PRESS RELEASE

Heidelberg Pharma to Participate in Leading Scientific and Financial Conferences in November 2024

Ladenburg, Germany, 24 October 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical-stage developer of innovative Antibody Drug Conjugates (ADCs), announces it will present its ADC candidates and ADC technology platforms at leading scientific and financial conferences throughout November.

The Company’s most advanced Amanitin-based ADC product candidate, HDP-101, is currently in a Phase I/IIa trial for the treatment of relapsed or refractory multiple myeloma. In late September, Heidelberg Pharma presented clinical data from the fifth patient cohort, demonstrating a case of complete remission in a patient who had been treated multiple times. This patient showed a partial response after the second treatment cycle, with a complete remission observed after 11 cycles. In addition, several patients exhibited promising biological activity and objective improvements, underscoring the potential of HDP-101 as a treatment option for patients with this disease.

HDP-201, Heidelberg Pharma’s first Exatecan-based ADC candidate, is a topoisomerase I inhibitor that has proven success in cancer therapy and is already used in two approved ADCs. Its distinct mode of action from Amanitin broadens the Company’s portfolio of active ingredients. HDP-201 targets guanylyl cyclase-C (GCC), a receptor expressed on the surface of intestinal cells and cancer cells in various gastrointestinal tumors. Preclinical data suggest that the tolerability and efficacy of HDP-201 is at least on a par with existing, approved Exatecan-based ADCs. Following extensive preclinical testing, the final development candidate for HDP-201 was determined in recent weeks, with colorectal cancer identified as the target indication for its clinical development.

World ADC San Diego 2024

Deutsches Eigenkapitalforum

Walter Miller will be available for one-on-one meetings, which can be arranged via the online conference system.

About Heidelberg Pharma

Heidelberg Pharma is a biopharmaceutical company working on a new treatment approach in oncology and developing novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with cytotoxic compounds, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kill the diseased cells.

Heidelberg Pharma uses several compounds and has built up an ADC toolbox that overcomes tumor resistance via numerous pathways and addresses different types of cancer using various antibodies. The goal is to develop targeted and highly effective ADCs for the treatment of a variety of malignant hematologic and solid tumors. Heidelberg Pharma is the first company to use the compound Amanitin from the green death cap mushroom in cancer therapy. The biological mechanism of action of the toxin represents a new therapeutic modality and is used as a compound in the Amanitin-based ADC technology, the so-called ATAC technology. It offers the opportunity to overcome therapy resistance and also eliminate dormant tumor cells, which could lead to significant progress in cancer therapy – even for patients who no longer respond to other treatment.

The most advanced product candidate HDP-101 is a BCMA-ATAC for the indication multiple myeloma, which is currently in clinical development.

The first candidate that Heidelberg Pharma is developing with a toxin other than Amanitin is HDP-201, an Exatecan-based ADC. Exatecan is a topoisomerase I inhibitor that has proven itself in cancer therapy and is used in two already approved ADCs. It differs in its mode of action from that of Amanitin and thus expands the company’s range of compounds.

The company is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com.

ATAC^® is a registered trademark of Heidelberg Pharma Research GmbH.

ITAC™, ETAC™ are pending trademark applications of Heidelberg Pharma Research GmbH.

This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will”, “should”, “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.

Hamburg, Germany, 23 October 2024:
Evotec SE (Frankfurt Stock Exchange: EVT, SDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) today announced progress within the Company’s strategic partnership with Bristol Myers Squibb relating to building a molecular glue-based pipeline. Key scientific achievements drive the expansion of the pipeline of molecular glue degraders in fields beyond oncology, triggering a programme-based payment of US$ 50 m to Evotec. Based on potential programme-based milestones, the expansion contributes to the deal value.

