Genenta Reports Long-Term Survival Trends and Immune Findings in Brain Tumor (GBM) Trial




Genenta Reports Long-Term Survival Trends and Immune Findings in Brain Tumor (GBM) Trial

Company Announces Approximately $30 Million in Cash and Short-Term Investments Following Its October 27th Registered Direct Offering

MILAN, Italy and NEW YORK, Nov. 24, 2025 (GLOBE NEWSWIRE) — Genenta Science (Nasdaq: GNTA), a clinical-stage biotechnology company developing a cell-based platform for targeted delivery of therapeutic payloads in oncology, today announced an update from its ongoing TEM-GBM study in newly diagnosed glioblastoma multiforme (GBM) patients with an unmethylated MGMT (uMGMT) gene promoter. As of the November 21, 2025 data cut, 25 patients have been treated with Temferon. These data¹ are compared to the previously disclosed April 15, 2025 cut, communicated on July 1, 2025.

More than seven months after the prior update, key survival metrics for the TEM-GBM patients remain consistent.

• 44% of patients have reached 18-month survival, compared to 38% reported in April.
• Two-year survival rate continues to be 29% and median overall survival remains at 17 months, both consistent with prior findings. For context, historical cohorts of uMGMT patients treated with standard of care typically show a two-year survival rate of approximately 14% and median overall survival of 13–15 months.
• The study includes the first patient who has reached three years of survival following Temferon administration (39 months from initial surgery). During this period, the patient did not receive additional therapeutic interventions or second-line treatments. At the follow-up visit conducted at three years, imaging indicated disease progression and the patient subsequently underwent a second surgery. The patient has continued on protocol-scheduled assessments and has recently completed the 3.5-year follow-up visit within the Long-Term surveillance study. This patient is also the second in the study who has not required further therapeutic interventions during the reported follow-up, a period that overlaps with the window in which recurrence is commonly observed in GBM. These observations are descriptive only, occur within a disease setting known for heterogeneous clinical courses, and individual patient outcomes may vary.

As the first clinical setting in which the platform is being evaluated, the GBM study also provides early immune observations on Temferon’s behavior within the tumor microenvironment. These preliminary findings include indications that bone-marrow-derived myeloid cells can reach the tumor site and deliver immunotherapeutic payloads in situ, in a manner that is consistent with the intended design of the platform. While exploratory in nature and subject to further confirmation in larger controlled studies, these observations are helping to inform the broader development of Temferon – including potential combination approaches – and the evolution of the underlying cell-based delivery technology.

Following the closing of the October 27^th registered direct offering, the Company held approximately $30 million in cash and short-term investments as of November 1^st.

About Genenta Science
Genenta Science (Nasdaq: GNTA) is a clinical stage immuno-oncology company developing a proprietary hematopoietic stem cells therapy for the treatment of a variety of solid tumor cancers. Genenta’s first in class product candidate is Temferon™, which is designed to allow the expression of immune-therapeutic payloads within the tumor microenvironment by bone marrow-derived myeloid cells and enable a durable and targeted response. Genenta has completed the Phase 1 trial for newly diagnosed Glioblastoma Multiforme (GBM) patients with an unmethylated MGMT gene promoter, which suggests the potential reprogramming of the tumor microenvironment and inhibition of myeloid-induced tolerance, while allowing the induction of T cell responses, potentially breaking immune tolerance. Genenta has initiated a Phase 1/2a metastatic Renal Cell Carcinoma study that will also include a combination with immune checkpoint inhibitors. Genenta’s treatments are designed as one-time monotherapies, but with the additional potential, when used in combination, to significantly enhance the efficacy of other approved therapeutics.

Forward-Looking Statements
Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Genenta’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the funding provided by the recently acquired Mandatory Convertible Bond, the Phase 1/2a clinical trial for newly diagnosed GBM patients with uMGMT-GBM, its clinical trial for metastatic RCC or any related studies, as well as Genenta’s ability to fund its research and development plans. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in Genenta’s Annual Report on Form 20-F for the year ended December 31, 2024 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of the date of this announcement, and Genenta undertakes no duty to update such information except as required under applicable law. This press release discusses product candidates that are under preclinical or clinical evaluation and that have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. Until finalized in a clinical study report, clinical trial data presented herein remain subject to adjustment as a result of clinical site audits and other review processes. No representation is made as to the safety or effectiveness of these product candidates or the use for which such product candidates are being studied. Temferon™ is an investigational product candidate for which the effectiveness and safety have not been established. In addition, Temferon™ is not approved for use in any jurisdiction.

Genenta Science Media
Tiziana Pollio, Mobile: +39 348 23 15 143
E-mail: tiziana.pollio@genenta.com

¹ The clinical data included in this release are preliminary and reflect information collected directly from clinical sites. These data have not yet undergone full quality control review or independent verification by the clinical research organization (CRO).

Rakovina Therapeutics Showcases Compelling Preclinical Data on AI-Discovered CNS-Penetrant ATR/mTOR Inhibitors at the 2025 Society for Neuro-Oncology Annual Meeting




Rakovina Therapeutics Showcases Compelling Preclinical Data on AI-Discovered CNS-Penetrant ATR/mTOR Inhibitors at the 2025 Society for Neuro-Oncology Annual Meeting

Variational AI’s Enki™ generative AI platform designed novel ATR/mTOR dual inhibitors with brain penetrance and activity in PTEN-deficient tumor models

VANCOUVER, British Columbia, Nov. 24, 2025 (GLOBE NEWSWIRE) — Rakovina Therapeutics Inc. (“Rakovina” or the “Company”) (TSX-V: RKV)(FSE: 7JO0), a biopharmaceutical company advancing cancer therapies through AI-enabled drug discovery, today announced impressive results from its AI-enabled ATR program at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting which took place November 19-23 in Honolulu, Hawaii.

The poster, titled “Discovery and development of a novel CNS-penetrating ATR inhibitor: Dual inhibition of ATR and mTOR in PTEN-deficient tumors,” highlights the discovery and early characterization of novel ATR/mTOR dual inhibitors designed using the Enki™ generative AI platform. The compounds are engineered to modulate two well-established cancer-driving pathways that, despite their importance, have never before been combined in a single therapeutic agent. Notably, Rakovina’s lead molecules were designed specifically to cross the blood–brain barrier and reach tumor cells within the central nervous system, supporting their potential relevance in primary brain cancers and cancers with a high risk of brain metastasis.

Rakovina’s senior management team presented the findings showing that the AI-discovered ATR+mTOR inhibitors achieve meaningful CNS penetration, addressing a key limitation of current clinical ATR inhibitors, which have poor CNS distribution. In direct comparisons, multiple Rakovina compounds showed >50% ATR inhibition at 1 µM and exhibited equal or greater enzymatic potency than leading ATR inhibitors ceralasertib, tuvusertib, and elimusertib, while maintaining similar PIKK-family selectivity.

Importantly, these compounds were engineered with a mechanistic rationale to co-target ATR and mTOR, two pathways on which PTEN-deficient tumors (including those prone to brain metastasis) are highly dependent. By simultaneously blocking ATR-mediated DNA damage response and mTOR-driven survival signaling, these CNS-penetrant inhibitors have the potential to overcome key resistance mechanisms in PTEN-deficient cancers and deliver therapeutic effects not achievable with ATR-only agents.

