Inspire Medical Systems, Inc. Announces Third Quarter 2025 Financial Results and Updates 2025 Outlook




Inspire Medical Systems, Inc. Announces Third Quarter 2025 Financial Results and Updates 2025 Outlook

MINNEAPOLIS, Nov. 03, 2025 (GLOBE NEWSWIRE) — Inspire Medical Systems, Inc. (NYSE: INSP) (Inspire, or the company), a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea, today reported financial results for the quarter ended September 30, 2025.

Recent Business Highlights

• Generated revenue of $224.5 million in the third quarter of 2025, a 10% increase over the same quarter last year
• Achieved gross margin of 85.8% in the third quarter of 2025
• Net income was $9.9 million in the third quarter of 2025. Adjusted net income was $11.2 million
• Income per share was $0.34 in the third quarter of 2025. Adjusted diluted earnings per share was $0.38
• Generated operating cash flow of $68.5 million for the third quarter of 2025, bringing the year-to-date total to $64.5 million
• Presented Inspire V safety and efficacy data at recent industry meetings
• Completed $50 million in share repurchase

“The Inspire team had a very productive third quarter focusing on the transition to the Inspire V system while delivering very strong results globally,” said Tim Herbert, Chairman and Chief Executive Officer of Inspire Medical Systems. “Further, at recent industry meetings, we presented clinical evidence demonstrating that the Inspire V system offers enhanced performance, building on the strong foundation established by our legacy systems.”

“Patient safety is paramount, and with our Inspire V study in Singapore of 44 patients and the Limited-Market-Release study of over 100 patients in the United States, 100% of patients had a successful device implant,” continued Mr. Herbert. “Device performance was equally impressive starting with a 20% reduction in surgical procedure time, and statistically significant and clinically relevant reductions in disease severity. Recent field experience with the Inspire V system is generating very positive feedback from clinicians, and the team is making excellent progress with the U.S. launch with over 75% of centers ready to transition to Inspire V. We remain laser-focused on execution and with our strong performance and disciplined investments and cost management, we are reaffirming our full year revenue guidance of $900 to $910 million and increasing our diluted net income per share guidance to $0.90 to $1.00, up from $0.40 to $0.50 previously. I am very proud of how our team is executing and I look forward to a strong finish to the year.”

Third Quarter 2025 Financial Results

Revenue was $224.5 million for the third quarter, a 10% increase from $203.2 million in the corresponding prior year period. U.S. revenue for the quarter was $214.4 million, an increase of 9% as compared to the prior year quarter. Third quarter revenue outside the U.S. was $10.1 million, an increase of 37% as compared to the third quarter of 2024.

Gross margin was 85.8% for the third quarter of 2025 compared to 84.1% in the third quarter of 2024. The year-over-year increase was due to higher sales volume and higher Inspire V sales mix, which carries a lower cost of goods sold.

Operating expenses were $183.1 million for the third quarter of 2025, as compared to $156.5 million in the corresponding prior year period, an increase of 17%. This increase primarily reflected patient marketing expenses and general corporate costs, partially offset by a reduction in R&D. Operating expenses also included an additional $1.3 million in certain litigation-related legal expenses which do not reflect costs associated with our ongoing operations. A reconciliation table has been included at the bottom of this release.

Operating income was $9.6 million for the third quarter of 2025, as compared to $14.3 million in the prior year period.

Net income was $9.9 million for the third quarter of 2025 as compared to $18.5 million in the corresponding prior year period. Adjusted EBITDA for the third quarter of 2025 was $44.0 million as compared to $44.5 million in the corresponding prior year period. The diluted net income for the third quarter of 2025 was $0.34 per share, as compared to $0.60 per share in the prior year period. The adjusted net income for the third quarter of 2025 was $0.38 per share, as compared to $0.60 per share in the prior year period.

As of September 30, 2025, cash, cash equivalents, and investments were $410.9 million compared to $516.5 million on December 31, 2024.

Full Year 2025 Guidance

Inspire is maintaining full year 2025 revenue guidance to be in the range of $900 million to $910 million, which represents growth of 12% to 13% over full year 2024 revenue of $802.8 million.

The company is maintaining its full year 2025 gross margin guidance of 84% to 86%.

Inspire anticipates diluted net income per share guidance for the full year 2025 to be in the range of $0.90 to $1.00. This compares to the prior guidance of $0.40 to $.50 per share.

Webcast and Conference Call

Inspire’s management will host a conference call after market close today, Monday, November 3, 2025, at 5:00 p.m. Eastern Time to discuss these results and answer questions.

To access the conference call, please preregister on
https://register-conf.media-server.com/register/BIcaef92f7ac51467ca25919f83cd3e22e.
Registrants will receive confirmation with dial-in details.

A live webcast of the event can be accessed on https://edge.media-server.com/mmc/p/7um4yofb/. A replay of the webcast will be available on https://investors.inspiresleep.com starting approximately two hours after the event and archived on the site for two weeks.

About Inspire Medical Systems

Inspire is a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea. Inspire’s proprietary Inspire therapy is the first and only FDA, EU MDR and PDMA-approved neurostimulation technology of its kind that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.

For additional information about Inspire, please visit www.inspiresleep.com.

Use of Non-GAAP Financial Measures

This press release includes the non-GAAP financial measures of Adjusted net income, Adjusted earnings per share (“EPS”), Adjusted EBITDA, and Adjusted EBITDA margin, which differ from financial measures calculated in accordance with U.S. generally accepted accounting principles (“GAAP”).

We define Adjusted net income as net income or loss, plus items that are not indicative of our ongoing operations. Net income is the most directly comparable GAAP financial measure to adjusted net income. Adjusted EPS is calculated as adjusted net income divided by the dilutive weighted average shares outstanding. Diluted EPS is the most directly comparable GAAP financial measure to adjusted EPS. We define Adjusted EBITDA as net income or loss, less interest income, plus interest expense, plus income tax expense, plus depreciation and amortization, plus stock-based compensation expense, plus litigation-related legal expenses and other non-operating expenses less non-operating income. Net income is the most directly comparable GAAP financial measure to Adjusted EBITDA. We define Adjusted EBITDA margin in this release as Adjusted EBITDA divided by revenue. Net income margin is the most directly comparable GAAP measure to Adjusted EBITDA margin. Reconciliations of these non-GAAP financial measures to their most directly comparable GAAP measures are included in this press release.

These non-GAAP financial measures are presented because we believe they are useful indicators of our operating performance. Management uses these measures principally as measures of our operating performance and for planning purposes, including the preparation of our annual operating plan and financial projections. We believe these measures are useful to investors as supplemental information and because they are frequently used by analysts, investors and other interested parties to evaluate companies in our industry. We also believe these non-GAAP financial measures are useful to our management and investors as a measure of comparative operating performance from period to period.

These non-GAAP financial measures should not be considered as an alternative to, or superior to, the most directly comparable GAAP financial measures, as measures of financial performance or cash flows from operations, as a measure of liquidity, or any other performance measure derived in accordance with GAAP, and they should not be construed to imply that our future results will be unaffected by unusual or non-recurring items. In addition, Adjusted EBITDA is not intended to be a measure of cash flow for management’s discretionary use, as it does not reflect certain cash requirements such as tax payments, capital expenditures and certain other cash costs that may recur in the future. Adjusted EBITDA contains certain other limitations, including the failure to reflect our cash expenditures, cash requirements for working capital needs and cash costs to replace assets being depreciated and amortized. In evaluating our non-GAAP financial measures, you should be aware that in the future we may incur expenses that are the same as or similar to some of the adjustments in this presentation. Our presentation of non-GAAP financial measures should not be construed to imply that our future results will be unaffected by any such adjustments. Management compensates for these limitations by primarily relying on our GAAP results in addition to using non-GAAP financial measures on a supplemental basis. Our definition of these non-GAAP financial measures is not necessarily comparable to other similarly titled captions of other companies due to different methods of calculation.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including, without limitation, statements regarding full year 2025 financial outlook and our expectations regarding the launch of our Inspire V neurostimulation system, including the timeline to complete the full transition to that product. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ “future,” “outlook,” “guidance,” ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’ ‘‘contemplate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘potential,’’ ‘‘continue,’’ or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.

These forward-looking statements are based on management’s current expectations and involve known and unknown risks and uncertainties that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, our history of operating losses and dependency on our Inspire therapy for revenues; commercial success and market acceptance of our Inspire therapy; our ability to achieve and maintain adequate levels of coverage or reimbursement for our Inspire therapy or any future products we may seek to commercialize; competitive companies, technologies and pharmaceuticals in our industry; our involvement in current or future legal disputes or regulatory proceedings; our ability to expand our indications and develop and commercialize additional products and enhancements to our Inspire therapy; future results of operations, financial position, research and development costs, capital requirements and our needs for additional financing; our ability to accurately forecast customer demand for our Inspire therapy and manage our inventory; our dependence on third-party suppliers, contract manufacturers and shipping carriers; consolidation in the healthcare industry; our ability to expand, manage and maintain our direct sales and marketing organization, and to market and sell our Inspire therapy in markets outside of the U.S.; risks associated with international operations; our ability to manage our growth; our ability to hire and retain our senior management and other highly qualified personnel; risk of product liability claims; our ability to address quality issues that may arise with our Inspire therapy; our ability to successfully integrate any acquired business, products, or technologies; changes in global macroeconomic trends; challenges experienced by patients in obtaining prior authorization, our ability to achieve and maintain adequate levels of coverage or reimbursement for our Inspire therapy; our business model and strategic plans for our products, technologies and business, including our implementation thereof; the impact of glucagon-like peptide 1 class of drugs on demand for our Inspire therapy; risks related to information technology and cybersecurity; our ability to commercialize or obtain regulatory approvals for our Inspire therapy, or the effect of delays in commercializing or obtaining regulatory approvals; and FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this press release can be found under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations“ in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as updated in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 to be filed with the SEC, and as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website at www.inspiresleep.com. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by applicable law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this press release.

Investor & Media Contact
Ezgi Yagci
Vice President, Investor Relations
ezgiyagci@inspiresleep.com
617-549-2443

Inspire Medical Systems, Inc.

Consolidated Statements of Operations and Comprehensive Income (unaudited)

(in thousands, except share and per share amounts)

Inspire Medical Systems, Inc.

