Immunic Highlights 2024 Accomplishments and Upcoming Milestones

Issuer: Immunic AG

/ Key word(s): Miscellaneous

07.01.2025 / 12:30 CET/CEST

The issuer is solely responsible for the content of this announcement.

Immunic Highlights 2024 Accomplishments and Upcoming Milestones

Top-Line Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Expected in April – 

– Reported Positive Outcome from Interim Analysis of Ongoing, Twin Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Both Trials on Track to Be Completed in 2026 – 

– Strengthened Management Team and Board of Directors with Key Hires – 

– Announced a Three-Tranche Private Placement Totaling Up to $240 Million, Extending Cash Runway Into the Third Quarter of 2025, Based on Initial $80 Million Tranche – 

NEW YORK, January 7, 2025 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today highlighted its 2024 accomplishments and upcoming milestones.

“The past year was marked by substantial progress for our orally available lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), as we continued to advance both our phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and our twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS),” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “Looking ahead, we eagerly anticipate reporting top-line data from the CALLIPER trial in April. The previously reported interim results showed a clear reduction versus placebo in neurofilament light chain (NfL) levels across the PMS patient population, hinting to potential neuroprotective effects of the drug.”

“We also achieved a significant milestone for our phase 3 ENSURE program, having received a positive interim result from an unblinded Independent Data Monitoring Committee (IDMC), which concluded that the trials are not futile and recommended they should continue as planned, without any sample size increase. These favorable recommendations corroborated our initial assumptions about the design, powering and relapse rate of the trials and illustrate that they remain on track. The result makes us immensely confident and excited as we await the completion of the twin phase 3 trials: ENSURE-1 remains on track for completion in the second quarter of 2026, with ENSURE-2 expected to follow in the second half of 2026.”

Jason Tardio, President and Chief Operating Officer of Immunic, added, “Since joining Immunic in July 2024, we have ramped up our efforts preparing for the potential commercial launch of vidofludimus calcium. There continues to be a large unmet medical need for new therapeutic advancements in the treatment of MS that address both the neuroinflammatory and neurodegenerative aspects of the disease to better slow disability worsening. Vidofludimus calcium is the only medicine in development that targets activation of Nurr1 for neuroprotection and combines that with selective inhibition of DHODH for anti-inflammatory and antiviral effects. We believe our drug has the potential to become the first oral disease-modifying therapy approved to treat both relapsing and progressive MS to address the full spectrum of the disease.”

Dr. Vitt concluded, “In 2024, we were also honored to have had our previously reported results from the phase 1/1b clinical trial of IMU-856, our orally available and systemically acting small molecule modulator targeting Sirtuin 6 (SIRT6), a protein which serves as a transcriptional regulator of intestinal barrier function and physiological regeneration of bowel epithelium, published in the peer reviewed journal, The Lancet Gastroenterology & Hepatology. Data from this study showed that, in patients with celiac disease during periods of gluten-free diet and gluten challenge, IMU-856 demonstrated positive effects over placebo in four key dimensions of celiac disease, including protection of the gut architecture, improvement of patients’ symptoms, biomarker response, and enhancement of nutrient absorption. We continue to believe that IMU-856 could offer a new therapeutic approach for various gastrointestinal disorders, also beyond celiac disease.”

2024 Corporate Highlights

  • Strengthened the Board of Directors in July, with the appointment of Simona Skerjanec, M.Pharm, MBA, a thought-leader in brain health with decades of experience.
  • In July, appointed seasoned biopharmaceutical executive, Jason Tardio, as President and Chief Operating Officer, to lead internal efforts in positioning the company for the potential launch of vidofludimus calcium and to work closely with Patrick Walsh, Chief Business Officer, to prepare the company for a range of potential partnership outcomes. Additionally, reported that Werner Gladdines, former Vice President, Program Management & Clinical Development Operations, was promoted to Chief Development Officer.
  • Announced a three-tranche private placement totaling up to $240 million, with participation from select new and existing investors, in January. The initial tranche successfully closed on January 8, 2024, with Immunic securing $80 million in gross proceeds. 

