Applied Therapeutics (APLT) AI Stock Analysis

• Market Cap: $85.36M
• Dividend Yield: N/A
• Average Volume (3M): 2.27M
• Price to Earnings (P/E): ―
• Beta (1Y): 1.06
• Revenue Growth: N/A
• EPS Growth: N/A
• Country: US
• Employees: 35
• Sector: Healthcare
• Sector Strength: 38
• Industry: Biotechnology
• EPS (TTM): -0.15
• Shares Outstanding: 141,575,530
• 10 Day Avg. Volume: 2,053,271
• 30 Day Avg. Volume: 2,266,037
• PEG Ratio: <0.01
• Price to Book (P/B): 0.80
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -0.47
• Enterprise Value/Market Cap: N/A
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: N/A
• Enterprise Value/Ebitda: N/A
• 1Y Price Target: $2.25
• Price Target Upside: 275.00% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 3

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

APLT will present the full 12-month clinical data from the Phase 3 INSPIRE study and additional new topline data at 18 and 24 months for patients.

Management Changes

The strengthening of Applied's management team is a key step in rebuilding the company's reputation and regulatory readiness.

Regulatory Strategy

Govorestat still has a lot of support from the galactosemia KOL community and patient advocates, highlighting the unmet need.

Negative Factors

Financial Performance

Applied reported a net loss of $21.8 million in the first quarter.

Market Uncertainty

The company's stock is expected to continue trading at current levels until there is clarity on when or how either govorestat program will progress toward registration.

Regulatory Challenges

APLT received a CRL for govorestat in classic galactosemia, which was followed by a warning letter from the FDA.

Applied Therapeutics Business Overview & Revenue Model

Company Description

Applied 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 Money

Applied 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 faces significant financial hurdles characterized by negative revenue, persistent losses, and high leverage. The cash position offers some relief, but the overall financial health is challenged by ongoing operational inefficiencies and cash burn, necessitating strategic changes to achieve sustainable growth.

Income Statement

The company exhibits significant challenges in its income statement. The TTM (Trailing-Twelve-Months) shows negative revenue and a substantial net loss. Revenue growth has been negative, indicating a lack of revenue generation, while profit margins remain deeply negative. The EBIT and EBITDA margins are also unfavorable, reflecting continuous operating losses.

Balance Sheet

The balance sheet reveals high liabilities relative to equity, with a low stockholders' equity position. The debt-to-equity ratio is concerning, indicating financial leverage risk. However, the company maintains a relatively high level of cash and short-term investments compared to its total assets, providing some liquidity buffer.

Cash Flow

Cash flow analysis shows consistent negative operating and free cash flows, indicating cash burn. The operating cash flow to net income ratio suggests inefficiencies in converting income to cash, and the lack of positive free cash flow highlights the company's reliance on financing activities for cash generation.

Breakdown
TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement		Total Revenue
-211.00K	455.00K	9.99M	0.00	0.00	0.00
	Gross Profit
-799.00K	455.00K	9.64M	-441.00K	-415.00K	-380.00K
	EBIT
-92.28M	-104.30M	-64.53M	-82.95M	-105.62M	-94.47M
	EBITDA
-92.18M	-104.30M	-64.53M	-82.07M	-105.17M	-94.47M
	Net Income Common Stockholders
-187.31M	-105.62M	-119.76M	-81.69M	-104.61M	-93.02M
Balance Sheet		Cash, Cash Equivalents and Short-Term Investments
3.28M	79.40M	49.90M	30.58M	80.82M	96.83M
	Total Assets
0.00	86.69M	54.83M	38.36M	89.89M	104.51M
	Total Debt
0.00	2.79M	777.00K	891.00K	1.33M	1.74M
	Net Debt
3.28M	-76.60M	-49.12M	-15.77M	-52.55M	-55.73M
	Total Liabilities
0.00	29.68M	71.98M	34.30M	27.35M	22.57M
	Stockholders Equity
2.29M	57.01M	-17.15M	4.06M	62.54M	81.94M
Cash Flow		Free Cash Flow
-81.84M	-84.31M	-55.17M	-78.09M	-90.73M	-78.21M
	Operating Cash Flow
-81.84M	-84.31M	-55.17M	-78.09M	-90.73M	-78.21M
	Investing Cash Flow
0.00	0.00	13.87M	13.17M	12.43M	-19.47M
	Financing Cash Flow
143.25M	113.81M	74.54M	27.69M	74.72M	136.29M

Applied Therapeutics Technical Analysis

• Technical Analysis Sentiment: Neutral
• Last Price: 0.60
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Negative
• MACD: Negative
• RSI: Negative
• STOCH: Negative

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 0.6 is above the 20-day moving average (MA) of 0.42, above the 50-day MA of 0.44, and below the 200-day MA of 3.60, indicating a neutral trend. The MACD of 0.02 indicates Negative momentum. The RSI at 71.18 is Negative, neither overbought nor oversold. The STOCH value of 87.56 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for APLT.

Applied Therapeutics Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
CTMX	68 Neutral	$319.82M	4.09	-58.97%	―	23.81%	146.45%
Sector *	52 Neutral	$5.15B	3.05	-44.13%	2.84%	16.42%	-0.48%
AGEN	44 Neutral	$95.14M	―	260.68%	―	-38.34%	31.19%
FBIO	41 Neutral	$53.52M	―	-181.84%	―	-32.11%	88.12%
APLT	39 Underperform	$85.36M	―	-83.71%	―	―	―
SKYE	38 Underperform	$58.87M	―	-47.27%	―	―	87.22%

Applied Therapeutics Corporate Events

Applied Therapeutics Faces Leadership Changes and Regulatory Hurdles

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.

Applied Therapeutics Faces FDA Challenges with Govorestat

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.