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Pieris Pharmaceuticals to Host Full-Year 2020 Investor Call and Provide Corporate Update on March 30, 2021

On March 23, 2021 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that it will host a full-year 2020 investor call on Tuesday, March 30, 2021 at 8:00 AM EDT to discuss financial results and provide a corporate update (Press release, Pieris Pharmaceuticals, MAR 23, 2021, View Source [SID1234577037]).

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To access the call, participants may dial 877-407-8920 (Toll Free US & Canada) or 412-902-1010 (International) at least 10 minutes prior to the start of the call.

An archived replay of the call will be available for 30 days by dialing 877-660-6853 (Toll Free US & Canada) or 201-612-7415 (International) and providing the Conference ID #13661472.

Vincerx Pharma Reports Fourth Quarter and Full Year 2020 Financial Results and Provides a Corporate Update

On March 23, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported financial results for the fourth quarter and full year, ended December 31, 2020, and provided a corporate update (Press release, Vincerx Pharma, MAR 23, 2021, View Source [SID1234577036]).

"Over the past months, Vincerx has completed transformative milestones; licensing a compelling oncology pipeline from Bayer, launching as a public company, and strengthening our already proven leadership team," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "These accomplishments, in combination with our strong balance sheet, leave us well positioned as we prepare to launch Phase 1b studies of VIP152, our highly selective and potent CDK9 inhibitor, in Myc-driven hematologic malignancies and solid tumors, as well as relapsed/refractory chronic lymphocytic leukemia. With robust preclinical on-mechanism activity, and compelling early signals of Phase 1 clinical activity in challenging patient populations, including those with double-hit DLBCL, we are confident that VIP152 represents a compelling and differentiated opportunity."

Dr. Hamdy continued, "In addition to this clinical progress, we have in parallel continued to develop our preclinical bioconjugation platform, consisting of our next-generation antibody-drug conjugates which have the potential to overcome limitations of currently approved ADCs and our innovative small molecule drug conjugate, which will have data presented at AACR (Free AACR Whitepaper). We are excited to embark on this new phase of development and look forward to continued execution in 2021 across our strategic clinical program with VIP152, a potential best-in-class asset with multiple Accelerated Approval opportunities."

Corporate Highlights

Announced exclusive license agreement with Bayer AG for oncology portfolio including VIP152, a highly selective PTEFb/CDK9 inhibitor with encouraging Phase 1 monotherapy activity, including complete responses in DH-DLBCL, as well as a preclinical bioconjugation platform designed to overcome limitations of small-molecule and antibody-drug conjugates used to treat cancer
Announced completion of business combination transaction with LifeSci Acquisition Corp. on December 23, 2020, and listing on Nasdaq, with net proceeds of approximately $62 million
VIP152 IND officially transferred from Bayer to Vincerx
Appointed Hermes Garbán, M.D., Ph.D., as Chief Medical Officer
Appointed Hans-Georg Lerchen, Ph.D., as Chief Scientific Officer
Appointed Tom Thomas, as General Counsel and Chief Legal Officer
Announced presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 with preclinical data for the Company’s small molecule drug conjugate in development for the treatment of multiple cancer types
Hosted Key Opinion Leader Webinar on VIP152 for the treatment of solid tumors with presentations by KOLs Ian Flinn, M.D., Ph.D., Director of Sarah Cannon Center for Blood Cancer, John Byrd, M.D., D. Warren Brown Chair of Leukemia Research, The Ohio State University Comprehensive Cancer Center, and Howard "Skip" Burris III, M.D., President and Chief Medical Officer of Sarah Cannon, who discussed the CDK9 inhibitor landscape with Vincerx management providing details on the development plan for VIP152
Fourth Quarter and Full Year 2020 Financial Results

Vincerx Pharma ended the fourth quarter with $61.8 million in cash and cash equivalents. Net cash used in operations was $2.3 million for the twelve months ended December 31, 2020.
Net loss for the year ended December 31, 2020 was $10.7 million, which is comprised primarily of a $5.0 million license fee in connection with the Bayer license agreement and $4.4 million of stock-based compensation.
Research and development (R&D) expenses were $2.1 million for the year ended December 31, 2020, consisting primarily of stock-based compensation.
General and administrative (G&A) expenses were $3.6 million for the year ended December 31, 2020, consisting primarily of stock-based compensation of $2.3 million and approximately $1.0 million of legal and professional services incurred in connection with the Bayer license agreement and business combination.

