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

In T€	EVT Execute	EVT Innovate	Intersegment eliminations	Evotec Group 2023	Evotec Group 2022
External revenues1)	514,542	266,884		781,426	751,448
Intersegment revenues	224,196	–	(224,196)	–	–
Gross margin in %	14.5	30.8	–	22.4	23.2
R&D expenses2)	(4,391)	(78,636)	14,487	(68,529)	(76,642)
SG&A expenses	(130,810)	(38,800)	–	(169,610)	(156,190)
Impairment result (net)	(5,016)	–	–	–	–
Other operating income (expenses), net	(10,166)	30,762	–	20,596	79,617
Operating result	(43,018)	(4,489)	–	(47,507)	20,850
Adjusted EBITDA3)	65,394	958	–	66,352	101,654

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

The German industrial hemp and cannabis group SYNBIOTIC SE acquires Ilesol Pharmaceuticals from Varaždin/Croatia. Ilesol has a 3,400 m2 production facility for the manufacture of cannabinoid extracts and isolates. The company also produces and distributes its own CBD natural cosmetics range. With the acquisition of Ilesol, SYNBIOTIC will be able to produce CBD isolates with the “Made in EU” label and distribute them through the companies of the SYNBIOTIC Group.

“We are thus integrating another crucial process step into our supply chain,” says Daniel Kruse, Managing Director of SYNBIOTIC. “The in-house production and refinement of hemp and cannabis extracts and corresponding isolates is an enormous competitive advantage. The market for hemp extracts and CBD isolates alone is a growth market worth billions. The cosmetics industry has long since discovered hemp and CBD for itself and demand is increasing significantly. And if the EU Commission decides in favour of the numerous novel food applications next year, the demand for hemp extracts and CBD isolates in the food supplement sector will increase many times over.”

“The acquisition of Ilesol is therefore strategically significant news for our group of companies and investments. And for our investors and shareholders, it is the second successful takeover in four months after Bushdoctor,” adds Kruse.

SYNBIOTIC is ideally positioned in the CBD product segment with leading brands and, in future, Ilesol. What was missing until now was an independent production facility for refining the extracts and manufacturing isolates that was not dependent on external factors. Ilesol closes precisely this gap in the supply chain. Moreover, the additional cosmetics range from Ilesol fits perfectly into the distribution programme of SYNBIOTIC’s subsidiaries Solidmind and Hempro International.

“As part of the SYNBIOTIC group of companies, we can take the next steps together on a European level. As an experienced manufacturer with independent, technologically mature production processes, we will be an absolute asset to everyone involved in SYNBIOTIC in every respect,” explains Sasha Bajilo, CEO and Co-Founder, Ilesol Pharmaceuticals.

The declared aim of CEO Daniel Kruse is to establish SYNBIOTIC as the leading group of companies for industrial hemp and cannabis not only on the German market, but also on the European market. With the acquisitions of Bushdoctor and Ilesol, SYNBIOTIC is now also active in Austria and Croatia.

“The Group’s pan-European orientation is the logical step towards a strong market position throughout Europe. This not only completes our supply chain and increases our sales potential, but also increases SYNBIOTIC’s importance for large, strategic investors from outside Europe,” says Kruse.

About Ilesol Pharmaceuticals
Ilesol Pharmaceuticals is an industrial manufacturer of cannabinoid extracts and CBD isolates specialising in cosmetic ingredients, cosmetic products and dietary supplements. The company, based in Varaždin /Croatia, has its own production facility with an area of 3,400 metres2 and covers the entire production process.

Publisher
SYNBIOTIC SE
Daniel Kruse
Managing Director
Münsterstrasse 336
40470 Düsseldorf
Germany

Media contact
Rüdiger Tillmann
SYNBIOTIC
Public Relations Manager
E-mail ruediger.tillmann@synbiotic.com
Mobile +49 171 3677028
c/o JOLE.group

About SYNBIOTIC
SYNBIOTIC is a listed group of companies in the hemp and cannabis sector and pursues a buy and build investment strategy focussed on the EU. The group covers the entire value chain from cultivation to production and retail – from the field to the shelf. The core businesses of the vertically integrated company are research and development, production and commercialisation of hemp, CBD and cannabis products.
SYNBIOTIC has a clear strategy to further expand along the value chains of its business areas – hemp and CBD, medical cannabis and consumer cannabis.

Vancouver, BC, Canada, April 23rd, 2024 – Defence Therapeutics Inc. (“Defence” or the “Company”), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a Canadian biopharmaceutical company developing novel immune-oncology therapeutics and drug delivery technologies, is pleased to announce that its second-generation ARMTM anti-cancer vaccine using AccuTOX®, called ARM-002TM, is therapeutically effective against pre-established melanoma when combined with the anti-PD-1 immune-checkpoint inhibitor.

Defence’s application of reprogrammed mesenchymal stromal cells (“MSCs”) represents a leading vaccination platform due to its ease in manufacturing and the therapeutic potency that this allogeneic off-the-shelf vaccine can provide. The use of AccuTOX® to reprogram these MSCs relies mainly on the induction of protein aggregation. This process is known to induce the activation of the unfolded protein response, a cellular defense mechanism normally triggered to destroy any captured protein aggregates due to the toxicity and disturbance it causes to cell integrity.

“Defence’s AccuTOX^® was initially known for its ability to kill cancer cells. In addition, our team found that at specific doses, AccuTOX^® forms protein aggregates when mixed with tumor lysate, a process that pushes MSCs to degrade these intracellular complexes resulting in potent antigen presentation.” says Mr. Plouffe, Chief Executive Officer of Defence Therapeutics.

The original ARM^TM vaccine was potent against melanoma. The ARM-002^TM vaccine is even more potent, as it actually requires 10x less protein. This was confirmed both in vitro (using antigen cross-presentation assay) and in vivo where ARM-002^TM pulsed with 0.05 mg/ml of tumor lysate resulted in similar outcomes compared to ARM-002^TM generated using a dose of 0.5 mg/ml. In addition, the potency of the ARM-002^TM vaccine was comparable in both male and female mice, with no noticeable side effects detected in vaccinated animals. Defence is currently testing the ARM-002^TM vaccine on “hard-to-treat” cancers such as pancreatic, colon and ovarian cancers. These results will set the target indication for the Phase I trials, and it also shows how versatile and adaptable the ARM-002^TM anti-cancer vaccine is.

About Defence:

Defence Therapeutics is a publicly-traded clinical-stage biotechnology company working on engineering the next generation vaccines and ADC products using its proprietary platform. The core of Defence Therapeutics platform is the ACCUM® technology, which enables precision delivery of vaccine antigens or ADCs in their intact form to target cells. As a result, increased efficacy and potency can be reached against catastrophic illness such as cancer and infectious diseases.

For further information:

Sebastien Plouffe, President, CEO and Director

P: (514) 947-2272

Splouffe@defencetherapeutics.com

www.defencetherapeutics.com

 

Cautionary Statement Regarding “Forward-Looking” Information

This release includes certain statements that may be deemed “forward-looking statements”. All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company’s management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management’s beliefs, estimates or opinions, or other factors, should change.

Neither the CSE nor its market regulator, as that term is defined in the policies of the CSE, accepts responsibility for the adequacy or accuracy of this release.

News Source: Xlife Sciences AG