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Evotec SE unveils new strategy and provides 2025 guidance bolstered by strong Q4 2024 results

On April 17, 2025 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported its financial results for FY 2024, provided guidance for FY 2025 and outlook for 2028 reflecting the path to sustainable profitable growth, following the completion of its strategic review process (Press release, Evotec, APR 17, 2025, View Source [SID1234651971]).

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Dr Christian Wojczewski, Chief Executive Officer of Evotec, said:

"Evotec’s ambitious new direction paves the way for sustainable profitable long-term growth. We are refocusing Evotec on its core strengths: technology and science leadership, where we deliver maximum impact for customers and patients. By combining cutting-edge technology platforms, disruptive science, and AI-driven innovation, we are accelerating the journey from concept to cure with our partners. We delivered on 2024 financial guidance, and I am excited about the opportunities that lie ahead of us. Together with our talented teams, we are writing the next chapter of Evotec’s success story as a drug discovery pioneer."

Evotec unveils new strategy to refocus on core strengths and define clear roadmap to sustainable profitable growth

· Technology and science leadership – refocusing on our strong, unique heritage

· Two pillars: Drug Discovery & Pre-clinical Development (Shared R&D) and Just – Evotec Biologics

· Drug Discovery & Pre-clinical Development will leverage automation, industrialisation, next generation platforms and AI to accelerate our customers journey and to increase their success rates

· Business model simplified: focus on high-value services and therapeutic areas, asset portfolio streamlined by ~30%, R&D supporting next-generation technology development. Exiting equity participations

· Just – Evotec Biologics growth underpinned by existing partnerships and further strengthened by leveraging its capabilities as a scalable technology and service provider, anticipating pivot to an asset lighter model

· Beating market growth via our scientific and operational expertise, focus, and differentiated technology

· Commitment to operational excellence for a step-change in performance. Driving operational leverage through our backbone with higher focus on automation. Anchored cost-out initiatives via refined footprint, optimised COGS and SG&A delivering > € 50 m gross savings by 2028 on top of Priority Reset (€ 40 m)

2024 revenue and EBITDA within guidance. Priority Reset on track. Q4: Second highest quarterly revenues ever amid challenging market environment

· Group revenues increased by 2% to € 797.0 m (2023: € 781.4 m); Q4 2024 revenues increased by 10% to € 221.2 m from € 201.3 m in Q4 2023

· Evotec’s Just – Evotec Biologics segment saw impressive growth, with revenues rising by 71% year-over-year, contributing € 185.6 m (2023: € 108.4 m) to the overall topline

· Total Shared R&D revenues decreased by 9% to € 611.4 m (2023: € 673.0 m); Demand still affected by temporary Pharma restructuring and selective funding for Biotech

· Adjusted Group EBITDA totalled € 22.6 m (2023: € 66.4 m) driven by a mismatch between revenues and cost base in the Shared R&D segment

· Priority Reset on track to secure an annualised adjusted EBITDA improvement of over € 40 m. One-off costs recognised at € 54.9 m, vs. initial provision of € 68.5 m

· Net debt leverage ratio significantly improved to 1.9x net debt / EBITDA

Strengthened partnerships in 2024 paving the way for 2025 growth in soft market environment

· Group revenue growth expected to accelerate vs. 2024, driven by Just – Evotec Biologics, while Shared R&D revenues expected to remain around 2024 levels

· Tariffs & US government funding development are expected to have a limited impact on Evotec’s business

· Expansion of technology partnership with Sandoz and new customers for long-term development and commercial manufacturing in Biologics

· Progress and extension of multi-year collaboration with Bristol Myers Squibb ("BMS") in neuroscience and targeted protein degradation

· New technology development partnership with Novo Nordisk to support next-generation cell therapies

· New multi-year master research collaboration with Pfizer, initially focusing on early discovery research for metabolic and infectious diseases

Guidance for full-year 2025

· Group revenues expected in the range of € 840 – 880 m (2024: € 797.0 m)

· R&D expenditures are expected in a range of € 40 – 50 m (2024: € 50.8 m)

· Adjusted Group EBITDA is expected to reach € 30 – 50 m (2024: € 22.6 m)

Outlook 2028

· Group revenues CAGR2024-2028 targeted to be in a range of 8 – 12 %

· Adj. EBITDA margin 2028 expected to be above 20%

CAGR: Compound annual growth rate

More detailed information and financial tables are available in the annual report published on the Evotec website under the following link: View Source

Webcast/Conference Call

The Company is going to host a conference call to discuss 2024 results as well as to provide an update on the concluded strategic review process. The conference call will be held in English.

