On November 4, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer and population sequencing, reported financial results for the third quarter ended September 30, 2021 (Press release, Personalis, NOV 4, 2021, View Source [SID1234594516]).

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Third Quarter and Recent Highlights

Reported quarterly revenue of $22.3 million in the third quarter of 2021 compared with $19.8 million in the third quarter of 2020, a 12% increase
Record quarterly revenue of $8.6 million from biopharma and all other customers, excluding the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP), in the third quarter of 2021 compared with $5.7 million in the third quarter of 2020, a 50% increase
Record new orders received for cancer genomic testing from biopharma and all other customers, excluding the VA MVP; order value of more than three-times (3x) the amount of quarterly revenue reported in the third quarter of 2021
Received new order from the VA MVP with an aggregate value of approximately $10 million over a six-month period of performance from September 17, 2021 to March 31, 2022
Announced a collaboration with Mayo Clinic to provide clinical-grade comprehensive cancer genomic sequencing for patients; creates framework for Personalis to sponsor future defined research studies and establishes Personalis as a preferred provider to Mayo Clinic for research and clinical sequencing and analysis services, particularly in the area of immuno-oncology
Announced the appointment of Robert Bruce to the newly created position of Vice President, Reimbursement; the new role is tasked with driving efforts with Medicare and private payers
Announced the signing of a new building lease agreement in Fremont, California for approximately 100K square feet for laboratory capacity and office space, which is planned to be the new company headquarters and support future growth
Ended the third quarter of 2021 with cash and cash equivalents and short-term investments of $305.2 million
"I’m proud to say that revenue from our oncology customers grew 50% over the same period of the prior year, and increased sequentially for the eighth consecutive quarter. In addition, our new-orders-to-revenue ratio during the third quarter was more than three-to-one, and gives us confidence in our future growth," said John West, Chief Executive Officer. "Looking ahead, and building on our recent oncology success, we are working to enhance our clinical, regulatory, and reimbursement capabilities as we prepare to launch NeXT Personal, our Minimal Residual Disease (MRD) offering in December as planned. We expect initial orders to come from our pharma customers and, later in 2022, we will pursue orders for patient diagnostic tests in clinical settings."

Third Quarter 2021 Financial Results

Revenue was $22.3 million in the three months ended September 30, 2021, up 12% from $19.8 million in the same period of the prior year.

Gross margin was 36.2% in the three months ended September 30, 2021, compared with 26.9% in the same period of the prior year.

Operating expenses were $25.8 million in the three months ended September 30, 2021, compared with $15.0 million in the same period of the prior year.

Net loss was $17.7 million in the three months ended September 30, 2021 and net loss per share was $0.40 based on a weighted-average basic and diluted share count of 44.5 million, compared with a net loss of $9.5 million and a net loss per share of $0.27 based on a weighted-average basic and diluted share count of 35.5 million in the same period of the prior year.

Business Outlook

Personalis expects the following for the fourth quarter of 2021:

Total revenue to be in the range of $20.2 million to $20.4 million
Revenue from biopharma and all other customers, excluding VA MVP, to be in the range of $12.5 million to $14.5 million
Net Loss to be in the range of $22 million to $23 million and estimated outstanding shares of approximately 45 million
Personalis expects the following for the full year of 2021:

Total revenue to be approximately $85 million
Revenue from biopharma and all other customers, excluding VA MVP, to be in the range of $37 million to $39 million
Net Loss to be in the range of $67 million to $68 million and estimated outstanding shares of approximately 45 million
Webcast and Conference Call Information

Personalis will host a conference call to discuss the third quarter 2021 financial results before market opens on Thursday, November 4, 2021 at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time. The conference call can be accessed live over the phone by dialing (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using the conference ID: 7896264. The live webinar can be accessed at View Source

On November 4, 2021 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that the first patient has been dosed in the Phase I dose escalation portion of a company-sponsored Phase I/II trial of BT7480, a novel, fully synthetic Bicycle tumor-targeted immune cell agonist (Bicycle TICA) targeting Nectin-4 and agonizing CD137 (Press release, Bicycle Therapeutics, NOV 4, 2021, View Source [SID1234594515]). Preclinical studies have demonstrated that BT7480 activates CD137 only in the presence of Nectin-4 expressing tumor cells. The Phase I/II trial of BT7480 will be conducted in patients with advanced solid tumors associated with Nectin-4 expression.

