Market Newsdesk

PRINCETON, N.J., Dec. 23, 2024 (GLOBE NEWSWIRE) — CytoSorbents Corporation (NASDAQ: CTSO) announces the commencement of its Rights Offering, previously detailed in our December 9, 2024 announcement press release.

Stockholders and certain Warrantholders of record on December 16, 2024 are now being distributed a dividend of one non-transferable Subscription Right Warrant (“Subscription Right”) for each share of common stock owned on the record date.

• Each Subscription Right, when exercised before the expiration date of 5:00PM EST on January 10, 2025, enables one Unit purchase at a subscription price of $1.00 per Unit. Each Unit consists of one share of common stock and two transferable short-term Right Warrants to purchase up to two additional shares of common stock, if available, at discounted prices.
• D.F. King & Co., Inc., the information agent for the offering, has mailed Subscription Right certificates and a copy of the prospectus and prospectus supplement for the offering to certain Subscription Right holders. Stockholders who hold their shares in “street name” through a brokerage account, bank or other nominee will not receive physical Subscription Right certificates, but will generally be notified in the “Messages” or “Corporate Action” section of their online brokerage or bank account where their CTSO shares are held, and must instruct their broker, bank or nominee whether to exercise the Subscription Rights on their behalf.
• Investors can exercise all, some, or none of their Subscription Rights by completing the associated online or hard copy documentation or speaking to their broker or banking representative, and arranging payment.
• Investors who exercise all of their basic subscription rights will also have the opportunity to participate in an oversubscription of unsubscribed Subscription Rights, if available. If desired, they must elect this option at the time of their subscription rights exercise.
• Upon completion of the subscription period on January 10, 2025, participating stockholders who purchased Units will then receive the associated shares of common stock and Right Warrants to their brokerage account, subject to pro-rata adjustment if the Rights Offering is oversubscribed.
• Brokers may require earlier action to process orders. Exercise instructions received after the expiration date and time will not be honored, so investors who wish to participate may need to exercise ahead of the deadline.
• Any payment received from either the exercise of the basic right or oversubscription privilege and not applied will be refunded to the stockholder without interest or penalty.  

For any questions or further information about this Rights Offering, please call D.F. King & Co., Inc., the information agent for the offering, at (800) 549-6864 (toll-free) or (212) 269-5550 (broker-dealers and nominees), or email to: [email protected].

A short presentation on this Rights Offering has been filed with the SEC as a free writing prospectus and can be found in the presentation section on our investor relations website at https://ir.cytosorbents.com/events-presentations. Additional information about the Company can be found at www.cytosorbents.com and https://ir.cytosorbents.com/.

Moody Capital Solutions, Inc. is the dealer manager for the offering. Any interested broker dealers may contact Moody at [email protected].

The Rights Offering is being made pursuant to CytoSorbents’ effective shelf registration statement on Form S-3
(File No. 333-281062), and a related prospectus supplement containing the detailed terms of the rights offering filed with the SEC. The information in this press release is not complete and is subject to change. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful under the securities laws of such state or jurisdiction. The Rights Offering is being made only by means of a prospectus and a related prospectus supplement. The prospectus incorporates all the Company’s SEC filings by reference. Copies of the prospectus and related prospectus supplement, are being distributed to all Subscription Right recipients and may also be obtained free of charge at the website maintained by the SEC at 


www.sec.gov


 or by contacting the information agent for the offering.

About CytoSorbents Corporation (

NASDAQ: CTSO

)

CytoSorbents Corporation
 is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents’ proprietary blood purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, ECMO, heart-lung machines). CytoSorbents’ technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding and 2) the removal of inflammatory agents in common critical illnesses such as sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments.

CytoSorbents’ lead product, CytoSorb®, is approved in the European Union and distributed in 76 countries worldwide, with more than a quarter million devices used cumulatively to date. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure, to reduce pro-inflammatory cytokine levels. CytoSorb is not yet approved in the United States.

In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received two FDA Breakthrough Device Designations: one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. In September 2024, the Company submitted a De Novo medical device application to the U.S. FDA requesting marketing approval to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024. In November 2024, the Company received its Medical Device Single Audit Program (MDSAP) certification and submitted its Medical Device License (MDL) application to Health Canada. DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively.

The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit the Company’s website at https://ir.cytosorbents.com/ or follow us on Facebook and X. 

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, representations and contentions, and the outcome of our regulatory submissions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 14, 2024, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

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U.S. Company Contact:

Peter J. Mariani, Chief Financial Officer
305 College Road East
Princeton, NJ 08540
[email protected]

Investor Relations Contact:

Aman Patel, CFA
Investor Relations, ICR-Westwicke
(443) 450-4191
[email protected]

– RAPT obtains worldwide rights excluding China –

– Jemincare receives $35 million upfront payment, up to $672.5 million in milestone payments and high single-digit to low-double digit royalties on future sales –

– Jemincare is currently conducting Phase 2 trials in asthma and chronic spontaneous urticaria in China –