Webcast details

Date: Thursday, 17 April 2025

Time: 2.00 pm CEST (1.00 pm BST, 8.00 am ET)

To join the audio webcast and to access the presentation slides, please register via this link.

The on-demand version of the webcast will be available on our website: www.evotec.com.

Conference call detail

To join via phone, please pre-register via this link

You will then receive a confirmation email with dedicated dial-in details such as telephone number, access code and PIN to access the call.

Following FDA Compassionate Use Approval for Pancreatic Carcinoma with Can-Fite’s Namodenoson, Leading U.S. Medical Centers Seek Authorization for their Patients

On April 17, 2025 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported that leading Medical Centers in the US are approaching the FDA, asking for compassionate use approval to treat patients with pancreatic carcinoma with the company oncological drug Namodenoson (Press release, Can-Fite BioPharma, APR 17, 2025, View Source [SID1234651970]).

Namodenoson has recently received FDA approval for its first single-patient compassionate use treatment, marking a significant milestone in its clinical journey. This approval has sparked growing interest from oncologists at leading U.S. medical centers, who are now seeking to treat their pancreatic cancer patients with Namodenoson under compassionate use protocols.

Simultaneously, Can-Fite is actively enrolling patients in Israel for a Phase IIa study—an open-label trial designed for individuals with advanced pancreatic adenocarcinoma whose disease has progressed despite at least first-line therapy. The trial aims to assess the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this challenging patient population. The study is led by Dr. Salomon Stemmer, a renowned key opinion leader at the Institute of Oncology, Rabin Medical Center, Israel. Notably, Namodenoson has been granted Orphan Drug Designation by the U.S. FDA, further underscoring its potential as a promising therapeutic option.

"We are thrilled that more top-tier U.S. medical centers are recognizing the potential of Namodenoson and are eager to participate in our compassionate use program," said Motti Farbstein, CEO of Can-Fite. "Our goal is to provide this underserved patient population with a novel treatment that may extend survival and improve quality of life."

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), and in a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.

Clarity signs high-volume commercial-scale copper-64 Supply Agreement with Nusano

On April 17, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop and commercialise next-generation products that improve treatment outcomes for people with cancer, reported the signing of a commercial-scale Supply Agreement for copper-64 with Nusano (Press release, Clarity Pharmaceuticals, APR 17, 2025, View Source [SID1234651958]).

Nusano’s 190,000 square foot state-of-the-art facility in West Valley City, Utah is expected to begin production in 2025 with copper-64 isotope supply planned to commence in early 2026. The accelerator-based proprietary technologies employed by Nusano are particularly well suited for cost-effective mass production of copper-64. The Nusano facility is capable of producing more than 1,000 Ci (37,000 GBq) of copper-64 per day at capacity, which translates into more than 18,000 patient doses per day at 200 MBq per dose, with a 48-hour shelf-life, well in excess of commercial-scale demands across multiple large oncology indications in line with Clarity’s commercialisation strategy. Nusano is also developing in-house production of the target material for copper-64 manufacturing, nickel-64 (Ni-64), and plans to commence production of copper-67 (Cu-67 or 67Cu) and actinium-225 (Ac-225 or 225Ac) isotopes in 2025-2026. Both of these isotopes are used in Clarity’s pipeline of theranostic products in development.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The signing of this Supply Agreement with Nusano will complement Clarity’s existing network of US-based copper-64 suppliers, providing capacity to ensure abundant and seamless supply of the isotope. As Clarity is generating exceptional data in a number of late-stage clinical trials, we now also have a cost-effective, large-scale supply strategy locked in for the commercial roll-out of our Targeted Copper Theranostics (TCTs) in the largest healthcare market in the world, the US. This Agreement is an important part of a larger commercial manufacturing strategy, which we will continue implementing as we get closer to the filing of New Drug Applications (NDA) with the US Food and Drug Administration (FDA).

"The ability to make isotopes and products in the US for the treatment of the American people is an important advantage in the current geo-political and economic environment. By building a supply chain that is fully integrated, from high-volume isotope production, to centralised product manufacture, to delivering these ready-to-use diagnostics to imaging sites in every state of the US on time and on demand, we are aiming to build a model that is impervious to economic and political instability.

