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Oncocyte Changes Name to Insight Molecular Diagnostics Inc. (iMDx), Moves Headquarters to Nashville
GlobeNewswire News Room· 2025-06-17 11:00
The Company remains committed to its goal of delivering a clinically available molecular diagnostic kit to expand testing access for kidney transplant patients, which it anticipates will unlock value in the estimated $1 billion addressable market for transplant rejection testing. So far in 2025, iMDx believes it has made disciplined and focused progress toward this goal, executing the critical steps required to transition from product development to commercialization. To support these efforts, iMDx is reloc ...
Medicare Boosts Reimbursement for Oncocyte's Flagship Technology
GlobeNewswire News Room· 2025-05-19 20:05
New price of $2,753 for the GraftAssureCore™ assay increases total addressable market size and margin opportunityBrings pricing in line with existing competitive technologyExpands market appeal for prospective FDA-cleared kitted product at transplant centers IRVINE, Calif., May 19, 2025 (GLOBE NEWSWIRE) -- Oncocyte Corp., (Nasdaq: OCX), a diagnostics technology company, today provided a positive update on pricing for its next-generation lab-developed test (LDT), GraftAssureCore. The new reimbursement rate s ...
Oncocyte(OCX) - 2025 Q1 - Earnings Call Transcript
2025-05-12 22:02
OncoCyte (OCX) Q1 2025 Earnings Call May 12, 2025 05:00 PM ET Company Participants Josh Riggs - President & Chief Executive OfficerAndrea James - Chief Financial OfficerEkkehard Schütz - Chief Science OfficerYuan Zhi - Managing Director Conference Call Participants Mark Massaro - MD & Senior Equity Research AnalystMason Carrico - Research AnalystThomas Flaten - Senior Research AnalystMike Matson - Senior Equity Research Analyst Operator Welcome everyone and Welcome, everyone, and thank you for joining us to ...
Oncocyte(OCX) - 2025 Q1 - Earnings Call Transcript
2025-05-12 22:00
OncoCyte (OCX) Q1 2025 Earnings Call May 12, 2025 05:00 PM ET Speaker0 Welcome everyone and Welcome, everyone, and thank you for joining us to discuss OncoCyte's first quarter twenty twenty five results. If you have not seen today's shareholder letter, please visit OncoCyte's Investor Relations page at investors.oncoCyte.com. Today's prepared remarks build upon the information already shared in this robust letter. Joining us today are OncoCyte President and CEO, Josh Riggs Chief Science Officer, Ecky Schutz ...
Oncocyte(OCX) - 2025 Q1 - Quarterly Report
2025-05-12 20:12
Revenue Growth - Total net revenue increased to $2.1 million for the three months ended March 31, 2025, compared to $176,000 in the same period in 2024, representing a 1115% increase [212]. - Pharma Services revenue increased by $2.0 million, with revenue from one existing customer amounting to approximately $2.1 million during Q1 2025 [214]. Expenses - Research and development expenses rose by $612,000, driven by costs associated with the development of GraftAssureCore, GraftAssureIQ, DetermaIO, and DetermaCNI [214]. - Sales and marketing expenses increased by $360,000, primarily due to ramped-up activities related to the transplant business and oncology commercialization efforts [214]. - General and administrative expenses increased by $442,000, mainly due to higher personnel-related expenses and professional fees [214]. - Research and development expenses increased by 26% to $2.9 million for the three months ended March 31, 2025, compared to $2.3 million in the same period of 2024 [219]. - Sales and marketing expenses rose by 43% to $1.2 million for the three months ended March 31, 2025, up from $846,000 in the prior year [221]. - General and administrative expenses increased by 17% to $3.1 million for the three months ended March 31, 2025, compared to $2.7 million in 2024 [222]. Net Loss and Financial Position - The net loss for the three months ended March 31, 2025, was $6.7 million, a reduction of $2.5 million compared to a net loss of $9.1 million in the prior year [214]. - The net loss for the period was $6.7 million, with net cash used in operating activities amounting to $5.9 million [240]. - The company had an accumulated deficit of $357.2 million as of March 31, 2025 [229]. - Cash and cash equivalents stood at $31.0 million as of March 31, 2025 [229]. Financing Activities - A private placement in February 2025 raised approximately $29.1 million in gross proceeds, with net proceeds of approximately $28.7 million after expenses [211]. - The gross proceeds from the February 2025 Offering were approximately $29.1 million, with net proceeds