PAION receives positive CHMP opinion recommending approval of remimazolam for the induction and maintenance of general anesthesia in adults

PAION AG / Key word(s): Miscellaneous

PAION receives positive CHMP opinion recommending approval of remimazolam for the induction and maintenance of general anesthesia in adults

27-Jan-2023 / 12:59 CET/CEST

Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News – a service of EQS Group AG.

The issuer is solely responsible for the content of this announcement.


PAION receives positive CHMP opinion recommending approval of remimazolam for the induction and maintenance of general anesthesia in adults

Aachen (Germany), 27 January 2023 – The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) announces that today the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has published a positive opinion recommending the approval of remimazolam for the induction and maintenance of general anesthesia in adults.

The European Commission will review the CHMP recommendation and a final decision on the Marketing Authorization Application (MAA) for remimazolam in the EU (including European Economic Area (EEA) countries) is expected in the first half of 2023. In addition, the UK Medicines & Healthcare products Regulatory Agency (MHRA) will also consider a potential approval in Great Britain.


Information and Explanation of the Issuer to this announcement:

The positive CHMP opinion for remimazolam is based on the data from a comprehensive clinical program in general anesthesia. Remimazolam was already approved in Japan and South Korea for general anesthesia.

Gregor Siebert, CEO at PAION AG, commented: “This positive CHMP opinion for remimazolam brings us closer to our ambition to delivering the first innovative treatment option for anesthesia in Europe for decades. We will drive forward the necessary preparations to make the product available very soon to patients and physicians for general anesthesia with a plan to launch in the second half of 2023.”

Contact

Ralf Penner
Senior Vice President Investor Relations & Corporate Communications
PAION AG
Heussstrasse 25
52078 Aachen – Germany
Phone +49 241 4453-152
E-mail r.penner@paion.com

www.paion.com

Disclaimer:

This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG’s management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from PAION AG’s assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update any such forward-looking statements to reflect future events or developments.


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Evotec announces agreement with Janssen to develop immune-based therapies

EQS-News: Evotec SE

/ Key word(s): Miscellaneous

Evotec announces agreement with Janssen to develop immune-based therapies
26.01.2023 / 07:30 CET/CEST

The issuer is solely responsible for the content of this announcement.

  • STRATEGIC PARTNERSHIP LEVERAGES EVOTEC’S EXPERTISE & INTEGRATED PLATFORM FOR DISCOVERY AND DEVELOPMENT

 

Hamburg, Germany, 26 January 2023:
Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) announced today that the Company has entered into a strategic collaboration and licence agreement with Janssen Biotech, Inc. (“Janssen”), one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The collaboration focuses on the development of first-in-class targeted immune-based therapies for oncology, which will ultimately be commercialised by Janssen. The agreement was facilitated by Johnson & Johnson Innovation.

The collaboration leverages Evotec’s integrated discovery and development capabilities and manufacturing optimisation processes, including an option for the GMP manufacture of the immune-based therapies. Evotec will collaborate closely with Janssen during the pre-clinical R&D phase while Janssen will assume full responsibility for the clinical development and commercialisation.

Besides research funding, Evotec is entitled to an undisclosed upfront payment, success-based research and commercial milestones exceeding US$ 350 m as well as tiered royalties on products resulting from the collaboration.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “We are very excited about this collaboration with Janssen. Novel immune-based therapies with disease-relevant, targeted mechanisms are expected to benefit large number of patients. Evotec is committed to leading the way in transformational innovation to treat and ultimately cure diseases of high unmet need.”

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 leverages this “Data-driven R&D Autobahn to Cures” for proprietary projects and within a network of partners including 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 4,500 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 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, Phone: +49.(0)40.56081-255, gabriele.hansen@evotec.com

Hinnerk Rohwedder, Director of Global Corporate Communications, Tel.: +49.(0)151 4070-4843, hinnerk.rohwedder@evotec.com

IR Contact Evotec SE:
Volker Braun, SVP Head of Global Investor Relations & ESG, Phone: +49.(0)40.56081-775, volker.braun@evotec.com


26.01.2023 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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Archive at www.eqs-news.com


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PAION AG: Extraordinary General Meeting approves capital reductions and creates scope for further corporate financing

EQS-News: PAION AG

/ Key word(s): AGM/EGM

PAION AG: Extraordinary General Meeting approves capital reductions and creates scope for further corporate financing
25.01.2023 / 17:35 CET/CEST

The issuer is solely responsible for the content of this announcement.