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"BT7480 is our first Bicycle TICA to enter the clinic and is one of a new class of tumor-targeting agents," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "Overexpression of Nectin-4, a well-validated tumor antigen, has been observed in several common tumor types and is associated with poor disease prognosis. Activation of CD137, a co-stimulatory receptor expressed on multiple components of the immune system, can drive anti-tumor immunity, but activation outside of the tumor may give rise to toxicity. Preclinical studies have shown encouraging results, and we look forward to studying the safety and efficacy of this unique asset as we begin the dose escalation portion of the trial."

The Phase I/II multi-center, open-label trial will evaluate BT7480 administered once weekly. Enrollment is ongoing in the Phase I dose escalation of BT7480 given as a monotherapy, and the Company plans to evaluate BT7480 dosed in combination with nivolumab in future Phase I dose escalation cohorts. The Phase I portion of the trial is primarily designed to assess the safety and tolerability of BT7480, and to determine a recommended Phase II dose (RP2D). Following selection of an RP2D, Bicycle expects to initiate a Phase II dose expansion portion with the primary objective of evaluating the clinical activity of BT7480 as monotherapy and in combination with nivolumab in patients with Nectin-4-positive tumors.

On November 4, 2021 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to EZM0414, the Company’s novel, first-in-class, oral SETD2 inhibitor, as an investigational agent for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Press release, Epizyme, NOV 4, 2021, View Source [SID1234594514]). In addition, the Company has initiated a Phase 1/1b study to evaluate safety and determine the optimal dose of EZM0414. Following this dose-ranging phase, the study will be expanded to evaluate EZM0414 in three patient cohorts: t(4;14) multiple myeloma, non t(4;14) multiple myeloma, and DLBCL.

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"Today we are excited to announce an important milestone for Epizyme, as we prepare to bring another investigational candidate into the clinic with the initiation of this first-in-human clinical trial of our SETD2 inhibitor, EZM0414," said Grant Bogle, President and Chief Executive Officer at Epizyme. "As leaders in pioneering therapies against novel epigenetic targets, bringing EZM0414 to the clinic is an important advancement as we strive to fulfill our vision of making transformative therapies a reality for patients living with cancer."

SETD2 is a histone methyltransferase, similar to EZH2, which plays multiple important roles in oncogenesis. Epizyme recently shared data demonstrating potent preclinical in vitro and in vivo activity for a selective inhibitor of the SETD2 histone methyltransferase at the 2021 European Hematology Association (EHA) (Free EHA Whitepaper) meeting. The Company plans to share additional preclinical data and the Phase 1/1b trial design as a trial in progress at an upcoming medical meeting.

"The receipt of Fast Track designation underscores the urgent need for innovative therapies that may significantly improve the lives of patients living with devastating diseases such as DLBCL," said Dr. Shefali Agarwal, Executive Vice President and Chief Medical and Development Officer at Epizyme. "Additionally, through the initiation of our Phase 1/1b study, we look forward to evaluating the safety and efficacy of EZM0414 in both DLBCL and multiple myeloma, including high-risk t(4;14) multiple myeloma. Multiple myeloma patients with this high-risk mutation often have a poorer prognosis and is an area of high unmet medical need. We believe the inhibition of SETD2 may play an important role in treating these patients."

The FDA Fast Track program is designed to facilitate the development of important new drugs and to provide patients access to those drugs more quickly. The designation enables early and frequent communication between FDA and a product sponsor throughout the drug development and review process. Through the Fast Track program, a product may be eligible for priority review at the time of a new drug application (NDA) filing and may also be eligible to submit completed sections of the NDA on a rolling basis before the complete application is submitted. These expedited processes can potentially reduce development time and cost associated with bringing a drug to market.

On November 4, 2021 Hologic, Inc. (Nasdaq: HOLX) reported that its new Genius Digital Diagnostics System is now commercially available in Europe (Press release, Hologic, NOV 4, 2021, View Source [SID1234594513]). The Genius Digital Diagnostics System is the next generation of cervical cancer screening that combines deep learning-based artificial intelligence (AI) with advanced volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells in women. It was developed to provide actionable insights, and improve workflow and lab efficiency, all with one goal in mind – to eradicate cervical cancer.

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With the Genius Digital Diagnostics System, cutting-edge image analysis thoroughly interrogates every cell on a ThinPrep Pap test image to curate a single view of the most clinically relevant objects. The new algorithm – GeniusTM Cervical AI – narrows tens of thousands of cells down to an AI-generated gallery, which arms healthcare providers with the critical information they need to guide earlier detection and better treatment decisions for the patients in their care.