PTEN deficiency in cancer

PTEN is one of the most frequently lost tumor-suppressor genes in human cancer and serves as a key brake on the PI3K/AKT/mTOR signaling pathway that governs cell growth, metabolism, and survival. Its loss promotes unchecked proliferation, genomic instability, therapy resistance, and aggressive tumor progression.

PTEN deficiency is particularly prevalent in cancers with a high propensity for CNS spread, including ovarian, lung, breast, and melanoma – where tumor cells rely heavily on mTOR-driven growth and survival. In these settings, mTOR becomes an adaptive escape pathway, especially under ATR inhibition, allowing PTEN-deficient tumors to accelerate growth and diminish the effectiveness of ATR-only therapeutic strategies.

Using the ENKI generative AI platform, the Company designed a virtual library of 138 predicted compounds, from which, 43 priority molecules were synthesized for evaluation in biochemical and cellular assays. Multiple compounds demonstrated >50% inhibition of recombinant ATR at 1 µM and exhibited potency comparable to or exceeding ATR inhibitors currently in development including ceralasertib, tuvusertib, and elimusertib.

Pharmacokinetic profiling in mice following a single 5 mg/kg intraperitoneal dose revealed favorable tolerability, metabolic stability in human liver microsomes, and measurable CNS exposure, supporting further evaluation in brain tumor models.

“Sharing these data at SNO is an important milestone for our ATR/mTOR program,” said Prof. Mads Daugaard, President and Chief Scientific Officer of Rakovina Therapeutics. “To our knowledge, no company has previously generated a single small-molecule therapeutic designed to combine ATR and mTOR inhibition with CNS penetration. Seeing generative AI propose compounds with this level of precision gives us a fundamentally new way to address these difficult-to-treat cancers with a high risk of brain involvement.”

“The reception to our data at SNO has been very encouraging,” added Jeffrey Bacha, executive chairman of Rakovina Therapeutics. “This program showcases how combining Variational AI’s Enki™ platform with the translational capabilities at the Vancouver Prostate Centre allows us to rapidly pursue differentiated DDR-targeted therapeutics with potential clinical relevance in areas of significant unmet need.”

About Rakovina Therapeutics Inc.
Rakovina Therapeutics is a biopharmaceutical research company focused on the development of innovative cancer treatments. Our work is based on unique technologies for targeting the DNA-damage response powered by Artificial Intelligence (AI) using the proprietary Deep-Docking™ and Enki™ platforms. By using AI, we can review and optimize drug candidates at a much greater pace than ever before.

The Company has established a pipeline of distinctive DNA-damage response inhibitors with the goal of advancing one or more drug candidates into human clinical trials in collaboration with pharmaceutical partners. Further information may be found at www.rakovinatherapeutics.com.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

Notice Regarding Rakovina Therapeutics Forward-Looking Statements:
This release includes forward-looking statements regarding the company and its respective business, which may include, but is not limited to, statements with respect to the proposed business plan of the company and other statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans,” “is expected,” “expects,” “scheduled,” “intends,” “contemplates,” “anticipates,” “believes,” “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events, or results “may,” “could,” “would,” “might,” or “will” be taken, occur, or be achieved. Such statements are based on the current expectations of the management of the company. The forward-looking events and circumstances discussed in this release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the company, including risks regarding the biopharmaceutical industry, economic factors, regulatory factors, the equity markets generally, and risks associated with growth and competition.

Although the company has attempted to identify important factors that could cause actual actions, events, or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events, or results to differ from those anticipated, estimated, or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made, and the company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. The reader is referred to the company’s most recent filings on SEDAR+ for a more complete discussion of all applicable risk factors and their potential effects, copies of which may be accessed through the company’s profile page at www.sedar.com.

For Further Information Contact:
Michelle Seltenrich, BSc MBA
Director, Corporate Development
IR@rakovinatherapeutics.com
778-773-5432

DXS INTERNATIONAL PLC (AQSE: DXSP): Notice of 2025 Annual General Meeting




DXS INTERNATIONAL PLC (AQSE: DXSP): Notice of 2025 Annual General Meeting

Monday 24 November

DXS INTERNATIONAL PLC (AQSE: DXSP)

Notice of 2025 Annual General Meeting

The Board of DXS International plc (“the Company” or “DXSP”), the AQSE Growth Market quoted healthcare information and digital clinical decision support systems provider, is pleased to announce that its Annual General Meeting is scheduled to take place on Thursday 18^th December at 11.30 at Elm House, Tanshire Park, Shackleford Road. Elstead, Surrey GU8 6LB.

For further information in relation to the AGM, shareholders should refer to the Notice of Annual General Meeting and the AGM Letter which have been despatched to shareholders. Copies of these documents, along with the Company’s Annual Report for the year ended 30 April 2025, are available for download from the Company’s website https://www.dxs-systems.co.uk/corporate-documents.php

The Directors of DXS International plc accept responsibility for this announcement. This announcement contains information which, prior to its disclosure, was inside information as stipulated under Regulation 11 of the Market Abuse (Amendment) (EU Exit) Regulations 2019/310 (as amended).

Contacts:

Notes to Editors

About DXS:

DXS International presents up to date treatment guidelines and recommendations, from Clinical Commissioning Groups and other trusted NHS sources, to doctors, nurses and pharmacists in their workflow and during the patient consultation. This effective clinical decision support ultimately translates to improved healthcare outcomes delivered more cost effectively and which should significantly contribute towards the NHS achieving its projected efficiency savings.

ONWARD Medical Drives Strong US ARC-EX Adoption and Achieves Important Scientific and Regulatory Milestones in Q3 2025




ONWARD Medical Drives Strong US ARC-EX Adoption and Achieves Important Scientific and Regulatory Milestones in Q3 2025

EINDHOVEN, the Netherlands, Nov. 24, 2025 (GLOBE NEWSWIRE) — ONWARD Medical N.V. (Euronext: ONWD – US ADR: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries (SCI) and other movement disabilities, today announced its results for the third quarter of 2025 and provides a comprehensive business update:

• Commercial traction: The Company met its objective of 40 ARC-EX^® Systems sold in Q3.
• Regulatory milestones: The US Food and Drug Administration (FDA) approved an investigational device exemption (IDE) for the ARC-IM^® System, allowing the initiation of the Empower BP global pivotal study. The Company received CE Mark certification for the ARC-EX System. In November, the FDA also cleared the ARC-EX System for home use in the US.
• Science & technology leadership: Key publications in Nature, Nature Medicine, and Neurology: Clinical Practice added to the strong body of clinical evidence supporting the Company’s innovative therapies.
• Financial highlights: The Company reported EUR 1.7 million in revenue in Q3 and successfully raised over EUR 50 million in equity capital in October, extending runway into Q1 2027.

