26/10/2021: Theradiag launches a Rights Issue

On October 26, 2021 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and Theranostics, reported the launch of a rights issue for a target amount of €5,334,745,24, at a price of €1.22 per share with a nominal discount of 30.05% to the closing price on 21 October 2021, and a ratio of 1 new share for every 2 existing shares (the "Rights Issue") (Press release, Theradiag, OCT 26, 2021, View Source [SID1234591930]).

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Bertrand de Castelnau, CEO of Theradiag, said: "Our strategic refocus on innovation and the commercial development of our two activities, Theranostics and in vitro diagnostics, has enabled us to post very solid growth in recent semesters and be close to breakeven in the first half of 2021[1]. On the basis of buoyant activity for our innovative solutions and a healthier cost structure, we are entering a new phase of profitable growth with the aim of strengthening our global leadership on the biotherapy monitoring market.

Theradiag stands out on this growing biotherapy monitoring market through its expertise and its ties with the healthcare professionals ecosystem in France and abroad. Building on these assets, the Company wants to begin a new chapter in its history through this fundraising operation that will enable it to finance the five projects that will structure its future growth:

Secure the quality and commercial supply of antibodies via the Humabdiag project developed thanks to the recent partnership with the University of Tours (bioproduction of human monoclonal antibodies);
Accelerate the internationalization of existing activities in the world’s main healthcare countries, and in particular accelerate sales in the United States (which already account for 19% of Theranostics revenue);
Develop a technological solution to ensure Near Patient Testing;
Invest in new therapeutic fields with a substantial medical need and strong growth (e.g. oncology, central nervous system, rheumatology, etc.);
Thanks to the expertise acquired in autoimmune diseases, reposition and revive FIDIS technology, in particular in the United States, and the activity covering serums used in quality control.
Through our current structure and these five routes of development that present substantial synergies, our unique positioning will provide a response to the substantial demand on the rapidly growing global biotherapy monitoring market.

In this perspective, the planned use of the funds raised in the capital increase will be as follows:

50% of the funds will be used to strengthen the sales team by recruiting sales professionals in the United States, France and the rest of the world, to develop the autoimmunity portfolio and to design a marketing campaign for Theradiag products;
30% of the funds to research new therapeutic areas, develop new products and adapt near-patient testing;
10% of the funds raised to accelerate product registrations in several countries, particularly the United States, in order to increase international sales; and
Up to 10% of the funds raised, in order to finance Theradiag’s working capital requirements, open subsidiaries and improve production facilities.
If the issue is limited to 75%, the funds will be used as follows:

50% of the funds will be used to strengthen the sales team by recruiting sales professionals in the United States, France and the rest of the world, to develop the autoimmunity portfolio and to design a marketing campaign for Theradiag’s products;
30% of the funds to research new therapeutic areas, develop new products and adapt near-patient testing;
10% of the funds raised to accelerate product registrations in several countries, particularly the United States, in order to increase international sales; and
10% of the funds raised to finance Theradiag’s working capital requirements, open subsidiaries and improve production facilities.
Theradiag is thus preparing for a new growth phase that requires the financial means to match its ambitions. We want to involve you in this new phase by launching a Rights Issue of approximately 5.3 million euros (through the issuance of up to 4,372,742 shares at a price of €1.22 each). The funds raised will be allocated to boost our R&D and internationalize our activities in our key geographic areas, which are France and the United States. Our goal is to achieve annual revenue of over €40 million[2] within five years while keeping our costs strictly under control in order to achieve an operating margin of between 20 and 30%. This ambition should be achieved through organic growth and the implementation of the five development axes described. With the exception of public grants and subsidies, the Company does not expect to call on other complementary financing".

Pierre Morgon, Chairman of the Board, adds: "We are determined to take Theradiag to a new dimension thanks to the added value of our solutions and the current dynamic of the market segments we are targeting. On behalf of the Board of Directors and our entire team, I would like to thank you for your trust in and support for this operation that should put Theradiag on a track to faster growth and contribute to strengthening its leadership position in biotherapy monitoring".

[1] The Company’s operating result and net result at 30 June 2021 amount to -178 K€ and -92 K€ respectively.

[2] The Company’s sales as at 30 June 2021 was €5.5 million.

Avid Bioservices to Join S&P SmallCap 600 Index

On October 26, 2021 Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported that the company will be added to the S&P SmallCap 600 Index, effective prior to the open of trading on Friday, October 29, 2021 (Press release, Avid Bioservices, OCT 26, 2021, View Source [SID1234591948]).

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"We are pleased to be added to the S&P SmallCap 600 Index as it is a further demonstration of the momentum that Avid continues to generate as we successfully execute against our comprehensive growth strategy. This recognition is also an important testament to the hard work and key contributions that every member of the Avid team has made to the company’s ongoing success," said Nick Green, president and chief executive officer of Avid Bioservices.