"We strive to develop innovative solutions that meet our customers’ needs. We are delighted in the overwhelming positive feedback from the customers who have been the first in the world to use this technology," said Andrew Pieprzyk, vice president, Strategic Development Diagnostics, International, Hologic. "The technology enhances the capabilities of individual laboratories and also has the potential to radically transform how cervical cancer screening is carried out, by enabling laboratories within the same network to collaborate across the world to manage the case load."

Hologic has been working with leading laboratories in Europe to give them an early opportunity to evaluate the new system including ZotzKlimas Diagnostics Laboratories in Germany, where Founder, Dietmar Klimas, M.D., has led the review.

"As one of the largest labs in Germany, our main objective is to deliver accurate results to doctors and ultimately patients," said Dr Klimas. "We were one of the first in the world to work with the Genius Digital Diagnostics system. The trial proved to me that this system can help my team to accurately process samples faster and more easily. We are continuing to use it following the trial."

The Genius Digital Diagnostics System enables seamless and dynamic collaboration across laboratories within a network, connecting pathologists with remote review capabilities so each patient can benefit from the collective knowledge of geographically dispersed experts. Digital case review promises to enhance the experience for lab partners by improving workflow and accelerating review time.

Hologic now offers the first CE-marked comprehensive cervical cancer screening portfolio from sample collection to digital diagnosis.1 The Genius Digital Diagnostics System consists of the GeniusTM Digital Imager for image acquisition, the GeniusTM Cervical AI algorithm for analyzing images, the GeniusTM Image Management Server (IMS) for storing images and the GeniusTM Review Station for case review. The complete system is scalable, designed to fit the present and future needs of laboratories.

On November 4, 2021 Novartis reported that it will highlight new data on Scemblix (asciminib), recently approved by the US Food and Drug Administration, as well as its next-generation CAR-T platform and the latest research results for an array of hematology medicines at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (December 11-14; Atlanta and virtually) (Press release, Novartis (Austria), NOV 4, 2021, View Source [SID1234594512]). More than 100 abstracts, including 24 oral presentations, will be shared at the meeting.

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New data will be presented for Kymriah (tisagenlecleucel), as well as CAR-T pipeline compounds YTB323 and PHE885, along with sabatolimab (MBG453), Scemblix (asciminib), iptacopan (LNP023), Adakveo (crizanlizumab), Jakavi* (ruxolitinib) and Promacta/Revolade (eltrombopag).

"Novartis is relentless in its pursuit of breakthrough innovation for patients with blood cancers and life-threatening blood disorders," said Susanne Schaffert, PhD, President, Novartis Oncology. "The breadth of new data presented at ASH (Free ASH Whitepaper) demonstrates the promise of our advanced therapeutic platforms with exciting new approaches in immuno-oncology and CAR-T therapies that aim to transform the lives of patients."

Data highlights include:

