Media Release

Planegg/Munich, Germany, April 24, 2024

MorphoSys To Present New Phase 3 MANIFEST-2 Data on Pelabresib in Myelofibrosis in Oral Presentation at 2024 ASCO Annual Meeting

Additional ASCO 2024 poster presentation will include new findings from the Phase 2 study of tulmimetostat 

MorphoSys AG (FSE: MOR; NASDAQ: MOR) today announced that new efficacy and safety data from the Phase 3 MANIFEST-2 trial of pelabresib, an investigational BET inhibitor, in combination with the JAK inhibitor ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis will be highlighted during an oral presentation on Friday, May 31, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The congress is being held in Chicago, Illinois, from May 31 to June 4, 2024.

Additionally, new data from the Phase 2 study of tulmimetostat, an investigational next-generation dual inhibitor of EZH2 and EZH1, in patients with advanced solid tumors or hematologic malignancies will be showcased in a poster presentation at ASCO 2024.

ASCO 2024 Presentation Details

The full text of each abstract will be available on May 23 at 4:00 p.m. CDT. Please refer to the ASCO 2024 online program for full session details and data presentation listings.

About MorphoSys 
At MorphoSys, we are driven by our mission: More life for people with cancer. As a global biopharmaceutical company, we develop and deliver innovative medicines, aspiring to redefine how cancer is treated. MorphoSys is headquartered in Planegg, Germany, and has its U.S. operations anchored in Boston, Massachusetts. To learn more, visit us at www.morphosys.com and follow us on Twitter at X and LinkedIn. 

About Pelabresib 
Pelabresib (CPI-0610) is an investigational selective small molecule designed to promote anti-tumor activity by inhibiting the function of bromodomain and extra-terminal domain (BET) proteins to decrease the expression of abnormally expressed genes in cancer. Pelabresib is being investigated as a treatment for myelofibrosis and has not been approved by any regulatory authorities. Its safety and efficacy have not been established. 

The development of pelabresib was funded in part by The Leukemia and Lymphoma Society^®.

About MANIFEST-2
MANIFEST-2 (NCT04603495) is a global, double-blind, Phase 3 clinical trial that randomized 430 JAK inhibitor-naïve adult patients with myelofibrosis 1:1 to receive pelabresib in combination with ruxolitinib or placebo plus ruxolitinib. The primary endpoint of the study is a 35% or greater reduction in spleen volume (SVR35) from baseline at 24 weeks. The key secondary endpoints of the study are the absolute change in total symptom score (TSS) from baseline at 24 weeks and the proportion of patients achieving a 50% or greater improvement in total symptom score (TSS50) from baseline at 24 weeks. TSS is measured using the myelofibrosis self-assessment form (MFSAF) v4.0, which asks patients to report the severity of seven common symptoms, rating each of them on a scale from 0 (absent) to 10 (worst imaginable).

Additional secondary endpoints include progression-free survival, overall survival, duration of the splenic and total symptom score response, hemoglobin response rate and improvement in bone marrow fibrosis, among others.

Constellation Pharmaceuticals, Inc., a MorphoSys company, is the MANIFEST-2 trial sponsor.

About Myelofibrosis
Myelofibrosis is a blood cancer – belonging to a group of diseases called myeloproliferative neoplasms – caused by genetic abnormalities in bone marrow stem cells and characterized by four hallmarks: enlarged spleen, anemia, impaired bone marrow microenvironment causing fibrosis, and debilitating disease-associated symptoms, including severe fatigue, night sweats, itching, increased bleeding and significant pain caused by their enlarged spleen. For many living with myelofibrosis, the combination of symptoms often severely impacts their quality of life. At diagnosis, several factors, such as age, genetics and bloodwork, help determine a patient’s long-term prognosis. About 90% of newly diagnosed patients have intermediate- to high-risk disease, which has a worse prognosis and a higher likelihood of disease-associated symptoms. While JAK inhibitors, the current standard of care, address some aspects of the disease, no agent provides broad disease control. There is an urgent need for novel, well-tolerated therapeutic options capable of changing the natural course of myelofibrosis to provide patients with deep and durable responses across its four hallmarks.

About Tulmimetostat
Tulmimetostat (CPI-0209) is an investigational compound designed to exert anti-tumor activity by inhibiting the function of enhancer of zeste homolog 1 and 2 (EZH1 and EZH2) proteins to reactivate tumor suppressor genes or silencing the oncogenic pathways. Tulmimetostat is being tested as a once-daily oral treatment in a Phase 1/2 trial (NCT04104776) in patients with advanced solid tumors or lymphomas, including ARID1A-mutated ovarian clear cell carcinoma, endometrial carcinoma and other solid tumors, diffuse large B-cell lymphoma, peripheral T-cell lymphoma, BAP1-mutated mesothelioma and castration-resistant prostate cancer. The primary objectives of the trial include determining the maximum tolerated dose and/or recommended Phase 2 dose and evaluating antitumor activity of tulmimetostat monotherapy. The safety and efficacy of tulmimetostat have not been established.

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CureVac Announces Financial Results for the Fourth Quarter and Full-Year 2023
and Provides Business Update
 

• Organizational redesign and rightsizing initiated across company to streamline structures, increase efficiency and reduce operating costs
   
• Together with GSK, ended Pandemic Preparedness Agreement (PPA) with Federal Republic of Germany, after consultation with the German Federal Ministry of Health 
   
• Cash and cash equivalents position of €402.5 million as of December 31, 2023; cash runway extended into Q4 2025 with organizational redesign and despite PPA wind-down
   
• Strategic collaboration signed with world-leading oncology center MD Anderson, creating unique expertise to jointly discover and develop novel cancer vaccines
   
• Appointment of Thaminda Ramanayake as Chief Business Officer, bringing more than 15 years of biopharma company development and deal-making experience
   
• Promising COVID-19 and seasonal flu Phase 2 data confirms proprietary mRNA platform elicits strong overall antibody titers at well-tolerated dose levels
   
• New Phase 1/2 study in avian flu started in collaboration with GSK addressing potential future pandemic threat
   
• Successful safety review of data from glioblastoma Phase 1 Part A with multiepitope cancer vaccine candidate, CVGBM, enables progressing to Part B with expected start mid-2024
   
• CureVac to host conference call and webcast today at 9 a.m. ET / 3 p.m. CET
   

TÜBINGEN, Germany/BOSTON, USA – April 24, 2024 – CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced financial results for the fourth quarter and full-year 2023 and provided a business update.

