NEW YORK, Sept. 19, 2024 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces an investigation into 23andMe Holding Co. (NASDAQ:ME) regarding whether the board of directors and the co-founder and current CEO Anne Wojcicki ("Wojcicki") of 23andMe breached their fiduciary duties in connection with Wojcicki's ongoing effort to purchase all 23andMe shares she does not already own. If you are a holder of 23andMe, you are encouraged to submit your information at: https://www.bfalaw ...

Board Resignations and CEO's Response - Seven out of eight board members of 23andMe have resigned, leaving the CEO as the sole remaining member [1] - The resigning directors cited dissatisfaction with the CEO's buyout offer, stating it was not in the best interest of non-affiliated shareholders [2] - The CEO expressed surprise and disappointment at the resignations, maintaining that taking the company private remains the best strategic option [3] Buyout Proposal and Rejection - The CEO proposed to acquire all outstanding shares not owned by her or her affiliates at $0.40 per share in July [4] - A special committee rejected the proposal, deeming it insufficient and not in the best interest of non-affiliated shareholders [5] - The directors noted no significant progress over the past five months, leading them to believe no satisfactory proposal is forthcoming [6] Financial and Market Performance - 23andMe's share price dropped to a new low of $0.30 following the board resignations, rebounding slightly to $0.35 the next day [7] - The company is now valued at less than its cash reserves and is being referred to as a penny stock by financial publications [7] - Since going public in 2021, 23andMe has never turned a profit and risks depleting its cash reserves by next year [8] Operational Challenges - 23andMe is best known for its saliva-based genetic ancestry test kits [8] - The company has faced significant challenges, including a data breach that compromised the personal information of nearly 7 million users [8]

All seven members of 23andMe's board resigned in a stinging rebuke to a proposal by CEO Anne Wojcicki's plans to to take the company private. Wojcicki, who has been trying to take the company private since April, proposed to acquire all outstanding shares of 23andMe not owned by her or her affiliates for $0.40 per share, in July. "I am surprised and disappointed by the decision of the directors to resign," Wojcicki said in a memo Tuesday to employees obtained by The Post. 3 All seven members of 23andMe's bo ...

Anne Wojcicki, co-founder and chief executive officer of 23andme Inc., during the South by Southwest (SXSW) festival in Austin, Texas, US, on Friday, March 10, 2023. All seven independent directors of 23andMe resigned from the company's board Tuesday, a move that CEO Anne Wojcicki said left her "surprised and disappointed," according to a memo to employees. Wojcicki, who co-founded 23andMe in 2006, said she remains committed to taking the company private. The genetic-testing company went public in 2021 thro ...

SOUTH SAN FRANCISCO, Calif., Sept. 17, 2024 (GLOBE NEWSWIRE) -- The independent directors of the Board of 23andMe Holding Co. (Nasdaq: ME), today sent the following letter to Anne Wojcicki, Chief Executive Officer, Co-Founder, and Chair of the Board of Directors of 23andMe, in which the independent directors have provided their resignation from the Board, effective immediately: Dear Anne, We, the independent directors of the 23andMe Board, hereby tender our resignations, effective immediately. After months ...

23ME-00610 monotherapy demonstrates preliminary evidence of clinical benefit in clear-cell renal-cell carcinoma, with one confirmed partial response Higher tumor expression of CD200 and human genetics correlated with increased clinical benefit, suggesting potential value as patient selection biomarkers Greater response in "cold" tumors suggests opportunity in patients unable to benefit from PD-1/PD-L1 checkpoint inhibitors SUNNYVALE, Calif., Sept. 15, 2024 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME ...

23ME-01473 inhibited tumor growth in a patient-derived xenograft mouse model of non-small cell lung cancer Elevated levels of soluble and tumor-bound ULBP6 confirmed in squamous cell carcinomas and a subset of adenocarcinomas, offering potential indications to assess clinical activity Phase 1 trial ongoing with first patient dosed in March 2024 SUNNYVALE, Calif., Sept. 15, 2024 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) ("23andMe"), a leading human genetics and biopharmaceutical company, announced ...

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]

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]

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]