NeoGenomics, Inc.

Issued on behalf of Oncolytics Biotech Inc. USA News Group News Commentary VANCOUVER, BC, Jan. 15, 2025 /PRNewswire/ -- As 2025 begins, the American Association for Cancer Research (AACR) recently published forecasts from experts showcasing transformative advances in cancer research, including cutting-edge AI technologies, novel targeted therapies, and innovative cancer vaccines. With over 50 oncology drug approvals in 2024, including the first tumor-infiltrating lymphocyte cell therapy, this year holds great promise for precision medicine and immunotherapy. Amid growing expectations for an active year for biotech stocks in 2025, developers of new cancer therapies are already releasing important developments, with recent news coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Adaptive Biotechnologies Corporation (NASDAQ: ADPT), NeoGenomics, Inc. (NASDAQ: NEO), Elevation Oncology, Inc. (NASDAQ: ELEV), and ORIC Pharmaceuticals, Inc. (NASDAQ: ORIC). The article continued: Statista analysts project that the oncology drugs market will generate an estimated revenue of $208.9 billion in 2025. Meanwhile, Global Market Insights reports that the global oncology market, valued at approximately $320.3 billion in 2024, is expected to grow at a compound annual growth rate (CAGR) of 10.8% from 2025 to 2034, reaching $866.1 billion. Regulatory Approval Clears Path for Oncolytics Biotech® to Advance Promising Pancreatic Cancer Treatment, Following a Review of Safety Data Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Germany's medical regulatory body, the Paul-Ehrlich-Institute (PEI), has approved the continuation of patient enrollment into Cohort 5 of the GOBLET study. This cohort is evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®) in newly diagnosed pancreatic ductal adenocarcinoma (PDAC) patients. Following a positive safety review by the independent Data Safety Monitoring Board (DSMB), which recommended continuation, the PEI's approval allows Cohort 5 to progress to full enrollment. Early safety data will be presented at the upcoming 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium later this month, with initial efficacy results expected in the second half of the year. "Pelareorep has the potential to meaningfully improve outcomes for patients with metastatic pancreatic cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "Encouraging tumor response rates observed in an earlier cohort of the GOBLET study underscore pelareorep's promise in this disease. GOBLET Cohort 5 extends our evaluation by testing pelareorep with a different chemotherapy regimen, mFOLFIRINOX, which broadens the range of pancreatic cancer patients who may benefit from this innovative therapy. Positive results from this cohort may ultimately enable pelareorep to benefit the large majority of metastatic pancreatic patients for whom improved treatment options are badly needed." The Phase 1/2 GOBLET study is testing pelareorep, an oncolytic reovirus, in combination with other treatments for advanced gastrointestinal cancers, including pancreatic, colorectal, and anal cancers. Conducted at 17 centers in Germany, the study aims to evaluate response rates, safety, and biomarkers across multiple treatment arms, with promising cohorts advancing to further testing. AIO is a non-profit organization that evolved from the medical oncology working group within the German Cancer Society (DKG). Dedicated to advancing science and research in medical oncology, AIO has grown into a prominent sponsor and study management company. Over the years, it has established a strong reputation both within Germany and on the international stage for its contributions to oncology research and study development. Oncolytics Biotech's work represents a significant step forward in the fight against metastatic pancreatic cancer, addressing a critical need for more effective treatment options in this aggressive disease. By leveraging the innovative potential of pelareorep in combination with established therapies, the company is paving the way for breakthroughs that could transform outcomes for patients and unlock value for investors. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Adaptive Biotechnologies Corporation (NASDAQ: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, NeoGenomics, Inc. (NASDAQ: NEO), a leading oncology testing services company, recently announced a multi-year exclusive strategic commercial collaboration that will advance minimal residual disease (MRD) monitoring options for patients with select blood cancers. Adaptive's clonoSEQ® is the first and only FDA-cleared test for detecting minimal residual disease (MRD) in lymphoid cancers, while NeoGenomics' COMPASS® and CHART® offer comprehensive and personalized testing for complex blood cancers. By combining clonoSEQ with these advanced services, oncologists can develop tailored treatment plans, assess patient risk more accurately, and gain real-time insights into disease progression, enhancing care for blood cancer patients. "As a leader in oncology testing with an extensive menu of precision oncology offerings, NeoGenomics is a natural partner for us," said Chad Robins, CEO and Co-Founder of Adaptive Biotechnologies. "We are proud of this collaboration, which