– RAPT plans to initiate Phase 2b trial in food allergy next year –

– RAPT to host a conference call at 8:30 a.m. ET –

SOUTH SAN FRANCISCO, Calif., Dec. 23, 2024 (GLOBE NEWSWIRE) — RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients with significant unmet needs in inflammatory diseases, and Shanghai Jemincare Pharmaceutical Co., Ltd (“Jemincare”), a subsidiary of Jiangxi Jemincare Group, a leading pharmaceutical company in China, today announced they have entered into an exclusive license agreement for JYB1904 (RAPT designation RPT904), a clinical-stage, half-life extended anti-immunoglobulin E (IgE) monoclonal antibody. Under the terms of the license agreement, RAPT is granted worldwide rights excluding mainland China, Hong Kong, Macau and Taiwan (together, the “Jemincare Territory”) to develop and commercialize RPT904. As consideration for the license, Jemincare receives a $35 million upfront license fee, up to $672.5 million in additional payments upon the achievement of various regulatory and commercial milestones, and royalties on future sales of RPT904 outside the Jemincare Territory. RPT904 is being developed to offer patients a potentially improved therapeutic option compared to omalizumab (marketed as Xolair^®), an anti-IgE monoclonal antibody approved for several allergic disorders, including asthma, chronic spontaneous urticaria (CSU), chronic rhinosinusitis with nasal polyps and, most recently, food allergy. RAPT plans to pursue development of RPT904 initially in food allergy. Separately, Jemincare is conducting Phase 2 clinical trials of JYB1904 in China in asthma and CSU.

“We’re delighted to partner with Jemincare and excited by RPT904 and its potential to be a novel best-in-class treatment option for patients with food allergy. Omalizumab’s rapid uptake in food allergy since its approval earlier this year confirms the high unmet need and large opportunity in this growing market,” commented Brian Wong, M.D., Ph.D., President and CEO of RAPT. “RPT904 targets the same clinically validated epitope as omalizumab and combined with extended half-life, gives this molecule a best-in-class profile. We plan to initiate a Phase 2b clinical trial of RPT904 in food allergy in the second half of 2025.”

“We are delighted to be working with RAPT Therapeutics to advance development of JYB1904 in food allergy and other allergic disorders. We trust this partnership could significantly enhance and accelerate the development and potential commercialization of JYB1904 to benefit patients,” commented Xiaoxiang Li, President of Jemincare.

Jemincare has completed a randomized, double-blinded, Phase 1 single-dose dose-escalation study in 56 healthy volunteers in China focused on safety, pharmacokinetics (“PK”) and pharmacodynamics (“PD”). Five dose levels of JYB1904 and one dose level of omalizumab were compared to placebo. Overall safety and tolerability of JYB1904 was good, and all treatment-related adverse events were Grade 1-2. The pharmacokinetics of JYB1904 were approximately dose-proportional, and the median half-life of JYB1904 was more than two times that of omalizumab at the same dose. The Phase 1 study also showed deeper and more sustained reduction of free IgE and higher total IgE accumulation by JYB1904 compared to omalizumab at the same dose.

Jemincare is currently conducting two Phase 2 trials of JYB1904 in China. The Phase 2 trial in asthma is primarily focused on PK and PD profiles compared to omalizumab to help inform dosing for a potential Phase 3 registrational trial. Jemincare expects to have topline data from the Phase 2 asthma trial in the second half of 2025. The Phase 2 trial in CSU is focused on evaluating safety and efficacy, and Jemincare expects to have topline data from this trial in the first half of 2026.

Webcast Conference Call Information

RAPT will host a webcast conference call today, December 23, 2024 at 8:30 a.m. ET. To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. The live webcast and audio archive of the presentation may be accessed on the RAPT Therapeutics website at https://investors.rapt.com/events-and-presentations.

About JYB1904/RPT904

JYB1904/RPT904 is a novel, half-life extended anti-IgE monoclonal antibody (mAb) for the treatment of patients with food allergies, chronic spontaneous urticaria and other allergic inflammatory diseases. RPT904 is designed to bind free human immunoglobulin E (IgE), a key driver of allergic diseases, and in early clinical studies has demonstrated more than twice the half-life, as well as extended pharmacokinetics and pharmacodynamic properties, compared to omalizumab (Xolair^®), a first generation anti-IgE mAb.

About RAPT Therapeutics, Inc.

RAPT Therapeutics is a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing therapies for patients with significant unmet needs in inflammatory diseases. The company leverages its proprietary discovery and development platform to advance both biologics and selective small molecules aimed at normalizing critical immune drivers underlying these conditions.

About Jemincare

Jiangxi Jemincare Group Co., Ltd. is a leading pharmaceutical company from China. Founded in 1999, Jemincare is mainly engaged in the pharmaceutical industry. The company is dedicated to the development, manufacturing and commercialization of therapeutics in its strategic fields including oncology, nephrology, cerebro-cardiovascular, anti-infection, analgesic, respiratory and Pediatrics. Shanghai Jemincare Pharmaceutical Co., Ltd is the R&D center of Jiangxi Jemincare Group Co., Ltd. Shanghai Jemincare has developed a strong scientific team with end-to-end drug discovery and development capability. More than 10 programs have entered clinical stage from Jemincare’s in-house pipeline. For more information, please visit www.jemincare.com        

RAPT Forward-Looking Statements

This press release contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about the licensing agreement and potential future milestone payments and royalties; the company’s business and clinical development plans, including plans to develop RPT904 and associated clinical trial and development timelines; the potential therapeutic potential of RPT904; the potential commercial opportunity for RPT904; the ability to obtain necessary regulatory approvals and other statements that are not historical fact. Factors that may cause actual results to differ materially from the plans, intentions and expectations disclosed in these forward-looking statements include uncertainties inherent in the initiation, progress and completion of clinical trials and clinical development of RAPT’s product candidates; the risk that clinical trials may have unsatisfactory outcomes; risks associated with preclinical development of product candidates; risks that efforts to secure licensing and other business development opportunities may not be successful; and other important factors, detailed in RAPT’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and subsequent filings made by RAPT with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements.

