On July 18, 2022 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and Theranostics, reported its half-year revenue and cash position on June 30, 2022, data that is currently being audited (Press release, Theradiag, JUL 18, 2022, View Source [SID1234616717]).

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Over the six months to June 30, 2022, Theradiag generated revenue of €6.3 million, compared with €5.5 million in the first half of 2021, giving growth of 14.3%.

Theranostics activity recorded another semester of solid growth, with revenue increasing by 9.3% to more than €3.0 million on June 30, 2022. This activity keeps on growing thanks to dynamic sales of the automated i-Track10 driven by an expanding range of i-Tracker tests adapted to this analyzer that thus allows the development of individualized therapeutic monitoring of even more biotherapies.

In France, Theranostics saw a solid level of activity with sales increasing by 10.5% to over €1 million. Abroad, Theranostics activity also generated satisfactory sales of approximately €2.0 million, up 8.7% compared with the first half of 2021. Moreover, the Company is in a period of reflection in order to optimize its commercial activities on the North American market.

IVD (In Vitro Diagnostics) activity recorded strong sales growth of 19.3% to over €3.2 million on June 30, 2022. This activity achieved a particularly noteworthy performance in France, where sales jumped by 29.3% to €2.1 million. These exceptional performances are the result of non-recurrent commercial opportunities. Indeed, during the first half of this year, Theradiag recorded some opportunistic sales of diagnostic instruments, notably to the veterinary sector, and logged sales of genetic tests that were temporarily increased before the closure and resumption of this distribution line.

Cash position

Theradiag had a net cash position of €6.0 million on June 30, 2022, versus €7.1 million on December 31, 2021. This level is in line with the Company’s roadmap outlined at the time of the rights issue carried out in October 2021.

Bertrand de Castelnau, Theradiag’s CEO, commented: "Theradiag is continuing to record solid commercial performances in the first half of 2022. We were able to maintain our customary growth in Theranostics and make the most of market opportunities in in vitro diagnostics. Along with this good sales dynamic, strategic and structural milestones were achieved by the Company in terms of R&D, such as the launch of ez-Track1 that is accelerating our differentiation in biotherapy monitoring and strengthening our leadership position on this market. Moreover, Theradiag has taken the implementation of IVDR* onboard and is focusing its attention on the next measures imposed by this new regulation. In the second half of 2022, we will strive to continue implementing our strategic plan that will allow us to improve all our financial indicators."

Pierre Morgon, Chairman of Theradiag’s Board of Directors, added: "Theradiag keeps on developing its Theranostics activity, which is the cornerstone of its growth strategy, and will remain agile by seizing any opportunities that arise on the IVD market. This strategy is enabling Theradiag to establish its leadership position on its key markets, which have excellent prospects."

Reminder of the main H1 2022 highlights

January 2022: Signing of a distribution agreement with BIOSYNEX of their AMPLIQUICK SARS-CoV-2 PCR test
May 2022: Launch of two new i-Tracker kits: i-Tracker Certolizumab and i-Tracker Anti-Certolizumab
May 2022: Launch of ez-Track1, a Point-of-Care Testing solution for therapeutic drug monitoring
June 2022: Partnership with Quotient Limited to advance autoimmune disease diagnostics
Next financial press release:

– H1 2022 results, on Monday September 19, 2022, before market

On July 18, 2022 GSK plc (LSE/NYSE: GSK) reported that completed the demerger of the Consumer Healthcare business from the GSK Group to form the Haleon Group (Press release, GlaxoSmithKline, JUL 18, 2022, View Source [SID1234616716]). The shares of Haleon plc (ticker "LSE: HLN") will be admitted at 8.00 a.m. today to the Premium Listing segment of the Official List and to trading on the Main Market of the London Stock Exchange ("LSE").

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It is expected that American Depositary Shares representing shares of Haleon plc (ticker: "NYSE: HLN") ("Haleon ADSs") will commence "regular-way" trading on the New York Stock Exchange (the "NYSE") at market open on Friday 22 July 2022. In addition, we expect that Haleon ADSs will begin trading on a "when-issued" basis on the NYSE from market open today up to and including Thursday 21 July 2022. Each Haleon ADS represents two Haleon ordinary shares.

