On November 7, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the third quarter ended September 30, 2023 (Press release, Veracyte, NOV 7, 2023, View Source [SID1234637168]).

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"I am pleased to share we delivered another quarter of strong revenue growth, fueled by continued demand for our Decipher Prostate and Afirma tests," said Marc Stapley, Veracyte’s chief executive officer. "These products are serving a critical unmet need for patients dealing with prostate and thyroid cancer, indications for which we believe there remains ample opportunity to fuel outsized, long-term growth."

Key Business Highlights

Increased third quarter total revenue by 19% to $90.1 million, compared to the third quarter of 2022.
Grew total test volume to 32,544, an increase of 23% compared to the third quarter of 2022.
Presented 13 abstracts for our diagnostic tests and capabilities, as well as our biopharmaceutical offerings, at leading medical conferences. These included an oral presentation, at the American Society for Radiation Oncology (ASTRO) annual meeting, of findings from a phase 3, randomized trial demonstrating the Decipher Prostate Genomic Classifier’s performance as a tool to help guide therapeutic decisions for patients with prostate cancer.
Published study findings in JCO Precision Oncology, which suggest the potential of Decipher Genomic Resource for Intelligent Discovery (GRID)-derived gene signatures to predict treatment response in patients with recurrent prostate cancer.
Unveiled the Afirma GRID, a new research-use-only tool that leverages Veracyte’s Afirma-based whole-transcriptome sequencing platform to help identify new molecular hallmarks of thyroid nodules and cancer.
Entered into a multi-year in vitro diagnostic agreement with Illumina to broaden availability of our tests for patients globally by offering them on Illumina’s NextSeq 550Dx next-generation sequencing instrument.
Further strengthened the Veracyte leadership team with the additions of Phil Febbo, M.D., as chief scientific officer and chief medical officer and Marie-Claire Taine, Ph.D., as GM, IVD Business Unit.
Generated $14.2 million of cash from operations and ended the third quarter with $202.5 million of cash and cash equivalents.
Third Quarter 2023 Financial Results

Total revenue for the third quarter of 2023 was $90.1 million, an increase of 19% compared to $75.6 million reported in the third quarter of 2022. Testing revenue was $82.0 million, an increase of 27% compared to $64.6 million in the third quarter of 2022, driven primarily by the strong performance of our Decipher Prostate and Afirma tests. Product revenue was $4.0 million, an increase of 21% compared to $3.3 million in the third quarter of 2022. Biopharmaceutical and other revenue was $4.1 million, a decrease of 47% compared to $7.7 million in the third quarter of 2022.

Total gross margin for the third quarter of 2023, including the amortization of acquired intangible assets, was 64%, compared to 59% in the third quarter of 2022. Non-GAAP gross margin, excluding the amortization of acquired intangible assets and other acquisition related expenses was 69%, compared to 66% in the third quarter of 2022.

Operating expenses, excluding cost of revenue, were $89.4 million, which included an impairment charge of $34.9 million associated with the nCounter Analysis System license given the company’s decision to move to a multi-platform strategy for its IVD tests. Non-GAAP operating expenses, excluding cost of revenue, amortization of acquired intangible assets, other acquisition related expenses and other restructuring costs, grew 13% to $57.7 million compared to $51.1 million in the third quarter of 2022.

Net loss for the third quarter of 2023 was $29.6 million, an increase of 240% compared to the third quarter of 2022, primarily related to the impairment charge. Basic and diluted net loss per common share was $0.41, an increase of $0.29 compared to the third quarter of 2022. Net cash provided by operating activities in the first nine months of 2023 was $28.7 million, an improvement of $30.9 million compared to the same period in 2022.

A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

2023 Financial Outlook

The company is raising full-year 2023 total revenue guidance to $352 million to $354 million, representing year-over-year growth of approximately 19%, and an improvement compared to prior guidance of $342 million to $350 million.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call dial-in can be accessed by registering at the following link: https://register.vevent.com/register/BI6a0979098d6445eba9396420f175fc44

On November 7, 2023 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultrarare genetic diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s chief executive officer and president, will participate in a fireside chat at the upcoming Jefferies London Healthcare Conference on Tuesday, November 14, 2023, at 12:30 p.m. GMT (Press release, Ultragenyx Pharmaceutical, NOV 7, 2023, View Source [SID1234637167]).

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The live and archived webcast of the panel will be accessible from the company’s website at View Source

On November 7, 2023 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported financial results for the quarter ended September 30, 2023 and highlighted recent corporate progress (Press release, Tyra Biosciences, NOV 7, 2023, View Source [SID1234637166]).

