Applied Therapeutics, Inc. (APLT): History, Ownership, Mission, How It Works & Makes Money

Applied Therapeutics, Inc. (APLT): History, Ownership, Mission, How It Works & Makes Money

US | Healthcare | Biotechnology | NASDAQ

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Have you ever wondered about the journey of Applied Therapeutics, Inc. (APLT), a clinical-stage biopharmaceutical company dedicated to addressing unmet medical needs? With a focus on developing novel drug candidates, Applied Therapeutics has carved a niche for itself in the competitive biopharmaceutical landscape, particularly in the realm of rare diseases. As of April 2025, the company's stock is trading around $0.32, reflecting the dynamic nature of its market position and the challenges it faces, including a potential Nasdaq delisting if it cannot maintain a minimum bid price of $1.00 by August 6, 2025. Keep reading to discover how Applied Therapeutics operates, its mission, and how it strives to generate revenue in the complex world of biopharmaceuticals.

Applied Therapeutics, Inc. (APLT) History

Applied Therapeutics, Inc. Founding Timeline

Year established

Applied Therapeutics, Inc. was founded in 2016.

Original location

The company is headquartered in New York, NY.

Founding team members

While specific names of all founding team members are not readily available in the provided search snippets, Shoshana Shendelman is identified as the Chief Executive Officer and one of the key figures associated with the company's establishment.

Initial capital/funding

Information regarding the specific initial capital or funding at the time of founding is not available in the search results.

Applied Therapeutics, Inc. Evolution Milestones

Year Key Event Significance
2019 Acquired rights to AT-001 (caficrestat) Expanded the company's pipeline with a promising compound for the treatment of Diabetic Cardiomyopathy (DCM).
2020 Initiated Phase 3 ARISE-HF study of AT-001 in patients with Diabetic Cardiomyopathy (DCM) Advanced the clinical development of AT-001, marking a critical step toward potential regulatory approval.
2021 Announced positive topline results from the Phase 3 INSPIRE study of AT-007 in patients with Galactosemia Demonstrated the efficacy of AT-007, potentially offering a new treatment option for patients with Galactosemia.
2023 Received a Refusal to File letter from the FDA for their New Drug Application (NDA) for Govorestat for the treatment of classic galactosemia. Experienced a setback in their regulatory pathway, requiring additional data and analysis before resubmission.
2024 Submitted a formal dispute resolution request (FDRR) to the FDA regarding the RTF letter for Govorestat. Challenged the FDA's decision, seeking a re-evaluation of their application based on existing clinical data.

Applied Therapeutics, Inc. Transformative Moments

  • Strategic Pipeline Expansion: The acquisition and development of drug candidates like AT-001 and AT-007 have been pivotal in shaping the company's focus on addressing unmet medical needs in specific disease areas.
  • Clinical Trial Outcomes: Results from Phase 3 trials, such as the INSPIRE study for AT-007, have significantly influenced the company's valuation and future prospects, guiding subsequent regulatory strategies.
  • Regulatory Interactions: The interactions with regulatory bodies, including the FDA, have had transformative impacts, as seen with the Refusal to File letter for Govorestat and the subsequent dispute resolution efforts.
  • Focus on Rare Diseases: A strategic emphasis on developing therapies for rare diseases like Galactosemia has allowed the company to target niche markets with limited treatment options.

To gain further insights into the company's guiding principles, explore: Mission Statement, Vision, & Core Values of Applied Therapeutics, Inc. (APLT).

Applied Therapeutics, Inc. (APLT) Ownership Structure

Understanding Applied Therapeutics, Inc.’s ownership structure provides insights into its control and governance. The company's shares are distributed among institutional investors, retail investors, and company insiders, each holding varying degrees of influence.

Applied Therapeutics, Inc.'s Current Status

Applied Therapeutics, Inc. is a public company, trading on the Nasdaq Global Market under the ticker symbol APLT. This means that its shares are available for purchase by the general public, and the company is subject to regulations and reporting requirements set forth by the U.S. Securities and Exchange Commission (SEC).

Applied Therapeutics, Inc.'s Ownership Breakdown

The ownership of Applied Therapeutics, Inc. is distributed among various types of shareholders. Here’s a detailed breakdown:

Shareholder Type Ownership, % Notes
Institutional Investors 71.46% These are firms that manage large sums of money, including mutual funds, hedge funds, pension funds, and insurance companies. Their holdings can significantly influence the company's stock performance.
Individual Investors 24.44% These are retail investors who directly own shares of Applied Therapeutics. The collective impact of retail investors can be substantial, especially in heavily traded stocks.
Insiders 4.10% These are the company’s officers and directors, who may hold shares or options in the company. Their ownership aligns their interests with the company’s performance.

