Palisade Bio Announces $4 Million Private Placement Priced At-The- Market Under Nasdaq Rules




Palisade Bio Announces $4 Million Private Placement Priced At-The- Market Under Nasdaq Rules

Carlsbad, CA, May 02, 2024 (GLOBE NEWSWIRE) — Palisade Bio, Inc. (Nasdaq: PALI), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, is announcing today that it has entered into a definitive agreement with an institutional investor for the purchase of 615,242 shares of common stock (or certain pre-funded warrants in lieu thereof) in a private placement at a purchase price per share of $6.5015, priced at-the-market under Nasdaq rules. The Company expects to receive gross proceeds of approximately $4 million, before deducting placement agent fees and other offering expenses payable by the Company.

Ladenburg Thalmann & Co. Inc. is acting as the exclusive placement agent for the offering.

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

The company has also agreed to issue to the investor, unregistered warrants to purchase up to 922,863 shares of common stock (the “Common Warrants”). These Common Warrants will have a term of seven (7) years and an exercise price of $6.314 per share. The closing of the offering is expected to take place on or about May 6, 2024, subject to the satisfaction of customary closing conditions.

The shares of common stock, pre-funded warrants, and Common Warrants (and the shares of common stock underlying such pre-funded warrants and Common Warrants) are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”) and/or Regulation D promulgated thereunder, and such securities have not been registered under the Act or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. The company has agreed to file a registration statement with the SEC registering the resale of the shares of common stock and shares of common stock issuable upon the exercise of the pre-funded warrants and Common Warrants no later than 10 calendar days following the closing and to use its best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 60 days after the date of such agreement.

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

About Palisade Bio 

Palisade Bio is a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to www.palisadebio.com.

Forward Looking Statements

This communication contains “forward-looking” statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the extent of our cash runway; our ability to successfully develop our licensed technologies; estimates about the size and growth potential of the markets for our product candidates, and our ability to serve those markets, including any potential revenue generated; future regulatory, judicial, and legislative changes or developments in the United States (U.S.) and foreign countries and the impact of these changes; our ability to maintain the Nasdaq listing of our securities; our ability to build a commercial infrastructure in the U.S. and other markets; our ability to compete effectively in a competitive industry; our ability to identify and qualify manufacturers to provide API and manufacture drug product; our ability to enter into commercial supply agreements; the success of competing technologies that are or may become available; our ability to attract and retain key scientific or management personnel; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; our ability to obtain funding for our operations; our ability to attract collaborators and strategic partnerships; and the impact of the COVID-19 pandemic or any global event on our business, and operations, and supply. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon the Company’s current expectations. Forward-looking statements involve risks and uncertainties. The Company’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the Company’s ability to advance its nonclinical and clinical programs, the uncertain and time-consuming regulatory approval process; and the Company’s ability to secure additional financing to fund future operations and development of its product candidates. Additional risks and uncertainties can be found in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2024. These forward-looking statements speak only as of the date hereof and the Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Investor Relations Contact
JTC Team, LLC
Jenene Thomas
833-475-8247
PALI@jtcir.com

Palisade Bio Announces $4 Million Private Placement Priced At-The- Market Under Nasdaq Rules




Palisade Bio Announces $4 Million Private Placement Priced At-The- Market Under Nasdaq Rules

Carlsbad, CA, May 02, 2024 (GLOBE NEWSWIRE) — Palisade Bio, Inc. (Nasdaq: PALI), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, is announcing today that it has entered into a definitive agreement with an institutional investor for the purchase of 615,242 shares of common stock (or certain pre-funded warrants in lieu thereof) in a private placement at a purchase price per share of $6.5015, priced at-the-market under Nasdaq rules. The Company expects to receive gross proceeds of approximately $4 million, before deducting placement agent fees and other offering expenses payable by the Company.

Ladenburg Thalmann & Co. Inc. is acting as the exclusive placement agent for the offering.

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

The company has also agreed to issue to the investor, unregistered warrants to purchase up to 922,863 shares of common stock (the “Common Warrants”). These Common Warrants will have a term of seven (7) years and an exercise price of $6.314 per share. The closing of the offering is expected to take place on or about May 6, 2024, subject to the satisfaction of customary closing conditions.

The shares of common stock, pre-funded warrants, and Common Warrants (and the shares of common stock underlying such pre-funded warrants and Common Warrants) are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”) and/or Regulation D promulgated thereunder, and such securities have not been registered under the Act or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. The company has agreed to file a registration statement with the SEC registering the resale of the shares of common stock and shares of common stock issuable upon the exercise of the pre-funded warrants and Common Warrants no later than 10 calendar days following the closing and to use its best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 60 days after the date of such agreement.

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

About Palisade Bio 

Palisade Bio is a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to www.palisadebio.com.

