On May 17, 2021 Boundless Bio, a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in aggressive cancers, reported that scientific founders, Paul Mischel, M.D., Roel Verhaak, Ph.D., and Howard Chang, M.D., Ph.D., will participate in an educational session at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Boundless Bio, MAY 17, 2021, View Source [SID1234580164]). The scientists will deliver a series of presentations on Extrachromosomal DNA in Cancer. The session is available to registered conference attendees.

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The session details are as follows:

Session Title: Extrachromosomal DNA in Cancer
Chairperson: Paul Mischel, M.D.
Session Category: ED004
Date and Time: May 21, 2021, 1:45 p.m. – 3:15 p.m. ET

Title: Introduction: Where things are matters: The role of extrachromosomal DNA (ecDNA) in cancer
Presenter: Paul Mischel, M.D., Professor and Vice Chair of Research for the Department of Pathology and Institute Scholar of ChEM-H at Stanford University

Title: Uneven segregation and clustering of extrachromosomal DNA elements
Presenter: Roel Verhaak, Ph.D., Professor and Associate Director of Computational Biology at The Jackson Laboratory

Title: Control of cancer genes beyond chromosomes
Presenter: Howard Chang, M.D., Ph.D., Virginia and D.K. Ludwig Professor of Cancer Genomics and Genetics at Stanford University and Howard Hughes Medical Institute Investigator

Title: Plasticity of extrachromosomal and intrachromosomal BRAF amplifications in mediating targeted therapy dosage challenges
Presenter: Thomas Graeber, Ph.D., Professor of Molecular and Medical Pharmacology and Director of the Metabolomics Center at UCLA

About ecDNA
Extrachromosomal DNA, or ecDNA, are distinct circular units of DNA lacking centromeres but containing functional genes, including oncogenes, that are separated from tumor cell chromosomes. ecDNA replicate within cancer cells and can be passed to daughter cells asymmetrically during cell division, thereby constituting a primary driver of focal gene amplification and copy number heterogeneity in cancer. By leveraging the plasticity afforded by ecDNA, cancer has the ability to increase or decrease copy number of select oncogenes located on ecDNA to enable survival under selective pressures, including chemotherapy, targeted therapy, immunotherapy, or radiation, making ecDNA one of cancer cells’ primary mechanisms of recurrence and treatment resistance. ecDNA are not found in healthy cells but are present in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes.

On May 17, 2021 Asgard Therapeutics reported that it was shortlisted as a finalist of the 2021 Merck EU Advance Biotech Grants Program (Press release, Asgard Therapeutics, MAY 17, 2021, View Source [SID1234580109]). This program aims to support emerging biotech companies pushing innovative drugs to the market by allowing grant recipients to receive free products and services.

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On May 17, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that it will host a virtual investor update event on Wednesday, May 26, 2021 (Press release, Hutchison China MediTech, MAY 17, 2021, View Source [SID1234580125]). Members of the senior management team will provide updates on product launches in China, preparations for US commercialization, R&D, as well as a review of new data presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Analysts and investors are invited to join a conference call and audio webcast presentation. The event will take place at 8:00 a.m. Eastern Daylight Time / 1:00 p.m. British Summer Time (BST) / 8:00 p.m. Hong Kong Time (HKT) on Wednesday, May 26. A first Q&A session will immediately follow the prepared remarks. For Asian investors, a recording of the webcast will be available for viewing the following morning and a second Q&A session will start at 12:00 noon HKT on Thursday, May 27.

The event will be webcast live and can be accessed at www.hutch-med.com/event. Investors interested in listening to the live webcast should log on before the start time to download any software required. A replay of the event will be available shortly thereafter for approximately 90 days.

On May 17, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported financial results for the three months ended March 31, 2021 and provided a business update (Press release, Onconova, MAY 17, 2021, View Source [SID1234580149]).