Investor Contact:

Sylvia Wheeler
[email protected]

Media Contact:

Aljanae Reynolds
[email protected]

• Mixed Martial Arts Group Limited (“MMA”) is redefining the landscape of the combat sports industry by delivering a unifying technology platform providing the best digital fan experience, social platform, training experiences, business tools, and partnership opportunities.
• 2024 was a transformative year that focused on rapid execution of growth in market share and an expanding commercial footprint, positioning MMA for strong forecast revenue growth in 2025.
• Across the platform, MMA has grown to over 5 million social media followers, 530,000 user profiles, 50,000 active students, 18,000 published gyms, and 802 active locations across 16 countries, creating significant opportunities for growing engagement and monetization.
• In 2025, MMA will integrate its products and ecosystem into a unified digital experience, focused on growing both B2B and B2C revenue from its footprint, including a benchmark partnership with UFC Gym. Furthermore, MMA plans to launch exciting new products, including its community app and enhanced business tools for gyms and coaches.

New York, NY, Dec. 23, 2024 (GLOBE NEWSWIRE) —
Mixed Martial Arts Group Limited (NYSE American: MMA) (“MMA” or the “Company”), a leading technology company building the commercial and cultural epicenter for the mixed martial arts and combat sports industry, today issued a letter to shareholders from its Founder and CEO, Nick Langton:

Dear Mixed Martial Arts Group Shareholders & Stakeholders,

As 2024 Draws to a Close, A Year of Transformation for MMA

As we approach the end of 2024, I am proud to reflect on what has been the most transformative year in MMA’s history. We’ve achieved extraordinary milestones and established strong momentum for a ground-breaking 2025. I am excited to share the tremendous progress we’ve made in our mission to unify and empower the mixed martial arts and combat sports industry.

The sector in which we are building our company is truly thriving. The UFC now boasts over 700 million fans worldwide, and the number of combat sports gyms in the U.S. is expected to exceed 68,000 next year. With millions of participants and an industry valued at over $18 billion annually in the U.S. alone, the potential for growth is undeniable.

Addressing the Industry’s Fragmentation

For decades, the mixed martial arts and combat sports industry has remained fragmented, lacking the infrastructure and cohesion seen in more established sports ecosystems. MMA was founded to solve this. By creating a comprehensive platform that unites participants, fans, gyms and practitioners, we are creating the foundations for all sector stakeholders to enjoy sustainable growth and innovation within this high growth industry. Just as the assembly line revolutionized manufacturing, MMA’s mission is to unite and transform the global combat sports community for the benefit of all its participants, with ground-breaking tools and resources.

The last 10 years of the sport’s growth has been characterized by the pre-eminence of the UFC and the battle for media rights contracts and viewership as the sport has become increasingly mainstream. We believe the next 10 years will see a significant increase in fan engagement, community development and ultimately participation, where MMA is well positioned to take advantage of the tailwinds created by the professional leagues as they continue to grow global audiences. We believe our position as currently the only listed company that has pure play exposure to the growth in martial arts participation, has us particularly well placed to capitalize on these trends.

Leveraging Our Legacy and Positioning for Growth

Our journey is built on a decade of success through our Warrior Training Program, which has given thousands of people the opportunity to become combat athletes. This legacy has equipped us with strong and enduring gym partnerships, unparalleled sector expertise, and a deep understanding of how to engage the fan consumer in a training journey. These assets ensure we are well positioned to capitalize on the explosive growth of the sector via our new B2B tools and B2C products and programs.

Driving Our Mission Forward

At the core of our business remains our unwavering mission: to enrich lives by enabling everyone to experience the community and transformative power of martial arts.

As we look ahead, we are confident that MMA is uniquely poised to not only lead the evolution of the mixed martial arts and combat sports industry but also deliver significant value to our investors, partners, and stakeholders.

Summary of Our 2024 Achievements

• Successful $6.5 million IPO on the New York Stock Exchange under the ticker MMA.
• Built robust user engagement, as evidenced by the numbers: 5 million social media followers, 530,000 user profiles and 10,000 published athlete profiles.
• Successfully acquired leading gym management and fintech platform BJJLink, further expanding MMA’s reach to over 50,000 active students, 18,000 gyms, and 802 active locations across 16 countries, creating new channels for engagement and monetization
• Deepened our collaboration with UFC Gym, with the opportunity to expand the reach of our 20-week Warrior Training Program across over 150 global gym locations.
• Launched new revenue streams through acquisition of Hype.co, which brought valuable technology expertise and skills into the business to help further our product roadmap and create additional revenue streams in 2025.
• Strengthened financial position through funding round in which our executives and board members invested alongside high net worth investors.
• Continued and deepened game-changing partnerships with MMA icons and collaborations with world-renowned gyms helping expand our reach and connection to 700 million UFC fans.
• Enhanced industry leadership with addition of Mark Mastrov and Adam Sedlack, renowned leaders in the fitness industry, to our advisory board.
• Renamed Alta Global Group Limited to Mixed Martial Arts Group Limited representing another key step in our mission to unify and elevate the mixed martial arts and combat sports industry and drive consumer participation.

Looking Ahead: Key Goals for 2025

MMA is poised for a transformative year and inflection points as we build upon our momentum and focus on accelerating key growth initiatives:

1. Expanding our partnership with UFC Gym

Through our landmark partnership with UFC Gym, we aim to expand the footprint of our 20-week Warrior Training Program, empowering more participants to transform their lives through martial arts. Our target is to scale this program to 150 global UFC Gym locations over the next 24 months.