Forward Looking Statements

This communication contains “forward-looking” statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the extent of our cash runway; our ability to successfully develop our licensed technologies; estimates about the size and growth potential of the markets for our product candidates, and our ability to serve those markets, including any potential revenue generated; future regulatory, judicial, and legislative changes or developments in the United States (U.S.) and foreign countries and the impact of these changes; our ability to maintain the Nasdaq listing of our securities; our ability to build a commercial infrastructure in the U.S. and other markets; our ability to compete effectively in a competitive industry; our ability to identify and qualify manufacturers to provide API and manufacture drug product; our ability to enter into commercial supply agreements; the success of competing technologies that are or may become available; our ability to attract and retain key scientific or management personnel; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; our ability to obtain funding for our operations; our ability to attract collaborators and strategic partnerships; and the impact of the COVID-19 pandemic or any global event on our business, and operations, and supply. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon the Company’s current expectations. Forward-looking statements involve risks and uncertainties. The Company’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the Company’s ability to advance its nonclinical and clinical programs, the uncertain and time-consuming regulatory approval process; and the Company’s ability to secure additional financing to fund future operations and development of its product candidates. Additional risks and uncertainties can be found in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2024. These forward-looking statements speak only as of the date hereof and the Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Investor Relations Contact
JTC Team, LLC
Jenene Thomas
833-475-8247
PALI@jtcir.com

Corvus Pharmaceuticals Announces Pricing of $30.6 Million Registered Direct Offering




Corvus Pharmaceuticals Announces Pricing of $30.6 Million Registered Direct Offering

BURLINGAME, Calif., May 02, 2024 (GLOBE NEWSWIRE) — Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS) (GLOBAL NEWSWIRE), a clinical-stage biopharmaceutical company, today announced that it has entered into a securities purchase agreement with new and existing investors to raise approximately $30.6 million dollars in aggregate gross proceeds through the sale of shares of its common stock, par value $0.0001 per share (the “Common Stock”) and pre-funded warrants to purchase Common Stock in lieu thereof (the “Pre-Funded Warrants”), and accompanying common warrants to purchase Common Stock (or Pre-Funded warrants in lieu thereof) (the “Common Warrants,” and together with the Common Stock and Pre-Funded Warrants, the “Securities”), excluding the proceeds, if any, from the exercise of the Pre-Funded Warrants and the Common Warrants and before deducting offering expenses.

The offering includes participation from health-care dedicated investors including Point72, Samlyn Capital, Armistice Capital, OrbiMed, Puissance Capital and Altamont Pharmaceutical Holdings, and other existing investors including Richard Miller, the Company’s chief executive officer.

The purchase and sale will be completed via a registered direct offering of 13,512,699 shares of Common Stock and accompanying Common Warrants to purchase 13,078,509 shares of Common Stock (or Pre-Funded Warrants in lieu thereof) at a combined offering price of $1.7312 per Share, and Pre-Funded Warrants to purchase 4,144,085 shares of Common Stock and accompanying Common Warrants to purchase 4,010,927 shares of Common Stock (or Pre-Funded Warrants in lieu thereof) at a combined offering price of $1.7311 per share underlying each Pre-Funded Warrant and Common Warrant, which equals the offering price per share of the Common Stock and Common Warrant less the $0.0001 exercise price per share of the Pre-Funded Warrants. The Pre-Funded Warrants have an exercise price of $0.0001 per share of Common Stock and are exercisable at any time after the date of issuance, subject to certain ownership limitations. The Common Warrants have an exercise price of $3.50 per share of Common Stock (or $3.4999 per Pre-Funded Warrant in lieu thereof) and are exercisable at any time after the date of issuance, subject to certain ownership limitations, and expire on June 30, 2025.  

All of the Securities are being offered by Corvus. The offering is expected to close on or about May 6, 2024, subject to the satisfaction of customary closing conditions. Since the offering of the Securities was made without an underwriter or a placement agent, the Company will not be paying any underwriting discounts or placement agent fees in connection with the offering.

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

The Securities are being offered by Corvus Pharmaceuticals pursuant to a registration statement on Form S-3 (File No. 333-270921) previously filed and declared effective by the Securities and Exchange Commission (“SEC”). A final prospectus supplement and accompanying base prospectus relating to and describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management and include, but are not limited to, statements regarding the timing for closing of the offering and the Company’s ability to complete the offering. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to market conditions and the satisfaction of closing conditions related to the offering, the uncertainties inherent in the drug development process, including the Company’s programs’ clinical stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the Company’s ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations, and other risks and uncertainties described under the heading “Risk Factors” in documents the Company files from time to time with the SEC, including the Company’s annual report on Form 10-K filed on March 19, 2024, and its other SEC filings. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein.

INVESTOR CONTACT:
Leiv Lea
Chief Financial Officer
Corvus Pharmaceuticals, Inc.
+1-650-900-4522
llea@corvuspharma.com

MEDIA CONTACT:
Sheryl Seapy
Real Chemistry
+1-949-903-4750
sseapy@realchemistry.com

Medigene AG Expands Patent Portfolio with European Patent Grant for its NY-ESO-1 – targeted T Cell Receptor




Medigene AG Expands Patent Portfolio with European Patent Grant for its NY-ESO-1 – targeted T Cell Receptor

Planegg/Martinsried, May 2, 2024. Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, announces today that the Company has been issued a patent by the European Patent Office protecting its T cell receptor (TCR) targeting NY-ESO-1 (New York esophageal squamous cell carcinoma 1), a well-recognized and validated cancer-testis antigen, which is expressed in multiple tumor types. 

“We are delighted to announce the protection of our NY-ESO-1-targeted TCR in Europe. This TCR, together with the PD1-41BB costimulatory switch protein (CSP), serves as the main component of our lead program MDG1015. This patent grant adds to similar patents that were also granted in the United States, Japan, South Korea, Taiwan and Australia and reinforces the key technologies of our End-to-End Technology platform and its ability to generate optimal affinity 3S (sensitive, specific and safe) TCRs,“ said Selwyn Ho, CEO at Medigene AG. “Along with our differentiated TCR-T therapies for solid tumors, such as MDG1015, we are also exploring opportunities to expand the application of our potential best-in-class TCRs into other modalities such as T cell engagers (TCE) and TCR natural killer cell (TCR-NK) therapies.”

