Evotec, CDP Venture Capital and Angelini Ventures launch translational partnership “Extend” with leading Italian academic institutions

On October 28, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported the launch of "Extend", a translational BRIDGE partnership in cooperation with CDP Venture Capital Sgr, a strategic pillar to Italy’s economic growth and innovation, and Angelini Ventures, the Corporate Venture Capital arm of the multi-business industrial group Angelini Industries (Press release, Evotec, OCT 28 , 2022, View Source [SID1234622561]).

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Extend is a joint venture between Evotec, CDP Venture Capital and Angelini Ventures to develop translational drug discovery partnerships with highly renowned universities and research centres in Italy. Extend aims to use Evotec’s best-in-class technology platforms to accelerate the translation of academic innovation into robust and investable data points and Angelini Ventures’ network and knowledge of the life science sector to launch successful new companies.

The partnership brings together several academic institutions with strong track records in life science innovation from across Italy: Ospedale San Raffaele in Milan, the Universities of Milan, Florence, Modena and Reggio Emilia, Padua, Sapienza in Rome, the regional research district of Puglia through H-Bio and the Human Technopole. Extend will be located within Milan’s MIND district, the new centre of scientific excellence in Italy focused on life sciences.

Evotec’s BRIDGE (Biomedical Research, Innovation & Development Generation Efficiency) collaborations provide an integrated fund and award framework to validate exciting academic projects in collaborations with Pharma, biotech, and Venture Capital partners with the goal to form new companies.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "We are excited to launch Extend together with our partners at CDP Venture Capital and Angelini Ventures. The Academic sector in Italy has historically been a driving force behind innovation at a global scale. Extend provides researchers from the member institutions with a unique way to fast-track their projects, validate them on our industrial-grade platform and create partnering options that include the formation of new companies."

Enrico Resmini, CEO and General Manager of CDP Venture Capital, said: "The launch of the Extend National Technology Transfer Hub adds a key step to the path we are building to bridge the Italian tech transfer gap and open University laboratories to international markets. The pharmaceutical and drug discovery sectors represent one of the most striking examples of how research and deep tech technologies can shape people’s lives in a short time, as we have all experienced first-hand during the health emergency."

Prof. Sergio Marullo di Condojanni, CEO of Angelini Industries, added: "We are delighted to participate in the creation of Polo Extend together with high-level partners in the biotech and innovation sectors. Being involved in this project represents an important opportunity for Angelini Industries to contribute to the development of the Italian innovation ecosystem, of which Extend represents a virtuous example. The participation of Angelini Ventures, under the leadership of CEO and Managing Director Paolo Di Giorgio, underlines our desire to strengthen the bridge between the excellence of Italian academic research and the development of drug discovery programs in order to identify new treatment options"

Cytovation presents Phase I dose escalation results at ESMO

On October 28, 2022 Cytovation reported the poster recently presented at ESMO (Free ESMO Whitepaper) – European Society for Medical Oncology Congress 2022 (Press release, Cytovation, OCT 28, 2022, View Source;utm_medium=rss&utm_campaign=cytovation-presents-phase-i-dose-escalation-results-at-esmo [SID1234622556]).

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FIRST-IN-HUMAN, DOSE ESCALATION PHASE I TRIAL OF INTRATUMORAL CYPEP-1 IN PATIENTS WITH ADVANCED SOLID TUMORS
Eskens et al. Annals of Oncology, Volume 33, S758, 476P

Conclusions:
Administration of CyPep-1 is well tolerated. Both molecular and clinical findings suggest strong biologic activity.

Nykode Therapeutics to Present a Poster on Interim Results from the Pre-planned Interim Analysis from the C-02 trial with VB10.16 in advanced cervical patients at the European Society of Gynaecological Oncology’s 23rd Annual Meeting (ESGO 2022)

On October 28, 2022 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported the presentation of a poster at the European Society of Gynaecological Oncology’s 23rd Annual Meeting, being held in Berlin, October 27-30 (Press release, Nykode Therapeutics, OCT 28, 2022, View Source [SID1234622555]). The presentations will include results from a pre-planned interim analysis of the VB C-02 trial with VB10.16, Nykode’s wholly owned therapeutic DNA vaccine specifically targeting antigen presenting cells, in combination with atezolizumab in patients with advanced HPV16-positive cervical cancer.

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The new data further supports the use of specific blood based biomarkers as prognostic and predictive factors of treatment outcome.

Michael Engsig, Nykode’s Chief Executive Officer, stated: "It is a great opportunity to present the VB C-02 interim data, including data that have not been released before, to the scientific community at ESGO. We look forward to continue updating the scientific community as we dive deeper into the interim data of VB C-02 to further our understanding of how VB10.16 works to the benefit of patients and how biomarkers can be used to predict clinical outcome."

Poster accepted for presentation at ESGO 2022 Abstract ID 447; PA-004:

• Efficacy and safety of VB10.16, therapeutic DNA vaccine specifically targeting antigen presenting cells, in combination with atezolizumab in patients with advanced HPV16-positive cervical cancer: results from a pre-planned interim analysis

The poster will be made available in the Scientific Papers and Presentations section of the Company’s website at View Source

Consolidated Financial Results for the Six-month Period Ended September 30, 2022

On October 28, 2022 NEC reported that Consolidated Financial Results for the Six-month Period Ended September 30, 2022 (Press release, NEC, OCT 28, 2022, View Source [SID1234622554])

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1. Consolidated Financial Results for the Six-month Period Ended September 30, 2022 (April 1, 2022 – September 30, 2022)

(1) Consolidated Operating Results
(2) Consolidated Financial Position

2. Dividends
3. Consolidated Financial Results Forecast for the Year Ending March 31, 2023 (April 1, 2022 – March 31, 2023)

*This consolidated financial results falls outside the scope of quarterly review procedures to be performed by certified
public accountants or an audit firm.

