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Corcept Therapeutics to Announce Fourth Quarter and Full-year 2021 Financial Results, Provide Corporate Update and Host Conference Call

On February 8, 2022 Corcept Therapeutics Incorporated (NASDAQ: CORT) reported it will report fourth quarter and full-year 2021 financial results and provide a corporate update on February 15, 2022 (Press release, Corcept Therapeutics, FEB 8, 2022, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announce-fourth-quarter-and-full-year-2021 [SID1234607843]). The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

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Conference Call Information
To participate, click the link below and enter your information. The link will become active 15 minutes prior to the scheduled start time.

Click to Join Meeting

Alternatively, you may dial 1-833-693-0540 from the United States or 1-661-407-1581 internationally approximately 15 minutes before the start of the call. The passcode will be 1861918.

A replay will be available through February 22, 2022, at 1-855-859-2056 from the United States and 1-404-537-3406 internationally. The passcode will be 1861918. You may also access a replay on the Investors / Past Events tab of www.corcept.com

Veracyte to Participate in 11th Annual SVB Leerink Global Healthcare Conference

On February 8, 2022– Veracyte, Inc. (Nasdaq: VCYT) reported that Marc Stapley, chief executive officer, and Rebecca Chambers, chief financial officer, reported that it will participate in a fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on February 16, at 2:20 p.m. Eastern Time (Press release, Veracyte, FEB 8, 2022, View Source [SID1234607842]).

A live audio webcast of the company’s presentation will be available on Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

QIAGEN beats outlook for fourth quarter and full-year 2021, delivers 22% CER full-year sales growth from non-COVID products

On February 8, 2022 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported results for the fourth quarter and full-year 2021 (Press release, Qiagen, FEB 8, 2022, View Source [SID1234607841]).

Net sales for Q4 2021 rose 2% (+4% CER) to $582 million from Q4 2020, well ahead of the outlook for a 9% CER decline. Sales were driven by high demand for COVID-19 test products and confirmed good trends in the non-COVID portfolio. Adjusted diluted earnings per share (EPS) were $0.74 ($0.75 CER) compared to the Q4 2021 outlook for at least $0.60 CER. Full-year 2021 results also exceeded the outlook for net sales growth of at least 15% CER and for adjusted diluted EPS of at least $2.48 CER.

"Our very solid results in the fourth quarter capped a tremendous year for QIAGEN, especially the 22% CER growth in our non-COVID product portfolio that has consistently outperformed. We continue to support the global response to the pandemic while again showing QIAGEN is not COVID dependent and has a portfolio to drive future growth," said Thierry Bernard, Chief Executive Officer of QIAGEN N.V.

"Going into 2022, we are optimistic about opportunities in the research environment amid healthy increases in national funding programs, as well as robust trends in regular clinical testing for molecular diagnostics. Our outlook for 2022 is based on expectations for double-digit CER growth in our non-COVID portfolio, as we continue to execute on our commitments while also taking into consideration the volatile pandemic trends. QIAGEN is well-positioned for strong mid-term growth as we sharpen our focus on targeted growth opportunities in the Life Sciences and Molecular Diagnostics," Bernard said.

Roland Sackers, Chief Financial Officer of QIAGEN N.V., said: "We are very pleased to finish 2021 with strong levels of sales, profitability and cash flow while making investments to strengthen our portfolio. We are moving ahead with manufacturing upscaling projects and investments in R&D for menu expansion of our key platforms, especially our five pillars of growth. These investments are designed to enable QIAGEN to transition the rapid growth in our installed base of instruments and systems into new applications while supporting the global response to the COVID-19 pandemic. We are confident in QIAGEN’s growth prospects and our ability to create long-term value."

Please find the full press release incl. tables here

Investor presentation and conference call

A conference call is planned for Wednesday, February 9, 2022, at 15:00 Central European Time (CET) / 9:00 Eastern Standard Time (EST). A live audio webcast will be made available in the investor relations section of the QIAGEN website, and a replay will also be made available after the event. A presentation will be available at View Source

VerImmune Announces Research Collaboration with Janssen to Leverage its Unique Immuno-oncology therapeutic Platform

On February 8, 2022 VerImmune Inc. (VerImmune), a biotechnology company developing a new therapeutic modality that redirects the body’s pre-existing immunity toward cancer, reported that the company has entered into a Research Collaboration with Janssen Research & Development, LLC ("Janssen"), one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Press release, VerImmune, FEB 8, 2022, View Source [SID1234607840]). The agreement was facilitated by Johnson & Johnson Innovation.

Verimmune is also a resident of JLABS @ Washington, DC., part of Johnson & Johnson Innovation’s global network of life science incubators and plans to set up its research and development laboratories in this new cutting edge site located at the heart of the BioHealth Capital Region (BHCR) cluster which consists of Maryland, Washington D.C and Virginia.

