Christopher Flores, PhD appointed as President and Chief Research and Development Officer of Doloromics, Inc.

On November 8, 2021 Doloromics has reported the appointment of Dr. Chris Flores as their new President and Chief Research and Development Officer (Press release, Lifescience Newswire, NOV 8, 2021, View Source [SID1234594729]). In this role, Dr. Flores will be responsible for leading the Doloromics portfolio of drug discovery and development programs, two of which are scheduled to launch in early 2022, while building relationships with strategic partners and collaborators in support of these efforts.

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"After an extensive and diverse experience in the Pharmaceutical and Consumer sectors of Johnson & Johnson, I’m both thrilled and privileged to commit the full measure of my expertise and passion in executing the core mission of Doloromics, to eradicate pain in patients who remain tragically underserved by current standards of care." — Chris Flores, PhD.

Dr. Flores will complement the Doloromics leadership team after a successful, 19-year career at Johnson & Johnson, where he held several executive positions, including Vice President of Neuroscience, La Jolla R&D Site Head, Pain Franchise Strategy Leader, Head of Pain Discovery and Global External Innovation Head of Discovery Sciences within Janssen Research & Development as well as Head of Emerging Science and Innovation Strategy for J&J Consumer Companies.

Invitae Reports $114.4 Million in Revenue Driven by 296,000 in Billable Volume in Third Quarter of 2021

On November 8, 2021 Invitae (NYSE: NVTA), a leading medical genetics company, reported financial and operating results for the third quarter ended September 30, 2021 (Press release, Invitae, NOV 8, 2021, View Source [SID1234594728]).

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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)

"Year-over-year growth continued at a fast pace in the third quarter as volumes remained strong across the platform," said Sean George, Ph.D., co-founder and CEO of Invitae. "In particular, progress in the oncology group is reflected in current volumes and preparations for high-value, high-margin product introductions over the coming year, supported by multiple ongoing studies. We saw continued progress in our data and platform services, underscored by the integration of Medneon and the Ciitizen technology platform that bolster our ability to collect, house and deliver benefits from patient data collected on their behalf. We look forward to continued robust volume growth in the coming periods as we introduce new testing capabilities and increase access to our lifelong testing and data platform."

Third Quarter 2021 Financial Results

Generated revenue of $114.4 million in the quarter, a more than 66% increase compared to $68.7 million in the same period in 2020.
Reported billable volume of 296,000 in the quarter, approximately 89% increase compared to 157,000 in the same period in 2020.
Reported average cost per billable unit of $296 in the quarter compared to $297 average cost per billable unit in the same period in 2020. Non-GAAP average cost per unit was $249 in the quarter.
Achieved gross profit for the third quarter of 2021 of $26.7 million, compared to $22.1 million in the same period in 2020. Non-GAAP gross profit was $40.7 million in the third quarter.
Total operating expense, which excludes cost of revenue, for the third quarter of 2021 was $220.0 million compared to $102.9 million in the same period in 2020. Non-GAAP operating expenses for the quarter was $201.8 million.

Net loss for the third quarter of 2021 was $198.2 million, or a $0.91 net loss per share, compared to a net loss of $102.9 million, or a $0.78 net loss per share, in the third quarter of 2020. Non-GAAP net loss for the quarter was $175.9 million, or a $0.81 non-GAAP net loss per share.

At September 30, 2021, cash, cash equivalents, restricted cash and marketable securities totaled $1.25 billion as compared with $1.54 billion as of June 30, 2021. Net increase in cash, cash equivalents and restricted cash for the quarter was $186.1 million. Cash burn was $286.0 million for the quarter. Cash burn for the quarter would have been $148.1 million excluding the cash paid for acquisitions, primarily related to the cash paid to acquire Medneon and Ciitizen.