"In large oncology indications, such as prostate-specific membrane antigen (PSMA) positron emission tomography (PET) diagnostics (which Clarity is addressing with our key product, SAR-bisPSMA), ensuring stable, abundant and seamless supply of isotopes is crucial for a successful commercial launch.

"We have seen first-hand from the current generation of radio-diagnostics that efficient and timely product supply can make or break the adoption of the products and their expansion in the oncology practice. The current market leaders in PSMA PET imaging face several limitations associated with their short half-life (less than 2 hours vs. 12.7 hours for copper-64). These include short shelf-lives, restricted availability throughout the imaging site’s workday, and narrow imaging windows. At Clarity, our strategy is straightforward: we are determined to overcome these limitations and lay a strong foundation for the successful roll-out of TCTs globally.

"Our goal is to take radiopharmaceuticals to the next level by building a reliable and accessible supply that is consistent with the big pharma oncology model and deliver advantages to patients, their treating clinicians and imaging sites. Under this central manufacture model, the imaging sites will receive the copper-64 based diagnostics on demand, at any time and in volumes consistent with the rapidly growing demand of this blockbuster market. The clinicians have the added flexibility to administer the copper-based diagnostics and image patients over a significantly longer timeframe than what the current products allow. This translates into more flexibility for patient imaging and potentially higher lesion detection sensitivity that could lead to better identification of cancer lesions, helping to determine the best course of treatment for oncology patients.

"With our SAR-bisPSMA product generating a lot of exciting data and 3 US FDA Fast Track Designations granted for this product1,2,3 for accelerating its development, locking in commercial-scale supply of copper-64 means we are now closer than ever to changing the paradigm of prostate cancer diagnosis, ensuring no man is left waiting for a PSMA PET scan," said Dr Taylor.

Nusano’s Chief Executive Officer, Chris Lowe, commented, "Nusano is commercialising a breakthrough radioisotope production platform in 2025 capable of producing more than 25 radioisotopes for life science applications, including copper-64, copper-67 and actinium-225. We are excited to enter into a Supply Agreement with Clarity for copper-64 to enable their clinical and commercial efforts with a dependable supply of radioisotopes from our world-class production facility in Utah."

Additional Disclosure
The Supply Agreement is effective as of 16 April 2025 and is for an initial period of 3 years with automatic renewal for successive 2-year periods. Cancellation provisions are aligned with industry standard rates.

LaNova Medicines Announces FDA Clearance of the IND Application for a Phase 2 study of LM-108 in Combination with other Anti-Cancer Agents

On April 16, 2025 LaNova Medicines Ltd. reported that its core pipeline asset, LM-108, an anti-CCR8 mAb, has been granted to conduct a phase 2 study in combination with other anti-cancer agents (Press release, LaNova Medicines, APR 16, 2025, View Source [SID1234656023]).

OncoC4 Selected to Present at the 2025 AACR Meeting’s Showcase Session

On April 16, 2025 OncoC4, Inc., a late-stage biopharmaceutical company developing novel medicines for cancer reported that it will present during the Showcase Session at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Oncology Industry Partnering Event being held April 24-25, 2025, in Chicago, Illinois (Press release, OncoC4, APR 16, 2025, View Source [SID1234655988]). The Showcase Session is a new addition to the 2025 program that features companies selected from a competitive application process.

"We are pleased to be selected to share recent progress across our pipeline of best-in-class and first-in-class drugs targeting both validated and novel immune checkpoints at this year’s AACR (Free AACR Whitepaper) Showcase Session," said Yang Liu, PhD, Co-Founder, Chief Executive Officer and Chief Scientific Officer of OncoC4. "Our two lead wholly owned programs are advancing in the clinic including AI-081, a differentiated PD-1/VEGF bispecific antibody with stronger cooperative interactions and the potential for superior patient outcomes, and ONC-841, an anti-Siglec-10 antibody that promotes anti-tumor immunity by blocking the novel immune checkpoint implicated in tumor evasion. Both candidates have the potential to significantly impact the treatment landscape for solid tumors, and we look forward to initial dose-escalation data for both programs in advanced solid tumors in the second half of 2025."

Showcase Session Corporate Presentation Details

Date: Thursday, April 24, 2025

Time: 5:05 p.m. ET

Session: Showcase Session 2 (W192)

Presenter: Pan Pan, Senior Vice President of Business Development