“We closed out 2023 on a sturdy footing and are poised to advance strongly through 2024 with strategic initiatives to make CureVac fit-for-purpose. We are adapting unnecessary residual pandemic infrastructure, optimizing our workforce and aligning our structures and resources to the right size for our business scope and development priorities. Under this streamlined structure, we intend to move forward with purpose and determination,” said Dr. Alexander Zehnder, Chief Executive Officer of CureVac. “As we advance our pipeline in both infectious disease and oncology, we continue to seize opportunities to accelerate development of our differentiated mRNA approach. This is most recently evidenced by our collaboration with MD Anderson, one of the world’s leading cancer centers. Further expanding such strategic collaborations and partnerships will be the key focus for Thaminda Ramanayake, who will join the management team as Chief Business Officer in June.”

“We finished 2023 with a robust cash position of €402.5 million supported in Q4 by the recognition of a €15 million milestone from GSK for the start of the Phase 2 development of our joint seasonal flu program,” said Pierre Kemula, Chief Financial Officer of CureVac. “Going into 2024, we have had a strong focus on cost management and increased operational efficiency. Importantly, and despite the wind-down of the Pandemic Preparedness Agreement with the German government, these efforts enable us to extend our runway into the fourth quarter of 2025.”

Selected Business Updates

Organizational Redesign

Following a comprehensive operational assessment in 2023, CureVac is implementing in 2024 an organizational redesign to streamline structures and reduce operating costs across most areas of the company. The program was initiated with a “voluntary leaver” program, with the aim to reduce 150 positions. The redesign will be tailored to CureVac’s business scope and pipeline priorities, significantly increasing efficiency and performance while maintaining a strong focus on innovation and R&D activities. The initiated redesign is expected to result in financial savings from the second half of 2024 onwards and extend the company’s cash runway.

Termination of the Pandemic Preparedness Agreement

Due to a rapidly changing epidemiological environment following the end of the COVID-19 pandemic, CureVac and GSK decided to end the Pandemic Preparedness Agreement jointly concluded with the Federal Republic of Germany in April 2022. This decision was made after consultation with the German Federal Ministry of Health and the German Center for Pandemic Vaccines and Therapeutics (ZEPAI). The agreement included the provision of production capacity and supply of mRNA-based vaccines in the event of a public health emergency in Germany.

Termination will take effect on May 31, 2024, with no further financial obligations. Completion of CureVac’s GMP IV manufacturing plant for the production mRNA-based vaccines is unaffected and progressing. Contingent upon regulatory approval, the facility is expected to be certified in the second half of 2024.

Strategic Collaborations

In April 2024, CureVac entered into a strategic co-development and licensing agreement with The University of Texas MD Anderson Cancer Center, one of the world’s leading academic oncology centers. The collaboration centers on the joint development of novel, off-the-shelf mRNA-based cancer vaccine candidates in selected hematological and solid tumor indications with high unmet medical need. It creates strong synergies between CureVac’s unique end-to-end capabilities for cancer antigen discovery, mRNA design, and manufacturing and MD Anderson’s world-class expertise in cancer antigen discovery and validation, translational drug development, and clinical research.

Both parties will contribute to the identification of differentiated cancer antigens based on whole genome sequencing, combined with long- and short-read RNA-sequencing and cutting-edge bioinformatics. Joint preclinical validation of the highest-quality cancer antigens and subsequent selection of promising clinical lead candidates is expected to be followed by initial Phase 1/2 studies in appropriate clinical indications.

Under the terms of the agreement, CureVac has worldwide exclusive rights to late-stage development, commercialization, or partnering of the candidates. MD Anderson is eligible for downstream payments based on potential future commercialization.

Corporate Development

Thaminda Ramanayake was appointed to the CureVac Management Team as Chief Business Officer effective June 1, 2024. Mr. Ramanayake has more than 15 years of international experience in biopharma company development and deal-making. He has built a strong track record of successful clinical collaborations, M&A, asset in-licensing and strategic financing initiatives as well as deep expertise in the fields of immunology and oncology. His focus will be on business strategies to accelerate CureVac’s pipeline, mature the organization, and enable further strategic partnerships.

Mr. Ramanayake joins CureVac from Affini-T Therapeutics, where he served as Chief Business Officer and was responsible for creating the company’s business development organization. He previously served as Vice President and Global Head of Business Development in Oncology at Sanofi, where he established the Clinical Trial Supply Agreement Center of Excellence and negotiated collaborations valued in the hundreds of millions to billions of dollars. He also held positions at BioMarin Pharmaceuticals where he in-licensed numerous gene therapy and oligonucleotide-based assets in hearing loss, cardiology, neurology and other therapeutic areas, and at Amgen, where he negotiated a number of international commercialization agreements.

Mr. Ramanayake holds a master’s degree in immunology from the University of Rochester and an MBA in Finance from the University of Rochester Simon School of Business. He holds a bachelor’s degree in cellular, molecular and systems biology.

Prophylactic Vaccines

Executing on Broad Second-Generation mRNA Vaccine Program, Jointly Developed with GSK

CureVac continues to advance its clinical development programs in prophylactic vaccines in collaboration with GSK. All currently tested candidates apply modified mRNA and are based on CureVac’s proprietary second-generation mRNA backbone, targeting improved intracellular mRNA translation for early and strong immune responses.

Avian Flu (H5N1) Program

Start of the Phase 1 part of a combined Phase 1/2 study of an investigational influenza A (H5N1) pre-pandemic vaccine candidate was announced on April 24, 2024. The H5N1 avian flu virus is considered a potential future pandemic threat, known to sporadically cross species from its original bird host to other animals and humans. The study represents the latest program progressing to clinical trials under the broad infectious disease collaboration agreement with GSK, first announced in July 2020. It assesses the safety, reactogenicity and immunogenicity of a monovalent vaccine candidate based on CureVac’s proprietary second-generation mRNA backbone, encoding an influenza A H5-antigen. In the initial Phase 1 dose-escalation part of the study, up to five dose levels will be assessed compared to a placebo control in healthy younger adults aged 18 to 64 and healthy older adults aged 65 to 85.

Seasonal Flu Program

In the ongoing Phase 2 part of the combined 1/2 study in seasonal flu, CureVac reported promising data from a planned interim analysis on April 4, 2024. The Phase 2 part assessed the reactogenicity, safety, and immunogenicity of a potentially differentiated, multivalent vaccine candidate in 960 healthy younger and older adults. The candidate was tested in comparison to age-matched licensed comparator vaccines, which featured a standard dose seasonal vaccine for younger adults and a high dose seasonal vaccine for older adults. It encodes antigens matched to all four WHO recommended flu strains and was selected from a comprehensive Phase 1 part, which tested mRNA vaccine candidates with up to eight separate mRNA constructs per candidate.

