On November 2, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the third quarter ended September 30, 2022 (Press release, Personalis, NOV 2, 2022, View Source [SID1234622832]).

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Third Quarter and Recent Highlights

Reported quarterly revenue of $14.9 million in the third quarter of 2022 compared with $22.3 million in the third quarter of 2021
Revenue from biopharma and other customers, excluding the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP), of $14.9 million in the third quarter of 2022 compared with $8.6 million in the third quarter of 2021, a 73% increase
Revenue from biopharma and other customers includes revenue of $7.4 million from Natera in the third quarter of 2022
Launched a research collaboration with BC Cancer using NeXT Personal to determine the optimal time for ctDNA sampling for molecular residual disease (MRD) detection in colorectal and pancreatic cancers, with the aim of identifying cancer progression before current standard of care tests
Announced a research collaboration with Duke University, deploying NeXT Personal to profile and accurately track MRD in patients with advanced gastroesophageal cancer over the course of therapy with the aim of better predicting a patient’s immune response to therapy
Appointed Christopher Hall as SVP who will lead the company’s Diagnostic Business, bringing 20 years of experience including leading the commercial organization at Veracyte and growing its business to nearly $100M in diagnostic revenue
Launched marketing and sales outreach to oncologists to begin generating demand for NeXT Dx, the company’s tissue-based clinical test that covers the whole exome and transcriptome and assesses genomic alterations in matched tumor and normal specimens to report variants and help oncologists with decision-making for therapy selection
Won an exclusive five-year contract and received the initial order from the VA MVP (contract work is pending the resolution of a bidder protest)
Cash, cash equivalents, and short-term investments were $192.8 million as of September 30, 2022
"We are pleased with the pace of our oncology revenue growth, as well as the continued adoption of our NeXT Platform," said John West, Chief Executive Officer of Personalis. "We are making excellent progress on our strategic priorities, as demonstrated with the addition of new collaborations with leading cancer institutions that will use our extremely sensitive MRD offering, NeXT Personal, in studies designed to advance the field of oncology with the aim of enhancing the standard of care."

Third Quarter 2022 Financial Results

Revenue was $14.9 million in the three months ended September 30, 2022
Gross margin was 16.7% in the three months ended September 30, 2022
Operating expenses were $29.7 million in the three months ended September 30, 2022
Net loss was $26.5 million in the three months ended September 30, 2022, and net loss per share was $0.58 based on a weighted-average basic and diluted share count of 45.9 million
Cash, cash equivalents, and short-term investments were $192.8 million as of September 30, 2022
Full Year 2022 Outlook

Personalis expects the following for the full year of 2022:

Total company revenue is expected to be in the range of $63.0 million to $64.0 million
Revenue from biopharma and all other customers, excluding the VA MVP, is expected to be in the range of $55.5 million to $56.5 million
Net loss is expected to be in the range of $111.0 million to $114.0 million
Webcast and Conference Call Information

Personalis will host a conference call to discuss the third quarter 2022 financial results after market close on Wednesday, November 2, 2022 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. To access the live call via telephone, please register in advance using the link here. Upon registering, each participant will receive an email confirmation with dial-in numbers and a unique personal PIN that can be used to join the call. The live webinar can be accessed at View Source A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On November 2, 2022 Amneal Pharmaceuticals, Inc. (NYSE: AMRX) ("Amneal" or the "Company") reported that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration ("FDA") for leuprolide acetate for injection (Press release, Amneal Pharmaceuticals, NOV 2, 2022, View Source [SID1234622831]).

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Harsher Singh, SVP for Amneal Biosciences, stated, "We are making tremendous progress expanding our injectables business. This latest new product is another key therapeutic for the institutional market and another complex, high value launch by the team."

Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer. For full prescribing information, see package insert located here.

According to IQVIA, U.S. annual sales for this product for the 12 months ended September 2022 were $81 million.

On November 2, 2022 Blaze Bioscience, Inc. the Tumor Paint Company (Blaze), a biotechnology company dedicated to improving the lives of patients through development and commercialization of products for fluorescence guided cancer surgery, reported that its pivotal Phase 2/3 study "A randomized, blinded study of fluorescence detection of pediatric primary central nervous system tumors in subjects receiving tozuleristide and imaged with the Canvas system" is now closed to enrollment, having achieved its trial accrual endpoints (Press release, Blaze Bioscience, NOV 2, 2022, View Source [SID1234622830]).

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The trial enrolled 123 subjects with various types of pediatric central nervous system (CNS) tumors. Subjects between the ages of one month and 30 years of age were enrolled and received tozuleristide prior to their planned tumor resection. A total of 9 clinical sites across the United States participated in the trial coordinated through the Pacific Pediatric Neuro-Oncology Consortium (PNOC). Gateway for Cancer Research provided support for patient and other costs and the Norcliffe Foundation provided Seattle Children’s Hospital (SCH) with a grant which allowed the inclusion of the Canvas imaging system at all sites in the study. The study was headed by Sarah Leary, M.D., neuro-oncologist at SCH and clinical investigator at the Ben Towne Center for Childhood Cancer Research at Seattle Children’s Research Institute.