of approximately $28.7 million after expenses [231]. Strategic Developments - The company received a positive coverage decision from MolDx for GraftAssureCore (Kidney) in August 2023, with commercial availability starting in January 2024 [203]. - The company confirmed Medicare reimbursement for monitoring certain high-risk patients in December 2024 [203]. - The company is focusing on commercializing its oncology product line, including DetermaIO, over the next 12 months [207]. - A global strategic partnership with Bio-Rad was established to collaborate on the development and commercialization of transplant products [234]. Contingent Consideration and Impairments - As of March 31, 2025, total contingent consideration liabilities were $38.8 million, up from $37.9 million as of December 31, 2024 [251]. - Stock-based compensation for the three months ended March 31, 2025, was $473,000, compared to $418,000 for the same period in 2024 [257]. - A total impairment of $41.9 million was recorded for certain oncology-related IPR&D intangible assets as of December 31, 2024 [253]. - An impairment loss of $169,000 was recognized on held for sale assets during the three months ended March 31, 2024 [254]. - The company established an allowance for credit losses of $36,000 as of March 31, 2025, compared to $16,000 as of December 31, 2024 [256]. Cash Flow and Investment Activities - Net cash used in operating activities amounted to $3.8 million, excluding noncash items totaling $4.0 million [241]. - Cash used in investing activities for the three months ended March 31, 2024, was $24,000 [242].
Oncocyte(OCX) - 2025 Q1 - Quarterly Results
2025-05-12 20:10
Exhibit 99.1 Oncocyte Reports Q1 2025 Results and Business Progress We're off to a fast and intensely focused start in 2025. Just two months ago, we shared our strategic outlook — and since then, we've remained heads down, executing. Our top priority is unchanged: bringing our first clinical molecular diagnostic test kit to market so that we may begin capturing value in the estimated $1 billion total addressable market for transplant rejection testing. The first quarter was defined by disciplined progress, ...
Oncocyte Reports Q1 2025 Results and Business Progress
Globenewswire· 2025-05-12 20:05
Q1 2025 pharma services revenue of $2.1 million, at 62% gross marginThree of the top 10 U.S. transplant centers expected to participate in clinical trialTen globally leading transplant hospitals are now using our GraftAssure research-use-only kitsTo reflect our larger market opportunity, we plan to rename the company in Q2 IRVINE, Calif., May 12, 2025 (GLOBE NEWSWIRE) -- Oncocyte Corp. (Nasdaq: OCX), a diagnostics technology company, today published the following letter to shareholders in conjunction with i ...
Oncocyte to Release First Quarter 2025 Results on May 12, 2025
Globenewswire· 2025-05-07 20:10
IRVINE, Calif., May 07, 2025 (GLOBE NEWSWIRE) -- Oncocyte Corp., (Nasdaq: OCX), a leading diagnostics technology company, today announced that it will report first quarter 2025 financial results after the market closes on Monday, May 12, 2025. Oncocyte will host a live Zoom webinar to discuss the company's financial results at 2:00 p.m. PT that same day. The live webinar to discuss financial results, followed by Q&A, will be accessible via registration at the following link: Oncocyte Q1 2025 Earnings Webina ...
Oncocyte Provides Positive Update on Clinical Trial Progress
GlobeNewswire News Room· 2025-04-30 12:30
Central Institutional Review Board approved, final preparatory steps underway at first transplant centersThree of the top 10 U.S. transplant centers expected to participate in trialNearly 10% of annual U.S. transplant volume represented in trial site interestPreparing for final Q-sub FDA meeting ahead of clinical validation IRVINE, Calif., April 30, 2025 (GLOBE NEWSWIRE) -- Oncocyte Corp., (Nasdaq: OCX), a leading diagnostics technology company, today provided a positive update on its substantial progress ...
Oncocyte's Proprietary Assay Demonstrates Long-Term Clinical Validity
GlobeNewswire News Room· 2025-04-29 12:30
Robust data set of 131 patients with 151 kidney biopsies enrolled over four years at Charité University in BerlinSupports market expansion for testing of high-risk patient populationNew findings advance understanding of the biology of organ rejection IRVINE, Calif., April 29, 2025 (GLOBE NEWSWIRE) -- Oncocyte Corp., (Nasdaq: OCX), a leading diagnostics technology company, today announced the publication of new and positive data regarding its proprietary blood-based transplant rejection assay. The publicatio ...