The vaccine candidate was shown to have an acceptable safety and tolerability profile, confirming previous findings that CureVac’s mRNA platform elicits strong overall antibody titers at well-tolerated dose levels. It boosted antibody titers against all encoded flu strains and across all age groups and tested dose levels. Among younger and older adults, geometric mean titers generated by the vaccine candidate against influenza A strains numerically exceeded the geometric mean titers of the licensed comparator vaccines across all tested dose levels. For influenza B strains, geometric mean titers were lower than those elicited by the licensed comparator vaccines, in line with expectations and other initial mRNA-based clinical flu development programs. Further optimizations to enhance immune responses against influenza B strains will be tested in an additional Phase 2 study.

COVID-19 Program

On January 5, 2024, CureVac reported positive results from the planned interim analysis of the ongoing Phase 2 study in COVID-19. The study assessed the safety and immunogenicity of two modified mRNA COVID-19 vaccine candidates: the monovalent candidate, CV0601, encoding the spike protein of the omicron BA.4-5 variant and the bivalent candidate, CV0701, encoding the spike proteins of the omicron BA.4-5 variant and the original SARS-CoV-2 strain. Vaccine candidates were compared to a licensed bivalent mRNA COVID-19 comparator vaccine. All tested dose levels of the vaccine candidates were below those used in mRNA-based COVID-19 vaccines licensed in the U.S. and EU. The study is fully enrolled with 427 healthy adults aged 18 and older equally randomized between dose groups.

The data confirmed favorable reactogenicity profiles for both candidates across all dose levels, showing a lower or similar proportion of participants reporting solicited adverse events relative to the comparator vaccine. Interim immunogenicity data for CV0601, tested at a single dose level, showed neutralizing antibody titers against the Omicron BA.4-5 variant on day 29 following the booster vaccination that were 5.0 times the pre-boosting titers, numerically exceeding the 3.6-fold ratio generated by the licensed comparator vaccine. For the three dose levels tested for CV0701, neutralizing antibody titers against BA.4-5 on day 29 following the booster vaccination were 2.7-fold, 3.7-fold and 4.6-fold the titers before the booster, compared to a 3.6-fold ratio of post- to pre-booster titers for the comparator vaccine. The Phase 2 study is currently ongoing with Part B, assessing different vaccine candidate shelf-life conditions.

Oncology

Broadening of Oncology Footprint with mRNA Cancer Vaccines

CureVac continues to develop the next generation of targeted mRNA-based cancer vaccines based on cutting-edge technologies for antigen discovery and its second-generation mRNA backbone, focusing on two approaches: 1) the development of off-the-shelf cancer vaccines based on tumor antigens shared across different cancer indications and 2) the development of fully personalized cancer vaccines based on a patient’s individual tumor genomic profile.

Clinical off-the-shelf program in glioblastoma

CureVac’s Phase 1 study of patients with glioblastoma has successfully completed enrollment of all four dose levels within the study’s dose-escalation Part A with multiepitope cancer vaccine candidate, CVGBM.

Following review of the Part A safety data, the Data Safety Monitoring Board (DSMB) has confirmed no dose-limiting toxicities and recommended a 100 µg dose for the subsequent dose-confirmation Part B of the study. Part B is expected to start recruitment mid-2024. A first data readout of the study is expected in the second half of 2024.

The open-label study evaluates the safety and tolerability of CVGBM in patients with newly diagnosed and surgically resected MGMT-unmethylated glioblastoma or astrocytoma with a molecular signature of glioblastoma. CVGBM features a single unmodified mRNA encoding eight epitopes derived from known tumor-associated antigens with demonstrated immunogenicity in glioblastoma.

More information can be found at clinicaltrials.gov (NCT05938387).

The RNA Printer® in Oncology

The RNA Printer®, CureVac’s end-to-end solution for integrated and automated manufacturing of GMP-grade mRNA vaccines and therapeutics, successfully achieved the next milestone in an ongoing regulatory review process. The system was granted a framework license that significantly broadens its regulatory freedom and flexibility to manufacture different mRNA vaccine candidates in support of CureVac’s oncology strategy. The framework license represents an extension of the initial manufacturing license CureVac announced on November 14, 2023. 

Protection of Intellectual Property Rights

CureVac is asserting its intellectual property rights in litigation against Pfizer/BioNTech in Germany, the U.S. and the UK.

In the U.S., a magistrate judge recently granted a motion by Acuitas Therapeutics to intervene, sever and stay the CureVac’s U.S. litigation against Pfizer/BioNTech. The motion is based on co-ownership and co-inventorship claims related to one patent family covering four patents out of the 10 patents at issue in the U.S. These four patents cover the specific design of a COVID-19 vaccine, using a lipid nanoparticle. The magistrate judge recommended to stay litigation of all ten patents before the District Court of the Eastern District of Virginia until the Acuitas Therapeutics claim is resolved. CureVac is preparing objections to this recommendation and anticipates a decision within the next two months.

In Germany, on December 19, 2023, the German Federal Patent Court granted in the first instance the request filed by BioNTech SE to nullify the German part of CureVac patent EP 1 857 122 B1. CureVac will appeal the decision to the German Federal Court of Justice once a written decision has been issued, remaining highly confident in the strength of its broad intellectual property portfolio and its essential contributions to safe and efficacious COVID-19 vaccines. The decision does not affect the ongoing litigation in Germany regarding seven other intellectual property rights that cover strong foundational as well as COVID-19-specific mRNA innovation. Following this decision, the Regional Court Düsseldorf suspended infringement proceedings in the German part of EP 1 857 122 B1 on December 28, 2023.

Conference call and webcast details

CureVac will host a conference call and webcast today at 3 p.m. CET / 9 a.m. ET.
Dial-in numbers to participate in the conference call:

U.S. Toll-Free:  +1-877-407-0989

International: +1-201-389-0921

Germany: 0800-182-0040 (landline access) / 0800-184-4713 (cell phone access)

The live webcast link can be accessed via the newsroom section of the CureVac website at https://www.curevac.com/en/newsroom/events/

Corresponding presentation slides will be posted shortly before the start of the webcast.

A replay will be made available at this website after the event.

