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1. Company Snapshot

1.a. Company Description

OncoCyte Corporation, a molecular diagnostics company, researches, develops, and commercializes proprietary laboratory-developed tests for the detection of cancer in the United States and internationally.The company offers DetermaRx, a molecular test for early-stage adenocarcinoma of the lung; and DetermaIO, a proprietary gene expression assay.It also provides biomarker discovery testing, assay design and development, and clinical trial support services, as well as various biomarker tests for pharmaceutical companies.


The company has a collaboration agreement with Life Technologies Corporation to develop and collaborate in the commercialization of Oncomine Comprehensive Assay Plus and Determa IO assay for use with Ion Torrent Genexus integrated sequencer and purification system.OncoCyte Corporation was incorporated in 2009 and is based in Irvine, California.

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1.b. Last Insights on OCX

The recent 3 months performance of OncoCyte Corporation was negatively impacted by the company's failure to meet expectations in its Q1 2025 earnings release. Despite positive updates on clinical trial progress and the launch of its GraftAssure RUO assay in July 2024, the company's revenue growth was sluggish, with Q4 2024 revenue of $1.5 million in pharma services and full-year revenue of $1.9 million. The company's reliance on a single revenue stream and its limited product portfolio may have contributed to its slow growth. Additionally, the company's decision to participate in the 24th Annual Needham Virtual Healthcare Conference in April 2025 may have been overshadowed by its disappointing earnings release.

1.c. Company Highlights

2. Insight Molecular Diagnostics' Q3 2025 Earnings: A Promising Trajectory

Insight Molecular Diagnostics reported a loss per share of -$0.30422, slightly worse than the estimated -$0.24. The company's cash and equivalents stood at $20 million, with no debt, and lab services revenue came in as expected. The cash burn for Q3 was kept below the stated goal of $6 million, although it is expected to tick up slightly in Q4 due to expenses related to the FDA submission and clinical trial. Analysts estimate revenue growth of 44.5% for the next year.

Publication Date: Nov -21

📋 Highlights
  • Anticipated FDA Authorization Timeline:: Expected FDA clearance for GraftAssure DX by mid-2026, with a 150-day review process post-submission, despite delays from the government shutdown.
  • Financial Strength:: Closed Q3 with $20 million in cash and equivalents, no debt, and cash burn below $6 million in Q3; expects Q4 cash burn to rise slightly to $6.5–7 million due to FDA submission costs.
  • Market Opportunity:: Total addressable market exceeds $1 billion, targeting 150,000 annual transplants, 10x patient management volume, and two tests/year per patient, with Medicare-reimbursed kidney tests at $2,753 per result.
  • Clinical Trial Progress:: Five active clinical trial sites, 10 registry sites engaged, and 4–6 months until patient enrollment for the registry; expects to complete FDA submission data collection by year-end despite government shutdown.

Financial Performance and Position

The company's financial position remains solid, with $20 million in cash and no debt. The cash burn rate is expected to increase slightly in Q4 due to the FDA submission and clinical trial expenses. The lab services revenue was in line with expectations, and the company anticipates billing around $100,000 worth of these services in Q4. The actual EPS was -$0.30422, which was worse than the estimated -$0.24.

Regulatory Progress and Commercialization Plans

Insight Molecular Diagnostics is making significant progress towards FDA authorization for GraftAssure DX, expected in mid-2026. The company has engaged with around 10 sites for its registry and anticipates seeing patients within 4-6 months. Despite the government shutdown, the company remains confident about meeting its submission deadline. The GraftAssure franchise has a significant total addressable market, estimated to be over $1 billion, driven by the LCD for Palmetto GBA.

Market Opportunity and Growth Prospects

The company is poised to capitalize on a substantial market opportunity, with a total addressable market estimated to be over $1 billion for kitted transplant testing. The GraftAssure DX test is expected to drive revenue growth, and the company's registry will facilitate the adoption of its technology. The company is also exploring opportunities in cancer testing markets. With a P/S Ratio of 40.87 and an EV/EBITDA of -2.47, the market is pricing in significant growth expectations.

Valuation and Risks

The company's valuation metrics indicate a high growth expectation, with a P/S Ratio of 40.87. The EV/EBITDA ratio is negative due to the company's current loss-making position. The biggest risk to the company's timeline is the FDA review process, although it is preparing answers to potential questions in advance to mitigate this risk. The company's ROE is -2898.07%, and the ROIC is -135.87%, reflecting its current investment phase.