Vidofludimus Calcium 2024 Highlights and Upcoming Milestones

  • Completion of the ENSURE-1 trial of vidofludimus calcium in RMS is anticipated in the second quarter of 2026, with completion of ENSURE-2 expected in the second half of 2026.
  • Top-line data for the phase 2 CALLIPER trial of vidofludimus calcium in PMS is expected in April of this year.
  • Announced a positive outcome of the interim analysis of the phase 3 ENSURE program, investigating vidofludimus calcium for the treatment of RMS, in October. An unblinded IDMC confirmed that the trials are not futile and recommended they should continue without changes, including no need for a potential increase of the sample size.
  • Presented key data on vidofludimus calcium in four presentations at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in September. The data included the NfL interim data from the phase 2 CALLIPER trial, antiviral data suggesting an effect on reducing fatigue, Nurr1 target data supporting a neuroprotective profile, and pathogenic T cell data further supporting the drug’s anti-inflammatory effects.
  • Announced enrollment of the first patient in the investigator-sponsored phase 2 RAPID_REVIVE trial of vidofludimus calcium in patients with post COVID syndrome in September.
  • Hosted an MS R&D Day in New York City in September, focused on vidofludimus calcium’s potential to become the treatment of choice for both RMS and PMS patients. Presenting MS industry experts included Francesca Montarolo, Ph.D., Neuroscience Institute Cavalieri Ottolenghi (NICO) and University of Turin, Italy and Amit Bar-Or, M.D., FRCPC, Department of Neurology, Perelman School of Medicine, University of Pennsylvania.
  • Published extended data from the phase 2 EMPhASIS trial of vidofludimus calcium in relapsing-remitting MS in the peer reviewed journal, Neurology® Neuroimmunology & Neuroinflammation, an official journal of the American Academy of Neurology, in April.
  • Hosted an MS R&D Day in San Francisco in April, during which management discussed the latest developments in the MS landscape, along with recent preclinical and clinical data supporting the neuroprotective potential of vidofludimus calcium.
  • Received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) in March, for a patent covering the composition-of-matter of a specific polymorph of vidofludimus calcium and a related method of production of the material. The company’s multilayered intellectual property strategy now provides protection into 2041 in the United States, unless extended further.
  • Presented data from the company’s phase 2 CALLIPER and CALVID-1 trials of vidofludimus calcium, in two poster presentations at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024 in February.

IMU-856 2024 Highlights and Upcoming Milestones 

  • Announced the publication of data from the phase 1/1b clinical trial of IMU-856 in the peer reviewed journal, The Lancet Gastroenterology & Hepatology in November.
  • Based on the positive data from the phase 1b clinical trial, the company continues preparing for clinical phase 2 testing of IMU-856, contingent on financing, licensing or partnering. 

Immunic’s management, business development and investor relations teams will be hosting one-on-one meetings in connection with the 43rd Annual J.P. Morgan Healthcare Conference taking place January 13-16, 2025, in San Francisco. To schedule a meeting, please contact: Jessica Breu at jessica.breu@imux.com. 

About Immunic, Inc.

Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company’s lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com. 

Cautionary Statement Regarding Forward-Looking Statements 

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic’s development programs and the targeted diseases; the potential for Immunic’s development programs to safely and effectively target diseases; preclinical and clinical data for Immunic’s development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; the executive and board structure of the company; and the company’s expected cash runway. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, including the ability to satisfy the minimum average price and trading volume conditions required to receive funding in tranche 2 and 3 of the January 2024 private placement, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned “Risk Factors,” in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024, and in the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.

Contact Information 
 
Immunic, Inc. 
Jessica Breu 
Vice President Investor Relations and Communications
+49 89 2080 477 09 
jessica.breu@imux.com 

US IR Contact                                                                                                                                Rx Communications Group                                                                                                         Paula Schwartz                                                                                                                               +1 917 633 7790                                                                                                     immunic@rxir.com 

US Media Contact                                                                                                                    KCSA Strategic Communications                                                                                               Caitlin Kasunich                                                                                                                               +1 212 896 1241                                                                                                    ckasunich@kcsa.com


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Pentixapharm Receives EUR 6.77 Million for Intangible Assets Formerly Developed by Glycotope

EQS-News: Pentixapharm Holding AG

/ Key word(s): Agreement

Pentixapharm Receives EUR 6.77 Million for Intangible Assets Formerly Developed by Glycotope

07.01.2025 / 10:30 CET/CEST

The issuer is solely responsible for the content of this announcement.

