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23andMe to Present Updates on Clinical Immuno-oncology Programs 23ME-00610 and 23ME-01473 at ESMO Congress 2024
GlobeNewswire News Room· 2024-09-03 11:30
Core Insights - 23andMe Holding Co. will present preliminary clinical data on its anti-CD200R1 antibody 23ME-00610 and anti-ULBP6 monoclonal antibody 23ME-01473 at the ESMO Congress 2024 in Barcelona, Spain from September 13 to September 17 [1][2][6] Group 1: Clinical Trial Data - The company will showcase efficacy data for 23ME-00610 in clear-cell renal-cell carcinoma and high tumor microsatellite instability/high tumor mutational burden patient cohorts during the Phase 2a portion of its ongoing Phase 1/2a clinical trial [2][3] - Preliminary data from the Phase 1/2a clinical trial indicates that 23ME-00610 has an acceptable safety profile and shows preliminary clinical benefits in neuroendocrine and ovarian cancer cohorts [3][8] - The Phase 1/2a trial of 23ME-00610 is designed to evaluate its effectiveness as a first-in-class anti-CD200R1 monoclonal antibody targeting advanced solid malignancies [8][9] Group 2: Biomarker Analysis - The company will present analyses on CD200 as a potential tissue-based biomarker associated with the efficacy of 23ME-00610 [1][2] - CD200R1, the target of 23ME-00610, is identified as an immuno-oncology target with implications for immune tolerance and cancer treatment [8][9] Group 3: Preclinical Data - 23andMe will present preclinical data on 23ME-01473, which targets soluble ULBP6 to enhance anti-tumor immunity through NK and T cells [4][10] - The ongoing Phase 1 clinical trial for 23ME-01473 began in March 2024, focusing on its role in restoring immune cell recognition of cancer cells [4][11] Group 4: Company Background - 23andMe utilizes its proprietary database of human genetic and health information, with over 15 million genotyped customers, to identify potential therapeutic targets [5][12] - The company aims to empower a healthier future through genetics-led consumer healthcare and biopharmaceutical innovations [13]
23andMe (ME) - 2025 Q1 - Earnings Call Transcript
2024-08-09 19:58
Financial Data and Key Metrics - Revenue for Q1 2025 was $40 million, a 34% decrease YoY, primarily due to the conclusion of the GSK collaboration and lower consumer services revenue [15] - Gross profit for the quarter was $21 million, a 33% decrease YoY, driven by lower research data revenue, partially offset by improvements in membership and telehealth margins [16] - Net loss for the quarter was $69 million, an improvement from a net loss of $105 million in the prior year, driven by reduced stock-based compensation and lower GSK collaboration expenses [18] - Adjusted EBITDA deficit for Q1 was $35 million, compared to a $50 million deficit in the prior year, reflecting cost discipline and investment prioritization [19] - Cash and cash equivalents at the end of the quarter were $170 million, down from $216 million as of March 31, 2024 [19] Business Line Data and Key Metrics - Consumer services revenue represented 97% of total revenue, with research data revenue accounting for 3% [16] - Membership revenue growth improved YoY, with better retention metrics, higher upgrade rates, and increased lifetime value (LTV) in telehealth [8] - The company launched a GLP-1 weight loss telehealth membership on the Lemonaid Health platform, aiming to enhance preventive health services [7] - The research data business collaborated on a lung cancer study and published findings on the LRRK2 gene in Parkinson's disease, leveraging its large database [9][10] Market Data and Key Metrics - The company is focusing on improving membership offerings, including adding polygenic risk score reports and a biological age feature [7][8] - A collaboration with Nightingale Health aims to pilot a metabolomics blood biomarker panel, potentially enhancing health tracking for customers [8] - The therapeutics business presented data on 23ME610 and 23ME1473 at major oncology conferences, with plans to share additional clinical data later in 2025 [11][12] Company Strategy and Industry Competition - The company is prioritizing membership growth in its PGS segment, leveraging telehealth, and expanding its research data business [5][9] - AI development is a key focus, with new models being developed to unlock insights from the human genome and improve therapeutic target discovery [10][11] - The company is exploring combination strategies for its clinical assets, including 23ME610, to enhance therapeutic efficacy [11][29] Management Commentary on Operating Environment and Future Outlook - Management remains optimistic about the company's progress, particularly in membership growth, cost management, and AI-driven innovation [14][19] - The company is focused on achieving adjusted EBITDA profitability and improving margins through cost discipline and revenue growth [19] - Management highlighted the potential for AI to transform human health and therapeutic development, leveraging the company's extensive database [38][39] Other Important Information - The Therapeutics Discovery Group was eliminated, but this does not impact the development of the company's two clinical assets or its ability to pursue collaborations [13] - The company is working to regain NASDAQ listing compliance and is considering a reverse stock split if necessary [32] - Management is actively discussing financing options to address liquidity challenges and extend the cash runway [34] Q&A Session Summary Question: Status update on Total Health launch - Total Health has not yet rolled out to existing customers, with a potential relaunch planned for the fall [22][23] Question: Potential for further price increases - The company has already increased subscription pricing from $29 to $69 for 23andMe+ and is exploring further efficiencies in marketing spend [25][26] Question: Impact of Therapeutics Discovery Group wind-down - The wind-down does not impact the development of the company's two clinical assets, which remain a priority [28] Question: Potential combination strategies for 23ME610 - The company is actively exploring combination strategies, including with tyrosine kinase inhibitors, and plans to present additional data later this year [29][30] Question: Plans to regain NASDAQ compliance - The company has a 180-day extension to regain compliance and is seeking shareholder approval for a reverse stock split if necessary [32] Question: Addressing liquidity challenges - The company is focusing on driving revenue growth, improving margins, and exploring financing options to extend its cash runway [34] Question: Engagement with pharmaceutical stakeholders - The company is exploring opportunities to recruit patients for clinical trials and improve trial design using polygenic risk scores [35][37] Question: AI deployment plans - AI is expected to play a significant role in improving disease prevention, management, and therapeutic discovery, leveraging the company's extensive database [38][39]