Medigene continually extends and strengthens its patent portfolio with new technologies and expands existing patents into additional jurisdictions. The Company maintains over 20 different patent families worldwide covering applications protecting Medigene’s 3S TCRs as well as its exclusive E2E Platform technologies.

—  end of press release  —

About Medigene AG

Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing differentiated T cell therapies for treatment of solid tumors. Its End-to-End Platform is built on multiple proprietary and exclusive technologies that enable the Company to generate optimal T cell receptors against both cancer testis antigens and neoantigens, armor and enhance these T cell receptor engineered (TCR) -T cells to create best-in-class, differentiated TCR-T therapies, and optimize the drug product composition for safety, efficacy and durability. The End-to-End Platform provides product candidates for both its own therapeutics pipeline and partnering. Medigene’s lead TCR-T program MDG1015 is expected to receive IND/CTA approval in the second half of 2024. For more information, please visit https://medigene.com/

About Medigene’s MDG1015 Program

MDG1015 is a first-in-class, 3rd generation T cell receptor engineered T cell (TCR-T) therapy targeting NY-ESO-1/ LAGE-1a, a well-recognized and validated cancer testis antigen, which is expressed in multiple tumor types. MDG1015 contains our optimal affinity 3S (sensitive, specific and safe) NY-ESO-1/LAGE-1a TCR combined with our proprietary PD1-41BB costimulatory switch protein that blocks the PD1/PD-L1 inhibitory axis while simultaneously activating the T cell through the well described -41BB pathway further enhancing the activity and persistence of the TCR-T in the hostile tumor microenvironment. The Company expects IND/CTA approval for MDG1015 in the second half of 2024.

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene^® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.

Medigene AG

Pamela Keck
Phone: +49 89 2000 3333 01
E-mail: investor@medigene.com

In case you no longer wish to receive any information about Medigene, please inform us by e-mail (investor@medigene.com). We will then delete your address from our distribution list.

Ikerian AG, Parent Company of RetinAI U.S. Inc. Announces Final Close of USD 6.18M (CHF 5.65M) Series A Extension Financing




Ikerian AG, Parent Company of RetinAI U.S. Inc. Announces Final Close of USD 6.18M (CHF 5.65M) Series A Extension Financing

• RetinAI Medical AG rebranded as Ikerian AG “Ikerian”, to spearhead development beyond ophthalmology, with wholly-owned subsidiary RetinAI U.S. Inc. “RetinAI” focused on the ophthalmology and optometry market.
• Ikerian’s Series A Extension final close at USD 6.18M (CHF 5.65M) brings in a new lead investor, the Corporate Venture Capital arm of Topcon Healthcare, Inc; First close of Series A Extension in 2023 brought Zürcher Kantonalbank (ZKB) as a new investor, together with existing investors.
• Total of USD 11.66M (CHF 10.66M) raised across Seed, Series A and Series A Extension.
• Funds will support continued development and commercial roll out of RetinAI Discovery^® in ophthalmology and optometry and for Ikerian’s expansion into new therapeutic areas prioritizing neurodegenerative disorders, vascular conditions and rare diseases.

BERN, Switzerland and BOSTON, May 02, 2024 (GLOBE NEWSWIRE) — Ikerian AG and its subsidiary, RetinAI U.S. Inc., a leading developer of software solutions for medical image and data management, and artificial intelligence (AI) in healthcare, announced today the successful close of its USD 6.18M (CHF 5.65M) Series A Extension financing, with new and existing investors.

The final close was led by strategic investor the Corporate Venture Capital arm of Topcon Healthcare, Inc. The first close in 2023 added Zürcher Kantonalbank (ZKB) as a new investor alongside existing Seed and Series A venture firms, the btov Industrial Technologies fund, managed by Matterwave Ventures, Verve Ventures, and private investors.

As part of the financing, and to facilitate its evolution and growth, the company has concluded its corporate restructuring commenced in 2023, to spearhead development beyond ophthalmology with RetinAI Medical AG rebranded as Ikerian AG, and wholly-owned subsidiary RetinAI U.S. Inc. focused on the ophthalmology market.

Dr. Carlos Ciller, Chairman and CEO of Ikerian, and CEO of RetinAI said: “The successful closing of this financing confirms the importance of our AI technology to re-invent workflows for clinical and pharmaceutical research to support more efficient and effective patient care. These funds will allow us to expedite development efforts of our RetinAI Discovery^® platform and our pipeline of AI technologies, and to collaborate with Topcon Healthcare and the industry to advance AI in ophthalmology and beyond.”

A commercial stage ophthalmology company, with growing revenues, RetinAI continues to advance its product offerings for pharma, life sciences companies, and ophthalmology and optometry clinics. The company is expanding its Real-World Evidence (RWE) database across eye diseases, including Geographic Atrophy (GA), Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Retinopathy (DR), where eye biomarkers play a role in diagnosis and disease monitoring. The company helps customers evaluate real world outcomes in diverse patient populations driven by AI insights on these biomarkers.

Dr. Sandro De Zanet, Chief Scientific Officer at Ikerian and RetinAI said: “Having a portfolio of RWE insights allows RetinAI to deliver even greater value to pharma by accelerating clinical studies and enriching AI-based data analysis to support future treatments. In addition, generative AI technology is helping us revolutionize analysis and patient screening for clinical studies. The Discovery tool and AI biomarkers that we have developed will simplify analysis across vast imaging datasets needed to successfully complete a clinical trial.”

