin, Chief Executive Officer of Cango. “As a forward-looking company, our future-ready business model ensures we are well-positioned for sustained growth, global expansion, and operational flexibility in the Bitcoin mining sector in 2025 and beyond.”

Since transitioning to a capital-light Bitcoin mining model in Q4 2024, Cango has achieved a number of milestones, including leading the industry in productivity per hash rate with 17.81 Bitcoin per EH/s and securing a hashrate of 32 EH/s, ranking 3^rd globally.

About Cango Inc.

Cango Inc. (NYSE: CANG) primarily operates a leading Bitcoin mining business. Headquartered in Shanghai, China, Cango has deployed its mining operation across strategic locations including North America, Middle East, South America, and East Africa. Cango expanded into the crypto assets market in November 2024, driven by the development in blockchain technology, increasing prevalence of crypto assets and its endeavor to diversify its business. Meanwhile, Cango has continued to operate the automotive transaction service in China since 2010, aiming to make car purchases simple and enjoyable. For more information, please visit: www.cangoonline.com.

Safe Harbor Statement

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Cango may also make written or oral forward-looking statements in its periodic reports to the SEC, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about Cango’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: Cango’s goal and strategies; Cango’s expansion plans; Cango’s future business development, financial condition and results of operations; Cango’s expectations regarding demand for, and market acceptance of, its solutions and services; Cango’s expectations regarding keeping and strengthening its relationships with dealers, financial institutions, car buyers and other platform participants; general economic and business conditions; and assumptions underlying or related to any of the foregoing. Further information regarding these and other risks is included in Cango’s filings with the SEC. All information provided in this press release and in the attachments is as of the date of this press release, and Cango does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Investor Relations Contact

Yihe Liu
Cango Inc.
Tel: +86 21 3183 5088 ext.5581
Email: [email protected]

Helen Wu

Piacente Financial Communications
Tel: +86 10 6508 0677
Email: [email protected]

View original content:https://www.prnewswire.com/news-releases/cango-inc-joins-bitwise-bitcoin-standard-corporations-etf-302404470.html

SOURCE Cango Inc.

March 18, 2025 8:34 am

CAMP4 Appoints Multiple Industry Veterans to its Board of Directors

With decades of experience in pharmaceutical development and extensive genetic medicine expertise, Doug E. Williams, Ph.D., and Murray Stewart, DM FRCP, will provide strategic guidance for CAMP4’s multiple drug development efforts

CAMBRIDGE, Mass., March 18, 2025 (GLOBE NEWSWIRE) — CAMP4 Therapeutics Corporation (“CAMP4”) (Nasdaq: CAMP), a clinical-stage biotechnology company developing a pipeline of regRNA-targeting antisense oligonucleotide (ASO) therapies to upregulate gene expression to restore healthy protein levels, today announced the appointments of Doug E. Williams, Ph.D., and Murray Stewart, DM FRCP, to the Company’s Board of Directors.

“We are delighted to welcome Drs. Williams and Stewart to our Board of Directors,” said Josh Mandel-Brehm, Chief Executive Officer of CAMP4. “With their combined expertise spanning critical aspects of R&D and clinical development, we will benefit greatly from their strategic insights as we advance our lead clinical program for urea cycle disorders and our preclinical program for SYNGAP1-related disorders, while continuing to develop additional RNA-targeting medicines designed to upregulate gene expression and meaningfully address diseases where we believe modest increases in protein levels can have a tremendous impact on the lives of patients.”

Dr. Williams commented, “CAMP4’s approach is opening exciting possibilities to upregulate gene expression, a long-sought-after and challenging feat in the field of genetic medicine. I look forward to working with the team to unlock the full potential of this approach and ultimately advance novel therapeutics to the clinic.”

Dr. Stewart added, “I’m thrilled to join the CAMP4 team and support its mission of advancing programmable RNA therapeutics for genetic diseases where decreased protein expression drives disease pathophysiology. By pioneering new ways to restore gene expression, CAMP4 has the potential to bring life-changing therapies to patients who currently have limited or no disease-modifying treatment options.”

With over 30 years in the biopharma industry, Dr. Williams has contributed to the development of several transformative drugs, including LEUKINE^®, ENBREL^®, ADCETRIS^®, TECFIDERA^®, APROLIX^®, ELOCTATE^®, and SPINRAZA^®. He was previously President of R&D at Sana Biotechnology and the Founding President & CEO of Codiak BioSciences. Prior to Sana, Dr. Williams served as EVP of R&D at Biogen, and earlier in his career was CEO of ZymoGenetics (acquired by BMS), and held leadership roles at Seattle Genetics, Amgen, and Immunex. Over the course of his career, he has served on the Board of Directors and Advisory Boards of more than two dozen biotech companies.