GSK Share Consolidation
At the GSK General Meeting on 6 July 2022, alongside the demerger, GSK shareholders also approved the consolidation of GSK shares (the "GSK Share Consolidation"). The GSK Share Consolidation is expected to take place after the market closes today. It is expected that admission and dealings in the new GSK shares on the LSE will commence at 8.00 a.m. on Tuesday 19 July 2022. GSK will provide an update following the completion of the GSK Share Consolidation at around 7.00 a.m. on Tuesday 19 July 2022.

The ratio for the GSK Share Consolidation cannot be fixed at this time as it will depend on fluctuations in the volume and price of the GSK shares in the period between 8.00 a.m. and 4.30 p.m. today.

As at the time of this announcement, GSK’s issued share capital consists of 5,389,096,045 ordinary shares of 25 pence each (including 304,905,950 ordinary shares held in treasury). Therefore, the total number of voting rights in the Company is 5,084,190,095. If the total number of GSK shares in issue prior to the record time at 8.00 p.m. today is not exactly divisible by the denominator in the consolidation ratio, then shortly before the GSK Share Consolidation, GSK will issue up to 49 ordinary shares to ensure that following the GSK Share Consolidation there are no fractional ordinary shares outstanding.

Further information on and key dates in relation to the proposed demerger of Haleon and the GSK Share Consolidation is set out at the end of this announcement ("Expected Timetable of Principal Events") and can also be found in the Circular to Shareholders published on 1 June 2022. The Circular is available on GSK’s website at www.gsk.com/demerger.

On July 18, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its highly productive bacterial Mimicry drug discovery platform, reported that it has signed a strategic R&D collaboration and license agreement with Nestlé Health Science targeting food allergies and inflammatory bowel disease (IBD) (Press release, Enterome, JUL 18, 2022, View Source [SID1234616715]).

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The aims for the collaboration are to:

successfully develop and commercialize Enterome’s lead EndoMimics pipeline candidate EB1010. EB1010 is a potent local inducer of IL-10 designed to provide improved therapeutic outcomes for patients with food allergies and IBD. EB1010, which is due to enter clinical trials in 2023, was discovered using Enterome’s novel bacterial Mimicry drug discovery platform. The same platform will also be used to identify and develop new EndoMimics as potential novel therapies for inflammation associated with food allergies.
identify and create a pipeline of novel AllerMimics (allergen immunotherapies for food allergies) using Enterome’s Mimicry platform with an initial focus on peanut allergens as the basis for a novel class of immunotherapies that aims to suppress allergic reactions.
Under the terms of the agreement Enterome will receive €40 million upfront in cash and in equity from Nestlé Health Science and is also eligible to receive clinical and sales milestone payments for each licensed therapeutic candidate plus royalties on net sales. Enterome will be responsible for leading drug discovery activities and bear related costs up to the investigational new drug (IND) application.

"We will generate new AllerMimics candidates using our highly productive Mimicry drug discovery platform, which has already allowed us to discover multiple first-in-class small protein and peptide drug candidates in a broad range of therapeutic areas. AllerMimicsare a truly novel class of specific antigens produced by the microbiome that are similar to food allergens, and work by helping the body’s immune system tolerize to these specific allergens," said Dr. Christophe Bonny, Chief Scientific Officer of Enterome. "The collaboration will also allow us to progress the clinical development of EB1010, the first candidate originating from our EndoMimicspipeline. We believe that EB1010, administered orally as a pill, has the potential to prevent or diminish the intensity of allergic reactions in the gut. EB1010, which will also be evaluated in inflammatory bowel disease, will be applicable to many different types of food allergies, potentially in combination with selected AllerMimics."

Hans-Juergen Woerle, Chief Scientific and Medical Officer of Nestlé Health Science said, "Approximately 220 million people around the world live with food allergies, while seven million live with inflammatory bowel disease. Through this collaboration, we are aiming to develop novel therapies for these two disease areas with high unmet medical need. We are excited about the opportunity to partner with Enterome on their unique microbiome drug discovery platform striving to develop first-in-class, high-quality treatment solutions that will help patients to live a healthier life."