Dave Marver, CEO of ONWARD Medical, said: “We continued to deliver strong commercial execution in Q3, and we achieved several meaningful scientific and regulatory milestones across our technology platforms. Home-based ARC-EX Therapy greatly enlarges the US market opportunity and helps fulfill our mission to provide the SCI community with broad and convenient access to innovative therapies. We are also well positioned to initiate Empower BP, our second global pivotal study and the first to evaluate the ARC-IM implanted neuromodulation platform to address blood pressure instability after SCI. The recent well-supported financing allows us to further advance our strategic priorities with focus, discipline and determination.”

Commercial traction

The Company met its objective of 40 ARC-EX Systems sold in Q3, demonstrating continued strong commercial traction for its groundbreaking external spinal cord stimulation technology.

ARC-EX Therapy is now available in over 60 clinics across the US.

Regulatory milestones

The Company received CE Mark certification for the ARC-EX System, allowing commercialization for both clinic and home use in the European Union. The CE Mark facilitates a streamlined regulatory pathway in other countries, including the UK and Switzerland. First commercial sales of the ARC-EX System in Europe are expected in Q4.

In November, the Company received 510(k) clearance to expand the ARC-EX System indication for home use in the US. ARC-EX is the first and only FDA-cleared technology demonstrated to improve hand strength and sensation in people with SCI.

The US FDA also approved an IDE for the ARC-IM System, allowing the initiation of the Empower BP global pivotal study designed to assess the safety and effectiveness of this novel technology designed to manage blood pressure instability in people with SCI. The first patient enrollment in Empower BP is anticipated before the end of the year.

Science & technology leadership

The Company announced the simultaneous publication of two landmark articles in Nature and Nature Medicine. They highlighted advances in blood pressure regulation after SCI and added to the compelling body of scientific and clinical evidence supporting the ARC-IM System ahead of the initiation of Empower BP. Detailed results from clinical feasibility studies show immediate improvement in blood pressure stability and durable reduction of hypotensive symptoms, resulting in improved quality of life.

The results of the LIFT Home Study, published in Neurology: Clinical Practice, showed that continued use of ARC-EX Therapy at home is effective in maintaining and extending gains achieved in the clinic.

Financial highlights

The Company reported EUR 1.7 million in revenue in Q3, exceeding the EUR 1 million mark in quarterly revenue for the first time.

In October, the Company successfully raised over EUR 50 million in equity capital. The transaction was supported by strong demand from existing and new high-quality, long-only, and sector specialist investors. The net proceeds from the transaction are expected to provide the Company with cash runway into Q1 2027, assuming no draw down of the Company’s debt facility. As of October 31, 2025, the cash balance was EUR ​77.7 million.

BNP Paribas’ broker Portzamparc initiated coverage with a Buy rating and Target Price of EUR 10.20, expanding the Company’s equity research coverage to five leading banks, each with Buy ratings.

Outlook

Continued demand for the ARC-EX System and positive feedback from users suggest the Company is on track to deliver a strong first year as a commercial organization. The CE Mark certification and FDA clearance to market the ARC-EX System for home use put the Company in a strong position to accelerate growth in 2026.

The Company anticipates first patient enrollment in the Empower BP pivotal study before the end of the year. It also plans additional implants of its ARC-IM and ARC-BCI^® Systems to explore potential future indications, including mobility in SCI and Parkinson’s disease.

Webcast details

ONWARD Medical will hold a webcast today, November 24, 2025, at 2:00 p.m. CET / 8:00 a.m. ET, hosted by CEO Dave Marver. To join the session, please register using this link.

About ONWARD Medical

ONWARD Medical is the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries and other movement disabilities. Building on decades of scientific discovery, preclinical research, and clinical studies conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company developed ARC Therapy. It has subsequently been awarded 10 Breakthrough Device Designations from the FDA. The Company’s ARC-EX^® System is cleared for commercial sale in the US and Europe. The Company is also developing an investigational implantable system called ARC-IM^®, designed to address several unmet needs, including blood pressure instability after spinal cord injury. It can also be paired with a brain-computer interface (BCI) and artificial intelligence (AI) to restore thought-driven movement.

Headquartered in the Netherlands, the Company has a Science and Engineering Center in Switzerland and a US office in Boston, Massachusetts. The Company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD) and its US ADRs can be traded on OTCQX (ticker: ONWRY). For more information, please visit ONWD.com.

To stay informed about ONWARD’s research studies, technologies, and the availability of therapies in your area, please complete this webform.

For Media Inquiries:
Sébastien Cros, VP Communications
media@onwd.com  

For Investor Inquiries:
investors@onwd.com

Forward-Looking Statements  

Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors, including, but not limited to, delays in regulatory approvals, changes in demand, competition, and technology, can cause actual events, performance, or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions, or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers nor representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors, nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Trademarks: ONWARD, ARC-EX, ARC-IM, ARC-BCI, and the stylized O-Logo are proprietary and registered trademarks of ONWARD Medical. Unauthorized use is strictly prohibited.

ARC-EX Indication for Use: The ARC-EX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic and with take-home exercises in the home to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, nonprogressive neurological deficits resulting from an incomplete spinal cord injury (C2-C8 inclusive). The ARC-EX System is intended to be operated in medical centers by rehabilitation professionals and at home by patients and persons providing assistance to patients, as needed.

Other Investigational Products: All other ONWARD Medical devices and therapies, including ARC-IM and ARC-BCI, are investigational and not available for commercial use.

Fagron strengthens EMEA leadership with acquisitions in Poland and Hungary and announces key developments for its North American business




Fagron strengthens EMEA leadership with acquisitions in Poland and Hungary and announces key developments for its North American business

Regulated information – inside information
Nazareth (Belgium)/Rotterdam (The Netherlands), 24 November 2025 – 7:00 AM CET

Fagron strengthens EMEA leadership with acquisitions in Poland and Hungary and announces key developments for its North American business

Fagron, the global leader in pharmaceutical compounding, has reinforced its EMEA position with the acquisitions of a book of business from Amara (Poland) and Magilab (Hungary). These deals support Fagron’s strategy to diversify its presence in dynamic markets and highlight its disciplined M&A approach as a driver of sustainable growth. With these transactions, Fagron has executed 10 acquisitions this year, underscoring its disciplined serial acquirer track record.

The businesses combined are expected to contribute mid-teens (€m) in annual revenue, at an EBITDA margin above Fagron’s existing group margin. The combined purchase price amounts to approximately €26 million.

Separately, we have secured a new U.S. dollar credit facility with extended maturities to support our growth ambitions in North America, at attractive terms. We are very pleased to have achieved this milestone, which further strengthens our financial flexibility and long-term strategy.

The Company has also received a license for its Fagron Sterile Services (“FSS”) facility in Boston from the California State Board of Pharmacy. This allows us to ship compounding medication to that state, reinforcing our presence in one of the largest and most tightly regulated healthcare markets in the U.S.

Amara

Amara is a relevant player in the compounding sector, operating raw materials in Poland, with over 30 years of experience and a number of active registrations — a prerequisite for operating in the Polish market. Amara’s book of business will enhance Fagron’s offering in Poland and will unlock significant synergy potential through operational leverage.