Berlin, January 7th, 2025 – Pentixapharm AG, a developer of innovative radiopharmaceuticals, receives 6.77 million Euro for intangible assets formerly developed by Glycotope from undisclosed Asian pharma and biotech companies. The transaction, which will be effective still in 2024, involves rights that had been transferred to Pentixapharm as part of the acquisition of Glycotope’s target discovery business in July 2024.

“The deal eliminates almost all of the remaining obligations from an earn-out that Pentixapharm had accepted with the purchase of the target discovery business”, comments Henner Kollenberg, Chief Business Officer. “While it will not significantly reduce the losses of Pentixapharm in 2024, it paves the way for the monetization other Glycotope assets acquired by Pentixapharm. The transaction also confirms the ongoing interest of major industry players in the know-how maintained and now furthered by Pentixapharm”.

The acquisition of Glycotope’s target discovery business in July 2024 included a portfolio of preclinical antibodies against multiple oncology targets, a unique tumor target database, the equipment needed to exploit a discovery platform, and the related IP. Transferred to Pentixapharm as part of the deal were also a range of patents, licenses and license agreements.

About Pentixapharm

Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals with offices in Berlin and Würzburg, Germany. It is committed to developing ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs. Its pipeline features CXCR4-targeted compounds as well as early-stage radionuclide-antibody conjugates addressing hematological and solid cancers, as well as cardiovascular, endocrine, and inflammatory diseases.

 

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com


07.01.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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Kuros Biosciences USA, Inc. announces an exclusive strategic agreement with the Medtronic spinal division

Kuros Biosciences AG / Key word(s): Agreement

07-Jan-2025 / 07:00 CET/CEST

Release of an ad hoc announcement pursuant to Art. 53 LR

The issuer is solely responsible for the content of this announcement.


  • Medtronic will act as the exclusive sales agent of MagnetOsTM for Kuros Biosciences USA, Inc. in mutually agreed upon sales territories for use in spine surgeries
  • Kuros will work collaboratively to sell, market and provide support services to Medtronic’s sales force
  • Kuros will keep responsibility for contracts, hospital partnerships and the recognition of revenue from sales
  • Kuros will continue to sell directly in non-contracted territories as well as in markets outside of spine
  • This agreement transforms an initial trial agreement into a strategic alliance 

Schlieren, Switzerland, January 7, 2025 – Kuros Biosciences USA Inc., (“Kuros”), a wholly owned subsidiary of Kuros Biosciences AG, a global leader in advanced musculoskeletal bone healing technologies, today announced a strategic five-year, exclusive sales agency agreement with Medtronic, a leading global healthcare technology company. The agreement provides Medtronic with exclusivity in certain spine geographies within the U.S. market, underscoring a shared commitment to expanding access to Kuros’ pioneering MagnetOs bone grafting technology.

This agreement positions Kuros for new opportunities in the U.S. spine market and also paves the way for broader adoption of the MagnetOs family of products, which are supported by robust clinical data and innovative designs. This agreement transforms an initial trial agreement into a strategic alliance for a period of five years.

Chris Fair, Chief Executive Officer of Kuros Biosciences, commented: “What started as a trial agreement has now evolved into a strategic alliance with Medtronic reflecting an important milestone for Kuros. This agreement will also help us drive the scaling up process, further optimize our operating leverage, and continue our rapid revenue growth both with Medtronic and in our own direct channels.”

For further information, please contact:

Kuros Biosciences AG 
Alexandre Müller
Investor Relations
t: +41 43 268 32 31

e: IR@kurosbio.com
Daniel Geiger
Chief Financial Officer
t: +41 79 673 43 69 
e: daniel.geiger@kurosbio.com

 

About MagnetOs
MagnetOs is a bone graft like no other: thanks to its NeedleGripTM surface technology, it grows bone even in soft tissues. This surface technology provides traction for our body’s vitally important ‘pro-healing’ immune cells (M2 macrophages). This in turn, unlocks previously untapped potential to stimulate stem cells – and form new bone throughout the graft. The growing body of science behind NeedleGrip is called osteoimmunology. But for surgeons and their patients it means one thing: a more predictable fusion. *†‡1-5

Indications statement
Please refer to the instructions for use for your local region for a full list of indications, contraindications, warnings and precautions.

