On May 5, 2020 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, reported that it will issue financial results for its fiscal quarter ended March 31, 2020 on Thursday, May 7th, 2020 (Press release, Anavex Life Sciences, MAY 5, 2020, View Source [SID1234561601]).

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!

Management will host a conference call on Thursday, May 7th, 2020 at 4:30pm Eastern Time to review financial results and provide an update on its clinical programs and corporate highlights. Following management’s formal remarks, there will be a question and answer session with equity analysts.

Conference Call / Webcast Information:

The live webcast of the conference call can be accessed online at View Source

To join the conference call, live via telephone, interested parties within the U.S. should dial, toll-free, 1 (866) 939-3921 and international callers should dial 1 (678) 302-3550. Please use confirmation number 49673201, followed by the pound sign (#).

A replay of the conference call will also be available on www.anavex.com.

On May 5, 2020 nvitae Corporation (NYSE: NVTA), a leading medical genetics company, reported financial and operating results for the first quarter ended March 31, 2020 (Press release, Invitae, MAY 5, 2020, View Source [SID1234561380]).

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!

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)

"We started the year with a very strong quarter, delivering record growth in volume and first quarter revenues and giving us strong momentum as we began experiencing impacts from the pandemic. As healthcare has shifted, we have been able to quickly leverage our pre-existing strengths, notably our telehealth offerings and our ability to deliver genetic testing remotely," said Sean George, co-founder and chief executive officer of Invitae. "Looking ahead, our investments in diversified products, services, technologies and geographies mean we are well-equipped to drive growth across an increasing number of customer segments as we drive genetics into mainstream medicine."

First Quarter 2020 Financial Results

Accessioned more than 154,000 samples in the first quarter of 2020, representing a nearly 64% increase over the 94,000 samples in the first quarter of 2019 and more accessioned samples in one quarter than in the full year of 2017. Billable volume exceeded 151,000 in the first quarter of 2020
Generated revenue of $64.2 million in the first quarter of 2020, representing a 58% increase over $40.6 million in revenue in the first quarter of 2019
Reported average cost per sample of $262 in the first quarter of 2020, representing a 16% increase from a $226 average cost per sample in the first quarter of 2019. Average non-GAAP cost per sample was $245 in the first quarter of 2020
Achieved gross profit of $23.8 million in the first quarter of 2020, representing a more than 23% increase from the $19.3 million of gross profit in the first quarter of 2019. Non-GAAP gross profit was $26.5 million in the first quarter of 2020
Total operating expense, excluding cost of revenue, for the first quarter of 2020 was $121.6 million. Non-GAAP operating expense, which excludes amortization of acquired intangible assets and acquisition-related stock-based compensation, was $101.9 million in the first quarter of 2020. Interest and other expense, net and net loss are preliminary and subject to change as we finalize acquisition-related adjustments. These adjustments will be incorporated in Invitae’s Form 10-Q to be filed with the SEC on or before May 11, 2020.

Preliminary net loss for the first quarter of 2020 was $102.2 million, or $1.03 preliminary net loss per share, compared to a net loss of $37.7 million in the first quarter of 2019, or $0.47 net loss per share. Preliminary non-GAAP net loss was $79.8 million in the first quarter of 2020, or $0.80 preliminary non-GAAP net loss per share.

At March 31, 2020 cash, cash equivalents, restricted cash, and marketable securities totaled $301.0 million. Net decrease in cash, cash equivalents and restricted cash for the quarter was $61.0 million. Cash burn, including various acquisition-related expenses, was $98.5 million for the quarter; $66.2 million when excluding $32.3 million cash paid to acquire Diploid.

In April, the company completed a public offering of common stock, resulting in gross proceeds of $184.0 million and $173.0 million in net proceeds after deducting underwriting discounts and commissions and offering expenses.

COVID-19 Impact
Global stay-at-home orders, lockdowns and shutdown of non-emergency healthcare and elective procedures began impacting Invitae during the second half of March. Invitae took a number of steps in response, including:

Ensured operational continuity in all production facilities, monitored and directed by a dedicated response team. Production facilities experienced no disruptions or shortages and remain fully operational
Leveraged pre-existing platforms for Invitae’s highly distributed workforce to ensure a quick transition for non-production employees to remote working
Implemented robust support for clinicians transitioning to telehealth (see below)
The impact of the pandemic on testing volume has and is likely to continue to vary based on clinical area, geography and clinician type. In response, the company has taken a number of steps to reduce cash burn.