Evotec and Bristol Myers Squibb entered their strategic protein degradation partnership in 2018 and expanded it in May of 2022, because of the highly productive initial collaboration generating a promising pipeline. Since the expansion, Evotec has significantly scaled up its activities to develop highly promising compounds from Bristol Myers Squibb’s industry-leading library of cereblon E3 ligase modulators (“CELMoDs™”). The partnership continues to deliver on its goal to maintain leadership in the field, adding a broad pipeline of novel molecular glue degraders for high-value targets, in this case for fields beyond oncology.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “We are delighted to expand our successful partnership with Bristol Myers Squibb into fields beyond oncology with a significant unmet medical need. The unique mode of action, combined with drug-likeness and oral administration make molecular glue degraders a promising and versatile therapeutic option. Our partnership with BMS continues to build an extraordinary pipeline of first-in-class product opportunities and we look forward to driving the joint portfolio of programmes towards clinical validation for the benefit of patients.”

About molecular glue degraders
Conventional small molecule therapeutics work via a drug-induced interference with a protein activity. This limitation to agonistic or antagonistic functions renders about 90% of proteins “undruggable”. Also, conventional small molecules only work while they are actively binding to the receptor, which typically requires a treatment regimen consisting of one or even several carefully dosed medications every day.

Molecular glue degraders are compounds that induce interactions between an E3 ubiquitin ligase and a molecular target. The induced interaction results in ubiquitination and subsequent degradation of the recruited protein. Through this mechanism of action molecular glues are not restricted to the agonistic/antagonistic features of a protein, thus massively expanding the range of the druggable proteome. Also, the molecular glue itself is not degraded in the process and can trigger the degradation process several times over, thus leading to longer-lasting therapeutic effects.

About Evotec’s strategic partnership with Bristol Myers Squibb in molecular glues
In 2018, Evotec entered a long-term strategic drug discovery and development partnership in the field of molecular glues with Celgene, now Bristol Myers Squibb. Bristol Myers Squibb is a leader in this field based on its unique library of cereblon E3 ligase modulators (CELMoDs™). The aim of this strategic alliance is to discover and develop a leading pipeline of molecular glue degraders for a range of therapeutic indications leveraging all of Evotec’s proprietary PanOmics and PanHunter platforms as well as A.I./M.L.-based drug discovery and development capabilities.

Evotec applies high-end proteomics and transcriptomics at industrial scale to profile and select promising drug candidates based on comprehensive cell biological profiles. Evotec’s leading PanOmics screening capabilities are delivering unmatched throughput. The selection of the most promising candidates for drug development is facilitated by Evotec’s PanOmics data analysis platform PanHunter, which was recently launched commercially as a software-as-a-service (“SAAS”) solution. PanHunter supports the integration and analysis of these data sets and thereby enables the selection of the most promising CELMoDs™ for further progression into lead optimisation.

Evotec announced in May of 2022 that the Company has further extended and expanded its partnership with Bristol Myers Squibb for another 8 years as the initial collaboration proved to be highly productive in generating a promising pipeline of molecular glue degraders. 

About Evotec SE
Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec provides high value pipeline co-creating partnerships and solutions to all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 5,000 highly qualified people. The Company’s sites in Europe and the USA offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to www.evotec.com and follow us on X/Twitter @Evotec and LinkedIn.

Forward-looking statements
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec’s expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. 

For further information, please contact:

Investor Relations

Volker Braun
EVP Head of Global Investor Relations & ESG
Volker.Braun@evotec.com

Media

Susanne Kreuter
VP Head of Strategic Marketing
Susanne.Kreuter@evotec.com

The Management Board of aap Implantate AG (“Company“) today resolved, with the approval of the Supervisory Board, to increase the Company’s share capital from currently EUR 10,979,625.00 by EUR 1,097,962.00 to EUR 12,077,587.00 by issuing 1,097.962 new no-par value bearer shares, each with a pro rata amount of the share capital of EUR 1.00 (“New Shares“), against cash contributions, making partial use of the authorized capital 2024/I and excluding shareholders’ subscription rights (“Cash Capital Increase“). The issue price per New Share is EUR 2.03. The Cash Capital Increase corresponds to around 10% of the existing share capital. The New Shares will be issued by way of a private placement to selected investors. The New Shares will carry dividend rights from January 1, 2024.

The cash capital increase serves to provide the necessary liquidity and strengthen the company’s equity base, thus securing its financing in the medium term, assuming normal business development. The gross issue proceeds from the cash capital increase will amount to around EUR 2.2 million.