Consolidated Balance Sheets (unaudited)

(in thousands, except share and per share amounts)

Inspire Medical Systems, Inc.

Reconciliation of Non-GAAP Financial Measures (unaudited)

(in thousands, except share and per share amounts)

Reconciliation of GAAP Net Income and Income per Share to Non-GAAP Adjusted Net Income and
Adjusted Net Income per Share

⁽¹⁾ Represents accelerated stock-based compensation expense for certain employees who are retirement eligible in accordance with the implementation of changes to the treatment of equity awards under the Inspire Medical Systems, Inc. 2018 Incentive Award Plan upon the holder’s death, disability, or retirement.

⁽²⁾ These costs represent legal-related expenses related to (a) a civil investigative demand from the Department of Justice, (b) a patent infringement suit that we filed against Nyxoah S.A. and its wholly-owned subsidiary, Nyxoah, Inc. (“Nyxoah”), and (c) a patent infringement suit brought against us by Nyxoah. These costs do not reflect costs associated with our normal ongoing operations.

⁽³⁾ Represents a non-cash impairment of a strategic investment, which does not reflect costs associated with our ongoing operations.

Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA

⁽⁴⁾ Total stock-based compensation expense.

Reconciliation of GAAP Net Income Margin and Non-GAAP Adjusted EBITDA Margin

⁽⁴⁾ Total stock-based compensation expense.

⁽⁵⁾ Net income margin is calculated as net income divided by total revenue.

⁽⁶⁾ Adjusted EBITDA margin is calculated as Adjusted EBITDA divided by total revenue.

Mdxhealth to Release Third Quarter 2025 Financial Results on November 12




Mdxhealth to Release Third Quarter 2025 Financial Results on November 12

Mdxhealth to Release Third Quarter 2025 Financial Results
on November 12

Company to Host Conference Call with Live Q&A, November 12, 2025, at 4:30pm ET / 22:30 CET

IRVINE, California – November 3, 2025 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH), a leading precision diagnostics company, today announced it will release its financial results for the third quarter ended September 30, 2025, after market close on Wednesday, November 12, 2025.

The webcast should be accessed 15 minutes prior to the conference call start time. A replay of the webcast will be available following the conclusion of the live call and will be accessible on the Company’s website.

About Mdxhealth

Mdxhealth is a leading precision diagnostics company that provides actionable molecular information to personalize patient diagnosis and treatment. The Company’s tests are based on proprietary genomic, epigenomic, exosomal and other molecular signatures and assist physicians with the diagnosis and prognosis of prostate cancer and other urologic diseases. The Company’s U.S. headquarters and laboratory operations are in Irvine, California, with additional laboratory operations in Waltham, Massachusetts and Plano, Texas. European headquarters are in Herstal, Belgium. For more information, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.

Attachment

• mdx11.25

Mdxhealth to Release Third Quarter 2025 Financial Results on November 12




Mdxhealth to Release Third Quarter 2025 Financial Results on November 12

Mdxhealth to Release Third Quarter 2025 Financial Results
on November 12

Company to Host Conference Call with Live Q&A, November 12, 2025, at 4:30pm ET / 22:30 CET

IRVINE, California – November 3, 2025 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH), a leading precision diagnostics company, today announced it will release its financial results for the third quarter ended September 30, 2025, after market close on Wednesday, November 12, 2025.

The webcast should be accessed 15 minutes prior to the conference call start time. A replay of the webcast will be available following the conclusion of the live call and will be accessible on the Company’s website.

About Mdxhealth

Mdxhealth is a leading precision diagnostics company that provides actionable molecular information to personalize patient diagnosis and treatment. The Company’s tests are based on proprietary genomic, epigenomic, exosomal and other molecular signatures and assist physicians with the diagnosis and prognosis of prostate cancer and other urologic diseases. The Company’s U.S. headquarters and laboratory operations are in Irvine, California, with additional laboratory operations in Waltham, Massachusetts and Plano, Texas. European headquarters are in Herstal, Belgium. For more information, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.

Attachment

• mdx11.25

Galapagos to Present New Data from Cell Therapy Program at ASH 2025




Galapagos to Present New Data from Cell Therapy Program at ASH 2025

Oral presentation of GLPG5101 data from the ATALANTA-1 study in patients with high-risk relapsed/refractory mantle cell lymphoma

Two abstracts featuring new Phase 2 data highlight the potential of CAR-T cell therapy candidate, GLPG5101, in relapsed/refractory non-Hodgkin lymphoma

Results demonstrate high rates of complete and durable responses along with low rates of high-grade toxicities using GLPG5101 manufactured on innovative median seven-day vein-to-vein time platform, potentially enabling broader access to cell therapy

Mechelen, Belgium; November 3, 2025, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced that it will present new and updated data for CAR T-cell therapy candidate, GLPG5101¹, at the 67^th American Society of Hematology (ASH) Annual Meeting in Orlando, FL, December 6-9, 2025.

Two abstracts, including one oral presentation, will feature new and updated Phase 2 data in relapsed/refractory mantle cell lymphoma (R/R MCL) and R/R large B-cell lymphoma (R/R DLBCL) for GLPG5101, Galapagos’ proprietary cell therapy candidate in R/R non-Hodgkin lymphoma (NHL). Galapagos will also host a company showcase, titled: Fast, Fresh, Fit: Unlocking the Potential of Cell Therapy through a Transformative, Scalable, and Accessible Approach to Impact More Patients Globally.

“We are excited to present promising new clinical data for our CD19 CAR T-cell therapy candidate in R/R mantle cell lymphoma and diffuse large B-cell lymphoma, two indications with high unmet medical need,” said Omotayo Fasan, MBBS, MRCP, Clinical Development Program Head, Oncology. “The data continue to support the hypothesis that the rapid delivery of fresh, fit, early-memory enriched CAR-T cells could improve outcomes for patients.”

The data to be presented are summarized below:

• The oral presentation on GLPG5101, Galapagos’ CD19 CAR-T candidate, will feature new and updated Phase 2 data in patients with high-risk R/R MCL. The results demonstrate high rates of complete response and minimal residual disease negativity, and durable responses, with low rates of severe grade toxicities (cut-off date: September 2, 2025).
• The poster presentation on GLPG5101, Galapagos’ CD19 CAR-T candidate, will feature new and updated Phase 2 data in R/R DLBCL. The data demonstrate high complete response rates, a low dropout rate, and mainly low-grade toxicities in patients with R/R DLBCL (cut-off date: September 2, 2025).
• The oral and poster presentations demonstrate the feasibility of the manufacturing platform, enabling rapid delivery of fresh, early-memory enriched CAR T-cell products with a median vein-to-vein time of seven days. The data show robust in-vivo expansion, durable persistence, high complete response rates, and a low incidence of high-grade toxicities, supporting outpatient administration.

The dates and times for the accepted abstracts are as follows:

About GLPG5101 and ATALANTA-1 (EudraCT 2021-003272-13; NCT 06561425)

GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. The safety, efficacy and feasibility of decentralized manufactured GLPG5101 are currently being evaluated in the ATALANTA-1 Phase 1/2 study in eight hematological malignancies with high unmet need. The primary objective of the Phase 1 part of the study is to evaluate safety and to determine the recommended dose for the Phase 2 part of the study. Secondary objectives include assessment of efficacy and feasibility of decentralized manufacturing of GLPG5101. The dose levels that were evaluated in Phase 1 are 50×10⁶ (DL1), 110×10⁶ (DL2) and 250×10⁶ (DL3) CAR+ viable T-cells. The primary objective of the Phase 2 part of the study is to evaluate the Objective Response Rate (ORR) while the secondary objectives include Complete Response Rate (CRR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and the feasibility of decentralized manufacturing. Each enrolled patient will be followed for 24 months. The ATALANTA-1 study is currently enrolling patients in the U.S. and Europe.

About Galapagos’ cell therapy manufacturing platform
Galapagos’ innovative decentralized cell therapy manufacturing platform has the potential for the administration of fresh, fit cells in a median vein-to-vein time of seven days, greater physician visibility, and improved patient experience. The platform consists of an end-to-end xCellit® workflow management and monitoring software system, a decentralized, functionally closed, automated manufacturing platform for cell therapies (using Lonza’s Cocoon®) and a proprietary quality control testing and release strategy.

For further information, contact Galapagos:
Investor Relations
Glenn Schulman

+1 412 522 6239
ir@glpg.com

Corporate Communications
Marieke Vermeersch
+32 479 490 603

media@glpg.com

Visit us at www.glpg.com or follow us on LinkedIn or X.

Forward-looking statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements are often, but are not always, made through the use of words or phrases such as “anticipate,” “expect,” “plan,” “estimate,” “will,” “continue,” “aim,” “intend,” “future,” “potential,” “could,” “indicate,” “forward,” “may,” as well as similar expressions. Forward-looking statements contained in this press release include, but are not limited to, statements regarding Galapagos’ plans, expectations and strategy with respect to its cell therapy business, including statements regarding its plans, expectations and strategy for GLPG5101 and its other product candidates and partnered programs, Galapagos’ intention to wind down its cell therapy business as part of its ongoing transformation, the expected timing, design and readouts of the ATALANTA-1 study, and the potential benefits of Galapagos’ product candidates. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause Galapagos’ actual results to be materially different from those expressed or implied by such forward-looking statements. These risks, uncertainties and other factors include, without limitation, the risk that Galapagos will not be able to successfully implement the winding down of its cell therapy business within the expected timeframe or at all, or if implemented, the wind down will not achieve its anticipated economic benefits; the risk that preliminary or interim clinical results may not be replicated in ongoing or subsequent clinical trials, the risk that ongoing and future clinical studies with Galapagos’ product candidates, including GLPG5101, may not be completed in the currently envisaged timelines or at all, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration or further development of GLPG5101 due to safety, efficacy or other reasons), Galapagos’ reliance on collaborations with third parties (including its collaboration partners Lonza and US WorldMeds), and that Galapagos’ estimations regarding its GLPG5101 development programs and regarding the commercial potential of GLPG5101 may be incorrect, as well as those risks and uncertainties identified in Galapagos’ Annual Report on Form 20-F for the year ended 31 December 2024 filed with the U.S. Securities and Exchange Commission (SEC) and its subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management’s current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations. Further, Galapagos cannot assess the impact of each such factor on its business or the extent to which any factor, or combination of factors, may cause actual results to be materially different from those contained in any forward-looking statement.