Financial Update for the Fourth Quarter and Full-Year 2023

Cash Position

Cash and cash equivalents amounted to €402.5 million at the end of December 2023, decreasing from €495.8 million at the end of 2022. In 2023, cash used in operations was mainly allocated to payments in connection with ongoing R&D activities, for expenditures for CureVac’s manufacturing facility, GMP IV, and the purchase of raw materials. This decrease was partially compensated by €219.8 million in net proceeds raised in a follow-on offering in the first quarter of 2023.

Revenues

Revenues amounted to €22.6 million and €53.8 million for the three and twelve months ended December 31, 2023, representing an increase of €10.9 million and a decrease of €13.6 million, or 93.1% and -20.3%, from €11.7 million and €67.4 million for the same period in 2022.

The year-on-year decrease was primarily driven by lower revenues from the two GSK collaboration agreements as the companies agreed to focus on the larger indications. As a consequence, total GSK related revenues of €47.1 million were recognized in 2023, representing a decrease of €15.2 million, compared to €62.3 million in the prior year period. For the three months ended December 31, 2023, revenue was higher compared to the prior year period, as a significant portion of the milestone related to the initiation of Phase 2 of the seasonal flu clinical trial was recognized.

Operating Result

Operating loss amounted to €88.0 million and €274.2 million for the three and twelve months ended December 31, 2023, representing a decrease of €33.5 million and an increase of €24.7 million from €121.5 million and €249.5 million for the same period in 2022.

The operating result was affected by several key drivers mainly related to the closing of our first-generation vaccine effort in COVID-19:

• Cost of sales decreased primarily due to lower write-off of raw materials. Furthermore, the prior year was impacted by additional costs related to the termination of CMO activities for the first-generation COVID-19 vaccine.
   
• Research and development expenses increased primarily with increased activity in infectious disease and oncology R&D projects and development of the workforce. Additionally, the prior year period was positively impacted by €38.5 million related to the reversal of an outstanding CRO provision and by a one-off net gain for a change in the contract termination provision resulting primarily in GSK taking over from the company committed capacity at a CMO.
   
• Other income decreased year-on-year due to a one-off compensation from GSK amounting to €32.5 million for reimbursement of prepayments and production set-up activities at a CMO positively impacting the previous year.

Financial Result (Finance Income and Expenses)

Net financial result for the three and twelve months ended December 31, 2023, amounted to €1.5 million and €14.2 million, or an increase of €8.7 million and €13.9 million from a financial loss of €7.2 million and a financial gain of €0.3 million for the same periods in 2022. This increase was mainly driven by interest income on cash investments.

Pre-Tax Loss

Pre-tax loss was €86.5 million and €260.0 million for the three and twelve months ended December 31, 2023, compared to €128.7 million and €249.2 million in the same period of 2022.

About CureVac

CureVac (Nasdaq: CVAC) is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing, optimizing, and manufacturing this versatile biological molecule for medical purposes. The principle of CureVac’s proprietary technology is the use of optimized mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. In July 2020, CureVac entered in a collaboration with GSK to jointly develop new products in prophylactic vaccines for infectious diseases based on CureVac’s second-generation mRNA technology. This collaboration was later extended to the development of second-generation COVID-19 vaccine candidates, and modified mRNA vaccine technologies. Based on its proprietary technology, CureVac has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac N.V. has its headquarters in Tübingen, Germany, and has more than 1,100 employees across its sites in Germany, the Netherlands, Belgium, Switzerland and the U.S. Further information can be found at www.curevac.com.

CureVac Media Contact

Patrick Perez, Junior Manager Public Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1831
patrick.perez@curevac.com
 

CureVac Investor Relations Contact

Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
sarah.fakih@curevac.com

Forward-Looking Statements CureVac

This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac N.V. and/or its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate Services GmbH, CureVac RNA Printer GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the “company”) regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the potential efficacy of the company’s vaccine and treatment candidates and the company’s strategies, financing plans, cash runway, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” or “expect,” “may,” “will,” “would,” “could,” “potential,” “intend,” or “should,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company’s industry, the effects of the COVID-19 pandemic on the company’s business and results of operations, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, fluctuations of operating results due to the effect of exchange rates, delays in litigation proceedings, different judicial outcomes or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please reference the company’s reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.
 

Cash and Condensed Consolidated Profit and Loss Data
 

CureVac Appoints Thaminda Ramanayake as New Chief Business Officer
 

• Mr. Ramanayake brings more than fifteen years of experience in biopharma company development and deal-making
   
• Strong track record of successful clinical collaborations, M&A, asset in-licensing and strategic financing initiatives across multiple therapeutic areas

TÜBINGEN, Germany/BOSTON, USA – April 24, 2024 — CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced that Thaminda Ramanayake has been appointed to the role of Chief Business Officer, effective June 1, 2024.

“Thaminda’s extensive experience in advancing corporate strategy, business development and strengthening strategic partnerships in specific areas will be a tremendous asset to CureVac as we work to progress best-in-class mRNA vaccines and medicines across multiple therapeutic areas,” said Dr. Alexander Zehnder, Chief Executive Officer of CureVac. “Mr. Ramanayake is an accomplished strategist whose distinctive leadership and advisory expertise will make him an essential thought partner in accelerating the development of impactful infectious disease, oncology and molecular therapies.”

Mr. Ramanayake has built a strong track record of successful clinical collaborations, M&A, asset in-licensing and strategic financing initiatives over more than 15 years of biopharma development and deal-making. He joins CureVac from Affini-T Therapeutics, where he served as Chief Business Officer and was responsible for creating the company’s business development organization. He previously served as Vice President and Global Head of Business Development in Oncology at Sanofi, where he established the Clinical Trial Supply Agreement Center of Excellence and negotiated collaborations valued in the hundreds of millions to billions of dollars. He also held positions at BioMarin Pharmaceuticals where he in-licensed numerous gene therapy and oligonucleotide-based assets in hearing loss, cardiology, neurology and other therapeutic areas, and at Amgen, where he negotiated a number of international commercialization agreements.

With an educational background in both immunology and business, Mr. Ramanayake began his career as a scientist at Johnson & Johnson and later held a succession of Wall Street business development and consulting roles. He holds a master’s degree in immunology from the University of Rochester Strong Medical Center and completed an MBA in Finance at the University of Rochester Simon School of Business. He holds a bachelor’s degree in cellular, molecular and systems biology from Berea College.