To gain more insights into who is investing in Applied Therapeutics and the motivations behind their investment decisions, check out this detailed analysis: Exploring Applied Therapeutics, Inc. (APLT) Investor Profile: Who’s Buying and Why?

Applied Therapeutics, Inc.'s Leadership

The leadership team at Applied Therapeutics, Inc. is responsible for the strategic direction and operational execution of the company. Key members of the leadership team as of April 2025 include:

  • Shoshana Shendelman, PhD: Founder, Chairwoman, and Chief Executive Officer
  • David Cohen, MD: Chief Medical Officer
  • John J. Spitznagel, MBA: Chief Commercial Officer
  • Kurt R. Gustafson: Chief Financial Officer
  • Steven Kwon, JD: General Counsel

This leadership team guides Applied Therapeutics in its mission to develop and commercialize novel therapies for unmet medical needs.

Applied Therapeutics, Inc. (APLT) Mission and Values

Applied Therapeutics, Inc. aims to develop transformative therapies for unmet medical needs, reflecting a commitment to innovation and patient well-being. The company's core values likely revolve around scientific rigor, patient-centricity, and ethical conduct.

Applied Therapeutics, Inc. Core Purpose

Official mission statement

Applied Therapeutics is a clinical-stage biopharmaceutical company dedicated to discovering, developing and commercializing novel therapeutics to alleviate human suffering and improve the quality of life of patients with debilitating diseases. They focus on unmet medical needs, particularly in areas such as:

  • Cardiorenal diseases
  • Diabetes
  • Neurodegenerative diseases

The company's approach involves targeting fundamental biological pathways to develop therapies that address the root causes of these diseases. This proactive strategy underscores a commitment to pioneering medical solutions and improving patient outcomes.

Vision statement

While Applied Therapeutics doesn't have a single, explicitly published vision statement, their actions and communications suggest a vision focused on:

  • Becoming a leader in developing innovative therapies for diseases with significant unmet needs.
  • Transforming the lives of patients and families affected by debilitating conditions.
  • Advancing scientific understanding of disease mechanisms to create more effective treatments.

This vision is reflected in their pipeline of drug candidates and their focus on rigorous scientific research.

Company slogan/tagline

Currently, there is no widely recognized official slogan or tagline for Applied Therapeutics. However, considering their focus, a possible tagline could be:

  • 'Transforming Lives Through Innovative Therapeutics.'
  • 'Pioneering Solutions for Unmet Medical Needs.'
  • 'Advancing Science, Improving Lives.'

These potential taglines encapsulate the company's dedication to innovation, patient care, and scientific advancement. To gain more insights into Applied Therapeutics, Inc., consider reading: Exploring Applied Therapeutics, Inc. (APLT) Investor Profile: Who’s Buying and Why?

Applied Therapeutics, Inc. (APLT) How It Works

Applied Therapeutics, Inc. is a biopharmaceutical company focused on developing novel therapeutics for unmet medical needs in rare, debilitating diseases. The company discovers, develops, and seeks to commercialize small molecule drugs targeting specific molecular mechanisms to improve patient outcomes.

Product/Service Portfolio

Product/Service Target Market Key Features
Sorbitol Dehydrogenase (SORD) Inhibitor (AT-007/Govorestat) SORD Deficiency An investigational new drug shown to reduce sorbitol levels, addressing the root cause of SORD deficiency.
PKC Inhibitor (AT-001/Caficrestat) Diabetic Cardiomyopathy (DbCM) Designed to inhibit Protein Kinase C (PKC), a key driver of DbCM, aiming to improve cardiac function and prevent disease progression.
ARI (AT-003) Neurodegenerative Diseases A CNS penetrant Aldose Reductase Inhibitor (ARI) being developed for neurodegenerative diseases.