The S&P SmallCap 600 Index is a stock market index established by Standard & Poor’s that is designed to measure the performance of the small-cap segment of the market and is composed of 600 constituent companies in the U.S. equities market. The index is designed to track companies that meet specific inclusion criteria to ensure that they are liquid and financially viable. To be included, companies must have an unadjusted market cap in the range of $850 million to $3.6 billion.

Zymeworks Announces Webcast to Present HERIZON-GEA-01 Pivotal Trial Design and Zanidatamab Commercial Strategy in Gastrointestinal Cancers

On October 26, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will host a conference call and webcast to provide details related to the launch of its Phase 3 first-line gastroesophageal adenocarcinoma (GEA) pivotal study, HERIZON-GEA-01, and to discuss the commercial potential of zanidatamab in gastrointestinal cancers (Press release, Zymeworks, OCT 26, 2021, View Source [SID1234591964]).

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HERIZON-GEA-01 is a randomized, global Phase 3 study evaluating zanidatamab plus chemotherapy with or without tislelizumab, versus standard of care (trastuzumab plus chemotherapy), for first-line treatment of locally advanced, unresectable, or metastatic HER2-positive GEA.

Event: HERIZON-GEA-01 Conference Call and Webcast

Date: Tuesday, November 9th

Time: 4:15 p.m. ET

Interested parties can access a live webcast via a link from Zymeworks’ website at View Source, which will also host recorded replays available afterwards.

About Zanidatamab

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. Zanidatamab’s unique binding properties result in multiple mechanisms of action including HER2-receptor clustering, internalization, and downregulation; inhibition of growth factor-dependent and -independent tumor cell proliferation; antibody-dependent cellular cytotoxicity and phagocytosis; and complement-dependent cytotoxicity. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC), and two Fast Track designations to zanidatamab, one as monotherapy for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations from the FDA for the treatment of GEA and BTC and from the European Medicines Agency for the treatment of biliary tract and gastric cancers.

Personalis Publishes New Data Demonstrating Performance and Utility of SHERPA for High-Accuracy Neoantigen Prediction and Cancer Diagnostic Biomarker Development

On October 26, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the publication of its study "Precision neoantigen discovery using large-scale immunopeptidomes and composite modeling of MHC peptide presentation," in the Immunopeptidomics Special Issue of the journal Molecular & Cellular Proteomics (Press release, Personalis, OCT 26, 2021, View Source [SID1234591982]).

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The Personalis authors created Systematic HLA Epitope Ranking Pan Algorithm (SHERPA), a novel pan-allelic machine learning algorithm for predicting MHC-peptide binding and presentation that demonstrates significantly improved performance compared to currently available prediction tools. To improve performance and generalizability, SHERPA was trained with immunopeptidomics data from newly engineered cell lines mono-allelic for HLA combined with other publicly available datasets. In addition, SHERPA was designed to more comprehensively capture epitope binding and presentation features to further enhance the predictive power of the algorithm. Using a composite model constructed with gradient boosting decision trees, multi-allelic deconvolution, and 2.15 million peptides encompassing 167 unique human HLA alleles, SHERPA achieved a 1.44-fold improvement of positive predictive value compared to existing tools when evaluated on independent mono-allelic datasets. Since publication, Personalis has further expanded the in-house generated immunopeptidomics training data set to a total of ~70 mono-allelic cell lines, resulting in a new version of SHERPA with further enhanced performance.

"Integrating data from diverse cell lines and tissue types improved the generalizability of our models compared to other in silico methods, a critically important aspect when applying our models to patient samples. With a high degree of accuracy, SHERPA has the potential to enable higher accuracy neoantigen binding prediction for many clinical applications," said Richard Chen, MD, Personalis’ CMO and SVP of R&D. "With this advancement, SHERPA is expected to facilitate the discovery of more predictive biomarkers for cancer therapy as well as empower the development of neoantigen-targeting, personalized cancer therapies. Our recently published NEOPS biomarker is one example of a SHERPA-derived composite biomarker that has shown promise in predicting immunotherapy response in cancer patients."

BERGENBIO ASA: Invitation to THIRD quarter 2021 results

On October 26, 2021 BerGenBio reported that senior management team will take place Tuesday 16th November 2021 at 10:00 am CET (Press release, BerGenBio, OCT 26, 2021, View Source [SID1234591949]).

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The live webcast link will be available at www.bergenbio.com in the Investors/Financial Reports section. A recording will be available shortly after the webcast has finished.

The first quarter report and presentation will be available on the Company’s website in the Investors/Financial Reports section from 7:00 am CET the same day.