Market Newsdesk

ANDOVER, Mass., Jan. 21, 2025 (GLOBE NEWSWIRE) — Mercury Systems, Inc. (NASDAQ: MRCY, www.mrcy.com), a technology company that delivers mission-critical processing power to the edge, today announced it was awarded a $24.5 million contract to develop a data processing and storage subsystem for a U.S. Defense Department satellite program.

Under a contract with an innovative space systems prime contractor, Mercury will deliver a number of these subsystems that leverage its commercial products and deep expertise in data recording, data processing, and subsystem integration for defense applications. The solution features Mercury’s SCFE6933 processing board that employs AMD Versal™ AI Core series FPGAs and the company’s new RH304T solid-state data recorder, a radiation-tolerant 3U device with 4.5 terabytes of capacity.

“We are proud to support this critical U.S. national security mission,” said Joe Plunkett, Vice President of Mercury’s Advanced Concepts Group, which was formed to drive innovative, next-generation technology solutions for customers. “The Mercury Processing Platform has an incredible breadth of capabilities that can be integrated in virtually limitless ways to enable mission-critical processing at the edge.”

“Mercury was chosen to develop this subsystem because of our unique model and approach to innovation, where commercial products can be leveraged to create new and valuable solutions,” said Roger Wells, Mercury’s Chief Operating Officer. “This success is owed in no small part to the more integrated organizational structure we put in place last year, which has unlocked Mercury’s potential and will fuel our growth in the years ahead.”

Mercury Systems – Innovation that matters^®

Mercury Systems is a technology company that delivers mission-critical processing power to the edge, making advanced technologies profoundly more accessible for today’s most challenging aerospace and defense missions. The Mercury Processing Platform allows customers to tap into innovative capabilities from silicon to system scale, turning data into decisions on timelines that matter. Mercury’s products and solutions are deployed in more than 300 programs and across 35 countries, enabling a broad range of applications in mission computing, sensor processing, command and control, and communications. Mercury is headquartered in Andover, Massachusetts, and has 23 locations worldwide. To learn more, visit mrcy.com. (Nasdaq: MRCY) 

Forward-Looking Safe Harbor Statement

This press release contains certain forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995, including those relating to the Company’s focus on enhanced execution of the Company’s strategic plan. You can identify these statements by the words “may,” “will,” “could,” “should,” “would,” “plans,” “expects,” “anticipates,” “continue,” “estimate,” “project,” “intend,” “likely,” “forecast,” “probable,” “potential,” and similar expressions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected or anticipated. Such risks and uncertainties include, but are not limited to, continued funding of defense programs, the timing and amounts of such funding, general economic and business conditions, including unforeseen weakness in the Company’s markets, effects of any U.S. federal government shutdown or extended continuing resolution, effects of geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in or cost increases related to completing development, engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technological advances and delivering technological innovations, changes in, or in the U.S. government’s interpretation of, federal export control or procurement rules and regulations, changes in, or in the interpretation or enforcement of, environmental rules and regulations, market acceptance of the Company’s products, shortages in or delays in receiving components, supply chain delays or volatility for critical components, production delays or unanticipated expenses including due to quality issues or manufacturing execution issues, capacity underutilization, increases in scrap or inventory write-offs, failure to achieve or maintain manufacturing quality certifications, such as AS9100, the impact of supply chain disruption, inflation and labor shortages, among other things, on program execution and the resulting effect on customer satisfaction, inability to fully realize the expected benefits from acquisitions, restructurings, and operational efficiency initiatives or delays in realizing such benefits, challenges in integrating acquired businesses and achieving anticipated synergies, effects of shareholder activism, increases in interest rates, changes to industrial security and cyber-security regulations and requirements and impacts from any cyber or insider threat events, changes in tax rates or tax regulations, changes to interest rate swaps or other cash flow hedging arrangements, changes to generally accepted accounting principles, difficulties in retaining key employees and customers, litigation, including the dispute arising with the former CEO over his resignation, unanticipated costs under fixed-price service and system integration engagements, and various other factors beyond our control. These risks and uncertainties also include such additional risk factors as are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended June 28, 2024 and subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company cautions readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. The Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made.

