On November 24, 2021 InDex Pharmaceuticals Holding AB reported that interim report January – September 2021 (Press release, InDex Pharmaceuticals, NOV 24, 2021, View Source [SID1234596008])

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Period July – September 2021
Net sales amounted to SEK 0.0 (0.0) million
Operating loss amounted to SEK –28.2 (–7.7) million
Result after tax amounted to SEK –28.2 (–7.7) million, corresponding to SEK –0.05 per share (–0.03) before and after dilution
Cash flow from operating activities amounted to SEK –26.5 (–8.3) million
Period January – September 2021
Net sales amounted to SEK 0.0 (0.0) million
Operating loss amounted to SEK –80.2 (–47.3) million
Result after tax amounted to SEK –80.2 (–47.3) million, corresponding to SEK –0.16 per share (–0.20) before and after dilution
Cash flow from operating activities amounted to SEK –80.1 (–63.1) million
Cash and cash equivalents at the end of the period amounted to SEK 463.1 (62.3) million
Number of employees at the end of the period was 8 (7)
Number of shares at the end of the period was 532,687,650
All comparative amounts in brackets refer to the outcome during the corresponding period 2020.

Significant events during the quarter
InDex received first regulatory approval from the Swedish MPA to start the phase III study CONCLUDE with cobitolimod
InDex received FDA clearance to start the phase III study CONCLUDE
Significant events after the quarter
InDex got new patent for cobitolimod granted in the US
InDex got new patent for cobitolimod granted in Canada
Other events
InDex announced that the company will conduct a clinical pharmacokinetic study (PK study) with cobitolimod in Sweden
InDex announced that two new employees have been appointed in the clinical development organisation in preparation of the start of the phase III study CONCLUDE with cobitolimod
CEO statement
We have now several clinics activated in the phase III study CONCLUDE and look forward to enrol the first patient in the near term. We are pushing hard to get more and more clinics ready to enrol patients as we receive regulatory approval to start the study in the respective countries. We have already approval in the US, Sweden, Hungary, and France, and expect approval in several more countries in the coming weeks.

CONCLUDE is a global clinical study, which will include 440 participants to evaluate cobitolimod as a new treatment for patients with moderate to severe left-sided ulcerative colitis. The study will be conducted at several hundred clinics in over 30 countries.

The pandemic continues to affect the start-up of new clinical studies in that the clinics report resource constraints and a need to prioritize their regular care and to manage the backlog. Once our study is up and running, we expect to reach the planned patient recruitment rate.

There continues to be a lot of news coming out of the field of ulcerative colitis. It was quite dramatic in September when the FDA updated their safety warnings for JAK inhibitors as a class. The FDA added serious heart-related events, cancer, blood clots, and death to the already boxed warnings of JAK inhibitors. They also limited all approved uses to patients who have failed TNF blockers. FDA’s decision firmly positions the JAK inhibitors as a last line treatment in ulcerative colitis. It is a reminder that a product’s safety profile is very important, and good news for cobitolimod that has demonstrated an excellent safety profile to date. Overall, the competitive landscape has clearly evolved in cobitolimod’s favour over the last 18 months.

We recently got a new patent for cobitolimod granted in the US, which is the most important pharmaceutical market in the world. This new patent provides protection for the 250 mg dose, which was successful in the phase IIb study CONDUCT and is now included in phase III. The patent will provide an exclusivity period until May 2038, with the possibility of up to 5 years term extension after market approval. It is a good example of our IP strategy to build a thicket of patents around cobitolimod. We continue to file new patent applications in the light of advances in the formulation and clinical development of cobitolimod, to provide exclusivity beyond the term of InDex’s already granted patents.

I am excited that we are close to enrol the first patient in the phase III study and I hope you will tune in to our upcoming investor presentations at HC Andersen Capital today and Erik Penser Bank tomorrow.

The full report is attached as a PDF and is available on the company’s website View Source

Publication
This information is information that InDex Pharmaceuticals Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication through the agency of the contact person set out above at 8:00 CET on November 24, 2021.

On November 24, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that the Swedish Medical Technologies Product (MTP) Council has recommended the Prosigna Breast Cancer Assay for immediate reimbursement and clinical use in all Swedish healthcare regions without legal restrictions beginning November 22, 2021 (Press release, Veracyte, NOV 24, 2021, View Source [SID1234596027]). The milestone follows recent G-BA reimbursement approval in Germany and underscores the test’s continued reimbursement momentum in the European Union.

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The recommendation from the Swedish MTP Council’s first-ever process of its kind specifies that physicians can use the Prosigna assay to help make decisions about adjuvant chemotherapy in individual women over the age of 50 with certain types of breast cancer when there is uncertainty about the benefit of this treatment. It is based on a prior positive assessment from the Swedish Dental and Pharmaceutical Benefits Agency (Tandvårds Läkemedelförmånsverketthe, TLV), which conducted a health technology assessment (HTA) and concluded that the Prosigna test is a cost-effective genomic diagnostic technology for breast cancer.