“With promising data accumulating in CureVac’s vaccine programs and the first clinical results in oncology anticipated later this year, it is an exciting time to join this pioneering team,” said Mr. Ramanayake. “My career has centered on immunology and oncology, so I have an immense appreciation for the decades of research CureVac has contributed to the mRNA field. One of the benefits of mRNA is its potential to deliver transformative medicines widely and equitably, offering greater access compared to other modalities. CureVac combines industry-shaping technology and outstanding talent, and I look forward to contributing to the company’s mission to use therapeutic mRNA to transform people and patients’ lives.”

About CureVac

CureVac (Nasdaq: CVAC) is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing, optimizing, and manufacturing this versatile biological molecule for medical purposes. The principle of CureVac’s proprietary technology is the use of optimized mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. In July 2020, CureVac entered in a collaboration with GSK to jointly develop new products in prophylactic vaccines for infectious diseases based on CureVac’s second-generation mRNA technology. This collaboration was later extended to the development of second-generation COVID-19 vaccine candidates, and modified mRNA vaccine technologies. Based on its proprietary technology, CureVac has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac N.V. has its headquarters in Tübingen, Germany, and has more than 1,100 employees across its sites in Germany, the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.

CureVac Media Contact

Patrick Perez, Junior Manager Public Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1831
M: +49 151 14 115247
patrick.perez@curevac.com

CureVac Media and Investor Relations Contact

Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
sarah.fakih@curevac.com

Forward-Looking Statements CureVac

This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac N.V. and/or its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate Services GmbH, CureVac RNA Printer GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the “company”) regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the potential efficacy of the company’s vaccine and treatment candidates and the company’s strategies, financing plans, cash runway, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” or “expect,” “may,” “will,” “would,” “could,” “potential,” “intend,” or “should,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company’s industry, the effects of the COVID-19 pandemic on the company’s business and results of operations, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, fluctuations of operating results due to the effect of exchange rates, delays in litigation proceedings, different judicial outcomes or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please reference the company’s reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

CureVac Announces Start of Combined Phase 1/2 Study in Avian Influenza (H5N1); Development in Collaboration with GSK
 

• Phase 1 part of combined Phase 1/2 study initiated as part of pandemic preparedness against highly pathogenic avian influenza (H5N1) virus, considered to be potential future pandemic threat
• Study will assess monovalent vaccine candidate, encoding an influenza A H5-antigen using proprietary second-generation mRNA backbone
• Avian influenza is latest program progressing to clinical trials under broad infectious disease collaboration agreement with GSK
   

TÜBINGEN, Germany/BOSTON, USA – April 24, 2024 – CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced the start of the Phase 1 part of a combined Phase 1/2 study of an investigational influenza A (H5N1) pre-pandemic vaccine candidate developed in collaboration with GSK. The H5N1 avian influenza virus is considered a potential future pandemic threat, known to sporadically cross species from its original bird host to other animal hosts and humans. The monovalent vaccine candidate is based on CureVac’s proprietary second-generation mRNA backbone and encodes an influenza A H5-antigen.

“The highly pathogenic avian influenza virus is frequently cited as one of the viruses with high pandemic potential, with cases of animal-to-human transmission of the H5N1 strain already documented. Leveraging our clinically validated mRNA-technology platform and second-generation mRNA backbone, we aim to provide an effective countermeasure to the pandemic threat of potential human-to-human transmission”, said Dr. Myriam Mendila, Chief Development Officer of CureVac. “This clinical milestone, in collaboration with GSK, expands the application of our mRNA technology into an additional indication in infectious diseases and addresses the need to be prepared for potential future pandemics.”

The combined Phase 1/2 study will evaluate the safety, reactogenicity and immunogenicity of an investigational influenza A (H5N1) pre-pandemic vaccine candidate in healthy younger adults aged 18 to 64 and healthy older adults aged 65 to 85.  In the initial Phase 1 dose-escalation part of the study, up to five dose levels will be assessed compared to a placebo control. The study will be conducted in the United States.

The broad CureVac-GSK infectious disease collaboration was first announced in July 2020. It focuses on applying CureVac’s mRNA-technology to the development of new products for infectious disease targets.

About CureVac

CureVac (Nasdaq: CVAC) is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing, optimizing, and manufacturing this versatile biological molecule for medical purposes. The principle of CureVac’s proprietary technology is the use of optimized mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. In July 2020, CureVac entered in a collaboration with GSK to jointly develop new products in prophylactic vaccines for infectious diseases based on CureVac’s second-generation mRNA technology. This collaboration was later extended to the development of second-generation COVID-19 vaccine candidates, and modified mRNA vaccine technologies. Based on its proprietary technology, CureVac has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac N.V. has its headquarters in Tübingen, Germany, and has more than 1,100 employees across its sites in Germany, the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.

CureVac Media Contact

Patrick Perez, Junior Manager Public Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1831
M: +49 151 14 115247
patrick.perez@curevac.com

CureVac Investor Relations Contact

Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
sarah.fakih@curevac.com

Forward-Looking Statements CureVac

This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac N.V. and/or its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate Services GmbH, CureVac RNA Printer GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the “company”) regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the potential efficacy of the company’s vaccine and treatment candidates and the company’s strategies, financing plans, cash runway, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” or “expect,” “may,” “will,” “would,” “could,” “potential,” “intend,” or “should,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company’s industry, the effects of the COVID-19 pandemic on the company’s business and results of operations, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, fluctuations of operating results due to the effect of exchange rates, delays in litigation proceedings, different judicial outcomes or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please reference the company’s reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

KELOWNA, BC / ACCESSWIRE / April 24, 2024 / Tryp Therapeutics, Inc. (“Tryp” or the “Company“) (CSE:TRYP)(OTCQB:TRYPF) is pleased to announce that the shareholders of Exopharm Limited ACN 163 765 991 (“Exopharm“) have approved the previously announced plan of arrangement (the “Arrangement“) between the parties.

The Company is also pleased to confirm that all conditions precedent to the completion of the Arrangement have been satisfied or waived (with the exception of the conditional approval of the Australian Securities Exchange (the “ASX“), which is expected to be received on April 30, 2024) and the parties anticipate that the Arrangement will be completed on or about May 1, 2024, with the combined company’s shares to commence trading on the ASX under the name “Tryptamine Therapeutics Limited” and the ticker symbol “TYP” on or about May 15, 2024, following the combined company’s satisfaction of the ASX admission conditions.

