OncoCyte Corporation (OCX): Business Model Canvas [Dec-2025 Updated]

You're looking to map out exactly how OncoCyte Corporation is funding its big pivot, and honestly, the story right now is all about the shift to transplant diagnostics, backed by a recent capital raise. After pulling apart their Q1 2025 figures, we see they are running on cash reserves of nearly $33 million, fueled by that $29.1 million equity offering back in February 2025, all while burning about $6 million per quarter to push the kitted IVD assay toward FDA clearance. To be fair, the existing pharma services-which brought in $2.1 million in Q1 2025-are keeping the lights on while they build out the high-margin, recurring revenue from the GraftAssure test. Let's break down the nine blocks of this model so you can see where the real value creation is supposed to happen.

OncoCyte Corporation (OCX) - Canvas Business Model: Key Partnerships

You're looking at the relationships OncoCyte Corporation (OCX) relies on to get its diagnostic technology, particularly for transplant monitoring, into the hands of clinicians and researchers. These partnerships are critical for commercial scale and clinical validation, so let's break down the key players as of late 2025.

Bio-Rad Laboratories as a strategic investor and commercialization partner

Bio-Rad Laboratories, Inc. is definitely more than just a backer; they are deeply integrated into OncoCyte Corporation (OCX)'s commercial strategy for the GraftAssure assay. Bio-Rad first became an investor and strategic partner in April 2024, and they followed up with participation in the February 2025 equity raise. As of March 2025, Bio-Rad held approximately 9.66% of OncoCyte Corporation (OCX)'s outstanding shares.

The commercial arrangement is specific: OncoCyte Corporation (OCX) and Bio-Rad Laboratories, Inc. co-market the research-use-only (RUO) GraftAssure assay in the U.S. and Germany, with OncoCyte Corporation (OCX) taking the commercial lead in those regions. Outside the U.S. and Germany, Bio-Rad holds exclusive global distribution and commercial rights for the RUO product. Furthermore, Bio-Rad Laboratories, Inc. has an option to commercialize the In-Vitro Diagnostic (IVD) Kits upon FDA clearance, an exercise that would trigger a second equity investment into OncoCyte Corporation (OCX). This support extends beyond equity, as Bio-Rad has pledged valuable financial support for the upcoming clinical trial and further commercialization assistance.

Leading transplant hospitals for multi-center clinical trials

The clinical validation of the transplant assay is happening across major medical centers. You need these institutions not just for data, but for credibility in a concentrated market. OncoCyte Corporation (OCX) is working to sign up a target of at least 20 transplant centers to use their GraftAssure research-use-only (RUO) kits by the end of 2025.

For the formal clinical trial needed for FDA authorization, the company has secured interest from top-tier sites. As of April/May 2025, at least three of the top 10 U.S. transplant centers were expected to participate. Collectively, these initial trial sites represent nearly 10% of the annual U.S. transplanted organ volume. The company estimates that each center that adopts the future clinical assay could represent a potential annual high-margin revenue stream ranging from several hundred thousand dollars up to $2 million of clinical-use tests, depending on the center's size.

Here's a quick look at the adoption and trial engagement:

Metric	Value as of Late 2025 Expectation	Data Point Reference
Total Transplant Centers Using RUO Kits (Target)	20 centers	End of 2025
Top 10 U.S. Transplant Centers in Clinical Trial	3 institutions	Expected participation
U.S. Transplant Volume Represented by Trial Sites	Nearly 10%	Collective volume
Estimated Annual Revenue Per Center (Future IVD)	\$0.2 Million to \$2 Million	Estimate per center

Pharmaceutical companies for DetermaIO co-development and drug rescue studies

OncoCyte Corporation (OCX)'s DetermaIO test, which assesses the tumor microenvironment to predict immunotherapy response, is primarily used as a research-use-only tool, engaging pharmaceutical partners in clinical programs. The company's pharmaceutical services business provides a full suite of molecular testing services to support drug development.

