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Insight Molecular Diagnostics (IMDX)
NASDAQ:IMDX
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Insight Molecular Diagnostics
(NASDAQ:IMDX)
Rating:43Neutral
Price Target:
$2.50
▼(-2.34% Downside)
Positive Factors
Market Opportunities
The use of dd-cfDNA as a biomarker for transplant rejection is validated and broadly adopted across transplant centers in the U.S.
Partnerships and Collaborations
IMDX remains confident in its partnership with BioRad, whereby BioRad and IMDX will comarket GraftAssure inside the US/Germany, and BioRad will take the commercial lead in the ROW.
Product Development
IMDX's launch of GraftAssureIQ research use only test (RUO) is going well and IMDX continues to sign on transplant centers ahead of its GraftAssureDx Kidney kitted test launch in mid-2026 upon FDA clearance.
Negative Factors
Financial Challenges
Cash use is a significant topic of discussion, indicating potential financial challenges for OncoCyte.
Stock Performance
Shares have traded down 66% since Josh Riggs took the helm on an interim basis.
Tariff Exposure
Tariff exposure is a concern that could negatively impact OncoCyte.
Insight Molecular Diagnostics (IMDX) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$74.41M
Dividend YieldN/A
Average Volume (3M)35.98K
Price to Earnings (P/E)―
Beta (1Y)0.46
Revenue Growth316.13%
EPS Growth18.34%
CountryUS
Employees46
SectorHealthcare
Sector Strength51
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.30
Shares Outstanding28,619,750
10 Day Avg. Volume30,194
30 Day Avg. Volume35,981
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)N/A
P/FCF RatioN/A
Enterprise Value/Market Cap1.02
Enterprise Value/Revenue17.81
Enterprise Value/Gross Profit28.07
Enterprise Value/Ebitda-1.22
Forecast
1Y Price Target
$6.13Price Target Upside139.45% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering3
Insight Molecular Diagnostics Business Overview & Revenue Model
Company DescriptionOncoCyte 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.
How the Company Makes MoneyIMDX generates revenue primarily through the sale of its molecular diagnostic tests to clinical laboratories and healthcare facilities. The company's revenue model is built on direct sales of its proprietary assays, which are often reimbursed by insurance providers and government healthcare programs. Additionally, IMDX may engage in partnerships with other healthcare organizations, research institutions, and pharmaceutical companies to develop and commercialize new diagnostic products, further diversifying its income streams. Significant collaborations and licensing agreements can provide upfront payments, milestone payments, and royalties, contributing to the company’s overall financial growth.
Insight Molecular Diagnostics Earnings Call Summary
Earnings Call Date:Aug 11, 2025
(Q2-2025)
| % Change Since: |
Next Earnings Date:Nov 06, 2025
Earnings Call Sentiment Neutral
The earnings call reflects a company making solid progress with its FDA submission and assay improvements, supported by strong engagement with transplant centers and a high positive predictive value achievement. However, these positive developments are tempered by challenges in revenue generation and clinical trial enrollment.Q2-2025 Updates
Positive Updates
Progress with FDA Submission
The company has made significant progress with its FDA product, ReftAssure DX, and is on track to submit a data package to the FDA by the end of the year, aiming for FDA approval in 2026.
Successful Assay and Workflow Design Improvements
Assay and workflow design improvements have been completed and transferred to manufacturing, resulting in positive early feedback and adoption by multiple centers.
Strong Engagement with Transplant Centers
The company has engaged with 20 sites to train on the GraftAssure workflow by the end of the year, with 10 sites already running the research use only assay across several countries.
High Positive Predictive Value Achieved
The company demonstrated a positive predictive value of close to 80% by combining two scores algorithmically, which is a substantial improvement over the typical PPV of 50%.
Solid Financial Position
The company ended the second quarter with $26 million in cash and managed cash burn effectively, with plans to continue investment in their FDA program.
Negative Updates
Pharma Services Revenue Decline
Q2 pharma services revenue came in under $500,000, as expected, reflecting a decline in this revenue stream.
Limited Revenue from Initial Product Sales
Only a small number of first-generation GraftAssure IQ kits were sold, amounting to $24,000, with second-generation kits not yet generating revenue.
Challenges with Clinical Trial Enrollment
Questions were raised about the number of sites actively enrolling for the clinical trial, with only two sites currently enrolling, raising concerns about meeting the year-end submission timeline.