In order to further strengthen the equity base, the Management Board of the company also intends, with the approval of the Supervisory Board, to increase the company’s share capital by up to EUR 400,000.00 (approx. 3.6% of the current share capital) against contributions in kind, excluding shareholders’ subscription rights, making further partial use of the authorized capital 2024/I. The object of the contribution in kind is to be shareholder loans granted to the company in the nominal amount of EUR 750,000.00 plus accrued interest, which are to be contributed to the company by way of a debt-to-equity swap in return for the granting of up to 400,000 new shares. The issue price of the New Shares therefore also corresponds to EUR 2.03. The implementation of the capital increase against contributions in kind requires a non-cash contribution audit by a court-appointed non-cash contribution auditor.

The capital increase against contributions in kind serves to strengthen the balance sheet structure by increasing equity while at the same time eliminating loan obligations and leads to a reduction in the interest burden associated with the granting of shareholder loans.

Contact:

If you have any questions, please contact:

aap Implantate AG; R. Di Girolamo; Chairman of the Management Board/CEO; Lorenzweg 5;

D-12099 Berlin

Tel.: +49/30/750 19 – 170; Fax: +49/30/750 19 – 290; r.digirolamo@aap.de

Immunic Announces Positive Outcome of Interim Analysis of Phase 3 ENSURE Program of Vidofludimus Calcium in Relapsing Multiple Sclerosis 

– Based on a Review of Unblinded Data, an Independent Data Monitoring Committee (IDMC) Confirmed that Predetermined Futility Criteria Have Not Been Met – 

– IDMC Also Recommended Continuing Trial without Changes, Including no Need for a
Potential Upsizing –

– ENSURE Program Remains on Track to be Completed in 2026 –

– Webcast to be Held Today, October 22, at 8:00 am ET – 

NEW YORK, October 22, 2024 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced a positive outcome of the non-binding, interim futility analysis of its phase 3 ENSURE program, investigating lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), for the treatment of relapsing multiple sclerosis (RMS). Based on the outcome of the interim futility analysis, an unblinded Independent Data Monitoring Committee (IDMC) has recommended that the trials are not futile and should continue as planned.

“While Immunic remains blinded to all data, the IDMC’s favorable recommendations in this interim analysis corroborate our initial assumptions for the design, powering and relapse rate of the twin phase 3 trials of vidofludimus calcium in RMS, and suggest that they are in line with the data observed so far,” stated Andreas Muehler, M.D., M.B.A., Chief Medical Officer of Immunic. “In particular, the planned sample size seems appropriate to address the primary endpoint of time to first relapse. As the IDMC recommends, we are continuing the ENSURE trials unchanged, with completion expected in 2026.”

“I am particularly excited about the positive outcome of the interim analysis of our phase 3 ENSURE trials, marking the successful achievement of a critical milestone for the program,” added Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “We are confident in vidofludimus calcium’s potential to transform the oral MS market and continue to believe that the phase 3 program provides a clear and straightforward path towards seeking potential regulatory approval in RMS. Our next clinical milestone for vidofludimus calcium is the top-line readout of our phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS), which we expect to release in April of next year. If this data set continues to show a neuroprotective effect for vidofludimus calcium, we believe our drug may be positioned as first-in-class oral treatment option for PMS, a form of MS with highest unmet medical needs.”

The interim futility analysis of the phase 3 ENSURE program was performed by an unblinded IDMC and based on a pre-specified assessment after approximately half of the planned first relapse events occurred in the double-blind treatment periods of each of the twin ENSURE-1 and ENSURE-2 trials. The analysis was intended to inform potential sample size adjustment and help prevent the final study readout from occurring before sufficient events have been achieved. The unblinded IDMC was asked to make two decisions: The first question, as to whether the trials are futile, was answered by the IDMC with “futility criteria have not been met.” The second question, as to whether the sample size in each trial should be increased, was answered by the IDMC with “continue as planned.” Both decisions were based on the conditional power of the trials at the time of the interim analysis. Immunic has remained blinded during the interim analysis and has not seen any of the data available to the IDMC to make their recommendations.