"We are thrilled to sign this R&D agreement to develop a new pipeline of novel AllerMimics candidates as well as further develop and commercialize EB1010, our lead EndoMimics candidate, with Nestlé Health Science, a world leader in food allergies," said Pierre Belichard, CEO of Enterome. "The signing of this collaboration further highlights both the potential and growing interest in our Mimicry platform as a source of novel immunotherapies. This milestone is all the more exciting following recent clinical and immunological validation of the mode of action of EO2401, our first-in-class off-the-shelf OncoMimics immunotherapy for Glioblastoma and Adrenal carcinoma."

Enterome’s Mimicry drug discovery platform is based on its unique ability to decode the interaction between the gut microbiome and the immune system. The Mimicry platform uses best-in-class biocomputational tools and bioassays to identify novel therapeutics for a broad range of indications from a proprietary database of 20+ million full-length gut microbiome peptides and proteins.

On July 16, 2022 EpiAxis Therapeutics is among the emerging-growth entrepreneurial companies reported that will present at youngStartup Ventures Network’s Venture Summit West 2022, which is being held in Silicon Valley from 19-20 July 2022 (Press release, EpiAxis Therapeutics, JUL 16, 2022, View Source;utm_medium=rss&utm_campaign=epiaxis-heads-to-venture-summit-west [SID1234616713]).

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The exclusive venture summit is dedicated to showcasing early-stage venture capitalists, corporate venture capitalists and angel investors committed to funding venture backed, emerging and early stage companies as well as showcasing more than 100 top innovators in the tech, fintech, cleantech, lifesciences, healthcare and medtech sectors.

More than 1000 attendees are expected at the summit, which will feature insightful discussions, the newest technologies and latest trends currently shaping the future.

EpiAxis recently published the results of its pioneering clinical trial EPI-PRIMED in leading cancer journal Frontiers of Oncology. EPI-PRIMED is the first time that an epigenetic inhibitor has been used in combination with chemotherapy to treat metastatic cancer. The findings of the EPI-PRIMED study give EpiAxis a solid foundation for its next clinical trial using its novel peptide inhibitors. The company is currently working with The Sage Group to raise US$12million to advance a candidate into an IND enabled program.

Dr Chrisp will pitch at Venture Summit West 2022 during Round III – Life Sciences/Healthcare at 1:50 pm (PDT) on 20 July 2022.

On July 15, 2022, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco" and the company) reported that the first global CD47×HER2 bispecific molecule (IMM2902) have received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for breast cancer (Press release, ImmuneOnco Biopharma, JUL 15, 2022, View Source [SID1234655664]). The grant of FTD by the US FDA is a major affirmation to IMM2902.

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After the drug candidate IMM2902 under development is granted the FTD status, the company will have more opportunities to communicate with the US FDA in the process of clinical trial and review. It is expected to be able to discover and solve problems in research and development in a timely manner, which will help to speed up clinical research and approval of the drug.

Preclinical studies demonstrate that IMM2902 exhibits robust anti-tumor activity in several breast and gastric tumor models, including HER2-expressing low and trastuzumab-resistant tumor models. We are conducting a Phase Ia/Ib clinical trial in China to evaluate the efficacy of IMM2902 in advanced HER2-positive and HER2 expressing-low solid tumors, including breast cancer, gastric cancer, non-small cell lung cancer and cholangiocarcinoma. The first patient was dosed in February 2022. We also initiated a clinical trial in advanced HER2-positive and HER2-expressing-low solid tumors in the United States, the first patient was dosed in June 2022.

Chairman and founder of ImmuneOnco, Dr. Tian, Wenzhi is full of confidence in the clinical research of IMM2902. He said: "We are highly inspired that our IMM2902 has been granted Fast Track designation for breast cancer by the U.S. FDA. IMM2902 is a bi-specific molecule for targets CD47 and HER2 developed based on our own R&D platform. The high affinity of the molecule allows it to preferentially bind to tumor cells. At the same time, it doesn’t bind to human erythrocytes so as avoiding the ‘antigen sink effect’ thus greatly enhancing the specific synergistic effect of two targets against tumors. Although HER2 antibody-drug conjugates (ADCs) have shown activity in certain HER2-low-expressing tumors in clinical trials, they are often associated with serious adverse reactions such as interstitial pneumonitis and even death, which bring potential risks to patients. We believe that the similar efficacy and better safety profiles demonstrated by IMM2902 will make it valuable in clinical development and commercial potential."