Company Guidance
In the call discussing Insight Molecular Diagnostics' (IMDx) second quarter 2025 results, the company outlined significant progress and future guidance concerning their FDA program and commercialization plans. CEO Josh Riggs highlighted key milestones, such as completing assay and workflow design improvements and initiating the first clinical trial site visits. IMDx remains on track to submit a data package to the FDA by the end of 2025, aiming for approval in 2026. The company has shipped second-generation RUO kits to beta sites, with plans to have 20 sites trained on their workflow by year-end. Currently, 10 sites are running the RUO assay across the US, Germany, the UK, Switzerland, Austria, and Southeast Asia. IMDx is optimistic about the positive predictive value of their assay, reaching nearly 80% through an algorithmic approach combining relative and absolute quantification. Financially, they reported Q2 revenue of $494,000 from laboratory services, with a gross margin of nearly 68%, and ended the quarter with $26 million in cash. They anticipate a cash burn of about $6 million per quarter until their commercial launch. The company also forecasts less than $300,000 in laboratory services revenue for Q3 2025.Insight Molecular Diagnostics Financial Statement Overview
Summary
Insight Molecular Diagnostics shows revenue growth but faces significant profitability and liquidity challenges. High debt levels and negative cash flows highlight financial instability, posing risks to future operations.Income Statement
Insight Molecular Diagnostics shows a mixed performance in its income statement. The company has experienced revenue growth, with a notable increase of 10.77% in the TTM period. However, profitability remains a significant challenge, as indicated by negative net profit margins and EBIT margins. The gross profit margin has improved to 63.42% in the TTM, but the company continues to struggle with substantial net losses, reflecting operational inefficiencies.45
Neutral
Balance Sheet
The balance sheet reveals a concerning financial structure with a high debt-to-equity ratio of 3.07 in the TTM, indicating heavy reliance on debt financing. The return on equity is negative, suggesting that the company is not generating sufficient returns on shareholders' investments. The equity ratio is low, pointing to potential financial instability and risk.30
Negative
Cash Flow
Cash flow analysis shows some positive trends, such as a 48% growth in free cash flow in the TTM. However, the company is still facing negative operating cash flow, which is concerning for its liquidity position. The operating cash flow to net income ratio is negative, indicating that the company is not generating enough cash from its operations to cover its net losses.40
Negative
| Breakdown | TTM | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 4.26M | 1.88M | 1.50M | 958.00K | 2.20M | 1.22M |
| Gross Profit | 2.70M | 740.00K | 501.00K | 78.00K | 188.00K | -639.00K |
| EBITDA | -62.03M | -59.02M | -23.12M | -13.31M | -48.46M | -30.54M |
| Net Income | -63.42M | -60.66M | -27.78M | -72.90M | -64.10M | -29.93M |
Balance Sheet | ||||||
| Total Assets | 50.52M | 35.08M | 74.89M | 100.09M | 159.56M | 55.42M |
| Cash, Cash Equivalents and Short-Term Investments | 24.29M | 8.64M | 9.43M | 20.43M | 33.85M | 7.82M |
| Total Debt | 3.37M | 3.66M | 2.87M | 3.54M | 5.68M | 8.63M |
| Total Liabilities | 49.42M | 47.35M | 49.30M | 65.80M | 94.35M | 21.94M |
| Stockholders Equity | 1.10M | -12.27M | 25.59M | 34.29M | 65.22M | 33.48M |
Cash Flow | ||||||
| Free Cash Flow | -23.35M | -21.23M | -23.61M | -49.91M | -38.19M | -27.21M |
| Operating Cash Flow | -23.04M | -20.71M | -23.32M | -45.57M | -35.94M | -25.98M |
| Investing Cash Flow | -953.00K | -512.00K | -932.00K | -4.34M | -13.96M | -11.75M |
| Financing Cash Flow | 39.03M | 20.43M | 12.19M | 35.81M | 78.36M | 22.80M |
Insight Molecular Diagnostics Technical Analysis
Neutral
2.56
Price Trends
2.76
Negative
2.89
Negative
2.76
Negative
Market Momentum
-0.06
Negative
47.60
Neutral
64.66
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For IMDX, the sentiment is Neutral. The current price of 2.56 is above the 20-day moving average (MA) of 2.54, below the 50-day MA of 2.76, and below the 200-day MA of 2.76, indicating a neutral trend. The MACD of -0.06 indicates Negative momentum. The RSI at 47.60 is Neutral, neither overbought nor oversold. The STOCH value of 64.66 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for IMDX.
Insight Molecular Diagnostics Risk Analysis
Insight Molecular Diagnostics disclosed 58 risk factors in its most recent earnings report. Insight Molecular Diagnostics reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 1 New Risks
1.
We currently market certain IVDs that have not been cleared by the FDA in reliance on the regulatory exemption for IVDs intended for RUO, but if the FDA determines that our RUO tests do not meet the applicable requirements for exemption or have intended uses that are inconsistent with RUO tests, we may be required to suspend commercialization of such products until we can obtain the requisite FDA clearance and/or subject to FDA warning or untitled letters, seizure, injunction, fines, or other enforcement action. Q3, 2024
Insight Molecular Diagnostics Peers Comparison
Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
52 Neutral | $111.87M | ― | -69.71% | ― | 303.47% | 73.70% | |
51 Neutral | $7.89B | -0.33 | -41.61% | 2.23% | 23.26% | -2.03% | |
47 Neutral | $96.66M | ― | 149.62% | ― | -5.22% | 82.06% | |
43 Neutral | $74.41M | ― | -532.89% | ― | 316.13% | 18.34% | |
43 Neutral | $104.43M | ― | -130.27% | ― | ― | 35.81% | |
36 Underperform | $98.54M | ― | -41.66% | ― | ― | -8.91% | |
| ― | $42.61M | ― | -1575.45% | ― | ― | ― |
* Healthcare Sector Average
Performance Comparison
IMDX
Insight Molecular Diagnostics
2.56
-0.63
-19.75%
ATOS
Atossa Therapeutics
0.77
-0.59
-43.38%
MGNX
MacroGenics
1.91
-1.41
-42.47%
ELUT
Aziyo Biologics
1.99
-2.01
-50.25%
SRZN
Surrozen
12.54
2.30
22.46%
TELO
Telomir Pharmaceuticals, Inc.
1.18
-3.58
-75.21%
Insight Molecular Diagnostics Corporate Events
Executive/Board ChangesShareholder MeetingsBusiness Operations and Strategy
Insight Molecular Diagnostics Approves Key Proposals at Annual Meeting
Positive
Jul 2, 2025
On June 27, 2025, Insight Molecular Diagnostics Inc. held its Annual Meeting of Shareholders virtually, with 73.46% of voting power represented. During the meeting, shareholders voted on several key proposals, including the election of four directors, ratification of the accounting firm CBIZ CPAs P.C., approval of executive compensation, and an amendment to increase shares under the 2018 Equity Incentive Plan. All proposals were approved, impacting the company’s governance and financial strategies positively.
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.