23andMe (ME) - 2025 Q1 - Quarterly Results
2024-08-08 20:06
Revenue and Financial Performance - Total revenue for Q1 FY2025 was $40 million, a 34% decrease compared to $61 million in the same period last year, primarily due to lower research revenue and decreased consumer revenue from PGS kit sales and telehealth orders[2][3] - Consumer services revenue, including PGS, telehealth, and membership services, accounted for 97% of total revenue, while research services revenue represented 3%[4] - Total revenue for the three months ended June 30, 2024, was $40.4 million, a decrease from $60.9 million in the same period in 2023[15] - Consumer and Research Services revenue for the three months ended June 30, 2024, was $40.4 million, down from $60.9 million in the same period in 2023[15] Operating Expenses and Net Loss - Operating expenses decreased to $92 million from $140 million in the prior year, driven by lower personnel-related expenses and reduced Therapeutics-related R&D spend[4] - Net loss for Q1 FY2025 was $69 million, an improvement from a net loss of $105 million in the same period last year[5] - Net loss for the three months ended June 30, 2024, was $69.4 million, compared to a net loss of $104.6 million in the same period in 2023[14] - Stock-based compensation expense for the three months ended June 30, 2024, was $21.6 million, compared to $51.1 million in the same period in 2023[15] - Cyber security incident expenses, net of probable insurance recoveries, were $9.4 million for the three months ended June 30, 2024[15] Adjusted EBITDA and Cash Flow - Adjusted EBITDA loss improved to $35 million from $50 million in the prior year, primarily due to lower R&D and personnel-related expenses[5] - Total Adjusted EBITDA for the three months ended June 30, 2024, was $(35.2) million, an improvement from $(49.8) million in the same period in 2023[15] - Therapeutics segment reported an Adjusted EBITDA loss of $(12.4) million for the three months ended June 30, 2024, compared to $(31.1) million in the same period in 2023[15] - Net cash used in operating activities for the three months ended June 30, 2024, was $(43.3) million, compared to $(69.4) million in the same period in 2023[14] Cash and Assets - Cash and cash equivalents stood at $170 million as of June 30, 2024, compared to $216 million as of March 31, 2024[5] - Cash and cash equivalents decreased to $169.97 million as of June 30, 2024, from $216.49 million as of March 31, 2024[13] - Total assets as of June 30, 2024, were $368.0 million, down from $395.2 million as of March 31, 2024[13] Research and Development Initiatives - The company launched a large-scale genetic research study to identify genetic mechanisms related to GLP-1 medications and plans to introduce a GLP-1 weight loss telehealth membership on the Lemonaid Health platform[2] - 23andMe introduced a new Polygenic Risk Score report for bipolar disorder, bringing the total number of such reports available to members to over 30[2] - The company announced a collaboration with Nightingale Health to pilot a metabolomics blood biomarker panel with a cohort of 23andMe+ members[2] - Enrollment for the 23ME-00610 phase 1/2a clinical trial was completed in April 2024, and data from the Phase 2a expansion cohorts were presented at ASCO[2]
23andMe Reports First Quarter Fiscal 2025 Financial Results
GlobeNewswire News Room· 2024-08-08 20:05
Core Insights - 23andMe Holding Co. reported a total revenue of $40 million for Q1 FY25, a decrease of approximately 34% compared to the same period last year, primarily due to lower research revenue and consumer revenue [2][4][5] - The company is focused on becoming a sustainably growing and profitable entity while enhancing its membership services and telehealth offerings [3][4] Financial Performance - Total revenue for Q1 FY25 was $40 million, down from $61 million in Q1 FY24, reflecting a 34% decline [4][5] - Revenue from consumer services accounted for approximately 97% of total revenue, while research services contributed about 3% [5] - Operating expenses decreased to $92 million from $140 million in the prior year, driven by lower personnel-related expenses and reduced R&D spending [6] - The net loss for Q1 FY25 was $69 million, an improvement from a net loss of $105 million in the same quarter last year [7] Cash Position - As of June 30, 2024, the company had cash and cash equivalents of $170 million, down from $216 million as of March 31, 2024 [8] Strategic Developments - The company announced a large-scale genetic research study to explore the efficacy and side effects of GLP-1 medications and plans to launch a telehealth membership for weight loss [2] - A new Polygenic Risk Score report for bipolar disorder was made available to 23andMe+ members, expanding the total to over 30 such reports [2] - Collaboration with Nightingale Health was announced to pilot a metabolomics blood biomarker panel [2]
ME Stock Alert: CEO Anne Wojcicki Enters $200 Million Buyout Offer for 23andMe
Investor Place· 2024-08-02 15:15
Core Viewpoint - 23andMe's co-founder, Anne Wojcicki, has proposed a $200 million deal to take the company private by offering 40 cents per share for ME stock, which aligns with its recent trading value [1][3]. Group 1 - The special committee of 23andMe is currently reviewing the offer and has engaged Wells Fargo for financial advice and Dechert LLP for legal counsel, emphasizing its commitment to act in the best interest of shareholders [2]. - The company's stock has been trading below $1 for nearly a year, putting it at risk of delisting from the Nasdaq Exchange, and going private could mitigate this risk [3]. - As of Friday morning, ME stock has increased by 1.1% but has seen a significant decline of 57.4% year-to-date [4].