INVESTOR CONTACT

Tyler Hojo
Vice President, Investor Relations
[email protected]

MEDIA CONTACT

Turner Brinton
Senior Director, Corporate Communications
[email protected]

– Presented data includes a 97% Calculated Objective Response Rate (ORR) of study subjects following treatment with VP-315

– Posters highlight the safety data, tolerability data, and antitumor efficacy data of VP-315 for the treatment of basal cell carcinoma as determined by histological clearance

WEST CHESTER, Pa., Jan. 21, 2025 (GLOBE NEWSWIRE) — Verrica Pharmaceuticals Inc. (“Verrica” or the “Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced the presentation of three posters that were presented at the 2025 Winter Clinical Dermatology Conference, which was held from January 17-19, in Miami, Florida. The posters featured clinical data from Part 2 of the Phase 2 study (the “Study”) of the Company’s novel oncolytic peptide, VP-315, for the treatment of basal cell carcinoma (“BCC”).

Verrica presented a poster titled “Calculated Objective Response Rate (ORR) of 97% from Post-Hoc Analysis of a Phase 2 Multicenter Study to Evaluate the Efficacy of VP-315, an Investigational therapy for Basal Cell Carcinoma (BCC)” while encore presentations of two additional posters (titled “Results of a Phase 2 Multicenter Study Evaluating the Safety and Tolerability of VP-315, an Investigational therapy for Basal Cell Carcinoma” and “Results of a Phase 2 Multicenter Study to Evaluate the Efficacy of VP-315, an Investigational Therapy for Basal Cell Carcinoma”) were also made at the conference. The posters included safety and histologic clearance data from 82 patients with up to two target BCC tumors (a total of 91 tumors) in Part 2 of the Study evaluating VP-315 for the treatment of BCC, including patients with tumors on the head and neck.

Part 2 of the Study was designed to explore dosing regimens to help Verrica identify the recommended regimen for a Phase 3 study program. Approximately 51% of tumors treated in the Study achieved complete histological clearance, while those patients with a residual tumor achieved, on average, approximately 71% reduction in tumor size. There were no Treatment Related Serious Adverse Events, and most Treatment Related Adverse Events were mild to moderate.

In the newly-presented poster, Verrica conducted a post-hoc analysis of the data from the Study and announced a Calculated ORR of 97%, defined as the percentage of study subjects who do not demonstrate disease progression and who experience at least a 30% level of tumor reduction along with partial or complete response following treatment The Company still expects genomic and T-cell (immune response) data in the first quarter of 2025 and plans to request an End-of-Phase 2 meeting with the FDA in the first half of 2025 to determine the next steps for the development of VP-315 for the treatment of BCC.

“We remain highly encouraged by the positive preliminary topline results from Part 2 of the Phase 2 study for VP-315, which we believe support a potential change in the treatment paradigm for patients with basal cell carcinoma,” said Dr. Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. “We believe these results will support the use of VP-315 as a potential first line therapy for use in both primary and neoadjuvant settings, and that VP-315 could provide the millions of basal cell carcinoma patients diagnosed in the United States each year with a non-surgical alternative to painful, invasive surgical treatments. We believe that VP-315 could represent a multi-billion-dollar commercial opportunity for Verrica. We look forward to our discussions with the FDA about designing a development path forward for VP-315 in 2025.”

About the Phase 2 Study of VP-315

The Study is a 2-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, pharmacokinetics, and efficacy of VP-315 when administered intratumorally to adults with biopsy-proven BCC. The study enrolled 92 adult subjects with a histological diagnosis of BCC in at least one eligible target tumor. For additional information about this clinical trial, please visit clinicaltrials.gov, identifier NCT05188729.

About VP- 315

VP-315 is a potential first-in-class oncolytic chemotherapeutic peptide immunotherapy administered directly into a tumor to induce immunogenic cell death and thereby unleashing a broad spectrum of tumor antigens for T cell responses, which may offer a non-surgical option for patients suffering from skin cancer. The technology is based on pioneering research in “host defense peptides” – nature’s first line of defense towards foreign pathogens. Verrica holds an exclusive worldwide license to develop and commercialize VP-315 for certain dermatologic oncology indications, including non-metastatic melanoma and non-metastatic merkel cell carcinoma, and intends to focus initially on basal cell and squamous cell carcinomas as the lead indications for development. VP-315 has demonstrated positive tumor-specific immune cell responses in multi-indication Phase 1/2 oncology trials.

About Basal Cell Carcinoma

Basal cell carcinoma is the most common form of cancer in the United States, and its incidence is rising worldwide. There are approximately 3-4 million diagnoses of basal cell carcinoma in the U.S. each year, with a high unmet need for new treatment options. Basal cell carcinoma is generally treated with invasive surgery to remove the tumor, which can cause pain, infection, bleeding and scarring.

