On February 17, 2021 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that Michael Kauffman, MD, PhD, Chief Executive Officer, will participate in a fireside chat at SVB Leerink’s 10th Annual Global Healthcare Conference and at the Barclays Global Healthcare Conference (Press release, Karyopharm, FEB 17, 2021, View Source [SID1234575190]). Details regarding these upcoming virtual investor conferences are below.

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SVB Leerink 10th Annual Global Healthcare Conference
Date: Wednesday, February 24, 2021
Time: 1:00 PM Eastern Time

Barclays Global Healthcare Conference
Date: Tuesday, March 9, 2021
Time: 9:10 AM Eastern Time

A live webcast of the fireside chats can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source A replay of the webcast will be archived on the Company’s website for 30 days following each fireside chat.

On February 17, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported it has enrolled the final patient in the recurrent arm of its ongoing Phase 2 clinical study of VAL-083 being conducted at the MD Anderson Cancer Center (MD Anderson) (Press release, Kintara Therapeutics, FEB 17, 2021, View Source [SID1234575207]). The recurrent arm of the study addresses patients suffering from glioblastoma multiforme (GBM) who have been pre-treated with temozolomide (TMZ) prior to disease recurrence. The trial was designed to enroll up to 83 patients (35 patients at 40 mg/m2/day and 48 patients at 30mg/m2/day) to determine whether treatment with VAL-083 improves overall survival.

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"Given the urgent need for improved treatment options for this deadly disease, we are pleased to have reached the very important milestone of full enrollment in the recurrent arm of this Phase 2 clinical study," commented Saiid Zarrabian, Kintara’s Chief Executive Officer. "We would like to thank our patients, their families, and MD Anderson for their participation and continued support for this arm of the trial and of course, for our adjuvant study arm as well. Moving forward, we anticipate reporting topline results from the recurrent arm in the second quarter of calendar 2021."

The Phase 2 trial is an open-label, two-arm, biomarker-driven study testing VAL-083 in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. Efficacy is being measured based on overall survival and progression-free survival. In addition to the recurrent arm, there is a second trial arm that is enrolling up to 36 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ, and who are receiving VAL-083 in place of standard of care TMZ for adjuvant therapy. In November 2020, the Company provided a clinical update on both arms of the study. For the recurrent arm, median overall survival (mOS) for the 77 efficacy evaluable patients who completed at least one cycle of treatment was 7.6 months (confidence interval: CI 6.4-10.6 months). Additionally, for the 43 efficacy evaluable patients initially receiving the 30 mg/m2/day dose that is being evaluated in the Global Coalition for Adaptive Research (GCAR) GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) registrational study, mOS was 8.5 months (CI 6.8-13.7 months). In the adjuvant therapy arm of the study, median progression-free survival (PFS) was 10.0 months (CI 7.6-10.8). Consistent with prior studies, myelosuppression was the most common adverse event with VAL-083 in both the recurrent GBM and adjuvant treatment setting. In the 30 mg/m2/day starting dose cohort (the planned dose for the GBM AGILE pivotal study) three subjects experienced a serious adverse event (SAE) possibly related to VAL-083 in the recurrent group and one patient experienced a possibly drug-related SAE in the adjuvant group.

VAL-083 is a "first-in-class," small molecule bifunctional alkylating agent that crosses the blood-brain barrier. VAL-083 is independent of the MGMT resistance mechanism and has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the U.S. National Cancer Institute (NCI). Published pre-clinical and clinical data indicate that VAL-083 has activity against a range of tumor types, including lung, brain, cervical, ovarian tumors and hematologic (blood) cancers. VAL-083 has been granted Orphan Drug Designation for GBM by the FDA and EMA and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA. In addition, the FDA has granted Fast Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. VAL-083 has not been approved for any indications outside of China.

On February 17, 2021 EMERCell, a biotechnology company developing immunotherapies and cell-based therapies for oncology targets through to pharmaceutical development, reported the signature of a strategic partnership with Onward Therapeutics (Press release, EMERCell, FEB 17, 2021, View Source [SID1234575226]). The significant investment, of a confidential amount, will be made in three instalments that will allow EMERCell to reach the first human clinical trials.