RetinAI has achieved notable successes to date. It has a strategic collaboration with Retina Consultants of America (RCA), and has collaborated with major pharma companies including Boehringer Ingelheim, Janssen (a J&J company) and Novartis. In February 2024, it entered a new market, launching its RetinAI Discovery^® Clinics platform for ophthalmology and optometry clinics across Europe, establishing a footprint of AI-driven workflows for patient management. RetinAI Discovery^® and the company’s AI models have 5 approvals including achieving FDA 510(k) clearance for the data management platform for clinical use and integration into U.S.-based clinics and in the European Union.

This Series A Extension brings to USD 11.66M (CHF 10.66M) the total equity raised including the Seed and Series A rounds. The company has initiated its Series B financing to fund further growth and development, including new opportunities to expand beyond ophthalmology.

Dr. Carlos Ciller added: “I am proud of the achievements RetinAI has made and look forward to this next stage of growth. Ikerian will use the ‘eye as a window to the body’ to advance healthcare in systemic and chronic diseases, such as neurological and cardiovascular conditions, generating new knowledge and playing an instrumental role in improving healthcare for individuals worldwide.”

For further information please contact:

At the company
Carlos Ciller, PhD, CEO – Ikerian AG and RetinAI Inc US carlos@ikerian.com, carlos@retinai.com

Media enquiries
Sue Charles, Charles Consultants – sue@charles-consultants.com +44 (0)7968726585

About Ikerian AG www.ikerian.com and RetinAI Inc. US www.retinai.com
Established in 2017, Ikerian AG (formerly RetinAI Medical AG) and its subsidiary, RetinAI U.S. Inc. (‘Ikerian’, ‘RetinAI’ and, together, ‘the company’), develops software solutions to accelerate clinical, research and pharmaceutical workflows globally using advanced machine learning and computer vision.

Focused on the ophthalmology and optometry market, RetinAI builds tools to collect, organize and analyze health data from the eyes, enabling healthcare professionals to make the right decisions sooner in healthcare. RetinAI’s international team leverages its clinical, technical, and scientific expertise to foster the transition from reactive to preventive medicine for severe eye diseases.

A commercial stage company with growing sales from RetinAI Discovery^®, RetinAI has established collaborations and partnerships with leading ophthalmology and pharmaceutical companies including RetinAI Consultants of America (RCA), Boehringer Ingelheim, J&J and Novartis.

Based in Bern, Switzerland and Boston, U.S.A., the company has raised USD 11.66M (CHF10.66M) in equity finance from investors including the Corporate Venture Capital arm of Topcon Healthcare, Inc, the Zürcher Kantonalbank (ZKB), b2venture, Matterwave Ventures and Verve Ventures.

Follow us on LinkedIn https://www.linkedin.com/company/ikerian/about/ and Ikerian https://www.linkedin.com/company/retinai/

About RetinAI Discovery^®‍
RetinAI Discovery^® (‘Discovery’) is a software platform to enable the right decisions sooner based on evidence, AI-derived insights, automation & data. Discovery is a modular and certified (FDA – 510(K) / CE – MDR) medical image & data platform that digests data, works via the web browser in the cloud, enables precision analysis with proprietary AI models and transfer of medical data linked to the patient, connecting devices, data sources & decisions in a seamless and secure manner. Discovery is the workbench for healthcare professionals throughout the entire journey of the disease, facilitating decisions for better patient care.

About Topcon Healthcare, Inc. https://topconhealthcare.com/
Topcon Healthcare is part of Topcon Corporation (TSE 7732). Our vision is to improve access and quality of healthcare while decreasing the overall cost. To achieve this mission, we have established Harmony, a platform to accelerate the evolution of AI-powered algorithms that enable the detection of systemic, neurological, and ophthalmic disease markers even before discernable symptoms are present. Topcon Healthcare is investing in innovators focused on healthcare transformation with an emphasis on AI-powered digital healthcare from the eye. This approach helps doctors to prevent disease and, when needed, to treat at the earliest disease state for better, less costly outcomes.

A truly global business, Topcon Corporation is focused on developing solutions to solve societal challenges in the mega-domains of healthcare, agriculture, and infrastructure. In healthcare, these challenges include increasing eye disease, rising medical costs, physician shortages, and unequal access to healthcare. By investing in value-driven innovations, Topcon Corporation works to help people enjoy good health and a better quality of life.

Follow us on LinkedIn https://www.linkedin.com/company/topcon-healthcare/

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e2aae1a0-6bad-4db0-b54f-bf4c4fc853d5

Iktos announces the appointment of Roman Fleck as Chairman of the Board  




Iktos announces the appointment of Roman Fleck as Chairman of the Board  

Paris (France), 2^nd May 2024 – Iktos, a company specialized in Artificial Intelligence for new drug design, announces the appointment of Roman Fleck as Chairman of the Board. Yann Gaston-Mathé steps down of his role as Chairman to focus on his CEO duties.

Roman Fleck holds an MBA from New York University (Sterne School of Business) and received a PhD in organic chemistry from MIT (Massachusetts Institute of Technology), USA.