About Kuros Biosciences
Kuros Biosciences is on a mission to discover, develop and deliver innovative biologic technologies. With locations in the United States, Switzerland and the Netherlands, the company is listed on the SIX Swiss Exchange. The company’s first commercial product, MagnetOsTM, is a unique advanced bone graft that has already been used across four continents. For more information on the company, its products and pipeline, visit kurosbio.com.

Forward Looking Statements
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors. Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

*Results from in vivo laboratory testing may not be predictive of clinical experience in humans. For important safety and intended use information please visit kurosbio.com.
MagnetOs is not cleared by the FDA or TGA as an osteoinductive bone graft.
MagnetOs has been proven to generate more predictable fusions than two commercially available alternatives in an ovine model of posterolateral fusion.

1.    Van Dijk, et al. eCM. 2021; 41:756-73.
2.    Duan, et al. eCM. 2019; 37:60-73.
3.    Van Dijk, et al. Clin Spine Surg. 2020;33(6): E276-E287.
4.    Van Dijk, et al. JOR Spine. 2018; e1039.
5.    Van Dijk, et al. J Biomed Mater Res. Part B: Appl Biomater. 2019;107(6):2080-2090.


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CHEPLAPHARM expands Management with Tamás Szóga as VP Commercial

EQS-News: Cheplapharm AG

/ Key word(s): Personnel

CHEPLAPHARM expands Management with Tamás Szóga as VP Commercial

02.01.2025 / 09:14 CET/CEST

The issuer is solely responsible for the content of this announcement.

CHEPLAPHARM EXPANDS MANAGEMENT WITH TAMAS SZOGA AS VP COMMERCIAL

 

Greifswald, January 2, 2025
 

The globally active CHEPLAPHARM Group, headquartered in Greifswald, is continuing to position itself for the future and is expanding its management team. Tamás Szóga started as Vice President (VP) Commercial on 1 January 2025. The position was newly created. Tamás Szóga comes from Recordati Spa and takes over the Commercial division for the entire CHEPLAPHARM Group. 

As VP Commercial, Tamás Szóga is responsible for the strategic planning and management of the Global Sales division of the entire CHEPLAPHARM Group. This includes developing and implementing strategies to optimise the existing sales organisation and ensuring targeted distributor management. Tamás Szóga is also responsible for the management and development of the CHEPLAPHARM affiliates. 

 

‘Maximisation of growth through strategic brand development and implementation of innovative commercial strategies will be the main tasks for Tamás Szóga. The newly created position of VP Commercial demonstrates the importance of this function within the company. I am therefore delighted that we have been able to recruit Tamás Szóga, a leader with two decades of expertise in the development of markets and product portfolios in the pharmaceutical industry,’ says Edeltraud Lafer, CEO of the CHEPLAPHARM Group. 

 

About Tamás Szóga

Tamás Szóga joins from Recordati Spa, where he has been responsible for portfolio development in 30 markets and Managing Director for the international business since the beginning of 2022. Prior to this, he was Director, Strategic Projects at EGIS focusing on global initiatives. He spent the longest part of his career at GlaxoSmithKline for 18 years across various geographies, where he held positions with increasing responsibility in portfolio development, commercial operations, market access and business development. Tamás Szóga started his career at management consultancies such as KPMG and Ernst & Young. Tamás Szóga holds an economist degree with finance and accountancy specification from Budapest Business University.

About CHEPLAPHARM

CHEPLAPHARM is a family-owned company with headquarters in Greifswald. For over 20 years, the company has been very successful in taking over well-known and well-established medicines from the research-based pharmaceutical industry and transferring them to an existing global network of partners for production and distribution. In this way, CHEPLAPHARM ensures the continuous supply of these medicines to patients worldwide. In addition to its headquarters in Greifswald, CHEPLAPHARM operates further sites in France, Japan, Russia and Switzerland. The company employs around 780 people worldwide.