PAION AG: Extraordinary General Meeting approves capital reductions and creates scope for further corporate financing

Aachen (Germany), 25 January 2023 – PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8), a specialty pharmaceutical company with innovative compounds for use in outpatient and in-hospital sedation, anesthesia, and intensive care, today successfully held its Extraordinary General Meeting. At the meeting, shareholders approved the proposed capital reductions by redemption and consolidation of shares with a large majority. At the AGM, 17.22% of the share capital was represented.

The current share capital of the Company of EUR 71,336,992.00 will therefore be reduced to EUR 7,133,699.00 by way of an ordinary capital reduction through a consolidation of shares in a ratio of 10:1. In order to achieve an even reduction ratio, the share capital will be reduced to EUR 71,336,990.00 in a first step. The entry of the capital reductions in the commercial register is expected to take place in March 2023, subject to any actions of annulment.

Gregor Siebert, CEO of PAION AG, said: “We are pleased that our shareholders have voted with a large majority in favour of the implementation of a capital reduction. We are currently working on a suitable financing concept in order to be able to drive forward our international marketing activities in the current fiscal year and beyond. In doing so, we are striving to keep all possible financing options open. With regard to the option of financing through equity, the resolutions passed today provide the necessary leeway for a possible capital increase in the future. For further corporate financing, we will carefully consider the options available to us.

The voting results of the Extraordinary General Meeting will soon be available on the company’s website at https://www.paion.com/medien-investoren/hauptversammlung.

About PAION

PAION AG is a publicly listed specialty pharmaceutical company with innovative drugs to be used in hospital-based sedation, anesthesia and critical care services. PAION’s lead compound is remimazolam, an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic. PAION is rolling out remimazolam (Byfavo®) in selected European markets. Remimazolam is partnered in multiple territories outside of Europe. Remimazolam is approved in the U.S., the EU/EEA/UK, China and South Korea for procedural sedation and in Japan and South Korea for general anesthesia.

In addition, PAION markets two intensive care products in selected European countries: Angiotensin II (GIAPREZA®), a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock, and eravacycline (XERAVA®), a novel fluorocycline type of antibiotic indicated for the treatment of complicated intra-abdominal infections in adults.

PAION’s mission is to be a leading specialty pharmaceutical company in the fields of anesthesia and critical care by bringing novel products to market to benefit patients, doctors and other stakeholders in healthcare.

PAION is headquartered in Aachen (Germany).

Contact

Ralf Penner
SVP Investor Relations & Corporate Communications
PAION AG
Heussstrasse 25
52078 Aachen – Germany
Phone +49 241 4453-152
E-mail r.penner@paion.com
www.paion.com

 

Disclaimer:

This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG’s management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from PAION AG’s assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update any such forward-looking statements to reflect future events or developments.

 

 

 


25.01.2023 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


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Original-Research: Spexis AG (von First Berlin Equity Research GmbH)

Original-Research: Spexis AG - von First Berlin Equity Research GmbH

Einstufung von First Berlin Equity Research GmbH zu Spexis AG

Unternehmen: Spexis AG
ISIN: CH0106213793

Anlass der Studie: Aufnahme der Coverage
Empfehlung: Buy
seit: 25.01.2023
Kursziel: 1,80 CHF
Kursziel auf Sicht von: 12 Monate
Letzte Ratingänderung: -
Analyst: Christian Orquera

First Berlin Equity Research has initiated coverage on Spexis AG (ISIN:
CH0106213793). Analyst Christian Orquera's rating is BUY with a price
target of CHF 1.80.
 
Abstract:
Spexis AG is a biotech company with a clinical-stage product pipeline
focused on rare diseases and oncology. Spexis is the result of the merger
of the rare diseases specialist EnBiotix Inc and the listed cancer and
infectious diseases biotech Polyphor AG. Spexis' proprietary discovery
technology generates drug candidates from a new class of drugs called
macrocycles. At present, Spexis focuses on two inhaled drug candidates for
the treatment of chronic, even lifelong infections in patients with the
rare disease cystic fibrosis (CF). I) Murepavadin is a macrocyclic drug
candidate which recently demonstrated safety in phase I trials in Europe.
II) ColiFin®, the lead drug candidate for treating CF infection, was
in-licensed with worldwide rights ex-Europe from PARI Pharma GmbH, a global
specialist in nebulised therapies. The product has been approved in Europe
since 2010 and is the market leader in the region. Spexis has obtained
approval for its phase III protocol from the US registration agency FDA.
The FDA has also granted ColiFin® orphan drug and fast-track designations
and 12-year US market exclusivity. Preparations for the phase III study are
underway, with the beginning of the pivotal study planned for H2 2023. We
estimate ColiFin®'s sales potential in the US/Canada at >USD 250m.
Spexis intends to build up its specialised sales force, in order to
maximise ColiFin®'s value through effective marketing. Opinion leaders
expect the product to become the leading treatment of infections in CF
patients in the US. Given that the product has European approval with more
than 15k administrations to date, the upcoming phase III study is
substantially de-risked. In our view, the publication due in 2023 of
positive headline results from the first part (COPILOT) of the phase III
trial should add substantial value to Spexis and positively impact the
share price. We initiate coverage of Spexis with a Buy rating and a CHF
1.80 price target.
 
