Applied Therapeutics, Inc. (APLT)

Applied Therapeutics, Inc. (APLT) Healthcare & Pipeline Overview

Applied Therapeutics, Inc. is a clinical-stage biopharmaceutical company specializing in novel therapies for cardiovascular diseases, galactosemia, and diabetic complications. With lead product candidates in Phase III trials and a focus on rare and underserved conditions, Applied Therapeutics aims to address significant unmet medical needs within the biotechnology sector.

What Is the Investment Thesis for APLT?

Applied Therapeutics, Inc. presents a high-risk, high-reward investment opportunity within the biotechnology sector. The company's value hinges on the successful clinical development and regulatory approval of its lead product candidates, AT-007 and AT-001. Positive Phase III trial results for AT-001 in diabetic cardiomyopathy and diabetic peripheral neuropathy could serve as major catalysts, potentially leading to significant market valuation increases. The company's focus on rare diseases, particularly galactosemia with AT-007, offers the potential for orphan drug designation and accelerated regulatory pathways. However, the company's negative profit margin of -1813.8% and gross margin of -2845.5% highlight the substantial financial risks associated with clinical-stage biopharmaceutical companies. Investors should closely monitor clinical trial outcomes, regulatory milestones, and the company's cash runway.

Based on FMP financials and quantitative analysis

APLT Key Highlights

• Market Cap of $14.86M reflects the company's current valuation and potential for growth upon successful clinical trial outcomes.
• Profit Margin of -1813.8% indicates the company's significant investment in research and development, typical for clinical-stage biopharmaceutical companies.
• Gross Margin of -2845.5% highlights the high costs associated with drug development and clinical trials.
• Beta of 2.08 suggests higher volatility compared to the overall market, reflecting the speculative nature of biotechnology stocks.
• No Dividend reflects the company's focus on reinvesting earnings into research and development rather than returning capital to shareholders.

Who Are APLT's Competitors?

APLT is benchmarked below against 8 industry peers on price, market cap, and our AI MoonshotScore.

AI Score by Stock Expert AI · Price data: FMP / Yahoo Finance

What Are APLT's Key Strengths?

• Novel product candidates targeting unmet medical needs.
• Clinical-stage pipeline with multiple programs in development.
• Focus on rare diseases with orphan drug designation potential.
• Experienced management team with expertise in drug development.

What Are APLT's Weaknesses?

• Limited financial resources and reliance on external funding.
• High risk of clinical trial failures and regulatory setbacks.
• Negative profit and gross margins.
• Small number of employees.

What Could Drive APLT Stock Higher?

• Phase III clinical trial results for AT-001 in diabetic cardiomyopathy.
• Phase III clinical trial results for AT-001 in diabetic peripheral neuropathy.
• Pediatric clinical study for AT-007 in the treatment of galactosemia.
• Regulatory submissions for AT-007 and AT-001.

What Are the Key Risks for APLT?

• Financial-distress signal — its Altman Z-Score of -27.42 sits in the distress zone (elevated bankruptcy risk).
• Negative return on equity (-65.6%) — the business is not currently generating profit on shareholder capital.
• Weak fundamentals — a Piotroski F-Score of 1/9 flags soft profitability, leverage or efficiency.
• Clinical trial failures for AT-007 and AT-001.
• Regulatory setbacks and delays in obtaining marketing approvals.
• Competition from established pharmaceutical companies and other biotech firms.
• Limited financial resources and reliance on external funding.
• Product liability claims and intellectual property disputes.

What Are the Growth Opportunities for APLT?