A notable collaboration is with Thermo Fisher Scientific for the development and co-marketing of DetermaIO as a distributed kit on the Genexus System. This aims for IVDR approval in Europe, potentially by the second half of the following year (late 2026), allowing physicians to run the testing locally. In the past, OncoCyte Corporation (OCX) has also engaged with partners like GRN and Fondazione to incorporate DetermaIO into their clinical programs.

The key activities here involve:

• Developing DetermaIO as a distributed kit on the Thermo Fisher Genexus System.
• Providing molecular testing services to support drug development for pharmaceutical companies.
• Engaging biopharma partners for research use of DetermaIO to build evidence for Medicare reimbursement.

Institutional investors leading the February 2025 $29.1 million equity offering

Securing capital is a key partnership function, and the February 2025 financing was led by existing, committed shareholders. OncoCyte Corporation (OCX) entered into securities purchase agreements for a registered direct offering and a concurrent private placement, resulting in total gross cash proceeds of $29.1 million, priced at $2.05 per share.

The round was led by the company's five largest shareholders, which specifically included Bio-Rad Laboratories, Inc. Two members of the company's management team also participated in the private placement. The company stated the net proceeds from this offering were expected to fully fund the development of the FDA In-Vitro Diagnostic (IVD) transplant assay program through clearance.

Here are the components of that February 2025 financing:

• Total Gross Proceeds: $29.1 million.
• Registered Direct Offering Shares Sold: 3,609,755 shares.
• PIPE Offering Shares Sold: 7,536,708 common shares plus pre-funded warrants.
• Price Per Share: $2.05.

Finance: draft 13-week cash view by Friday.

OncoCyte Corporation (OCX) - Canvas Business Model: Key Activities

You're looking at the engine room of OncoCyte Corporation's strategy, which is currently a dual-track effort: pushing the core diagnostic kit through regulatory hurdles while using existing lab services to fund that progress. The key activities here are all about execution against tight regulatory and commercial timelines.

Developing and seeking FDA clearance for the kitted transplant IVD assay

This is the main event, the activity that unlocks the $1 billion global total addressable market for transplant rejection testing. OncoCyte Corporation is pursuing a Class II de novo pathway for its kitted test, which quantifies the donor-derived cell-free DNA (dd-cfDNA) biomarker. The team had its first meeting with the FDA on December 5, 2024, and they are targeting the final FDA submission by the end of 2025. Success here means anticipated FDA authorization in the first half of 2026. To ensure they hit that submission target, the company secured gross cash proceeds totaling $29.1 million in February 2025 through a registered direct offering and concurrent private placement, adding to over $50 million in total equity raises to fully fund the In-Vitro Diagnostic (IVD) program development.

Conducting multi-center clinical trials for the GraftAssure clinical test kit

The clinical trial is the critical bridge to that FDA submission. The company completed the clinical trial design and secured approval from a large central Institutional Review Board (IRB). As of the latest reports, the plan is to welcome three of the top 10 U.S. transplant centers as participants. These engaged centers collectively represent nearly 10% of U.S. transplant volume, which is a strong validation point for the data quality they expect to generate. This trial is noted as the only one required to obtain the necessary FDA authorization for the kitted test.

Providing pharma services for drug development and biomarker analysis

This activity is the current revenue driver, helping to offset the net loss, which was $6.7 million in Q1 2025. The revenue from these services is lumpy, but the operational efficiency is improving fast. Here's a look at the recent performance:

Metric	Q4 2024	Q1 2025
Pharma Services Revenue	$1.5 million	$2.1 million (or $2.14 million)
Gross Margin	40%	62%
Projected Q2 2025 Revenue Guidance	N/A	< $500,000

The gross margin expansion to 62% in Q1 2025, up from 40% in Q4 2024, came from lab automation and workflow enhancements at their Nashville lab. Also, the lab-developed version of the test, GraftAssureCore, achieved Medicare reimbursement of $2,753 per result following a claims expansion confirmation by CMS in January 2025.