First Berlin Equity Research hat die Coverage von Spexis AG (ISIN:
CH0106213793) aufgenommen. Das Rating von Analyst Christian Orquera ist BUY
bei einem Kursziel von CHF 1,80.
 
Zusammenfassung:
Spexis AG ist ein Biotech-Unternehmen mit einer Produktpipeline in der
klinischen Entwicklungsphase, die sich auf seltene Krankheiten und
Onkologie konzentriert. Spexis ist aus dem Zusammenschluss der auf seltene
Krankheiten spezialisierten EnBiotix Inc. und dem börsennotierten Krebs-
und Infektionskrankheiten-Biotechunternehmens Polyphor hervorgegangen. Die
firmeneigene Forschungstechnologie von Spexis generiert Wirkstoffkandidaten
aus einer neuen Klasse von Medikamenten, den so genannten Makrozyklen.
Derzeit konzentriert sich Spexis auf zwei inhalative Medikamentenkandidaten
für die Behandlung chronischer, sogar lebenslanger Infektionen bei
Patienten mit der seltenen Krankheit Mukoviszidose (CF). I) Murepavadin ist
ein makrozyklischer Arzneimittelkandidat, der kürzlich in Phase-I-Studien
in Europa seine Sicherheit unter Beweis gestellt hat. II) ColiFin®, der
führende Arzneimittelkandidat zur Behandlung von Mukoviszidose-Infektionen,
wurde mit weltweiten Rechten außerhalb Europas von der PARI Pharma GmbH,
einem globalen Spezialisten für vernebelte Therapien, einlizensiert. Das
Produkt ist seit 2010 in Europa zugelassen und in der Region marktführend.
Spexis hat von der US-Zulassungsbehörde FDA die Genehmigung für sein
Phase-III-Protokoll erhalten. Die FDA hat ColiFin® außerdem den
Orphan-Drug-Status und den Fast-Track-Status zuerkannt und ein 12-jähriges
US-Marktexklusivitätsrecht gewährt. Die Vorbereitungen für die
Phase-III-Studie sind im Gange, und der Beginn der Zulassungsstudie ist für
das zweite Halbjahr 2023 geplant. Wir schätzen das Umsatzpotenzial von
ColiFin® in den USA/Kanada auf >USD 250 Mio. Spexis beabsichtigt, sein
spezialisiertes Verkaufsteam auszubauen, um den Wert von ColiFin® durch
effektives Marketing zu maximieren. Meinungsführer erwarten, dass das
Produkt in den USA zur führenden Behandlung von Infektionen bei
CF-Patienten werden wird. Da das Produkt in Europa bereits zugelassen ist
und bisher mehr als 15.000 Mal verabreicht wurde, ist das Risiko für die
bevorstehende Phase-III-Studie deutlich geringer. Unserer Ansicht nach
dürfte die Veröffentlichung positiver Ergebnisse aus dem ersten Teil
(COPILOT) der Phase-III-Studie, die für 2023 vorgesehen ist, den Wert von
Spexis erheblich steigern und den Aktienkurs positiv beeinflussen. Wir
beginnen die Coverage von Spexis mit einer Kaufempfehlung und einem
Kursziel von CHF 1,80.
 
Bezüglich der Pflichtangaben gem. §85 Abs. 1 S. 1 WpHG und des
Haftungsausschlusses siehe die vollständige Analyse.

Die vollständige Analyse können Sie hier downloaden:
http://www.more-ir.de/d/26293.pdf

Kontakt für Rückfragen
First Berlin Equity Research GmbH
Herr Gaurav Tiwari
Tel.: +49 (0)30 809 39 686
web: www.firstberlin.com
E-Mail: g.tiwari@firstberlin.com

-------------------übermittelt durch die EQS Group AG.-------------------


Für den Inhalt der Mitteilung bzw. Research ist alleine der Herausgeber bzw. 
Ersteller der Studie verantwortlich. Diese Meldung ist keine Anlageberatung
oder Aufforderung zum Abschluss bestimmter Börsengeschäfte.