Dr. Stewart currently serves as a Senior Medical Advisor to several biopharma companies, and was most recently the Chief Medical Officer at Rhythm Pharmaceuticals. Prior to this position, he served as Head of R&D at Novelion Therapeutics. Before joining Novelion, he served as corporate Chief Medical Officer at GlaxoSmithKline. With extensive clinical development experience, he has led studies across all stages, from first-in-human trials to large Phase 4 cardiovascular outcome studies. Dr. Stewart has played a key role in the successful registration and launch of multiple therapies, including AVANDIA^®, ARIXTRA^®, TANZEUM^®, and XOLREMDI^®. Before transitioning to industry, he served as a Consultant Physician and Head of Clinical Services at the Diabetes Centre in Newcastle upon Tyne, UK, where his research was focused on lipid metabolism and type 2 diabetes.

About CAMP4 Therapeutics

CAMP4 is developing disease-modifying treatments for a broad range of rare and prevalent genetic diseases where increasing healthy protein levels may offer meaningful therapeutic benefits. Our approach allows for targeted gene upregulation by harnessing a fundamental mechanism of how genes are controlled. To increase gene expression, our therapeutic ASO drug candidates target regRNAs, which act locally on transcription factors and are the master regulators of gene expression. CAMP4’s proprietary RAP Platform™ enables the mapping of regRNAs and generation of therapeutic candidates designed to target the regRNAs associated with genes underlying haploinsufficient and recessive partial loss-of-function disorders, of which there are more than 1,200, in which a modest increase in protein expression may have the potential to be clinically meaningful. Learn more about us at www.CAMP4tx.com and follow us on LinkedIn and X.

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, you can identify forward-looking statements 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 CAMP4’s plans, objectives, expectations and intentions. 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; 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; 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 and are not guarantees of future events. 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, you should not unduly rely on these forward-looking statements. 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. Investors, potential investors, and others should give careful consideration to these 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.

Contacts

Investor Relations:

Sandya von der Weid
LifeSci Advisors
[email protected]

Media:

Jason Braco, Ph.D.
LifeSci Communications
[email protected]

March 18, 2025 8:33 am

TSA PreCheck® Enrollment Pop-up Events at the ItsEasy.com Offices in the Iconic NYC Locations: The MetLife Building and Rockefeller Center

ItsEasy.com and Telos Corporation announce new TSA PreCheck enrollment pop-up events, reinforcing their commitment to making travel as easy and convenient as possible.

NEW YORK and ASHBURN, Va., March 18, 2025 (GLOBE NEWSWIRE) — ItsEasy.com Passport & Visa Services, the leading passport and visa expediting company that has processed over 2 million passport and visa applications, and Telos Corporation (NASDAQ: TLS), an authorized TSA PreCheck^® enrollment provider, today announced pop-up TSA PreCheck enrollment events at two of ItsEasy.com’s NYC office locations within the iconic and easily accessible Manhattan landmarks, the MetLife Building and Rockefeller Center (Concourse Level). The event will run from Tuesday, March 25, to Saturday, March 29, 2025.

“This partnership reflects our ongoing dedication to simplifying and streamlining our customers’ travel experiences while saving them valuable time,” said David Alwadish, founder and CEO of ItsEasy.com Passport & Visa Services. “Our offices are centrally located in Manhattan, providing the utmost convenience for anyone looking to enroll in the TSA PreCheck Application Program. Offering TSA PreCheck enrollments provided by Telos rounds out our service offering so that we are the one-stop shop for simplifying and managing both domestic and global travel document processes and programs.”

The locations of the ItsEasy.com TSA PreCheck enrollment provided by Telos pop-up events are in the heart of Grand Central Station: The MetLife Building Lobby, 200 Park Ave., New York, NY 10166; and at the iconic Rockefeller Center, 30 Rockefeller Plaza, Floor 1 (Concourse Level), New York, NY 10112. Below are the hours of operation for the TSA PreCheck enrollment pop-up events:

TSA PRECHECK ENROLLMENT EVENT HOURS (ET)
Tues., March 25:	7:30 a.m. – 5:30 p.m.
Wed., March 26:	9:30 a.m. – 7:30 p.m.
Thurs., March 27:	9:30 a.m. – 7:30 p.m.
Fri., March 28:	7:30 a.m. – 5:30 p.m.
Sat., March 29:	8:00 a.m. – 5:00 p.m.