2. Scaling Technology and Infrastructure

Our focus will be on further enhancing the Mixedmartialarts.com platform to deliver seamless experiences for gyms and participants. Bringing together our acquisitions of Hype.co and now BJJLink, we are developing new tools to support gym management, digital content creation, customer acquisition and engagement with fans, solidifying MMA as the cultural and commercial epicentre of MMA. These tools are expected to roll out during the first half of 2025 including the launch of our community app on iOS and Android.

3. Deepening Customer Engagement

Building on our partnerships with UFC Gym and our leading athlete identities and global ambassadors, we plan to launch new community driven initiatives to inspire participation and accelerate user base growth. These initiatives will include exclusive seminars, live events, competitions and unique digital content campaigns.

4. Driving Industry Integration

MMA will continue to build relationships across the combat sports ecosystem, fostering collaborations that unlock new revenue streams for gyms, coaches and practitioners while driving greater participation and engagement among MMA’s 700 million fans.

Our Vision for the Future

As we enter 2025, Mixed Martial Arts Group stands at its most exciting juncture in our growth journey. With a strong foundation of industry leading strategic partnerships, innovative products and a passionate community, we are ideally positioned to build significantly on our 2024 achievements. Our mission to unify and empower the global martial arts and combat sports industry has never been more relevant and the opportunities ahead feel boundless.

I want to thank the entire MMA team for their unwavering dedication and our shareholders, partners and stakeholders for your continued support and belief in our vision. Together, we are building a future where martial arts and combat sports can thrive like never before.

Here’s to a successful and transformative 2025.

Sincerely,
Nick Langton
Founder & CEO
Mixed Martial Arts Group Limited

ABOUT MIXED MARTIAL ARTS GROUP LIMITED

Mixed Martial Arts Group Limited is a technology company that is seeking to increase consumer participation in martial arts and combat sports whilst building upon existing community offerings within the sector. Mixed Martial Arts Group Limited currently has four business units designed to provide services to and monetize all key stakeholders in the sector, namely fans, participants, coaches, gym owners and athletes.

• TrainAlta (
  
  
  www.trainalta.com
  
  
  ) partners with gyms and coaches to deliver a range of consumer products that drive participation in martial arts for fans and beginners.
• Hype (
  
  
  www.hype.co
  
  
  ) is a mobile marketing platform designed to help gym owners, coaches and athlete partners grow revenue from their followers and audiences in today’s age of social media.
• MixedMartialArts.com (
  
  
  www.mixedmartialarts.com
  
  
  ) is a leading platform for the MMA community, providing access to MMA news and media, fighter data, fight schedules and access to the legendary Underground forum.
• BJJLink (
  
  
  www.bjjlink.com
  
  
  ) BJJLink offers the most complete gym management solution specifically catering to jiu jitsu academy needs around the world including a comprehensive suite of tools for payment processing, marketing, student engagement, website building, and content monetization.

For further information about Mixed Martial Arts Group Limited (NYSE American: MMA), please visit www.mma.inc

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Forward-Looking Statements

This press release may include forward-looking statements. Any statements contained herein regarding our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management, other than statements of historical facts, are forward-looking statements. The forward-looking statements included herein include or may include, but are not limited to, statements that are predictive in nature, depend upon or refer to future events or conditions, or use or contain words, terms, phrases, or expressions such as “achieve,” “forecast,” “plan,” “propose,” “strategy,” “envision,” “hope,” “will,” “continue,” “potential,” “expect,” “believe,” “anticipate,” “project,” “estimate,” “predict,” “intend,” “should,” “could,” “may,” “might,” or similar words, terms, phrases, or expressions or the negative of any of these terms. Any statements in this press release that are not based upon historical fact are forward-looking statements and represent our best judgment as to what may occur in the future. Any references to active gyms or partner gyms refer to a gym profile that has been claimed or created and has accepted the terms and conditions and/or a previous license agreement to run the Warrior Training Program. Any references to estimated or targeted revenue per active gym do not guarantee that the gym will generate the specified revenue or any revenue at all. Forward-looking statements involve a number of known and unknown risks and uncertainties, including, but not limited to, those discussed in the “Risk Factors” section contained in our Registration Statement on Form F-1 as filed with the SEC. Given the risks and uncertainties, readers should not place undue reliance on any forward-looking statement and should recognize that the statements are predictions of future results which may not occur as anticipated. New risk factors emerge from time to time, and it is not possible for management to predict all such risk factors, nor can it assess the impact of all such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should carefully read the factors described in the “Risk Factors” section of the Form 20-F for the fiscal year ended June 30, 2024 filed with the SEC to better understand the risks and uncertainties inherent in our business and industry, and underlying any forward-looking statements. Except where required by law, the Company assumes no obligation to update, withdraw or revise any forward-looking statements to reflect actual results or changes in factors or assumptions affecting such forward-looking statements.

Media Contacts

Peter Jarmain
Mixed Martial Arts Group Limited
E: [email protected]

NEWTOWN, Pa., Dec. 23, 2024 (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 the first PoNS System sale to the VA Healthcare System. The PoNS System sale through our distributor, Lovell Government Services (“Lovell”), was at the contracted price of $23,844, comprised of $16,499 for the PoNS Controller and $7,345 for the PoNS Mouthpiece.