Lonza Delivers Strong 2022 Performance with 15.1% CER Sales Growth and 32.1% CORE EBITDA Margin

Lonza Group AG / Key word(s): Annual Results

25-Jan-2023 / 07:00 CET/CEST

Release of an ad hoc announcement pursuant to Art. 53 LR

The issuer is solely responsible for the content of this announcement.


Ad hoc announcement pursuant to Art. 53 LR

  • In 2022, Lonza delivered CHF 6.2 billion sales and 15.1%1 CER sales growth
  • CHF 2.0 billion CORE EBITDA resulted in a margin of 32.1% 
  • Growth investment continues as 2022 CAPEX reached 30% of sales
  • Group Outlook 2023: high single-digit CER sales growth and CORE EBITDA margin of 30 to 31%
  • Mid-Term Guidance 2024 confirmed
  • Proposed dividend increase of 17% to CHF 3.50 per share
  • Share buyback program of up to CHF 2 billion announced, starting in 2023

Basel, Switzerland, 25 January 2023 – Lonza has reported sales of CHF 6.2 billion, sales growth of 15.0% AER2 (15.1%1 CER),and CHF 2.0 billion CORE EBITDA, resulting in a margin of 32.1%. These robust financial results are driven by strong underlying business performance and a COVID-related sales peak in 2022 which enhanced both sales and margin.

Lonza continued its accelerated investment program to support future growth, with CAPEX at CHF 1.9 billion (30% of sales). New CAPEX projects announced in 2022 included a ~CHF 500 million investment in a large-scale, commercial drug product facility in Stein (CH).

In 2022, Lonza continued to extend its broad and balanced portfolio of CDMO customer contracts, with approximately 115 new customers and approximately 375 new clinical and commercial programs. Lonza now serves more than 790 CDMO customers.

Lonza maintained momentum in its ESG ambitions in 2022. Year-on-year, the company achieved a 6%3 reduction in energy intensity, a 13%3 reduction in GHG emissions intensity, and a 10%3 reduction in water intensity.

Lonza provided its Outlook 2023 at high single-digit CER sales growth, which reflects strong underlying business performance, balanced by a reduction in COVID-related sales following the peak in 2022. A CORE EBITDA margin of 30 to 31% is supported by strong productivity and pricing, offset by residual inflation and the ramp-up of new assets. In 2023, Lonza plans to maintain CAPEX at 30% of sales. Lonza also confirmed its Mid-Term Guidance 2024.

Lonza’s Board of Directors is proposing a dividend of CHF 3.50 per share, representing a year-on-year increase of 17% or CHF 0.50. Subject to approval at the upcoming Annual General Meeting, 50% of the dividend of CHF 3.50 per share will be paid out of the capital contribution reserve and will therefore be free from Swiss withholding tax.

Lonza intends to initiate the return of excess capital to shareholders through a share buyback of up to CHF 2 billion, based on its strong balance sheet and positive outlook. The share buyback will not impact Lonza’s capability to invest in organic growth and bolt-on M&A. Lonza remains committed to maintaining its strong investment grade rating. The buyback is expected to commence in H1 2023 and be completed in H1 2025. The program will be executed via a second trading line at the SIX Swiss Exchange and its implementation is subject to applicable regulatory requirements.

Pierre-Alain Ruffieux, CEO, Lonza, commented: “In 2022, we delivered a strong financial performance in line with Outlook. This reflects our resilient business model and sustained market demand, despite an uncertain macroeconomic environment. We have also maintained our ambitious approach to CAPEX investment to support our long-term growth.
“Looking to 2023, we will continue to grow the company while building our customer pipeline and driving operational excellence. We will remain focused on executing our growth plans and pursuing new projects. We are also pleased to confirm our Mid-Term Guidance 2024, supported by new capacity coming online and robust industry fundamentals. More widely, we will continue to build on our position as a leading CDMO player to capture value in the healthcare market.”

Divisional Overview

  • The Biologics division reported strong sales growth of 21.7%1, compared to Full-Year 2021, supported by a robust underlying business and a COVID-related sales peak in 2022. The business delivered a CORE EBITDA margin of 37.5%.
  • Small Molecules reported sales growth of 5.9%1, compared to Full-Year 2021, and a CORE EBITDA margin of 30.3%. This was supported by a solid base business and the ramp-up of new assets.
  • Cell & Gene reported sales growth of 13.6%1 compared to Full-Year 2021, and a CORE EBITDA margin of 16.7%. Bioscience delivered a strong performance, while Cell & Gene Technologies faced delays in clinical trials and customer product challenges.
  • In Capsules & Health Ingredients, sales growth of 5.9%compared to Full-Year 2021 was mainly driven by price increases and pharma demand. The division delivered a CORE EBITDA margin of 33.0%.

