On September 19, 2022 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and Theranostics, reported its half-year results to June 30, 2022, as approved by the Board of Directors on September 15, 2022 (Press release, Theradiag, SEP 19, 2022, View Source [SID1234619635]).

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Bertrand de Castelnau, Theradiag’s CEO, commented: "In the first half of 2022, Theradiag was able to deploy solid commercial momentum within a healthier cost structure. The financial indicators on our traditional scope of activity thus substantially improved over the semester. Indeed, we increased our net result by 38% despite the fact that this figure had benefited from an exceptional contribution of €150 thousand from Covid activity in the first half of 2021. Over the period, we also continued our investments in all strategic domains to drive future profitable growth. Buoyed by this very positive trend, we will continue to apply our strategic plan with a view to achieving a structurally positive margin from 2023".

"Thanks to the concerted efforts of all its teams and to the strategic reorientation initiated in recent semesters, Theradiag is continuing its progress towards profitability, which should be achieved by early 2023 at the latest. Furthermore, Theradiag has amazing development potential, given the size of the biotherapy monitoring market and its regular growth. Theradiag will thus continue to deploy all of its strategic tools to ensure its successes on this fast-growing market", added Pierre Morgon, Chairman of Theradiag’s Board of Directors.

2 Solid growth in activity thanks to the recurring dynamism of Theranostics and to market opportunities in In Vitro Diagnostics

Over the six months to June 30, 2022, Theradiag generated revenue of €6.3 million, compared with €5.5 million in the same period 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 at 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.

IVD (In Vitro Diagnostics) activity recorded strong sales growth of 19.3% to over €3.2 million at June 30, 2022. This performance is the result of non-recurring 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 a temporary boost in sales of genetic tests, prior to stopping this distribution line at the end of 2023. Financial indicators closing in on profitability and maintaining of investments to drive future growth

Over the first half of 2022, Theradiag continued its substantial progress towards profitability. Indeed, the operating loss shrank by 28% compared to the same period of 2021, despite a high basis for comparison due to Covid activity having contributed €150 thousand in the first half of 2021. As previously reported, Theradiag decided to end its antigen activities in the second semester of 2021. As well as significantly improving its profitability on its traditional markets, Theradiag has maintained its strategic investments in several fields that will drive the Company’s future growth: Marketing and Market access, Research & Development and Quality (compliance with the European Union’s directive on in vitro diagnostic medical devices (IVDR)). Furthermore, without impacting the strategic penetration of markets, in particular key markets, Theradiag’s Management will continue to optimize its commercial organization in its strategic countries to accelerate the return to strong profitability in the coming months.

The net loss before non-recurring items is slightly down this semester with a decrease of €33 thousand compared with the same period of 2021 due to lower Research Tax Credit. The overall net result improved by 38% to-€56 thousand at June 30, 2022 versus-€92 thousand at June 30, 2021. It is now close to breakeven and represents-0.9% of revenue.

Cash position and Financial structure 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.

Reminder of the main H1 2022 highlights
• January 2022: Signing of a distribution agreement with BIOSYNEX regarding their AMPLIQUICK SARS-CoV-2 PCR test
• May 2022: Launch of two new i-Tracker kits: i-Tracker Certolizumab and i-Tracker AntiCertolizumab
• May 2022: Launch of ez-Track, a diagnostic Point-of-Care Testing solution
• June 2022: Partnership with Quotient Limited to advance autoimmune disease diagnostics

On September 19, 2022 Targovax and our sector reported that we invite you to an Investor Event Tuesday 27 September 2022 (Press release, Targovax, SEP 19, 2022, View Source [SID1234619634]). DNB will provide an analyst’s view of the biotech industry followed by presentations from Targovax with a focus on circRNA. We will finish the event with an opportunity for you to speak with members of our management team in an informal setting with food and refreshments.

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Targovax’s management team will present in Norwegian and are available for questions during the social event.

Date: Tuesday 27 September
Time: 17.00-19.00
Location: Sentralen, Øvre Slottsgate 3, Oslo

An analyst’s view of the biotech market
Dr. Geir Hiller Holom, Senior Equity Analyst at DNB Markets
Targovax Business Overview
Dr. Erik Digman Wiklund, CEO of Targovax
Circular RNA (circRNA) – the new frontier in RNA therapeutics discovered in Scandinavia
Dr. Thomas Hansen, VP Research at Targovax
There will be an informal Q&A and serving of food from 17:45.

Lubor Gaal, CFO og Andreas Storsve, VP Business Development, will also be present.

On September 19, 2022 Bugworks Research Inc., a clinical stage biopharmaceutical company, and Cytecare Cancer Hospitals reported the launch of a first-of-its-kind collaboration (Press release, Bugworks Research, SEP 18, 2022, View Source [SID1234627139]). Bugworks develops best-in-class, novel therapies for cancer and infectious diseases & has set up a dedicated research center within Cytecare, which is committed to excellence in treating cancer patients.

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The coming together of a leading innovator in drug discovery and a state-of-the-art cancer hospital promises to be a game changer in saving countless human lives. Bugworks’ drug discovery engine coupled with Cytecare’s excellence in delivering optimal clinical outcomes will offer differentiated solutions to patients all over the world.

Commenting on the significance of this strategic collaboration, Suresh Ramu, Co-Founder & CEO, Cytecare Cancer Hospitals, said, "We are excited to partner with Bugworks Research, in this inspiring endeavor to discover novel treatments for different types of cancers. In 2016, we started with the vision of building the country’s best institution for cancer care, supported by India-specific research data. At Cytecare, we are committed to provide the best possible treatment to patients and support cutting-edge research. We strongly believe that affordable and accessible immuno-oncology therapies can come from India and be made accessible to all patients. This collaboration heralds a brave new beginning to a healthier future."

