ImmunoPrecise Announces Participation at the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021 (Virtual Conference)

On March 4, 2021 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA) (TSXV: IPA), a leader in full-service, therapeutic antibody discovery and development, reported that it will be presenting at the H.C. Wainwright Global Life Sciences Conference being held virtually on March 9-10, 2021 (Press release, ImmunoPrecise Antibodies, MAR 4, 2021, View Source [SID1234576077]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Jennifer Bath, CEO of ImmunoPrecise, will provide an overview of the Company’s business during the live presentation and will be available to participate in one-on-one meetings with investors who are registered to attend the conference.

If you are an institutional investor, and would like to attend the Company’s presentation, please click on the following link (View Source) to register for the conference. Once your registration is confirmed, you will be prompted to log into the conference website to request a one-on-one meeting with the Company.

Event: H.C. Wainwright Global Life Sciences Conference (Virtual Conference)

Date: March 9-10, 2021

Presentation Day & Time: The pre-recorded presentation will be available on-demand starting March 9 at 7:00 A.M. (EST).

H.C. Wainwright is a full‐service investment bank dedicated to providing corporate finance, strategic advisory and related services to public and private companies across multiple sectors and regions. H.C. Wainwright & Co. also provides research and sales and trading services to institutional investors. According to Sagient Research Systems, H.C. Wainwright’s team is ranked as the #1 Placement Agent in terms of aggregate CMPO (confidentially marketed public offering), RD (registered direct offering) and PIPE (private investment in public equity) executed cumulatively since 1998.

About IPA’s PolyTope Platform.

IPA’s SARS-CoV-2 PolyTope monoclonal therapies are designed to protect against mutagenic escape with an emphasis on efficacy for every patient, variant, and strain of SARS-CoV-2. They are created with the goal of sustainable efficacy in the face of an evolving virus, combining extensively characterized, potently neutralizing, synergistic antibodies exhibiting richly diverse epitope coverage.

ERYTECH to Host Fourth Quarter and Full Year 2020 Conference Call and Business Update

On March 4, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that it will host its fourth quarter and full year 2020 conference call and webcast on Tuesday, March 9, 2021, at 2:30 PM CET/8:30 AM ET to discuss operational highlights (Press release, ERYtech Pharma, MAR 4, 2021, View Source [SID1234576093]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Checkpoint Therapeutics to Participate in H.C. Wainwright Global Life Sciences Virtual Conference

On March 4, 2021 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that James Oliviero, President and Chief Executive Officer, will participate in the H.C. Wainwright Global Life Sciences Virtual Conference, taking place March 9-10, 2021 (Press release, Checkpoint Therapeutics, MAR 4, 2021, View Source [SID1234576109]). The company’s presentation will be available for on-demand viewing beginning on Tuesday, March 9, 2021, at 7:00 a.m. ET, on the Events page, located within the Investors section of Checkpoint’s website, View Source, for approximately 30 days.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!


ViewRay Reports Fourth Quarter and Full Year 2020 Results

On March 4, 2021 ViewRay, Inc. (Nasdaq: VRAY) (the "Company") reported financial results for the fourth quarter and year ended December 31, 2020 (Press release, ViewRay, MAR 4, 2021, View Source [SID1234576125]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Full Year 2020 Highlights

Total revenue of $57.0 million primarily from nine revenue units, including two system upgrades, compared to 2019 revenue of approximately $87.8 million, primarily from 15 revenue units, including two system upgrades.
Received 17 new orders for MRIdian systems, including two upgrades, totaling $94.6 million, compared to 22 new orders, including three upgrades, totaling $118.5 million in 2019.
Total backlog increased to $241.3 million as of December 31, 2020, compared to $227.3 million as of December 31, 2019.
Cash and cash equivalents were $156.7 million as of December 31, 2020. Cash burn in the fourth quarter of 2020 was approximately $7.2 million.
Fourth Quarter 2020 Highlights

Total revenue of approximately $18.5 million in the fourth quarter of 2020, primarily from three revenue units including one system upgrade, compared to total revenue of approximately $16.5 million, primarily from three revenue units including one system upgrade, in the fourth quarter of 2019.
Received five new orders for MRIdian systems totaling $24.0 million in the fourth quarter of 2020, compared to four new orders totaling $21.2 million in the fourth quarter of 2019.
2021 Public Offering of Common Stock

In January 2021, the Company raised aggregate net proceeds of approximately $53.5 million after deducting the underwriting discounts, commissions, and estimated offering expenses via a public offering in which 11,856,500 shares of our common stock were issued and sold, including the full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $4.85 per share.
"We are pleased with our solid fourth quarter and full year 2020 results despite the ongoing impact of the COVID-19 pandemic. Our recently bolstered balance sheet, coupled with our clinical, strategic, and economic value propositions, have positioned us well for 2021 and beyond," said Scott Drake, President and CEO. "Innovation is the hallmark of ViewRay, and our pipeline is focused on sub-20 minute treatment times, improved workflow and efficiency, and cost reduction. By protecting and extending our innovation lead, we are improving the lives of cancer patients worldwide."

Financial Results

Total revenue for the three months ended December 31, 2020 was $18.5 million compared to $16.5 million for the same period last year. Total revenue for the full year 2020 was $57.0 million compared to $87.8 million for the full year 2019.

Total cost of revenue for the three months ended December 31, 2020 was $18.3 million compared to $20.4 million for the same period last year. Total cost of revenue was $61.1 million for the full year 2020 compared to $93.3 million for the full year 2019.