Expanding commercial adoption of GraftAssure Research-Use-Only (RUO) kits

The RUO kit is the company's 'land-and-expand' strategy in action, getting the workflow into the hands of researchers and clinicians now. As of Q1 2025, ten leading transplant hospitals globally were using the kits. This user base included 3 in the US, 6 in Europe, and 1 in Southeast Asia. The goal is to sign up a total of 20 transplant centers by the end of 2025. Management projects that securing these 20 centers could translate to approximately $20 million in annual recurring revenue once the clinical kit receives FDA authorization. For context, the company estimates that each future clinical center customer could represent an annual high-margin revenue stream between several hundred thousand dollars to $2 million of clinical-use tests.

• The international response to the RUO assay, launched in July 2024, has been exceeding expectations.
• The US sales funnel of confirmed interest represents approximately 25% of US transplant volumes as of mid-2024.
• The company is leveraging its partnership with Bio-Rad Laboratories for co-marketing in the US and Germany.

Finance: draft 13-week cash view by Friday.

OncoCyte Corporation (OCX) - Canvas Business Model: Key Resources

You're looking at the core assets that power the business model of the entity formerly known as OncoCyte Corporation, now Insight Molecular Diagnostics Inc. (iMDx) as of mid-2025. These are the tangible and intangible things they absolutely must have to make their value proposition work.

The financial foundation for near-term development was solidifying after a capital raise earlier in the year. The cash position at the end of the first quarter of 2025 was reported as $32.7 million in cash, cash equivalents, and restricted cash, which was bolstered by a $28.7 million net financing cash flow from offerings in February 2025. This capital was earmarked to fund In Vitro Diagnostic (IVD) development, with a targeted cash burn rate of about $6 million per quarter. Also, the company raised $29.1 million in February 2025 specifically to drive development and commercialization efforts for its transplant assay.

The technological core revolves around their specialized testing platforms. This includes their proprietary digital PCR (dPCR) technology, which is key for quantifying donor-derived cell-free DNA (dd-cfDNA). This technology is leveraged in their transplant monitoring assays, like VitaGraft Kidney™, which quantifies dd-cfDNA to assess graft health non-invasively. The company is targeting 510(k)/De Novo clearance for its initial IVD kit by the end of 2025.

A significant physical asset is the operational laboratory infrastructure. The company's principal executive office relocated to Nashville, Tennessee, which houses their CAP/CLIA-Certified Laboratory. This facility includes a 4,826-square-foot CLIA-approved laboratory space. This lab supports their testing services, including the GraftAssureCore test, which is a CLIA-certified, laboratory developed test.

The intangible assets, specifically intellectual property, protect their market position. This IP surrounds several key assays:

• VitaGraft™: A clinical blood-based solid organ transplantation monitoring test.
• GraftAssure™: A research use only (RUO) blood-based solid organ transplantation monitoring test, co-marketed with Bio-Rad Laboratories, Inc. in the US and Germany.
• DetermaIO™: A gene expression test assessing the tumor microenvironment to predict response to immunotherapies.

The intellectual property portfolio is strengthened by specific patents, such as U.S. Patent No. 11,155,872 for the digital polymerase chain reaction (dPCR) technique used for molecular detection of solid organ allograft rejection.

Here's a quick breakdown of the key physical and intellectual assets:

Resource Category	Specific Asset Detail	Metric/Value
Financial Capital (Q1 2025 End)	Cash, cash equivalents, and restricted cash	$32.7 million
Physical Infrastructure	CLIA-certified laboratory size in Nashville, TN	4,826-square-foot
Technology/IP	U.S. Patent Number for dPCR Technique	No. 11,155,872
Technology Focus	Core technology for transplant assays	Proprietary digital PCR (dPCR)
Development Funding	Financing raised in February 2025	$29.1 million

Also, the company has a research and development lab in Göttingen, Germany, which they expect to maintain despite the headquarters move.