Corporate and Scientific Highlights

Acquired patient-centric consumer health tech company Ciitizen to enhance Invitae’s platform by providing patients an easy-to-use, centralized hub for their genomic and clinical information, which together comprise a powerful dataset with the potential to drive research and improve healthcare decision-making.
Announced new data from the TRACERx lung cancer research collaboration. The data further validate the value of liquid biopsy as a less invasive and more comprehensive approach to guiding personalized cancer treatment. The data underscore previous findings from the TRACERx cohort that monitoring for cancer circulating tumor DNA (ctDNA) based minimal residual disease (MRD) detected relapse of non-small cell lung cancer (NSCLC) up to three years earlier than standard of care imaging surveillance in some instances.
Presented research demonstrating that genetic findings informed clinical management changes that led to improved seizure control and outcomes in the majority of epilepsy patients with actionable findings. The findings were presented in September at the National Society of Genetic Counselors 40th Annual Conference.
Outlook and Guidance
The company has adjusted its 2021 annual revenue guidance to $450 million – $475 million, or year-over-year revenue growth of between 60% and 70%. The change in revenue outlook was primarily due to greater than expected seasonal impact in Q3.

Webcast and Conference Call Details
Management will host a conference call and webcast today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss financial results and recent developments. To access the conference call, please register at the link below:

View Source

Upon registering, each participant will be provided with call details and a conference ID.

The live webcast of the call and slide deck may be accessed here or 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.

InDex Pharmaceuticals presents at Redeye Life Science Day 2021

On November 8, 2021 InDex Pharmaceuticals Holding AB (publ) reported that CEO Peter Zerhouni will present the company at Redeye Life Science Day 2021 on November 11 at 09.00 CET (Press release, InDex Pharmaceuticals, NOV 8, 2021, View Source [SID1234594727]). The presentation will be livestreamed and can be followed at View Source." target="_blank" title="View Source." rel="nofollow">View Source

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The presentation will also be available afterwards on View Source, on the company’s page in Redeye Universe (www.redeye.se/company/index-pharmaceuticals), as well as on InDex’s website (View Source).

IGM Biosciences to Present at the Stifel 2021 Virtual Healthcare Conference

On November 8, 2021 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that management will participate in a fireside chat at the Stifel 2021 Virtual Healthcare Conference on Monday, November 15, 2021 at 2:00 p.m. EST (Press release, IGM Biosciences, NOV 8, 2021, View Source [SID1234594726]).

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

Ichnos Sciences Welcomes Eric Feldman, M.D., as New Chief Medical Officer

On November 8, 2021 Ichnos Sciences Inc., a global biotechnology company developing innovative biologic treatments in oncology and autoimmune diseases, reported the appointment of Eric J. Feldman, M.D., to the position of Chief Medical Officer (CMO), effective immediately (Press release, Ichnos Sciences, NOV 8, 2021, View Source [SID1234594725]).

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Dr. Feldman, who reports to President and Chief Executive Officer Cyril Konto, M.D., will be responsible for all pipeline development activities, including Clinical Development, Clinical Operations, Regulatory Sciences, Pharmacokinetics and Translational Sciences, Biometrics and Drug Safety. Additionally, he will be the Co-Chair of the R&D leadership team and will collaborate closely with the discovery and antibody engineering organizations at Ichnos’ sites in Switzerland to select and set priorities for research targets.

Previously, Dr. Feldman served as Senior Vice President, Chief Medical Officer, at GlycoMimetics, leading the Phase 3 registration study of uproleselan in acute myeloid leukemia, as well as other early-stage assets. He also served as Chief Medical Officer at Amphivena, focusing on bispecific antibody therapies for blood cancers, and directed the myeloid leukemia antibody-drug conjugate (ADC) program at Seattle Genetics, Inc.

"My career has been devoted to developing new and better treatments for people with cancer and I am thrilled to join Ichnos to continue this journey," said Dr. Feldman. "I believe the BEAT platform[1] has immense potential and I look forward to leading the development efforts as we work to provide new options to cancer patients."

"Eric has over three decades of immuno-oncology drug development experience in industry and academia, during which he developed a broad spectrum of antibody-based therapeutics, including novel T-cell bispecific engagers for hematological malignancies and solid tumors," said Cyril Konto, M.D., CEO of Ichnos Sciences. "I am confident Ichnos will benefit from his knowledge and scientific leadership as we continue to advance the oncology portfolio."

Dr. Feldman received a medical degree at New York Medical College, and he holds a B.A. from Tulane University. His broad academic career includes a position as Professor of Medicine and Director of the Hematological Malignancies Service at Weill-Cornell/New York Presbyterian Hospital, and he has authored over 150 scientific articles and served as a former editor-in-chief of the Leukemia Research journal.