Toronto, Ontario--(Newsfile Corp. - December 18, 2025) - Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) (the "Company" or "Telo"), a leader in diagnostic and prognostic innovation through advanced telomere analytics, today announced the initiation of a new multiple myeloma (MM) Minimal Residual Disease (MRD) clinical trial in collaboration with the University of Athens. This retrospective study is a key component of Telo's expanding, multi-center MRD validation program and is designed to evaluate the clin ...

Core Insights - Telo Genomics presented its innovative approach to Minimal Residual Disease (MRD) testing for Multiple Myeloma at the 67th American Society of Hematology Annual Meeting, showcasing the potential of its TeloView® 3D telomere profiling platform [1][4] Company Overview - Telo Genomics is a biotech company focused on developing diagnostic and prognostic tests for human diseases through telomere analysis, with applications in oncology and neurological diseases [9] - The company aims to provide actionable insights for medical professionals treating Multiple Myeloma, a challenging blood cancer [9] MRD Testing Insights - The new MRD evaluation method combines the enumeration of individual MM Circulating Tumor Cells (CTCs) from peripheral blood with the TeloView® platform, achieving a detection limit of 1 in 10^7 [2] - TeloView® has identified distinct 3D genome profile clusters that correlate with mutation rates, with larger studies planned to validate these MRD profiles for predicting relapse risks [3] Market Potential - The global MRD testing market is projected to reach USD 4.1 billion by 2032, driven by advancements in drug development and personalized healthcare [6] - The total addressable market for Multiple Myeloma assays is over 750,000 tests per year in the US, highlighting significant demand for MRD testing [8] Clinical Relevance - MRD is defined as the small number of cancer cells remaining post-treatment, providing critical information for clinicians regarding patient remission status [5] - The FDA's acceptance of MRD as a clinical endpoint for accelerated approval of new therapies in Multiple Myeloma indicates a shift towards more rapid drug approvals [5]

Financial Data and Key Metrics Changes - Total company revenue for Q3 2025 was $94 million, representing a 102% increase year over year [14] - Adjusted EBITDA was $28 million compared to a loss of $14.3 million a year ago [14] - Net income for the quarter was $9.5 million [14] - MRD revenue grew 52% year over year to $56.8 million [14] - Total company gross margin, excluding non-cash revenue from Genentech, was 70% [15] - Total operating expenses were $83.7 million, up 6% year over year [15] Business Line Data and Key Metrics Changes - ClonoSEQ clinical revenue grew 83% year over year and 18% quarter over quarter [6] - ClonoSEQ test volume increased 38% year over year to 27,111 tests delivered [14] - MRD Pharma revenue grew 11% year over year, including $6.5 million in milestone revenue [10] - Immune medicine revenue from pharma and academic services was $3.4 million, down from $5.5 million a year ago [15] Market Data and Key Metrics Changes - Blood-based testing now represents 45% of total MRD test volume, achieving the full-year goal ahead of plan [6] - Community-based testing accounted for 31% of total ClonoSEQ volume [7] - The number of ordering healthcare providers grew 38% year over year to over 4,100 [7] Company Strategy and Development Direction - The company is focused on expanding MRD testing integration into patient care and enhancing clinical utility [4] - EMR integration efforts are aimed at increasing test volume and protecting against competition [8] - The company plans to further expand its EMR footprint and expects continued acceleration from integrated accounts [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the trajectory of the MRD business, highlighting its cash flow positivity and consistent growth [18] - The company is raising its full-year MRD revenue guidance to a range of $202-$207 million, reflecting stronger than expected performance [17] - Management noted that recent guideline updates are expected to enhance clinical uptake and utilization of MRD testing [30] Other Important Information - The NCCN guidelines were updated to incorporate MRD-guided treatment options, enhancing the clinical relevance of ClonoSEQ [5] - The company achieved several policy wins, including coverage from major payers, which is expected to drive future growth [7] Q&A Session Summary Question: Insights on MRD pharma business backlog - Management indicated that the $200 million backlog is expected to be recognized generally over a five to seven-year timeframe, with strong bookings anticipated for 2026 and beyond [20] Question: Expectations for MRD volume growth in 2026 - Management expressed confidence in achieving growth in the range of 30% for MRD volume in 2026, supported by various underlying factors [22] Question: ClonoSEQ ASP projections for next year - Management refrained from providing specific numbers for 2026 but expressed confidence in achieving meaningful growth in ASP, with a long-term target of $1,700-$1,800 per test [23][24] Question: Community penetration and sales force strategy - Management noted that community penetration is currently at 30% and emphasized the potential for growth, with no immediate plans for significant expansion of the sales force [37][39] Question: Drivers of sequencing gross margin improvement - The increase in sequencing gross margin to 66% was primarily driven by the implementation of NovaSeq X, which contributed significantly to the improvement [42] Question: Impact of EMR tools on testing frequency - Management explained that EMR tools allow for serial testing orders, which are expected to increase testing frequency and improve patient care [44][46] Question: Future potential for ClonoSEQ as a primary endpoint - Management indicated that efforts are ongoing to establish ClonoSEQ as an accelerated endpoint for approval in CLL and DLBCL, with expectations for faster progress compared to multiple myeloma [57]