He began his career as a principal scientist with Boehringer Ingelheim Pharmaceuticals, where he led drug development projects in oncology, inflammation and cardiovascular disease. After that he joined investment firm Index Ventures Life Sciences, which became Medicxi Ventures in 2014. He has notably invested in GlycoVaxyn (sold to GSK), Versartis (NASDQ: VSAS) and Novocure (NASDQ: NVCR). He represented Medicxi Ventures on the boards of these companies.

From 2017 to 2022, he was CEO of Janpix, Ltd, an oncology-focused biotech that became part of Centessa Pharmaceuticals in 2021.

Roman is currently Chairman of HDAX Therapeutics, a biotech focused on CNS (central nervous system), and an Independent Board Member at ReColony, a microbiome focused company. 

 Roman Fleck appointed Chairman of Iktos’ Board of Directors

Roman Fleck is the author of numerous publications in prestigious scientific journals. He has filed over 20 patents in the course of his career.

Roman Fleck, Chairman of the Supervisory Board, comments: “I am delighted to join the Board of Iktos, a pioneering company which has been advancing AI-driven drug discovery since 2016. Since then, Iktos has developed a technology platform which allows it to offer comprehensive drug discovery solutions to its clients that are unique in the industry. I look forward to sharing my insights and supporting Yann & Iktos as it continues to advance its strategy and builds upon its position as a leader in the field.”

Yann Gaston-Mathé, co-founder and CEO of Iktos, comments: “Roman has an exceptional professional background with unvaluable experience in pharmaceutical research, investment and company leadership. We are delighted that he has agreed to chair Iktos’ Board of Directors. His deep understanding of the biotech industry and broad network within the investment and pharma communities will be a strategic advantage for the development of Iktos. At a personal level, I look forward to working closely with Roman and learning from his experience.”

—

About Iktos
Incorporated in October 2016, Iktos is a French start-up company specialized in the development of artificial intelligence solutions applied to chemical research, more specifically medicinal chemistry and new drug design. Iktos is developing a proprietary and innovative solution based on deep generative models, which enables, using existing data, to design molecules that are optimized in silico to meet all the success criteria of a small molecule discovery project. The use of Iktos technology enables major productivity gains in upstream pharmaceutical R&D. Iktos offers its technology through the SaaS software platforms Makya™ for generative drug design and Spaya™ for retrosynthesis, and through strategic collaborations with pharma companies where Iktos mobilizes its unique platform and leading-edge capabilities to expedite small molecule drug discovery for the benefit of its partners. Iktos is also developing Iktos Robotics, a unique AI-driven synthesis automation platform which dramatically accelerates the Design-Make-Test cycle in drug discovery.
More information on: http://www.iktos.ai/

Press contacts
Iktos: Yann Gaston-Mathé (CEO) – contact@iktos.com 

Ulysse Communication
Nicolas Daniels – ndaniels@ulysse-communication.com / + 33 6 63 66 59 22
Iva Baytcheva – ibaytcheva@ulysse-communication.com / + 33 6 28 59 07 03

Attachments

• Iktos Roman Fleck
• CP Iktos_Nomination Roman Fleck VE VDef

Verona Pharma to Present Additional Analyses of Positive Phase 3 ENHANCE Studies in COPD at ATS 2024




Verona Pharma to Present Additional Analyses of Positive Phase 3 ENHANCE Studies in COPD at ATS 2024

PDUFA Target Action Date of June 26, 2024

Eight posters including two oral presentations support potential of ensifentrine,
an investigational, first-in-class, selective, dual inhibitor of PDE3 and PDE4

LONDON and RALEIGH, N.C., May 02, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces eight posters, including two mini oral symposia, on additional analyses from its successful Phase 3 ENHANCE studies with ensifentrine for the treatment of chronic obstructive pulmonary disease (“COPD”) will be presented at the American Thoracic Society International Conference (“ATS”) 2024. Pooled analysis demonstrating reductions in the rate and risk of exacerbations with ensifentrine will be presented as part of the ‘Late Breaking Mini Symposium’ designed to highlight new breakthroughs. The posters are published on the ATS website and in the publication, American Journal of Respiratory and Critical Care Medicine.

Ensifentrine is a novel selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. The investigational product is currently under review by the US FDA, and, if approved, is expected to be the first novel inhaled mechanism for the maintenance treatment of COPD in more than 20 years.

The posters are based on pooled analyses from the ENHANCE-1 and ENHANCE-2 trials, first reported by the Company on December 20, 2022, and August 9, 2022, respectively. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 demonstrating statistically significant improvements in lung function across both primary and secondary endpoints. In a pre-specified endpoint, ensifentrine substantially reduced the rate and risk of moderate/severe exacerbations in a pooled analysis of ENHANCE-1 and ENHANCE-2. The posters will summarize the efficacy and safety endpoints of ensifentrine when added to a long-acting muscarinic antagonist (“LAMA”) or a long-acting beta-agonist/inhaled corticosteroids (“LABA/ICS”), reductions in the rate of exacerbations regardless of eosinophil count and delayed progression of exacerbations, and the impact of ensifentrine on improving dyspnea. In addition, the Company will host an exhibition booth exploring the role of phosphodiesterase (“PDE”) in inflammation and lung function impairment in COPD as well as three innovation hub presentations led by clinical experts.

Frank Sciurba, MD, Associate Professor of Medicine at the University of Pittsburgh School of Medicine, commented: “These pooled analyses from the ENHANCE studies provide further evidence of ensifentrine’s potential to become an important therapy in a broad population of COPD patients. The substantial reduction in exacerbation rate and risk with ensifentrine is particularly exciting for patients and physicians.”