VerImmune’s technology platform is a novel and highly configurable Virus-inspired Platform (ViP). Using this ViP, VerImmune has developed a first-in-class novel therapeutic approach called "Anti-tumor Immune Redirection". This approach uses the ViP platform (now termed AIR-ViP) to redirect natural pre-existing immunity from past viral infections or childhood vaccinations to target cancer. This is a broadly applicable treatment paradigm, based on a single therapy, that can act against multiple human cancers due to the ubiquitous nature of pre-existing responses to childhood vaccines and/or past infections

"We are excited to enter into this collaboration with Janssen and employ VerImmune’s AIR-ViP platform to advance the development of our new therapeutic modality. Our fundamental goal is to change treatment paradigms and deliver patients with more innovative yet safe and efficacious therapies" said Joshua Wang, Ph.D., VerImmune’s Founding CEO and President.

Under the terms of the collaboration, VerImmune will collaborate with Janssen immuno-oncology scientists to conduct feasibility studies to evaluate VerImmune’s proprietary Anti-tumor Immune Redirection Virus-inspired Particle (AIR-ViP) technology platform.

MaaT Pharma and Skyepharma Have Entered a Partnership to Establish the First Exclusive Microbiome Ecosystem Therapies cGMP Manufacturing Facility in France

On February 8, 2022 MaaT Pharma and Skyepharma reported that they Have Entered a Partnership to Establish the First Exclusive Microbiome Ecosystem Therapies cGMP Manufacturing Facility in France (Press release, MaaT Pharma, FEB 8, 2022, View Source [SID1234607839])

The partnership will provide MaaT Pharma with a dedicated 1,500 square meter site, with the potential for double if needed, in order to increase its cGMP manufacturing capacities to support clinical and then commercial development of its most advanced assets MaaT013 and MaaT033, as well as to expand R&D manufacturing capacities for its new drug generation (MaaT03x).

MaaT Pharma will deploy a facility entirely dedicated to the production of the Company’s Microbiome Ecosystem Therapy (MET) and will be the first resident biotechnology company of the Skyepharma SkyeHub Bioproduction.
This first plant, dedicated to complete ecosystems, could enable France to strengthen its national biomanufacturing capacity by acquiring a new bioproduction site in France integrating breakthrough technologies.
Lyon and Saint-Quentin-Fallavier, France, February, 8 2022 – 6:00pm CET – MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech (Phase 3) and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer and Skyepharma, a Contract Development and Manufacturing Organization (CDMO) specialized in formulating and manufacturing complex and controlled release drugs, reported they have entered a partnership agreement to build, to date, France’s largest specialized cGMP manufacturing facility for ecosystem microbiome-based therapeutics. The facility, located near Lyon (Saint-Quentin-Fallavier) will boast an initial area of 1,500 square meters, that could be increased to 3,000 square meters depending on MaaT Pharma’s manufacturing needs. The plant will allow MaaT Pharma to increase its manufacturing capacities ten-fold in order to support clinical and commercial development by 2030. The facility will aim to annually produce several thousand enemas of the Company’s lead candidate (MaaT013) dedicated to Graft-versus-Host disease and several hundreds of thousands capsules of its second drug candidate (MaaT033) designed to improve survival in patients receiving allogeneic stem cell transplantation. A designated area will be dedicated to R&D and clinical manufacturing of the MaaT03X range by 2030, using MaaT Pharma’s innovative ecosystem co-fermentation technology to increase response rate in immunotherapy treatments.

"As we enter Phase 3 with our lead product MaaT013, the agreement with Skyepharma will allow us to scale up manufacturing to meet product demands, including commercial launch. We can look forward to expanding our product portfolio for cancer patients with serenity," commented Hervé Affagard, Co-founder and CEO of MaaT Pharma. "This partnership is fully in line with France’s ambition, as stated in the 2030 innovation plan for health, to become a nation at the forefront of biotherapies and ensure health independence in biomanufacturing. The emerging microbiome industry could open up an opportunity to position France as a leader."

David Lescuyer, Managing Director of Skyepharma added, "SkyeHub will increase cGMP production capacity for microbiome-based drugs in France. Our partnership acts as a value booster as each company brings its know-how and expertise."

Under the terms of the agreement, which follows a bilateral letter of intent signed in September 2021 and whose financial conditions remain confidential, MaaT Pharma will have a dedicated facility within SkyeHub Bioproduction and construction will be financed by Skyepharma. It is planned that the production site, expected to be operational in 2023, will host MaaT Pharma’s team and proprietary equipment. In this context, the Lyon-based biotech will retain controlling oversight of the R&D as well as clinical and commercial production of its diverse portfolio of enema and capsule drug candidates. In addition to providing the cGMP building, Skyepharma will also provide its extensive expertise in product quality standards, regulatory affairs, certification, and large-scale production.

This new plant will also allow MaaT Pharma to accelerate the development of MaaT03X, its new generation of drug candidates, using its unique proprietary microbiome ecosystem co-fermentation technology, for which the Company was recently awarded two public grants (Plan France Relance and the 4th Programme d’Investissements d’Avenir (PIA4)). This new oral class of MET products includes hundreds of species and is tailor-made based on clinical data.