ELEV Elevation Oncology Inc.

7.81
-0.2  -3%
Previous Close 8.01
Open 8.01
52 Week Low 7.38
52 Week High 16.22
Market Cap $181,392,225
Shares 23,225,637
Float 20,037,868
Enterprise Value $20,820,404
Volume 24,916
Av. Daily Volume 47,824
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Drug Stage Catalyst Date
Seribantumab (CRESTONE)
Solid Tumors
Phase 2
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Latest News

  1. NEW YORK, Oct. 20, 2021 /PRNewswire/ -- Elevation Oncology, Inc. (NASDAQ:ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, today announced the appointment of Valerie M. Jansen, M.D., Ph.D., as Chief Medical Officer. Dr. Jansen was promoted from her prior role as Vice President, Clinical Development.

    "Dr. Jansen has made significant contributions to Elevation Oncology's vision since her arrival at the Company earlier this year and we are thrilled to have her take on this role within the Elevation Oncology executive team," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "Valerie has an extensive background…

    NEW YORK, Oct. 20, 2021 /PRNewswire/ -- Elevation Oncology, Inc. (NASDAQ:ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, today announced the appointment of Valerie M. Jansen, M.D., Ph.D., as Chief Medical Officer. Dr. Jansen was promoted from her prior role as Vice President, Clinical Development.

    "Dr. Jansen has made significant contributions to Elevation Oncology's vision since her arrival at the Company earlier this year and we are thrilled to have her take on this role within the Elevation Oncology executive team," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "Valerie has an extensive background in oncology and a deep understanding of precision medicine, and under her leadership, Elevation Oncology is well positioned for success. I am confident in her continued oversight of our current clinical program targeting NRG1 fusions with seribantumab, reporting on the first clinical data from the Phase 2 CRESTONE study in mid 2022, and contributing to the development of new therapies that can make the genomic map of each patient's tumor actionable."

    Dr. Jansen commented: "Seribantumab is the first proof point for Elevation Oncology's approach for developing precision medicines, by identifying oncogenic drivers through genomic testing and developing therapeutics that are designed to intervene and improve patient outcomes. Through the adaptable and responsive clinical trial model that has been developed with our diagnostic partners for CRESTONE, we can meet the patients where they are in their journey and provide a potential treatment option. I look forward to continuing the successes that Elevation Oncology has achieved thus far, and building a pipeline of therapeutic candidates in support of our ultimate goal to develop therapeutics by targeting the underlying causes of oncogenesis."

    Prior to joining Elevation Oncology, Dr. Jansen served as Executive Medical Director at Mersana Therapeutics, a clinical-stage biopharmaceutical company with a focus in oncology, where she led clinical development of antibody-drug conjugate therapies for patients living with cancer. Previously, she was a senior medical advisor at Eli Lilly and Company, where she led global translational science for abemaciclib and served as lead Clinical Research Physician on early and late phase clinical trials.

    Prior to joining the pharmaceutical industry, Dr. Jansen started her career in academia as a faculty member at Vanderbilt University, with a translational research program focused on understanding mechanisms of resistance to cancer targeted therapies. She received her M.D. from the University of Chicago Pritzker School of Medicine and her Ph.D. in Molecular Sciences from the University of Tennessee Health Science Center. She completed residency in Internal Medicine and fellowship in Medical Oncology through the ABIM Physician-Scientist Research Pathway at Vanderbilt. Dr. Jansen is board certified in Internal Medicine and Medical Oncology.

    About Elevation Oncology

    Elevation Oncology is founded on the belief that every patient living with cancer deserves to know what is driving the growth of their disease and have access to therapeutics that can stop it. We aim to make genomic tests actionable by selectively developing drugs to inhibit the specific alterations that have been identified as drivers of tumor growth. Together with our peers, we work towards a future in which each tumor's unique genomic test result can be matched with a purpose-built precision medicine to enable an individualized treatment plan for each patient. Our lead candidate, seribantumab, is intended to inhibit tumor growth driven by NRG1 fusions and is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 gene fusion. Details on CRESTONE are available at www.NRG1fusion.com. For more information visit www.ElevationOncology.com.