The company is continuing to closely monitor the impact of the COVID-19 pandemic and plans to continue to reduce previously communicated cash burn through the remainder of 2020.

Given the unknown duration and extent of COVID-19’s impact on our business, and the healthcare system in general, Invitae has previously withdrawn its 2020 guidance.

Corporate and Scientific Highlights

Introduced expanded services and support for transition to telehealth across customer types
Launched new capabilities for Gia, the advanced clinical chatbot that became part of Invitae through the acquisition and rapid integration of Clear Genetics. New workflows added to Gia 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
Acquired Diploid, developer of an artificial-intelligence engine, 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
Acquired YouScript and Genelex in April 2020 to bring best-in-class pharmacogenetic testing, and robust, integrated clinical decision support to Invitae
Submitted research abstracts to the American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting and the World Congress of Cardiology, which were moved to an online format. Among the data shared:
Among 13 abstracts at ACMG, research from the Invitae Detect Prostate Cancer program that found the frequency of actionable genetic findings was similar across stages of disease severity at approximately 13%. The study found more than half of patients with actionable findings showed no family history of disease and suggests that broadening testing criteria identifies patients with actionable findings with clinical implications, such as qualification for approved therapies or clinical trials.
Research shared via the World Congress of Cardiology included a study showing 96% of individuals with genetically-positive cardiomyopathy would be falsely reassured by a negative result provided by limited genotyping testing strategies available in common direct-to-consumer services. The study also showed that comprehensive genetic testing identifies actionable variants in a substantial portion of cardiology patients which may confer eligibility for gene-specific precision therapies and guide implementation of established management recommendations.
Added 12 new biopharma partnerships, bringing the total number of partnership programs to more than 90
Partnered with the Muscular Dystrophy Association (MDA) to offer the Detect Muscular Dystrophy program in MDA’s network of more than 150 care centers in the United States.
Added Axovant Gene Therapies as a sponsor of the Invitae Detect Lysosomal Disorders program, which offers no-charge genetic testing to facilitate faster diagnoses of lysosomal storage disorders, including Tay-Sachs/Sandhoff disease.
Added Biogen, Encoded Therapeutics, Neurogene, Praxis Precision Medicines and PTC Therapeutics to its sponsored testing partnership program, Behind the Seizure, to expand access to testing for pediatric epilepsy to children under eight who experience an unprovoked seizure.
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. The dial-in numbers for the conference call are (866) 324-3683 for domestic callers and (509) 844-0959 for international callers, and the reservation number for both is 9557177. Please note, after dialing in, you will be prompted to enter the Conference ID and then the pound "#" sign to enter the call. Following prepared remarks, management will respond to questions from investors and analysts, subject to time limitations.

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.

On May 5, 2020 PierianDx, the leading clinical genomics informatics company, and University Hospital of Augsburg reported a strategic development partnership to optimize an interpretation and reporting workflow based on the PierianDx Clinical Genomics Workspace platform for the AmpliSeq for Illumina Myeloid and Focus assays (Press release, PierianDx, MAY 5, 2020, View Source [SID1234558227]). Under the agreement, University Hospital of Augsburg will use the PierianDx Clinical Genomics Workspace to create an out-of-the-box bioinformatics and clinical genomics reporting workflow optimized for these AmpliSeq assays and tailored to the specific needs of the European market.

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!

The AmpliSeq Myeloid and Focus assays accommodate DNA or RNA samples and investigate a number of genes, gene fusions, or expression levels with known relevance to solid- and blood-based cancers. These assays, already in use by University Hospital of Augsburg, are a key part of the hospital’s overall plan to expand its NGS testing program to offer precision medicine treatments to the community it serves.

As assays become more sophisticated, interpretation and reporting have usurped library preparation and sequencing as the most complex portion of the workflow. Manually interpreting each case is simply not scalable, especially with frequently changing literature, guidelines, and clinical trials.

To address these challenges, University Hospital of Augsburg will use the PierianDx Clinical Genomics Workspace, which includes a highly-curated, rules-based knowledgebase and clinical sharing network for the rapid classification of variants. Concurrent to its use of Clinical Genomics Workspace, University Hospital of Augsburg will work with PierianDx on an ongoing basis to refine a European market-specific reporting workflow for the AmpliSeq assays. The result will be a refined clinical genomics report, complete with assay-specific variant filters, that is optimized with European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) guidelines, EMA drug labels, and active and recruiting European clinical trials, all of which have been included in the PierianDx platform since 2019.