Details of Verona Pharma’s posters and the symposia are listed below and linked to the ATS website.

Late-Breaking Mini Symposium: Ensifentrine Reduces Exacerbation Frequency and Delays Progression from Gold B to Gold E
Presenter: Frank Sciurba, MD, University of Pittsburgh Medical Center
Session: B14 – Late Breaking Abstracts: Science that will impact clinical care

Mini Symposium: Ensifentrine added on to LAMA Therapy Improved Lung Function and Reduced Exacerbations in Symptomatic Subjects with Moderate-to-Severe COPD 
Presenter: Mark Dransfield, MD, University of Alabama Birmingham & Birmingham VA Medical Center
Session: C95 – New clinical trial results in chronic lung disease

Poster: P624 – Ensifentrine, A Novel, Selective Inhibitor of PDE3 and PDE4, Reduced Moderate/Severe Exacerbation Rate and Risk in Subjects With COPD Regardless of Baseline Blood Eosinophils
Participant: Frank Sciurba, MD, University of Pittsburgh Medical Center
Session: B52 – Evidence for therapeutic strategies in COPD: from established to emerging

Poster: P625 – Ensifentrine Added on to LABA/ICS Therapy Improved Lung Function and Reduced Exacerbations in Symptomatic Subjects With Moderate-to-Severe COPD
Presenter: Nathan Marchetti, MD, Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University
Session: B52 – Evidence for therapeutic strategies in COPD: from established to emerging

Poster: P704 – Improvements in Breathlessness, COPD Symptoms and Quality of Life Reported With Ensifentrine in a Pooled Analysis of the ENHANCE Trials
Presenter: Dave Singh, Professor of Respiratory Pharmacology at the University of Manchester
Session: A101 – Full metal jacket targeting COPD and chronic airways disease

Poster: P901 – Ensifentrine Added on to LAMA Therapy Improved COPD Symptoms and Quality of Life in Subjects With Symptomatic Moderate-to-Severe COPD
Presenter: Ravi Kalhan, MD, Pulmonology and Critical Care, Northwestern University
Session: A27 – Emerging treatments and therapeutic strategies in COPD: results of clinical trials and observational studies

Poster: P909 – Ensifentrine, A Novel, Selective Inhibitor of PDE3 and PDE4, Improved Dyspnea in Subjects With Symptomatic, Moderate-to-Severe COPD Over 24 Weeks
Presenter: Donald Mahler, MD, Valley Regional Hospital in Claremont
Session: A27 – Emerging treatments and therapeutic strategies in COPD: results of clinical trials and observational studies

Poster: P911 – Ensifentrine Added on to LABA/ICS Therapy Reduced Dyspnea and Improved Quality of Life in Subjects With Symptomatic Moderate-to-Severe COPD
Presenter: Antonio Anzueto, MD, Medicine/Pulmonary Critical Care, South Texas Veterans Healthcare System
Session: A27 – Emerging treatments and therapeutic strategies in COPD: results of clinical trials and observational studies

About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. In the third quarter of 2023, the US Food and Drug Administration accepted for review the Company’s NDA for ensifentrine for the maintenance treatment of patients with COPD and assigned a PDUFA target action date of June 26, 2024. If approved, ensifentrine has the potential to become the first inhaled non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule, and the first novel inhaled mechanism for the maintenance treatment of COPD in more than 20 years. The Company has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations in a pooled analysis from ENHANCE-1 and ENHANCE-2. Two additional formulations of ensifentrine have been evaluated in Phase 2 trials for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”); and a fixed-dose combination formulation with ensifentrine and glycopyrrolate, a LAMA, is currently under development, also for the treatment of COPD. Ensifentrine also has potential applications in cystic fibrosis, non-cystic fibrosis bronchiectasis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

For further information please contact:

Forward-Looking Statements

This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements relating to the timing of the FDA’s potential approval of the NDA for ensifentrine by the PDUFA date of June 26, 2024, or at any other time, statements regarding the potential for ensifentrine to be the first novel inhaled mechanism available for the maintenance treatment of COPD in over 20 years, the first therapy for the treatment of respiratory diseases to combine bronchodilator and non-steroidal anti-inflammatory effects in one molecule, and the potential of ensifentrine to become an important therapy in a broad population of COPD patients, the potential of ensifentrine in the treatment of cystic fibrosis, non-cystic fibrosis bronchiectasis, asthma and other respiratory diseases, and the potential of the DPI and pMDI formulations of ensifentrine.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how with third parties for the development and commercialization of ensifentrine; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, as updated in our Quarterly Reports on Form 10-Q and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

IBA signs contract with Yale New Haven Health and Hartford HealthCare to install Proteus®ONE proton therapy solution in Connecticut, US




IBA signs contract with Yale New Haven Health and Hartford HealthCare to install Proteus®ONE proton therapy solution in Connecticut, US

Louvain-La-Neuve, Belgium, 2 May 2024 – IBA (Ion Beam Applications S.A., EURONEXT), the world leader in particle accelerator technology, today announces that it has signed a contract with the Connecticut Proton Therapy Center, a collaboration between Yale New Haven Health, Hartford HealthCare and Proton International, for the installation of a Proteus^®ONE¹ compact proton therapy system. The contract includes a multi-year operation and maintenance agreement, and it is expected that the center will start treating patients in the spring of 2026. The first downpayment has been received.