    Forward Looking Statements:

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated preclinical and clinical development activities, expected timing of announcements of clinical results, potential benefits of seribantumab and the company's other future product candidates, potential market opportunities for seribantumab and the company's other future product candidates, the ability of seribantumab and the company's other future product candidates to treat their targeted indications, and our expectations about our cash runway. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "potential," "possible," "will," "would," and other words and terms of similar meaning.  Although the company believes that the expectations reflected in such forward-looking statements are reasonable, the company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, the impact of the COVID-19 pandemic on the Company's business, the Company's ability to fund development activities and achieve development goals, the Company's ability to protect intellectual property, the Company's ability to establish and maintain collaborations with third parties and other risks and uncertainties described under the heading "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

    Contact:

    Argot Partners

    212-600-1902

    IR@ElevationOncology.com 

     

    (PRNewsfoto/Elevation Oncology)

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/elevation-oncology-announces-the-promotion-of-valerie-malyvanh-jansen-md-phd-to-chief-medical-officer-301404230.html

    SOURCE Elevation Oncology

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  2. NEW YORK, Oct. 14, 2021 /PRNewswire/ -- Elevation Oncology, Inc. (NASDAQ:ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, today announced an investigator-presented case series from the Cancer Molecular Screening and Therapeutics (MoST) study at the Australasian Gastro-Intestinal Trials Group (AGITG) 2021 Annual Scientific Meeting, taking place virtually October 12-15, 2021. The presentation was selected as one of four "Best of the Best" at the meeting and provides a select case series of patients treated on the MoST program, which uses genomic profiling to characterize molecular changes in tumors from patients with treatment-refractory advanced…

    NEW YORK, Oct. 14, 2021 /PRNewswire/ -- Elevation Oncology, Inc. (NASDAQ:ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, today announced an investigator-presented case series from the Cancer Molecular Screening and Therapeutics (MoST) study at the Australasian Gastro-Intestinal Trials Group (AGITG) 2021 Annual Scientific Meeting, taking place virtually October 12-15, 2021. The presentation was selected as one of four "Best of the Best" at the meeting and provides a select case series of patients treated on the MoST program, which uses genomic profiling to characterize molecular changes in tumors from patients with treatment-refractory advanced cancers and matches those patients with targeted oncology agents.

    A patient with treatment-refractory metastatic pancreatic cancer had their tumor genomically profiled through the MoST program, was found to harbor an NRG1 fusion, and subsequently received treatment with seribantumab through a compassionate use program provided by Elevation Oncology. As of the data cut-off for the presentation, treatment with seribantumab resulted in durable clinical benefit for over 9 months, an approximately 90% reduction in the cancer biomarker CA19-9, and an ongoing 3 month confirmed partial response per RECIST criteria with a maximum tumor reduction of over 50%.

    "The MoST program is focused on exploring the importance of matching therapeutics to patients based upon genomic evaluation of their individual tumors," said Dr Subotheni Thavaneswaran, Medical Oncologist at The Kinghorn Cancer Centre and a research fellow and principal investigator of the MoST program, Garvan Institute of Medical Research and NHMRC Clinical Trials Centre. "We are pleased to have been able to gain access to an investigational treatment option for this patient, following identification of an NRG1 fusion. Compassionate early access to seribantumab following three prior lines of therapy resulted in a clinical benefit for this individual patient, and is an important reminder of the potential for matching specific therapeutics to genomic tumor profiling results."

    The full presentation from AGITG can be accessed here.

    The details for the AGITG 2021 poster presentation are as follows:

    Title: Comprehensive genomic profiling reveals novel opportunities for treatment-refractory gastrointestinal cancers

    Authors: Wei Yen Chan1, Subotheni Thavaneswaran1,2,3, Frank Lin2,3, Lucille Sebastian3, Mandy Ballinger2, John Grady2, Maya Kansara2, Anthony Joshua1,2, Rasha Cosman1, John Simes3, David Thomas1,2

    1 The Kinghorn Cancer Centre St Vincent's Hospital Sydney; 2 Garvan Institute of Medical Research, Faculty of Medicine, UNSW; 3 NHMRC Clinical Trials Centre, University of Sydney

    Presenter: Wei Yen Chan, The Kinghorn Cancer Centre, St. Vincent's Hospital, Sydney

    Session: Best of the Best

    Date and time: Thursday, October 14, 2021; 11:15 to 12:15 AEDT

    Distinct from the compassionate use program through which this patient was treated, seribantumab is currently being investigated by Elevation Oncology in the company-sponsored Phase 2 CRESTONE study, a tumor-agnostic "basket trial" in patients with solid tumors that harbor an NRG1 fusion and have progressed after at least one prior line of standard therapy. The CRESTONE study is currently enrolling across the U.S. at over 26 active clinical sites and is anticipated to expand to other global regions. Elevation Oncology expects to report clinical data from an interim analysis of the CRESTONE study in mid-2022.