¹ On October 21, 2025, Galapagos announced its intention to wind down its cell therapy business and pursue new transformational business development transactions with its available cash resources. This intention is subject to the conclusion of consultations with works councils in Belgium and the Netherlands, during which Galapagos will continue to operate the business (including, among other things, presenting clinical data at scientific conferences). Galapagos would consider any viable proposal to acquire all, or part of the cell therapy business, if such a proposal emerges during the wind down process.

Attachment

• Galapagos to Present New Data from Cell Therapy Program at ASH 2025

Rendever Receives Nearly $4.5 Million in NIH Funding to Overcome Social Isolation for Older Adults while Supporting Caregivers




Rendever Receives Nearly $4.5 Million in NIH Funding to Overcome Social Isolation for Older Adults while Supporting Caregivers

BOSTON, Nov. 03, 2025 (GLOBE NEWSWIRE) — Rendever, the company leading the industry in immersive technology for aging, has secured nearly $4.5 million in grant funding from the National Institutes of Health (NIH) to improve the aging process through technology-enabled social networks. The funding includes $3.8 million for the Thrive At Home Program and an additional grant to build a caregiver support network in VR. These funds will pave the way for Rendever to bring their technology to the large majority of individuals and caregivers who are aging in place and lacking in structural social support.

This significant investment continues Rendever’s work alongside the University of California in Santa Barbara, and also involves new partnerships with the research organization RAND and with Right at Home, a leading provider of home care services, to bring this technology into the home care market. Together, they will conduct studies to evaluate the effectiveness of VR technology in building relationships across living environments, thereby reducing social isolation, improving mental health, and enhancing overall well-being throughout the aging lifespan. At the same time, Rendever will be studying the impact of caregiving tools, including its recent Dementia & Empathy training program. With the definition and experience of “home” shifting continually in a way that can disrupt critical social engagement, this initiative has the potential to revolutionize the way seniors experience care and community.

“Our Phase II trial has shown the power of VR to effectively build and enhance family relationships across distances – even across country lines. The future of aging depends on technology that effectively reshapes how we experience these core parts of the human experience as we get older,” said Kyle Rand, Rendever’s CEO. “We know there’s nothing more holistically impactful than our social health. Over the next three years, we’ll work across the industry to build the next generation of community infrastructure that delivers real happiness and forges new relationships, all while driving meaningful health outcomes.”

Previous work in this NIH line of research has shown that family members experience a significant reduction in stress and depression after a four-week social intervention in Rendever. Recent results show that the positive effects of social VR interventions are increased for families navigating dementia and Alzheimer’s Disease.

Along with this funding announcement, Rendever is welcoming Sarah Thomas to its Board of Directors. Thomas is a global expert on aging, serving as both a thought leader and a venture partner in the AgeTech industry. Notably, she’s worked with major companies to launch products in new aging markets and has been integral in the formation of membership models that transform the senior living industry.

“I’m honored to join Rendever’s Board at a pivotal moment for AgeTech adoption,” said Thomas. “Virtual reality is proving its power to combat isolation, improve mental and cognitive health, and elevate quality of life for older adults. I look forward to helping scale Rendever’s impact across senior living and into the home – advancing clinically-validated, engaging, and accessible VR experiences that enable older adults to live fuller, healthier, more connected lives.”

For more information about Rendever, visit www.rendever.com.

About Rendever
Rendever is overcoming social isolation and improving care through the power of virtual reality and shared experiences. From senior living communities to hospitals, the platform is being used to reduce depression and loneliness by fostering personal connections among populations where life has become limited. Participants in group sessions can check off bucket list items together, revisit meaningful places and share stories, stay engaged with family members, and more. Rendever is being used by high-profile senior living operators, including Oakmont Management Group, Marquis Health, and MBK Senior Living, healthcare systems such as UCHealth and Cleveland Clinic, has research funded by the NIH and NIA, and has launched commercial partnerships with major organizations like AARP and Verizon. Rendever is a four-time Inc. 5000 honoree, a two-time TIME Best Invention winner, and a TIME100 Most Influential Company. To learn more, please visit www.rendever.com.

Media Contact
Erica Torres
Uproar by Moburst for Rendever
erica.torres@moburst.com

Legend Biotech Announces 10 Presentations at the 67th American Society of Hematology (ASH) Annual Meeting




Legend Biotech Announces 10 Presentations at the 67th American Society of Hematology (ASH) Annual Meeting

Two oral and seven poster presentations further support the CARVYKTI^® research in multiple myeloma

First-in-Human Phase 1 data for allogeneic CAR-T cell therapy for NHL to be featured in oral session

SOMERSET, N.J., Nov. 03, 2025 (GLOBE NEWSWIRE) — Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced that it will present two oral presentations and seven poster presentations on CARVYKTI^® (ciltacabtagene autoleucel; cilta-cel) for multiple myeloma at the 67th Annual American Society of Hematology (ASH) Annual Meeting taking place from December 6-9, 2025, in Orlando, FL.

In addition to the CARVYKTI data, the Company will also deliver an oral presentation on Lucar-G39D, its investigational and novel anti-CD20/CD19 dual-CAR allogeneic gamma delta T cell therapy, being evaluated in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).

“We’re proud to see the depth and breadth of data being presented at ASH this year, reflecting the continued innovation and clinical impact of our cell therapy programs,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “With nine abstracts highlighting CARVYKTI, these presentations further demonstrate the durability of responses, evolving safety profile, and real-world outcomes that support the potential of CAR-T therapy earlier in the multiple myeloma treatment journey. In addition, our first-in-human data on Lucar-G39D highlights our ongoing efforts to expand our pipeline into next-generation allogeneic cell therapies for patients with B-cell malignancies.”

CARVYKTI is the first and only BCMA-targeted CAR-T cell therapy approved for the treatment of patients with multiple myeloma who have had at least one prior line of therapy. Globally, CARVYKTI is now commercially available in 14 countries and has been used to treat more than 9,000 patients to date.

ASH Presentations (December 6-9, 2025)

CARVYKTI^® IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

INCREASED EARLY MORTALITY – In CARTITUDE-4, a (1:1) randomized controlled trial, there was a numerically higher percentage of early deaths in patients randomized to the CARVYKTI^® treatment arm compared to the control arm. Among patients with deaths occurring within the first 10 months from randomization, a greater proportion (29/208; 14%) occurred in the CARVYKTI^® arm compared to (25/211; 12%) in the control arm. Of the 29 deaths that occurred in the CARVYKTI^® arm within the first 10 months of randomization, 10 deaths occurred prior to CARVYKTI^® infusion, and 19 deaths occurred after CARVYKTI^® infusion. Of the 10 deaths that occurred prior to CARVYKTI^® infusion, all occurred due to disease progression, and none occurred due to adverse events. Of the 19 deaths that occurred after CARVYKTI^® infusion, 3 occurred due to disease progression, and 16 occurred due to adverse events. The most common adverse events were due to infection (n=12).

CYTOKINE RELEASE SYNDROME (CRS), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI^®. Among patients receiving CARVYKTI^® for RRMM in the CARTITUDE-1 & -4 studies (N=285), CRS occurred in 84% (238/285), including ≥ Grade 3 CRS (ASTCT 2019) in 4% (11/285) of patients. Median time to onset of CRS, any grade, was 7 days (range: 1 to 23 days). CRS resolved in 82% with a median duration of 4 days (range: 1 to 97 days). The most common manifestations of CRS in all patients combined (≥10%) included fever (84%), hypotension (29%) and aspartate aminotransferase increased (11%). Serious events that may be associated with CRS include pyrexia, hemophagocytic lymphohistiocytosis, respiratory failure, disseminated intravascular coagulation, capillary leak syndrome, and supraventricular and ventricular tachycardia. CRS occurred in 78% of patients in CARTITUDE-4 (3% Grade 3 to 4) and in 95% of patients in CARTITUDE-1 (4% Grade 3 to 4).

Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.

Confirm that a minimum of 2 doses of tocilizumab are available prior to infusion of CARVYKTI^®.

Of the 285 patients who received CARVYKTI^® in clinical trials, 53% (150/285) patients received tocilizumab; 35% (100/285) received a single dose, while 18% (50/285) received more than 1 dose of tocilizumab. Overall, 14% (39/285) of patients received at least 1 dose of corticosteroids for treatment of CRS.

Monitor patients at least daily for 7 days following CARVYKTI^® infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 2 weeks after infusion. At the first sign of CRS, immediately institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids.

Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.

NEUROLOGIC TOXICITIES, which may be severe, life-threatening, or fatal, occurred following treatment with CARVYKTI^®. Neurologic toxicities included ICANS, neurologic toxicity with signs and symptoms of Parkinsonism, GBS, immune mediated myelitis, peripheral neuropathies, and cranial nerve palsies. Counsel patients on the signs and symptoms of these neurologic toxicities, and on the delayed nature of onset of some of these toxicities. Instruct patients to seek immediate medical attention for further assessment and management if signs or symptoms of any of these neurologic toxicities occur at any time.

Among patients receiving CARVYKTI^® in the CARTITUDE-1 & 4 studies for RRMM, one or more neurologic toxicities occurred in 24% (69/285), including ≥ Grade 3 cases in 7% (19/285) of patients. Median time to onset was 10 days (range: 1 to 101) with 63/69 (91%) of cases developing by 30 days. Neurologic toxicities resolved in 72% (50/69) of patients with a median duration to resolution of 23 days (range: 1 to 544). Of patients developing neurotoxicity, 96% (66/69) also developed CRS. Subtypes of neurologic toxicities included ICANS in 13%, peripheral neuropathy in 7%, cranial nerve palsy in 7%, parkinsonism in 3%, and immune mediated myelitis in 0.4% of the patients.

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Patients receiving CARVYKTI^® may experience fatal or life-threatening ICANS following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS.

Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, ICANS occurred in 13% (36/285), including Grade ≥3 in 2% (6/285) of the patients. Median time to onset of ICANS was 8 days (range: 1 to 28 days). ICANS resolved in 30 of 36 (83%) of patients, with a median time to resolution of 3 days (range: 1 to 143 days). Median duration of ICANS was 6 days (range: 1 to 1229 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Of patients with ICANS, 97% (35/36) had CRS. The onset of ICANS occurred during CRS in 69% of patients, before and after the onset of CRS in 14% of patients, respectively.

Immune Effector Cell-associated Neurotoxicity Syndrome occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3) and in 23% of patients in CARTITUDE-1 (3% Grade 3). The most frequent (≥2%) manifestations of ICANS included encephalopathy (12%), aphasia (4%), headache (3%), motor dysfunction (3%), ataxia (2%), and sleep disorder (2%).

Monitor patients at least daily for 7 days following CARVYKTI^® infusion for signs and symptoms of ICANS. Rule out other causes of ICANS symptoms. Monitor patients for signs or symptoms of ICANS for at least 2 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. Advise patients to avoid driving for at least 2 weeks following infusion.

Parkinsonism: Neurologic toxicity with parkinsonism has been reported in clinical trials of CARVYKTI^®. Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, parkinsonism occurred in 3% (8/285), including Grade ≥3 in 2% (5/285) of the patients. Median time to onset of parkinsonism was 56 days (range: 14 to 914 days). Parkinsonism resolved in 1 of 8 (13%) of patients with a median time to resolution of 523 days. Median duration of parkinsonism was 243.5 days (range: 62 to 720 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. The onset of parkinsonism occurred after CRS for all patients and after ICANS for 6 patients.

Parkinsonism occurred in 1% of patients in CARTITUDE-4 (no Grade 3 to 4) and in 6% of patients in CARTITUDE-1 (4% Grade 3 to 4).

Manifestations of parkinsonism included movement disorders, cognitive impairment, and personality changes. Monitor patients for signs and symptoms of parkinsonism that may be delayed in onset and managed with supportive care measures. There is limited efficacy information with medications used for the treatment of Parkinson’s disease for the improvement or resolution of parkinsonism symptoms following CARVYKTI^® treatment.

Guillain-Barré Syndrome: A fatal outcome following GBS occurred following treatment with CARVYKTI^® despite treatment with intravenous immunoglobulins. Symptoms reported include those consistent with Miller-Fisher variant of GBS, encephalopathy, motor weakness, speech disturbances, and polyradiculoneuritis.

Monitor for GBS. Evaluate patients presenting with peripheral neuropathy for GBS. Consider treatment of GBS with supportive care measures and in conjunction with immunoglobulins and plasma exchange, depending on severity of GBS.

Immune Mediated Myelitis: Grade 3 myelitis occurred 25 days following treatment with CARVYKTI^® in CARTITUDE-4 in a patient who received CARVYKTI^® as subsequent therapy. Symptoms reported included hypoesthesia of the lower extremities and the lower abdomen with impaired sphincter control. Symptoms improved with the use of corticosteroids and intravenous immune globulin. Myelitis was ongoing at the time of death from other cause.

Peripheral Neuropathy occurred following treatment with CARVYKTI^®. Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, peripheral neuropathy occurred in 7% (21/285), including Grade ≥3 in 1% (3/285) of the patients. Median time to onset of peripheral neuropathy was 57 days (range: 1 to 914 days). Peripheral neuropathy resolved in 11 of 21 (52%) of patients with a median time to resolution of 58 days (range: 1 to 215 days). Median duration of peripheral neuropathy was 149.5 days (range: 1 to 692 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff.

Peripheral neuropathies occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3 to 4) and in 7% of patients in CARTITUDE-1 (2% Grade 3 to 4). Monitor patients for signs and symptoms of peripheral neuropathies. Patients who experience peripheral neuropathy may also experience cranial nerve palsies or GBS.

Cranial Nerve Palsies occurred following treatment with CARVYKTI^®. Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, cranial nerve palsies occurred in 7% (19/285), including Grade ≥3 in 1% (1/285) of the patients. Median time to onset of cranial nerve palsies was 21 days (range: 17 to 101 days). Cranial nerve palsies resolved in 17 of 19 (89%) of patients with a median time to resolution of 66 days (range: 1 to 209 days). Median duration of cranial nerve palsies was 70 days (range: 1 to 262 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Cranial nerve palsies occurred in 9% of patients in CARTITUDE-4 (1% Grade 3 to 4) and in 3% of patients in CARTITUDE-1 (1% Grade 3 to 4).

The most frequent cranial nerve affected was the 7th cranial nerve. Additionally, cranial nerves III, V, and VI have been reported to be affected.

Monitor patients for signs and symptoms of cranial nerve palsies. Consider management with systemic corticosteroids, depending on the severity and progression of signs and symptoms.

HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH)/MACROPHAGE ACTIVATION SYNDROME (MAS): Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, HLH/MAS occurred in 1% (3/285) of patients. All events of HLH/MAS had onset within 99 days of receiving CARVYKTI^®, with a median onset of 10 days (range: 8 to 99 days), and all occurred in the setting of ongoing or worsening CRS. The manifestations of HLH/MAS included hyperferritinemia, hypotension, hypoxia with diffuse alveolar damage, coagulopathy and hemorrhage, cytopenia, and multi-organ dysfunction, including renal dysfunction and respiratory failure.

Patients who develop HLH/MAS have an increased risk of severe bleeding. Monitor hematologic parameters in patients with HLH/MAS and transfuse per institutional guidelines. Fatal cases of HLH/MAS occurred following treatment with CARVYKTI^®.

HLH is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of HLH/MAS should be administered per institutional standards.

PROLONGED AND RECURRENT CYTOPENIAS: Patients may exhibit prolonged and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI^® infusion.

Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, Grade 3 or higher cytopenias not resolved by Day 30 following CARVYKTI^® infusion occurred in 62% (176/285) of the patients and included thrombocytopenia 33% (94/285), neutropenia 27% (76/285), lymphopenia 24% (67/285), and anemia 2% (6/285). After Day 60 following CARVYKTI^® infusion, 22%, 20%, 5%, and 6% of patients had a recurrence of Grade 3 or 4 lymphopenia, neutropenia, thrombocytopenia, and anemia, respectively, after initial recovery of their Grade 3 or 4 cytopenia. Seventy-seven percent (219/285) of patients had one, two, or three or more recurrences of Grade 3 or 4 cytopenias after initial recovery of Grade 3 or 4 cytopenia. Sixteen and 25 patients had Grade 3 or 4 neutropenia and thrombocytopenia, respectively, at the time of death.

Monitor blood counts prior to and after CARVYKTI^® infusion. Manage cytopenias with growth factors and blood product transfusion support according to local institutional guidelines.

INFECTIONS: CARVYKTI^® should not be administered to patients with active infection or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after CARVYKTI^® infusion.

Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, infections occurred in 57% (163/285), including Grade ≥3 in 24% (69/285) of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 6%, bacterial infections in 5%, and fungal infections in 1% of patients. Overall, 5% (13/285) of patients had Grade 5 infections, 2.5% of which were due to COVID-19. Patients treated with CARVYKTI^® had an increased rate of fatal COVID-19 infections compared to the standard therapy arm.

Monitor patients for signs and symptoms of infection before and after CARVYKTI^® infusion and treat patients appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to the standard institutional guidelines. Febrile neutropenia was observed in 5% of patients after CARVYKTI^® infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care, as medically indicated. Counsel patients on the importance of prevention measures. Follow institutional guidelines for the vaccination and management of immunocompromised patients with COVID-19.

Viral Reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients with hypogammaglobulinemia. Perform screening for Cytomegalovirus (CMV), HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) or any other infectious agents if clinically indicated in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice.

Reactivation of John Cunningham (JC) virus, leading to progressive multifocal leukoencephalopathy (PML), including cases with fatal outcomes, have been reported following treatment. Perform appropriate diagnostic evaluations in patients with neurological adverse events.

HYPOGAMMAGLOBULINEMIA: can occur in patients receiving treatment with CARVYKTI^®. Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, hypogammaglobulinemia adverse event was reported in 36% (102/285) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 93% (265/285) of patients. Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in 94% (267/285) of patients treated. Fifty-six percent (161/285) of patients received intravenous immunoglobulin (IVIG) post CARVYKTI® for either an adverse reaction or prophylaxis.

Monitor immunoglobulin levels after treatment with CARVYKTI^® and administer IVIG for IgG <400 mg/dL. Manage per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.

Use of Live Vaccines: The safety of immunization with live viral vaccines during or following CARVYKTI^® treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during CARVYKTI^® treatment, and until immune recovery following treatment with CARVYKTI^®.

HYPERSENSITIVITY REACTIONS occurred following treatment with CARVYKTI^®. Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, hypersensitivity reactions occurred in 5% (13/285), all of which were ≤2 Grade. Manifestations of hypersensitivity reactions included flushing, chest discomfort, tachycardia, wheezing, tremor, burning sensation, non-cardiac chest pain, and pyrexia.

Serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide (DMSO) in CARVYKTI^®. Patients should be carefully monitored for 2 hours after infusion for signs and symptoms of severe reaction. Treat promptly and manage patients appropriately according to the severity of the hypersensitivity reaction.

IMMUNE EFFECTOR CELL-ASSOCIATED ENTERCOLITIS (IEC-EC) has occurred in patients treated with CARVYKTI^®. Manifestations include severe or prolonged diarrhea, abdominal pain, and weight loss requiring parenteral nutrition. IEC-EC has been associated with fatal outcome from perforation or sepsis. Manage according to institutional guidelines, including referral to gastroenterology and infectious disease specialists.

In cases of refractory IEC-EC, consider additional workup to exclude alternative etiologies, including T-cell lymphoma of the GI tract, which has been reported in the post marketing setting.

SECONDARY MALIGNANCIES: Patients treated with CARVYKTI^® may develop secondary malignancies. Among patients receiving CARVYKTI^® in the CARTITUDE-1 & -4 studies, myeloid neoplasms occurred in 5% (13/285) of patients (9 cases of myelodysplastic syndrome, 3 cases of acute myeloid leukemia, and 1 case of myelodysplastic syndrome followed by acute myeloid leukemia). The median time to onset of myeloid neoplasms was 447 days (range: 56 to 870 days) after treatment with CARVYKTI^®. Ten of these 13 patients died following the development of myeloid neoplasms; 2 of the 13 cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy. Cases of myelodysplastic syndrome and acute myeloid leukemia have also been reported in the post marketing setting. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI^®. Mature T-cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusions, and may include fatal outcomes.

Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Janssen Biotech, Inc., at 1-800-526-7736 for reporting and to obtain instructions on collection of patient samples.

ADVERSE REACTIONS

The most common nonlaboratory adverse reactions (incidence greater than 20%) are pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting. The most common Grade 3 or 4 laboratory adverse reactions (incidence greater than or equal to 50%) include lymphopenia, neutropenia, white blood cell decreased, thrombocytopenia, and anemia.

Please read full Prescribing Information, including Boxed Warning, for CARVYKTI^®.

ABOUT CARVYKTI^® (CILTACABTAGENE AUTOLEUCEL; CILTA-CEL)

Ciltacabtagene autoleucel is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. The cilta-cel CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.ⁱ

In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen), a Johnson & Johnson company, to develop and commercialize cilta-cel. In February 2022, cilta-cel was approved by the U.S. Food and Drug Administration (FDA) under the brand name CARVYKTI^® for the treatment of adults with relapsed or refractory multiple myeloma. In April 2024, cilta-cel was approved for the second-line treatment of patients with relapsed/refractory myeloma who have received at least one prior line of therapy, including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide.

In May 2022, the European Commission (EC) granted conditional marketing authorization of CARVYKTI^® for the treatment of adults with relapsed and refractory multiple myeloma. In September 2022, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI^®. Cilta-cel was granted Breakthrough Therapy Designation in the U.S. in December 2019 and in China in August 2020. In addition, cilta-cel received a PRIority MEdicines (PRIME) designation from the European Commission in April 2019. Cilta-cel also received Orphan Drug Designation from the U.S. FDA in February 2019, from the European Commission in February 2020, and from the Pharmaceuticals and Medicinal Devices Agency (PMDA) in Japan in June 2020. In March 2022, the European Medicines Agency’s Committee for Orphan Medicinal Products recommended by consensus that the orphan designation for cilta-cel be maintained on the basis of clinical data demonstrating improved and sustained complete response rates following treatment.

ABOUT CARTITUDE-4

CARTITUDE-4 (NCT04181827) is an ongoing, international, randomized, open-label Phase 3 study evaluating the efficacy and safety of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy, including a PI and an IMiD.ⁱⁱ  

ABOUT CARTITUDE-1

CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory with multiple myeloma who have received at least 3 prior lines of therapy or are double refractory to a PI and IMiD, received a PI, an IMiD, and anti-CD38 antibody and documented disease progression within 12 months of starting the most recent therapy. The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the recommended Phase 2 dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint.ⁱⁱⁱ

ABOUT LUCAR-G39D

NCT06395870 is a Phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39D, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.^iv

About MULTIPLE MYELOMA

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.^v In 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.^vi While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems, or infections.^vii 

About Legend Biotech
With over 2,800 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. The company is at the forefront of the CAR-T cell therapy revolution with CARVYKTI^®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Headquartered in the US, Legend is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI’s patient access and therapeutic potential. From this platform, the company plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.

Learn more at www.legendbiotech.com and follow us on LinkedIn.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives, and the potential benefits of Legend Biotech’s product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third-party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 11, 2025. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated, or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

INVESTOR CONTACT:
Jessie Yeung
Tel: (732) 956-8271
jessie.yeung@legendbiotech.com

PRESS CONTACT:
Alexandra Ventura
Tel: (732) 850-5598
media@legendbiotech.com

________________________

ⁱ CARVYKTI™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.

ⁱⁱ ClinicalTrials.gov. A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4). https://www.clinicaltrials.gov/study/NCT04181827. Accessed March 2024.

ⁱⁱⁱ ClinicalTrials.gov. A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma (CARTITUDE-1). Available at: https://clinicaltrials.gov/ct2/show/NCT03548207 Accessed October 2022.

^iv ClinicalTrials.gov. Targeting CD19/​CD20 Dual-targeted Cell in Patients With Relapsed/​Refractory B-cell Non-Hodgkin Lymphoma. Available at: https://clinicaltrials.gov/study/NCT06395870 Accessed November 2024.

^v American Cancer Society. ”What is Multiple Myeloma?”. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed March 2024.

^vi American Cancer Society. “Key Statistics About Multiple Myeloma.” Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html. Accessed March 2024

^vii American Cancer Society. Multiple myeloma: early detection, diagnosis, and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Accessed March 2023.

NeuroSigma Announces New Publication Showing Real-Time Effects of External Trigeminal Nerve Stimulation (eTNS) on Brain Activity




NeuroSigma Announces New Publication Showing Real-Time Effects of External Trigeminal Nerve Stimulation (eTNS) on Brain Activity

Peer-reviewed results of PET neuroimaging demonstrate rapid and profound changes to humans receiving eTNS

LOS ANGELES, Nov. 03, 2025 (GLOBE NEWSWIRE) — NeuroSigma, Inc., a Los Angeles-based bioelectronics company, today announced a new publication in the journal Neuromodulation: Technology at the Neural Interface. The publication, titled “Oxygen-15 Labeled Positron Emission Tomography During External Trigeminal Nerve Stimulation,” is the first-ever to report the real-time effects on brain activity among humans receiving eTNS. The study was conducted by a team of researchers at UCLA including Dr. Christopher DeGiorgio, Professor and Vice Chairman of the UCLA Department of Neurology, and Dr. Ian Cook, Professor Emeritus in the UCLA Departments of Psychiatry and Biobehavioral Sciences and of Bioengineering.

“Publication of these results represents a significant milestone for eTNS as this therapeutic modality enters the mainstream,” said Dr. Cook. “An improved understanding of the eTNS mechanisms of action will allow clinicians to better tailor the treatment to individual patients and develop new therapeutic indications.”

The study included five adults, each receiving a series of six PET scans of their brain. PET is a neuroimaging technique that detects regional brain activity by measuring changes in cerebral blood flow. For all six scans, an eTNS device was applied to the test subject: three with eTNS turned on for 60 seconds, and three with eTNS turned off for 60 seconds. The data were then pooled and analyzed to look for significant differences in blood flow between the on and off scans. Results show a two-part mechanism of action where some brain regions exhibited increased activity while others showed decreased activity during eTNS.

“These findings increase our understanding of the mechanism of action of eTNS for multiple neurological and psychiatric disorders, including Attention-deficit/hyperactivity disorder (ADHD), depression and epilepsy. Activations of the medial frontal lobe and cingulate gyrus indicate a potential mechanism for the improvements in attention and mood reported in clinical trials and create a roadmap for future applications in cognitive and behavioral neuroscience,” added Dr. DeGiorgio. “In contrast, the areas of deactivation support a mechanism for the anti-seizure effect of eTNS because decreased brain activity was observed in regions typically associated with the spread of seizures.”

“Publication of these important findings is timely as NeuroSigma is preparing to launch the second-generation Monarch eTNS® System in the United States in early 2026,” said Dr. Colin Kealey, President and CEO of NeuroSigma. “The PET biomarker data generated by Dr. Cook and Dr. DeGiorigo complement previous EEG findings in children with ADHD and will help guide clinicians as they add the Monarch device to their clinical practice.”

NeuroSigma’s Monarch eTNS System is an FDA-cleared device for treatment of pediatric ADHD in the United States. Interested patients, physicians, and caregivers can visit www.monarch-etns.com to learn more.

About NeuroSigma

NeuroSigma is a Los Angeles, California-based bioelectronic medical device company developing technologies to transform medical practice and patients’ lives. The company’s lead product is the Monarch eTNS System, which is the first non-drug treatment for pediatric ADHD cleared by the FDA. Pipeline indications for the Monarch eTNS System include neurodevelopmental disorders such as autism spectrum disorder (ASD), learning disabilities, and epilepsy. NeuroSigma has received Breakthrough Device Designation for the Monarch eTNS System from the FDA in drug-resistant epilepsy. For more information about NeuroSigma, please visit www.neurosigma.com. For more information on the Monarch eTNS System, please visit www.monarch-etns.com.

Contact:
Colin Kealey, M.D., President of NeuroSigma at CKealey@neurosigma.com  

Legal Steroids for Bulking, Cutting, Strength from CrazyBulk: Best Selling Legal Steroid Alternatives for Muscle Growth and Bodybuilding in 2025




Legal Steroids for Bulking, Cutting, Strength from CrazyBulk: Best Selling Legal Steroid Alternatives for Muscle Growth and Bodybuilding in 2025

Crazy Bulk’s Introduces Best Legal Steroid Alternatives Safe and Most Popular Legal Steroids for Muscle Building and Cutting supplements in 2025. It Help to Boost testosterone, and improve muscle growth, strength, and repair.

NEW YORK, Nov. 03, 2025 (GLOBE NEWSWIRE) —

NEW YORK, Oct 31, 2025, Best Legal Steroids For Muscle Growth, Bulking, Cutting, Bodybuilding, and strength supplement for men launched by CrazyBulk in 2025, offering an alternative to Anabolic Steroids.

What are the best legal steroid alternatives for muscle gain and fat loss from CrazyBulk?

 In 2025, demand for legal, non-hormonal “steroid alternatives” is surging as bodybuilders, lifters, and competitive athletes chase measurable gains without gambling with health or eligibility.

Athletes know what anabolic steroids can do—but the trade-offs (health risks, failed tests, legal trouble) aren’t worth it. Hence, the pivot to modern, compliant alternatives built to support muscle growth, training intensity, recovery, and fat loss—within the rules.

CrazyBulk leads this space with targeted formulas for bulking and cutting—without the dangers tied to banned or misused anabolics.

1. CrazyBulk Bulking stack supplements: Add size and strength fast. D-Bal is the flagship legal alternative for rapid muscle gain.

     2. CrazyBulk Cutting Stack Supplements: Keep lean mass while dropping body fat to reveal definition. Anavar-style alternatives are the go-to for cutting and fat loss.

Different goals, different tools: some products emphasize protein synthesis and training output; others drive metabolism and muscle retention for a sharper, fuller look while cutting.

