On March 3, 2022 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported financial results for the year ended December 31, 2021 (Press release, Elevation Oncology, MAR 3, 2022, View Source;utm_medium=rss&utm_campaign=elevation-oncology-reports-fourth-quarter-and-full-year-2021-financial-results [SID1234609449]).
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"2021 was a year of substantial growth and accomplishment for Elevation Oncology, one where we built the foundation for a multi-asset, precision oncology company to deliver on the promise of precision medicine with first-in-class therapeutics for patients with genomically defined cancers," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "We are excited about the prospect of reporting initial clinical data in 2022, providing proof-points around the potential clinical benefit of seribantumab in patients harboring NRG1 fusions. In addition, we are eager to explore opportunities to expand our product candidate pipeline and advance new discoveries through our Caris Life Sciences collaboration and ongoing business development activities. We are committed to uncovering additional true oncogenic drivers, developing therapies to target them, and identifying the patients who will most likely benefit."
2021 Key Corporate Achievements
Seribantumab
Launched new global clinical trial sites. The Phase 2 CRESTONE study is now enrolling patients across the US, Australia, and Canada.
Announced an investigator-presented case study. A patient with pancreatic cancer harboring an NRG1 fusion was treated with seribantumab under a compassionate use program. Data from the case study showed a confirmed partial response and durable clinical benefit.
Established 3 grams weekly as the optimized dose. As part of our ongoing Phase 2 CRESTONE study, the Company established the optimal dosing for seribantumab.
Presented new preclinical data. Preclinical data on additional tumor models harboring an NRG1 fusion was presented at AACR (Free AACR Whitepaper) 2021.
Published a preclinical manuscript. A preclinical manuscript on the effect of seribantumab in NRG1 fusion models was published in Clinical Cancer Research.
Corporate
Entered into a joint discovery and development collaboration with Caris Life Sciences. Under the terms of the agreement, the partners will utilize Caris’ diagnostic data to accelerate the identification of new, actionable genomic alterations for potential future drug development.
Formed new strategic diagnostic collaborations. In 2021 the Company organized a diagnostic consortium of 10 patient identification collaborators for the Phase 2 CRESTONE study.
Completed a successful initial public offering. The company raised $106.5 million in gross proceeds, before deducting underwriting discounts, commissions, and estimated offering expenses.
Strengthened corporate leadership team. With the addition of Joseph Ferra as Chief Financial Officer, the promotion of Valerie Malyvanh Jansen, MD, PhD to Chief Medical Officer and the appointment of R. Michael Carruthers to the Board of Directors, the Company continues to build a world class, experienced leadership team.
Expected 2022 Milestones and Operational Objectives
Complete enrollment of the first 20 patients in Cohort 1 of the CRESTONE study in mid-2022
Present initial clinical data from approximately 10 patients from Cohort 1 of the CRESTONE study treated with seribantumab at 3 grams weekly at a major medical meeting in mid-2022
Ongoing target evaluation and continued execution of our strategy for future pipeline expansion
Fourth Quarter and Full Year 2021 Financial Results
Research and development expenses for the fourth quarter 2021 were $6.2 million, compared to $8.4 million for the fourth quarter 2020. The decrease in R&D expense was primarily related to a decrease in manufacturing activity in the fourth quarter of 2021. For the year ending December 31, 2021, research and development expenses were $23.6 million, compared to $15.5 million for the year ended December 31, 2020. The increase in R&D expense was primarily related to an increase in manufacturing, personnel costs and clinical trial expenses associated with the CRESTONE study.
General and administrative expenses for the fourth quarter 2021 were $3.4 million, compared to $0.5 million for the fourth quarter 2020. For the year ending December 31, 2021, G&A expenses were $8.5 million, compared to $1.8 million for the year ended December 31, 2020. The quarterly and yearly increases in G&A expense were primarily related to personnel costs, professional services and consulting, and other administrative costs.
Net loss for the fourth quarter 2021 was $9.6 million, compared to a net loss of $8.9 million for the fourth quarter 2020. For the year ending December 31, 2021, the Company reported a net loss of $32.0 million, compared to a net loss of $17.3 million for the year ended December 31, 2020.
Financial Outlook
As of December 31, 2021, the Company had cash and cash equivalents totaling $146.3 million, which is expected to fund current operations into the second quarter of 2023.
About Seribantumab and NRG1 Gene Fusions
Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (HER3). HER3 is traditionally activated through binding of its primary ligand, neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner protein to create chimeric NRG1 "fusion proteins". The NRG1 fusion protein is often also able to activate the HER3 pathway, leading to unregulated cell growth and proliferation. Importantly, NRG1 gene fusions are predominantly mutually exclusive with other known genomic driver mutations and are considered a unique oncogenic driver event associated with tumor cell survival.
NRG1 fusions have been identified in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, neuroendocrine, cholangiocarcinomas, and sarcomas. In preclinical experiments, seribantumab prevented the activation of HER3 signaling in cells that harbor an NRG1 gene fusion and destabilized the entire ERBB family signaling pathway including the activation of HER2, EGFR, and HER4. In addition to extensive nonclinical characterization and testing, seribantumab has been administered to over 800 patients across twelve Phase 1 and 2 studies, both as a monotherapy and in combination with various anti-cancer therapies. Seribantumab is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion.
About the Phase 2 CRESTONE Study
Clinical Study of Response to Seribantumab in Tumors with Neuregulin-1 (NRG1) Fusions. CRESTONE is a Phase 2 tumor-agnostic "basket trial" of seribantumab in patients with solid tumors that harbor an NRG1 fusion and have progressed after at least one prior line of standard therapy. The primary objective of the study is to describe the anti-tumor activity and safety of seribantumab as a monotherapy specifically in patients whose solid tumor is uniquely driven by an NRG1 gene fusion. CRESTONE offers a clinical trial opportunity for patients with advanced solid tumors who have not responded or are no longer responding to treatment. Patients are encouraged to talk to their doctor about genomic testing of their tumor. CRESTONE is open and enrolling today in the United States, Australia, and Canada. For more information visit www.NRG1fusion.com.