    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 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. For more information visit www.NRG1fusion.com.

    About Elevation Oncology, Inc.

    Elevation Oncology is founded on the belief that every patient living with cancer deserves to know what is driving the growth of their disease and have access to therapeutics that can stop it. We aim to make genomic tests actionable by selectively developing drugs to inhibit the specific alterations that have been identified as drivers of tumor growth. Together with our peers, we work towards a future in which each tumor's unique genomic test result can be matched with a purpose-built precision medicine to enable an individualized treatment plan for each patient. Our lead candidate, seribantumab, is intended to inhibit tumor growth driven by NRG1 fusions and is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 gene fusion. Details on CRESTONE are available at www.NRG1fusion.com. For more information visit www.ElevationOncology.com.

    Forward Looking Statements:

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated preclinical and clinical development activities, expected timing of announcements of clinical results, potential benefits of seribantumab and the company's other future product candidates, potential market opportunities for seribantumab and the company's other future product candidates, the ability of seribantumab and the company's other future product candidates to treat their targeted indications, and our expectations about our cash runway. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "potential," "possible," "will," "would," and other words and terms of similar meaning.  Although the company believes that the expectations reflected in such forward-looking statements are reasonable, the company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, the impact of the COVID-19 pandemic on the Company's business, the Company's ability to fund development activities and achieve development goals, the Company's ability to protect intellectual property, the Company's ability to establish and maintain collaborations with third parties and other risks and uncertainties described under the heading "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

    Contact:

    Argot Partners

    212-600-1902

    IR@ElevationOncology.com 

    (PRNewsfoto/Elevation Oncology)

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/elevation-oncologys-seribantumab-included-as-part-of-a-case-series-presentation-at-the-australasian-gastro-intestinal-trials-group-2021-annual-scientific-meeting-301400080.html

    SOURCE Elevation Oncology

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  3. NEW YORK, Sept. 7, 2021 /PRNewswire/ -- Elevation Oncology, Inc. (NASDAQ:ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, today announced that Shawn M. Leland, PharmD, Rph, Founder and Chief Executive Officer of Elevation Oncology, will present virtually at the H.C. Wainwright 23rd Annual Global Investment Conference.  The presentation will be available on demand starting at 7:00 a.m. ET on Monday, September 13, 2021.

    A webcast of the event  will be accessible for 30 days on the Events page of the Company's Investor Relations website at https://investors.elevationoncology.com.

    About Elevation Oncology, Inc.
    Elevation Oncology is founded on the…

    NEW YORK, Sept. 7, 2021 /PRNewswire/ -- Elevation Oncology, Inc. (NASDAQ:ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, today announced that Shawn M. Leland, PharmD, Rph, Founder and Chief Executive Officer of Elevation Oncology, will present virtually at the H.C. Wainwright 23rd Annual Global Investment Conference.  The presentation will be available on demand starting at 7:00 a.m. ET on Monday, September 13, 2021.

    A webcast of the event  will be accessible for 30 days on the Events page of the Company's Investor Relations website at https://investors.elevationoncology.com.

    About Elevation Oncology, Inc.

    Elevation Oncology is founded on the belief that every patient living with cancer deserves to know what is driving the growth of their disease and have access to therapeutics that can stop it. We aim to make genomic tests actionable by selectively developing drugs to inhibit the specific alterations that have been identified as drivers of tumor growth. Together with our peers, we work towards a future in which each tumor's unique genomic test result can be matched with a purpose-built precision medicine to enable an individualized treatment plan for each patient. Our lead candidate, seribantumab, is intended to inhibit tumor growth driven by NRG1 fusions and is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 gene fusion. Details on CRESTONE are available at www.NRG1fusion.com. For more information visit www.ElevationOncology.com.

    Investor Contact

    Argot Partners

    Phone: +1 (716) 371-1125

    Email: ir@ElevationOncology.com

    (PRNewsfoto/Elevation Oncology)

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/elevation-oncology-to-present-at-the-hc-wainwright-23rd-annual-global-investment-conference-301369354.html

    SOURCE Elevation Oncology

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  4. NEW YORK, Aug. 12, 2021 /PRNewswire/ -- Elevation Oncology, Inc. (NASDAQ:ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, today announced financial results for the quarter ended June 30, 2021.