 

Please refer to www.cheplapharm.com for additional information.

 

Press office:

CHEPLAPHARM ǀ Ziegelhof 24 ǀ 17489 Greifswald ǀ press(at)cheplapharm.com


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Change in Evolva Holding SA’s shareholder structure

Evolva Holding SA / Key word(s): Disposal

30-Dec-2024 / 07:00 CET/CEST

Release of an ad hoc announcement pursuant to Art. 53 LR

The issuer is solely responsible for the content of this announcement.


 PRESS RELEASE | AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR
 

Change in Evolva’s shareholder structure

Reinach, Switzerland, 30 December 2024 — Evolva Holding SA (SIX: EVE) (“Evolva”) was informed by its largest shareholder Nice & Green SA, Nyon, that it had sold all its Evolva shares to an unnamed third party.

Nice & Green SA, Nyon, Evolva’s largest shareholder with a latest reported shareholding of 19.344%, informed Evolva that it had sold all its Evolva shares to a third party. The identity of the third party is currently unknown to Evolva. Under applicable shareholding disclosure rules, the new investor is required to notify Evolva and the Disclosure Office of SIX Exchange Regulation AG within four trading days of the transaction. Evolva has the obligation to publish the disclosure within two trading days as of its receipt on the electronic publishing platform of the Disclosure Office.

 

Contact Evolva
Doris Rudischhauser
Investor Relations and Corporate Communications
+41 79 410 81 88
investors@evolvaholding.com

 

Disclaimer
This announcement is not an offer of securities into the United States. The securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and may not be offered, pledged, sold, delivered or otherwise transferred, directly or indirectly, in the United States, except pursuant to an exemption from, or transaction not subject to, the registration requirements of the Securities Act. No public offering of securities is being made in the United States. Further, the securities referred to herein have not been and will not be registered under the applicable securities laws of Canada, Australia or Japan or under the applicable securities laws of any other jurisdiction where to do so might constitute a violation of such laws.             
This press release contains specific forward-looking statements, e.g. statements including terms like believe, assume, expect or similar expressions. Such forward-looking statements are subject to known and unknown risks, uncertainties and other factors which may result in a substantial divergence between the actual results, financial situation, development or performance of the company and those explicitly or implicitly presumed in these statements. Against the background of these uncertainties readers should not place undue reliance on forward-looking statements. The company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.

Additional features:

File: Change in Evolva Holding SA’s shareholder structure


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Relief Therapeutics Provides Update on Potential Transaction with Renexxion

Relief Therapeutics Holding SA

/ Key word(s): Merger

Relief Therapeutics Provides Update on Potential Transaction with Renexxion

27.12.2024 / 07:00 CET/CEST

Relief Therapeutics Provides Update on Potential Transaction with Renexxion

GENEVA (DEC. 27, 2024) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTFRLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today provided an update on the potential reverse merger with Renexxion, Inc. (Renexxion), a privately-held U.S.-based clinical-stage biotechnology company specializing in gastrointestinal disorders therapies.

Following the announcement of the non-binding letter of intent earlier this year, Relief and Renexxion have made significant progress in advancing their transformative partnership and both companies are working closely to ensure the transaction is structured for long-term success. Efforts have concentrated on transaction structuring and integration planning to support the combined entity’s future growth. On this foundation, the parties now anticipate signing a definitive merger agreement in Q1 2025.

“As we continue discussions with Renexxion, we are focused on leveraging the complementary strengths of both companies to maximize value for our shareholders and stakeholders,” commented Dr. Raghuram Selvaraju, chairman of the board of directors of Relief. “At the same time, we are building on the recent advancements in Relief’s core development programs, with critical milestones expected in the coming year.”

While discussions and planning are progressing positively, there can be no assurance that a definitive agreement will be reached or that the proposed transaction will be completed as planned. Completion of the transaction remains subject to customary conditions.

ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief’s portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented TEHCLO™ and Physiomimic™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Headquartered in Geneva, Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

ABOUT RENEXXION
Renexxion, Inc. is a clinical-stage biopharmaceutical company pioneering therapies for gastrointestinal (GI) disorders. Renexxion’s lead compound, naronapride, is a potential best-in-class, highly selective dual-action 5-HT4 agonist/D2-antagonist prokinetic agent designed to enhance GI motility with minimal systemic absorption. Naronapride is currently being studied in a Phase 2 clinical trial for gastroparesis in collaboration with Renexxion’s strategic European partner, a leader in GI therapeutics. Additionally, Renexxion has received FDA IND clearance for naronapride as a potential treatment for proton pump inhibitor non-responsive symptomatic gastroesophageal reflux disease (PPI-nrsGERD). Through strategic partnerships, scientific advancements, and a commitment to addressing patients with high-unmet need, Renexxion aims to redefine GI healthcare and deliver transformative solutions for millions of patients worldwide. For more information, visit www.renexxion.com.

CONTACT:
RELIEF THERAPEUTICS Holding SA

Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com

DISCLAIMER
This press release contains forward-looking statements, which may be identified by words such as “believe,” “assume,” “expect,” “intend,” “may,” “could,” “will,” or similar expressions. These statements are based on current plans and assumptions and are subject to risks and uncertainties that could cause actual results, financial condition, performance, or achievements to differ materially from those expressed or implied. Such factors include, but are not limited to, changes in economic conditions, market developments, regulatory changes, competitive dynamics, and other risks or changes in circumstances. This communication is provided as of the date hereof, and Relief undertakes no obligation to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Participants in the Solicitation: Relief and Renexxion and their respective directors and officers and other members of management and employees may be deemed participants in the solicitation of proxies in connection with the proposed transaction. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies from Relief’s and Renexxion’s shareholders in connection with the proposed business transaction will be included in the definitive proxy statement/prospectus that Relief, Renexxion or a combined company intends to file with relevant regulatory authorities.

No Offer or Solicitation: This press release does not constitute (i) a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination or (ii) an offer to sell, a solicitation of an offer to buy, or a recommendation to buy any security of Renexxion, Relief or any of their respective affiliates. There shall not be any sale of any securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the laws of such other jurisdiction. No offering of securities in the United States shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.


Additional features:

File: Press release


End of Media Release


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Abivax Announces a Change to the Composition of its Board of Directors

EQS-News: ABIVAX

/ Key word(s): Personnel

Abivax Announces a Change to the Composition of its Board of Directors

23.12.2024 / 22:05 CET/CEST

The issuer is solely responsible for the content of this announcement.

Abivax Announces a Change to the Composition of its Board of Directors

PARIS, France, December 23, 2024, 10:05 PM CEST – Abivax SA (Euronext Paris & Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to modulate the inflammatory response in patients with chronic inflammatory diseases, today announced that Dr. Philippe Pouletty, representative of Truffle Capital, tendered his resignation as director of the Company effective on December 31, 2024. Dr. Philippe Pouletty’s decision is directly related to his appointment last week as Chairman and acting Chief Executive Officer of a French listed biotechnology company in the field of plastics recycling. Dr. Pouletty, also CEO of Truffle Capital, was Chairman of the Board of Directors of Abivax from the inception of the Company in December 2013 until August 2022 and has continued as a Board member since then.

Philippe Pouletty, MD said: “It is a great pride for me and Truffle Capital to have founded Abivax and to have contributed to the development of obefazimod for over a decade.  I am convinced that Abivax, led by a strong CEO, management team, and board of directors, has the potential to help hundreds of thousands of patients suffering from severe inflammatory diseases. I expect Truffle Capital to continue to be a great supporter of Abivax as a major shareholder through the next several inflection points, including the expected Phase 3 ABTECT data readout in 2025.”   

Sylvie Grégoire, PharmD, Chair of the Board of Abivax: “On behalf of the Board of Directors of Abivax I would like to thank Philippe for his numerous and significant contributions to Abivax over the past several years.  As a founder and former chairman, Dr. Pouletty has played a pivotal role in guiding the Company to the forefront of therapeutic innovation, particularly in the development of Abivax’s lead drug candidate, obefazimod, which is now in Phase 3 clinical trials for ulcerative colitis. We will initiate a search to complete the board composition with a strong candidate to contribute to the advancement of Abivax’s late-stage pipeline in IBD.”
 