Group Financial Summary

All financial information for financial year 2022 is unaudited. All financial information for financial year 2021 is based on “continuing operations”, i.e. exclusive of the Specialty Ingredients business (that was sold on 1 July 2021 and therefore reported as discontinued operations in 2021). For more detail on performance and financials, please refer to the Full-Year 2022 Presentation, Full-Year 2022 Report and Alternative Performance Measures (APM) 2022 Report.

External Auditor

Lonza announced today that its Board of Directors intends to propose Deloitte AG as its external auditor, effective for the financial year 2024. The proposal is subject to shareholder approval at Lonza’s 2023 Annual General Meeting on 5 May 2023. KPMG has been Lonza’s external auditor since 1999 and Lonza’s Board of Directors would like to thank the firm and its employees for their contribution and dedication.
 


Sales growth figures, expressed as a percentage (%), are at Constant Exchange Rate (CER)
2 Actual Exchange Rate
3 Based on Q1-3 2022 data plus Q4 2022 estimates
4 Includes environmental remediation expenses of CHF 300 million, predominantly related to Gamsenried (see note 14 of Lonza Annual Report 2021)

About Lonza

Lonza is a preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. Our business is structured to meet our customers’ complex needs across four divisions: Biologics, Small Molecules, Cell & Gene and Capsules & Health Ingredients. Our unparalleled breadth of offerings across divisions enables our customers to commercialize their discoveries and innovations in the healthcare industry.

Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With approximately 17,500 full-time employees, we comprise high-performing teams and individual talent who make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 6.2 billion with a CORE EBITDA of CHF 2.0 billion in Full-Year 2022. Find out more at www.lonza.com.

Follow @Lonza on LinkedIn 
Follow @LonzaGroup on Twitter 

Lonza Contact Details

Victoria Morgan
Head of External Communications
Lonza Group Ltd

Tel +41 61 316 2283
victoria.morgan@lonza.com

 
Lyle Wheeler
Investor Relations
Lonza Group Ltd

Tel +41 79 154 9522
lyle.wheeler@lonza.com


End of Inside Information


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 DEFENCE’S MELANOMA TARGETED VACCINE A1-REPROGRAMMED MSC (ARM) CELL POTENCY VALIDATED

EQS-News: Defence Therapeutics Inc.

/ Key word(s): Miscellaneous

 DEFENCE’S MELANOMA TARGETED VACCINE A1-REPROGRAMMED MSC (ARM) CELL POTENCY VALIDATED
24.01.2023 / 08:00 CET/CEST

The issuer is solely responsible for the content of this announcement.

 

_________________________________________________________________

CSE: DTC  FSE: DTC  USOTC: DTCFF  PRESS RELEASE

 

 

 DEFENCE’S MELANOMA TARGETED VACCINE A1-REPROGRAMMED MSC (ARM) CELL POTENCY VALIDATED

 

Vancouver, BC, Canada, January 24th, 2023 – Defence Therapeutics Inc. (“Defence” or the “Company”), a Canadian biopharmaceutical company specialized in the development of immune-oncology vaccines and drug delivery technologies, is pleased to report the validation of its ARM vaccine candidate in a melanoma model with a cure rate of 60%.  

 

Defence used a variant of the AccumTM (the A1) to reprogram innate MSCs into antigen presenting cells. This “off-the-shelf” universal vaccine (e.g. allogeneic to the recipient) was able to cure animals with pre-established lymphoma, and also the observed therapeutic effects synergised with the use of the anti-PD-1 immune-checkpoint blocker. The vaccinated animals survived, and the great majority rejected the established tumor and remained tumor free for over 3 months. Based on these strong results, Defence continued to accelerate the progress on the vaccine. These recently completed results add another therapeutic validation using the melanoma cancer model. This program was prepared by the same planned protocol for a potential Phase I clinical cancer trial, where the melanoma cell lysate was used to pulse the ARM vaccine prior to vaccination. 

 

“This experiment constitutes an important step in our advancement plan as it shows that Defence’s ARM vaccine can be used against any cancer tumor type given”, says Mr. Plouffe, the CEO of Defence Therapeutics.

 

Defence is currently working to begin the manufacturing of its ARM vaccine in Q1 of 2023 with the objective to start treating patients in Phase I clinical cancer trial with solid tumors by Q3/Q4 of 2023.  