In anticipation of the closing of the Arrangement, Tryp has voluntarily requested that trading in its common shares (the “Tryp Shares“) on the Canadian Securities Exchange (the “CSE“) and on the OTCQB Venture Market (the “OTCQB“) be halted effective April 29, 2024. Subsequent to the completion of the Arrangement, the Tryp Shares are expected to be delisted from the CSE and to cease trading on the OTCQB.

In order to receive the consideration to which they are entitled for their Tryp Shares, all registered shareholders of the Company must complete, sign, date and return the letter of transmittal, which has been previously mailed and is available under the Company’s SEDAR+ profile at www.sedarplus.ca, with accompanying Tryp Share certificate(s) or DRS advice-statement(s) (if applicable) to Computershare Investor Services Inc. Non-registered shareholders should contact their broker or other intermediary for instructions and assistance in receiving the consideration in respect of their Tryp Shares.

About Tryp

Tryp Therapeutics is a clinical-stage biotechnology company focused on developing proprietary, novel formulations for the administration of psilocin in combination with psychotherapy to treat diseases with unmet medical needs. Tryp’s lead program, TRP-8803, is a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin) that alleviates numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe. The Company has completed a Phase 2a clinical trial for the treatment of binge eating disorder at the University of Florida, which demonstrated an average reduction in binge eating episodes of greater than 80%. The Company also recently announced commencement of patient dosing in a Phase 2a clinical trial for the treatment of fibromyalgia in collaboration with the University of Michigan and is preparing to initiate a Phase 2a clinical trial in collaboration with Massachusetts General Hospital for the treatment of abdominal pain and visceral tenderness in patients suffering from irritable bowel syndrome. Each of the studies is utilizing TRP-8802 (synthetic, oral psilocybin) to demonstrate clinical benefit in these indications. Where a positive clinical response is demonstrated, subsequent studies are expected to utilize TRP-8803 (IV-infused psilocin), which has the potential to further improve efficacy, safety, and patient experience. For more information, please visit www.tryptherapeutics.com.

Investor & Media Contact

Peter Molloy
Chief Business Officer
Tryp Therapeutics Inc.
pmolloy@tryptherapeutics.com

Forward-Looking Information

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

SOURCE: Tryp Therapeutics, Inc.

• FINANCIAL RESULTS FOR 2023 FULLY MET UPDATED GUIDANCE
• PRIORITY RESET TO PROFITABLE GROWTH: SIZE & FOOTPRINT ADJUSTMENTS TO DRIVE EXPECTED ANNUALISED EBITDA IMPROVEMENT GREATER THAN € 40 M
• EVOTEC’S REPORTING STRUCTURE WILL CHANGE TO BUSINESS SEGMENTS “SHARED R&D” AND “JUST – EVOTEC BIOLOGICS” STARTING Q1 2024

Hamburg, Germany, 24 April 2024:
Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) today reported financial results and corporate updates for the fiscal year ended 31 December 2023 and announced a priority reset to optimise its business to meet evolving market demand and focus on profitable growth in 2024 and beyond.

CONTINUED GROWTH DESPITE MULTIPLE CHALLENGES

• Group revenues up 4% to € 781.4 m (+6% at constant fx rates (2022: € 751.4 m))
• Revenues from Just – Evotec Biologics up 111% to € 108.4 m (2022: € 51.3 m)
• Base business excluding Just – Evotec Biologics down (4)%, including approx. (10)% impact as a result of the severe cyber-attack
• Gross margin of 22.6% (2022: 23.2%) despite low contribution from milestones and business disruption during Q2 2023
• Adjusted Group EBITDA at € 66.4 m (2022: € 101.7 m), adjusted for one-off effects related to the recovery from the severe cyber-attack of € 15.9 m
• Unpartnered R&D expenses of € 64.8 m down (8)% (2022: € 70.2 m)

SELECTED BUSINESS HIGHLIGHTS

• Substantial progress within strategic partnerships with Bristol Myers Squibb (“BMS”)
  • Significant expansion of iPSC-based neurodegeneration collaboration with BMS for an additional 8 years
  • Key scientific progress in the targeted protein degradation alliance with BMS relating to building a molecular glue-based pipeline
• Strategic collaboration with Janssen for immune-based therapies
• New long-term strategic partnership entered with Sandoz for Just – Evotec Biologics
• Evotec-partner Jingxin receives approval for EVT201 in China
• Approval of Evotec’s near-term targets by Science Based Targets initiative (“SBTi”)
• Completion of Chief Executive Officer (“CEO”) transition with Dr Christian Wojczewski taking over effective 01 July (after period-end)
• Creation of Chief People Officer (“CPO”) position with Aurélie Dalbiez joining effective 15 June (after period-end)

PERFORMANCE REVIEW, PRIORITY RESET & OUTLOOK

• Focusing on sustainable and profitable growth
  • Focusing & rightsizing organisation to overcome challenging market environment, and return to sustainable and profitable growth
  • Shared R&D and Just – Evotec Biologics to replace EVT Execute & EVT Innovate segments in streamlined reporting structure as of Q1 2024
  • Expected annualised EBITDA improvement greater than € 40 m
  • Evotec plans to update the market on its mid-term forecast with its H1 results
• Financial guidance for 2024
  • Group revenues expected to grow by a double-digit percentage (2023: € 781.4 m)
  • Mid-single to low double digit percentage reduction of unpartnered research and development expenses expected (2023: € 64.8 m)
  • Adjusted Group EBITDA expected to grow by a double-digit percentage (2023: € 66.4 m)
  • Refined guidance to be assessed together with new CEO; update planned for H1 results

Dr Mario Polywka, Interim Chief Executive Officer of Evotec: “Evotec’s business displayed great resilience in a challenging market environment. Our central focus for 2024 is to protect our strong balance sheet and refocus the Company on profitable growth. Through the planned priority reset and measures to rightsize our operational and corporate structure, we are taking the necessary steps to ensure that we continue to work with our partners to shape the medicines that matter for many years to come.”

CONTINUED GROWTH DESPITE MULTIPLE CHALLENGES

Key figures of consolidated income statement & segment information

Evotec SE & subsidiaries

1) Adjusted for exchange rate effects of € 13.8 m, Group revenues would have amounted to € 795.2 m.

2) Includes unpartnered R&D expenses of € 64.8 m in 2023 (2022: € 70.2 m).

3) Before changes in contingent consideration, income from bargain purchase and excluding impairments on goodwill, other intangible and tangible assets as well as the total non-operating result.