OncoCyte Corporation (OCX) - Canvas Business Model: Value Propositions

You're looking at the core promises OncoCyte Corporation (OCX) is making to its customers, which is key to understanding their strategy as they push toward commercialization of their kitted diagnostic tests. Honestly, the value propositions are clearly segmented between the transplant and oncology markets, with a strong underpinning in their pharma services revenue.

Transplant: Earlier, more affordable, and faster detection of organ rejection

The primary value here is moving beyond current limitations in monitoring organ health. OncoCyte Corporation (OCX) is focused on providing earlier, more actionable data using their blood-based assay that measures donor-derived cell-free DNA (dd-cfDNA). This science is being leveraged to support patients over the long haul; for instance, data shows their proprietary assay remains clinically valid for patients up to 13.7 years post-transplant. Furthermore, the economic value is being cemented with secured payer coverage; they have a confirmed CMS reimbursement price of $2,753 per result for the high-risk patient population. This positions their test as a more affordable alternative to current methods, especially considering the estimated global total addressable market (TAM) for this testing exceeds $1 billion annually. The U.S. portion of that market is estimated around $500 million per year.

Transplant: Simple workflow for local lab adoption via a distributable kitted test

The shift from a central lab service model to a distributable kit is a major value driver, aiming to democratize access and capture local lab revenue. The design itself is simple, requiring just a two-pipetting-step workflow for existing HLA labs. This decentralized approach is gaining traction, as evidenced by their progress in signing up key centers. Management reiterated its commitment to have 20 transplant centers signed up by the end of 2025. As of Q3 2025, they had 19 engaged centers (11 in clinical trials, 12 utilizing the research-use-only version), up from ten leading transplant hospitals using the RUO kits in Q1 2025. The potential is significant; each center that adopts the kitted clinical assay is estimated to represent a potential annual high-margin revenue stream ranging from several hundred thousand dollars to $2 million in clinical-use tests.

Here's a quick look at the adoption progress versus the target:

Metric	Value	Target/Context
Target Transplant Centers by End of 2025	20 centers	Management commitment
Engaged Centers (Q3 2025)	19 centers	Includes those in clinical trials and RUO use
RUO Kit Users (Q1 2025)	10 leading transplant hospitals	Indicated strong early market interest
Potential Annual Revenue Per Center	$0.5 million to $2 million	Estimate for high-margin clinical-use tests post-approval

Oncology: Predicting patient response to immunotherapy using the DetermaIO assay

For oncology clients, the value proposition of the DetermaIO assay centers on providing clarity on which patients will actually benefit from expensive immunotherapy treatments. The data is compelling: in one study, patients testing positive with DetermaIO (IO+) achieved a pathologic complete response (pCR) rate of 69.8% when given a combination of atezolizumab and chemotherapy. This contrasts sharply with the 46.9% pCR rate seen in the chemotherapy-alone group for those same IO+ patients. For IO-negative patients, there wasn't a significant improvement with the addition of atezolizumab, showing the test's ability to stratify responders. The company plans to use this data to support a submission for CMS reimbursement coverage.

High-quality, scientifically sound data delivery for pharma clients

Before the kitted products generate material revenue, the pharma services business provides crucial, high-margin revenue that validates the lab's scientific capabilities. The team in Nashville is delivering on this, generating Q1 2025 pharma services revenue of $2.1 million with a gross margin of 62%. This was an improvement from Q4 2024 revenue of $1.5 million at a 40% gross margin. For the full year 2024, this segment contributed $1.9 million in revenue. This revenue stream is a testament to the team's ability to achieve on-time delivery of clear, scientifically sound, and accurate data sets to these clients.

• Q1 2025 Pharma Services Revenue: $2.1 million
• Q1 2025 Gross Margin on Pharma Services: 62%
• Full Year 2024 Pharma Services Revenue: $1.9 million

Finance: finalize the Q3 2025 cash burn analysis by Monday.