Summary of Adaptive Biotechnologies FY Conference Call Company Overview - **Company**: Adaptive Biotechnologies (NasdaqGS:ADPT) - **Date**: September 10, 2025 - **Key Speakers**: Chad Robins (CEO), Kyle Piskel (CFO) Key Accomplishments and Goals - Achieved EBITDA profitability ahead of schedule, a significant milestone in the industry [2] - Successfully implemented Flatiron EMR integration and transitioned to NovaSeq X from NextSeqs [2] Market Penetration and Testing Insights - Market penetration for various hematologic malignancies: - Multiple Myeloma: 12% - Acute Lymphoblastic Leukemia (ALL): 28% - Mantle Cell Lymphoma (MCL): 7% - Chronic Lymphocytic Leukemia (CLL): 5% - Diffuse Large B-Cell Lymphoma (DLBCL): 3% [3] - Community penetration is growing rapidly, with a 16% quarter-over-quarter growth in community settings [4][5] - Blood-based testing now accounts for 44% of MRD testing volume, up from 40% in Q2 2024 [11] Testing Frequency and Clinical Utility - Average testing frequency: - ALL: 3.5 to 4 tests per patient per year - Multiple Myeloma: 2 to 2.5 tests per patient per year - CLL: 1 test per patient per year [8] - 80% of community oncologists are utilizing the new serial testing option integrated into EMR systems [10][26] - Clinical utility trials (MASTER and MIDUS) are enhancing market penetration and increasing test frequency [30][32] Reimbursement and Regulatory Updates - Recent CMS reimbursement for surveillance in MCL opens opportunities for other hematologic malignancies [20] - NCCN guideline updates strengthen recommendations for clonoSEQ testing in multiple myeloma [17] EMR Integration and Sales Strategy - 40 Epic integrations and 113 community accounts via oncoEMR, with a focus on quality over quantity [22] - Post-integration, accounts have seen a 25% growth in volume [23] - EMR integration is expected to drive consistent ordering patterns [26] Financial Performance and Projections - Targeting an ASP of $1,300 for clonoSEQ in 2025, with current performance exceeding $1,290 [45] - NovaSeq X rollout expected to improve gross margins by 5% to 8% [47] - Cash burn guidance has been reduced while maintaining over 25% top-line growth [48] Future Outlook - Excitement around the NeoGenomics partnership and its potential impact on community presence [27] - Continued focus on leveraging clinical utility data to drive growth in the community setting [50] - Long-term goal to establish a pan-disease recurrence monitoring paradigm [21] Additional Insights - The company is exploring monetization opportunities for returned assets from Genentech, including a digital TCR antigen map [39][40] - The integration of MRD as a primary endpoint in multiple myeloma trials is expected to enhance the company's pharma business [34][35] This summary encapsulates the key points discussed during the conference call, highlighting the company's achievements, market strategies, and future growth prospects.