expands access to the valuable insights that clonoSEQ MRD results offer, ultimately helping more providers and patients benefit from knowing their MRD status." Under a new agreement, clinicians using NeoGenomics' COMPASS diagnostic tool for blood cancers like multiple myeloma, B-ALL, CLL, and DLBCL can now include Adaptive Biotechnologies' clonoSEQ Clonality (ID) test at diagnosis to identify patient-specific DNA sequences for ongoing MRD (minimal residual disease) tracking. This integration allows seamless monitoring of disease burden throughout treatment using CHART, giving patients access to clonoSEQ insights and increasing eligibility for clinical trials that rely on MRD testing to guide therapy decisions. All clonoSEQ testing will be conducted at Adaptive's specialized laboratory, ensuring accurate and consistent results. Adaptive and NeoGenomics are preparing to implement the infrastructure for their partnership, with cross-promotional efforts expected to launch later this year, though financial terms remain undisclosed. iBio, Inc. (NYSE-American: IBIO) an AI-driven innovator of precision antibody immunotherapies, in collaboration with AstralBio Inc., recently announced they've developed a breakthrough antibody targeting Activin E, a key protein linked to cardiometabolic disorders and obesity. This achievement demonstrates the strength of iBio's platform in tackling challenging targets and advancing innovative therapies, with plans for rapid testing of this and other candidates in advanced disease models. "Developing a functional antibody against Activin E, an achievement we believe to be an industry first, is a significant milestone for iBio," said Martin Brenner, Ph.D., DVM, iCEO and Chief Scientific Officer of iBio. "This breakthrough strengthens our efforts to expand our therapeutics pipeline for the treatment of cardiometabolic disorders and obesity with innovative next-generation solutions." Elevation Oncology, Inc. (NASDAQ: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, recently announced program updates and upcoming milestones. The company is advancing its pipeline with EO-3021, a potentially best-in-class antibody drug conjugate targeting Claudin 18.2 in advanced gastric/GEJ cancer, showing promising early results with a 42.8% overall response rate and a differentiated safety profile. The ongoing Phase 1 trial includes monotherapy and combination studies, with additional data expected in 2025 and 2026, while EO-1022, a HER3-targeting ADC for solid tumors, is progressing toward preclinical data release in 2025 and an IND filing in 2026. "We are rapidly advancing EO-3021 to address significant unmet needs in treating earlier lines of advanced gastric/GEJ cancer, where we believe we have a unique ability to improve on the standard of care," said Joseph Ferra, President and CEO of Elevation Oncology. "As we enter 2025, we are honing our focus, leveraging the competitive anti-tumor activity and differentiated safety profile of EO-3021 to explore combination approaches in the first- and second-line settings." ORIC Pharmaceuticals, Inc. (NASDAQ: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, recently provided early Phase 1b combination data for ORIC-944, operational highlights for 2024, and anticipated upcoming milestones. ORIC-944, a potent PRC2 inhibitor, has shown strong potential in treating metastatic castration-resistant prostate cancer (mCRPC), with deep and durable PSA responses and a favorable safety profile in early Phase 1b combination trials with apalutamide and darolutamide. Alongside advancements in ORIC-114 for NSCLC, ORIC's 2024 milestones include promising clinical data, strategic collaborations with Johnson & Johnson and Bayer, and a robust cash position expected to support operations into late 2026, positioning the company for continued progress in oncology drug development. "We made strong progress on multiple fronts in 2024, most notably with the initiation of multiple cohorts for ORIC-114 in NSCLC and ORIC-944 in mCRPC," said Jacob M. Chacko, M.D., President and CEO of Oric. "We also forged three strategic collaborations with leading pharma partners, strengthened our leadership team to expand functional capabilities, and completed a $125 million PIPE financing, extending our cash runway into late 2026. These accomplishments position us well for 2025 and beyond, with seven anticipated data readouts over the next 18 months as we advance toward potentially initiating registrational studies for ORIC-114 in the second half of 2025 and for ORIC-944 in early 2026." Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. 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FT. MYERS, Fla.--( BUSINESS WIRE )-- NeoGenomics, Inc. (“NeoGenomics” or the “Company”) (NASDAQ:NEO) , a leading oncology testing services company, today provided financial guidance for fiscal year 2025 and updated its Long-Range Financial Plan. “We enter 2025 with our patient-centric strategy in place, focusing on product innovation, further optimization and expansion of our commercial organization, and enhancing operational efficiencies,” said Chris Smith, chief executive officer of NeoGenomics. “Building on the strong momentum of double-digit revenue growth and margin expansion we have delivered over the last few years, we are updating our Long-Range Plan and now expect revenue growth of 12-13% annually, while expanding our leadership position in oncology testing.” 