“We are excited to announce the first PoNS System sale to the VA and are proud to support advancing the treatment of gait deficit for Veterans with MS,” said Dane Andreeff, Helius President and Chief Executive Officer. “Since the approval of PoNS for inclusion on the Federal Supply Schedule contract, we have worked hard to integrate with the VA as an approved vendor to streamline future operations. This sale to one of the larger VA Centers of Excellence in MS, serves as a launching point for further penetration into this patient population of up to 70,000 veterans with MS as we continue to expand our sales coverage which currently extends across many of the VAs on the east coast and southeast. Additionally, this order provides valuable market pricing evidence that supports our efforts to advance discussions for broader Medicare reimbursement with CMS.”

PoNS is indicated in the U.S. for use as a short-term treatment of gait deficit in adults with mild-to-moderate symptoms from MS when used in conjunction with physical therapy. The VA estimates that between 55,000 and 70,000 veterans in the U.S. are living with MS. The Company is committed to supporting this community as demonstrated in a recent spotlight on KATU that featured veteran and PoNS user Kevin Byrne, whose inspiring journey underscores the potential of PoNS Therapy^®. The Company now has a team of independent sales professionals covering many VA locations along the east coast and in the southeast and is working to further expand coverage to all VA MS Centers of Excellence (“MSCoE”) network facilities across the U.S.

The PoNS device was approved for inclusion on Lovell’s Veterans Affairs (VA) Federal Supply Schedule (FSS) and General Services Administration (GSA) Advantage contracts earlier in 2024. The contract award number #V797D-50450 enables the VA and other federal entities to purchase PoNS at pre-approved pricing via the VA’s FSS Medical Equipment and Surgical (Med/Surg) Contract at VA National Acquisition Center MedSurg Catalog and via the GSA Advantage online catalog at GSA Advantage. The PoNS system, Item # S1-001-02, is priced at $23,843.72 and the PoNS mouthpiece, Item # M1-001 is priced at $7,344.97.

About Lovell^® Government Services

Lovell Government Services has been a trusted SDVOSB vendor since 2013 with a proven track record of successfully introducing suppliers to the government market. Lovell is a two-time Inc. 5,000 honoree and leader in the federal space. They partner with medical and pharmaceutical companies looking to better serve Veteran and military patient populations, increase their federal revenue stream, and win government contracts. Learn more at www.lovellgov.com.

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 and 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 PoNS System sales to the VA, the Company’s future communications with CMS and the results of such communications, and the uses and effectiveness of PoNS and PoNS Therapy.

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]

NORWELL, Mass. and ATLANTA, Dec. 23, 2024 (GLOBE NEWSWIRE) — DIH Holding US, Inc. (“DIH”)(NASDAQ:DHAI), a global provider of advanced robotic devices used in rehabilitation, which incorporate visual stimulation in an interactive manner to enable clinical research and intensive functional rehabilitation and training in patients with walking impairments, reduced balance and/or impaired arm and hand functions, today announced the appointment of Shepherd Center as DIH Center of Excellence. Through this partnership, DIH and Shepherd Center aim to further enhance rehabilitation outcomes and drive advancements in rehabilitation, creating new opportunities for patient recovery.

The DIH Center of Excellence program recognizes strategic partners that showcase best practices in rehabilitation robotics while demonstrating how DIH therapy solutions contribute to successful patient outcomes.  These Centers also contribute to the development of advanced rehabilitation technologies.

Based in Atlanta, Georgia, Shepherd Center is renowned for its expertise in neurorehabilitation. The center’s integration of state-of-the-art technology aligns perfectly with its mission to provide world-class clinical care, research, and family support for people experiencing the most complex conditions, including spinal cord and brain injuries, multi-trauma, traumatic amputations, stroke, multiple sclerosis and pain.

Shepherd Center utilizes Erigo®Pro for early patient mobilization, Lokomat®Pro for intensive gait training, and C-Mill VR+ for balance and gait evaluation and training. In addition, the complete Armeo® product family supports advanced arm and hand therapy, catering to a wide range of patient needs, from acute to mild. These devices complement Shepherd’s comprehensive therapy offerings and dedication to excellence in the rehabilitation space.

“We’re thrilled to partner with Shepherd Center as a DIH Center of Excellence,” said Dr. Patrick Bruno, Chief Market Officer, at DIH. “Their expertise in neurorehabilitation, combined with our cutting-edge technology, will help drive patient outcomes and foster innovation in the field. At DIH, we’re dedicated to transforming lives through innovation, and this partnership is an important step in that mission.”

“Being honored as a DIH Center of Excellence reflects our dedication to advancing neurorehabilitation through cutting-edge technology both in the clinical and research setting,” said Deborah Backus, PT, Ph.D. FACRM, vice president of research and innovation at Shepherd Center. “We look forward to our partnership with DIH helping us maximize recovery and independence for our patients now and in the future.”

About DIH Holding US, Inc.

DIH stands for the vision to “Deliver Inspiration & Health” to improve the daily lives of millions of people with disabilities and functional impairments through providing devices and solutions enabling intensive rehabilitation. DIH is a global provider of advanced robotic devices used in physical rehabilitation, which incorporate visual stimulation in an interactive manner to enable clinical research and intensive functional rehabilitation and training in patients with walking impairments, reduced balance and/or impaired arm and hand functions. Built through the mergers of global-leading niche technology providers, DIH is a transformative rehabilitation solutions provider and consolidator of a largely fragmented and manual-labor-driven industry.