OncoCyte Corporation (OCX) - Canvas Business Model: Customer Relationships

High-touch, direct engagement with leading transplant centers and clinicians

OncoCyte Corporation (OCX) is executing a land-and-expand strategy centered on transplant centers using the GraftAssure research-use-only (RUO) test kit as the initial point of contact. The company is on track to have at least 20 transplant centers trained on the GraftAssure RUO workflow by the end of 2025. Currently, ten globally leading transplant hospitals are utilizing the GraftAssure research-use-only kits. The plan involves involving at least three of the top 10 U.S. transplant centers in the upcoming clinical trial. The transplant market outside the U.S. is similarly concentrated within high-end academic institutions.

Dedicated support for pharma clients in clinical trial services

The Nashville laboratory provides molecular diagnostic services to pharmaceutical customers, which serves as a current, albeit lumpy, revenue stream. Pharma services revenue for Q1 2025 was reported as $2.1 million. This Q1 2025 revenue represented a gross margin of 62%, an increase from 40% in Q4 2024, driven by operational efficiencies. The CFO guided Q2 2025 pharma services revenue to be < $500k due to the inherent lumpiness of this business. The company maintained a cash position of $32.7 million at the end of Q1 2025.

Building credibility through published clinical data and scientific integrity

Scientific validation supports the direct engagement efforts with clinicians. Published clinical data demonstrates that OncoCyte Corporation (OCX)'s technology can detect signs of kidney transplant rejection more than 11 months sooner than standard protocols. An NEJM study was published in May 2024. The company is progressing toward an FDA submission by the end of 2025, with anticipated authorization in the first half of 2026.

Long-term focus for recurring, high-margin revenue from kitted product sales

The kitted product model is the primary long-term focus, counter-positioned to the central lab service model. The company estimates that transplant centers becoming customers of the clinical kitted assay each represent a potential annual high-margin revenue stream of several hundred thousand dollars to $2 million of clinical-use tests. The commitment is to have 20 transplant centers signed up by the end of 2025, which management projects could yield approximately $20 million in annual recurring revenue post-approval. The expected largest increase in revenue from this kitted product is projected to begin in 2027.

Here's a quick look at the key engagement and financial metrics as of the Q1 2025 reporting period:

Metric Category	Specific Data Point	Value/Amount
Pharma Services Revenue (Q1 2025)	Reported Revenue	$2.1 million
Pharma Services Margin	Q1 2025 Gross Margin	62%
RUO Kit Adoption	Leading Centers Currently Using Kits	10
2025 Target	Target for Centers Signed Up by Year-End 2025	20
Future Recurring Revenue Potential	Projected Annual Recurring Revenue from Target Centers (Post-Approval)	~$20 million
Clinical Trial Engagement	Top U.S. Transplant Centers Expected to Participate	3 of top 10
Liquidity	Cash, Cash Equivalents, and Restricted Cash (End Q1 2025)	$32.7 million

The relationship strategy is clearly bifurcated:

• Support existing pharma service contracts to maintain cash flow and operational credibility.
• Aggressively land research-use-only (RUO) sites to convert to high-margin, recurring kitted product sales post-FDA clearance.

If onboarding for the RUO kits takes longer than anticipated, the land-and-expand timeline for the $20 million recurring revenue goal could shift past 2025.

OncoCyte Corporation (OCX) - Canvas Business Model: Channels

You're looking at how OncoCyte Corporation (OCX) gets its value propositions-like the GraftAssure technology-into the hands of customers. The Channels block is a mix of current service revenue and future kitted product distribution, which is a key strategic pivot for the company.

Direct sales force targeting transplant centers and hospitals

The direct sales effort is laser-focused on the concentrated transplant market. The total addressable market for transplant rejection testing is estimated at $1 billion globally. The strategy involves getting centers to adopt the Research-Use-Only (RUO) assay first, which is part of the land-and-expand approach.

Here's what the pipeline looks like as of early 2025:

• Commitment to have more than 20 transplant centers running GraftAssure tests by the end of 2025.
• The US funnel of confirmed interest for the RUO product currently represents 25% of transplant volumes.
• At least three of the top 10 U.S. transplant centers are expected to participate in the upcoming clinical trial for the regulated test kit.