2025 Financial Guidance NeoGenomics is providing financial guidance 1 for 2025. The Company expects total revenues in the range of $735 million to $745 million and adjusted EBITDA in the range of $55 million to $58 million. FY 2024 Guidance FY 2025 Guidance YoY % Change from FY'24 ($ millions) Midpoint Low High Low High Total Revenue $661 $735 $745 11% 13% Adj. EBITDA $38.5 $55 $58 43% 51% With a strong cash position, we currently expect to retire the 2025 convertible notes maturing on May 1, 2025, with cash on hand. Long-Range Growth Plan The Long-Range Plan builds upon the successful execution of the previous three years. NeoGenomics intends to achieve the following: 12-13% revenue growth annually, including NGS growth of ~25% per year 2 Gross margin expansion of 100-150 bps per year Adjusted EBITDA improvement of 250-300 bps per year Positive cash flow from operations in 2025 and beyond Serving more than 1 million patients annually by 2028 and beyond ____________________ 1 The Company reserves the right to adjust this guidance at any time based on the ongoing execution of its business plan. Current and prospective investors are encouraged to perform their own due diligence before buying or selling any of the Company’s securities, and are reminded that the foregoing estimates should not be construed as a guarantee of future performance. 2 Revenue growth excludes MRD About NeoGenomics NeoGenomics, Inc. is a premier cancer diagnostics company specializing in cancer genetics testing and information services. We offer one of the most comprehensive oncology-focused testing menus across the cancer continuum, serving oncologists, pathologists, hospital systems, academic centers, and pharmaceutical firms with innovative diagnostic and predictive testing to help them diagnose and treat cancer. Headquartered in Fort Myers, FL, NeoGenomics operates a network of CAP-accredited and CLIA-certified laboratories for full-service sample processing and analysis services throughout the US and a CAP-accredited full-service sample-processing laboratory in Cambridge, United Kingdom. Forward-Looking Statements This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “could,” “would,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” “guidance,” “plan,” “potential” and other words of similar meaning, although not all forward-looking statements include these words. This press release includes forward-looking statements. These forward-looking statements address various matters, including statements regarding improving operational efficiency, returning to profitable growth and its ongoing executive recruitment process. Each forward-looking statement contained in this press release is subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the Company's ability to identify and implement appropriate financial and operational initiatives to improve performance, to identify and recruit executive candidates, to continue gaining new customers, offer new types of tests, integrate its acquisitions and otherwise implement its business plan, and the risks identified under the heading "Risk Factors" contained in the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and the Company's other filings with the Securities and Exchange Commission. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov , for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document (unless another date is indicated), and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Pairing Adaptive Biotechnologies’ clonoSEQ MRD results with NeoGenomics’ COMPASS and CHART assessment services empowers clinicians and patients with meaningful insights across the treatment continuumSEATTLE and FORT MYERS, Fla., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq:ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, and NeoGenomics, Inc. (Nasdaq:NEO), a leading oncology testing services company, today announced a multi-year exclusive strategic commercial collaboration that will advance minimal residual disease (MRD) monitoring options for patients with select blood cancers. Adaptive’s next-generation sequencing (NGS)-based clonoSEQ® is the first and only FDA-cleared in vitro diagnostic (IVD) test to detect MRD in lymphoid cancers. NeoGenomics’ COMPASS® and CHART® are a family of comprehensive and personalized assessment services for complex blood cancers, offering a unique multi-modal testing approach for every patient. With the growing adoption of MRD testing, the integration of clonoSEQ with COMPASS and CHART will help oncologists provide patients with personalized treatment strategies using advanced methods for evaluating patient risk status and delivering real-time insights into disease progression. “Our partnership with NeoGenomics reflects our shared commitment to empowering oncologists and pathologists to deliver the highest quality patient care,” said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. “As a leader in oncology testing with an extensive menu of precision oncology offerings, NeoGenomics is a natural partner for us. We are proud of this collaboration, which expands