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"From the start, TYRA has focused on developing precision therapies that target large opportunities that exist in FGFR biology, and we continue to follow the data. We continue to advance TYRA-300, our oral FGFR3-selective inhibitor, as we dose expand and escalate in our SURF301 oncology study and strengthen our preclinical data package in achondroplasia," said Todd Harris, CEO of TYRA. "Before the end of the year, we expect to update our guidance on the timing and design of our planned Phase 2 study in achondroplasia and the dosing of our first patient with TYRA-200."

Third Quarter 2023 and Recent Corporate Highlights

TYRA-300

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SURF301 Phase 1/2 Study for Oncology Continued to Advance. SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors) (NCT05544552) is a multi-center, open label study designed to determine the optimal and maximum tolerated doses (MTD) and the recommended Phase 2 dose of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. Enrollment is ongoing in Part A and Part B and dose escalation is ongoing in Part B in Phase 1 of the study at multiple clinical sites in the U.S., Europe, and Australia. In this study, multiple doses and schedules of TYRA-300 will be evaluated to inform dosing decisions in future metastatic urothelial carcinoma (mUC), non-muscle invasive bladder cancer (NMIBC) and achondroplasia studies.
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Presented Positive Preclinical Data for Achondroplasia at ASBMR and ASH (Free ASH Whitepaper)G Meetings. In October and early November 2023, TYRA presented additional preclinical results on TYRA-300 in achondroplasia at the American Society for Bone and Mineral Research (ASBMR) and the American Society of Human Genetics (ASHG) 2023 annual meetings, respectively. In preclinical mice models of achondroplasia conducted at The Imagine Institute in Paris, TYRA-300 increased bone growth, improved the shape of the skull, improved the shape of the foramen magnum, restored the architecture of the growth plate, and increased chondrocyte proliferation and differentiation.
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Granted Orphan Drug Designation for Achondroplasia from FDA. In July 2023, TYRA-300 was granted Orphan Drug Designation (ODD) for the treatment of achondroplasia from the U.S. Food and Drug Administration (FDA).

TYRA-200

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Phase 1 Study on Track to be Initiated by YE ‘23. TYRA continued to advance activities to support the initiation of the planned Phase 1 clinical study of TYRA-200, an FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. The trial will be focused on intrahepatic cholangiocarcinoma resistant to prior FGFR inhibitors. TYRA remains on track to dose the first patient in this trial before year-end 2023.

SNÅP Platform and Pipeline

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TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, to develop therapies in targeted oncology and genetically defined conditions including FGF19+/FGFR4-driven cancers and others.

Third Quarter 2023 Financial Results

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Third quarter 2023 net loss was $21.2 million compared to $12.5 million for the same period in 2022.
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Third quarter 2023 research and development expenses were $19.3 million compared to $10.9 million for the same period in 2022.
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Third quarter 2023 general and administrative expenses were $4.7 million compared to $2.7 million for the same period in 2022.
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As of September 30, 2023, TYRA had cash and cash equivalents of $215.7 million that are expected to support TYRA’s important clinical and operational milestones over at least the next two years.

About TYRA-300

TYRA-300 is the Company’s lead precision medicine program stemming from its in-house SNÅP platform. TYRA-300 is an investigational, oral, FGFR3-selective inhibitor currently in development for the treatment of cancer and skeletal dysplasias, including achondroplasia. In oncology, TYRA-300 is being evaluated in a multi-center, open label Phase 1/2 clinical study, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors). SURF301 (NCT05544552) was designed to determine the optimal and MTD and the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. SURF301 is currently enrolling adults with advanced urothelial carcinoma and other solid tumors with FGFR3 gene alterations. In skeletal dysplasias, TYRA-300 has demonstrated positive preclinical results, and the Company expects to submit an IND for the initiation of a Phase 2 clinical study in pediatric achondroplasia in 2024. In July 2023, TYRA-300 was granted Orphan Drug Designation for the treatment of achondroplasia from the FDA.

On November 7, 2023 Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Michael A. Metzger, Chief Executive Officer of Syndax, will participate in a fireside chat at the Stifel Healthcare Conference on Tuesday, November 14, 2023, at 4:45 p.m. ET (Press release, Syndax, NOV 7, 2023, View Source [SID1234637164]).

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A live webcast of the fireside chat can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the event will also be available for a limited time.

On November 7, 2023 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that Jack Khattar, President and CEO of Supernus Pharmaceuticals, will participate in a fireside chat at the Jefferies London Healthcare Conference on Wednesday, November 15, 2023, at 9:00 a.m. ET (2:00 p.m. GMT) at the Waldorf Hilton, London, UK (Press release, Supernus, NOV 7, 2023, View Source [SID1234637163]).

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Investors interested in arranging a meeting with company management during the conference should contact the Jefferies conference coordinator. A live audio webcast of the presentation can be accessed here or by visiting Events & Presentations in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of the webcast will be available for 60 days on the Company’s website following the conference.