Magilab

Magilab is a well-trusted brand and a specialized player in the hospital pharmacy segment of Hungary’s compounding raw materials market. This acquisition consolidates Fagron’s position in a market with high compounding per capita and enables operational excellence and scale effects.

New credit facility

Fagron has secured a new credit facility with PGIM totaling up to $225 million with maturities up to 15 years. An initial $125 million has already been drawn, with a final maturity of 12 years and an average tenor of 10 years. This new facility complements the existing €575 million bank facility, provides funding in local currency, extends our maturities, ensures healthy and diversified access to debt sources and provides Fagron enough flexibility to fund its robust M&A pipeline that we aim to execute at strict accretive criteria.

Licensing Update

The California State Board of Pharmacy granted the license to FSS Boston, Massachusetts, to ship compounding medication to that state, a key milestone towards reinforcing an integrated operation at FSS, alongside our facility in Wichita, Kansas, covering the whole nation. This permit is also expected to unlock further opportunities with key customers located in California.

Following the granting of this license, all Fagron’s 503B facilities in the U.S. are entitled to ship to California.

Rafael Padilla, CEO of Fagron, commented:

“The acquisitions of Amara and Magilab are key steps in consolidating our leadership in EMEA’s dynamic markets and support our ambition to reinforce our global position in the B&E segment.

In North America, we are making significant progress by securing the funding required to support our growth ambitions, at attractive terms. Additionally, obtaining the California license for our FSS Boston facility will allow us to fully integrate our FSS operation in the U.S. while reinforcing our presence in one of the largest healthcare markets within the country and unlock significant opportunities with new customers. Separately, the previously announced acquisition of UCP, will also deepen Fagron’s further position in California through a 503A pharmaceutical compounder specializing in the health and wellness segment.

We are very pleased to showcase today our commitment to disciplined M&A, operations excellence and prudent balance sheet management, which are key enablers of sustained growth and long-term success.”

Financial calendar
12 February 2026                Full year results 2025
9 April 2026                        Trading update first quarter 2026
11 May 2026                       Annual General Meeting 2025
30 July 2026                       Half year results 2026
8 October 2026                   Trading update third quarter 2026

Results and trading updates are published at 7.00 AM CET.

Further information
Ignacio Artola
Global Investor Relations Leader
Tel. +34 670385795
ignacio.artola@fagron.com

About Fagron
Fagron is the leading global company active in pharmaceutical compounding, focusing on delivering personalized medicine to hospitals, pharmacies, clinics, and patients in more than 35 countries around the world.

The Belgian company Fagron NV is based on Venecoweg 20A in Nazareth and is listed on Euronext Brussels and Euronext Amsterdam under the ticker symbol ‘FAGR’. Fagron’s operational activities are managed through the Dutch company Fagron BV. Fagron BV’s head office is located in Rotterdam.

Important information regarding forward-looking statements
Certain statements in this press release may be deemed to be forward-looking. Such forward-looking statements are based on current expectations and are influenced by various risks and uncertainties. Consequently, Fagron cannot provide any guarantee that such forward-looking statements will, in fact, materialize and cannot accept any obligation to update or revise any forward-looking statement as a result of new information, future events or for any other reason.

In the event of differences between the English translation and the Dutch original of this press release, the latter prevails.

Attachment

• Fagron strengthens EMEA leadership with acquisitions in Poland and Hungary and announces key developments for its North American business

Nanox Announces $15 Million Registered Direct Offering of Common Stock




Nanox Announces $15 Million Registered Direct Offering of Common Stock

PETACH TIKVA, Israel, Nov. 23, 2025 (GLOBE NEWSWIRE) — NANO-X IMAGING LTD (“Nanox” or the “Company”, Nasdaq: NNOX), an innovative medical imaging technology company, today announced that it has entered into a securities purchase agreement with a single institutional investor for the purchase and sale of 3,826,530 ordinary shares (“Common Stock”) in a registered direct offering. The offering is expected to result in gross proceeds of approximately $15 million, before deducting offering expenses. The closing of the offering is expected to occur on or about November 25, 2025, subject to the satisfaction of customary closing conditions.

The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.

“This successful capital raise further strengthens our balance sheet and accelerates our key growth initiatives including advancing the Company’s technologies, expanding our market presence, and enhancing our AI infrastructure,” said Erez Meltzer, Chief Executive Officer of Nanox. “As we scale deployments and expand our capabilities, we expect these efforts to reinforce our growth trajectory while advancing our mission to make high-quality medical imaging more accessible worldwide.”

Titan Partners Group, a division of American Capital Partners, is acting as the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form F-3 (File No. 333-271688) that was filed by Nanox with the U.S. Securities and Exchange Commission (the “SEC”), under the Securities Act of 1933, as amended (the “Securities Act”), and became effective on May 5, 2023, as amended. The proposed offering of these securities is being made only by means of a prospectus and a related prospectus supplement describing the terms of the offering, which will be filed with the SEC and, once filed, will be available on the SEC’s website located at http://www.sec.gov. Additionally, when available, electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, from Titan Partners Group LLC, a division of American Capital Partners, LLC, 4 World Trade Center, 49th Floor, New York, NY 10007, or by telephone at 929-833-1246, or by email at prospectus@titanpartnersgrp.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities or any other securities, nor shall there be any offer, solicitation or sale of these securities or any other securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Nano-X Imaging Ltd.

Nanox (NASDAQ: NNOX) is focused on driving the world’s transition to preventive health care by bringing a full solution of affordable medical imaging technologies based on advanced AI and proprietary digital X-ray source.

Nanox’s vision encompasses expanding the reach of Nanox technology both within and beyond hospital settings, providing a seamless end-to-end solution from scan to diagnosis, leveraging AI to enhance the efficiency of routine medical imaging technology and processes, in order to improve early detection and treatment and maintaining a clinically driven approach. The Nanox ecosystem includes Nanox.ARC – a multi-source digital tomosynthesis system that is cost-effective and user-friendly; Nanox.AI LTD – an AI-based suite of algorithms that augment the readings of routine CT imaging to highlight early signs often related to chronic diseases; Nanox.CLOUD – a cloud-based software platform that manages and stores data collected by Nanox devices, and provides users with tools for in-depth imaging analysis; Nanox.MARKETPLACE – a proprietary decentralized marketplace through Nanox’s subsidiary, USARAD Holdings Inc., that provides remote access to radiology and cardiology experts, and a comprehensive teleradiology services platform. By improving early detection and treatment, Nanox aims to enhance better health outcomes worldwide. For more information, please visit www.nanox.vision.