Run them in structured cycles, and pair with smart nutrition, programmed training, and adequate sleep—the difference between spinning your wheels and real progress.

Best Legal Steroid Alternatives in 2025: CrazyBulk’s Range.

Steroids have been a controversial topic in the world of bodybuilding for decades. Some people argue that they are essential for achieving optimal muscle growth and performance, while others believe there are too many risks and side effects.

The legality of steroids is also a major concern for many bodybuilders. In some countries, they are available over the counter, while in others, they are completely banned and considered illegal.

Fortunately, with the rise of online shopping, bodybuilders now have access to legal steroids from reputable sources. In this guide, we will explore where you can buy legal steroids online in 2024 and the important considerations to keep in mind before making a purchase.

The name Crazy Bulk is well-known in the bodybuilding industry. It’s an established company that’s been selling legal steroids online for a long time. The chances are that, if you are not familiar with Crazy Bulk, you will know somebody who is.

Visit the Official Website to view Crazy Bulk’s range of Best steroid alternatives 

Crazy Bulk offers a wide range of legal steroids that cater to different bodybuilding needs. It uses natural ingredients that work in synergy to enhance protein metabolism and provide additional benefits that set physical endurance and muscle growth into overdrive.

As with traditional anabolic steroids, some Crazy Bulk Legal Steroid Alternatives are more suitable for bulking, while others work better for cutting or enhancing physical performance.

One of the best things about the Crazy Bulk brand is the presence of a lengthy money-back guarantee. It applies to all the company’s products regardless of whether you buy them individually or as part of a stack.

The other nice thing is that if you order two legal steroids or legal steroid stacks, Crazy Bulk will ship you a third free of charge. It also offers free rapid shipping on all orders, large and small.

As with all Crazy Bulk Best Legal Steroid Alternatives, the above three options are manufactured to high-quality standards in an FDA-approved production facility based in the United States.

Dianabol (D-Bal)

Visit the Official Website. See DBal availability and pricing from CrazyBulk

Also known as Methandrostenolone, Dianabol is a popular anabolic steroid. It’s known for its ability to increase muscle mass and strength rapidly.

However, due to its many adverse effects, such as liver damage and hormonal imbalances, it has been banned in most countries. Easily the best legal Dianabol on the market, Crazy Bulk D-Bal is a Best Legal Steroid alternative that boasts a similar muscle-building potency without any side effects.

D-Bal works by improving nitrogen retention in the muscle tissues, which results in increased protein synthesis and, ultimately, muscles that are bigger and stronger. It also improves blood flow and oxygen delivery to the muscles, giving you greater endurance during workouts.

A legal steroid that gives that little bit more, D-Bal also tweaks metabolism to support total body fat reduction, and aids bone and tendon healing, helping make hard-worked bodies less susceptible to injuries.

Furthermore, unlike Dianabol and many other anabolic steroids, D-Bal doesn’t present cardiovascular risks by screwing up blood lipids. Going the opposite route, it supports a healthier cholesterol profile instead.

(Trenorol)

Visit the Official Website. See (Trenorol) availability and pricing from CrazyBulk 

One of the most popular bodybuilding steroids, Trenorol Best Legal Steroid alternative for bulking. Although the muscle gains it provides can be dramatic, so can the side effects, which may include acne and oily skin at one end of the scale and liver damage and prostate cancer at the other.

With zero side effects and a similar muscle-building potency, Trenorol is the Crazy Bulk solution for bodybuilders and strength athletes who want the benefits of Trenorol without any health risks.

Trenorol works by increasing free testosterone levels to provide solid muscle gains without water retention, helping to provide a hard, well-defined, and muscular-looking physique.

Although it’s not a top choice for cutting cycles, Trenoral also supports decent levels of body fat reduction without loss of lean muscle mass.

Working on different levels, Crazy Bulk’s legal Trenorol improves nitrogen retention, helping to improve circulation and blood flow to the muscles. Combined with the lack of water retention, this ability has allowed Trenorol to become one of the best legal steroids for improving vascularity.

HGH (HGHx2)

Visit the Official Website. See legal HGH  Availability and pricing from CrazyBulk

Human Growth Hormone (HGH) plays a vital role in muscle growth and recovery. It’s often used by bodybuilders to push their limits and achieve a more muscular physique.

However, synthetic HGH is illegal without a prescription and can cause severe side effects, such as joint pain, carpal tunnel syndrome, and increased risk of diabetes.

Crazy Bulk offers the perfect legal solution. It’s called HGHx2. This powerful supplement stimulates natural increases in HGH production without presenting the risk of adverse reactions.

Like testosterone, HGH is a highly anabolic hormone that plays a key role in muscle growth and repair. By boosting HGH production within the body, HGHx2 delivers significant improvements in muscle mass, improved muscle recovery and repair, and enhanced strength.

Crazy Bulk HGHx2 also boosts the body’s metabolic rate, increasing daily calorie expenditure, even during times of low activity. Although it’s not Crazy Bulk’s most potent fat burner and has far more value as a muscle growth enhancer, HGHx2 still supports improvements in lean muscle mass, muscle definition, and overall body composition.

Bulking Stack: Tren-Max and Testo-Max for Aggressive Mass and Strength

Visit the Official Website to See CrazyBulk Bulking Stack Supplements

How We Selected the Best Legal Steroid Alternatives Brands

Finding the best legal steroids was no easy task. We had to search out all the most popular legal steroid options and then conduct a systematic review of each one.

We had to look at several factors. Some of the main ones were:

• Effectiveness: The most important factor was whether or not the natural steroids were effective in delivering results.
• Safety: The safety and lack of side effects were also crucial as we only wanted to recommend products that are safe to use.
• Ingredients: We made sure to check the ingredients list of each product to ensure that they were free from banned substances and any harmful additives.
• Customer Reviews: Finally, we took into account the feedback and reviews from customers who have used these legal steroids. This type of feedback always provides a better understanding of products’ effectiveness and safety.

Our selection process was thorough and detailed, ensuring that only the best legal steroids made it onto our list.

It didn’t take us long to realize that Crazy Bulk was the clear winner. Although we have only detailed three of the most popular options, without exception, all of its other legal steroid options are miles ahead of any similar supplements on the market.

However, although Crazy Bulk is ahead of the other brands, Brutal Force is only a few steps behind so we had to give credit where credit is due.

Furthermore, in addition to all the points we have mentioned above, by providing the option to get free bottles of legal steroids and offering money-back guarantees, both brands ensure their customers get maximum satisfaction and value for money.

The Cutting Steroid Stack: for Definition and Performance

Visit the Official Website to See CrazyBulk Cutting Stack Supplements

Legal steroids are a great choice for anyone who wants to enhance their athletic performance, build muscle mass quickly, increase their strength, or improve their overall physical appearance.

However, it’s important to understand that no steroid, legal or otherwise, will work miracles on its own.

To see significant results from steroids, you need to maintain a strict workout regimen and a healthy diet. Anabolic steroids or their legal counterparts only enhance the efforts athletes are making. They are not a substitute for healthy living and appropriate training.

The bottom line is that if you want to see fruits for your labor, you will need to work hard. By boosting energy levels and supporting improvements in stamina, steroids can certainly help you to make the most of your time in the gym, keep adding extra weight to the bar, and reap much better results. However, it’s up to you to make sure you turn up regularly and train.

1. Can I legally buy steroids online for bodybuilding purposes?

Yes, but only if you have a prescription from a licensed healthcare provider. Anabolic steroids are controlled substances in many countries, including the United States, and can only be legally obtained with a prescription due to their potential for abuse and serious health risks.

2. What should I consider when looking for a legal source to buy steroids online?

Always ensure that the online pharmacy or source is legitimate and that it requires prescriptions for anabolic steroid purchases. Check for certification from relevant pharmaceutical regulatory bodies or verifications like the VIPPS (Verified Internet Pharmacy Practice Sites) accreditation in the U.S.

3. Are there safe and legal alternatives to anabolic steroids for bodybuilding?

Yes, there are legal supplements that are marketed as safer alternatives to anabolic steroids. These products typically contain natural ingredients designed to enhance muscle growth and performance without the legal and health risks associated with steroids. Always research these products thoroughly before purchasing.

4. How can I verify if an online steroid source is legal and safe?

Check the website for clear contact information, licensing details, and a requirement for a prescription. Additionally, look for customer reviews, third-party testing, and quality assurance measures. Be wary of sites selling steroids without prescriptions or those making unrealistic claims.

5. What are the risks of buying steroids from an illegitimate online source?

Purchasing steroids from unverified sources can lead to serious legal consequences and health risks. These can include receiving counterfeit or tainted products, experiencing dangerous side effects, facing fines or imprisonment for possession of a controlled substance, and having personal information compromised. Always choose safety and legality over convenience or promises of fast results.

Do legal steroids require post-cycle therapy?

No, legal steroids do not require post-cycle therapy (PCT) because they do not suppress testosterone or disrupt natural hormone production. When you stop taking them, there is no need to worry about any form of follow-up treatment.

What’s the best legal steroid cycle?

The research scientists responsible for creating the steroids distributed by the two leading brands suggest a cycle length of at least 8 weeks. However, longer cycles are permissible because Crazy Bulk and Brutal Force steroids do not have any known side effects.

Many users choose to follow 12-week cycles. It’s hard to fault the logic of this because, when you order enough legal steroids to last for two months, you receive enough to last for three.

How long before I see results of using steroids?

Although some people respond to legal steroids better than other people do, most users notice notable increases in training capacity and muscular strength within their first week of treatment and look visually bigger and more defined by the time they finish their first bottle.

Why CrazyBulk Leads the Legal Steroid Market in 2025

CrazyBulk continues to lead because its supplements are built around how serious athletes actually train in real life.

DBal is the flagship among CrazyBulk’s legal steroid-style options for size, driving noticeable muscle gain during focused mass phases.

The Bulking Stack—Tren-Max plus Testo-Max alongside DBal—works in harmony: nutrient utilization, speed of recovery, and, most importantly, training intensity-often translated into significant jumps in size and strength compared to earlier cycles.

When it comes to cutting, Anvarol is outstanding because it helps you to hang on to lean muscle and performance, so you can uncover definition without losing strength.