Sebastian Dintner, Head of Molecular Pathology, University Hospital of Augsburg, states "We are happy to work with PierianDx to optimize the workflow and pioneer one of the first region-specific reporting solutions for the AmpliSeq assays. By doing so, we will be able to accomplish our mission of expanding our precision medicine offerings to provide advanced cancer care for our patients. "

"As we provide streamlined interpretation and supporting solutions for leading assay manufacturers, it’s imperative that we acknowledge region-specific needs of the market," states Rakesh Nagarajan, Founder, President, and Chief Technology and Visionary Officer of PierianDx. "We are excited to partner with University Hospital of Augsburg because it helps us refine our system for the European market."

On May 5, 2020 Mateon Therapeutics Inc. (OTCQB:MATN) reported that the US Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation for CA4P/ Fosbretabulin for the treatment of of stage IIB–IV melanoma due to genetic mutations that disproportionately affect pediatric patients as a drug for a "rare pediatric disease" (Press release, Mateon Therapeutics, MAY 5, 2020, View Source [SID1234557482]).

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!

"We are excited about this Rare Pediatric Disease designation for our lead anti-melanoma tumor drug candidate for pediatric of stage IIB–IV melanoma patients who are in urgent need for therapeutic innovations", said Dr. Vuong Trieu, Chief Executive Officer of Mateon. "This builds on our previous Rare Pediatric Disease designation for our lead drug candidate for pancreatic cancer and glioblastoma, OT-101, for pediatric brain cancer patients (DIPG). We are looking to continuing to refocus the company efforts in the US to rare pediatric indications, while expanding our footprint to China."

Preclinical studies in which CA4P was combined with an anti-CTLA4 antibody using an EMT-6 mammary tumor model showed that 7 out of 8 mice receiving a combination of CA4P and an anti-CTLA4 antibody experienced complete remission of their tumors, compared to only 1 of 8 in the CA4P monotherapy arm and 2 of 8 in the anti-CTLA4 antibody monotherapy.

CA4P as single agent resulted in 2 Stable Disease (SD) of 5 melanoma patients who failed standard therapies. CA4P combination with carboplatin and paclitaxel resulted in one Partial Response (PR) of 6 melanoma patients who failed first-line therapy with dacarbazine and sorafenib.

Building on the single agent activity of CA4P, we are expecting that combination of CA4P with Ipilimumab or other immune-oncology drug would result in improved tumor control for the target pediatric population above the 2 PR out of 17 patients treated with Ipilimumab alone which supported the approval of Ipilimumab in pediatric melanoma.

The FDA grants rare pediatric disease designation for diseases with serious or life-threatening manifestations that primarily affect people aged from birth to 18 years, and that affect fewer than 200,000 people in the U.S. Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives an approval of a new drug application or biologics license application for a product for the prevention or treatment of a rare pediatric disease may be eligible for a voucher, which can be redeemed to obtain priority review for any subsequent marketing application, and may be sold or transferred. In August 2019, AstraZeneca has reportedly paid approximately $95 million to buy a priority review voucher from Swedish Orphan Biovitrum (Sobi) (View Source). Likewise, Biohaven Pharmaceutical Holding Company Ltd. reportedly paid approximately $105 million for a priority review voucher in March 2019 (View Source).

On May 5, 2020 Immunophage, a Nanjing biotech, reported that it closed a $14 million Pre-A financing, led by Jinfang Hongrui Investment Management, to support its immune-regulating candidates for cancer, autoimmune and neurodegenerative indications (Press release, Nanjing Immunophage Biotech, MAY 5, 2020, View Source [SID1234557192]). The company’s lead cancer projects have dual or multiple anti-tumor properties that pair inhibitors of tumor growth with mechanisms that reverse the tumor’s immunosuppressive environment. IPG1094 inhibits tumor growth and the formation of target-mediated myeloid suppressor cells. IPG7236 inhibits tumor metastasis and tumor-related regulatory T cell infiltration. Immunophage’s R&D operations are in Shanghai’s Caohejing Pujiang High-Tech Park.

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!