Bugworks’ current research in immuno-oncology centers around modulating the tumour microenvironment that includes adenosine antagonism – an area of research with applications across many solid tumours. The drug candidates from this research will undergo translational testing on patient-derived tumours in the ex vivo laboratories at Cytecare, prior to progressing to first-in-human clinical studies.

Dr. V. Balasubramanian, Co-Founder and COO, Bugworks, noted, "We are discovering highly differentiated, novel small molecule immunotherapeutic agents that target the immunosuppressive and tumour-promoting microenvironment. The ex vivo laboratories at Cytecare Cancer Hospitals, as part of our collaboration, will greatly aid the translation of our research to high percentage successful clinical outcomes."

At present, immunotherapy is an important pillar in the armamentarium of cancer care. The currently approved agents are indeed life-saving, albeit only for a small segment of patients. Bugworks’ approach, in collaboration with Cytecare Hospitals, offers new avenues to increase the percentage of patients who would benefit from these life-saving immunotherapies. The current collaboration is a small, yet significant step in helping India become a biotech powerhouse.

On September 18, 2022 Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven") reported that it has set a record date of September 26, 2022 (the "Record Date") for the previously announced spin-off by Biohaven of its Biohaven Ltd. ("SpinCo") subsidiary, which will own the Kv7 ion channel activators, glutamate modulation, myeloperoxidase inhibition and myostatin inhibition platforms, preclinical product candidates, and certain corporate infrastructure currently owned by Biohaven (Press release, Biohaven Pharmaceutical, SEP 18, 2022, View Source [SID1234619639]). The completion of the spin-off remains subject to closing conditions noted in Biohaven’s Proxy Statement filed on August 30, 2022, including receipt of shareholder approval at Biohaven’s special meeting of shareholders to be held on September 29, 2022.

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On the date of the distribution (the "Distribution Date"), each holder of Biohaven common shares will receive one common share of SpinCo for every two common shares of Biohaven held as of the Record Date. No action or payment is required by Biohaven shareholders to receive shares of SpinCo.

Beginning on September 23, 2022, and continuing until the occurrence of the distribution on the Distribution Date, Biohaven common shares will trade with an entitlement to the distribution under the symbol "BHVN". Any holders of Biohaven common shares who sell shares on or before the Distribution Date will also be selling their right to receive SpinCo common shares. Investors are encouraged to consult with their financial advisors regarding the specific implications of buying or selling Biohaven common shares on or before the Distribution Date.

Beginning on September 23, 2022, SpinCo common shares are expected to begin trading on a "when-issued" basis on the New York Stock Exchange under the symbol "BHVN WI" and under "Biohaven Ltd." When-issued trading of SpinCo common shares will continue until the distribution occurs. SpinCo common shares are expected to begin "regular-way" trading on the NYSE under the symbol "BHVN" on the first trading day following the Distribution Date.

On September 18, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, reported that ATG-101, the company’s in-house developed novel PD-L1/4-1BB bispecific antibody, has been granted an Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer (Press release, Antengene, SEP 18, 2022, View Source [SID1234619631]). This ODD will help Antengene facilitate regulatory communication with the FDA, accelerate the clinical development and the future registration of ATG-101.

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At present, no PD-L1/4-1BB bispecific antibody has been approved for the treatment of pancreatic cancer worldwide.

Orphan Drugs, also known as Rare Disease Drugs, refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. Orphan Drug Designations by the U.S. FDA are meant to support the development of drug candidates that could potentially bring substantial therapeutic benefits to patients with rare diseases (a condition with a prevalence of less than 200,000 in the U.S.), and to provide incentives to the subsequent development, registration and commercialization to designated drugs. Those incentives include tax credit on expenditures incurred in clinical studies, a waiver of the New Drug Application (NDA) fee, and 7-year market exclusivity in the U.S. regardless of the patent status of the designated drug.

Pancreatic cancer is a highly malignant type of gastrointestinal cancer. According to the statistics by the World Health Organization (WHO), pancreatic cancer was ranked 13th and 7th globally by its incidence and mortality rates in 2012. In 2018, the U.S. reported over 55,000 newly- diagnosed pancreatic cancer cases and 44,330 related deaths. Whereas still defined as an orphan disease currently, it is projected that by 2030, pancreatic cancer will become the second most common cause of cancer-related deaths.

ATG-101 is a novel PD-L1/4-1BB bispecific antibody that was designed to block the binding of immunosuppressive PD-1/PD-L1 and conditionally induce 4-1BB stimulation, thus activating anti-tumor immune effectors, while delivering enhanced anti-tumor activity, with an improved safety profile. In preclinical studies, ATG-101 demonstrated significant anti-tumor activity in animal models of resistant tumors as well as those that had progressed on anti-PD-1/L1 treatment. Furthermore, ATG-101 has also shown an excellent safety profile in Good Laboratory Practice (GLP) toxicology studies. ATG-101 is the first PD-L1/4-1BB bispecific antibody entering clinical development in Australia and is currently being evaluated in clinical studies in Australia, China, and the U.S.

Dr. Bo Shan, Antengene’s Chief Scientific Officer, said, "We are very encouraged by this Orphan Drug Designation from the U.S. FDA and are hopeful that ATG-101 will offer a novel therapeutic to patients with pancreatic cancer. As Antengene’s first in-house developed asset with global rights, ATG-101 has already entered clinical development in Australia, China, and the U.S. We will strive to accelerate the global clinical development of ATG-101 in efforts to provide a new treatment option to patients around the world."