The Prosigna assay is the only breast cancer genomic test that is both CE-IVD marked and recommended by the MTP Council without legal caveats regarding either General Data Protection Regulation (GDPR) compliance or adherence to processing of personal data requirements in Sweden and the European Union. The Prosigna test is performed locally by laboratories in Sweden and other countries on the nCounter Analysis System instrument.

"The positive TLV and MTP recommendations represent an important milestone for women with breast cancer throughout Sweden, because it makes it possible for them and their physicians to access the Prosigna test without restrictions to inform individual treatment decisions," said Morten Frost, Veracyte’s general manager, Pulmonology and Breast Cancer. "The Swedish HTA is internationally recognized as a robust assessment with strict evidence and cost-effective requirements. We believe this recommendation reflects the robust evidence supporting the Prosigna assay, and we are actively working to make the test available to physicians and breast cancer patients who could benefit from it in other European countries."

The incidence of breast cancer is continuing to climb globally.i According to a report published by the Swedish National Board of Health & Welfareii, breast cancer is the most common cancer diagnosis for Swedish women, with up to about 10,000 new cases every year. In September 2020, the Swedish MTP Council decided to begin evaluating genomic diagnostics for breast cancer as part of the country’s Orderly introduction framework, which aims to manage the national introduction of novel technologies.

"Clinical research and experience have demonstrated that understanding the gene expression profile of each patient’s breast cancer is critical to selecting the most appropriate, individual treatment," said Johan Hartman MD, Ph.D., professor of Pathology, Karolinska Institutet, Stockholm, Sweden. "By making it possible for physicians in Sweden to access this detailed genomic information through regulatory approved diagnostic technologies such as the Prosigna test, the MTP and TLV recommendation could help improve care and outcomes for women across the country."

The Prosigna test is included in the European medical guidelines for the diagnosis and treatment of breast cancer. In addition to the Swedish MTP Council, UK NICE diagnostics guidance (DG34) and G-BA in Germany have recommended the test, which is also reimbursed in Spain, Denmark, Switzerland, and Israel.

"We are delighted that the Swedish MTP Council’s recommendation will help ensure that the Prosigna test is accessible to women in Sweden with breast cancer," said Marc Stapley, Veracyte’s chief executive officer. "Further, this latest milestone supports our strategic approach of offering our advanced genomic tests, beginning with Prosigna, in Europe and other countries on the nCounter Analysis System, which enables laboratories to run them for physicians and their patients locally. We believe this approach aligns well with the European regulatory environment and can improve patient outcomes by providing important clinical information more effectively and efficiently versus having to send patient samples back to the United States."

About The Prosigna Breast Cancer Assay

The Prosigna Breast Cancer Assay is a prognostic genomic test, built from PAM50 molecular subtypes, which combines tumor gene expression with clinicopathologic factors to better inform treatment decisions. The assay is indicated in female breast cancer patients who have undergone either mastectomy or breast-conserving therapy in conjunction with locoregional treatment consistent with standard of care, either as a prognostic indicator for distant recurrence-free survival at 10 years in post-menopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer, or lymph node-positive (1–3 positive nodes, or 4 or more positive nodes), Stage II or IIIA breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The Prosigna Breast Cancer Assay also provides the intrinsic subtypes of the tumor tissue within three groups – low, intermediate and high.* The test is performed on the nCounter Analysis System, enabling hospitals and laboratories to run it locally.

The Prosigna test has received the CE-IVD mark and is available for use by healthcare professionals in the European Union and other countries that recognize the CE-IVD mark, as well as in Canada, Israel, Australia, New Zealand and Hong Kong. The Prosigna test is FDA 510(k) cleared in the United States for use on the nCounter Analysis System and is available for use when ordered by a physician. The assay is widely covered by government and private payers in the countries where it is available, including by Medicare and leading private payers in the United States.

On November 24, 2021 Allorion Therapeutics, a company focusing on next-generation precision medicine for oncology and autoimmune disease, reported the completion of $40M Series A financing (Press release, Allorion Therapeutics, NOV 24, 2021, View Source [SID1234596011]). This financing round is led by Qiming Venture Partners and participated by IDG Capital, Octagon Capital, Firstred Capital, and Elikon Venture. Existing investors – TF Capital and Med-Fine Capital – continued to support in this round.

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The proceeds will be used to support Allorion’s preclinical projects, IND-enabling studies and IND applications of two drug candidates in China and the United States. Allorion will also increase its investment in its platform technologies in the systematic screen for allosteric inhibitors and synthetic lethality targets with matching tool compounds and enhance the clinical and business development teams.

The drug discovery engine of Allorion integrates technological breakthroughs in protein structure, big data, machine learning and gene editing to systematically discover and develop highly selective small molecules, including covalent and allosteric inhibitors of well-validated targets. Allorion has also built a unique synthetic lethality screening platform to expand the scope of targeted therapies for cancer patients, laying a solid foundation for the company’s long-term success. Allorion endeavors in target selection and project execution and upholds high standards of drug discovery and data quality to gain international recognition and collaboration.