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"We are delighted to partner with Onward Therapeutics, whose teams have recognized expertise in the development of new drugs in oncology and with whom we have strong synergies. Their participation is a recognition of our expertise and will allow us to accelerate our development," said Patrick Henno, founder and Chairman of EMERCell.

"We are pleased to collaborate with EMERCell to scale up their patented process of activation and amplification of the allogeneic NK cells for clinical development," said Dr. C. Grace Yeh, Chairman and CEO of Onward. "Accessing to the highly activated NK cells allows Onward to explore their potentials for improved efficacy in the immunotherapy for cancer patients."

During the last few years, EMERCell, with the support of the Italian company Bioline diagnostici, has developed and patented, in partnership with the University Hospital of Montpellier, the University of Montpellier and Inserm, a process for the production of a therapeutic tool composed of NK cells. EMERCell is now focusing on the development of its first product, NK-001, a new innovative therapy drug (ATMP) for the treatment of cancer.

On February 17, 2021 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its fourth quarter and year-end 2020 financial results on Tuesday, February 23, 2021, before the open of the U.S. financial markets. Clovis’ senior management will host a conference call and live audio webcast at 8:30 a.m. ET to discuss the Company’s results in greater detail.

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The conference call will be simultaneously webcast on the Clovis Oncology website www.clovisoncology.com, and a replay of the webcast will be available for 30 days.

Dial-in numbers for the conference call are as follows: US participants (877) 698-7048, International participants (647) 689-5448, conference ID: 5869256.

On February 17, 2021 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported financial and operating results for the fourth quarter and full year ended December 31, 2020 (Press release, Invitae, FEB 17, 2021, View Source [SID1234575191]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

"Our results in 2020 demonstrate our ability to deliver sustained growth through commercial execution, a diversified global organization and continuous strategic additions to our menu, services and platform," said Sean George, co-founder and chief executive officer of Invitae. "Even amid the challenges of the pandemic, the durability of our relationships and the value of the information we provide to clinicians and patients was clear. As we enter 2021, we are committed to maintaining the pace we’ve set, making it ever-easier to integrate genetic information into healthcare decision-making by clinicians and patients at all stages of life."

Full Year and Fourth Quarter 2020 Financial Results

Generated revenue of $279.6 million in 2020, including $100.4 million in the fourth quarter.
Reported 659,000 in billable test volume in 2020, including 238,000 in the fourth quarter.
Reported average cost per unit of $299 during 2020, and $284 in the fourth quarter. Non-GAAP average cost per unit was $261 for the year and $227 in the fourth quarter.
Reported gross profit of $81.3 million in 2020, including $32.2 million in the fourth quarter. Non-GAAP gross profit was $106.8 million in 2020, and $45.5 million in the fourth quarter.
Total operating expense, excluding cost of revenue, for the full year 2020 was $733.5 million. Operating expense for the fourth quarter of 2020 was $363.7 million. Non-GAAP operating expense was $456.1 million for the full year 2020 and $145.9 million in the fourth quarter.

For the full year 2020, net loss was $608.9 million, or a $4.52 net loss per share. For the fourth quarter of 2020, Invitae reported a net loss of $241.0 million, or a $1.34 net loss per share. Non-GAAP net loss was $373.9 million, or a $2.78 non-GAAP net loss per share in 2020. For the fourth quarter of 2020, Invitae reported a non-GAAP net loss of $113.1 million, or a $0.63 non-GAAP net loss per share.

At December 31, 2020, cash, cash equivalents, restricted cash and marketable securities totaled $360.7 million. Net decrease in cash, cash equivalents and restricted cash was $26.1 million in 2020 and a net increase of $18.4 million for the fourth quarter. Cash burn was $441.1 million in the fourth quarter of 2020, which includes $352.7 million for cash paid for acquisitions, primarily of ArcherDX, and $13.6 million for cash paid for acquisition related expenses. Cash burn for the quarter would have been approximately $74.8 million, which includes $29.1 million of burn by ArcherDX in the fourth quarter, without the acquisition and acquisition-related costs.