    "The second quarter marked a pivotal period for Elevation Oncology, with our debut in the public markets raising over $100 million which extends our cash runway into Q2 2023 and positions the Company to execute on our lead program, seribantumab, and build an industry leading precision oncology pipeline," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "Looking ahead, we anticipate completing enrollment of the first…

    NEW YORK, Aug. 12, 2021 /PRNewswire/ -- Elevation Oncology, Inc. (NASDAQ:ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, today announced financial results for the quarter ended June 30, 2021.

    "The second quarter marked a pivotal period for Elevation Oncology, with our debut in the public markets raising over $100 million which extends our cash runway into Q2 2023 and positions the Company to execute on our lead program, seribantumab, and build an industry leading precision oncology pipeline," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "Looking ahead, we anticipate completing enrollment of the first 20 patients in Cohort 1 of the tumor-agnostic Phase 2 CRESTONE study of seribantumab for patients with tumors harboring an NRG1 fusion later this year or in early 2022, and presenting the clinical data from the interim analysis in mid-2022 at a major medical conference. Through our recent coloration with Caris Life Sciences, we are identifying oncogenic fusions and driver mutations to enable pipeline expansion opportunities within genomically defined patient populations as part of our commitment to expand the potential of precision medicine."

    Recent Business Highlights

    • Entered into a collaboration with Caris Life Sciences. In June 2021, Elevation Oncology and Caris announced a strategic collaboration to jointly discover and develop therapeutics targeted against oncogenic fusions and driver alterations. The two Companies will leverage genomic data from Caris's leading WTS and WES molecular diagnostics platform, prioritize targets that are likely to be actionable driver alterations, and jointly discover and develop therapeutics to target them.



    • Completed a successful initial public offering (IPO). The Company's common stock commenced trading on The NASDAQ Global Market under the ticker symbol "ELEV" on June 25, 2021. The IPO raised $106.5 million in gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses.



    • Strengthened corporate leadership. During the second quarter, the Company appointed Joseph Ferra as Chief Financial Officer, bringing to Elevation two decades of biopharma industry leadership including in investment banking and, most recently, as a public-company CFO. Further, Elevation Oncology appointed Michael Carruthers, an experienced biotech executive, to the Board of Directors and Chair of the Audit Committee.

    Clinical Development and Pre-Clinical Data

    • Opened additional clinical trial sites in CRESTONE. There are now 26 trial sites that are open and enrolling across the US. Through the "just-in-time" clinical site model in partnership with Caris Life Sciences, Tempus, and US Oncology, there are over 400 available sites that can be activated within CRESTONE.



    • Established additional diagnostic partnerships. With the addition of Genomic Testing Collaborative, PathGroup, and Exactis, there are now a total of nine partnerships in place to support the identification and enrollment of patients with tumors harboring an NRG1 fusion in CRESTONE, including pre-existing partnerships with Ashion Analytics (now Exact Sciences), NeoGenomics, Caris Life Sciences, Strata Oncology, Tempus, and US Oncology.



    • Presented new preclinical data on additional tumor models harboring an NRG1 fusion. Along with its collaborators in the Marc Ladanyi laboratory at Memorial Sloan Kettering (MSK), the Company presented data at the American Association of Cancer Research (AACR) Virtual Annual Meeting 2021. The preclinical data was in pancreatic and cholangiocarcinoma PDX models on the specific inhibition of HER3 with seribantumab to block NRG1 fusion signaling. These results further support the investigation of seribantumab for the treatment of any solid tumor harboring an NRG1 fusion regardless of fusion partner in the ongoing Phase 2 CRESTONE study.



    • Published a preclinical manuscript on the effect of seribantumab in NRG1 fusion models. A publication in Clinical Cancer Research highlights the specific inhibition of HER3 by seribantumab in preclinical NRG1 fusion in vitro and in vivo PDX models of lung and ovarian cancer. These results showed that seribantumab efficiently inhibited ligand-dependent activation of HER3 by NRG1 fusions, destabilizes the entire ERBB family signaling pathway including the activation of EGFR, HER2, and HER4, and established a predicted biologically effective dose range of seribantumab for tumors driven by an NRG1 fusion that provides confidence in the optimized clinical dose and schedule of 3g weekly being studied in the CRESTONE study.