Forward-Looking Statements

This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, any statements relating to the ability to execute and consummate the transaction, the ability to successfully integrate VHC IT following the acquisition as well as to improve deployment speed pace and implementation quality, the initiation, timing, progress and results of the Company’s research and development, manufacturing, and commercialization activities with respect to its X-ray source technology and the Nanox.ARC, the ability to realize the expected benefits of its recent acquisitions and the projected business prospects of the Company and the acquired companies. In some cases, you can identify forward-looking statements by terminology such as “can,” “might,” “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “should,” “could,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to (i) Nanox’s ability to complete development of the Nanox System; (ii) Nanox’s ability to successfully demonstrate the feasibility of its technology for commercial applications; (iii) Nanox’s expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its technology, the Nanox.ARC and Nanox.CLOUD from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; (iv) Nanox’s ability to realize the anticipated benefits of the acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired companies to grow and manage growth profitably and retain their key employees; (v) Nanox’s ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.ARC; (vi) the market acceptance of the Nanox System and the proposed pay-per-scan business model; (vii) Nanox’s expectations regarding collaborations with third-parties and their potential benefits; (viii) Nanox’s ability to conduct business globally; (ix) changes in global, political, economic, business, competitive, market and regulatory forces; (x) risks related to the current war between Israel and Hamas and any worsening of the situation in Israel; (xi) risks related to macroeconomic factors, including tariff policy, inflation, interest rate levels and supply chain costs; (xii) potential litigation associated with our transactions; and (xiii) the Company’s ability to maintain expected growth and manage expenses.

For a discussion of other risks and uncertainties, and other important factors, any of which could cause Nanox’s actual results to differ from those contained in the Forward-Looking Statements, see the section titled “Risk Factors” in Nanox’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings with the SEC. The reader should not place undue reliance on any forward-looking statements included in this press release. Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to actual results or to changes in the Company’s expectations.

Company Contact:

Investor Contact:
Mike Cavanaugh
ICR Healthcare
mike.cavanaugh@icrhealthcare.com

Media Contact:
Ben Shannon
ICR Healthcare
NanoxPR@icrinc.com

Inventiva reports 2025 Third Quarter Financial Information¹




Inventiva reports 2025 Third Quarter Financial Information¹

• Cash and cash equivalents at €97.6 million, and €24.7 million in short-term deposits² as of September 30, 2025.
• Revenues of €4.5 million for the first nine months of 2025.
• Cash runway expected until the end of the first quarter of 2027³, including net proceeds from the November 2025 public offering.

Daix (France), New York City, (New York, United States), November 21, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported its cash position as of September 30, 2025 and its revenues for the first nine months of 2025.

Cash and cash equivalents

As of September 30, 2025, the Company’s cash and cash equivalents amounted to €97.6 million, compared to cash and cash equivalents at €96.6 million as of December 31, 2024.

Net cash used in operating activities amounted to (€76.3) million in the first nine months of 2025, compared to (€63.7) million for the same period in 2024, up by 20%, while R&D expenses for the first nine months of 2025 were slightly lower by 11% at (€64.6) million, compared to the same period of 2024. The increase in net cash used in operating activities is due to working capital evolution and, to a lesser extent, the net cash impact of the implementation of the Company’s previously disclosed pipeline prioritization plan initiated in the first half of 2025.

Net cash used in investing activities for the first nine months of 2025 amounted to (€25.0) million, compared to €8.9 million generated for the same period in 2024. The change is mostly due to the variation in short-term² deposits during the period.

Net cash generated from financing activities for the first nine months of 2025 amounted to €103.4 million, compared to €41.9 million in the same period in 2024. Net cash generated from financing activities during the first nine months of 2025 primarily comes from the receipt of gross proceeds of €115.6 million (net proceeds of €108.0 million) from the settlement in May 2025 of the second tranche⁴ of the structured financing announced by the Company in October 2024 (the “Structured Financing”). Net cash generated from financing activities during the first nine months of 2024 was mainly comprised of (i) the second tranche of €25 million drawn in January 2024 under the unsecured loan agreement granted by the European Investment Bank, and (ii) the issuance of royalty certificates in July 2024 for €20.1 million.

Over the first nine months of 2025, the Company recorded a negative exchange rate effect on cash and cash equivalents of (€1.0) million, compared to none for the same period in 2024, due to the evolution of the EUR/USD exchange rate.

Financial information after closing the accounts

In November 2025, the Company completed a public offering in the United States of 44,805,193 American Depositary Shares (“ADSs”) for aggregate gross proceeds of approximately €149 million (€139.3 million net proceeds)⁵, including the exercise in full of the underwriters’ option to purchase additional ADSs.

Considering its current cost structure and forecasted expenditures, the Company estimates that its cash, cash equivalents and short-term deposits, including the net proceeds from the public offering, should enable it to finance its operations until the end of the first quarter of 2027. Assuming the potential exercise in full of the Tranche 3 warrants issued in the Structured Financing for proceeds of up to €116.0 million, the Company estimates that such potential additional proceeds would enable it to finance its activities until the middle of the third quarter of 2027⁶.

Revenues

Revenues for the first nine months of 2025 amounted to €4.5 million, compared to none generated for the same period in 2024.

Revenues recorded by the Company in the first nine months of 2025 consist mainly of the $10 million gross proceeds (net proceeds of €8.6 million) milestone payment invoiced to Chia Tai Tianqing Pharmaceutical Group (“CTTQ”) and the $5 million (€4.3 million) credit notes recognized under the license agreement with CTTQ following the closing of the second tranche of the Structured Financing in May 2025. The milestone payment from CTTQ was received in July 2025.

          ***

Next key milestones expected

• Topline results of NATiV3 – expected in the second half of 2026

Upcoming shareholders meeting

• Combined General Meeting of Shareholders – November 27, 2025

Upcoming investor conference participation

• Euronext Tech Leaders Forum – November 26, 2025 – Paris
• Piper Sandler 37^th Annual Healthcare Conference – December 2-4, 2025 – New York

Upcoming scientific conference participation

• MASH-TAG – January 7-11, 2026 – Park City

Next financial results publication

• Full-Year 2025 Revenues and cash and cash equivalents: Thursday, February 16, 2026 (after U.S. market close)

About Inventiva

Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease.

Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). http://www.inventivapharma.com  

Contacts

Important Notice

This press release contains certain “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, unaudited financial information, forecasts and estimates with respect to Inventiva’s cash resources, the potential exercise by investors of warrants and pre-funded warrants, including the warrants and pre-funded warrants issued in connection with the Structured Financing, the potential benefit of the pipeline prioritization plan and related workforce reduction, and Inventiva’s future activities, expectations, plans, growth and prospects of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “would”, “could”, “might”, “should”, “designed”, “hopefully”, “target”, “potential”, “opportunity”, “possible”, “aim”, and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management’s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance, or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva’s control. There can be no guarantees with respect to product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates due to a number of factors, including that interim data or data from any interim analysis of ongoing clinical trials may not be predictive of future trial results, that the recommendation of the DMC may not be indicative of a potential marketing approval, Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction on the results or timing of the NATiV3 trial or regulatory matters with respect thereto, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to continue as a going concern, Inventiva’s ability to obtain financing and to enter into potential transactions, on the expected timing or at all, and whether, when and to what extent dilutive instruments may be exercised, and by which holders, Inventiva’s future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva’s and its partners’ clinical trials may not support Inventiva’s and its partners’ product candidate claims, Inventiva’s expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or additional amendments to Inventiva’s clinical trials, Inventiva’s expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva’s ability to identify additional products or product candidates with significant commercial potential, Inventiva’s expectations with respect to its pipeline prioritization plan and related workforce reduction, including potential benefits, expenses and consequences relating thereto, Inventiva’s ability to execute on its commercialization, marketing and manufacturing capabilities and strategy, Inventiva’s ability to successfully cooperate with existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its existing and future partnerships on the clinical development, regulatory approvals and, if approved, commercialization of its product candidates, and the achievement of milestones thereunder and the timing thereof, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva’s and its partners’ control, Inventiva’s product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva’s business, and pre-clinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by changes in laws and regulations, unfavorable conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, the conflict in the Middle East and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, political turmoil, and natural catastrophes, uncertain financial markets and disruptions in banking systems. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. 