If these centers convert to customers for the kitted clinical assay post-regulatory approval, each one is estimated to represent a potential annual high-margin revenue stream of several hundred thousand dollars to $2 million in clinical-use tests, depending on the center's size. OncoCyte Corporation is devoting significant financial and management resources to recruiting, training, and managing its sales force to drive this adoption.

Clinical Laboratory Improvement Amendments (CLIA) lab testing services (VitaGraft)

This channel represents the current revenue base, primarily through the Nashville, Tennessee, CLIA-certified/CAP-accredited laboratory. This is where the VitaGraft Kidney LDT is run as a service, which is distinct from the future kitted product.

The financial performance here is tied directly to Pharma Services revenue, as the bulk of the current top-line comes from this lab work. A major recent win is the expansion of Medicare coverage for VitaGraft Kidney to monitor patients with newly developed donor-specific antibodies (dnDSA+) for antibody-mediated rejection (AMR). The CMS increased reimbursement to $2,753 per result for the CLIA lab test (GraftAssureCore).

The patient population driving this service volume is significant: up to 20% of patients will have detectable DSA within the first five years post kidney transplant, which translates to greater than 10,000 patients per year in the US.

Distribution agreements and licensing for kitted products (future)

The move to kitted products is central to OncoCyte Corporation's long-term, capital-light strategy, aiming for software-like gross margins. Commercialization of these RUO products is expected through a mix of direct sales, partnering, distribution agreements, and licensing. First commercial RUO orders are anticipated later in 2025.

The current global adoption of the GraftAssure RUO kit sets the stage for future distribution agreements:

Geographic Area	Number of Leading Transplant Centers Using RUO Kit	Estimated Transplant Volume Share
US	Undisclosed (Part of the 10 total)	Representing about 2% of US transplant volumes (as of late 2024)
Europe	6	Representing about 9% of German transplant volumes (as of late 2024)
Southeast Asia	1	Not specified
Total Globally	10	N/A

OncoCyte Corporation plans to pursue CE Marketing under In Vitro Diagnostic Regulation (IVD-R) in Europe.

Pharma services team for direct contract research organization (CRO) sales

This team drives revenue through direct contracts for molecular testing services, which the company views as providing non-dilutive capital, though it is not central to the long-term strategy. The Nashville lab performs these services.

The financial performance for this channel in the first quarter of 2025 was strong, though lumpy:

• Q1 2025 revenue reached $2.1 million (or $2.14 million).
• Gross margin for these services improved sequentially to 62% in Q1 2025, up from 40% in Q4 2024, due to lab automation and workflow enhancements.
• The CFO guided Q2 2025 pharma services revenue to be less than $500,000 due to the inherent lumpiness of the business, as the vast majority of Q1 revenue came from a single corporate customer.

The potential market for immune-therapy clinical trial services to pharma companies developing ICIs is estimated at $1 billion.

OncoCyte Corporation (OCX) - Canvas Business Model: Customer Segments

You're looking at the core groups OncoCyte Corporation (OCX) is targeting as it pushes its diagnostic pipeline toward commercialization. The focus is clearly on transplant diagnostics, but the pharma services arm is still a meaningful revenue source in the near term.

Transplant centers and hospitals (primary focus for kitted IVD and RUO)

This segment is the linchpin for OncoCyte Corporation's future recurring revenue model, centered around the GraftAssure kitted product, which is expected to become an In Vitro Diagnostic (IVD) device. The strategy is a land-and-expand approach, starting with Research Use Only (RUO) adoption to build clinical familiarity ahead of the expected mid-2026 IVD clearance.