About Verrica Pharmaceuticals Inc. 

Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s product YCANTH^® (VP-102) (cantharidin), is the first and only commercially available treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. YCANTH^® (VP-102) is also in development to treat common warts and external genital warts, two of the largest remaining unmet needs in medical dermatology. Verrica is developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 (formerly LTX-315 and VP-LTX-315) for non-melanoma skin cancers, including basal cell carcinoma and squamous cell carcinoma. For more information, visit www.verrica.com.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include statements concerning the potential of VP-315, the Company’s research, development and regulatory plans for VP-315, the timing of the Company’s planned clinical trials for VP-315 and reporting data from the Company’s clinical trials, and the potential market size opportunity for the treatment of basal cell carcinoma. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, Verrica’s reliance on third parties over which it may not always have full control and uncertainties that are described in Vernica’s Annual Report on Form 10-K for the year ended December 31, 2023, Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 and other filings Verrica makes with the U.S. Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

FOR MORE INFORMATION, PLEASE CONTACT:

[email protected]

Investors:

Kevin Gardner
LifeSci Advisors
[email protected]

Chris Calabrese
LifeSci Advisors
[email protected]

• ELYXYB^®, a rapid onset and ready-to-use formulation of Celecoxib, delivers a first line non-opioid therapeutic alternative to habit-forming opioids and acetaminophen, the leading cause of acute liver failure in the U.S.⁽¹⁾
• DelveInsight estimates there were approximately 100 million cases of acute pain in the United States and that the total acute pain market in the U.S. was approximately $3 billion in 2021.⁽²⁾
• Approximately 40 million Americans with acute pain are prescribed an opioid to manage their discomfort each year.⁽³⁾
• ELYXYB^® is the first and only ready to use oral solution designed to deliver fast and long-lasting migraine relief with the proven safety of COX-2 selectivity that is FDA-approved for the acute treatment of migraine, with or without aura, in adults.⁽⁴⁾
• Acute pain has been defined as “the physiologic response and experience to noxious stimuli that can become pathologic, is normally sudden in onset, time limited, and motivates behaviors to avoid actual or potential tissue injuries.”⁽¹⁾ Acute pain usually lasts for less than seven days but often extends up to 30 days; for some conditions, acute pain episodes may recur periodically. In some patients, acute pain persists to become chronic.⁽⁵⁾

PALO ALTO, Calif., Jan. 21, 2025 (GLOBE NEWSWIRE) — Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), 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, following the formation of its proposed joint venture with IPMC Company, in neurodegenerative and cardiometabolic disease, today announced that it will be filing today of a Supplemental New Drug Application (SNDA) with the FDA for ELYXYB^® in acute pain indication.

The analgesic efficacy and safety of ELYXYB^®, a new oral liquid formulation of celecoxib with more rapid absorption than the capsule, were evaluated in the treatment of acute pain in adult patients after dental surgery. In this randomized, double-blind, placebo-controlled, dose-ranging study, 120 otherwise healthy adults who underwent the extraction of bilateral impacted mandibular third molar teeth and experienced moderate to severe pain post-surgery were randomly assigned to receive one dose of either placebo or ELYXYB^®: 62.5, 125, or 250 mg. All 3 doses of ELYXYB^® were significantly superior to placebo in SPID6 (summed pain intensity difference over 6 hours). In addition, ELYXYB^® was generally superior to placebo in other endpoints, including reduction of pain intensity, speed and magnitude of pain relief, treatment satisfaction, and rescue medication use (oxycodone / acetaminophen). ELYXYB^® was similar to placebo in the incidence of adverse events with no apparent dose-related effects.⁽⁶⁾

“It is very exciting to see the advancement of new effective therapeutic options for acute pain. Opioid-sparing medications are a priority in both non-operative and post-operative pain control. Reducing reliance on opioids with a new rapidly absorbed liquid formulation of celecoxib is very much welcomed. The rapid onset of action and convenience of dosing will significantly improve our armamentarium to provide the best patient care,” said Aakash A. Shah, M.D., physician for NBA team Miami Heat and President of the Medical Staff at Mid-America Surgery Institute.