The Connecticut Proton Therapy Center will be the first of its kind in the state, and located in Wallingford, Connecticut. Proton therapy treatments will be provided by physicians affiliated with the Yale School of Medicine, the Yale New Haven Smilow Cancer Hospital, and Yale Cancer Center, which is a National Cancer Institute-designated (NCI) Comprehensive Cancer Center, and the Harford HealthCare Cancer Institute

IBA’s Proteus^®ONE, as the only user-centric compact Imaged Guided Intensity Modulated Proton Therapy solution, includes an isocentric Cone Beam Computed Tomography (CBCT) system and an open gantry enabling high-quality treatments with optimized patient throughput and excellent user and patient experience.

The typical end-user price for a Proteus^®ONE system with a multi-year maintenance contract ranges between 40-50 million US dollars.

Olivier Legrain, Chief Executive Officer of IBA, commented: “We are very proud to have signed this contract, which, once installed, will provide patients in Connecticut with access to cutting-edge proton therapy technology. We look forward to working with Yale New Haven Health and Hartford HealthCare Corporation as they seek to deliver world-class cancer care to patients.”     

Peter Glazer, MD, PhD, chief of Radiation Oncology, Yale New Haven Hospital and chair, Therapeutic Radiology, Yale School of Medicine added: “We are pleased to have secured IBA as the technology leader to move forward with our proton therapy initiative, completing our panel of comprehensive cancer care. Our oncology experts are excited to provide this life changing treatment to our patients.”

Andrew Salner, M.D., Director of the Hartford HealthCare Cancer Institute, stated: “We are proud to be part of the first proton therapy project in the State of Connecticut and look forward to seeing the benefit to our community. Working with IBA will enable us to offer patients with the latest and most advanced proton therapy technology.”

Chris Chandler, Chief Executive Officer of Proton International LLV., said: “We are honored to assist the Connecticut Proton Therapy Center for the design and development of the facility which will be the first proton cancer treatment center in the State of Connecticut. At the moment patients have to travel out of state, the nearest locations being in New York City and Boston, to receive this advanced option for cancer treatment.”

***

About IBA
IBA (Ion Beam Applications S.A.) is the world leader in particle accelerator technology. The company is the leading supplier of equipment and services in the field of proton therapy, considered to be the most advanced form of radiation therapy available today. IBA is also a leading player in the fields of industrial sterilization, radiopharmaceuticals and dosimetry. The company, based in Louvain-la-Neuve, Belgium, employs approximately 2,000 people worldwide. IBA is a certified B Corporation (B Corp) meeting the highest standards of verified social and environmental performance.

IBA is listed on the pan-European stock exchange EURONEXT (IBA: Reuters IBAB.BR and Bloomberg IBAB.BB).

More information can be found at: www.iba-worldwide.com

About Hartford HealthCare Corporation (HHC)
HHC is a nonstock corporation existing under the laws of the State.  HHC was organized in 1985 and is the controlling entity of a series of affiliated entities that own and operate a health care system that offers a broad range of health care services to most residents of the State and to residents of more than two dozen towns and cities in Massachusetts and Rhode Island, through a network of seven hospitals, a behavioral health network, a multispecialty physician group, a variety of senior care facilities, home care services, and a comprehensive physical therapy and rehabilitation network, among other services.   HHC is governed by a 16-member Board of Directors.  Additional information about HHC can be found on its website: https://hartfordhealthcare.org/about-us.

About Yale New Haven Health Services Corporation (YNHHS)
YNHHS is a nonstock corporation existing under the laws of the State.  YNHHS was formed in 1996 to enhance the quality and scope of healthcare services of residents of the State and now serves the State as well as eastern New York, southern Rhode Island and beyond.  YNHHS includes five hospitals as well as other operating entities providing health care services across the health care continuum and has a formal affiliation agreement with Yale University School of Medicine (“YSM”) to support patient care, medical education and clinical research.  YNHHS is also affiliated with YSM’s clinical practice – Yale Medicine – which is the largest academic multispecialty practice in New England, with more than 1,500 physicians practicing in over 160 specialties.  YNHHS is governed by a 18-member Board of Trustees.  Additional information about YNHHS can be found on its website: https://www.ynhhs.org/about.

About Proton International
Proton International, www.protonintl.com, has an experienced team dedicated to bringing proton therapy to patients. The company works with hospitals and physician groups to develop one- and two-room proton therapy facilities on a turnkey basis. The PI team has developed and operated multiple centers and is currently active on several projects.

Proton International completed proton centers at William Beaumont Hospital in Royal Oak, Michigan University, Medical Center in Groningen, The Netherlands, Delray Beach, Florida; and Proton International Arkansas LLC where the centers are currently treating patients. The company has several additional centers under design and construction. PI’s business model ensures that projects are completed on time, on budget, and within the scope and needs of the institution. Services include business planning, organizational structure, financing, building design and construction, installation and commissioning, equipment, staff training, and more.

For further information, please contact:

IBA
Soumya Chandramouli
Chief Financial Officer
+32 10 475 890
Investorrelations@iba-group.com

Olivier Lechien
Corporate Communication Director
+32 10 475 890
communication@iba-group.com

For media and investor enquiries:
ICR Consilium
Amber Fennell, Angela Gray, Lucy Featherstone
+44 (0) 20 3709 5700
IBA@consilium-comms.com

¹ Proteus^®ONE is the brand name of Proteus®235

Attachment

• 240502-IBA-Yale-ProteusONE-EN-b

ONWARD® Medical Convocation of the 2024 Annual General Meeting of Shareholders and Proposed Resolutions




ONWARD® Medical Convocation of the 2024 Annual General Meeting of Shareholders and Proposed Resolutions

EINDHOVEN, the Netherlands, May 02, 2024 (GLOBE NEWSWIRE) — ONWARD Medical N.V. (Euronext: ONWD), a medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today has convened the 2024 Annual General Meeting of Shareholders (AGM), which will include consideration of the resolutions to be submitted for adoption at the AGM, which will be held in Amsterdam, the Netherlands, on June 13, 2024.