access to the valuable insights that clonoSEQ MRD results offer, ultimately helping more providers and patients benefit from knowing their MRD status.” Under the terms of the exclusive agreement, COMPASS evaluations performed for patients with multiple myeloma (MM), B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and diffuse large B-cell lymphoma (DLBCL) can now include a clonoSEQ Clonality (ID) test, which identifies patient-specific DNA sequences at initial diagnosis and enables that patient for clonoSEQ MRD tracking. Subsequent CHART assessments performed for those patients can then include clonoSEQ MRD testing throughout the continuum of care. clonoSEQ testing will continue to be performed by Adaptive Biotechnologies’ CLIA-certified, CAP-accredited laboratory in Seattle. Clinicians using NeoGenomics’ COMPASS to confirm a blood cancer diagnosis can now simultaneously identify the DNA sequences required to track their patient’s cancer, ensuring newly diagnosed patients have access to clonoSEQ MRD insights throughout their treatment. These patients also increase their likelihood of qualifying for the growing number of clinical trials that rely on clonoSEQ to guide or assess therapy. The ability for clinicians to obtain ongoing MRD testing via CHART, will make longitudinal monitoring of disease burden seamless and will enable clinicians less familiar with MRD to leverage the results at the most medically appropriate timepoints. “MRD testing is widely recognized as an integral part of blood cancer patient care, serving not only as a powerful prognostic tool but also guiding clinical decision-making,” said Chris Smith, chief executive officer of NeoGenomics. “NeoGenomics is proud to offer our customers access to clonoSEQ, the gold standard for clinical MRD monitoring. We believe Adaptive is the market leader in heme MRD and this strategic commercial collaboration reflects our broader commitment to providing best-in-class, personalized diagnostic testing for patients for their entire cancer journey while strengthening our leadership position in hematology testing.” Following today’s announcement, Adaptive and NeoGenomics will begin implementing the commercial and operational infrastructure needed to support the partnership. The companies expect to launch cross-promotional efforts later this year. Specific financial terms of the agreement are not disclosed. About clonoSEQ clonoSEQ® is available as an FDA-cleared in vitro diagnostic (IVD) test service provided by Adaptive Biotechnologies to detect measurable residual disease (MRD) in bone marrow from patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). Additionally, clonoSEQ is available for use in other lymphoid cancers and specimen types as a CLIA-validated laboratory developed test (LDT). To review the FDA-cleared uses of clonoSEQ, visit clonoSEQ.com/technical-summary. clonoSEQ is CE-marked under the In Vitro Diagnostic Regulation (IVDR) in the European Union (EU). For the approved intended use in the EU under IVDR, please refer to the instructions for use, available on request. clonoSEQ leverages Adaptive Biotechnologies’ proprietary immune medicine platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The assay provides standardized, accurate, and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to treatment, inform changes in therapy, monitor disease burden over time, and detect potential relapse early. Clinical practice guidelines in hematologic malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes have been shown to be strongly associated with MRD levels measured by clonoSEQ in patients diagnosed with CLL, MM, B-ALL and DLBCL. About Adaptive BiotechnologiesAdaptive Biotechnologies (“we” or “our”) is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business segments: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer and autoimmune disorders. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient. About NeoGenomics, Inc.NeoGenomics, Inc. is a premier cancer diagnostics company specializing in cancer genetics testing and information services. We offer one of the most comprehensive oncology-focused testing menus across the cancer continuum, serving oncologists, pathologists, hospital systems, academic centers, and pharmaceutical firms with innovative diagnostic and predictive testing to help them diagnose and treat cancer. Headquartered in Fort Myers, FL, NeoGenomics operates a network of CAP-accredited and CLIA-certified laboratories for full-service sample processing and analysis services throughout the US and a CAP-accredited full-service sample-processing laboratory in Cambridge, United Kingdom. Forward Looking StatementsThis press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under “Risk Factors,” “Management's Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. Adaptive Investor Contact:Karina Calzadilla, Vice President, Investor Relations and FP&A201-396-1687investors@adaptivebiotech.com Adaptive Media Contact:Erica Jones, Associate Director, Corporate Communications206-279-2423media@adaptivebiotech.com NeoGenomics Investor Contact:Kendra Sweeney, Vice President, Investor Relations, Communications, and ESGkendra.sweeney@neogenomics.com NeoGenomics Media Contact:Andrea Sampsonasampson@sampsonprgroup.com