23andMe Special Committee responds to CEO's take-private proposal
Newsfilter· 2024-08-02 12:00
SOUTH SAN FRANCISCO, Calif., Aug. 02, 2024 (GLOBE NEWSWIRE) -- The Special Committee of the Board of Directors of 23andMe Holding Co. (NASDAQ:ME), a leading human genetics and biopharmaceutical company, today sent the following letter to Anne Wojcicki, Chief Executive Officer, Co-Founder, and Chair of the Board of Directors of 23andMe, in response to Ms. Wojcicki's previously disclosed preliminary non-binding indication of interest to acquire all of the outstanding shares of 23andMe not owned by her or her ...
23andMe Special Committee responds to CEO's take-private proposal
GlobeNewswire News Room· 2024-08-02 12:00
Core Viewpoint - The Special Committee of 23andMe Holding Co. has expressed disappointment with CEO Anne Wojcicki's preliminary proposal to acquire outstanding shares, citing lack of premium, committed financing, and conditional nature of the offer as key issues [2][3]. Group 1: Proposal Evaluation - The proposal from Anne Wojcicki offers cash consideration of $0.40 per share for Class A and Class B Common Stock, which does not provide any premium over the closing price on July 31 [1][2]. - The Special Committee views the proposal as insufficient and not in the best interest of non-affiliated shareholders, requesting the withdrawal of any opposition to alternative transactions [2][4]. Group 2: Expectations for Revised Proposal - The Special Committee expected a fully-financed and actionable proposal that aligns with the interests of non-affiliated shareholders, and is willing to provide additional time for a revised proposal [3][4]. - Any revised proposal must include fully committed financing and should not impose deal expenses on unaffiliated shareholders, while remaining subject to approval by the Special Committee and a majority of unaffiliated shareholders [4][5]. Group 3: Future Actions - In the absence of a satisfactory revised offer, the Special Committee plans to engage a consultant to develop a revised business plan aimed at achieving a more sustainable financial profile and profitability [5].
23andMe Announces CEO's Take-Private Proposal
Newsfilter· 2024-08-01 12:00
SOUTH SAN FRANCISCO, Calif., Aug. 01, 2024 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (NASDAQ:ME), a leading human genetics and biopharmaceutical company, has received a preliminary nonbinding indication of interest from Anne Wojcicki, Chief Executive Officer, Co-Founder, and Chair of the Board of Directors of 23andMe, to acquire all of the outstanding shares of 23andMe not owned by her or her affiliates or any other stockholder that she invites to roll over their shares for cash consideration of $0.40 per sha ...
23andMe CEO files proposal to take company private as stock craters
CNBC· 2024-07-31 22:11
A sign is posted in front of the 23andMe headquarters in Sunnyvale, California, on Feb. 1, 2024. Anne Wojcicki, CEO of 23andMe, has submitted a proposal to take the genetic testing company private as its stock price continues to hover below $1. Wojcicki said she was prepared to acquire all of 23andMe's outstanding shares of common stock in cash for 40 cents per share, according to a Wednesday filing with the U.S. Securities and Exchange Commission. She expressed interest in acquiring the company in April, s ...
23andMe to Report Q1 FY2025 Financial Results
Newsfilter· 2024-07-25 20:45
SOUTH SAN FRANCISCO, Calif., July 25, 2024 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (23andMe), a leading human genetics and biopharmaceutical company with a mission to help people access, understand, and benefit from the human genome, announced today that it will report financial results for the first quarter of fiscal year 2025 (FY2025) after the market closes on Thursday, August 8, 2024. The Company will webcast a conference call at 4:30 p.m. Eastern Time on that date to discuss the quarter's ...