Subsequent to the close of the fourth quarter on January 26, 2021, the company announced the sale of approximately 8.9 million shares of its common stock at a price of $51.50 per share, resulting in net proceeds, after underwriting discounts and commissions and offering expenses, of more than $434 million.

Looking ahead to 2021 and factoring in the continued impact associated with the COVID-19 pandemic, Invitae reiterates its stated outlook for revenue growth targets of 50% – 60% annual growth over the next few years consistent with its view at the time of the announcement of the ArcherDX acquisition. Invitae anticipates generating revenue in excess of $450 million in 2021.

This press release contains non-GAAP financial measures. Investors are encouraged to review the non-GAAP reconciliations provided in the tables below.

Full Year Corporate Highlights
Throughout 2020 and into early 2021, the company has maintained its focus on continued development of its menu, services and platform:

Menu
Added microbiome and infectious disease testing capabilities, offering a high-quality, low-cost, end-to-end metagenomics product (sequencing and results) and enabling the development of future offerings in infectious disease, preterm birth and wellness via the acquisition of One Codex.
Established an oncology offering encompassing germline and somatic testing, liquid biopsy and tissue genomic profiling via the Invitae platform through the acquisition of ArcherDX.
Added pharmacogenetic testing, and robust, integrated clinical decision support via the acquisition and integration of Genelex and You Script.
Added non-invasive prenatal screening (NIPS) based on whole genome sequencing (WGS) to the Invitae platform.
Services
Signed 89 biopharma partnership deals in 2020, including 30 biopharma partnership deals in the fourth quarter.
Partnered with a major health system to integrate clinical decision support software for use of pharmacogenetics in patient care.
Introduced routine exome reanalysis to help patients receive accurate diagnoses faster.
Introduced consumer-initiated telehealth genetic testing services in Canada, including carrier testing in early pregnancy, and cancer and cardiovascular inherited risk screening.
Introduced expanded services and support for telemedicine across customer types.
Launched new capabilities for Gia, our advanced clinical chatbot, to support obstetrician/gynecologists, oncologists, genetic counselors and other clinicians who order genetic testing.
Increased support for the use of at-home testing using saliva kits, which do not require an in-person clinician visit.
Provided professional education and support for clinicians transitioning to telehealth.
Platform
Added an industry-leading artificial-intelligence engine to the Invitae variant interpretation framework via the acquisition of Diploid to enable clinical diagnosis using exome and whole genome sequencing in minutes, enhancing Invitae’s capabilities to provide rapid answers to patients while further reducing the cost of genetic testing at scale.
Full Year Scientific Highlights

The company continued to advance research illustrating the broad utility of genetic information in routine clinical care.

Published findings from a multi-year collaboration with researchers at Mayo Clinic that found one in eight patients with cancer had an inherited, cancer-related gene mutation, half of whom would not have been detected using a standard guidelines-based approach and one-third of whom had their therapy changed as a result of their genetics. The data support changing the standard of care to include germline genetic testing for all solid tumor cancer patients.
Announced partnership with Bristol Myers Squibb, Janssen Research & Development, LLC (Janssen), Novartis and Genentech, a member of the Roche Group, to standardize molecular residual disease (MRD) data generation and assessment and to accelerate acute myeloid leukemia (AML) clinical trial programs to help bring novel therapies to patients in need faster.
Published research showing germline genetic testing detects actionable findings missed by tumor-only sequencing, suggesting all cancer patients could benefit from both germline and somatic testing and demonstrating the utility of germline testing in identifying additional treatment options for cancer patients.
Presented data showing one in ten men with prostate cancer harbor genetic changes linked to hereditary cancer syndromes and three-quarters of those patients met criteria for changes in cancer management or treatment based on their genetic findings suggesting broader screening for prostate cancer patients.
Webcast and Conference Call Details
Management will host a conference call and webcast today at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss financial results and recent developments. To register for the conference call and webcast, please use one of the methods below. Upon registering, each participant will be provided with call details and a registrant ID. Reminders will also be sent to registered participants via email.

Online registration: View Source
Phone registration: 833-508-4355 or 415-481-6010

The live webcast of the call and slide deck may be accessed by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.