 

About Defence:

Defence Therapeutics is a publicly-traded biotechnology company working on engineering the next generation vaccines and ADC products using its proprietary platform. The core of Defence Therapeutics platform is the ACCUMTM 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
https://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.

 

 


24.01.2023 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


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Biotest AG: First patient treated with Cytotect® CP Biotest in study after heart and lung transplantation

EQS-News: Biotest AG

/ Key word(s): Study

Biotest AG: First patient treated with Cytotect® CP Biotest in study after heart and lung transplantation
24.01.2023 / 07:00 CET/CEST

The issuer is solely responsible for the content of this announcement.

 

PRESS RELEASE

 

First patient treated with Cytotect® CP Biotest in study after heart and lung transplantation

 

  • High medical need due to severe cytomegalovirus (CMV) infections and resulting mortality after organ transplantation
  • Study will provide data to optimise treatment strategies with CMV hyperimmunoglobulins after heart and lung transplantation
  • 500 patients in prospective, international observational study

 

Dreieich, 24 January 2023. Biotest AG announced today that the first patient has been enrolled in Biotest’s prospective, multicentre, observational study on the use of CMV hyperimmunoglobulins after heart and lung transplantation. “We are very hopeful and confident that the insights of the new study will allow us to optimise treatment options with CMV hyperimmunoglobulins,” emphasises PD Dr Markus Barten, UKE Hamburg, Coordinating Investigator of the study.

The non-interventional study will be conducted in 20 transplant centres in Austria, Belgium, Croatia, Germany, Italy, Spain and the United Kingdom and is expected to enrol a total of around 500 patients. The objectives of the large-scale study are to collect detailed data on the use of Cytotect® CP and clinical outcomes in the management of cytomegalovirus (CMV) after heart or lung transplantation.

While a CMV infection is usually asymptomatic or mild in healthy people, the virus can lead to serious sequelae and even death in people with a weakened immune system, especially in patients after organ or stem cell transplantation. Cytotect® CP is a CMV-specific hyperimmunoglobulin from Biotest AG that represents a supplement or, in some cases, an alternative to antiviral therapy in the context of CMV management after transplantation. “Studies have been able to show that prophylactic treatment with CMV hyperimmunoglobulins in patients after organ transplantation is particularly beneficial in patients with a high risk of CMV infection or disease”, emphasises PD Dr Markus Barten.

The results of the international study will provide valuable insights into the use and benefits of CMV hyperimmunoglobulins and enable optimisation of treatment strategies for patients after heart and lung transplantation.

 

 

About Cytotect® CP Biotest

Cytotect® CP is a cytomegalovirus-specific hyperimmunoglobulin preparation with a high antibody titre against CMV. The product is approved for the prophylaxis of clinical manifestations of CMV infection in patients on immunosuppressive therapy, particularly in transplant recipients. Concurrent administration of appropriate antivirals should be considered for CMV prophylaxis. Cytotect® CP (also marketed in various countries as Megalotect®, Megalotect CP®, Cytomegatect® and NeoCytotect®.

Cytotect® CP approved in more than 20 countries. Biotest is currently in the process of applying for approval of Cytotect® CP in additional markets.

 

About Biotest

Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 2,200 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.

 

 

IR contact

Dr Monika Buttkereit

Phone: +49-6103-801-4406
E-mail: ir@biotest.com

 

PR contact

Dirk Neumüller

Phone: +49-6103-801-269
E-mail: pr@biotest.com

 

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

 

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201

Preference shares: securities’ ID No. 522723; ISIN DE0005227235

Listing: Frankfurt (Prime Standard)

Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

 

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

 


24.01.2023 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


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Defence Therapeutics Inc.:  DEFENCE TO PRESENT AT THE 9TH ANNUAL IMMUNO-ONCOLOGY 360º SUMMIT IN NEW-YORK FEBRUARY 7-10, 2023

EQS-News: Defence Therapeutics Inc.

/ Key word(s): Conference

Defence Therapeutics Inc.:  DEFENCE TO PRESENT AT THE 9TH ANNUAL IMMUNO-ONCOLOGY 360º SUMMIT IN NEW-YORK FEBRUARY 7-10, 2023
23.01.2023 / 08:00 CET/CEST

The issuer is solely responsible for the content of this announcement.

CSE: DTC     FSE: DTC       USOTC: DTCFF             PRESS RELEASE

  

 DEFENCE TO PRESENT AT THE 9TH ANNUAL IMMUNO-ONCOLOGY 360º SUMMIT IN NEW-YORK FEBRUARY 7-10, 2023.

