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Applied Therapeutics Inc (APLT)
NASDAQ:APLT

Applied Therapeutics (APLT) AI Stock Analysis

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Applied Therapeutics

(NASDAQ:APLT)

Rating:39Underperform
Price Target:
Applied Therapeutics is in the early stages of revenue generation, but significant challenges in achieving profitability and sustaining operations through negative cash flow pose risks. The technical analysis shows downward momentum, and valuation metrics reflect its current unprofitability. Focus remains on operational improvements and expense management to navigate financial instability.
Positive Factors
Clinical Data and Research
Significant lowering of blood sorbitol levels was reported among patients treated with govorestat, with a 33.1% relative reduction compared to placebo.
Leadership Strengthening
The strengthening of Applied's management team is a key step in rebuilding the company's reputation and regulatory readiness.
Negative Factors
Financial Performance
Applied reported a net loss of $21.8 million in the first quarter.
Regulatory Challenges
It is increasingly unclear when applications for govorestat in galactosemia and SORD deficiency will be rectified or submitted to regulators.

Applied Therapeutics (APLT) vs. SPDR S&P 500 ETF (SPY)

Applied Therapeutics Business Overview & Revenue Model

Company DescriptionApplied Therapeutics, Inc., a clinical-stage biopharmaceutical company, develops novel products to target cardiovascular disease, galactosemia, and diabetic complications. Its lead product candidate is AT-007 that has completed phase 1/2 for the treatment of galactosemia in healthy volunteers and adults, as well as is in pediatric clinical study for the treatment of galactosemia in kids; for treating sorbitol dehydrogenase deficiency; and for the treatment of phosphomannomutase enzyme-CDG. The company also develops AT-001 that is in phase III clinical trials for treating diabetic cardiomyopathy, as well as for the treatment of diabetic peripheral neuropathy. Its preclinical stage products include AT-003 for the treatment diabetic retinopathy; AT-104, a PI3K inhibitor for treating orphan hematological oncology T Cell Acute Lymphoblastic Leukemia. Applied Therapeutics, Inc. was incorporated in 2016 and is headquartered in New York, New York.
How the Company Makes MoneyApplied Therapeutics generates revenue primarily through the development and commercialization of its drug candidates. The company invests heavily in clinical trials to bring its products to market, seeking regulatory approvals from agencies like the FDA. Once approved, revenues are expected from product sales and potential partnerships or licensing agreements with larger pharmaceutical companies. These partnerships may provide milestone payments, royalties, or co-development funding. The success of its revenue model is contingent on the successful clinical development and commercialization of its therapies.

Applied Therapeutics Financial Statement Overview

Summary
Applied Therapeutics is beginning to generate revenue, but profitability and cash flow remain significant challenges. The company is reliant on external financing to sustain its operations, which could pose risks if the funding environment tightens. Despite some improvements in financial position, the biotechnology company needs to focus on achieving operational efficiencies and managing expenses to move towards profitability.
Income Statement
40
Negative
Applied Therapeutics has shown a significant increase in total revenue from $0 to $9.993 million in 2023 and to $455,000 in 2024, indicating initial revenue generation in the last two years. However, the company is still reporting substantial net losses, with a negative net profit margin indicating ongoing challenges in achieving profitability. The EBIT and EBITDA margins are deeply negative, reflecting high operating expenses relative to revenue.
Balance Sheet
35
Negative
The company's balance sheet shows a moderate debt-to-equity ratio due to low total debt, but stockholders' equity has been negative in previous periods, indicating financial instability. The equity ratio is relatively low, reflecting a higher proportion of liabilities to assets. While there is an improvement in total assets and stockholders' equity in 2024, the company remains highly leveraged.
Cash Flow
45
Neutral
Operating cash flow remains negative, but there is a significant increase in financing cash flow, which suggests reliance on external funding to support operations. Free cash flow remains negative, indicating that the company is not yet generating cash from its operations, which is a concern for long-term sustainability.
Breakdown
TTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
265.00K455.00K9.99M0.000.000.00
Gross Profit
64.00K30.00K9.64M-441.00K-415.00K-380.00K
EBIT
-108.73M-104.30M-64.53M-82.95M-105.62M-94.47M
EBITDA
-108.55M-103.87M-64.53M-82.07M-105.17M-94.47M
Net Income Common Stockholders
-43.51M-105.62M-119.76M-81.69M-104.61M-93.02M
Balance SheetCash, Cash Equivalents and Short-Term Investments
50.76M79.40M49.90M30.58M80.82M96.83M
Total Assets
56.91M86.69M54.83M38.36M89.89M104.51M
Total Debt
2.70M2.79M777.00K891.00K1.33M1.74M
Net Debt
-48.06M-76.60M-49.12M-15.77M-52.55M-55.73M
Total Liabilities
20.24M29.68M71.98M34.30M27.35M22.57M
Stockholders Equity
36.67M57.01M-17.15M4.06M62.54M81.94M
Cash FlowFree Cash Flow
-94.03M-84.31M-55.17M-78.09M-90.73M-78.21M
Operating Cash Flow
-94.03M-84.31M-55.17M-78.09M-90.73M-78.21M
Investing Cash Flow
0.000.0013.87M13.17M12.43M-19.47M
Financing Cash Flow
-1.69M113.81M74.54M27.69M74.72M136.29M

