On July 29, 2021 UCB reported to adapt, delivering strong performance (Press release, UCB, JUL 29, 2021, View Source [SID1234585355]). Our employees and partners have been extremely agile, responding to the changing environment. UCB is in a position of confidence – for our late-stage pipeline, for delivery on our ambitious targets and for our ability to lead in five patient populations in 2025.

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The first half of 2021 has been another time of strong delivery and growth. I am so proud of how we have kept all our pipeline projects on track, despite the pandemic. All clinical development programs are on track, with six phase 3 studies to readout as planned plus one phase 3 readout, now expected earlier.

We’re excited to be preparing for the launch of our new asset for people living with psoriasis. In June, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending granting marketing authorisation. And I’m also pleased to reveal that phase 3 readouts for additional indications for this same asset are on track by year-end, plus the one for hidradenitis suppurativa (HS) due to arrive early.

Also the two phase 3 readouts in myasthenia gravis for two different assets are unchanged expected late 2021 and early 2022.

I have full confidence in our late-stage pipeline and our ability to deliver on our short- and long-term guidance and lead in five patient populations in 2025. Our expectations for 2025 are confirmed: we aim for revenue in 2025 to reach at least € 6 billion and underlying profitability (adjusted EBITDA) to reach the low- to mid-thirties in per cent of revenue.

And, last but not least, I am satisfied of the steps forward in the areas of sustainability critical to our long-term success. Our progress – most predominantly around quality and risk – has been recognised by top sustainability rankings, including ISS ESG, MSCI and Sustainalytics.

Key numbers
The Investor Relations team has worked extremely hard preparing our HY21 financial report while handing over all the know how and tips and tricks from Nathalie to Julien and Alex.
(Plus my two cents :o) ) Nathalie has set her sails to new endavours and I am very thankful for the tremendous contribution she made – professionally and personally. The new IR Team at UCB is on hand to answer any questions you may have – test us! You might want to ask the financial questions towards Julien, our new Corporate Access and IR Manager – or chat with him about sports and his latest cocktail recipe. Discussing our pipeline and the science behind it gets engaging with Alex, our new Investor Relations Lead – you get a similar engagement when turning the discussion towards cowboys, good food and corresponding drinks. And, yes, you have my number – always happy to chat with you!

I leave you by wishing you a safe and healthy second half of 2021, and with these key figures from the first six months of the year:

Revenue increased to € 2.8 billion (+7%, +11% CER), net sales € 2,651 million (+6%, +11% CER)
Underlying profitability (adjusted EBITDA) was € 843 million (+8%, +16% CER) or 30% of revenue compared to the first six months of 2020
Financial guidance for 2021 is confirmed: Revenue expected to reach € 5.45 – 5.65 billion, adjusted EBITDA 27 – 28% of revenue, Core EPS of € 5.60 – 6.10 expected
Financial guidance for 2025 confirmed as well: Revenue of at least € 6 billion and adj. EBITDA margin in the low to mid-thirties.

On July 29, 2021 Cellectis S.A. (NASDAQ: CLLS – EURONEXT GROWTH: ALCLS) (the "Company"), a gene-editing platform company with clinical-stage immuno-oncology programs using allogeneic chimeric antigen receptor (CAR) T-cells and gene therapy programs for monogenic diseases, reported that it will report its financial results for the second quarter and first six-month period ending June 30, 2021, on Thursday, August 5, 2021, after the close of the US market (Press release, Cellectis, JUL 29, 2021, View Source [SID1234585371]). The announcement will be followed by a conference call at 8:00 AM EDT / 2:00 PM CET on Friday, August 6, 2021, prior to the open of the US market.

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On July 29, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported that Chief Executive Officer, Bill Newell, will participate in a panel titled "ADCs – Take Me to Your Tumor" at the 12th Annual Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 11, at 2:20 p.m. ET / 11:20 a.m. PT (Press release, Sutro Biopharma, JUL 29, 2021, View Source [SID1234585387]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the presentation will be accessible through the News and Events page of the Investor Relations section on the company’s website at www.sutrobio.com. Archived replays of the webcasts will be available on the company’s website for approximately 30 days following each live presentation.