    • Published a clinical manuscript. The Phase 1 dose escalation and expansion study for seribantumab monotherapy in patients with advanced solid tumors was published in Investigational New Drugs. The study was designed to evaluate the safety and tolerability of seribantumab monotherapy in patients with any solid tumor, not tumors harboring an NRG1 fusion. Seribantumab monotherapy was well tolerated across all dose levels and a maximum tolerated dose was not reached. Safety and PK data from this study support the 3g weekly dosing of seribantumab in the CRESTONE study which is the first study of seribnatumab in patients with tumors harboring an NRG1 fusion.

    Upcoming Milestones

    • Complete enrollment of the first 20 patients in Cohort 1 of the Phase 2 CRESTONE study and conduct an interim analysis (Q4 2021 - Q1 2022)



    • Meet with the U.S. Food & Drug Administration to discuss the Phase 2 CRESTONE study (H1 2022)



    • Present clinical data from CRESTONE interim analysis at a major medical meeting (mid-2022)

    Second Quarter 2021 Financial Results

    As of June 30, 2021, the Company had cash and cash equivalents totaling $158.0 million, which is expected to fund current operations into the second quarter of 2023.

    Research and development expenses for the second quarter 2021 were $3.9 million, compared to $3.0 million for the second quarter 2020. The increase in R&D expense was primarily related to an increase in clinical trial expenses associated with the CRESTONE study.

    General and administrative expenses for the second quarter 2021 were $1.1 million, compared to $0.4 million for the second quarter 2020. The increase in G&A expense was primarily related to personnel costs, professional services and consulting, and other administrative costs.

    Net loss for the second quarter 2021 was $5.1 million, compared to $3.4 million for the second quarter 2020.

    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 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. For more information visit www.NRG1fusion.com.

    About Elevation Oncology, Inc.

    Elevation Oncology is founded on the belief that every patient living with cancer deserves to know what is driving the growth of their disease and have access to therapeutics that can stop it. We aim to make genomic tests actionable by selectively developing drugs to inhibit the specific alterations that have been identified as drivers of tumor growth. Together with our peers, we work towards a future in which each tumor's unique genomic test result can be matched with a purpose-built  precision medicine to enable an individualized treatment plan for each patient. Our lead candidate, seribantumab, is intended to inhibit tumor growth driven by NRG1 fusions and is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 gene fusion.

    Forward Looking Statements:

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to,

    anticipated preclinical and clinical development activities, expected timing of announcements of clinical results, potential benefits of seribantumab and the company's other future product candidates, potential market opportunities for seribantumab and the company's other future product candidates, the ability of seribantumab and the company's other future product candidates to treat their targeted indications, and our expectations about our cash runway . All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "potential," "possible," "will," "would," and other words and terms of similar meaning.  Although the company believes that the expectations reflected in such forward-looking statements are reasonable, the company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, the impact of the COVID-19 pandemic on the Company's business, the Company's ability to fund development activities and achieve development goals, the Company's ability to protect intellectual property, the Company's ability to establish and maintain collaborations with third parties and other risks and uncertainties described under the heading "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

    Contact:

    Argot Partners

    212-600-1902

    IR@ElevationOncology.com

    Selected Financial Information

    (In thousands, except share and per share data)

    (unaudited)



















    Three months ended June 30,





    2021



    2020

    Statement of Operations items:













    Research and development



    $

    3,914



    $

    3,004

    General and administrative





    1,145





    414

    Total operating expenses





    5,059





    3,418

    Loss from operations





    (5,059)





    (3,418)

    Other income, net









    12

    Net loss



    $

    (5,059)



    $

    (3,406)

    Net loss per share, basic and diluted



    $

    (4.84)



    $

    (4.32)

    Weighted average common shares outstanding, basic and diluted





    1,046,228





    788,846































































    June 30,



    December 31,

    Selected Balance Sheet items:



    2021



    2020

    Cash and cash equivalents



    $

    158,017



    $

    79,400















    Working capital1





    155,237





    74,001















    Total assets





    159,062





    80,907















    Total stockholders' equity (deficit)





    155,337





    (23,081)

    _________________________

    We define working capital as current assets less current liabilities.

     

     

    (PRNewsfoto/Elevation Oncology)

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/elevation-oncology-reports-second-quarter-2021-financial-results-301354698.html

    SOURCE Elevation Oncology

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