Plus Therapeutics Enters Into Master Services Agreement with Piramal Pharma Solutions, a Leading Contract Development and Manufacturing Organization

On March 23, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, reported that it has entered into a master services agreement (MSA) with Piramal Pharma Solutions (PPS) for the development, manufacture, and supply of Plus’ Rhenium NanoLiposome (RNL) intermediate drug product (Press release, Cytori Therapeutics, MAR 23, 2021, View Source [SID1234577035]).

The MSA includes the transfer of analytical methods, development of microbiological methods, process transfer and optimization, intermediate drug product manufacturing and stability studies. The transfer will be performed at PPS’s drug product facility in Lexington, Kentucky. Plus anticipates that the MSA will lead to clinical and commercial supply agreements for the drug product at the appropriate stage of development.

PPS’s Lexington site is recognized as a North American leader in formulation development and manufacture of sterile parenteral drug products.

"This agreement represents another significant milestone for Plus as we work to advance development of RNL as a novel treatment option for patients diagnosed with glioblastoma," said Marc Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "The team at PPS has the knowledge, experience and expertise to support our needs, both now and in the future as we advance RNL towards regulatory approval."

"We are thrilled to enter into this agreement with Plus Therapeutics," said Peter DeYoung, Chief Executive Officer of Piramal Pharma Solutions. "Our expectation is that this MSA represents the start of a long, mutually beneficial relationship that will address our ultimate collective objective of reducing the burden of disease on patients."

BioNTech to Report Full Year Financial Results for 2020 and Provide Corporate Update on the Fourth Quarter on March 30, 2021

On March 23, 2021 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported its financial results for the fourth quarter 2020 on Tuesday, March 30th, 2021. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CET) to report its financial results and provide a corporate update on the fourth quarter and full year 2020 (Press release, BioNTech, MAR 23, 2021, View Source [SID1234577034]).

The slide presentation and audio of the webcast will be available via the following link: View Source

To participate in the conference call, please dial the following numbers ten minutes prior to the start and provide the Conference ID:

Participants may also access the slides and the webcast of the conference call via the "Events & Presentations" page of the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

Bio-Techne’s Exosome Diagnostics Laboratory Announces CE-IVD Certification For ExoDx Prostate Test

On March 23, 2021 Bio-Techne Corporation (NASDAQ:TECH) reported that Exosome Diagnostics, a Bio-Techne brand, has completed its clinical validation of an in vitro diagnostic (IVD) version of the ExoDx Prostate test (EPI) kit enabling self-certification as CE-IVD as of March 22, 2021 (Press release, Bio-Techne, MAR 23, 2021, View Source [SID1234577033]). The EPI-CE test will be performed immediately in our Munich ISO 15189 accredited clinical laboratory and be made available throughout Europe through various distribution channels.

Exosome Diagnostics is the world leader in developing exosomal liquid biopsy-based diagnostic assays. The EPI test is a non-invasive, urine-based genomic test that helps inform the prostate biopsy decision. This liquid biopsy test continues to expand its presence and usage among urologists and primary care physicians in the US. The EPI test is a risk assessment tool that assists physicians and their patients with determining if a prostate biopsy is needed when presented with an ambiguous PSA test result, thereby reducing complications from unnecessary and invasive procedures. The EPI-CE test demonstrated comparable results to the US ExoDx Prostate test with high sensitivity of 92% and high negative predictive value (NPV) of 89% for ruling out clinically significant prostate cancer.

These findings can have significant implications for both clinical and economic outcomes. According to Alexander Kretschmer, M.D., Assistant Professor of Urology at Ludwig-Maximilians-University Munich, "From a clinical perspective, deferring biopsy can help a patient avoid the undesirable complications from a biopsy, such as pain, hematuria, infection and potentially hospitalization. Many patients are frightened to undergo the biopsy procedure; however, introducing an EPI test can identify which patients should proceed to biopsy, and which patients can avoid biopsy, so it’s really about performing the procedure for the right patient at the right time."

"The EPI test could have important implications from an economic perspective in Europe and the UK," commented Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "Avoiding unnecessary biopsy procedures represents an estimated savings to the healthcare system in Europe of more than €1,000 per patient, in addition to added costs for treating complications. There are economic consequences to missing high grade prostate cancer as well. Risk stratification tools such as the ExoDx Prostate test can help appropriately guide clinicians to treat the highest risk patients earlier. We look forward to enabling European men to make more informed decisions on whether to proceed with an invasive, and potentially dangerous, prostate biopsy."