Here's the quick math on their transplant center engagement as of the latest updates:

Metric	Target/Actual Number	Context/Timing
Target Number of Centers for Clinical Assay	20	Target for signing by end of 2025
Projected Annual Recurring Revenue (Post-Approval)	$20 million	From the target of 20 centers
Estimated Annual Revenue Per Center (Clinical Use)	Several hundred thousand to $2 million	Depending on center size
RUO Kits in Use (as of Q1 2025)	10	Globally leading transplant hospitals using GraftAssure RUO
RUO Kit Goal (End of 2025)	At least 20 centers	To establish technology footprint
Top 10 U.S. Centers in Clinical Trial	At least 3 expected participants	Enhancing credibility
Total Addressable Market (TAM)	Estimated $1 billion	Global market for transplant rejection testing

What this estimate hides is that the revenue from the clinical assay is contingent on achieving FDA authorization, which management is targeting for the first half of 2026. If onboarding takes 14+ days, churn risk rises.

Pharmaceutical and biotech companies (for pharma services and DetermaIO partnering)

Pharmaceutical and biotech companies serve two distinct roles. First, they are the source of the current, non-core revenue via lab services. Second, they represent future partnering opportunities for the oncology test, DetermaIO, which assesses the tumor microenvironment to predict immunotherapy response.

• Q1 2025 Pharma Services Revenue: $2.1 million
• Q4 2024 Pharma Services Revenue: $1.5 million at a 40% gross margin
• Full Year 2024 Pharma Services Revenue: $1.9 million
• Q2 2025 Pharma Services Guidance: Expected to be less than $500,000 due to lumpiness and pivot to core focus
• DetermaIO Progress: Partner discussions are ongoing, with a SWOG 800-patient readout hoped for by year-end 2025

Transplant physicians and clinicians (end-users of diagnostic results)

Physicians and clinicians are the ultimate decision-makers who will integrate the test results into patient management protocols. Their alignment is critical for the land-and-expand strategy to work, as they will drive the adoption of the kitted product once it is cleared for clinical use.

• Medicare reimbursement for the CLIA lab test (GraftAssureCore) is $2,753 per result, which helps bridge to future kit reimbursement
• The kitted test is designed for simple use, requiring a 'two-pipetting-step workflow for existing HLA labs'
• The value proposition is providing faster, more affordable tests that can be run at local labs, improving patient monitoring

Researchers and academic institutions (users of GraftAssure RUO kits)

These institutions are key early adopters for the RUO kits, allowing OncoCyte Corporation to gather essential field feedback and build credibility within the transplant community before the IVD launch. This segment directly supports the clinical trial pipeline.

• The RUO launch began in July 2024
• Adoption momentum is building, with 10 leading centers globally running the RUO kits as of Q1 2025
• The company is progressing with assay validation pipelines at leading transplant centers

Finance: draft 13-week cash view by Friday.

OncoCyte Corporation (OCX) - Canvas Business Model: Cost Structure

You're looking at the spending side of OncoCyte Corporation (OCX) as they push toward their FDA submission target by the end of 2025. The cost structure is heavily weighted toward development and regulatory hurdles right now, which is typical for a diagnostics company at this stage.

High research and development (R&D) costs for FDA IVD clearance are a major component. The company is making focused investments to get its transplant assay through the regulatory gauntlet. The proceeds from the February 2025 financing, totaling $29.1 million in gross proceeds, were explicitly expected to fully fund the development of the FDA In-Vitro Diagnostic (IVD) transplant assay program through clearance. R&D expenses in the first quarter of 2025 were reported at $2.9 million. This figure specifically reflected increased expenses tied to kitted product development, which included necessary FDA-compliant software development expenses, laboratory supplies, and personnel costs.

The overall spending results in significant operating expenses. For the first quarter of 2025, OncoCyte Corporation reported total operating expenses of $8.1 million. This number includes both cash and non-cash charges. To give you a clearer picture of where that money went in Q1 2025, here's a breakdown of the key expense categories:

Expense Category	Q1 2025 Amount (Millions USD)
Total Operating Expenses	$8.1
Research and Development Expenses	$2.9
General and Administrative Expenses	$3.1
Sales and Marketing Expenses	$1.2

The Sales, General, and Administrative (SG&A) expenses for commercial expansion are currently being managed with cost discipline, though they are a necessary spend as they prepare for launch. In Q1 2025, Sales and marketing expenses were flat sequentially at $1.2 million. General and administrative expenses for that quarter were $3.1 million, which included a one-time charge of $279,000 related to realizing previously deferred expenses from a terminated Sales Agreement.