WHAT TO EXPECT

Enroll and Schedule: Start your TSA PreCheck application online at https://tsaprecheckbytelos.tsa.dhs.gov and book an in-person appointment at the nearest ItsEasy.com pop-up TSA PreCheck enrollment location. Ensure you have the required identification for your appointment.
Visit: During your 10-minute in-person appointment, we will scan and validate your identity documents, capture your photo and fingerprints, and collect payment.
Complete: Once your application is submitted, your data will be securely transmitted to TSA, which will make the final decision on TSA PreCheck eligibility. Most applicants receive their Known Traveler Number (KTN) within 3-5 days.

“Telos is pleased to partner with ItsEasy.com to deliver more ways for travelers to enroll or renew into the TSA PreCheck Application Program, providing pop-up enrollment centers in New York City for the first time through this game-changing partnership,” said John B. Wood, CEO and chairman, Telos. “Given their five decades of travel document expertise, ItsEasy.com is a logical venue for TSA PreCheck enrollments.”

New TSA PreCheck applicants can start their applications online and schedule an in-person enrollment appointment at one of Telos’ 223 enrollment centers across the U.S. by visiting the authorized TSA PreCheck Enrollment by Telos website, https://tsaprecheckbytelos.tsa.dhs.gov.

Existing TSA PreCheck members throughout the U.S. can renew directly on Telos’ authorized TSA PreCheck website, regardless of the provider they enrolled with originally: https://tsaprecheckbytelos.tsa.dhs.gov.

About TSA PreCheck
^®

TSA PreCheck is a Department of Homeland Security (DHS) Trusted Traveler program that allows enrolled travelers expedited screening through airport security. TSA PreCheck lanes are located at over 200 airports with 90+ airlines participating. Since TSA first launched the TSA PreCheck application program as a DHS Trusted Traveler Program for low-risk travelers in December 2013, active membership in the program has grown to more than 19 million members.

About ItsEasy.com Passport & Visa Services

ItsEasy.com
Passport & Visa Services is a leading passport and visa expediting company that has processed over 2 million passport and visa applications on behalf of their US-based customers. ItsEasy.com has been a trusted agent of the US Department of State since 1976, authorized to provide US passport services to the public for a fee. ItsEasy.com’s team of qualified passport and visa experts help passport & visa processes go forward, pre-review their customers’ applications & photos to ensure they’re in line with governmental requirements, and provide their customers with peace of mind, while saving them time and effort when they request these important government documents. ItsEasy.com submits passport & visa applications and obtains passports and visas on behalf of their customers. If there is a problem with an application, ItsEasy.com can interact with the U.S. Government or foreign agencies on the customer’s behalf to resolve problems at hand. Taking all the headache out of obtaining passports and visas, ItsEasy.com Passport & Visa Services is known for its ItsEasy Passport Renewal & Photo App, which offers the safest and most cost-effective way to renew a passport from one’s home or office. For urgent passports needed within 14 days, ItsEasy.com offers rush services. ItsEasy.com Passport & Visa Services has been featured in The Wall Street Journal, The New York Times, Forbes, The Washington Post, and more.

About Telos Corporation

Telos Corporation (NASDAQ: TLS) empowers and protects the world’s most security-conscious organizations with solutions for continuous security assurance of individuals, systems, and information. Telos’ offerings include cybersecurity solutions for IT risk management and information security; cloud security solutions to protect cloud-based assets and enable continuous compliance with industry and government security standards; and enterprise security solutions for identity and access management, secure mobility, organizational messaging, and network management and defense. The company serves commercial enterprises, regulated industries and government customers around the world. 

FORWARD LOOKING STATEMENTS – TELOS CORPORATION

This press release contains forward-looking statements which are made under the safe harbor provisions of the federal securities laws. These statements are based on Telos Corporation’s (“the Company”) management’s current beliefs, expectations and assumptions about future events, conditions and results and on information currently available to them. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. The Company believes that these risks and uncertainties include, but are not limited to, those described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” set forth from time to time in the Company’s filings and reports with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024, as well as future filings and reports by the Company, copies of which are available at https://investors.telos.com and on the SEC’s website at www.sec.gov.

Although the Company bases these forward-looking statements on assumptions that its management believes are reasonable when made, the Company cautions the reader that forward-looking statements are not guarantees of future performance and that the Company’s actual results of operations, financial condition and liquidity, and industry developments, may differ materially from statements made in or suggested by the forward-looking statements contained in this release. Given these risks, uncertainties and other factors, many of which are beyond its control, the Company cautions the reader not to place undue reliance on these forward-looking statements. Any forward-looking statement speaks only as of the date of such statement and, except as required by law, the Company undertakes no obligation to update any forward-looking statement publicly, or to revise any forward-looking statement to reflect events or developments occurring after the date of the statement, even if new information becomes available in the future. Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless specifically expressed as such, and should only be viewed as historical data.

Media: [email protected]
Investors: [email protected]