FINANCIAL PERFORMANCE

Resilience in a challenging year
Evotec demonstrated the resilience of its business model in financial year 2023, which was marked by challenging macro-economic headwinds, an increasingly competitive market environment, and the severe cyber-attack that impacted the business in Q2 2023. Encouraging revenue development evidenced the Company’s successful strategy to extend existing collaborations and expand its network of alliances.

In financial year 2023, Evotec increased its consolidated revenues by 4%. During the twelve months ended 31 December 2023, Group revenues increased by € 30.2 m to € 781.4 m compared with the same period of the previous year (2022: € 751.4 m). The rise against the prior-year period was mainly driven by new collaborations. At constant fx rates, Group revenues grew by 6% to € 795.2 m. The base business increased by 7% from € 714.4 m in 2022 to € 766.5 m in 2023 despite severe operational impediments in Q2 caused by the cyber-attack. Just – Evotec Biologics contributed € 108.4 m to the total group revenue compared to € 51.3 m in 2022, reflecting a 111% growth.

Adjusted Group EBITDA for the twelve months ended 31 December 2023 amounted to € 66.4 m (versus € 101.7 m in 2022), which is the result of a well-balanced development between the very favourable growth and profitability of Evotec’s base business, preparations for future growth of Just – Evotec Biologics, and a lower contribution from milestones, upfronts and licenses. Moreover, higher energy costs as well as overall inflation affect the year-over-year comparison.

R&D expenses were at € 68.5 m in 2023, compared to € 76.6 m in the twelve months ended 31 December 2022 ((11)%). The decrease in unpartnered R&D expenses by (8)% (€ 64.8 m vs. 2022: € 70.2 m) represents a balance between strong investments in Evotec’s capabilities to improve efficiency and precision medicine platforms, and financial stewardship in the year impacted by the cyber-attack.

SELECTED BUSINESS HIGHLIGHTS

Broader and deeper strategic alliance with Bristol Myers Squibb (BMS)
a) Significant expansion of iPSC-based neurodegeneration collaboration
In March 2023, BMS and Evotec extended and expanded the neurodegeneration partnership, originally signed in 2016, for an additional eight years. In July, Evotec announced that BMS has exercised its option to enter into an exclusive global licence agreement, which covers selected discovery programmes that were developed and progressed within the neurodegeneration partnership. As part of this expanded collaboration, and under the licence agreement, BMS rapidly developed several programmes using Evotec’s precision medicine platforms.
b) Further progress within targeted protein degradation alliance
In March 2023, Evotec announced key scientific progress in the targeted protein degradation alliance with BMS relating to building a molecular glue-based pipeline and first signed in 2018.

Strategic collaboration with Janssen for immune-based therapies
In January 2023, Evotec announced a new strategic collaboration and licence agreement with Janssen focussing on the development of first-in-class targeted immune-based therapies for oncology. Besides research funding, Evotec is entitled to an undisclosed upfront payment, as well as possible downstream commercial milestones and tiered royalties of up to $ 350 m.

New strategic long-term partnership with Sandoz for Just – Evotec Biologics
In May 2023, Just – Evotec Biologics and Sandoz launched a multi-year, long-term partnership for the development and subsequent manufacturing of multiple biosimilars. The agreement includes an undisclosed double-digit-million initial payment, as well as future payments dependent on successful development progress of up to $ 640 m as well as additional payments dependent on progress into commercial manufacturing.

Evotec-partner Jingxin receives approval for EVT201 in China
In December 2023, Zhejiang Jingxin Pharmaceutical Co., Ltd (“Jingxin”) has received the approval from the Chinese National Medical Products Administration for the novel insomnia treatment EVT201, also known as Dimdazenil in China. Evotec is entitled to receive double-digit royalties of net sales as well as milestones based on commercial success and further sub-licensing.

Evotec received approval of its near-term targets from SBTi
In October 2023, the Science Based Targets initiative (“SBTi”) informed Evotec that the Company’s greenhouse gas emissions reduction targets have been validated and approved. The science-based near-term targets are compliant with SBTi criteria and recommendations and consistent with levels required to meet the goals of the Paris Agreement. The SBTi has classified Evotec’s scope 1 and 2 target ambition and has determined that it is in line with a 1.5°C trajectory.

Completion of CEO transition (after period-end)
In January 2024, following Dr Lanthaler’s departure from the Company, Evotec conducted a smooth and prompt transition of tasks and responsibilities to Dr Mario Polywka, who currently serves as Interim CEO. Mario Polywka played a vital role in building Evotec into the leader it is today – as COO and, later, as a long-standing member of the Supervisory Board. On 23 April, the Supervisory Board of Evotec SE unanimously appointed Dr Christian Wojczewski as the Company’s new CEO, effective 01July 2024. Dr Mario Polywka will retire from his position at the end of June and will also not seek re-election for his dormant Supervisory Board mandate, which expires with the 2024 Annual General Meeting.

Creation of CPO position (after period-end)
Effective 15 June, Aurélie Dalbiez will join Evotec’s Management Board as the Chief People Officer. Aurélie Dalbiez joins Evotec from Corbion, where she served as Chief HR Officer. Previously, she was Head of HR for the Capsules and Health Ingredients business at Lonza, and previously worked in various HR roles at Novartis.

PERFORMANCE REVIEW, PRIORITY RESET & OUTLOOK

Focusing on sustainable and profitable growth
The biopharma industry continues to experience economic headwinds with outsourcing demands remaining largely flat. Evotec anticipates that the business climate in selected areas will only start improving toward the end of 2024. Over the course of 2024, Evotec will proactively implement measures to reset its operational and corporate priorities with a focus on profitable growth and right size its business even more strongly around its key modalities, small molecules and biologics. Evotec aims to simplify its organisational structure and operating model, while also optimising its footprint and capacity. The priority reset is anticipated to result in expected annualised EBITDA improvement of greater than € 40 m.

Due to changing industry dynamics, associated pressure on margins, and the implementation of the priority reset, the new management team will be reviewing the mid-term outlook. Evotec plans to update the market on its mid-term forecast with the release of its H1 2024 results in August 2024.

Shared R&D and Just – Evotec Biologics to replace EVT Execute & EVT
Innovate segment reporting structure
As part of this priority reset and in line with market developments, Evotec will simplify its reporting to Shared R&D and Just – Evotec Biologics starting Q1 2024. Evotec has previously reported its financial results in two reporting segments, EVT Execute (representing Evotec’s core discovery alliance businesses) and EVT Innovate (where Evotec invests along its core competences in first-in-class and best-in-class targets to build a product pipeline together with its partners without taking major financial risks).