ELYXYB^® is formulated using the self-microemulsifying drug delivery system (SMEDDS), which is a clear, thermodynamically stable, oil-in-water emulsion of lipid, solubilized drug, and two surfactants, which spontaneously forms droplets < 100 nm in diameter. These components help deliver pre-solubilized drugs to the gastrointestinal tract, while protecting them from degradation in gastric acid or first-pass hepatic metabolism. The American Headache Society recently updated their consensus statement for the acute treatment of migraine and included a selective cyclo-oxygenase-2 selective inhibitor formulated in SMEDDS, celecoxib oral solution. ⁽⁴⁾ This SMEDDS formulation showed pronounced improvement in bioavailability compared with celecoxib capsules, allowing for a low dose of celecoxib in the oral solution to provide safe and effective acute migraine treatment.⁽⁷⁾ 

“We are well positioned to broaden the ELYXYB^® label with an additional acute pain indication and further solidify the potential role of ELYXYB^® as a cornerstone in opioid-sparing acute pain management regimens that support accelerated recovery and eventually freedom from pain”, said Dmitri Lissin, M.D., Chief Medical Officer of Scilex.

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 Scilex Holding Company Sustainability Report, refer to www.scilexholding.com/investors/sustainability.

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/

[email protected]  

About Scilex Holding Company

Scilex Holding Company 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, following the formation of its proposed joint venture with IPMC Company, in 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”), 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 Holding Company is headquartered in Palo Alto, California.

About Semnur Pharmaceuticals, Inc.

Semnur Pharmaceuticals, Inc. (“Semnur”) is a clinical late-stage specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. Semnur’s product candidate, SP-102 (SEMDEXA™), is the first non-opioid novel gel formulation administered epidurally in development for patients with moderate to severe chronic radicular pain/sciatica.

Semnur Pharmaceuticals, Inc. is headquartered in Palo Alto, California

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Elyxyb’s potential as an acute pain therapy, whether the FDA approves the sNDA for ELYXYB, ELYXYB’s potential to further expand Scilex’s non-opioid portfolio and its potential to address high unmet needs in treating acute pain, the potential market size and the size of the patient population for acute pain in the U.S., Gloperba being the first and only liquid oral version of the anti-gout medicine, Scilex’s plans to commercialize Gloperba and the potential for the amended license agreement to accelerate Scilex’s commercialization plans, Scilex’s proposed joint venture with IPMC Company and the potential development and commercialization of treatments for obesity, neurodegenerative, cardiometabolic disease.

Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: Scilex’s ability to commercialize GLOPERBA outside of the US, Scilex’s ability to consummate a joint venture or any other transaction with IPMC Company and develop and commercialize treatments for obesity, neurodegenerative, cardiometabolic disease; risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); 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 will be unable to successfully market or gain market acceptance of its 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 outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file with the SEC, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law.

Contacts:

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

Email: [email protected]

Website: www.scilexholding.com

References

      1.   Bunchorntavakul C, Reddy K. Acetaminophen (APAP or N-Acetyl-p-Aminophenol) and Acute Liver Failure. Clin Liver Dis. 2018 May;22(2):325-346. PMID: 29605069

      2.   DelveInsight Acute Pain – Market Insight, Epidemiology And Market Forecast – 2032; Dec 2022; https://www.delveinsight.com/report-store/acute-pain-market#:~:text=The%20DelveInsight’s%20acute%20pain%20market,be%20either%20acute%20or%20chronic

      3.   Lopez A, Jones J, Menzie AM, Peta S, Ippolito A, Rubin J. An evaluation of the prevalence of acute and chronic pain medication use in the United States: a real-world database analysis. Presented at: ASRA Annual Pain Medicine Meeting; November 10-11, 2023; New Orleans, LA.

      4.   Celecoxib Oral Solution Approved for Acute Migraine March 2020.

      5.   Tighe P, Buckenmaier CC, 3rd, Boezaart AP, et al. Acute pain medicine in the United States: a status report. Pain Med. 2015 Sep;16(9):1806-26. doi: 10.1111/pme.12760. PMID: 26535424

Treatments for Acute Pain: A Systematic Review | Effective Health Care (EHC) Program (ahrq.gov)

      6.   Neil Singla, et al. Efficacy and safety of single-dose DFN-15 for treatment of acute postsurgical dental pain: a randomized, double-blind, placebo-controlled study. Pain. 2022 Jan 1;163(1):91-99. PMID: 34252915

      7.   Silberstein S., Spierings E., Kunkelcorresponding T. Celecoxib Oral Solution and the Benefits of Self-Microemulsifying Drug Delivery Systems (SMEDDS) Technology: A Narrative Review. Pain Ther. 2023 Oct; 12(5): 1109–1119. PMID: 37329440

SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-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.