"We are pleased to announce that enrollment is complete on this important trial. Pediatric brain tumors are still the leading cause of cancer-related mortality in children and teens. Improving surgical resection of brain tumors has been shown to be the single most important factor in improving survival and quality of life in brain tumor patients," says Dr. Leary. "We are extremely grateful to the patients and their families who participated in this trial."

"Providing more options to patients and their families who are affected by a pediatric brain tumor is the driving force behind our work at Blaze," says Kristi Harrington, M.D., Ph.D., Blaze Senior Vice President of Clinical. "We are excited to move forward with full data analysis and we are hopeful that tozuleristide and the Canvas imaging system may one day be useful in supporting neurosurgeon’s decision-making during brain tumor resection."

About BLZ-100 (tozuleristide)

BLZ-100 (tozuleristide) is the first product candidate from Blaze’s Tumor Paint platform and consists of a targeting peptide and a fluorescent dye, which emits light in the near-infrared (NIR) range. In addition to a Phase 2/3 clinical trial in pediatric CNS tumors, BLZ-100 has been tested in four Phase 1 clinical trials and has demonstrated preliminary clinical proof of concept in brain, breast, and skin cancers. Additional potential applications include prostate, head and neck, lung, colorectal and other solid tumor cancers.

About the Canvas Imaging System

The Canvas imaging system is an investigational medical device designed to provide high sensitivity detection of NIR light in the operating room under ambient light conditions. The Canvas imaging system was developed and is manufactured by Teal Light Surgical, Inc., a wholly owned subsidiary of Blaze. The first Canvas imaging system under development is adapted for use with surgical microscopes.

On November 2, 2022 ROME Therapeutics and Enara Bio, two leading biotechnology companies focused on developing novel medicines driven by insights to the dark genome, reported that they will host the inaugural Dark Genome Symposium on Monday, November 7, 2022 at ROME’s headquarters in Boston (Press release, Rome Therapeutics, NOV 2, 2022, View Source [SID1234622829]). This one-day event brings together leaders from academia, biotech and pharma working on the dark genome to share knowledge, opportunities, applications and challenges to solve as a community.

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The dark genome, that is the 98% of the genome that is not traditionally associated with protein-encoding genes, is increasingly found to be associated with human diseases, from autoimmune and neurodegeneration to cancer and aging. A key goal of the meeting is to catalyze collaborations around dark genome research and its medical application, in order to accelerate discovery and development of new therapies.

"The therapeutic potential of the dark genome to address numerous debilitating conditions is increasingly clear, and it has been incredibly exciting to see the momentum growing for therapeutic application of this science in interesting and complementary ways," said Rosana Kapeller, M.D., Ph.D., President, Chief Executive Officer and Co-founder of ROME. "This event will convene some of the top minds working on the dark genome to share insights and new ideas as we work toward a common goal of unlocking the dark genome to improve human health, and we are thrilled to co-host this inaugural symposium with Enara Bio."

"We all recognize the complexity of the dark genome and know that it will take ambitious collaborations to speed progress in this field," said Kevin Pojasek, Ph.D., President and Chief Executive Officer of Enara Bio. "Alongside ROME, we’re excited to establish this event to share learnings widely, spark new avenues for research and new connections across our community. It’s vital we forge strong collaborative efforts to fully realize the potential of the dark genome for bringing new therapies to patients as quickly as possible."

The symposium will feature presentations and panel discussions on topics including viral mimicry, Dark Antigens in cancer, mapping of the dark genome and gene regulation. A list of confirmed speakers and the agenda for the event can be found here. Participation at the in-person symposium is by invitation. Those interested in attending the livestream may reach out to [email protected] for more details.

On November 2, 2022 Alterome Therapeutics, Inc., a biopharmaceutical company pioneering the development of alteration-specific targeted therapies for the treatment of cancer, reported that it has raised more than $35 million in a Series A2 financing, bringing total funds raised to nearly $100 million (Press release, Alterome Therapeutics, NOV 2, 2022, View Source [SID1234622828]). Colt Ventures and OrbiMed co-led the round, with participation from all Series A investors including Nextech Invest, Vida Ventures, and Boxer Capital. The original round of $64 million closed in January 2022.

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The proceeds will be used to advance Alterome’s pipeline of three next-generation precision oncology programs designed using "The Kraken," its in-house computational chemistry platform. The Kraken provides precise, atomic-level insights into molecular interactions and enables ligand activity and binding mode predictions that inform the company’s expert team of medicinal chemists with approaches to design novel, exquisitely selective, alteration-specific therapies.

"We are very pleased to welcome Colt Ventures to our investor syndicate and are grateful to our existing investors for their continued support of our vision to relentlessly push the boundaries of cancer treatments to transform the lives of patients, one alteration at a time," said Eric Murphy, Ph.D., founder, CEO and CSO of Alterome Therapeutics. "Our unique blend of computational chemistry, medicinal chemistry, and translational biology experience combined with next-generation drug discovery technologies enable the discovery of therapeutics that address well-known oncogenic drivers while increasing the safety profile."

Sundeep Agrawal, M.D., General Partner at Colt Ventures said, "By bringing the latest advances in chemistry, biology, pharmacology, and genomics to bear on genomically-defined alterations, we believe that Alterome can make a meaningful impact on patients with cancers where too few treatment options exist. We are thrilled to lead this funding round and believe Alterome’s experienced leadership team is well-positioned to deliver a truly transformational approach to precision cancer therapeutics."