Total gross margin for the three months ended December 31, 2020 was $0.2 million, compared to a gross margin of $(3.9) million for the same period last year. Total gross margin for the full year 2020 was $(4.1) million compared to $(5.5) million for the full year 2019.

Total operating expenses for the three months ended December 31, 2020 were $25.5 million, compared to $28.5 million for the same period last year. Total operating expenses for the full year 2020 were $101.9 million compared to $115.3 million for the full year 2019.

Net loss for the three months ended December 31, 2020 was $26.1 million, or $0.18 per share, compared to $35.2 million, or $0.31 per share, for the same period last year. Net loss for the full year 2020 was $107.9 million, or $0.73 per share, compared to $120.2 million, or $1.18 per share, for the full year 2019.

ViewRay had total cash and cash equivalents of $156.7 million at December 31, 2020.

Financial Guidance

Due to the ongoing impact and uncertainty of the COVID-19 pandemic globally, the company will not be providing financial guidance at this time.

Conference Call and Webcast

ViewRay will hold a conference call to discuss results on Thursday, March 4, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The conference ID number is 5976583. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available until March 11, 2021. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 5976583.

Kronos Bio Announces Positive End-of-Phase 2 Meeting with FDA for Entospletinib in Newly Diagnosed NPM1-mutated Acute Myeloid Leukemia (AML)

On March 4, 2021 Kronos Bio, Inc. (Nasdaq: KRON) reported, following receipt of minutes from its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), that the company will proceed with its plan to assess measurable residual disease (MRD) negative complete response (CR) as the primary endpoint in a registrational Phase 3 trial to support potential accelerated approval of entospletinib in patients newly diagnosed with NPM1-mutated acute myeloid leukemia (AML) (Press release, Kronos Bio, MAR 4, 2021, View Source [SID1234576147]). The company plans to initiate the Phase 3 trial in mid-2021, with MRD negative CR data expected in the second half of 2023.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Even with current therapies, about half of patients with newly diagnosed NPM1-mutated AML will die from the disease within five years. Given this urgent need, we are pleased with the outcome of the FDA meeting and look forward to initiating our Phase 3 trial to establish the benefit of entospletinib, in combination with chemotherapy, as a frontline treatment for NPM1-mutated AML," said Norbert Bischofberger, Ph.D., president and CEO of Kronos Bio. "As the first AML trial to use MRD negative CR as a primary endpoint, our trial is breaking new ground that may help deliver effective, targeted therapies more expeditiously to patients living with this devastating disease."

MRD is a term that describes small numbers of leukemic cells that are still detectable during or after treatment, even when a patient has achieved CR by standard criteria. Remaining leukemia cells in the body can become active and start to multiply, resulting in a relapse of the disease, which is fatal for the majority of patients. Achieving MRD negativity, which is associated with longer remissions and improved survival, means that a treatment has reduced the number of leukemic cells to below the limit of detection by the most sensitive analytical methods.

"MRD has been used as a surrogate endpoint for approvals in other forms of leukemia but not for AML, in part due to the requirement for a unique marker that can be used to track rare residual leukemia cells. In the case of NPM1-mutated AML, the mutated gene itself provides that unique marker," said John Byrd, M.D., D. Warren Brown Chair of Leukemia Research and Distinguished University Professor at The Ohio State University Comprehensive Cancer Center and chief medical officer of the Leukemia & Lymphoma Society’s Beat AML Master Trial. "The association between MRD negativity and improved survival in patients with NPM1-mutated AML is well established in the literature. Based on this body of evidence, AML experts around the world recommend monitoring MRD in patients with NPM1 mutation to guide treatment decisions. The best opportunity to achieve long-lasting remission and extend survival is to achieve MRD negativity with the first attempt at treatment."

Kronos Bio’s global, randomized, double-blind, placebo-controlled Phase 3 trial is designed to assess the efficacy and safety of entospletinib in approximately 180 adults who have been newly diagnosed with NPM1-mutated AML. Patients will be randomized to receive entospletinib or placebo, in combination with standard induction and consolidation chemotherapy, for a minimum of two cycles. The primary endpoint of the trial will be MRD negative CR as measured by next-generation sequencing, which affords a high degree of sensitivity to detect MRD. Event-free survival (EFS) will be a key secondary endpoint, and mature EFS data will be used to support potential full approval.

About Acute Myeloid Leukemia (AML)
Acute myeloid leukemia (AML) primarily affects adults and is one of the most difficult-to-treat blood cancers. AML starts in the bone marrow and can quickly move to the blood and other parts of the body including the lymph nodes, spleen and central nervous system. Approximately 20,000 Americans are diagnosed with AML each year,1 with the NPM1 genetic mutation found in approximately 30% of cases.2 Relapse in AML is common,3 and despite available treatments, nearly 11,000 Americans will die from the disease each year.1

About Entospletinib
Kronos Bio is developing entospletinib for the frontline treatment of NPM1-mutated acute myeloid leukemia (AML). Entospletinib is a selective inhibitor targeting spleen tyrosine kinase (SYK), a critical node in a dysregulated transcription regulatory network within AML defined by persistent high expression of the transcription factors HOXA9 and MEIS1 (HOX/MEIS).4 Multiple AML driver mutations, including NPM1 and MLL gene rearrangements, have been associated with elevation of HOX/MEIS.5,6 Entospletinib has been investigated in more than 700 patients with a variety of hematologic malignancies, including AML, with clinical results observed in AML patients with NPM1 mutations and MLL rearrangements that support further development of the therapy.6,7