On April 27, 2021 Bio-Techne Corporation (NASDAQ:TECH) reported the expansion of the Advanced Cell Diagnostics (ACD), a Bio-Techne brand, RNAscope technology with release of new DNAscope Assays (Press release, Bio-Techne, APR 27, 2021, View Source [SID1234578565]). The RNAscope technology is an advanced in situ hybridization (ISH) assay that enables visualization of single-molecule gene expression with single-cell resolution directly in intact cells and tissues.

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Bio-Techne’s new chromogenic DNA in situ hybridization (ISH) technology, DNAscope, employs the proven "double-Z" probe design and signal amplification system of RNAscope, enabling rapid and flexible probe development for any DNA target, enabling visualization of targets in formalin-fixed paraffin-embedded (FFPE) tissues. DNAscope delivers benefits over current commercial FISH techniques that fall short on morphological detail due to the use of fluorescent nuclear staining and rely on high-resolution microscopes to visualize gene rearrangement and copy number variation signals. Additionally, traditional FISH uses Bacterial Artificial Chromosome (BAC) clone-based probes that are large and tend to span multiple genes and lack single gene detection specificity which limits the scale and development of DNA research.

For accurate and reliable detection of DNA aberrations, the DNAscope chromogenic duplex (red/blue) staining allows researchers to use a standard bright-field microscope to visualize and quantify gene copy number variations (amplifications/deletions) and gene rearrangements/fusions in tissues with spatial and morphological context, at single cell resolution. Unlike most commercially available assays, DNAscope utilizes oligo probes coupled with proprietary signal amplification system to enable high resolution and precise target detection for small genomic regions/single gene locus.

"We are thrilled to expand our leadership in spatial genomic analysis with the launch of DNAscope which together with our RNAscope offering, allows for true multi-omic analysis," commented Kim Kelderman, President of Bio-Techne’s Diagnostics and Genomics Segment. "These new assays provide simple workflows, easy data interpretation and enable faster decision making in critical spatial applications within the DNA ISH market."

The DNAscope Assay kits from Bio-Techne are intended for Research Use Only.

On April 27, 2021 BostonGene Corporation, a biomedical software company focused on defining optimal precision medicine-based therapies for cancer patients, reported a research collaboration with the Medical College of Wisconsin (MCW) to analyze the role of the tumor microenvironment of pancreatic ductal adenocarcinoma (PDAC) in modulating the response to various therapies (Press release, BostonGene, APR 27, 2021, View Source [SID1234578581]).

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MCW, based in Milwaukee, is a distinguished leader and innovator in the education and development of the next generation of physicians, scientists, pharmacists and health professionals. With a mission to improve the health of the communities they serve, MCW discovers and translates new knowledge in the biomedical and health sciences while providing cutting-edge, collaborative patient care of the highest quality.

The research study aims to understand the molecular underpinnings of patients with PDAC treated with various therapies. As part of the collaboration, BostonGene will perform large-scale analytics on next generation sequencing (NGS data), including significant somatic alterations, gene expression patterns and enrichment of signaling pathways from an integrated cohort of PDAC patients. Additionally, BostonGene will apply comprehensive integrated genomic (whole exome sequencing) and transcriptomic (RNA-seq) analysis to characterize and classify the tumor and tumor microenvironment of PDAC patients with localized and metastatic disease and will match defined patterns with clinical outcomes. The results of this study could provide insight into the role of pancreatic cancer microenvironment in response to specific therapies and further improve therapy selection.

"We are pleased to collaborate with BostonGene for their sophisticated analysis of RNA-seq and exome sequencing," said Ben George, MD, William F. Stapp Endowed Chair and Associate Professor of Hematology and Oncology at MCW and Medical Director of the Clinical Trials Office at the Froedtert & MCW Clinical Cancer Center. "By partnering with BostonGene we are one step closer to developing prospective, biomarker-driven clinical trials that could personalize treatment options and improve PDAC patient outcomes."

"We are proud to partner with the Medical College of Wisconsin by bringing our next generation multi-platform analytics to the study of PDAC patients," said Andrew Feinberg, President and CEO at BostonGene. "Our sophisticated NGS analysis will identify the genomic and transcriptional alterations that could serve as predictive biomarkers of response to therapy and improve patient outcomes."