• AT-007 for Galactosemia: Applied Therapeutics has a significant growth opportunity with AT-007, targeting galactosemia, a rare genetic metabolic disorder. The market for galactosemia treatments is underserved, and AT-007's ongoing pediatric clinical study could lead to orphan drug designation and accelerated regulatory approval. Successful commercialization of AT-007 could establish Applied Therapeutics as a leader in the treatment of rare metabolic disorders, with potential for expansion into other related conditions. The timeline for potential FDA approval is estimated within the next 2-3 years pending successful trial data.
• AT-001 for Diabetic Cardiomyopathy: The Phase III clinical trials for AT-001 in treating diabetic cardiomyopathy represent a substantial growth opportunity. Diabetic cardiomyopathy is a major complication of diabetes, and effective treatments are limited. Positive trial results and subsequent regulatory approval could position AT-001 as a key therapy in this market. The increasing prevalence of diabetes globally further fuels the demand for effective treatments. The market size for diabetic cardiomyopathy treatments is projected to reach billions of dollars within the next 5 years.
• AT-001 for Diabetic Peripheral Neuropathy: Applied Therapeutics is also pursuing the development of AT-001 for the treatment of diabetic peripheral neuropathy, another common and debilitating complication of diabetes. The market for diabetic neuropathy treatments is large and growing, driven by the increasing incidence of diabetes worldwide. Successful clinical trials and regulatory approval of AT-001 could capture a significant share of this market. The company's focus on addressing both diabetic cardiomyopathy and neuropathy with AT-001 provides synergistic growth opportunities.
• AT-003 for Diabetic Retinopathy: The preclinical development of AT-003 for the treatment of diabetic retinopathy presents a longer-term growth opportunity. Diabetic retinopathy is a leading cause of blindness, and effective treatments are needed. Advancing AT-003 through preclinical and clinical development could lead to a valuable new therapy in this market. The company's expertise in diabetic complications positions it well to develop and commercialize AT-003. The timeline for potential market entry is estimated within the next 5-7 years.
• AT-104 for T Cell Acute Lymphoblastic Leukemia: The development of AT-104, a PI3K inhibitor for treating orphan hematological oncology T Cell Acute Lymphoblastic Leukemia, provides an opportunity to address a rare and underserved cancer market. Orphan drug designation and accelerated regulatory pathways could expedite the development and approval of AT-104. Successful commercialization of AT-104 could establish Applied Therapeutics in the oncology space and provide a platform for further expansion into other rare cancers. The timeline for potential market entry is estimated within the next 4-6 years.

What Opportunities Does APLT Have?

• Successful clinical development and regulatory approval of lead product candidates.
• Expansion into new therapeutic areas and indications.
• Strategic partnerships and collaborations with larger pharmaceutical companies.
• Potential for orphan drug designation and accelerated regulatory pathways.

What Threats Does APLT Face?

• Competition from established pharmaceutical companies and other biotech firms.
• Changes in regulatory requirements and healthcare policies.
• Product liability claims and intellectual property disputes.
• Economic downturns and market volatility.

What Are APLT's Competitive Advantages?

• Proprietary drug candidates with patent protection.
• Focus on rare diseases with orphan drug designation potential.
• Expertise in developing therapies for metabolic disorders and diabetic complications.
• Clinical-stage pipeline with multiple product candidates in development.

What Does APLT Do?

Applied Therapeutics, Inc., founded in 2016 and headquartered in New York City, is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for diseases with significant unmet medical needs. The company focuses on targeting cardiovascular disease, galactosemia, diabetic complications, and orphan hematological oncology. Applied Therapeutics' lead product candidate, AT-007, has completed phase 1/2 clinical trials for the treatment of galactosemia in healthy volunteers and adults and is currently in a pediatric clinical study for the treatment of galactosemia in kids, as well as for treating sorbitol dehydrogenase deficiency and phosphomannomutase enzyme-CDG. AT-007 represents a significant advancement in addressing these rare metabolic disorders. The company is also developing AT-001, which is in phase III clinical trials for treating diabetic cardiomyopathy and diabetic peripheral neuropathy. These trials aim to provide effective treatments for the complications arising from diabetes. Additionally, Applied Therapeutics has preclinical stage products, including AT-003 for the treatment of diabetic retinopathy and AT-104, a PI3K inhibitor for treating orphan hematological oncology T Cell Acute Lymphoblastic Leukemia. These early-stage programs demonstrate the company's commitment to expanding its therapeutic pipeline and addressing a broader range of medical conditions. With a focus on novel products and clinical development, Applied Therapeutics strives to bring innovative solutions to patients in need.