Summary of Natera Conference Call Company Overview - **Company**: Natera (NasdaqGS:NTRA) - **Industry**: Life Sciences and Diagnostics Key Points Signatera Performance - Natera reported record sequential volume growth for Signatera, with an upgraded volume growth outlook [3][4] - There is a significant increase in interest in minimal residual disease (MRD) testing, with Natera being the market leader [4][5] - The company noted strong data from the ASCO GI conference, particularly regarding colorectal cancer, which has driven growth [5][6] - New patient starts for Signatera doubled the previous record and tripled the normal figures, indicating robust demand despite competition [7][8] Market Penetration and Growth Potential - Current penetration in the MRD setting is described as low single digits, suggesting substantial growth potential [8][9] - Colorectal cancer is highlighted as a key area for growth due to its clinical utility in decision-making for adjuvant settings and recurrence monitoring [9][10] - Natera is capturing new patients from both newly diagnosed and prevalent populations, indicating a broad market opportunity [10][11] Physician Engagement and Education - Approximately 40% to 50% of oncologists in the U.S. are ordering Signatera, with ongoing efforts to educate more physicians about its benefits [18][19] - The company is expanding its commercial team to enhance physician engagement and increase adoption rates [18][19] Medicare Coverage and Revenue Potential - Natera has seven Medicare coverages and anticipates submitting for an additional ten indications over the next couple of years, potentially generating $250 million to $300 million in incremental revenue [21][24] - The company has a strong track record of quality studies, which is crucial for obtaining Medicare coverage [22][23] International Expansion - Natera is preparing for a commercial launch in Japan, expected in 2027, following FDA approval and pricing discussions with the national health system [28][31] - The colorectal cancer opportunity in Japan is comparable to that in the U.S., with significant unmet needs in the market [30][31] Women's Health and NIPT Market - Natera holds over 50% market share in the NIPT space, with a penetration rate of approximately 65% [32][33] - The company is launching new tests, including a fetal focus test that allows for direct detection of disorders in the fetus without needing the father's sample [36][37] Early Detection Initiatives - The PRESEDE CRC trial is set to provide data on early detection of colorectal cancer, with results expected soon [43][44] - Natera aims to be a major player in early cancer detection, with plans to launch its FIND study by 2027 [45] Financial Outlook - Natera reported a strong second quarter, raising revenue outlook while maintaining operational expense guidance [46][47] - The company is investing in product launches and clinical trials, anticipating significant growth in 2026 as the commercial team matures [48][50] Future Opportunities - The primary opportunities identified include continued growth of Signatera and advancements in AI and data initiatives, which have garnered interest from pharmaceutical partners [51][52] Additional Insights - Natera's focus on high-quality clinical trials and innovative technologies positions it well for future growth in both existing and new markets [40][41]

Financial Data and Key Metrics Changes - Total revenue for the second quarter was $58.9 million, representing a 36% growth year over year, with 85% from the MRD business and 15% from immune medicine [20][21] - MRD revenue grew 42% year over year to $49.9 million, with clinical and pharma contributions of 65% and 35% respectively [20][21] - Sequencing gross margin improved by 14 percentage points year over year to 64%, driven by lower labor and overhead costs alongside increasing volumes and higher pricing [22][23] - Cash burn for the quarter was approximately $11 million, a 36% improvement over the same period last year, ending with a solid cash position of $222 million [7][20] Business Line Data and Key Metrics Changes - ClonoSEQ revenue grew 57% year over year, with over 25,300 tests delivered, up 37% versus the prior year and up 10% sequentially [7][20] - The MRD business achieved positive adjusted EBITDA of $1.9 million, a significant improvement from a deficit of $11.3 million a year ago [23] - Immune medicine revenue was $8.9 million, up 13% from a year ago, with adjusted EBITDA loss improving by 14% year over year [23] Market Data and Key Metrics Changes - Blood-based testing represented 44% of MRD tests, up 40% from a year ago, with multiple myeloma accounting for 41% of U.S. ClonoSEQ volume [8][9] - The average selling price (ASP) for ClonoSEQ tests in the U.S. reached $12.90, a 17% increase year over year [10][21] - The backlog for MRD Pharma business grew to $218 million, up 21% from the prior year, with 175 active global clinical trials [12][13] Company Strategy and Development Direction - The company is focused on expanding EMR integrations to drive volume growth, with significant progress in integrating ClonoSEQ into Flatiron's Onco EMR [11][12] - The MRD Pharma business is expected to continue growing, with a strong pipeline and increasing global support for MRD testing as a key endpoint in clinical trials [13][106] - The company aims to achieve a cash burn target of $25 million to $30 million by scaling revenue generation from pharma partnerships while managing R&D investments [19][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving raised full-year guidance, driven by stronger-than-expected clinical volume performance and higher MRD milestone revenue anticipated for the year [20][26] - The company remains optimistic about the growing global support for MRD testing to accelerate new treatments across various malignancies [13][106] - Management highlighted the importance of the recent NCCN guidelines update for multiple myeloma, which is expected to support increased adoption of ID testing [96] Other Important Information - The company has begun processing ClonoSEQ tests on the NovaSeq X, which is expected to scale operations and improve margins [6] - The integration of ClonoSEQ into EMR systems is seen as a key driver of volume growth, with positive feedback from healthcare providers [11][34] Q&A Session Summary Question: Can you provide insights on the Flatiron integration and its impact on volume growth? - Management noted that the integration with Flatiron is in early stages, but initial results are promising, with expectations for consistent ordering at clinically appropriate time points [34][35] Question: What are the expectations for ClonoSEQ pricing and payer traction? - The company is seeing improvements in pricing due to contracting efforts, particularly with larger national payers, and anticipates continued pricing momentum in the second half of the year [37][38] Question: How does the company plan to balance investments in the business with EBITDA margin potential? - Management indicated that the business is set up to continuously produce positive adjusted EBITDA, with ongoing investments in MRD and international markets to support growth [42][44] Question: What are the implications of the NCCN guidelines update for multiple myeloma? - The update is viewed as a tailwind for the company, reinforcing the importance of ID testing at diagnosis, which is expected to contribute to ongoing volume growth [96][97] Question: Can you elaborate on the NEO collaboration and its expected impact? - The NEO collaboration is in its pilot phase, with expectations for material impact on volumes in 2026 and 2027, while the current focus is on operational processes [86][88]