 

Vancouver, BC, Canada, January 20th, 2023 – Defence Therapeutics Inc. (“Defence” or the “Company”), a Canadian biopharmaceutical company specialized in the development of immune-oncology vaccines and drug delivery technologies, is pleased to announce that Defence will attend, from February 7-10, 2023, the Immuno-Oncology 360º “IO360º” premier meeting across all stakeholders in Immuno-Oncology during the 2023 summit at the New-York Marriott Brooklyn Bridge in Brooklyn, New-York.    

IO360° offers an unparalleled opportunity to hear from stakeholders representing both the science and business communities who report on the latest data impacting Immuno-Oncology to fight a wider range of cancers. www.io360summit.com

Defence’s CEO, Mr. Sébastien Plouffe and Dr. Moutih Rafei, VP-Research and Development are looking forward to meeting you at the booth #16 during the Conference. In addition, Dr. Moutih Rafei will present live on Cell Therapy Day on Tuesday February 7th at 5:25 pm on Track A “Novel Engineered Cell Therapies and Concepts”. Defence’s ARM vaccine will be presented to the audience. Dr. Rafei will also present live on IO Novel Technology Showcase Day on Wednesday February 8th at 11:10 am on Track B during which Defence’s AccumTM platform technology will be introduced. This session showcases companies that have technologies and solutions that will help stakeholders in the IO field advance developments that provide treatment for cancer patients.

“With the field of cell therapy rapidly advancing with exciting results, Defence’s presence to the IO360˚ is definitely a key event to introduce its AccumTM platform technology to the US science and business communities by showing its data that will have a positive impact on immuno-oncology to fight multiple cancers”, says Mr. Plouffe, the CEO of Defence Therapeutics.

According to Research and Markets, the immuno-oncology market size was valued at US$45.12 billion in 2021 and is expected to grow at a compound annual growth rate (CAGR) of 20.30% during 2022-2030.

https://www.researchandmarkets.com/reports/5693577/immuno-oncology-market-size-share-trends?utm_source=GNOM&utm_medium=PressRelease&utm_code=nkffvp&utm_campaign=1785151+-+Immuno-oncology+Global+Market+Report+2022%3a+Approval+of+Novel+Therapies+Boosts+Sector+Growth&utm_exec=como322prd

 

About Defence:

Defence Therapeutics is a publicly-traded biotechnology company working on engineering the next generation vaccines and ADC products using its proprietary platform. The core of Defence Therapeutics platform is the ACCUMTM 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.

 


23.01.2023 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


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Stifel initiates research coverage of Xlife Sciences

Xlife Sciences AG

/ Key word(s): Miscellaneous

Stifel initiates research coverage of Xlife Sciences
23.01.2023 / 07:00 CET/CEST

 

The renowned investment bank Stifel commenced its research coverage of Xife Sciences (SIX: XLS). The corresponding initial analyst report rates Xlife Sciences’ stock with a “Buy” rating and calls for a price target of CHF 68.00.-

Stifel’s initiation report emphasizes that Xlife Sciences provides investors access to early-stage life science research projects from universities and other institutions. As competition is limited at this stage, the company can choose among the best projects. The report also outlines that Xlife Sciences plans to exit up to four of its portfolio companies in 2023 and ten to eleven in total until year-end 2024; the total targeted value creation of CHF 100-150 million with these planned exits is considered as “meaningful” amount for a small-cap company. The analyst report also takes note of the highly experienced Advisory Board as well as the competent Management Team.

At www.xlifesciences.ch/en/news-and-key-figures, a summary of Stifel’s first analyst report on Xlife Sciences can be viewed and downloaded. After Intron Health and Baader Bank, Stifel is the third financial services firm having initiated independent research coverage of Xlife Sciences.

Financial calendar

Annual Report 2022                                   April 20, 2023

AGM 2023                                                  June 20, 2023

Half-Year Report 2023                               September 21, 2023

Contact

Information for journalists: IRF Reputation AG, Valentin Handschin, handschin@irf-reputation.ch

Information for investors: Xlife Sciences AG, Dennis Lennartz, dennis.lennartz@xlifesciences.ch

Xlife Sciences AG, 
Talacker 35, 
8001 Zurich, 
Switzerland,
Phone +41 44 385 84 60
info@xlifesciences.ch, www.xlifesciences.ch
Commercial Register Zurich CHE-330.279.788 
Stock Exchange: SIX Swiss Exchange

About Xlife Sciences AG (SIX: XLS) 

Xlife Sciences is a Swiss company focused as incubator and accelerator on the value development and commercialization of promising research projects from universities and other research institutions in the life sciences sector, with the aim of providing solutions for high unmet medical needs and a better quality of life. The goal is to bridge research and development to healthcare markets. Xlife Sciences takes carefully selected projects in the four areas of technological platforms, biotechnology/ therapies, medical technology, and artificial intelligence/digital health to the next stage of development, and participates in their subsequent performance. For more information, visit www.xlifesciences.ch 

Disclaimer 

Some of the information contained in this media release contains forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Xlife Sciences undertakes no obligation to publicly update or revise any forward-looking statements. 