3. NewsRoom

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Oncocyte Changes Name to Insight Molecular Diagnostics Inc. (iMDx), Moves Headquarters to Nashville

Jun -17

Source: globenewswire.com

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Medicare Boosts Reimbursement for Oncocyte's Flagship Technology

May -19

Source: globenewswire.com

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OncoCyte Corporation (OCX) Q1 2025 Earnings Call Transcript

May -13

Source: seekingalpha.com

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Oncocyte Reports Q1 2025 Results and Business Progress

May -12

Source: globenewswire.com

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Oncocyte to Release First Quarter 2025 Results on May 12, 2025

May -07

Source: globenewswire.com

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Oncocyte to Release First Quarter 2025 Results on May 12, 2025

May -07

Source: prismmediawire.com

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Best Momentum Stocks to Buy for May 6th

May -06

Source: zacks.com

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May -06

Source: zacks.com

4. Business Breakdown

4.a. Revenues by Country

4.b. Revenues by Segment

5. Expected revenues mid-term growth (11.30%)

6. Segments

Diagnostic Tests

Expected Growth: 11.3%

OncoCyte Corporation's 11.3% growth in Diagnostic Tests is driven by increasing demand for early cancer detection, adoption of liquid biopsy technology, and expansion into new markets. Additionally, strategic partnerships, investments in R&D, and growing awareness of personalized medicine contribute to the segment's growth.

7. Detailed Products

DetermaRx

A non-invasive, liquid biopsy test for early detection of lung cancer

DetermaIO

A non-invasive, liquid biopsy test for immunotherapy response monitoring

DetermaTx

A non-invasive, liquid biopsy test for early detection of breast cancer

8. OncoCyte Corporation's Porter Forces

Forces Ranking

Threat Of Substitutes

OncoCyte Corporation's liquid biopsy tests are highly specialized and require significant expertise, making it difficult for substitutes to emerge.

Bargaining Power Of Customers

While customers have some bargaining power due to the availability of alternative diagnostic tests, OncoCyte's proprietary technology and strong relationships with healthcare providers mitigate this power.

Bargaining Power Of Suppliers

OncoCyte Corporation has a diversified supplier base, and the cost of switching suppliers is relatively low, reducing the bargaining power of suppliers.

Threat Of New Entrants

The liquid biopsy market is rapidly growing, and new entrants are attracted to the market, increasing the threat of new entrants for OncoCyte Corporation.

Intensity Of Rivalry

The liquid biopsy market is highly competitive, with multiple established players and new entrants, leading to a high intensity of rivalry for OncoCyte Corporation.

9. SWOT Analysis

Strength

Weaknesses

Opportunities

Threats

10. Capital Structure

10.a. Balance Sheet

10.b. Weighted Average Cost of capital

Value
Debt Weight 10.08%
Debt Cost 3.95%
Equity Weight 89.92%
Equity Cost 7.95%
WACC 7.54%
Leverage 11.21%

11. Quality Control: OncoCyte Corporation passed 2 out of 9 key points

12.a Historical Valuation

12.b Price/Earnings Ratio

12.c Margin Valuation

12.d Peers Valuation

Peers Group Analysis

Stock-Card
Seer

A-Score: 4.5/10

Value: 8.0

Growth: 4.2

Quality: 4.6

Yield: 0.0

Momentum: 6.5

Volatility: 3.7

1-Year Total Return ->

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2seventy bio

A-Score: 3.7/10

Value: 7.6

Growth: 4.4

Quality: 4.4

Yield: 0.0

Momentum: 5.0

Volatility: 0.7

1-Year Total Return ->

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Stock-Card
OncoCyte

A-Score: 3.7/10

Value: 7.0

Growth: 6.0

Quality: 3.2

Yield: 0.0

Momentum: 4.0

Volatility: 1.7

1-Year Total Return ->

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Vir Biotechnology

A-Score: 3.3/10

Value: 7.6

Growth: 3.6

Quality: 5.0

Yield: 0.0

Momentum: 2.0

Volatility: 1.7

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Biomea Fusion

A-Score: 3.2/10

Value: 6.8

Growth: 3.3

Quality: 3.6

Yield: 0.0

Momentum: 5.0

Volatility: 0.3

1-Year Total Return ->

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Pliant Therapeutics

A-Score: 2.6/10

Value: 7.8

Growth: 3.2

Quality: 3.5

Yield: 0.0

Momentum: 0.0

Volatility: 1.0

1-Year Total Return ->

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Peers Metrics

12.e Scoring Insights

12.f DCF BETA

Parameters

Short Term Growth

Short term Time

Long-Term Growth

WACC

Target Price

3.2$

Current Price

3.2$

Potential

-0.00%

Expected Cash-Flows