About Shepherd Center

Shepherd Center in Atlanta, Georgia is recognized globally as a leader in neurorehabilitation. Founded in 1975 by James Shepherd along with his parents Harold and Alana Shepherd following James’ own spinal cord injury experience, the center has grown into one of the top-ranked facilities specializing in medical treatment, research, and rehabilitation for people with spinal cord injury or disease (SCI/D), acquired brain injury (ABI), multiple sclerosis (MS), chronic pain conditions related to spine disorders.

Caution Regarding Forward-Looking Statements

This press release contains certain statements which are not historical facts, which are forward-looking statements within the meaning of the federal securities laws, for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. These forward-looking statements include certain statements made with respect to the business combination, the services offered by DIH and the markets in which it operates, and DIH’s projected future results. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions provided for illustrative purposes only, and projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties that could cause the actual results to differ materially from the expected results. These risks and uncertainties include, but are not limited to: general economic, political and business conditions; the ability of DIH to achieve its projected revenue, the failure of DIH realize the anticipated benefits of the recently-completed business combination and access to sources of additional debt or equity capital if needed. While DIH may elect to update these forward-looking statements at some point in the future, DIH specifically disclaims any obligation to do so.

Investor Contact

Greg Chodaczek
[email protected] 

WALTHAM, Mass., Dec. 23, 2024 (GLOBE NEWSWIRE) — TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today announced that it has entered into a term loan facility with Silicon Valley Bank (SVB), a division of First Citizens Bank, for up to $52.5 million. The first tranche of $32.5 million, advanced at loan closing, will be used to retire the existing convertible debt with K2 Health Ventures and the remainder for general corporate purposes.

TScan has the option through June 30, 2026, to draw the second $20.0 million tranche, subject to certain conditions and mutual agreement of TScan and SVB. Borrowings under the term loan facility will bear interest at an annual rate equal to the greater of 7.00%, or the prime rate minus 0.75%, subject to an interest rate cap of 9.75%. The term loans will mature on September 1, 2029, and will be subject to monthly interest-only payments until September 30, 2027, provided the Company achieves certain financial and clinical milestones, otherwise the term loans will mature on September 1, 2028, and the interest-only period will be through September 30, 2026.

“We’re pleased to enter into this non-dilutive agreement with SVB which allows us to significantly extend the interest-only period and maturity of our debt financing, providing TScan with added financial flexibility and liquidity,” said Jason A. Amello, Chief Financial Officer. “With this refinancing, we continue to expect our cash resources to fund our current operating plan into the fourth quarter of 2026. We’re looking forward to working with SVB as we deliver on our critical milestones, advance our mission to bring our potential therapies to patients with cancer, and enhance shareholder value.”  

“We’re excited to partner with TScan as they advance their innovative hematology and solid tumor programs,” said Lauren Cole, Managing Director with SVB Life Science and Healthcare Practice. “Silicon Valley Bank is thrilled to provide TScan with this refinancing to support their ongoing development efforts to positively impact patients’ lives.”

Further information with respect to the loan agreement is set forth in a Form 8-K filed by TScan with the Securities and Exchange Commission on December 23, 2024.

About TScan Therapeutics, Inc.

TScan is a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer. The Company’s lead TCR-T therapy candidates are in development for the treatment of patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation (the ALLOHA^TM Phase 1 heme trial). The Company has developed and continues to expand its ImmunoBank, the Company’s repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types, to provide customized multiplex TCR-T therapies for patients with a variety of cancers (the PLEXI-T^TM Phase 1 solid tumor trial). The Company is currently enrolling patients into both clinical programs.

About Silicon Valley Bank 

Silicon Valley Bank (SVB), a division of First Citizens Bank, is the bank of some of the world’s most innovative companies and investors. SVB provides commercial banking to companies in the technology, life science and healthcare, private equity and venture capital industries. SVB operates in centers of innovation throughout the United States, serving the unique needs of its dynamic clients with deep sector expertise, insights and connections. SVB’s parent company, First Citizens BancShares, Inc. (NASDAQ: FCNCA ), is a top 20 U.S. financial institution with more than $200 billion in assets. First Citizens Bank, Member FDIC. Learn more at svb.com