End of Media Release


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COLTENE announces key figures for the 2022 financial year

COLTENE Holding AG / Key word(s): Preliminary Results

20-Jan-2023 / 06:30 CET/CEST

Release of an ad hoc announcement pursuant to Art. 53 LR

The issuer is solely responsible for the content of this announcement.


Ad hoc announcement pursuant to Art. 53 LR

COLTENE, a leading international developer and manufacturer of dental consumables and small equipment, announces its first key figures for the 2022 financial year. Compared to the previously anticipated sales at the level of the 2021 business year (CHF 279.2 million), the company is expected to achieve sales of CHF 267.1 million. For the operating result, COLTENE now expects a margin of around 13%. At the same time, the company informs about a retirement-related change in the Group Executive Board.

The decline in turnover is due to several factors. Inflation and recession fears as well as COVID-related lockdowns in China led to declining demand in dental practices worldwide. In the Infection Control product area, continued backlogs of electronic components and a normalisation of demand for surface disinfection products had a negative impact on sales. Finally, the appreciation of the Swiss franc against the Euro led to lower consolidated net sales.

 

While the gross margin is expected to be around previous year’s level, the lower sales volume affects the operating margin despite tight cost control. Accordingly, the company expects an EBIT margin of around 13% for 2022 (previous year 15.7%).

 

COLTENE is confident that strategic projects, cost control and the easing of delivery backlogs will have a positive impact on business performance in 2023. Nevertheless, economic and political developments remain volatile. In the stable dental business, however, we can assume that postponed treatments will be quickly made up for when the economic situation brightens. Detailed information on the course of business and the outlook for 2023 will be published with the annual report 2022 on
3 March 2023.

 

Changes in the Group Executive Management

Stefan Helsing, Chief Operating Officer, will retire at the end of March. Gregor Picard (52 years old, German citizen) has been appointed as successor and will take up his new position on 1 April. He has many years of experience in the dental and automotive industries. Most recently, he worked for the KaVo Group as Vice President Operations. Prior to that, he held various senior operations positions within VDW and Autoliv in Germany.

 

The entire Board of Directors and CEO Martin Schaufelberger would like to express their sincere thanks to Stefan Helsing for his valuable contribution to the development of the COLTENE Group over the past years. In particular, with the integration of the two acquired companies SciCan and Micro Mega in 2018, he has made a valuable contribution to the now well positioned COLTENE Group.

 

 

 

For further information: Markus Abderhalden, CFO,
phone +41 71 757 54 80, mobile +41 79 436 26 22, e-mail markus.abderhalden@coltene.com

 

Financial calender
Media and analyst conference on 2022 financial year and
3 March 2023
Release of Annual Report 2022
Annual General Meeting 2023 19 April 2023
Release of Half-Year Report 2023 and 4 August 2023
Conference call on the half-year results 2023

About COLTENE
COLTENE is an international developer, manufacturer and seller of dental consumables and small equipment in the areas of Infection Control, Dental Preservation and Efficient Treatment. COLTENE has state-of-the-art production facilities in the USA, Canada, Germany, France and Switzerland as well as own sales organizations in all major markets including Europe, North and Latin America, Japan, China and India. Dentists, DSOs, dental clinics and dental labs all around the globe trust COLTENE’s high-quality products. The registered shares of COLTENE Holding AG (CLTN) are listed on SIX Swiss Exchange. Learn more about COLTENE and our products at www.coltene.com.

Contact
COLTENE Holding AG
Feldwiesenstrasse 20
9450 Altstätten, Switzerland
P + 41 71 757 53 00
investor@coltene.com
www.coltene.com

This written statement and oral statements or other statements made, or to be made, by us contain forward-looking statements that do not relate solely to historical or current facts. These forward-looking statements are based on the current plans and expectations of our management and are subject to a number of uncertainties and risks that could significantly affect our current plans and expectations, as well as future results of operations and financial conditions. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


End of Inside Information


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