The ongoing ENSURE program comprises two identical multicenter, randomized, double-blind phase 3 trials designed to evaluate the efficacy, safety and tolerability of vidofludimus calcium versus placebo in RMS patients. Each of the trials, titled ENSURE-1 and ENSURE-2, is expected to enroll approximately 1,050 adult patients with active RMS at more than 100 sites in more than 15 countries, including the United States, India and countries in Latin America, Central and Eastern Europe. Patients are being randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo and the primary endpoint for both trials is time to first relapse up to 72 weeks. Key secondary endpoints include time to confirmed disability worsening based on Expanded Disability Status Scale (EDSS) disability progression, volume of new T2-lesions, time to sustained clinically relevant changes in cognition, and percentage of whole brain volume change, grey matter volume and white matter volume. As previously reported, completion of ENSURE-1 is anticipated in the second quarter of 2026, with completion of ENSURE-2 expected in the second half of 2026.

Webcast Information

Immunic will host a webcast today at 8:00 am ET. To participate in the webcast, please register in advance at: https://imux.zoom.us/webinar/register/WN_fSJNHWuxRMGRPaMl3hUlqg or on the “Events and Presentations” section of Immunic’s website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial-in access.

An archived replay of the webcast will be available approximately one hour after completion on Immunic’s website at: ir.imux.com/events-and-presentations.

About Vidofludimus Calcium (IMU-838)

Vidofludimus calcium is a small molecule investigational drug in development as an oral next-generation treatment option for patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases. The selective immune modulator activates the neuroprotective transcription factor nuclear receptor related 1 (Nurr1), which is associated with direct neuroprotective properties. Additionally, vidofludimus calcium is a highly selective inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH), which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells. This mechanism is associated with the anti-inflammatory and anti-viral effects of vidofludimus calcium. Vidofludimus calcium has been observed to selectively act on hyperactive T and B cells while leaving other immune cells largely unaffected and enabling normal immune system function, e.g., in fighting infections. To date, vidofludimus calcium has been tested in more than 1,800 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country.

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; announcements regarding the positive outcomes of the interim analysis of the phase 3 ENSURE trials; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; 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; and the development and commercial potential of any product candidates of the company. 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 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@ksca.com

MEDIA RELEASE

Medacta unveils the extended enhancements to its Hip Revision Platform

CASTEL SAN PIETRO, October 21, 2024—Medacta Group SA (“Medacta,” SIX:MOVE) is pleased to announce the further expansion of its comprehensive Hip Revision Platform in the European market, reinforcing its commitment to providing innovative solutions for complex hip revision procedures. The expanded Hip Revision Platform now features a complete femoral and acetabular portfolio designed to address various levels of surgical complexity, supported by a medical education program delivered by esteemed Key Opinion Leaders.

“Medacta has always made substantial investments in R&D to empower surgeons to restore the patient’s anatomy, ranging from minimally invasive primary cases to highly complex hip revision surgeries. Our focus has been on maximizing the versatility of our implants and instruments while minimizing the complexity of the surgical flow,” says Francesco Siccardi, CEO of Medacta.

FEMUR
On the femoral side, the M-Vizion Femoral Revision System has been designed to deliver maximum stability and versatility with a simplified and streamlined procedure. Alongside a modular version available with a straight as well as a 4° taper, to address surgeon preferences and patient indications, M-Vizion Monobloc was introduced into the market with positive results. With the first cases of M-Vizion Distal Locking designed to solve complex cases through distal mechanical fixation, the M-Vizion Femoral System is being further expanded.

In addition to the M-Vizion Femoral Revision System, Medacta enables surgeons to address different levels of complexity with various solutions, including a long-cemented stem, AMIS-K Long, and a cementless monoblock triple taper long stem, QUADRA-R.

ACETABULUM
With the Mpact System, Medacta offers a complete and versatile acetabular revision portfolio to deal with increasing levels of complexity, addressing both surgeon preferences and patient indications: from multi-hole and rim-hole cups to cages and iliac fixation cups.