Another advantage is structure: CrazyBulk’s legal steroids are easy to schedule. Standard eight-week blocks slide neatly into off-season bulks and pre-event cuts.

To the athletes who wish to purchase legal bodybuilding supplements that will cater to their training calendar and pass the testing standards, CrazyBulk’s legal steroids pave the way for rapid growth and definition without the risks of banned steroids or traditional anabolic steroids.

Standout strengths:

Legal steroid alternatives designed to support specific phases—bulk or cut.

DBal for mass; Anvarol for cuts; Tren + Testo-Max for amplified results.

A roadmap that integrates with training, nutrition, and recovery across the year.Conclusion:

Final Thought: CrazyBulk Legal Steroid Alternatives – Build Big, Cut Clean, Stay Compliant

The modern athlete seeks success without resorting to doping.

That’s where CrazyBulk’s legal steroid alternatives come in: to drive muscle growth, protect performance, and avoid the risk of banned substances.

If your aim is mass and strength, then DBal is the reliable starting point.

For when you’re ready to push further, the Bulking Stack—DBal combined with Tren-Max and Testo-Max—creates an orchestrated surge that supports increased muscle growth and higher-quality, effective training sessions.

When it’s time to lean out and show detail, Anvarol leads the cut, supports lean muscle retention, and helps bring out shape and definition.

Combined, these legal steroids are the core muscle-building supplements many athletes use to go from off-season building to pre-season refining and stay sharp year-round.

Plan your cycles, match them with disciplined training and nutrition, and treat recovery like part of the program—because it is.

With the right legal steroid stack and clear periodized approach, you can add muscle in the bulk phase, hold muscle in the cut phase, and bring your best look at the right time—without crossing into banned performance enhancers or traditional anabolic steroids.

Welcome to the era of legal steroids. The question is: will you build, cut, and finish on your terms?

Disclaimer: This article is meant for educational purposes only and is not medical advice. No supplement regimen should be started without first consulting a qualified healthcare professional. Individual results may vary.

Manufactured under the Technical Guidance of:

Project name: Crazybulk
244 Madison Avenue,
New York City, NY 10016-2817
Postal code: NY 10016-2817
Media Contact:
Full Name – Neil Bowers
Company website: https://www.crazybulk.com/
email: support@crazybulk.com
+1 888-708-6394
Advertise with us: Info@allprsolution.com

Zelluna ASA – Contemplates private placement




Zelluna ASA – Contemplates private placement

Zelluna ASA – Contemplates private placement of NOK 50-55 million and retail offering to advance into first-in-human trial of its “off-the-shelf” TCR-NK therapy

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN AUSTRALIA, CANADA, THE HONG KONG SPECIAL ADMINISTRATIVE REGION OF THE PEOPLE’S REPUBLIC OF CHINA, SOUTH AFRICA, NEW ZEALAND, JAPAN OR THE UNITED STATES, OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL

Oslo, 3 November 2025: Zelluna ASA (“Zelluna” or the “Company”), a company pioneering allogeneic ‘off the shelf’ T Cell Receptor based Natural Killer (TCR-NK) cells for the treatment of cancer contemplates a private placement of NOK 50-55 million in gross proceeds and a retail offering of new shares through PrimaryBid raising gross proceeds of up to the NOK equivalent of EUR 1 million to initiate a phase I clinical trial of the Company’s lead asset, ZI-MA4-1 and generate patient data in mid 2026. The proceeds could bring meaningful impact for late-stage cancer patients amid growing industry appetite for accessible, ‘off-the-shelf’ cell therapies and enable the reach to a significant value inflection for the company.

The net proceeds from the Private Placement and the PrimaryBid Offering will be used to initiate a Phase I clinical trial with ZI-MA4-1 and generate initial patient data, develop the pipeline and for general corporate purposes.

Existing shareholders and primary insiders of the Company (the “Pre-Committing Shareholders”) have pre-committed to subscribe for and will be allocated Offer Shares in the Private Placement for NOK 50.7 million.

Overview of pre-commitments:

• Oxford Investors (a group of international private investors with strong track-record within the Life Science industry) for NOK 24.8 million;
• Sundt AS / Helene Sundt AB for NOK 10 million;
• Gjelsten Holding AS for NOK 5 million;
• MP Pensjon PK for NOK 5 million;
• Norda ASA for NOK 2 million;
• Ro Invest AS for NOK 1.5 million;
• Management for NOK 1.2 million;
  • Whereof Namir Hassan (CEO) for NOK 0.5 million;
• Members of the Board of Directors for NOK 1.2 million; and
  • Whereof Anders Tuv (Chair of the Board) for NOK 0.2 million

The Private Placement will entail the issuance of new shares at an offer price of NOK 10 per share (the “Private Placement”). The Company has engaged DNB Carnegie, a part of DNB Bank ASA as sole bookrunner (the “Manager”) to advise on and effect the contemplated Private Placement. The PrimaryBid Offering of new shares (together with the new shares in the Private Placement, the “Offer Shares”) of up to the NOK equivalent of EUR 1 million will be directed towards retail investors in Norway. The offer price in the Private Placement and the PrimaryBid Offering is NOK 10 per Offer Share.

The Private Placement

The bookbuilding period for the Private Placement will commence today, 3 November 2025 at 16:30 (CET) and close on 4 November 2025 at 08:00 (CET). The Company and the Manager may, however, at their sole discretion, resolve to extend or shorten the application period at any time and for any reason on short or without notice. If the application period is extended or shortened, the other dates referred to herein may be amended accordingly.

The Private Placement will be directed towards investors subject to and in compliance with applicable exemptions from relevant prospectus, filing and other registration requirements. The minimum application and allocation amount in the Private Placement has been set to the NOK equivalent of EUR 100,000. The Company may, however, at its sole discretion, allocate an amount below EUR 100,000 to the extent applicable exemptions from the prospectus requirement pursuant to the Norwegian Securities Trading Act and ancillary regulations (including Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017) are available. The Company will direct a separate tranche of the Private Placement, without a minimum application and allocation amount, towards board members and employees, subject to applicable exemptions from the applicable prospectus requirements.

Allocation of Offer Shares will be determined by the Board, at its sole discretion, in consultation with the Manager, following the expiry of the application period. The Offer Shares in the Private Placement are expected to be settled in two separate tranches (“Tranche 1” and “Tranche 2”), as described below.

Settlement of Offer Shares in Tranche 1 to investors other than the Pre-Committing Shareholders is expected to take place on or about 6 November 2025 on a delivery-versus-payment (DVP) basis by delivery of existing and unencumbered shares in the Company that are already listed on Euronext Oslo Børs, pursuant to a share lending agreement (the “Share Lending Agreement”) expected to be entered into between the Company, the Manager and Radforsk. The Offer Shares allocated to the investors in Tranche 1 of the Private Placement other than the Pre-Committing Shareholders will thus be tradable upon allocation. The share loan under the Share Lending Agreement will be settled with new shares in the Company to be issued by the Company’s Board of Directors (for Tranche 1) pursuant to an authorization granted by the general meeting of the Company held on 29 April 2025 (the “Board Authorization”). Settlement of the Offer Shares allocated to the Pre-Committing Shareholders in Tranche 1 will not be made on DVP-basis. The payment date for such Offer Shares is expected on or about 6 November 2025. Delivery of such Offer Shares will occur following registration of the share capital increase pertaining to such Offer Shares in the Norwegian Register of Business Enterprises (the “NRBE”), expected on or about 10 November 2025.

The payment date for Offer Shares in Tranche 2 is expected to be on or about 27 November 2025, and the delivery date for such Offer Shares is expected to be on or about 2 December 2025 (subject to the share capital increase pertaining to the issuance of such Offer Shares having been registered with the NRBE). The Offer Shares in Tranche 2 and part of the Offer Shares in Tranche 1 to be delivered to Pre-Committing Shareholders and/or Radforsk (as settlement of the share loan described above) will initially be delivered on a separate non-listed ISIN pending approval and publication of a listing prospectus, and the new shares to be issued in Tranche 2 and such part of the Offer Shares to be issued in Tranche 1 will thus not be listed or tradable on Euronext Oslo Børs until such prospectus has been published. Further the issuance of the Offer Shares in Tranche 2 is subject to approval by an extraordinary general meeting of the Company expected to be held on or about 25 November 2025 (the “EGM“). All investors in the Private Placement will receive Offer Shares in Tranche 1, except for the Pre-Committing Shareholders who will receive Offer Shares in Tranche 1 and Tranche 2.

Completion of the Private Placement is subject to all necessary corporate resolutions of the Company required to implement the Private Placement being validly made by the Company, including, without limitation, the Board resolving to complete the Private Placement, at its sole discretion, including to issue the Offer Shares in Tranche 1 of the Private Placement pursuant to the Board Authorization. Delivery of Offer Shares in Tranche 1 to investors other than the Pre-Committing Shareholders is subject to the Share Lending Agreement being entered into and remaining unmodified and in full force and effect. Delivery of Offer Shares in Tranche 1 to the Pre-Committing Shareholders is subject to the share capital increase pertaining to the issuance of the Offer Shares in Tranche 1 being registered with the NRBE. Completion of Tranche 2 of the Private Placement is further subject to (i) completion of Tranche 1; (ii) the EGM of the Company resolving to issue the Offer Shares in Tranche 2; and (iii) the share capital increase pertaining to the issuance of the Offer Shares in Tranche 2 being registered with the NRBE.

Tranche 1 of the Private Placement is not conditional upon Tranche 2, and an application for Offer Shares in Tranche 1 will be binding and may not be revoked if Tranche 2, for whatever reason, is not completed. Further, the Private Placement is not conditional on completion of the PrimaryBid Offering.

The Company reserves the right to, at any time and for any reason prior to notification of allocation, to cancel the Private Placement and/or to modify the terms of the Private Placement. Neither the Company nor the Manager will be liable for any losses incurred by applicants if the Private Placement is cancelled, irrespective of the reason for such cancellation.