On July 29, 2021 Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus) reported that its subsidiary, EXINI Diagnostics AB, was granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its digital application, aPROMISE (automated PROstate Cancer Molecular Imaging Standardized Evaluation) (Press release, Lantheus Medical Imaging, JUL 29, 2021, View Source [SID1234585404]). Clinicians will have the option to utilize aPROMISE with PYLARIFY (piflufolastat F 18) to increase the efficiency and reproducibility of their PSMA PET/CT assessments. PYLARIFY was recently approved by the FDA and is the first and only commercially available PSMA-targeted PET imaging agent for prostate cancer.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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aPROMISE is an artificial intelligence-based, medical device software that uses a deep learning algorithm trained and validated across over 3,000 PSMA images to date, to allow healthcare professionals and researchers to perform quantitative assessment of PSMA PET/CT images in prostate cancer. The PROMISE criteria were developed by leading experts in prostate cancer imaging to standardize quantitative evaluation of prostate cancer lesions by location using prostate-specific membrane antigen (PSMA) PET/CT.1 aPROMISE facilitates rapid and robust quantification of prostate cancer lesions in anatomical context, enabling clinicians to make routine use in the clinic of a comprehensive, automated approach to patient evaluation. aPROMISE includes a solution for automated body segmentation and marking, quantifying and reporting suspicious lesions in their anatomical context. aPROMISE provides enhanced consistency in quantitative analysis and standardized reports and has demonstrated increased efficiency and reproducibility of clinicians’ PSMA PET/CT image assessments.2,3

"Lantheus is pleased with the FDA clearance of aPROMISE, our AI-enabled digital application that expands our PSMA platform," said Etienne Montagut, Chief Business Officer for Lantheus. "We are excited to provide such an innovative tool for PSMA quantification and reporting that can empower clinicians to make more informed treatment decisions for their prostate cancer patients."

aPROMISE Indications for Use

aPROMISE is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States — an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2021, almost 250,000 new cases of prostate cancer will be diagnosed, and more than 30,000 men will die of the disease. Approximately 3.1 million men in the United States currently count themselves as prostate cancer survivors.4

About PYLARIFY (piflufolastat F 18) Injection

PYLARIFY (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope5 for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.6-10

PYLARIFY (piflufolastat F 18) Injection

Indication

PYLARIFY (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Important Safety Information
Contraindications

None.

Warnings and Precautions

Risk of Image Misinterpretation

Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Hypersensitivity Reactions

Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks

Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions

The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For important risk and use information about PYLARIFY Injection, please see Full Prescribing information.

On July 29, 2021 BioTools Innovator , a new program focused on accelerating life science tools and diagnostics, reported the ten companies selected to participate in the organization’s inaugural three-month virtual mentorship-focused Accelerator program (Press release, Research Corporation Tech, JUL 29, 2021, View Source [SID1234585448]). With in-depth, customized mentorship and support from senior industry leaders, finalists will compete for up to $200,000 in non-dilutive cash prizes during the final competition on October 15 in Carlsbad, Calif.

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The top ten leading-edge biotechnology startups are developing solutions for cell research, genomics, data and informatics, and synthetic biology and hail from across the U.S. and Europe.

BioTools Innovator’s 2021 Top 10 Accelerator Companies Include:

Celldom – San Carlos, Calif. Clara Biotech – Lawrence, Kan. Elemental Machines – Cambridge, Mass. Enrich Therapeutics – Branford, Conn. EpiCypher – Durham, N.C. Glyphic Biotechnologies – Cambridge, Mass. Kino Discovery – Irvine, Calif. lino Biotech – Zurich Machine Bio – Claremont, Calif. Stellate DNA – Farmington, Conn .

"Congratulations to the finalists selected for our first BioTools Innovator cohort, an impressive group of cutting-edge life science startups poised to advance research with exciting new innovations," said Kathryn Zavala, managing director of BioTools Innovator. "We built this Accelerator to support innovators in bringing their promising ideas to market. Together with our partners, we are proud to provide valuable education and expert mentorship to these entrepreneurs working to make a real impact on human health."

"As a founding partner of BioTools Innovator, we were honored to be part of the selection process for the companies that will participate in the first Accelerator program," said Shaun Kirkpatrick, president, RCT. "These talented entrepreneurs are developing technologies that could bring significant value to the life science research tools space, and we are eager to help accelerate these products towards commercialization and scale-up."

"The BioTools Innovator Accelerator cohort are developing products, platforms and services that have the potential to solve unmet needs in the industry," said Bill Snider, partner, BroadOak Capital Partners. "We look forward to sharing our expertise in helping life science companies grow and succeed with these entrepreneurs, and we look forward to supporting them in their journey to bring new innovations to the market."

The BioTools Innovator Capstone Event including the Final Competition will be held in Carlsbad, Calif. from October 14-15. Over 160 companies applied for the BioTools program, but only four startups from the 2021 BioTools cohort will advance to compete in the Grand Finals. The winning company, which will be determined by a live audience vote, stands to win a non-dilutive cash prize and the title of the BioTools Innovator 2021 Winner.

BioTools Innovator works closely with stakeholders across the industry to foster the growth of early to mid-stage startups. Funding for BioTools Innovator is provided by the Frederick Gardner Cottrell Foundation of Research Corporation Technologies, Inc. (RCT). Additional support is provided by BroadOak Capital Partners .