Medacta’s Hip Revision Acetabular solutions feature 3D Metal, a state-of-the-art advanced biomaterial structure which allows for engineering implants featuring maximized initial stability and enhanced connection with the bone, both of which are key aspects in revision hip arthroplasty.

Iliac Screw Mpact 3D Metal, a modular cup characterized by iliac fixation indicated for dysplasia, complex revisions and trauma cases has delivered positive results. Also, 3D Metal B-Cage, an anatomical cage compatible with dual mobility cemented cups and compression polyaxial locking screws for additional stability, has shown good results at follow-up. For complex cases in which a modular construct is preferred, 3D Metal Foam and Medacta F-Cage, a cup and cage construct, is available. This solution can be used in combination with 3D Metal Augments II to cover severe bone defects. 3D Metal Augments II can be coupled with Mpact System as well as with cemented cups.

Doz. Dr. Hofstätter, Austria, remarked, “Medacta’s hip revision portfolio offers a wide range of femoral and acetabular solutions that allow surgeons to effectively address different levels of complexity according to their preferences. Depending on the patient’s indication, the surgeons can manage revisions with short stems and standard stems with and without collar or have the option for longer modular/monoblock Wagner type femoral stems and choose among various acetabular solutions, the best solution to solve complex bone defects.”

To support the adoption of these advanced solutions, Medacta offers tailored medical education activities delivered by esteemed Key Opinion Leaders (KOLs). “Acetabular revision cases can be challenging, hence being confident with the implant and the relative instruments is key to achieve good results. Scientific sessions including case discussions, hands-on wetlabs, and one-to-one surgery support by international KOLs enable surgeons to gain experience with the products, help them shorten the learning curve and create connections with the Experts peers,“ concludes Prof. Randelli, Italy.

Medacta remains committed to advancing hip revision research, addressing increasingly complex clinical challenges, and developing personalized solutions to enhance patient outcomes and quality of life.

Medacta’s Hip Revision solutions as part of the comprehensive hip portfolio including primary, minimal invasive approaches and personalized technologies will be showcased at the main congresses in Europe: DKOU in Berlin (22-25 October), SIOT in Rome (29-31 October), and SOFCOT in Paris (11-13 November).

For more information, please visit hip.medacta.com

Contact
Gianluca Olgiati
Group Vice President Marketing
+41 91 696 60 60
media@medacta.ch

Medacta is a key global player specializing in the design, production, and distribution of innovative, personalized, and sustainable solutions for joint replacement, sports medicine, and spine surgery. Established in 1999 in Switzerland, Medacta is committed to improving the care and well-being of patients and maintains a strong focus on healthcare sustainability. Through close collaboration with expert surgeons globally, continuous investments in R&D, and the adoption of cutting-edge technologies, Medacta’s innovation prioritizes minimally invasive surgery and personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports surgeons with a comprehensive and tailored program dedicated to the advancement of medical education. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 60 countries. Follow us on Medacta TV, YouTube, LinkedIn and X.

RELATED TRADEMARKS

Medacta Group Related Trademarks are registered at least in Switzerland. The products and services listed below may not be all-inclusive, and other Medacta products and services not listed below may be covered by one or more trademarks. The following products and services may be covered by additional trademarks not listed below. Note that Swiss trademarks may have foreign counterparts. MySolutions™ Personalized Ecosystem, M-Vizion^®, AMIS^®-K Long, Quadra^®-R, Mpact^® System.

Mainz Biomed Reports Mid-Year 2024 Financial Results and Provides Corporate Update

Revenue increases 4% year over year while loss from operations decreases by 32%

Pooled Results of ColoFuture and eAArly DETECT studies published at ASCO showing groundbreaking performance with sensitivity for CRC of 92% and 82% for advanced adenomas, including 95.8% detection of high-grade dysplasia

Company highlights its path to success for 2025

BERKELEY, US – MAINZ, Germany – October 21, 2024 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today financial results for the first half of 2024, an update on 2024 accomplishments, and its outlook for the end of the year and strategic direction for 2025. 