The Private Placement and PrimaryBid Offering represent a deviation from the shareholders’ pre-emptive right to subscribe for and be allocated Offer Shares. The Board has considered the Private Placement and the PrimaryBid Offering in light of the equal treatment obligations under the Norwegian Public Limited Companies Act, and deems that the proposed Private Placement and PrimaryBid Offering is in compliance with these obligations. The Board is of the view that it will be in the common interest of the Company and its shareholders to raise equity through a private placement. By structuring the equity raise as a private placement, the Company expects to raise equity efficiently, with a lower discount to the current trading price, at a lower cost and with a significantly reduced completion risk compared to a rights issue. Furthermore, by including the PrimaryBid Offering, the Company makes the offering more accessible to all of its existing shareholders. In summary, the Company expects to be in a position to complete the contemplated equity issue in today’s market conditions in an efficient manner, at a higher subscription price and at significantly lower cost and with a lower completion risk than would have been the case for a rights issue.

The Company may, subject to completion of the Private Placement and certain other conditions, and depending on the participation of the Company’s existing shareholders in the Private Placement and the PrimaryBid Offering, consider a subsequent repair offering of new shares at the same subscription price as in the Private Placement and the PrimaryBid Offering, and otherwise in line with market practice.

The PrimaryBid Offering

The PrimaryBid Offering comprises a retail offer of up to the NOK equivalent of EUR 1 million to the public in Norway, subject to an exemption being available from prospectus requirements and any other filing or registration requirements and subject to other selling restrictions.

Key highlights and details for the PrimaryBid Offering are as follows:

• Price per Offer Share: NOK 10  
• Application period: From 3 November 2025 at 16:30 (CET) to 3 November 2025 at 21:00 (CET).
• No minimum order size.
• Available for investors in Norway.
• Applications can only be submitted through Nordnet’s website from the start to the end of the application period.

The Company may, at its sole discretion, resolve to extend or shorten the application period for the PrimaryBid Offering at any time and for any reason on short or without notice. If the application period is extended or shortened, any other dates referred to herein may be amended accordingly.

Please use the following link to apply for shares: https://www.nordnet.no/aksjer/ipo-emisjon (the transaction will appear when the PrimaryBid Offering is live, expected in approx. 15 minutes from the time of this announcement).

Completion of the PrimaryBid Offering is subject to (i) completion of the Private Placement, (ii) all necessary corporate resolutions of the Company required to implement the PrimaryBid Offering being validly made by the Company, including, without limitation, the Board resolving to complete the PrimaryBid Offering, at its sole discretion, including to issue the Offer Shares in the PrimaryBid Offering pursuant to the Board Authorization, and (iii) the Share Lending Agreement being entered into and remaining unmodified and in full force and effect. The PrimaryBid Offering will not be completed if the Private Placement is not completed.

The Company reserves the right to, at any time and for any reason prior to notification of allocation, cancel the PrimaryBid Offering and/or to modify the terms of the PrimaryBid Offering. Neither the Company nor the Manager will be liable for any losses incurred by applicants if the PrimaryBid Offering is cancelled, irrespective of the reason for such cancellation.

Allocation of Offer Shares will be determined by the Board, at its sole discretion, in consultation with the Manager, following the expiry of the application period for the Private Placement. The PrimaryBid Offering is incidental to the Private Placement and will in any case be limited to a maximum of the NOK equivalent of EUR 1 million. Allocations will be reduced at the Company’s discretion should demand exceed this limit.

Settlement of the Offer Shares in the PrimaryBid Offering is expected to take place on or about 6 November 2025 on a delivery-versus-payment (DVP) basis by delivery of existing and unencumbered shares in the Company that are already listed on Euronext Oslo Børs, pursuant to the Share Lending Agreement. The Offer Shares delivered to the investors in the PrimaryBid Offering are expected to be tradeable upon allocation.

Each applicant in the PrimaryBid Offering accepts the following by placing an application through the platform of Nordnet: an investment in the Offer Shares is made solely at the applicant’s own risk and is based on the applicant’s own assessment of the Company and the Offer Shares. An investment in the Offer Shares is only suitable for investors who can afford to lose the invested amount. No prospectus or other document providing a similar level of disclosure has been prepared in connection with the PrimaryBid Offering.

Advisors

DNB Carnegie, a part of DNB Bank ASA is acting as sole bookrunner for the Private Placement.

Advokatfirmaet Schjødt AS is acting as legal counsel to the Company in connection with the Private Placement.

For further information, please contact:

Namir Hassan, CEO, Zelluna ASA
Email: namir.hassan@zelluna.com
Phone: +44 7720 687608

Hans Vassgård Eid, CFO, Zelluna ASA
Email: hans.eid@zelluna.com
Phone: +47 482 48632

About Zelluna ASA

Zelluna’s mission is to deliver transformative treatments with the capacity to cure advanced solid cancers, in a safe and cost-efficient manner, to patients on a global scale. The Company aims to do this by combining the most powerful elements of the immune system through pioneering the development of “off the shelf” T cell receptor (TCR) guided natural killer (NK) cell therapies (TCR-NK). The TCR-NK platform offers a unique mechanism of action with broad cancer detection capability to overcome the diversity of tumours and will be used “off the shelf” to overcome scaling limitations of current cell therapies. The lead program is a world’s first MAGE-A4 targeting “off the shelf” TCR-NK for the treatment of various solid cancers; a pipeline of earlier products follows. The Company is led by a management team of biotech entrepreneurs with deep experience in discovery through to clinical development of TCR and cell-based therapies including marketed products.

Important notice

This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to section 5-12 the Norwegian Securities Trading Act.

This stock exchange announcement was published by Joachim Midttun, Financial Manager at Zelluna ASA, on 3 November 2025 at 16:45 CET.

This announcement is not and does not form a part of any offer to sell, or a solicitation of an offer to purchase, any securities of the Company. Copies of this announcement are not being made and may not be distributed or sent into any jurisdiction in which such distribution would be unlawful or would require registration or other measures.

The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”), and accordingly may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and in accordance with applicable U.S. state securities laws. The Company does not intend to register any part of the offering in the United States or to conduct a public offering of securities in the United States. Any sale in the United States of the securities mentioned in this announcement will be made solely to “qualified institutional buyers” as defined in Rule 144A under the U.S. Securities Act.

In any EEA Member State, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the EU Prospectus Regulation, i.e., only to investors who can receive the offer without an approved prospectus in such EEA Member State. The expression “EU Prospectus Regulation” means Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 as amended (together with any applicable implementing measures in any Member State).

In the United Kingdom, this communication is only addressed to and is only directed at Qualified Investors who (i) are investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended) (the “Order”) or (ii) are persons falling within Article 49(2)(a) to (d) of the Order (high net worth companies, unincorporated associations, etc.) (all such persons together being referred to as “Relevant Persons”). These materials are directed only at Relevant Persons and must not be acted on or relied on by persons who are not Relevant Persons. Any investment or investment activity to which this announcement relates is available only to Relevant Persons and will be engaged in only with Relevant Persons. Persons distributing this communication must satisfy themselves that it is lawful to do so.

Matters discussed in this announcement may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “strategy”, “intends”, “estimate”, “will”, “may”, “continue”, “should” and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believe that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict, and are beyond their control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not make any guarantee that the assumptions underlying the forward-looking statements in this announcement are free from errors nor does it accept any responsibility for the future accuracy of the opinions expressed in this announcement or any obligation to update or revise the statements in this announcement to reflect subsequent events. You should not place undue reliance on the forward-looking statements in this announcement.

The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice. The Company does not undertake any obligation to review, update, confirm, or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this announcement.

Neither the Manager nor any of its affiliates makes any representation as to the accuracy or completeness of this announcement and none of them accepts any responsibility for the contents of this announcement or any matters referred to herein.

This announcement is for information purposes only and is not to be relied upon in substitution for the exercise of independent judgment. It is not intended as investment advice and under no circumstances is it to be used or considered as an offer to sell, or a solicitation of an offer to buy any securities or a recommendation to buy or sell any securities of the Company. Neither the Manager nor any of its affiliates accepts any liability arising from the use of this announcement.

The distribution of this announcement and other information may be restricted by law in certain jurisdictions. Persons into whose possession this announcement or such other information should come are required to inform themselves about and to observe any such restrictions.

Candel Therapeutics to Present at Jefferies Global Healthcare Conference in London




Candel Therapeutics to Present at Jefferies Global Healthcare Conference in London

NEEDHAM, Mass., Nov. 03, 2025 (GLOBE NEWSWIRE) — Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that Paul Peter Tak, M.D., Ph.D., FMedSci, Candel’s President and Chief Executive Officer, will present at the Jefferies Global Healthcare Conference, being held on November 17-20, 2025 in London, United Kingdom.

Presentation Details:

Date: Tuesday, November 18, 2025
Time: 8:00-8:25 AM GMT / 4:00-4:25 AM ET
Webcast Link: Jefferies / Candel Presentation

A webcast of the presentation will be available by selecting Events and Presentations under the News & Events tab in the Investors section at www.candeltx.com. A replay of the webcast will be archived for up to 90 days following the session date.

About Candel Therapeutics

Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf, multimodal viral immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical-stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform.

The Company recently completed successful phase 2a clinical trials of CAN-2409 in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, randomized, placebo-controlled, phase 3 clinical trial of CAN-2409 in localized prostate cancer, conducted under a Special Protocol Assessment (SPA) agreed with the U.S. Food and Drug Administration (FDA). CAN-2409 plus prodrug (valacyclovir) has been granted Fast Track Designation by the FDA for the treatment of PDAC, stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy and localized primary prostate cancer in combination with radiation therapy. The FDA also granted Regenerative Medicine Advanced Therapy (RMAT) Designation to CAN-2409 for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease and Orphan Drug Designation to CAN-2409 for the treatment of PDAC.

CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma. Initial results were published in Nature and Science Translational Medicine and CAN-3110 received Fast Track Designation and Orphan Drug Designation from the FDA. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors.

For more information about Candel, visit: www.candeltx.com.

Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs, expectations regarding the submission of the Biologics License Application for CAN-2409 in intermediate-to-high-risk localized prostate cancer; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat, solid tumors; and expectations regarding the potential benefits conferred by the Company’s inclusion in the Russell indexes. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

Investor Contact
Theodore Jenkins
Vice President, Investor Relations, and Business Development
Candel Therapeutics, Inc.
tjenkins@candeltx.com

Media Contact
Ben Shannon
ICR Healthcare
CandelPR@icrhealthcare.com