Core Insights - QIAGEN N.V. (QGEN) is expanding its oncology diagnostics portfolio through partnerships with Tracer Biotechnologies and Foresight Diagnostics to enhance minimal residual disease (MRD) testing in clinical trials for companion diagnostics [1][8] Company Developments - The new collaborations aim to support the increasing demand for decentralized, non-invasive diagnostic tools that facilitate precision medicine and personalized care [2][8] - QIAGEN's MRD portfolio includes various sample technologies and testing platforms, focusing on scalable and cost-effective solutions using the QIAcuity digital PCR (dPCR) system [3][5] - The partnership with Tracer Biotechnologies will develop CDx for MRD testing in solid tumors, utilizing minimally invasive blood samples for high-sensitivity monitoring [5][6] - Foresight Diagnostics is collaborating with QIAGEN to create a kit-based version of the Foresight CLARITY assay for circulating tumor DNA (ctDNA) detection, aimed at broader clinical access [6][8] Market Position and Financials - QIAGEN has a market capitalization of $10.03 billion and an earnings yield of 5.2%, significantly higher than the industry average of -32.1% [4] - The global cancer diagnostics market is projected to grow at a compound annual growth rate of 6.1% from a valuation of $109.61 billion in 2024, driven by rising cancer prevalence and advancements in diagnostic technologies [9]

Financial Data and Key Metrics Changes - Company achieved revenues of over $20,600,000 in Q1 2025, representing a 6% increase compared to $19,500,000 in the same period last year [24][9] - Biopharma revenue grew to $13,600,000, a 39% increase from $9,800,000 in Q1 2024 [24][20] - Gross margin improved to 35% from 28.1% year-over-year, primarily due to a favorable customer mix [25][26] - Net loss for Q1 2025 was $15,800,000 compared to $13,000,000 in the prior year [27] Business Line Data and Key Metrics Changes - Clinical diagnostic business had its highest quarterly revenue to date, contributing to overall revenue growth [9] - Molecular tests delivered increased by 52% to 2,184 tests compared to 1,441 in Q4 2024 [10] - The company is tracking to achieve 30% to 40% quarter-over-quarter growth in molecular results [9] Market Data and Key Metrics Changes - The MRD testing market is expected to mature into a $20,000,000,000 market, with Personalis positioned for success [7] - Approximately 40% of MRD positive results are in the ultra-sensitive range, which is a key differentiator [11] Company Strategy and Development Direction - The company is focused on a "win in MRD" strategy, emphasizing customer care and robust experience [12] - Plans to deepen clinical evidence and achieve reimbursement for three indications: breast cancer, lung cancer, and immunotherapy monitoring [12][13] - The company aims to expand its tumor profiling product portfolio to capture additional business from biopharma [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving reimbursement for at least two indications in 2025 [13] - The company is optimistic about the potential of its colorectal cancer data to drive future revenue [18] - Management highlighted the importance of maintaining a balance between growth and cost management in the absence of reimbursement [42] Other Important Information - Cash and cash equivalents at the end of Q1 2025 were $185,700,000, providing a comfortable runway for growth objectives [9] - The company raised approximately $17,800,000 through common stock sales during the quarter [28] Q&A Session Summary Question: Will the company steer its commercial organization towards breast cancer patients if reimbursement comes through this year? - Management confirmed that efforts are already focused on breast cancer, lung cancer, and immunotherapy monitoring, with plans to accelerate once reimbursement is clear [32][33] Question: What is the retention rate of doctors ordering tests? - Management reported high retention rates, with several hundred physicians now ordering tests, a mix of new and recurring orders [35][36] Question: How does the company view the growth in marketing efforts pre- and post-reimbursement? - Management indicated that they are currently metering growth but could accelerate efforts significantly once reimbursement is achieved [40][41] Question: Can the company provide an update on the Victory study data? - Management expressed satisfaction with the interim results, noting high sensitivity in detecting recurrences in colorectal cancer patients [54][55] Question: What is the commercialization strategy following the MolDXPress filing? - Management reiterated confidence in tracking ahead of schedule for reimbursement approvals and highlighted the potential for catch-up revenue once positive decisions are made [74][75]