Key 2024 Accomplishments

• During the first six months of 2024, the Company’s revenue increased by 4% year over year while the loss from operations and net loss decreased by 32% and 26%, respectively. These decreases are the result of the Company’s efforts to reduce costs during the first half of the year.
• Mainz Biomed published key findings from its groundbreaking eAArly DETECT study during a poster presentation at the renowned Digestive Disease Week (DDW) 2024 in Washington D.C. The Company was awarded as a Poster of Distinction by the Digestive Disease Week judges for the presentation of industry leading results: 97% sensitivity for colorectal cancer (CRC) and 82% for advanced precancerous lesions. The eAArly DETECT results demonstrated that within the advanced precancerous lesion patients, 100% of those patients with high grade dysplasia were detected.
• The Company presented pivotal data from its largest cohort to date during a poster presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in Chicago, Illinois. This data combined results from the ColoFuture and eAArly DETECT studies including additional patient samples collected since the first reported study results, demonstrating the significance of its innovative screening approach. The new study data confirmed previous ColoFuture and eAArly DETECT study performance with sensitivity for CRC of 92% and 82% for advanced adenomas, including 96% detection of high-grade dysplasia.
• The Company announced significant improvements to its ColoAlert® product, currently being commercialized across Europe and in select international markets. These updates aim to enhance customer satisfaction and streamline lab operations. To increase screening/lab efficiency, Mainz Biomed introduced a novel DNA stabilizing buffer capable of accommodating varying sample volumes, addressing a common issue in the industry where samples are often either underfilled or overfilled, rendering them unsuitable for laboratory analysis. The new proprietary buffer used in ColoAlert® significantly reduces the necessity for additional sample submissions, thereby decreasing the time for the patients to obtain their results. This enhancement has enabled ColoAlert® to achieve the industry’s lowest retesting rates, ensuring that screening outcomes are delivered within just 2 – 3 days upon arrival at the laboratory. 
• The Company expanded its collaboration with Liquid Biosciences to Mainz Biomed’s next-generation detection test for pancreatic cancer. The companies are leveraging Liquid Biosciences proprietary AI analysis technology platform (EMERGE) to extend and optimize the selection of novel biomarkers for PancAlert. The first phase of the collaboration included the evaluation of biomarkers from the Company’s research program co-funded by the German Federal Ministry for Education and Research, and applied a single algorithm developed by Liquid Biosciences using its EMERGE platform. The results of this feasibility analysis were promising, leading the Company and Liquid Biosciences to believe that a PancAlert diagnostic test could, in the future, be combined with Mainz Biomed’s colorectal cancer screening product.

Post-period Update

• In September 2024, Mainz Biomed announced encouraging feedback received from the FDA for the breakthrough device designation with the request to expand the current clinical data set with additional average risk population.
• In October 2024, the Company made the strategic decision to focus its efforts on three key initiatives for the remainder of 2024 and into 2025 in order to maximize shareholder value. Those initiatives are:
  • The continued growth of its ColoAlert® business in Europe;
  • Development of its next generation colorectal cancer screening product; and
  • Running a 2,000 patient study, with average risk patients in the U.S., to read out in the second half of 2025 (eAArly DETECT 2). With eAArly DETECT 2, the Company addresses the recent FDA feedback and prepares for a new submission for breakthrough device designation with an expanded data set, including a larger average-risk patient population.

In line with these strategic initiatives, the Company restructured its operations and implemented cost reductions which included decreasing its operating costs, primarily driven by the reduction of personnel and external consulting costs.

“2024 has been a transitional year for Mainz Biomed. While navigating through a period of difficult markets, especially for small cap technology stocks, we are proud to have achieved many significant accomplishments to date,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “As the Board and management team evaluated our path forward, we believe that a narrower focus on key strategic initiatives gives us the best opportunity to unlock shareholder value in the remainder of 2024 and 2025.”

Condensed Consolidated Financial Statements (unaudited):

Condensed Consolidated Financial Statements (unaudited):
 

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About Mainz Biomed NV

Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, a non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer with high sensitivity and specificity. ColoAlert® is marketed in Europe and the United Arab Emirates. The Company is currently preparing a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For media inquiries

MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu

For investor inquiries, please contact info@mainzbiomed.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 9, 2024. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.