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding the Company’s plans, progress, and timing relating to the Company’s hematologic malignancies program, including clinical updates of the ALLOHA Phase 1 heme trial, presentation of data, opening of expansion cohorts, and initiation of registrational trials; the Company’s plans, progress, and timing relating to the Company’s solid tumor program, including, screening, enrolling, and dosing patients, presentation of data, and submission of additional INDs to expand the ImmunoBank; the progress of the hematologic malignancies and solid tumor programs being indicative or predictive of the success of each program; the engagement of CDMO being indicative of successful initiation or support of manufacturing activities or execution of definitive agreements; the Company’s current and future research and development plans or expectations; the structure, timing and success of the Company’s planned preclinical development, submission of INDs, and clinical trials; the potential benefits of any of the Company’s proprietary platforms, multiplexing, or current or future product candidates in treating patients; the Company’s ability to fund its operating plan with its existing cash, cash equivalents, and marketable securities; and the Company’s goals, strategy and anticipated financial performance. TScan intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan,” “on track,” or similar expressions or the negative of those terms. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. The express or implied forward-looking statements included in this release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: the beneficial characteristics, safety, efficacy, therapeutic effects and potential advantages of TScan’s TCR-T therapy candidates; TScan’s expectations regarding its preclinical studies being predictive of clinical trial results; TScan’s recently approved INDs being indicative or predictive of bringing TScan closer to its goal of providing customized TCR-T therapies to treat patients with cancer; the timing of the launch, initiation, progress, expected results and announcements of TScan’s preclinical studies, clinical trials and its research and development programs; TScan’s ability to enroll patients for its clinical trials within its expected timeline; TScan’s plans relating to developing and commercializing its TCR-T therapy candidates, if approved, including sales strategy; estimates of the size of the addressable market for TScan’s TCR-T therapy candidates; TScan’s manufacturing capabilities and the scalable nature of its manufacturing process; TScan’s estimates regarding expenses, future milestone payments and revenue, capital requirements and needs for additional financing; TScan’s expectations regarding competition; TScan’s anticipated growth strategies; TScan’s ability to attract or retain key personnel; TScan’s ability to establish and maintain development partnerships and collaborations; TScan’s expectations regarding federal, state and foreign regulatory requirements; TScan’s ability to obtain and maintain intellectual property protection for its proprietary platform technology and our product candidates; the sufficiency of TScan’s existing capital resources to fund its future operating expenses and capital expenditure requirements; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of TScan’s most recent Annual Report on Form 10-K and any other filings that TScan has made or may make with the SEC in the future. Any forward-looking statements contained in this release represent TScan’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, TScan explicitly disclaims any obligation to update any forward-looking statements.

Contacts

Heather Savelle
TScan Therapeutics, Inc.
VP, Investor Relations
857-399-9840
[email protected]   

Maghan Meyers
Argot Partners
212-600-1902
[email protected]

DENVER, Dec. 23, 2024 (GLOBE NEWSWIRE) —
SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that a 14^th site is now activated and able to enroll subjects in the NEUTRALIZE-AKI pivotal trial. The NEUTRALIZE-AKI trial is evaluating the safety and efficacy of the Company’s proprietary therapeutic Selective Cytopheretic Device (SCD) in patients with acute kidney injury (AKI) in the intensive care unit (ICU) receiving continuous renal replacement therapy (CRRT).

“We are pleased to welcome the 14^th hospital to our trial, especially as this site has been among the top CRRT programs in the country,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “As of today, 70 of the planned 200 subjects have been enrolled, including 24 so far in the fourth quarter. We plan to conduct an interim analysis at the trial’s 90-day primary endpoint with the first 100 subjects. Given the current pace of enrollment, we anticipate a Data Safety Monitoring Board (DSMB) recommendation on the interim results by mid-2025.”

“We estimate the annual U.S. total addressable market for the SCD in adult AKI at $4.7 billion to $6.3 billion. This significant market opportunity represents a highly attractive return on a clinical trial estimated to cost SeaStar Medical approximately $15 million, with some of those costs already incurred,” said Eric Schlorff, SeaStar Medical CEO. “AKI is one of several high-value indications for our SCD that we plan to pursue. As we work to increase accessibility of our therapeutic device among those afflicted with potentially life-threatening hyperinflammation, we believe that our clinical data showing reduced mortality and probable savings for the healthcare system will encourage adoption by the medical community.”

The SCD previously received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for adults with AKI, which is awarded to a therapy to treat a serious or life-threatening condition with preliminary clinical evidence indicating it may demonstrate substantial improvement over available therapies on clinically significant endpoints. In July 2024, the Centers for Medicare & Medicaid Services granted Category B coverage for certain expenses incurred by medical centers when treating Medicare or Medicaid patients enrolled in NEUTRALIZE-AKI.

NEUTRALIZE-AKI Pivotal Trial

The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) is expected to enroll up to 200 adults. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency among patients treated with SCD in addition to CRRT as the standard of care, compared with the control group receiving only CRRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.

Acute Kidney Injury (AKI) and Hyperinflammation

AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as COVID-19, sepsis, severe trauma and surgery. AKI can cause hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease requiring dialysis. Hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.

Selective Cytopheretic Device

The Selective Cytopheretic Device (SCD) is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during CRRT and reduces the hyperinflammatory milieu including the cytokine storm. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CRRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future renal replacement treatment (RRT), including dialysis.

The SCD has been awarded FDA Breakthrough Device Designation in four indications:

• Cardiorenal Syndrome – Left Ventricular Assist Device (CRS-LVAD)
• Adult Acute Kidney Injury (AKI)
• Hepatorenal Syndrome (HRS)
• Chronic Dialysis

QUELIMMUNE™, the Company’s SCD-Pediatric device, is being commercialized following FDA approval for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with RRT. QUELIMMUNE was approved in February 2024 under a Humanitarian Device Exemption (HDE) application, having met the applicable criteria with clinical results showing safety and probable clinical benefit in a limited population of critically ill children with AKI who have few treatment options.

About SeaStar Medical

SeaStar Medical is a commercial-stage medical technology company that is redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical’s novel technologies rely on science and innovation to provide life-saving solutions to critically ill patients. The Company is developing and commercializing cell-directed extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses. For more information visit www.seastarmedical.com or visit us on LinkedIn or X.

Forward-Looking Statements

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. These forward-looking statements include, without limitation, the ability of the SCD to treat patients with AKI and other diseases; anticipated patient enrollment and the expansion of the clinical trial sites; the estimated annual sales for the addressable AKI market; the anticipated Medicare and Medicaid reimbursement by CMS for patients enrolled in clinical trials; planned future clinical trials; expected clinical trial costs; the adoption of our products by the medical community; the expected regulatory approval process and timeline for commercialization of our clinical products; and the ability of SeaStar Medical to meet the expected timeline. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to access funding under existing agreements; (vi) the risk that third-parties suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.

