On September 15, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that two abstracts highlighting proteomic and genomic data based on their diagnostic tests were presented at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC) (Press release, Biodesix, SEP 15, 2021, View Source [SID1234587810]).

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The Role of Serum Proteomic Signature in Predicting Survival by PD-L1 Status in Patients with Non-Small Cell Lung Cancer Receiving Immunotherapy
Session P57 – Predictive Tumor Based Assays/ Biomarkers/ Pathology – ICI Biomarkers
An independent study presented by Leeseul Kim, MD of AMITA Health Saint Francis Hospital Evanston, IL, demonstrated that blood-based proteomic testing (Biodesix, Inc.) predicts survival outcomes in patients with non-small cell lung cancer (NSCLC) receiving an immune checkpoint inhibitor (ICI)-based regimen. The authors point out that while immunotherapy is very effective treating many patients with lung cancer, not all patients with lung cancer benefit.

Turnaround Time and Variant Prevalence of a Blood-based KRAS Test in Patients With NSCLC
Session P24 – Liquid Biopsy and Other Non-invasive Diagnostic Modalities – Targeted Therapy
A study presented by Edgardo Santos, MD, Florida Precision Oncology, Aventura, FL, demonstrated that the blood-based GeneStrat test, focusing specifically on the KRAS G12C/V/D+ testing for this analysis, delivered results to ordering clinicians in under 30 hours on average in two large patient cohorts representing a real-world clinical setting, enabling rapid detection of 3 common KRAS mutations across all stages of NSCLC. Expedited time-to-treatment for patients with actionable driver mutations, now including people with NSCLC that have the KRAS G12C mutation (drug Lumakras (sotorasib), Amgen, Inc.) will improve patient access and overall outcomes to the ever-evolving targeted therapies for eligible patients.

"Our mission is to Improve overall patient outcomes and lower healthcare costs by developing diagnostic solutions that reduce ineffective and unnecessary treatments", said Scott Hutton, CEO, Biodesix. "Additionally, it is always our goal to expedite treatment and remain the leader in turn-around times. These abstracts highlight the effectiveness of our approach in utilizing multiple technologies to determine the best treatment plans as rapidly as possible for patients with lung cancer."

On September 15, 2021 ENcell, a contract development and production company specializing in cell therapy, reported on the 15th that it signed a contract manufacturing agreement (CMO) with Ingenium Therapeutics on the 8th for an incurable leukemia treatment (IGNK001) (Press release, Ingenium Therapeutics, SEP 15, 2021, View Source [SID1234643519]).

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With this consignment production contract, ENcell will carry out turnkey production of 1/2 phase of samples and investigational drugs (IP) required for clinical trial approval (IND) of an anti-leukemia targeted NK cell therapy based on the Memory-like NK platform.

Jong-wook Jang, CEO of ENCell, said, "We will do our best to ensure that Ingenium Therapeutics’ NK cell therapy product successfully enters clinical trials," and added, "We will implement Ingenium Therapeutics’ latest technology with our GMP technology and know-how." "It will contribute to the development of advanced biopharmaceuticals," he said.

On September 15, 2021 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that Johnson Lau, CEO and Board Chairman, and Daniel Lang, Senior Director, Corporate Development will present at the Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit on Wednesday, September 22, 2021 at 10:45 a.m. ET (Press release, Athenex, SEP 15, 2021, View Source [SID1234587731]).

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A live audio webcast of the presentation and replay will be available in the "Events & Presentations" section of the Athenex website at View Source An audio archive of the webcast will also be available on Athenex’s website for the following 90 days.

On September 15, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported its support of legislation recently introduced into the U.S. House of Representatives and the U.S. Senate (Press release, Blue Earth Diagnostics, SEP 15, 2021, View Source [SID1234587765]). The bicameral, bipartisan bill, known as the "Facilitating Innovative Nuclear Diagnostics Act," or the FIND Act of 2021 (H.R. 4479/S. 2609), would reform the current Medicare payment system to improve Medicare beneficiaries’ access to innovative technologies and safeguard appropriate payment to hospitals for innovative diagnostic radiopharmaceuticals.