On April 27, 2021 Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) reported that the Annual Report for 2020 now is available at the company’s website: www.calliditas.com (Press release, Calliditas Therapeutics, APR 27, 2021, View Source [SID1234578599]).

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This information is information that Calliditas Therapeutics AB is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 14:30 CET on April 27, 2021.

On April 26, 2021 MannKind Corporation (Nasdaq: MNKD) reported that on April 22, 2021 it and MidCap Financial Trust, as agent, entered into an amendment of the credit and security agreement dated August 6, 2019 (the "MidCap Credit Facility") (Press release, Mannkind, APR 26, 2021, View Source [SID1234578480]). In addition, MannKind and Mann Group, LLC entered into an amendment of the terms of the Mann Group convertible note and repaid in full outstanding amounts under the Mann Group non-convertible note on April 22, 2021. In connection with these transactions, MannKind reduced its outstanding amount of indebtedness, yet retained flexibility to borrow additional amounts under tranche 3 of the MidCap Credit Facility, which is available to borrow until June 30, 2022, subject to the satisfaction of certain milestone conditions associated with Tyvaso DPI.

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The MidCap Credit Facility was amended to modify several terms, including: (i) increasing the funds available in tranche 3, if drawn by the Company, from $25.0 million to $60.0 million; (ii) revising the conditions to drawing tranche 3, including milestone conditions associated with Tyvaso DPI; (iii) providing for an exit fee of $1.0 million in connection with the prepayment described below in lieu of the existing prepayment penalty and exit fees; (iv) removing the requirement to issue a warrant to purchase shares of MannKind’s common stock upon the drawdown of tranche 3; (v) decreasing the interest rate on the remaining outstanding debt; (vi) extending the interest-only period and maturity of term loans under the MidCap Credit Facility; (vii) reducing the minimum cash covenant from $30.0 million to $10.0 million, effective immediately, and eliminating such covenant in the event that Tyvaso DPI is approved by the FDA; (viii) eliminating the requirement to test compliance with the minimum Afrezza net revenue covenant so long as the Company has $90.0 million or more of unrestricted cash; (ix) permitting the Company to make certain acquisitions subject to certain conditions; and (x) permitting the Company to make investments of up to an additional $9.0 million so long as the Company has $90.0 million or more of unrestricted cash following such investment. In connection with the amendment of the MidCap Credit Facility, MannKind prepaid $10.0 million in cash to reduce the principal balance under the MidCap Credit Facility from $50.0 million to $40.0 million.

The Mann Group convertible note was amended to lower the interest rate to 2.5% (from 7.0%), effective April 22, 2021, and to extend the maturity to December 2025 (from November 2024). In addition, MannKind repaid the entire principal amount of $35.1 million outstanding, together with accrued and unpaid interest thereon, under the Mann Group non-convertible note and paid all accrued and unpaid interest outstanding under the Mann Group convertible note.

MannKind also announced that it is evaluating the considerations underlying a potential sale-leaseback of its manufacturing facility in Connecticut, which is being negotiated under a previously announced letter of intent. The Company will update investors regarding its plans for the facility at a future date.

MannKind’s Chief Financial Officer, Steven B. Binder commented, "Starting with the convertible debt offering in March and ending with these debt reductions and restructurings, we have positioned the Company with ample cash and a manageable debt load to fund our near-term priorities, enabling us to focus on the development of our product pipeline, investing behind growing Afrezza and supporting our collaborations."

Further details about both transactions will be provided in a Current Report on Form 8-K filed with the Security and Exchange Commission.

TYVASO DPI is a trademark of United Therapeutics Corporation.

On April 26, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that it will release its financial results for the first quarter 2021 and provide a pipeline update, after the close of market on Monday, May 10, 2021 (Press release, Castle Biosciences, APR 26, 2021, View Source [SID1234578499]).

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Company management will host a conference call and webcast to discuss its financial results and pipeline update at 4:30 p.m. Eastern time on the same day.

Conference Call and Webcast Details

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website (View Source). Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until March 29, 2021.

To access the live conference call via phone, please dial 877-282-2581 from the United States and Canada, or +1 470-495-9479 internationally, at least 10 minutes prior to the start of the call, using the conference ID 6526639.

There will be a brief Question & Answer session following management commentary.