Medicine Abstract Title Abstract Number/
Presentation Details
CAR-T Therapies
YTB323 A First-in-Human Study of YTB323, a Novel, Autologous CD19-Directed CAR-T Cell Therapy Manufactured Using the Novel
T-Charge Platform, for the Treatment of Patients (Pts) With Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Abstract presentation #740
Oral presentation: Monday, December 13, 3:00 PM – 3:15 PM EST
PHE885 Phase I Study of PHE885, a Fully Human BCMA-Directed CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma Manufactured in <2 Days Using the
T-ChargeTM Platform Abstract presentation #3864
Poster available:
Monday, December 13, 6:00 PM – 8:00 PM EST
Kymriah
(tisagenlecleucel) Efficacy of Tisagenlecleucel in Adult Patients (Pts) With High-Risk Relapsed/Refractory Follicular Lymphoma (R/R FL): Subgroup Analysis of the Phase II ELARA Study Abstract presentation #131
Oral presentation: Saturday, December 11, 1:00 PM – 1:15 PM EST
Kymriah
(tisagenlecleucel) Real-World Outcomes for Pediatric and
Young Adult Patients With Relapsed or Refractory (R/R) B-Cell Acute Lymphoblastic Leukemia (ALL) Treated With Tisagenlecleucel: Update From the Center for International Blood and Marrow Transplant Research (CIBMTR) Registry Abstract presentation #428
Oral presentation: Sunday, December 12, 9:45 AM – 10:00 AM EST
Kymriah
(tisagenlecleucel) Real-World Efficacy and Safety Outcomes for Patients With Relapsed or Refractory (R/R) Aggressive B-Cell Non-Hodgkin’s Lymphoma (aBNHL) Treated With Commercial Tisagenlecleucel: Update From the Center for International Blood and Marrow Transplant Research (CIBMTR) Registry Abstract presentation #429
Oral presentation: Sunday, December 12, 10:00 AM – 10:15 AM EST
Malignant Hematology
Sabatolimab
(MBG453) Efficacy and Safety of Sabatolimab (MBG453) in Combination With Hypomethylating Agents (HMAs) in Patients (Pts) With Very High/High-Risk Myelodysplastic Syndrome (vHR/HR-MDS) and Acute Myeloid Leukemia (AML): Final Analysis From a Phase Ib Study Abstract presentation #244
Oral presentation: Saturday, December 11 2:45 PM – 3:00 PM EST
Scemblix
(asciminib) Efficacy and Safety Results from ASCEMBL, a Multicenter, Open-label, Phase 3 Study of Asciminib, a First-in-Class STAMP Inhibitor,
vs Bosutinib in Patients With Chronic Myeloid Leukemia in Chronic Phase After ≥2 Prior Tyrosine Kinase Inhibitors: Update After 48 Weeks Abstract presentation #310
Oral presentation: Saturday, December 11
4:45 PM – 5:00 PM EST
Scemblix
(asciminib) Trial in Progress: A Multicenter, Open Label, Randomized Phase III Study of Asciminib
(80 mg Once Daily) vs Investigator-selected TKIs in Newly Diagnosed Adult Patients With Chronic Myeloid Leukemia in Chronic Phase Abstract presentation #1478
Poster available:
Saturday, December 11
5:30 PM – 7:30 PM EST
Scemblix
(asciminib) Trial in Progress: A Multicenter, Open-label, Phase Ib/II Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Philadelphia Chromosome–positive Chronic Myeloid Leukemia in Chronic Phase Treated With ≥1 Prior Tyrosine Kinase Inhibitor Abstract presentation #2561
Poster available:
Sunday, December 12
6:00 PM – 8:00 PM EST
Jakavi*
(ruxolitinib) Patient-Reported Outcomes (PROs) Among Patients With Steroid-Refractory or -Dependent Chronic Graft-vs-Host Disease (cGVHD) Randomized to Ruxolitinib (RUX) vs Best Available Therapy (BAT) Abstract presentation # 3909
Poster available:
Monday, December 13, 6:00 PM – 8:00 PM EST
Non-Malignant Hematology
Iptacopan
(LNP023) 12-Month Analysis of a Phase 2 Study of Iptacopan (LNP023) Monotherapy for Paroxysmal Nocturnal Hemoglobinuria Abstract presentation #2173
Poster available:
Sunday, December 12
6:00 PM – 8:00 PM EST
Adakveo
(crizanlizumab) Initial Safety and Efficacy Results From the Phase II, Multicenter, Open-Label SOLACE-Kids Trial of Crizanlizumab in Adolescents With Sickle Cell Disease (SCD) Abstract presentation #12
Oral presentation: Saturday, December 11, 10:45 AM – 11:00 AM EST
Adakveo
(crizanlizumab) Characterization of Two Anti-P-Selectin Monoclonal Antibodies (mAbs): Crizanlizumab Shows Comparable or Stronger Effects Versus Inclacumab Across Cell Adhesion Assays In Vitro Abstract presentation #2032
Poster available:
Sunday, December 12
6:00 PM – 8:00 PM EST
Promacta/Revolade
(eltrombopag) Efficacy and Safety of Eltrombopag Combined With Cyclosporine as First-Line Therapy in Adults With Severe Acquired Aplastic Anemia: Results of the Interventional Phase 2 Single-Arm SOAR Study Abstract presentation #2174
Poster available:
Sunday, December 12
6:00 PM – 8:00 PM EST
Adakveo
(crizanlizumab) Early Evaluation of the Use of Crizanlizumab in Sickle Cell Disease: A National Alliance of Sickle Cell Centers Study Abstract presentation #3113
Poster available:
Monday, December 13
6:00 PM – 8:00 PM EST
Product Information
Approved indications for products vary by country and not all indications are available in every country. The product safety and efficacy profiles have not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that compounds will become commercially available with additional indications.

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