Media release

Doubling of production capacity at the manufacturing site in Malmö

Baar, 8 January 2025 – PolyPeptide Group AG (SIX: PPGN), a focused global CDMO for peptide-based active pharmaceutical ingredients, announces the planned doubling of solid-phase peptide synthesis (SPPS) capacity at its manufacturing site in Malmö, Sweden.

The construction work is already underway, along with the supporting infrastructure, including a tank farm. PolyPeptide uses its proprietary manufacturing technology with an integrated engineering design and advanced automation and process control to ensure high productivity, safety, and sustainability. A modular approach is intended to accelerate time to market, while enhancing flexibility to ensure high utilization. As part of its mid-term outlook communicated on 13 August 2024, PolyPeptide plans to invest around EUR 100 million at the site and to create approximately100 permanent new positions.

The additional production capacity will mainly serve to fulfill one of the large commercial agreements previously communicated by PolyPeptide. It relates to one of the growth initiatives reflected in the mid-term outlook, whereby PolyPeptide targets to double 2023 revenue by 2028 and to deploy capital expenditures of 15% to 20% of revenue to ensure capacity, also beyond 2028.

Juan José González, CEO of PolyPeptide: “The large-scale capacity expansion in Malmö allows us to further deepen the long-standing collaboration with an important GLP-1 customer. We are making good progress with the implementation of our growth strategy to meet our mid-term targets, benefiting from balanced, supportive partnerships with customers.”

Contact

PolyPeptide Group AG

Michael Stäheli

Head of Investor Relations & Corporate Communications

michael.staeheli@polypeptide.com

T: +41 43 502 0580

About PolyPeptide

PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a focused Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide offers products and services from pre-clinical through to commercial stages, including generics. Its active custom projects pipeline reflects the opportunities from novel drug therapies in development to fight both widespread and rare diseases. Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India. PolyPeptide’s shares (SIX: PPGN) are listed on SIX Swiss Exchange.

For more information, please visit polypeptide.com.  

@PolyPeptide – follow us on LinkedIn

Disclaimer

This media release has been prepared by PolyPeptide Group AG and contains certain forward-looking statements that reflect the current views of management. Such statements are subject to known and unknown risks, uncertainties and other factors that may cause actual developments to differ materially from those expressed or implied in this release. In particular, the statements related to the guidance for 2024, and mid-term outlook constitute forward-looking statements and are not guarantees of future financial performance. The Group’s actual results of operations could deviate materially from those set forth in the guidance for 2024 and mid-term outlook. As such, investors should not place undue reliance on the statements related to the guidance for 2024 and mid-term outlook. PolyPeptide Group AG is providing the information in this release as of this date and, except as required by applicable laws or regulations, does not undertake any obligation to update any statements contained in it as a result of new information, future events or otherwise.

Press Release

QUANTRO Therapeutics achieves breakthrough in transcriptomic drug discovery with first successful simultaneous 10-target multiplex-screening

• QUANTRO’s proprietary time-resolved functional transcriptomic discovery platform accelerates target screening for complex indications in oncology and inflammation
• QUANTRO CEO Dr. Michael Bauer to attend Biotech Showcase and participate in the WuXi Global Forum in San Francisco, January 13-16, 2025

Vienna, Austria, 7 January 2025: QUANTRO Therapeutics (QUANTRO), a pioneer in the discovery of first-in-class transcription factor targeting cancer treatments, announced today that the company has successfully completed its first ten-target multiplex-screening campaign, which yielded validated hits and functional proof of on-target activity for multiple molecular targets. This milestone further expands the capability to establish QUANTRO’s innovative QUANTROseq^® platform as a pioneering technology in the fight against diseases driven by transcriptional dysregulation, such as cancer and inflammation indications.

After successfully establishing its technology for single- and dual-target screenings at a current capacity of approximately one million compounds per year, QUANTRO has now completed the first-ever simultaneous 10-target multiplexing high-throughput screening (HTS). This pilot project, which screened a 10,000-compound diversity library, met all quality control criteria and achieved a 100% hit rate for both positive and negative controls. Furthermore, the QUANTROseq^® platform identified high-quality hits across most of the selected targets, providing deep insights into transcriptional changes as well as on-target potency and selectivity, while minimizing off-target effects.

“This achievement represents a significant breakthrough for QUANTRO and more broadly for drug discovery, unlocking unprecedented opportunities for the discovery of novel targeted therapies,” said Dr. Michael Bauer, CEO of QUANTRO. “By advancing our capabilities from single and dual target screenings now up to currently 10-target multiplexed high-throughput screenings, we are effectively profiling entire compound libraries for multiple targets, redefining the possibilities in transcription factor drug discovery. The unparalleled precision and depth of information generated by our QUANTROseq® platform now enable us to rapidly create proprietary compound libraries for a wide range of targets, including those previously deemed ‘undruggable’.”

Meet QUANTRO at Biotech Showcase in San Francisco, USA, January 13-16, 2025

QUANTRO also confirms its attendance at Biotech Showcase, a premier investor conference for private and micro-mid-cap biotechnology companies. Dr. Michael Bauer, CEO of QUANTRO, will participate in this important industry event to discuss how QUANTRO’s innovative technology is pushing the boundaries of transcriptomic drug discovery. Dr. Bauer welcomes the opportunity to connect with industry leaders and potential investors to explore strategic partnerships and investment opportunities, including discussions about QUANTRO’s current financing round. To schedule a meeting, please use the conference partnering system or contact QUANTRO directly.

In addition, Dr. Bauer will participate in the WuXi Global Forum 2025 on January 14, where he will host an Executive Roundtable from 2:30 – 3:30 pm PST. This interactive session is designed to encourage personalized, in-depth discussions, reflecting the collaborative and innovative nature of the industry.

About QUANTRO:

QUANTRO Therapeutics is a transcriptomic Drug Discovery and R&D company focused on building a highly innovative pipeline of modulators, inhibitors or degraders of transcription factors, transcriptional regulators and cell signaling targets. QUANTRO’s transcriptomic discovery platform is using a novel and proprietary time-resolved gene expression profiling technology to target gene transcription factors, so far considered un-druggable.

The technology is uniquely positioned to quantify changes in gene expression over time with unprecedented precision and sensitivity, overcoming the deficiencies of traditional RT-qPCR based technologies like DRUG-seq, which are limited to only measure RNA abundance, without information on transcriptional activity and dynamics.

QUANTRO was founded in 2019 as a spin-out from the prestigious research institutes IMBA and IMP in Vienna, Austria. Since 2020, the company has been supported by Boehringer Ingelheim Venture Fund (BIVF) and Evotec as seed investors. In total, EUR 11 million was earned in milestone-driven tranches during 2020 and 2023, complemented by undisclosed proceeds from a strategic collaboration on selected oncology targets with Boehringer Ingelheim Oncology.

Please find more information on our website at www.quantro-tx.com.

Contact

QUANTRO Therapeutics GmbH

Dr. Michael Bauer, CEO
Email: Contact | QUANTRO
Phone: +43 122 66001

Media Contacts

MC Services AG
Dr. Cora Kaiser, Dr. Johanna Kobler (international and German-speaking media inquiries)
Shaun Brown (international trade press)
Phone: +49 89 210228 0
Email: quantro@mc-services.eu

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 40^th 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

Berlin, January 7^th, 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

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

 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.

Relief Therapeutics Provides Update on Potential Transaction with Renexxion

GENEVA (DEC. 27, 2024) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (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.

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.

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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.