The resolutions, proposed by the Board, to be submitted for adoption at the AGM, are as follows:

• Adoption of the Company’s statutory annual accounts for the financial year ended December 31, 2023, prepared in accordance with International Financial Reporting Standards (IFRS-EU). The 2023 statutory accounts were filed with the Netherlands Authority for the Financial Markets (AFM) on April 25, 2024, and are posted on the Company’s website (www.ir.onwd.com) and the AFM’s website (afm.nl).

• Implementation of the compensation policy over the financial year 2023 (advisory non-binding voting item).

• Release from liability of the members of the Board with respect to the performance of their duties during the financial year 2023.

• Instruction to Ernst & Young Accountants LLP for the external audit of the Company’s annual accounts for the financial year 2024.

• Re-appointment of Mr. Jan Koch Øhrstrøm as non-executive director of the Board for a four-year term expiring at the end of the 2028 AGM.

• Re-appointment of Mr. John Paul de Koning as non-executive director of the Board for a four-year term expiring at the end of the 2028 AGM.

• Delegation of the authority of the Board to issue ordinary shares and to grant rights to subscribe for ordinary shares in the capital of the Company for 10% of the Company’s issued share capital and to limit or exclude pre-emptive rights in connection therewith.

• Delegation of the authority of the Board to issue ordinary shares and to grant rights to subscribe for ordinary shares in the capital of the Company for 50% of the Company’s issued share capital and to limit or exclude pre-emptive rights in connection with one or more potential capital raises, or strategic purposes.

• Authorization of the Board to acquire ordinary shares in the Company’s capital.

• Amendment of the Company’s articles of association.

The record date for all shareholders to participate at the AGM will be May 16, 2024. The convening notice, the complete agenda, and all relevant detailed information concerning the 2024 AGM, as well as all related AGM materials, are available on the Company’s website in the financial information of the Investors section (www.ir.onwd.com) and made available to shareholders in compliance with legal requirements as of May 2, 2024.

To learn more about ONWARD Medical’s commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit ONWD.com.

*All ONWARD Medical devices and therapies, including but not limited to ARC-IM^®, ARC-EX^®, ARC-BCI^™, and ARC Therapy^™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.

About ONWARD Medical

ONWARD^® Medical is a medical technology company creating therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and movement disabilities. Building on more than a decade of scientific discovery, preclinical, and clinical research conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company has developed ARC Therapy^™, which has been awarded ten Breakthrough Device Designations from the US Food and Drug Administration (FDA).

ONWARD ARC Therapy, which can be delivered by external ARC-EX^® or implantable ARC-IM^® systems, is designed to deliver targeted, programmed spinal cord stimulation. Positive results were presented in 2023 from the Company’s pivotal study, called Up-LIFT, evaluating the ability for transcutaneous ARC Therapy to improve upper extremity strength and function. The Company has submitted its regulatory application to the FDA for clearance of the ARC-EX System in the US and is preparing for regulatory submission in Europe. In parallel, the Company is conducting studies with its implantable ARC-IM Therapy, which demonstrated positive interim clinical outcomes for improved blood pressure regulation following SCI. Other ongoing studies include use of ARC-IM Therapy to address mobility after SCI and gait challenges in Parkinson’s disease as well as using the ARC-BCI platform to restore thought-driven movement of both upper and lower limbs after SCI.

Headquartered in Eindhoven, the Netherlands, ONWARD Medical has a Science and Engineering Center in Lausanne, Switzerland and a US office in Boston, Massachusetts. The Company is listed on Euronext Brussels and Amsterdam (ticker: ONWD).

For more information, visit ONWD.com, and connect with us on LinkedIn and YouTube.

For Media Inquiries:
Aditi Roy, VP Communications
media@onwd.com

For Investor Inquiries:
Khaled Bahi, Interim CFO
investors@onwd.com

Disclaimer

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

argenx to Report First Quarter 2024 Financial Results and Business Update on May 9, 2024




argenx to Report First Quarter 2024 Financial Results and Business Update on May 9, 2024

May 2, 2024

Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will host a conference call and audio webcast on Thursday, May 9, 2024 at 2:30 PM CET (8:30 AM ET) to discuss its first quarter 2024 financial results and provide a business update.

A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for approximately one year following the presentation.

Dial-in numbers:

Belgium         32 800 50 201
France                 33 800 943355
Netherlands         31 20 795 1090
United Kingdom 44 800 358 0970
United States         1 800 715 9871
Japan                 81 3 4578 9081
Switzerland         41 43 210 11 32

Use the access code 1231519 to join the call. Please dial in 15 minutes prior to the live call.

About argenx

argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan, Israel, the EU, the UK, Canada and China. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, X/Twitter, Instagram, Facebook, and YouTube.

For further information, please contact:

Media:

Ben Petok
BPetok@argenx.com

Investors:

Alexandra Roy (US)
aroy@argenx.com

Lynn Elton (EU)
lelton@argenx.com