Applied Therapeutics Technical Analysis

Technical Analysis Sentiment
Neutral
Last Price0.40
Price Trends
50DMA
0.40
Negative
100DMA
0.48
Negative
200DMA
3.18
Negative
Market Momentum
MACD
-0.02
Positive
RSI
49.86
Neutral
STOCH
50.88
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For APLT, the sentiment is Neutral. The current price of 0.4 is below the 20-day moving average (MA) of 0.41, below the 50-day MA of 0.40, and below the 200-day MA of 3.18, indicating a bearish trend. The MACD of -0.02 indicates Positive momentum. The RSI at 49.86 is Neutral, neither overbought nor oversold. The STOCH value of 50.88 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for APLT.

Applied Therapeutics Risk Analysis

Applied Therapeutics disclosed 62 risk factors in its most recent earnings report. Applied Therapeutics reported the most risks in the “Tech & Innovation” category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Applied Therapeutics Peers Comparison

Overall Rating
UnderperformOutperform
Sector (54)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
61
Neutral
$415.92M5.31-58.97%23.81%146.45%
54
Neutral
$5.31B3.26-45.10%2.79%16.76%0.02%
52
Neutral
$59.14M-181.84%-32.11%88.12%
51
Neutral
$163.13M260.68%-38.34%31.19%
39
Underperform
$52.27M-83.71%
38
Underperform
$75.29M-47.27%87.22%
$66.07M-111.42%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
APLT
Applied Therapeutics
0.40
-4.71
-92.17%
AGEN
Agenus
5.55
-11.62
-67.68%
CTMX
CytomX Therapeutics
2.64
1.01
61.96%
FBIO
Fortress Biotech
2.13
0.17
8.67%
SKYE
Skye Bioscience
2.34
-7.64
-76.55%
IMMX
Immix Biopharma
2.34
0.27
13.04%

Applied Therapeutics Corporate Events

Executive/Board ChangesLegal ProceedingsRegulatory Filings and Compliance
Applied Therapeutics Faces Leadership Changes and Regulatory Hurdles
Negative
Dec 20, 2024

Applied Therapeutics, Inc. has appointed John H. Johnson as Executive Chairman and Les Funtleyder as interim CEO, following the resignation of Dr. Shoshana Shendelman. The company is navigating regulatory challenges, having received a Complete Response Letter from the FDA and withdrawing a European MAA for govorestat, while planning to submit a new NDA for Sorbitol Dehydrogenase deficiency after Q1 2025.

Product-Related AnnouncementsLegal ProceedingsRegulatory Filings and Compliance
Applied Therapeutics Faces FDA Challenges with Govorestat
Negative
Dec 2, 2024

Applied Therapeutics, Inc. faces challenges with its New Drug Application for govorestat after the FDA issued a warning letter highlighting data capture issues and a dosing error in the AT-007-1002 study. The company has provided detailed records and intends to respond within 15 business days to address these issues. However, forward-looking statements regarding its operations and market prospects involve significant uncertainties, emphasizing the risks and challenges in achieving projected outcomes.

Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.

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.