*Explanation concerning the appropriate use of the financial results forecast and other special matters
(Adjusted profit (loss))
"Adjusted operating profit (loss)" is an indicator for measuring underlying profitability in order to clarify the contribution of acquired companies to the NEC Group’s overall earnings. It is measured by deducting amortization of intangible assets recognized as a result of M&A and expenses for acquisition of companies (financial advisory fees and other fees) from operating profit (loss). Also, "Adjusted net profit (loss) attributable to owners of the parent" is an indicator for measuring underlying profitability attributable to owners of the parent. It is measured by deducting adjustment items of operating profit (loss) and corresponding amounts of tax and non-controlling interests from net profit (loss) attributable to owners of the parent.

(Cautionary statement with respect to forward-looking statements)
The forward-looking statements such as operating results forecast contained in this statements summary are based
on the information currently available to NEC Corporation ("the Company") and certain assumptions considered
reasonable. Actual operating results may differ significantly from these forecasts due to various factors. For details,
please refer to "2. Cautionary Statement with Respect to Forward-Looking Statements" on page 14.

(How to obtain supplementary financial materials and information on the financial results briefing)
On October 28, 2022, the Company will hold a financial results briefing for the institutional investors and analysts.
Presentation materials will be posted on the company website after the release of financial results, and the
presentation video and Q&A summary will be also posted on the company website promptly after the financial results
briefing.

In addition to the above, the Company periodically holds briefings on business and operating results for the individual
investors. Presentation materials and Q&A summary will be posted on the company website promptly after the
briefing. For the schedule and details, please check the company website

Press Release: Continued strong growth in Q3 with key regulatory milestones achieved

On October 28, 2022 Sanofi reported that Continued strong growth in Q3 with key regulatory milestones achieved (Press release, Sanofi, OCT 28, 2022, View Source [SID1234622553])

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Q3 2022 sales growth of 9.0% at CER driven by Specialty Care and Vaccines

Specialty Care grew 19.9% driven by Dupixent performance (€2,314 million, +44.5%) and launch momentum in Rare Disease
Vaccines up 23.5% from strong Flu sales in the quarter, rebound of Travel vaccines and growth of Meningitis and PPH franchises
General Medicines achieved 2.4% core assets growth despite lower Lovenox sales due to decreasing demand from COVID-19
CHC up 1.9% with strong growth in Digestive Wellness and Cough & Cold in a normalizing market environment post-COVID-19
Q3 2022 business EPS(1) up 17.9% at CER driven by higher sales and margin expansion

BOI margin up 1.9 ppt to 36.0% due to gross margin improvement from efficiency gains, product mix and EUROAPI deconsolidation
Business EPS(1) of €2.88, up 32.1% on a reported basis and 17.9% at CER
IFRS EPS of €1.66, down 9.8 %, reflecting a €1,586 billion impairment charge related to SAR444245

Progress on Corporate Social Responsibility strategy

Access to Medicine Foundation recognized Sanofi Global Health Unit’s work to improve insulin access in low-middle income countries

Key R&D milestones and regulatory achievements

Dupixent approved in the U.S. as the first and only treatment for adults with prurigo nodularis
FDA granted priority review for Altuviiio (efanesoctocog alfa) for the treatment of hemophilia A
FDA approved XenpozymeTM for the treatment of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients
CHMP recommended approval of Beyfortus (nirsevimab) for prevention of RSV disease in infants
CHMP recommended approval of Enjaymo in adult patients with cold agglutinin disease (CAD)

Full-year 2022 business EPS guidance revise upward

Sanofi now expects 2022 business EPS(1) to grow approximately 16%(2) at CER, barring unforeseen major adverse events. Applying average October 2022 exchange rates, the positive currency impact on 2022 business EPS is estimated between +9.5% to +10.5%

Sanofi Chief Executive Officer, Paul Hudson, commented:

"Our strong results for the third quarter demonstrate that Sanofi is on the right path, with a remarkable performance of 20% growth in both Specialty Care and Vaccines, leading us to again raise our business EPS guidance for the full-year. Our commitment to breakthrough science is bearing fruit. Three of our priority first or best-in-class medicines reached important regulatory milestones. Beyfortus was recommended by EMA’s CHMP for prevention of RSV disease in all infants while Altuviiio was granted priority review by the US FDA for people with hemophilia A. Dupixent keeps breaking new ground with a recent US FDA approval making it the first and only treatment indicated for prurigo nodularis, the second indication in dermatology, and fifth overall for Dupixent in the US. Social impact continues to be at the center of our company’s agenda, as illustrated by the introduction of our first two carbon offsetting programs. Looking ahead, we are well positioned to achieve our BOI margin target of 30% in 2022 and to stay focused on our ambition to transform the practice of medicines for patients around the world."

Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 7). (1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 7). The consolidated income statement for Q3 2022 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) 2021 business EPS was €6.56; (3) Free cash flow is a non-GAAP financial measure (definition in Appendix 7).