Contact:

Alliance Advisors IR
Jody Cain
(310) 691-7100
[email protected]

# # #

Blarcamesine: Potential novel oral treatment to target upstream Alzheimer’s disease pathology through autophagy enhancement

Submission based on favorable ANAVEX^®2-73-AD-004 trial results in patients with early Alzheimer’s disease

Once daily oral administration of blarcamesine meaningfully slowed clinical decline in early Alzheimer’s disease patients, demonstrating a favorable safety profile with no associated neuroimaging adverse events

NEW YORK, Dec. 23, 2024 (GLOBE NEWSWIRE) — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer’s disease, Parkinson’s disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for blarcamesine (ANAVEX^®2-73), an investigational drug for the treatment of Alzheimer’s disease. The Company is looking forward to working with the EMA.

Blarcamesine is an orally once daily administered small molecule for the potential treatment of patients with Alzheimer’s disease.

“The EMA filing acceptance for blarcamesine to review the Marketing Authorization Application potentially brings us a step closer offering broader patient access to a new treatment option in Europe, and we look forward to continued engagement with the EMA,” said Juan Carlos Lopez-Talavera, MD, PhD, Head of Research and Development of Anavex. “Through our clinical development program, we have seen that blarcamesine has the potential to slow the progression of this relentless and ultimately fatal disease.” 

The MAA is supported by data from the randomized, double-blind, placebo-controlled Phase IIb/III, ANAVEX^®2-73-AD-004 trial and it’s up to 144 week open-label-extension (OLE) ATTENTION-AD ANAVEX®2-73-AD-EP-004 trial investigating blarcamesine in early Alzheimer’s disease. Former study was recently accepted in a peer-reviewed medical journal with focus on Alzheimer’s disease titled, “Blarcamesine for the treatment of Early Alzheimer’s Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial.”

Strengthening the submission is the 265 week (~5-year) Phase 2a trial investigating blarcamesine in mild-to-moderate Alzheimer’s disease, with interim preliminary data published in the peer-reviewed medical journal, Alzheimer’s & Dementia, titled: “A precision medicine framework using artificial intelligence for the identification and confirmation of genomic biomarkers of response to an Alzheimer’s disease therapy: Analysis of the blarcamesine (ANAVEX2-73) Phase 2a clinical study.”

“We look forward to working with the EMA and thank the team at Anavex for their work on the submission,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We are committed to improving patient access to novel and accessible oral medicines.”

Data from the Phase IIb/III trial demonstrated oral once daily blarcamesine pre-specified clinical efficacy through upstream SIGMAR1 activation. SIGMAR1 is an integral membrane protein which activates an upstream compensatory process: Blarcamesine induces autophagy through SIGMAR1 activation resulting in restoring cellular homeostasis.

Impaired autophagy precedes both amyloid beta and tau tangles, and therefore anticipates the neurodegenerative process in Alzheimer’s disease.¹ Hence, stabilization or restoration of autophagy can be seen as an early preventative measure countering the Alzheimer’s disease pathology.

Blarcamesine, a small molecule administered orally once daily, demonstrated clinically meaningful improvement over 48 weeks with primary endpoint ADAS-Cog13 score being larger than 2 points.² This suggests superior numerical clinical efficacy compared to approved therapies while also slowing neurodegeneration in early AD patients. Blarcamesine’s safety profile indicates not requiring routine MRI monitoring, and given its differentiated mechanism of action, oral blarcamesine could represent a novel treatment that could be complementary or an alternative to injectable anti-beta amyloid monoclonal antibody drugs.

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

About Alzheimer’s Disease

There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council.³ The World Health Organization (WHO) estimated the cost in Europe of caring for people with dementia, including Alzheimer’s disease, at $439 billion, or $31,144 per person in 2019. That includes hospital care, medicines, diagnostics, informal caregiver time, community services and long-term care facility costs.^4,5

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer’s disease, Parkinson’s disease, schizophrenia, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX^®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer’s disease, a Phase 2 proof-of-concept study in Parkinson’s disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX^®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. ANAVEX^®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX^®2-73 for the treatment of Parkinson’s disease. We believe that ANAVEX^®3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX^®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter,Facebook, Instagram, and LinkedIn.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

For Further Information:

Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: [email protected]

Investors:

Andrew J. Barwicki
Investor Relations

Tel: 516-662-9461
Email: [email protected]

---

¹ Christ MG, Clement AM, Behl C. The Sigma-1 Receptor at the Crossroad of Proteostasis, Neurodegeneration, and Autophagy. Trends Neurosci. 2020 Feb;43(2):79-81; Chen, J., He, HJ., Ye, Q. et al. Defective Autophagy and Mitophagy in Alzheimer’s Disease: Mechanisms and Translational Implications. Mol Neurobiol 58, 5289–5302 (2021).
² Muir RT, Hill MD, Black SE, Smith EE. Minimal clinically important difference in Alzheimer’s disease: Rapid review. Alzheimers Dement. 2024;20(5):3352-3363. doi:10.1002/alz.13770
³ https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/
⁴ Jönsson L. The personal economic burden of dementia in Europe. Lancet Reg Health Eur. 2022 Jul 25;20:100472. doi: 10.1016/j.lanepe.2022.100472. PMID: 35910037; PMCID: PMC9326307.
⁵ World Health Organization (WHO); 2021. Global status report on the public health response to dementia.