Peter Ding, Founder and CEO of Allorion Therapeutics, said, "Over the past year, Allorion has built up R&D capabilities in Boston and Guangzhou and formed a strong management and R&D team. Multiple projects achieved their milestones. The completion of this financing round shows investors’ recognition of the progress and the support for the company’s long-term strategy on highly innovative platforms for best- or first-in-class drug discovery. We are grateful to all the investors for their trust and support. We will continue our efforts in promoting innovative small molecule drugs to clinical research, fulfilling the unmet clinical needs. Allorion will leverage cutting-edge technologies and strive to make precision medicine more precise and accessible to more patients."

Chen Kan, Principal of Qiming Venture Partners, said, "There are huge unmet medical needs for autoimmune disease and cancer therapy globally. Based on data mining and an in-depth understanding of disease biology, Allorion focuses on the early discovery and development of precision medicines. We have confidence in the team’s strong R&D capabilities.. We hope to support Allorion to grow into a globally-recognized company and improve patients’ life quality."

On November 24, 2021 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that members of its senior management team are scheduled to participate in the following upcoming virtual investor conference (Press release, Innate Pharma, NOV 24, 2021, View Source [SID1234596028]):

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Evercore ISI 4th Annual HealthConX Virtual Conference
Event Date: December 1, 2021
Fireside Chat: 5:20-5:40pm CET / 11:20-11:40am ET

On November 24, 2021 Selvita Group reported that continued dynamic development in each segment of its activity (Press release, Selvita, NOV 24, 2021, View Source;utm_medium=rss&utm_campaign=selvita-group-reports-a-dynamic-increase-in-revenues-for-q3-2021-ytd [SID1234596012]). Commercial revenues from services executed in Poland amounted to EUR 22.8 million and were 23% higher compared to the three quarters of 2020, when these amounted to EUR 19.1 million. In the third quarter alone, those revenues increased by as much as 32% y/y to EUR 8.5 million. Such dynamic growth is the result of developments in the area of drug discovery services and stabilization of the regulatory studies market.

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Fidelta, representing the segment of services executed in Croatia, recorded EUR 20.0 million in revenues from clients in the first three quarters of 2021, with EBITDA of EUR 6.1 million (30.5% margin). In the third quarter of 2021, Fidelta achieved EUR 7.0 million in sales revenues (an increase of 34% y/y), and EBITDA of EUR 2.2 million (a margin of 31.4%).

The bioinformatics segment (Ardigen) closed the three quarters of 2021 with EUR 4.8 million in revenue from clients, as compared to EUR 2.8 million, in the corresponding period of 2020, indicating an increase of 72% EBITDA amounted to EUR 1.2 million (23.8% margin) and was 53% higher than in the previous year. In the third quarter of 2021 alone, revenues from clients amounted to EUR 1.9 million (an increase of 57% y/y), and EBITDA of EUR 0.6 million (a margin of 31.4%).

The reported period highlights a continued growth of services’ sales on foreign markets. With the acquisition of Fidelta, we observe a significant increase in revenues from sales to the customers in the EU and Switzerland, where the Croatian company generates most of its revenues. At the same time, the continued organic development of Selvita and Ardigen was responsible for the significant increase in revenues from sales to the customers in the United States and the United Kingdom.

After three quarters of 2021, revenues from the U.S., the most competitive market in the world, increased by 89% y/y and amounted to EUR 13.5 million. Selvita Group also recorded a significant increase in sales revenues in the U.K., which rose by 128% y/y.

– The first nine months of 2021 were an intense period for us. Since the beginning of the year, we have been working on integration of Selvita and Fidelta services’ offer. We want to make the most of the experience and capabilities that we gained as a result of Fidelta’s acquisition, in order to further develop the Group’s portfolio of services.

We are satisfied with the financial results achieved in all business segments. In the third quarter, revenues from services executed in Poland increased by 32% y/y, Fidelta maintains high profitability, and Ardigen maintains the highest growth dynamics in the Group – comments Bogusław Sieczkowski, co-founder, significant shareholder and Chief Executive Officer of Selvita.

In order to ensure the continued dynamic development of the Company in the coming years, we are constantly strengthening our team and investing in research infrastructure. In July this year, we have initiated the construction of Selvita Research Center in Krakow, at the same time, the adaptation of an additional over 2 000 sq m in Zagreb is close to completion, and we also plan to increase the space in our current locations in Krakow and Poznan. We continue to strengthen our research and sales teams because we are convinced that the best employees are key to our success and further development.

Strong growth in contracting across all business segments allows us to be optimistic about the future. We have no intention to slow down and plan to continue to grow organically, as well as through acquisitions, adds Sieczkowski.

Selvita Group’s backlog for 2021 currently sums up to EUR 65.1 million, which indicates an increase of 22% y/y, including the organic backlog (excl. Fidelta) which grew by 29% compared to the same period last year.