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Highlights for the first quarter of 2021 and subsequent weeks include:

The Phase 1 solid tumor study with ON 123300 in China is ongoing with no dose-limiting toxicities observed in the first two cohorts. Enrollment to the third cohort (120 mg) will now proceed.
The Phase 1 study with ON 123300 in the United States is open for enrollment, and actively screening patients.
The first patient has been dosed in an investigator-initiated Phase 2 study designed to assess the efficacy and safety of rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB)-associated locally advanced/metastatic squamous cell carcinoma (SCC).
The investigator-initiated Phase 1/2 study evaluating rigosertib in combination with the checkpoint inhibitor nivolumab in KRAS mutated non-small cell lung cancer has progressed nicely and has reached the maximum dose of oral rigosertib per the current protocol.
The Company strengthened its balance sheet with net proceeds of $35.2 million from two equity offerings; cash and cash equivalents as of March 31, 2021 were $48.0 million. The Company believes it has more than 18 months of cash runway.
Management Commentary

"We are off to a strong start in 2021 and remain focused on advancing our clinical programs, in particular with our lead product candidate ON 123300, a multi-kinase inhibitor that potently targets CDK 4 and 6, which are overexpressed in a number of cancers, including HR+ HER 2- metastatic breast cancer, a potential blockbuster commercial opportunity," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "We are delighted that our partner in China, HanX Biopharmaceuticals, is expected to begin the third cohort of their Phase 1 study at 120 mg per dose and that ON 123300 appears to be well tolerated with no dose-limiting toxicities observed to date. Notably, the HanX study is dosing patients on days 1 to 21 of 28-day cycles, while the U.S. Phase 1 study will be investigating a continuous daily dosing regimen. Collectively, we expect these complementary studies to generate important safety data that will inform the design of subsequent trials and potentially provide preliminary signals of efficacy in patients with advanced cancer."

Dr. Fruchtman continued, "Alongside the progress made with our lead product candidate, we have also seen advancements in several investigator-initiated trials evaluating rigosertib. The first patient was recently dosed in a Phase 2 trial evaluating rigosertib monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa, a disease with a critical unmet medical need. Additionally, the Phase 1/2 study evaluating rigosertib in combination with the checkpoint inhibitor nivolumab in KRAS mutated non-small cell lung cancer continues to progress and has reached the highest dose per the current protocol. We expect to continue leveraging our relationships with leading cancer centers and industry collaborators to advance these trials and commence additional investigator initiated studies in RAS-driven cancers in combination with checkpoint inhibitors. We expect such an approach to facilitate our near- and long-term growth by allowing us to preserve our primary focus and resources on ON 123300 while simultaneously pursuing opportunities to develop rigosertib in high unmet need indications."

First Quarter Financial Results

Cash and cash equivalents as of March 31, 2021 were $48.0 million, compared with $19.0 million as of December 31, 2020. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for more than 18 months.

Research and development expenses were $1.9 million for the first quarter of 2021, compared with $3.4 million for the first quarter of 2020. The decrease was primarily related to lower expenses for the oral rigosertib combination program and the completed Phase 3 INSPIRE study in the 2021 period.

General and administrative expenses were $2.2 million for the first quarter of 2021, compared with $1.8 million for the first quarter of 2020. The increase was primarily related to higher special stockholder meeting by proxy expenses and insurance costs in the 2021 period.

Net loss for the first quarter of 2021 was $4.7 million, or $0.02 per share on 219.2 million weighted average shares outstanding, compared with a net loss for the first quarter of 2020 of $5.1 million, or $0.03 per share on 160.3 million weighted average shares outstanding.

Conference Call and Webcast

Onconova will host an investment community conference call today beginning at 4:30 p.m. Eastern time, during which management will discuss financial results for the first quarter of 2021, provide a business update and answer questions. Interested parties can participate by dialing (855) 428-5741 (domestic callers) or (210) 229-8823 (international callers) and using conference ID 4895447.

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.

On May 17, 2021 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that Jim Clemmer, President and Chief Executive Officer, will present at the UBS Virtual Global Healthcare Conference at 12:00 p.m. ET on Tuesday, May 25, 2021 (Press release, AngioDynamics, MAY 17, 2021, View Source [SID1234580165]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the presentation will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.