About Abivax

Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to modulate the inflammatory response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. More information on the Company is available at www.abivax.com. Follow us on LinkedIn and on X, formerly Twitter, @Abivax.

*****

Contact:

Patrick Malloy
SVP, Investor Relations Abivax
patrick.malloy@abivax.com
+1 847 987 4878
 

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, including those relating to the Company’s business objectives. Words such as “intend,” “may,” “would,” “will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning or implying the therapeutic potential of Abivax’s drug candidates, the availability and timing of data from its clinical trials, Truffle Capital’s expected future support of the Company, the Company’s intentions regarding its search for a new Board member, and other statements that are not historical fact. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in its Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 5, 2024 under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development, including further assessment by the Company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are made only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell or the solicitation of an offer to purchase or subscribe for securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.


23.12.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


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Xlife Sciences AG Announces Potential Acquisition of Portfolio Company FUSE-AI GmbH by Pineapple Power Corporation PLC at an Expected Valuation of EUR 80-90 million

Xlife Sciences AG / Key word(s): IPO

23-Dec-2024 / 18:35 CET/CEST

Release of an ad hoc announcement pursuant to Art. 53 LR

The issuer is solely responsible for the content of this announcement.


Zurich, 23rd of December 2024: Xlife Sciences AG (SIX: XLS) is pleased to announce that its portfolio company, FUSE-AI GmbH, is engaged in discussions regarding a potential acquisition by Pineapple Power Corporation PLC, a UK-based company listed on the London Stock Exchange. The proposed transaction would represent a significant milestone in FUSE-AI GmbH’s journey to expand its innovative AI-powered solutions for the clinical sector.

The acquisition would include all shares of FUSE-AI GmbH, with the consideration to be provided in the form of shares issued by Pineapple Power Corporation PLC. This transaction, if finalized, would constitute a reverse takeover under the UK Listing Rules, paving the way for FUSE-AI GmbH to access global capital markets and further expand its operations.

The proposed transaction is expected to value FUSE-AI GmbH at EUR 80-90 million, reflecting its strong market potential and technological leadership in the field of medical AI. Pineapple Power Corporation PLC intends to acquire 100% of the issued share capital of FUSE-AI GmbH, with Xlife Sciences AG, as the largest shareholder with a 42.25% stake, set to significantly benefit from this milestone transaction. This valuation and stake highlight the strategic importance of FUSE-AI GmbH within Xlife Sciences AG’s portfolio and the broader healthcare innovation landscape.

Matthias Steffens, CEO of FUSE-AI GmbH, stated: «This development highlights the strong position of FUSE-AI GmbH in delivering cutting-edge AI solutions for clinical diagnostics. We are excited about the opportunities this collaboration can bring in reaching new markets and driving innovation.»

Oliver R. Baumann, CEO of Xlife Sciences AG, commented: «The potential acquisition of FUSE-AI GmbH by Pineapple Power Corporation PLC underscores the strength of Xlife Sciences AG’s approach to fostering groundbreaking technologies and providing them with strategic paths to growth and scalability. This transaction exemplifies our commitment to bridging the gap between research and commercialization.»

FUSE-AI GmbH is recognized for its innovative solution, «Prostate.Carcinoma.ai», which significantly enhances the efficiency and accuracy of prostate MRI analysis. With additional applications under development and an established distribution network in over 42 countries, FUSE-AI GmbH is well-positioned for continued growth in the field of medical AI.

Further details about the proposed acquisition and transaction timeline will be shared as they become available.