Financial Guidance for 2024
In 2024, Evotec expects revenue growth at a double-digit percentage versus the previous year’s revenues of € 781.4 m.

Evotec will continue to invest in its own unpartnered R&D to further develop high-value partnerships and expand its long-term and sustainable pipeline of first-in-class projects and platforms. Evotec expects a reduction of unpartnered R&D investments in a mid-single to low double digit percentage range.

Adj. EBITDA is also expected to grow at a double-digit percentage versus the 2023 result of € 66.4 m. Growth is expected to be at least in-line with revenue growth. Additional upside is linked to the implementation of efficiency measures and improving demand.

The full impact of the organisational efficiency and rightsizing initiative will only be partially reflected in the 2024 financial performance. A refined guidance will be assessed together with new CEO. Evotec intends to inform the market with its H1 results presentation in August.

WEBCAST/CONFERENCE CALL

The Company plans to hold a conference call to discuss the results as well as provide an update on its performance. The conference call will be held in English.

Webcast details

Date:   Wednesday, 24 April 2024
Time:   03.00 pm CEST (09.00 am EDT, 02.00 pm BST)

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/en/investor-relations/financial-publications.

Conference call details
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.

A simultaneous slide presentation for participants dialling in via phone is available under this link.

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 17 sites 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.

Media Contact Evotec SE:
Gabriele Hansen, SVP Head of Global Corporate Communications, Gabriele.Hansen@evotec.com
Hinnerk Rohwedder, Director of Global Corporate Communications, Hinnerk.Rohwedder@evotec.com

IR Contact Evotec SE:
Volker Braun, EVP Head of Global Investor Relations & ESG, Volker.Braun@evotec.com

Hamburg, Germany – Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, Prime Standard, ISIN: DE 000 566480 9, WKN 566480; NASDAQ: EVO) announces the appointment of Dr Christian Wojczewski as Chief Executive Officer of the Company, effective 01 July 2024. Dr Wojczewski holds a degree in chemistry and has over 20 years of experience in various management positions, most recently as CEO of Mediq and at Linde Healthcare.

Dr Mario Polywka, who has led Evotec as Interim CEO since 03 January 2024, will retire from his position at the end of June and will also not seek re-election for his dormant Supervisory Board mandate, which expires with the 2024 Annual General Meeting.

– End of the ad hoc release –

Contact: Volker Braun, EVP Head of Global Investor Relations & ESG, Evotec SE, Manfred Eigen Campus, Essener Bogen 7, 22419 Hamburg, Germany, Phone: +49 (0)40 228 999 338, volker.braun@evotec.com

Hamburg, Germany, 23 April 2024:
The Supervisory Board of Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) has appointed Dr Christian Wojczewski as the Company’s new Chief Executive Officer (“CEO”), effective 01 July 2024. The election was unanimous and is the result of an extensive selection process that began in January.

Dr Mario Polywka, who has led Evotec as Interim CEO since 03 January 2024, will retire from his position at the end of June and will also not seek re-election for his dormant Supervisory Board mandate, which expires with the 2024 Annual General Meeting.

Dr Christian Wojczewski holds a degree in chemistry and has over 20 years of experience in various management positions, most recently as CEO of Mediq and at Linde Healthcare. With his appointment, Evotec gains an experienced CEO from the healthcare industry with extraordinary success in the transformation of companies.

Prof. Dr Iris Löw-Friedrich, Chairperson of Evotec’s Supervisory Board, stated: “Dr Wojczewski is the ideal candidate to become the next CEO of Evotec. His impressive track record in building and leading large, high-performing life science organisations will be a perfect match for Evotec’s already very strong scientific teams. With his deep operational and transformational expertise, Dr Wojczewski brings all the skills and experience needed to adapt and shape Evotec’s strategy going forward and we wish him all the best for a successful start. On behalf of all members of the Supervisory Board, I also express my sincere and heartfelt gratitude to Mario for taking charge of the Company in a challenging time – as well as for his continued leadership and for his support in the selection process.”

Dr Christian Wojczewski, Evotec’s designated Chief Executive Officer, said: “I am delighted to join Evotec SE as its new CEO, and I look forward to leading the Company into the next phase of its evolution. Evotec is a leader in offering end-to-end R&D services and solutions to the life sciences industry. Evotec’s main success drivers are its best-in-class drug discovery and development platforms and the quality and expertise of its dedicated people. Together with the great people at Evotec and our partners we will continue to drive full speed for Medicines that Matter.”

Dr Mario Polywka, Evotec’s Interim Chief Executive Officer, added: “Dr Christian Wojczewski is an experienced healthcare industry executive with a long track record of establishing high performance teams, critical top and bottom-line focus, and strong customer orientation. I have full confidence in his ability to lead Evotec and its smart people into a bright future.”

About Dr Christian Wojczewski
Dr Christian Wojczewski (52) holds a diploma and a doctorate in chemistry from the Johann Wolfgang Goethe University in Frankfurt am Main. From 2000, he worked as a manager at McKinsey for companies in the pharmaceutical, biotech and chemical industries in Europe and the USA. In 2005, he joined Linde, the global market leader for medical and industrial gases. After various roles within the company, Wojczewski took over as Head of Group Strategy in 2007. During this time, he was responsible, among other things, for the integration of both companies, the transformation into a high-performance organisation and the strategic realignment of the Linde Group following the acquisition of BOC. After 2010, Wojczewski took over the management of Linde Healthcare, one of the Group’s key growth drivers. During this time, Linde Healthcare developed into the global market leader for medical gases and services for patients with chronic respiratory diseases. Under his leadership, sales in a total of 60 countries tripled to more than € 3 bn with leading EBITDA margins within the group. In 2017, Wojczewski joined Mediq in the Netherlands, a European leader in medical devices and related services. As group CEO, he led the strategic review of the portfolio, strengthened critical operating systems while streamlining business processes, and reinforced a high-performance culture throughout the organisation. Through a realignment and transformation, Mediq under Wojczewski’s leadership achieved an impressive turnaround with strong EBITDA recovery and towards profitable growth. Most recently, Wojczewski has served as a senior advisor to investors and biotech companies.

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 17 sites 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.

Media Contact Evotec SE:
Gabriele Hansen, SVP Head of Global Corporate Communications, Gabriele.Hansen@evotec.com
Hinnerk Rohwedder, Director of Global Corporate Communications, Hinnerk.Rohwedder@evotec.com

IR Contact Evotec SE:
Volker Braun, EVP Head of Global Investor Relations & ESG, Volker.Braun@evotec.com