Financial Data and Key Metrics Changes - Company achieved revenues of over $20,600,000 in Q1 2025, representing a 6% increase compared to $19,500,000 in the same period last year [24] - Biopharma revenue grew to $13,600,000, a 39% increase from $9,800,000 in Q1 2024 [24][21] - Gross margin improved to 35% from 28.1% year-over-year, primarily due to a favorable customer mix [26] - Net loss for Q1 was $15,800,000 compared to $13,000,000 in the prior year [28] Business Line Data and Key Metrics Changes - Clinical diagnostic business had its highest quarterly revenue to date, contributing to overall revenue growth [8] - Molecular tests delivered increased by 52% to 2,184 tests compared to 1,441 in Q4 2024 [10] - The company expects 30% to 40% quarter-over-quarter growth in molecular results for 2025 [9] Market Data and Key Metrics Changes - The MRD testing market is projected to mature into a $20,000,000,000 market, with Personalis positioned for success [6] - Approximately 40% of MRD positive results are in the ultra-sensitive range, which is a key differentiator [11] Company Strategy and Development Direction - The company is focused on a "win in MRD" strategy, emphasizing customer care and robust experience [12] - Plans to deepen clinical evidence and achieve reimbursement for three indications: breast cancer, lung cancer, and immunotherapy monitoring [12] - The company is targeting to achieve reimbursement for at least two indications in 2025 [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue guidance of $80,000,000 to $90,000,000 for 2025, despite potential reimbursement timing variability [30] - The company is optimistic about the impact of its ultra-sensitive MRD tests on patient management and outcomes [22] Other Important Information - Cash and cash equivalents at the end of the quarter were $185,700,000, providing a comfortable runway for growth objectives [8] - The company raised approximately $17,800,000 through common stock sales during the quarter [29] Q&A Session Summary Question: Will the company steer its commercial organization towards breast cancer patients if reimbursement comes through this year? - Management confirmed that efforts are already focused on breast cancer, lung cancer, and immunotherapy monitoring, with plans to accelerate once reimbursement is clear [33][34] Question: What is the retention rate of doctors ordering tests? - Management reported high retention rates, with several hundred physicians ordering tests, a mix of new and recurring orders [36] Question: How does the company view the growth in marketing efforts pre- and post-reimbursement? - Management indicated that they are currently metering growth but can accelerate efforts significantly once reimbursement is achieved [40][41] Question: Can the company provide insights on the demographics of patients in the Victory study? - Management noted that the study included a cross-section of colorectal cancer patients across all stages, with high sensitivity in detecting recurrences [55] Question: What is the company's confidence level regarding reimbursement approval timelines? - Management expressed confidence in the process, stating that they have not seen any impact from changes in Washington on their timelines [92]

Financial Performance - Total revenue for Q1 2025 was $52.4 million, a 25% increase year-over-year compared to $41.9 million in Q1 2024[23] - MRD (Minimal Residual Disease) revenue reached $43.7 million in Q1 2025, representing a 34% year-over-year growth[8, 23] - Excluding milestones, MRD revenue grew by 39% year-over-year[8] - Immune Medicine revenue was $8.7 million in Q1 2025, a 6% decrease compared to Q1 2024[23] - Total operating expenses decreased by 9% year-over-year[8, 23] - The company's Q1 2025 cash burn was approximately $23 million, a 38% reduction compared to Q1 2024[8] - The company had a strong cash position with approximately $233 million in cash, cash equivalents, and marketable securities as of March 31, 2025[8] MRD Business - Clinical testing revenue increased by 55% year-over-year in Q1 2025[11] - clonoSEQ US volume reached 22,368 in Q1 2025[12] - Ordering HCPs (Healthcare Professionals) increased by 31% year-over-year in Q1 2025[12] Guidance - The company increased its FY 2025 MRD revenue guidance to between $180 million and $190 million, compared to the previous guidance of $175 million to $185 million[26]