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The U.S. healthcare system relies on diagnostic imaging radiopharmaceuticals and nuclear medicine to inform patient management and assess disease severity and progression across a wide variety of medical conditions. According to the Society of Nuclear Medicine and Molecular Imaging (SNMMI), more than 20 million Americans benefit each year from nuclear medicine procedures1.

Although diagnostic radiopharmaceuticals are appropriately defined by the U.S. Food and Drug Administration as drugs, the Centers for Medicare and Medicaid Services (CMS) categorizes them as "supplies" by packaging them, after an initial three-year period, alongside nuclear medicine services, into "bundles" for procedures that are conducted in hospital outpatient settings. Bundling payment often reimburses only a fraction of the actual cost of newer diagnostic radiopharmaceuticals and impedes the scientific advancement of new products that can help patients. Procedural bundling results in hospitals not receiving appropriate payment, and patients’ access to advanced diagnostic imaging radiopharmaceuticals may be restricted or denied. The FIND Act, if passed, would help give patients greater access to a wide range of advanced diagnostic radiopharmaceuticals for conditions such as prostate and breast cancers, heart disease, Alzheimer’s and Parkinson’s disease, and neuroendocrine tumors.

"Blue Earth Diagnostics is the recognized leader in diagnostic PET prostate cancer imaging, and in line with our commitment to deliver innovative solutions that inform patient care, we fully support legislative passage of the FIND Act," said Terri Wilson, President, Blue Earth Diagnostics, Inc. "The FIND Act can correct CMS payment policies to provide patients with equity in access and payment, and encourage ongoing development of targeted radiopharmaceuticals that can have transformative effects in patient lives."

Further information about the FIND Act of 2021 is available at www.congress.gov (H.R.4479; S.2609).

On September 15, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported the outcome of the exercise of the warrants of series ALLR TO 3 that were issued in connection with the Company’s issue of units in June 2021 (Press release, Allarity Therapeutics, SEP 15, 2021, View Source [SID1234587827]). In total, 13,719,266 warrants of series TO 3 were exercised, corresponding to approximately 9.5 percent of the total number of outstanding warrants, for subscription of 13,719,266 shares at a subscription price of SEK 1.7 per share. Through the exercise of the warrants, Allarity will receive approximately SEK 23.3 million (U.S. $2.7 million) before issuing costs amounting to approximately SEK 1.4 million.

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UPDATE on the outcome of the exercise of the warrants of series ALLR TO 2 that were issued in connection with the Company’s issue of units in December 2019. In total, 8,820 warrants of series TO 2 were exercised, corresponding to approximately 0.02 percent of the total number of outstanding warrants, for subscription of 8,820 shares at a subscription price of SEK 6.0 per share. Through the exercise of the TO 2 warrants, Allarity will receive approximately SEK 53,000 before issuing costs. The final exercise period for the warrants of series TO 2 took place from September 1 up to and including September 15, 2021.

Chairman of Allarity’s Board of Directors Duncan Moore (who exercised 283,407 warrants) and the Company’s largest shareholder, Sass & Larsen ApS, were among the subscribers.

The exercise period for the warrants of series TO 3 took place from August 30 up to and including September 13, 2021. The accelerated exercise period was established, as previously announced, due to the Board of Directors’ determination that it was in the best interest of all shareholders as part of the Company’s plan to move to the U.S. Nasdaq stock market and to meet the requirements of the previously announced U.S. $20 Million recapitalization investment with 3i LP (New York).

Exercised warrants will be replaced with interim shares, pending registration with the Danish Business Authority. The interim shares are expected to be converted to shares within approximately two (2) weeks. Through the exercise, the number of shares in the Company increase from 390,063,114 shares to 403,791,200 shares, and the share capital increase by DKK 686.404,30, from DKK 19.503.155,70 to DKK 20,189,560,00.