All other trademarks are the property of their respective owners.

© 2025 Scilex Holding Company All Rights Reserved.

SAN JOSE, Jan. 21, 2025 (GLOBE NEWSWIRE) — Adeia Inc. (Nasdaq: ADEA), today announced it has renewed its intellectual property (IP) license agreement with Roku, the #1 TV streaming platform in the U.S. The multi-year renewal extends Roku’s access to Adeia’s media IP portfolio for its products and services.

“We are excited to renew our agreement with Roku, a leader in the streaming digital entertainment space,” said Dr. Mark Kokes, Adeia’s chief licensing officer and general manager, media. “This agreement demonstrates the ongoing relevance and importance of our technology in the streaming video field.”

Adeia’s advanced media technologies and intellectual property play a role in enhancing consumer experiences in the evolving digital entertainment landscape. Through its technology and intellectual property, Adeia continues to drive innovation and deliver cutting-edge solutions for the industry.

About Adeia

Adeia is a leading R&D and intellectual property (IP) licensing company that accelerates the adoption of innovative technologies in the media and semiconductor industries. Adeia’s fundamental innovations underpin technology solutions that are shaping and elevating the future of digital entertainment and electronics. Adeia’s IP portfolios power the connected devices that touch the lives of millions of people around the world every day as they live, work and play. For more, please visit www.adeia.com.

For Information Contact:

Investor Relations:
Chris Chaney
[email protected]

Media Relations:
JoAnn Yamani
[email protected]

MIAMI, Jan. 21, 2025 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Prime carotid stent system for the prevention of stroke, today announced that the Compensation Committee of InspireMD’s Board of Directors approved inducement grants to nine new non-executive employees in the aggregate amount of 372,135 shares of restricted stock outside of InspireMD’s 2021 Equity Compensation Plan, with a grant date as of January 7, 2025, as an inducement material to the employee entering into employment with InspireMD, in accordance with Nasdaq Listing Rule 5635(c)(4).

The inducement plan is used exclusively for the grant of equity awards to individuals who were not previously employees of InspireMD, or following a bona fide period of non-employment, as an inducement material to such individuals entering into employment with InspireMD, pursuant to Nasdaq Listing Rule 5635(c)(4).

The restricted stock vests over a three-year period, with one-third vesting on the first anniversary of the grant and the remainder vesting in two equal installments on the second and third anniversaries of the grant date, subject to continued employment with InspireMD as of such vesting dates.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet^® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR.

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding future events, future financial performance, strategies, expectations, competitive environment and regulation, including potential U.S. commercial launch. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” “scheduled” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with our history of recurring losses and negative cash flows from operating activities; substantial doubt about our ability to continue as a going concern; significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore
Chief Financial Officer
InspireMD, Inc.
888-776-6804
[email protected]

Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
[email protected]
[email protected]

–128 enrolled participants, as of December 31, 2024, exceeds initial target of 90 participants–

–150 maximum participant enrollment projected by end of January–

–The stroke registrational program is intended to demonstrate the safety and effectiveness of the novel Portable Neuromodulation Stimulator (PoNS^®) for improving balance and gait deficits in stroke survivors–

–On track for FDA submission for stroke authorization in the second quarter of 2025–

NEWTOWN, Pa., Jan. 21, 2025 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced it has completed and far exceeded the initial target enrollment for its stroke registrational program. With 128 participants randomized to-date the program is on track to reach the maximum enrollment target of 150 participants by the end of January 2025.

“Gait and balance deficits are the most frequently occurring disability in stroke patients and represent the largest market opportunity for PoNS Therapy^®,” said Dane Andreeff, Helius Medical President and Chief Executive Officer. “We are excited for the opportunity to make PoNS available to the over 7 million patients in the U.S. living with disability from stroke as we remain on target to achieve FDA authorization for stroke in 2025.”

In 2021, the U.S. Food and Drug Administration granted Breakthrough Designation for PoNS in stroke. Helius has designed and implemented the stroke registrational program to establish the effects of cranial-nerve non-invasive neuromodulation (“CN-NINM”), delivered using PoNS Therapy, on gait and balance in chronic stroke survivors to support an FDA submission to expand the PoNS device indication to this patient population. The registrational studies also aim at establishing PoNS efficacy on decreasing risk of falling and maintaining the therapeutic effect post-treatment.