What Products and Services Does APLT Offer?

• Develop novel products to target cardiovascular disease.
• Develop novel products to target galactosemia.
• Develop novel products to target diabetic complications.
• Develop AT-007 for the treatment of galactosemia.
• Develop AT-001 for treating diabetic cardiomyopathy.
• Develop AT-001 for treating diabetic peripheral neuropathy.
• Develop AT-003 for the treatment diabetic retinopathy.
• Develop AT-104, a PI3K inhibitor for treating orphan hematological oncology T Cell Acute Lymphoblastic Leukemia.

How Does APLT Make Money?

• Focus on developing novel therapies for diseases with unmet medical needs.
• Conduct clinical trials to evaluate the safety and efficacy of product candidates.
• Seek regulatory approval from the FDA and other regulatory agencies.
• Commercialize approved products through partnerships or direct sales.

What Industry Does APLT Operate In?

Applied Therapeutics operates within the biotechnology industry, a sector characterized by high innovation, intense competition, and significant regulatory oversight. The market for novel therapies targeting cardiovascular diseases, galactosemia, and diabetic complications is substantial, driven by the increasing prevalence of these conditions globally. The competitive landscape includes both established pharmaceutical giants and smaller biotech firms, all vying for market share. Applied Therapeutics differentiates itself through its focus on specific unmet medical needs and its pipeline of novel product candidates. The biotechnology industry is projected to continue its growth trajectory, fueled by advancements in genomics, personalized medicine, and drug delivery technologies.

Who Are APLT's Key Customers?

• Patients suffering from cardiovascular disease.
• Patients suffering from galactosemia.
• Patients suffering from diabetic complications.
• Healthcare providers who treat these patients.

Net sellingInsider Activity

Over the past six months, Applied Therapeutics, Inc. insiders filed 25 SEC Form 4 transactions — 25 sales and 0 purchases. On net that is roughly 6.9M shares disposed (about $1.3M), a signal worth weighing alongside the fundamentals.

APLT Valuation & Market Position

With a $14.86M market cap, Applied Therapeutics, Inc. sits in the micro-cap segment of the market. Relative to its peer group, APLT's quantitative score of 44/100 is below the peer average of 76/100.

ROE -66%Key Financial Metrics

Return on equity for Applied Therapeutics, Inc. stands at -65.6%, a gauge of how efficiently it converts shareholder capital into profit. Return on assets is -52.8%, showing how much profit it generates from its asset base. A current ratio of 0.96 means current liabilities exceed short-term assets, a liquidity point worth watching. Its earnings yield is -121.0%, the inverse of the P/E and a quick read on earnings relative to price.

F-Score 1/9Financial Health

Applied Therapeutics, Inc.'s Piotroski F-Score is 1/9, a 9-point checklist of profitability, leverage and efficiency — flagging fundamental weakness worth scrutiny. Its Altman Z-Score of -27.42 places it in the distress zone, a signal of elevated financial risk.

FY2026 estForward Outlook

Wall Street analysts project Applied Therapeutics, Inc. revenue of about $1.7M for fiscal 2026, with EPS near $-0.43. The estimate reflects 3 contributing analysts.

Company Profile

Applied Therapeutics, Inc. operates in the Biotechnology industry within the Healthcare sector. It is headquartered in New York City, US. The company is led by CEO Les D. Funtleyder. APLT has traded publicly since 2019.

APLT Financials

APLT Latest News

APLT Analyst Consensus

APLT MoonshotScore

Applied Therapeutics, Inc. Healthcare Stock: Key Questions Answered

Disclaimer: This content is for informational purposes only and does not constitute investment advice. Always do your own research and consult a financial advisor.

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