Please refer to the Universal Registration Document for the year ended December 31, 2024 filed with the Autorité des Marchés Financiers on April 15, 2025, the interim financial report for the six months ended June 30, 2025 published on September 29, 2025 and the Annual Report on Form 20-F for the year ended December 31, 2024 filed with the Securities and Exchange Commission (the “SEC“) on April 15, 2025 for other risks and uncertainties affecting Inventiva, including those described under the caption “Risk Factors”, and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All information in this press release is as of the date of the release. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

¹ Non-audited financial information.
² Short-term deposits were included in the category “other current assets” in the IFRS unaudited interim condensed consolidated statement of financial position and were considered by the Company as liquid and easily available.
³ This estimate is based on the Company’s current business plan and excludes any potential milestones payable to or by the Company, any proceeds from the potential exercise of the Tranche 3 warrants issued in the Structured Financing and any additional expenditures related to other product candidates or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based this estimate on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated.
⁴ Press release of May 5, 2025
⁵ Based on the exchange rate of €1.00 = $1.1576 as published by the European Central Bank on November 12, 2025
⁶ These estimates are based on the Company’s current business plan and exclude any potential milestones payable to or by the Company and any additional expenditures related to other product candidates or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based these estimates on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated. There can be no assurance whether, and to which extent, the Tranche 3 warrants will be exercised, if at all.

Attachment

• Inventiva – PR – Q3 2025 CA Cash – EN – 11 21 2025

Inventiva reports 2025 Third Quarter Financial Information¹




Inventiva reports 2025 Third Quarter Financial Information¹

• Cash and cash equivalents at €97.6 million, and €24.7 million in short-term deposits² as of September 30, 2025.
• Revenues of €4.5 million for the first nine months of 2025.
• Cash runway expected until the end of the first quarter of 2027³, including net proceeds from the November 2025 public offering.

Daix (France), New York City, (New York, United States), November 21, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported its cash position as of September 30, 2025 and its revenues for the first nine months of 2025.

Cash and cash equivalents

As of September 30, 2025, the Company’s cash and cash equivalents amounted to €97.6 million, compared to cash and cash equivalents at €96.6 million as of December 31, 2024.

Net cash used in operating activities amounted to (€76.3) million in the first nine months of 2025, compared to (€63.7) million for the same period in 2024, up by 20%, while R&D expenses for the first nine months of 2025 were slightly lower by 11% at (€64.6) million, compared to the same period of 2024. The increase in net cash used in operating activities is due to working capital evolution and, to a lesser extent, the net cash impact of the implementation of the Company’s previously disclosed pipeline prioritization plan initiated in the first half of 2025.

Net cash used in investing activities for the first nine months of 2025 amounted to (€25.0) million, compared to €8.9 million generated for the same period in 2024. The change is mostly due to the variation in short-term² deposits during the period.

Net cash generated from financing activities for the first nine months of 2025 amounted to €103.4 million, compared to €41.9 million in the same period in 2024. Net cash generated from financing activities during the first nine months of 2025 primarily comes from the receipt of gross proceeds of €115.6 million (net proceeds of €108.0 million) from the settlement in May 2025 of the second tranche⁴ of the structured financing announced by the Company in October 2024 (the “Structured Financing”). Net cash generated from financing activities during the first nine months of 2024 was mainly comprised of (i) the second tranche of €25 million drawn in January 2024 under the unsecured loan agreement granted by the European Investment Bank, and (ii) the issuance of royalty certificates in July 2024 for €20.1 million.

Over the first nine months of 2025, the Company recorded a negative exchange rate effect on cash and cash equivalents of (€1.0) million, compared to none for the same period in 2024, due to the evolution of the EUR/USD exchange rate.

Financial information after closing the accounts

In November 2025, the Company completed a public offering in the United States of 44,805,193 American Depositary Shares (“ADSs”) for aggregate gross proceeds of approximately €149 million (€139.3 million net proceeds)⁵, including the exercise in full of the underwriters’ option to purchase additional ADSs.

Considering its current cost structure and forecasted expenditures, the Company estimates that its cash, cash equivalents and short-term deposits, including the net proceeds from the public offering, should enable it to finance its operations until the end of the first quarter of 2027. Assuming the potential exercise in full of the Tranche 3 warrants issued in the Structured Financing for proceeds of up to €116.0 million, the Company estimates that such potential additional proceeds would enable it to finance its activities until the middle of the third quarter of 2027⁶.

Revenues

Revenues for the first nine months of 2025 amounted to €4.5 million, compared to none generated for the same period in 2024.

Revenues recorded by the Company in the first nine months of 2025 consist mainly of the $10 million gross proceeds (net proceeds of €8.6 million) milestone payment invoiced to Chia Tai Tianqing Pharmaceutical Group (“CTTQ”) and the $5 million (€4.3 million) credit notes recognized under the license agreement with CTTQ following the closing of the second tranche of the Structured Financing in May 2025. The milestone payment from CTTQ was received in July 2025.

          ***

Next key milestones expected

• Topline results of NATiV3 – expected in the second half of 2026

Upcoming shareholders meeting

• Combined General Meeting of Shareholders – November 27, 2025

Upcoming investor conference participation

• Euronext Tech Leaders Forum – November 26, 2025 – Paris
• Piper Sandler 37^th Annual Healthcare Conference – December 2-4, 2025 – New York

Upcoming scientific conference participation

• MASH-TAG – January 7-11, 2026 – Park City

Next financial results publication

• Full-Year 2025 Revenues and cash and cash equivalents: Thursday, February 16, 2026 (after U.S. market close)

About Inventiva

Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease.

Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). http://www.inventivapharma.com  

Contacts

Important Notice

This press release contains certain “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, unaudited financial information, forecasts and estimates with respect to Inventiva’s cash resources, the potential exercise by investors of warrants and pre-funded warrants, including the warrants and pre-funded warrants issued in connection with the Structured Financing, the potential benefit of the pipeline prioritization plan and related workforce reduction, and Inventiva’s future activities, expectations, plans, growth and prospects of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “would”, “could”, “might”, “should”, “designed”, “hopefully”, “target”, “potential”, “opportunity”, “possible”, “aim”, and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management’s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance, or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva’s control. There can be no guarantees with respect to product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates due to a number of factors, including that interim data or data from any interim analysis of ongoing clinical trials may not be predictive of future trial results, that the recommendation of the DMC may not be indicative of a potential marketing approval, Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction on the results or timing of the NATiV3 trial or regulatory matters with respect thereto, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to continue as a going concern, Inventiva’s ability to obtain financing and to enter into potential transactions, on the expected timing or at all, and whether, when and to what extent dilutive instruments may be exercised, and by which holders, Inventiva’s future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva’s and its partners’ clinical trials may not support Inventiva’s and its partners’ product candidate claims, Inventiva’s expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or additional amendments to Inventiva’s clinical trials, Inventiva’s expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva’s ability to identify additional products or product candidates with significant commercial potential, Inventiva’s expectations with respect to its pipeline prioritization plan and related workforce reduction, including potential benefits, expenses and consequences relating thereto, Inventiva’s ability to execute on its commercialization, marketing and manufacturing capabilities and strategy, Inventiva’s ability to successfully cooperate with existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its existing and future partnerships on the clinical development, regulatory approvals and, if approved, commercialization of its product candidates, and the achievement of milestones thereunder and the timing thereof, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva’s and its partners’ control, Inventiva’s product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva’s business, and pre-clinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by changes in laws and regulations, unfavorable conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, the conflict in the Middle East and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, political turmoil, and natural catastrophes, uncertain financial markets and disruptions in banking systems. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. 

Please refer to the Universal Registration Document for the year ended December 31, 2024 filed with the Autorité des Marchés Financiers on April 15, 2025, the interim financial report for the six months ended June 30, 2025 published on September 29, 2025 and the Annual Report on Form 20-F for the year ended December 31, 2024 filed with the Securities and Exchange Commission (the “SEC“) on April 15, 2025 for other risks and uncertainties affecting Inventiva, including those described under the caption “Risk Factors”, and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All information in this press release is as of the date of the release. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

¹ Non-audited financial information.
² Short-term deposits were included in the category “other current assets” in the IFRS unaudited interim condensed consolidated statement of financial position and were considered by the Company as liquid and easily available.
³ This estimate is based on the Company’s current business plan and excludes any potential milestones payable to or by the Company, any proceeds from the potential exercise of the Tranche 3 warrants issued in the Structured Financing and any additional expenditures related to other product candidates or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based this estimate on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated.
⁴ Press release of May 5, 2025
⁵ Based on the exchange rate of €1.00 = $1.1576 as published by the European Central Bank on November 12, 2025
⁶ These estimates are based on the Company’s current business plan and exclude any potential milestones payable to or by the Company and any additional expenditures related to other product candidates or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based these estimates on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated. There can be no assurance whether, and to which extent, the Tranche 3 warrants will be exercised, if at all.

Attachment

• Inventiva – PR – Q3 2025 CA Cash – EN – 11 21 2025

Scilex Holding Company Announces Update Regarding Distribution of Dream Bowl 2026 Meme Coin by Datavault AI Inc.




Scilex Holding Company Announces Update Regarding Distribution of Dream Bowl 2026 Meme Coin by Datavault AI Inc.

PALO ALTO, Calif., Nov. 21, 2025 (GLOBE NEWSWIRE) — Scilex Holding Company (“Scilex” or the “Company”) (Nasdaq: SCLX), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease, announced today that, with respect to the voluntary distribution by Datavault AI Inc. (“Datavault AI”) (Nasdaq: DVLT) of Dream Bowl 2026 Meme Coins to record holders of Scilex common stock, given that such distribution is being made by Datavault AI as a token of its appreciation for Scilex’s relationship with Datavault AI as a stockholder of Datavault AI, licensing partner and co-sponsor of the Dream Bowl XIV event to be held on January 11, 2026, Nasdaq has informed Datavault AI that it is not planning to make any announcement for Scilex regarding such distribution, whether as to the record date or an ex-dividend date. Notwithstanding the absence of such announcement, Datavault AI has informed the Company that it intends to make such voluntary distribution to record holders of Scilex common stock as of November 25, 2025 concurrently with the distribution of the Dream Bowl 2026 Meme Coins to Datavault AI’s eligible record equity holders, including the Company.

The Dream Bowl 2026 Meme Coins will be airdropped to Data Vault^® wallets following the payment date for the distribution, subject to recipient’s electing to opt-in to the distribution and setting up a digital wallet with Datavault AI and providing Datavault AI with documentation confirming same. Subject to the right of the Board of Directors of Datavault AI to change the record date, the payment date for this distribution will be determined by subsequent resolutions of the Board of Directors of Datavault AI, which will be within 60 days following the record date. Further instructions regarding wallet setup, token access, and distribution procedures will be provided by Datavault AI in a subsequent communication prior to the payment date.

The record date for the distribution may be changed by the Board of Directors of Datavault AI for any reason at any time prior to the actual payment date, and payment of the distribution is conditioned upon the Board not having revoked the dividend prior to the payment date, including for a material change to the solvency or surplus analysis presented to the Board of Directors of Datavault AI. 

For more information on Scilex Holding Company, refer to www.scilexholding.com

For more information on Semnur Pharmaceuticals, Inc., refer to www.semnurpharma.com

For more information on ZTlido^® including Full Prescribing Information, refer to www.ztlido.com.

For more information on ELYXYB^®, including Full Prescribing Information, refer to www.elyxyb.com.

For more information on Gloperba^®, including Full Prescribing Information, refer to www.gloperba.com.

https://www.facebook.com/scilex.pharm

https://www.linkedin.com/company/scilex-holding-company/

info@scilexholding.com

About Scilex Holding Company

Scilex is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido^® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB^®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba^®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.

In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA” or “SP-102”), which is owned by Semnur (a majority owned subsidiary of Scilex) and is a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of acute pain and for which Scilex has recently completed a Phase 2 trial in acute low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia.

Scilex is headquartered in Palo Alto, California.

Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts and may be accompanied by words that convey projected future events or outcomes, such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” or variations of such words or by expressions of similar meaning. These forward-looking statements include, but are not limited to, statements regarding future events, Datavault AI’s potential distribution of the Dream Bowl 2026 Meme Coin and the timing thereof (including that the Board of Directors of Datavault AI may change the record date and, as a result, the payment date thereof), future opportunities for Scilex and its subsidiaries, the future business strategies, long-term objectives and commercialization plans of Scilex and its subsidiaries, the current and prospective product candidates, planned clinical trials and preclinical activities and potential product approvals, as well as the potential for market acceptance of any approved products and the related market opportunity of Scilex and its subsidiaries, statements regarding SP-102, if approved by the FDA, Scilex’s potential to attract new capital and avoid the effects of negative debt leverage and other statements that are not historical facts. These statements are based on management’s current expectations of and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on, by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Scilex. These statements are subject to a number of risks and uncertainties regarding Scilex’s business, and actual results may differ materially. These risks and uncertainties include, but are not limited to, general economic, political and business conditions; risks related to legal proceedings that may be instituted against the parties regarding the Dream Bowl 2026 Meme Coin and the distribution thereof to holders of Scilex common stock; the risks associated with the right of the Board of Directors of Datavault AI to change the record date (and, as a result, the payment date) of the distribution of, and/or to revoke, the Dream Bowl 2026 Meme Coin; the ability of Scilex and its subsidiaries to develop and successfully market products; the ability of Scilex and its subsidiaries to grow and manage growth profitably and retain its key employees; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the prior results of the clinical trials may not be replicated; regulatory and intellectual property risks; the risk of failure to realize the anticipated benefits of the transactions contemplated with Datavault and other risks and uncertainties indicated from time to time and other risks set forth in Scilex’s filings with the SEC. There may be additional risks that Scilex presently does not know or that Scilex currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements provide Scilex’s expectations, plans or forecasts of future events and views as of the date of the communication. Scilex anticipates that subsequent events and developments will cause such assessments to change. However, while Scilex may elect to update these forward-looking statements at some point in the future, Scilex specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Scilex’s assessments as of any date subsequent to the date of this communication. Accordingly, investors are cautioned not to place undue reliance on these forward-looking statements.