“Completing enrollment of our registrational program’s studies is a significant step toward providing stroke patients with a new therapeutic tool to improve their mobility. We have shown PoNS is effective in treating gait deficits for MS patients and we are excited to reinforce similar therapeutic benefits to address a dire medical need in this patient population,” said Antonella Favit-Van Pelt, M.D., Ph.D., Helius Chief Medical Officer. “Our ability to enroll this study in a timely manner highlights providers’ interest in PoNS Therapy and demonstrates patients’ demand for impactful rehabilitation therapies. With maximum target enrollment expected by the end of the month, we are tracking to our goal to submit for stroke authorization in the second quarter of 2025.”

In March 2023, the FDA endorsed the stroke registrational program which originally included two initial studies. The first was an investigator-initiated randomized placebo-controlled trial (MUSC-RCT) in approximately 60 subjects, led by Dr. Steven Kautz at the Medical University of South Carolina (MUSC) and Dr. Mark Bowden at Brooks Rehabilitation. The second study was a company-sponsored open-label study (HMI-OLS), in approximately 30 subjects. In May 2024, Helius added a third company-sponsored randomized placebo-controlled trial (HMI-RCT) across five sites in Canada and the U.S. All three studies shared the same design and endpoints, including primary outcomes on gait and balance improvement, as well as key secondary endpoints with Type 1 error of reduced risk of falling and maintenance of effect at 12 weeks post-treatment.

Enrollment of the stroke registrational studies started at MUSC for the MUSC-RCT in August 2023 and, at Brooks Rehabilitation, in August 2024. In June 2024, Helius started enrollment of the HMI-OLS at five U.S. Centers of Excellence for Neurorehabilitation including Shepherd Center, MGH-IHP, REHABOLOGYM, Brooks Rehabilitation and New England Neurological Center. Enrollment continued, with the HMI-RCT, in July 2024 at Neuro-Concept Rehabilitation Center, Neuphysio, Synaptic Health, Bergin Motion in Canada and REHABOLOGYM in the U.S.

“By December 31, 2024, we have reached our goal and exceeded our previously communicated target enrollment of 90 subjects, by randomizing 128 participants across the three registrational programs’ studies and we expect to reach our full enrollment of 150 participants in the next couple of weeks. Achieving and exceeding enrollment rate of approximately 5 participants per site per month in such a short timeframe, significantly outperforming the enrollment benchmark for stroke-related medical device studies, is a monumental achievement for Helius,” Dr. Favit-Van Pelt continued. “We are grateful to all our investigators for their extraordinary contribution and dedication to make PoNS Therapy available to stroke patients.”

About the PoNS Device and PoNS Therapy

The Portable Neuromodulation Stimulator (“PoNS”) is an innovative, non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece connected to a controller while it’s used, primarily at home, with physical rehabilitation exercise, to improve balance and gait. The PoNS device, which delivers mild electrical impulses to the tongue, is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.

PoNS has shown effectiveness in treating gait or balance and a significant reduction in the risk of falling in stroke patients in Canada, where it received authorization for sale in three indications: (i) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from stroke and is to be used in conjunction with physical therapy; (ii) for use as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (iii) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait. For more information visit www.ponstherapy.com.  

About Helius Medical Technologies, Inc. 
Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using orally applied technology platform that amplifies the brain’s ability to engage physiologic compensatory mechanisms and promote neuroplasticity, improving the lives of people dealing with neurologic diseases. The Company’s first commercial product is the Portable Neuromodulation Stimulator. For more information about the PoNS or Helius Medical Technologies, visit www.heliusmedical.com.

Cautionary Disclaimer Statement

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “expect,” “continue,” “will,” “goal,” “aim” and similar expressions. Such forward-looking statements include, among others, statements regarding the timing and results of the stroke registrational program, the ability to make PoNS available to over 7 million patients, the ability to reach maximum target enrollment expected by the end of the month, and the timing or success of submitting and receiving stroke authorization. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties associated with the Company’s capital requirements to achieve its business objectives, availability of funds, the Company’s ability to find additional sources of funding, manufacturing, labor shortage and supply chain risks, including risks related to manufacturing delays, the Company’s ability to obtain national Medicare insurance coverage and to obtain a reimbursement code, the Company’s ability to continue to build internal commercial infrastructure, secure state distribution licenses, market awareness of the PoNS device, future clinical trials and the clinical development process, the product development process and the FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com. The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

Investor Relations Contact 
Philip Trip Taylor
Gilmartin Group
[email protected]