The company is actively managing its cash position, with a clear target for its quarterly cash burn. OncoCyte Corporation continues to target approximately $6 million per quarter in cash burn throughout 2025. This target is designed to ensure a financial runway of well over a year until the expected FDA authorization in the first half of 2026. The actual free cash flow for Q1 2025 was negative $6.2 million, which management noted was right in line with that $6,000,000 target.

The costs of lab operations, automation, and workflow enhancements are showing up as efficiency gains rather than just pure expense line items. You can see this in the gross margin. The gross margin saw a sharp sequential improvement, expanding to 62% in Q1 2025 from 40% in Q4 2024. Management attributed this margin expansion primarily to operational efficiencies achieved in their Nashville lab, specifically citing key contributors like automation and enhancements to their workflow, which allowed for a higher number of samples to be processed per batch and subsequently reduced the labor cost per sample.

The company's spending priorities for the near term include:

• FDA-compliant software development costs for the kitted product.
• Instrument purchases to support the clinical trial at partner sites.
• Maintaining a lean sales and marketing spend, as the customer market is concentrated.
• Diverting dollars toward sales and marketing at the end of the year as they get closer to the FDA submission.

Finance: draft 13-week cash view by Friday.

OncoCyte Corporation (OCX) - Canvas Business Model: Revenue Streams

You're looking at how OncoCyte Corporation currently brings in cash while building toward its core commercial offering. Right now, the revenue picture is split between services and early-stage product adoption, with the big financial leap dependent on regulatory clearance.

The most concrete, recent figure comes from the services side of the house. OncoCyte Corporation reported pharma services revenue of \$2.1 million in the first quarter of 2025, derived from work done at its Nashville clinical laboratory. That quarter also showed operational improvements, pushing the gross margin up to 62% from 40% in Q4 2024. Honestly, you need to remember this pharma services revenue is lumpy; for instance, the CFO noted that April 2025 had no services invoices, with Q2 pharma services revenue guided to be less than \$500,000.

Next up is revenue from the sales of the GraftAssure Research-Use-Only (RUO) test kits. This stream is about seeding the market and getting centers familiar with the workflow before the clinical version is cleared. As of Q1 2025, ten leading transplant hospitals globally were using these RUO kits. The company has a clear near-term goal here: management aimed to have at least 20 centers using these kits by the end of 2025. To be fair, the revenue from these RUO kits was not yet factored into the reported Q1 2025 revenue figures, as the focus remains on the future IVD product.

For the current lab-developed test (LDT) offering, VitaGraft Kidney, which runs at the CLIA lab as GraftAssureCore, reimbursement from Medicare is a key component. The Centers for Medicare & Medicaid Services (CMS) has established a new, favorable rate following workflow optimization. This new rate is a significant point for establishing a benchmark for the future kitted product.

Here's a quick look at the reimbursement structure for the LDT:

Test Version/Scenario	CMS Reimbursement Rate
GraftAssureCore (Optimized Workflow)	\$2,753 per result
Earlier Assay Version (First-Time Patient)	\$2,222
Earlier Assay Version (Subsequent Tests)	\$1,029

The future high-margin recurring revenue is what drives the valuation story here, hinging on FDA clearance for the kitted transplant tests, named GraftAssureDx. Management is targeting an FDA submission by year-end 2025, with authorization anticipated in the first half of 2026. When a transplant center converts to using the kitted clinical assay in-house, the potential revenue is substantial. This is the real prize.

The expected annual revenue potential per center using the future kitted test is:

• Annual high-margin revenue range: several hundred thousand dollars up to \$2 million per center
• US Total Addressable Market (TAM) estimate: \$1 billion
• Global TAM estimate: \$1 billion

The company is working to solidify this future stream by expecting at least three of the top 10 U.S. transplant centers to participate in the ongoing clinical trial. Finance: draft 13-week cash view by Friday.