Contacts:

Investors and Media
Scilex Holding Company
960 San Antonio Road
Palo Alto, CA 94303
Office: (650) 516-4310

Email: investorrelations@scilexholding.com

Website: www.scilexholding.com

SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a majority-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned.

ZTlido^® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company.

Gloperba^® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company.

ELYXYB^® is a registered trademark owned by Scilex Holding Company.

Scilex Bio™ is a trademark owned by Scilex Holding Company, Inc.

All other trademarks are the property of their respective owners.

© 2025 Scilex Holding Company All Rights Reserved.

Scilex Holding Company Announces Update Regarding Distribution of Dream Bowl 2026 Meme Coin by Datavault AI Inc.




Scilex Holding Company Announces Update Regarding Distribution of Dream Bowl 2026 Meme Coin by Datavault AI Inc.

PALO ALTO, Calif., Nov. 21, 2025 (GLOBE NEWSWIRE) — Scilex Holding Company (“Scilex” or the “Company”) (Nasdaq: SCLX), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease, announced today that, with respect to the voluntary distribution by Datavault AI Inc. (“Datavault AI”) (Nasdaq: DVLT) of Dream Bowl 2026 Meme Coins to record holders of Scilex common stock, given that such distribution is being made by Datavault AI as a token of its appreciation for Scilex’s relationship with Datavault AI as a stockholder of Datavault AI, licensing partner and co-sponsor of the Dream Bowl XIV event to be held on January 11, 2026, Nasdaq has informed Datavault AI that it is not planning to make any announcement for Scilex regarding such distribution, whether as to the record date or an ex-dividend date. Notwithstanding the absence of such announcement, Datavault AI has informed the Company that it intends to make such voluntary distribution to record holders of Scilex common stock as of November 25, 2025 concurrently with the distribution of the Dream Bowl 2026 Meme Coins to Datavault AI’s eligible record equity holders, including the Company.

The Dream Bowl 2026 Meme Coins will be airdropped to Data Vault^® wallets following the payment date for the distribution, subject to recipient’s electing to opt-in to the distribution and setting up a digital wallet with Datavault AI and providing Datavault AI with documentation confirming same. Subject to the right of the Board of Directors of Datavault AI to change the record date, the payment date for this distribution will be determined by subsequent resolutions of the Board of Directors of Datavault AI, which will be within 60 days following the record date. Further instructions regarding wallet setup, token access, and distribution procedures will be provided by Datavault AI in a subsequent communication prior to the payment date.

The record date for the distribution may be changed by the Board of Directors of Datavault AI for any reason at any time prior to the actual payment date, and payment of the distribution is conditioned upon the Board not having revoked the dividend prior to the payment date, including for a material change to the solvency or surplus analysis presented to the Board of Directors of Datavault AI. 

For more information on Scilex Holding Company, refer to www.scilexholding.com

For more information on Semnur Pharmaceuticals, Inc., refer to www.semnurpharma.com

For more information on ZTlido^® including Full Prescribing Information, refer to www.ztlido.com.

For more information on ELYXYB^®, including Full Prescribing Information, refer to www.elyxyb.com.

For more information on Gloperba^®, including Full Prescribing Information, refer to www.gloperba.com.

https://www.facebook.com/scilex.pharm

https://www.linkedin.com/company/scilex-holding-company/

info@scilexholding.com

About Scilex Holding Company

Scilex is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido^® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB^®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba^®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.

In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA” or “SP-102”), which is owned by Semnur (a majority owned subsidiary of Scilex) and is a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of acute pain and for which Scilex has recently completed a Phase 2 trial in acute low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia.

Scilex is headquartered in Palo Alto, California.

Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts and may be accompanied by words that convey projected future events or outcomes, such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” or variations of such words or by expressions of similar meaning. These forward-looking statements include, but are not limited to, statements regarding future events, Datavault AI’s potential distribution of the Dream Bowl 2026 Meme Coin and the timing thereof (including that the Board of Directors of Datavault AI may change the record date and, as a result, the payment date thereof), future opportunities for Scilex and its subsidiaries, the future business strategies, long-term objectives and commercialization plans of Scilex and its subsidiaries, the current and prospective product candidates, planned clinical trials and preclinical activities and potential product approvals, as well as the potential for market acceptance of any approved products and the related market opportunity of Scilex and its subsidiaries, statements regarding SP-102, if approved by the FDA, Scilex’s potential to attract new capital and avoid the effects of negative debt leverage and other statements that are not historical facts. These statements are based on management’s current expectations of and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on, by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Scilex. These statements are subject to a number of risks and uncertainties regarding Scilex’s business, and actual results may differ materially. These risks and uncertainties include, but are not limited to, general economic, political and business conditions; risks related to legal proceedings that may be instituted against the parties regarding the Dream Bowl 2026 Meme Coin and the distribution thereof to holders of Scilex common stock; the risks associated with the right of the Board of Directors of Datavault AI to change the record date (and, as a result, the payment date) of the distribution of, and/or to revoke, the Dream Bowl 2026 Meme Coin; the ability of Scilex and its subsidiaries to develop and successfully market products; the ability of Scilex and its subsidiaries to grow and manage growth profitably and retain its key employees; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the prior results of the clinical trials may not be replicated; regulatory and intellectual property risks; the risk of failure to realize the anticipated benefits of the transactions contemplated with Datavault and other risks and uncertainties indicated from time to time and other risks set forth in Scilex’s filings with the SEC. There may be additional risks that Scilex presently does not know or that Scilex currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements provide Scilex’s expectations, plans or forecasts of future events and views as of the date of the communication. Scilex anticipates that subsequent events and developments will cause such assessments to change. However, while Scilex may elect to update these forward-looking statements at some point in the future, Scilex specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Scilex’s assessments as of any date subsequent to the date of this communication. Accordingly, investors are cautioned not to place undue reliance on these forward-looking statements.

Contacts:

Investors and Media
Scilex Holding Company
960 San Antonio Road
Palo Alto, CA 94303
Office: (650) 516-4310

Email: investorrelations@scilexholding.com

Website: www.scilexholding.com

SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a majority-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned.

ZTlido^® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company.

Gloperba^® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company.

ELYXYB^® is a registered trademark owned by Scilex Holding Company.

Scilex Bio™ is a trademark owned by Scilex Holding Company, Inc.

All other trademarks are the property of their respective owners.

© 2025 Scilex Holding Company All Rights Reserved.