 

Financial calendar

Annual Report 2024 25 April 2025
Annual Shareholders Meeting 2025 24 June 2025
Half-Year Report 2025 23 September 2025

Kontakt
Information for investors and journalists: Xlife Sciences AG, Dr. Dennis Fink, dennis.fink@xlifesciences.ch

Xlife Sciences AG, 
Talacker 35, 
8001 Zurich, 
Switzerland,
Phone +41 44 385 84 60
info@xlifesciences.ch, www.xlifesciences.ch
Commercial Register Zurich CHE-330.279.788 
Stock Exchange: SIX Swiss Exchange


End of Inside Information


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Siegfried once again confirmed in the Dow Jones Sustainability Index Europe

Siegfried AG

/ Key word(s): Sustainability

Siegfried once again confirmed in the Dow Jones Sustainability Index Europe

23.12.2024 / 06:30 CET/CEST

Media Release
Zofingen, December 23, 2024

The DJSI is a highly regarded benchmark for evaluating corporate progress in environmental, social, and governance (ESG) performance across industries. Siegfried stands as the sole Contract Development and Manufacturing Organization represented in the DJSI Europe. 

Luca Dalla Torre, General Counsel and Chairman of the Siegfried Sustainability Board: “Being recognized as a sustainability leader in the DJSI Europe is a proud achievement for Siegfried and a testament to our unwavering commitment to sustainability. As one of our five core values and a cornerstone of our long-term strategy, sustainability drives us to continuously improve and advance ambitious ESG initiatives across our global network. This acknowledgment affirms our approach and inspires us to continue shaping a sustainable future.” 

Siegfried has been once again recognized as a sustainability leader with the inclusion in the Dow Jones Sustainability Index Europe (DJSI) for the fourth consecutive year. 

Contact  
   
Financial Analysts: Media:
   
Dr. Reto Suter Peter Stierli
Chief Financial Officer Head Corporate Communications
reto.suter@siegfried.ch peter.stierli@siegfried.ch
Tel. +41 62 746 11 35 Tel. +41 62 746 15 51
   
   
Siegfried Holding AG  
Untere Bruehlstrasse 4  
CH-4800 Zofingen  

About Siegfried

The Siegfried Group is a global life sciences company with sites in Switzerland, Germany, Spain, France, Malta, the USA and China. In 2023, the company achieved sales of CHF 1.272 billion and employed on 31.12.2023 more than 3700 people at twelve sites on three continents. Siegfried Holding AG is publicly listed on the SIX Swiss Exchange (SIX: SFZN).

Siegfried is active in manufacturing pharmaceutical APIs (and their intermediates) as well as drug products (tablets, capsules, sterile vials, ampoules, cartridges and ointments) for the pharmaceutical industry and provides development services. 

Cautionary Statements Regarding Forward-Looking Statements

This media release includes statements concerning the future. They are based on assumptions and expectations that may prove to be wrong. They should be considered with due caution as, by definition, they contain known and unknown risks, insecurities and other factors which could result in a difference in the actual results, financial situation, developments or the success of Siegfried Holding AG or Siegfried Group from the explicit or implicit assumptions made in these statements.

expect more
 

Siegfried AG
Untere Brühlstrasse 4
4800 Zofingen, Switzerland

+41 62 746 11 11
info@siegfried.ch
www.siegfried.ch

 


End of Media Release


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Viromed Medical AG completes acquisition of pharmedix GmbH

Viromed Medical AG / Key word(s): Takeover/Mergers & Acquisitions

Viromed Medical AG completes acquisition of pharmedix GmbH

20-Dec-2024 / 14:05 CET/CEST

Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News – a service of EQS Group.

The issuer is solely responsible for the content of this announcement.


Viromed Medical AG completes acquisition of pharmedix GmbH

  • Notarial purchase agreement signed today
  • Consolidated revenues are expected to multiply to a low double-digit million euro amount in fiscal year 2025.

Pinneberg, 20 December 2024 – Today, Viromed Medical AG (Ticker: VMED; ISIN: DE000A3MQR65) completed the announced acquisition of pharmedix GmbH by notarized purchase agreement. The acquisition is effective as of 1 January 2025. Following the successful acquisition of pharmedix GmbH, Viromed Medical AG now expects consolidated revenues in the low double-digit million euro range for the 2025 financial year, a significant increase over the previous year.

 

Contact Viromed Medical AG

Uwe Perbandt
CEO
Flensburger Straße 18
25421 Pinneberg
E-Mail: kontakt@viromed-medical.de
www.viromed-medical-ag.de

End of Inside Information


20-Dec-2024 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


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