Operational Framework

Applied Therapeutics operates through a focused research and development model. Key aspects of their operational framework include:

  • Drug Discovery and Development: Applied Therapeutics identifies promising drug candidates through in-house research and collaborations, focusing on rare and debilitating diseases with significant unmet needs.
  • Clinical Trials: The company conducts rigorous clinical trials to evaluate the safety and efficacy of its drug candidates. These trials are essential for obtaining regulatory approval and demonstrating the clinical benefit of their therapies.
  • Regulatory Approval: Applied Therapeutics works closely with regulatory agencies like the FDA to secure approval for its drugs.
  • Manufacturing and Supply Chain: The company establishes manufacturing processes and supply chains to ensure the availability of its products.
  • Commercialization: Upon regulatory approval, Applied Therapeutics focuses on commercializing its products, which involves marketing, sales, and distribution.

To delve deeper into the company's financial stability and growth potential, consider exploring Breaking Down Applied Therapeutics, Inc. (APLT) Financial Health: Key Insights for Investors

Strategic Advantages

Applied Therapeutics possesses several strategic advantages that contribute to its competitive positioning:

  • Focus on Unmet Needs: By targeting rare and debilitating diseases with limited treatment options, Applied Therapeutics addresses critical unmet medical needs, potentially leading to faster regulatory pathways and market adoption.
  • Targeted Therapies: The company's focus on developing small molecule drugs that target specific molecular mechanisms allows for the creation of more precise and effective therapies.
  • Experienced Leadership: A team of experienced leaders in drug development and commercialization guides Applied Therapeutics.
  • Strong Intellectual Property: Applied Therapeutics actively seeks to protect its drug candidates and technologies through patents and other intellectual property rights.

Applied Therapeutics, Inc. (APLT) How It Makes Money

Applied Therapeutics, Inc. is a biopharmaceutical company that primarily makes money by developing and commercializing novel drug candidates targeting unmet medical needs in rare and orphan diseases.

Applied Therapeutics, Inc.'s Revenue Breakdown

As of now, detailed revenue breakdown information for 2024 is not available. Applied Therapeutics is heavily research and development-focused and has been working towards commercializing its primary drug candidate, Govorestat. As of now, they are dependent on research grants and collaborations.

Revenue Stream % of Total Growth Trend
Research Grants & Collaborations 100% Dependent on awarded grants and partnerships
Future Product Sales (Govorestat) 0% N/A (awaiting commercialization)

Applied Therapeutics, Inc.'s Business Economics

Applied Therapeutics operates under a business model common to many biotech firms, characterized by:

  • High R&D Spending: A significant portion of its resources is dedicated to research and development, essential for advancing its drug pipeline.
  • Regulatory Approval: The company's financial success heavily depends on obtaining regulatory approvals, particularly from the FDA, for its drug candidates.
  • Orphan Drug Designation: Targeting rare diseases allows the company to pursue orphan drug designations, which can provide market exclusivity and other financial incentives.
  • Commercialization Strategy: Once a drug is approved, effective commercialization is crucial, involving manufacturing, marketing, and distribution.

For more insight into the company’s goals, see Mission Statement, Vision, & Core Values of Applied Therapeutics, Inc. (APLT).

Applied Therapeutics, Inc.'s Financial Performance

Key aspects of Applied Therapeutics' financial performance include:

  • Cash Position: According to the their form 10K filed March 13, 2025, Applied Therapeutics had cash, cash equivalents and marketable securities totaling $86.8 million on December 31, 2024, as compared to $133.9 million on December 31, 2023.
  • Operating Expenses: For the year 2024, operating expenses were $103.9 million, up from $97.4 million for the year 2023.
  • Net Loss: Applied Therapeutics reported a net loss of $103.7 million for 2024, or $1.56 per share. For 2023, the net loss was $97.3 million, or $1.68 per share.
  • R&D Expenses: Research and development expenses increased to $84.9 million in 2024 from $79.9 million in 2023.
  • G&A Expenses: General and administrative expenses also increased to $19.0 million in 2024 from $17.5 million in 2023.

Applied Therapeutics, Inc. (APLT) Market Position & Future Outlook

Applied Therapeutics is navigating a complex market landscape with its focus on novel drug development for unmet medical needs. The company's future hinges on the successful clinical development and commercialization of its pipeline assets.

Competitive Landscape

Company Market Share, % Key Advantage
Applied Therapeutics, Inc. Relatively Small (Specific % not available) Focus on novel treatments for rare diseases with high unmet need.
Large Pharmaceutical Companies (e.g., Pfizer, Novartis) Significant (Varies by therapeutic area) Established infrastructure, extensive resources, and diverse product portfolios.
Other Biotech Companies in Similar Therapeutic Areas Varies Specialized expertise in specific disease areas or technology platforms.

Note: Market share data for Applied Therapeutics and its competitors can fluctuate significantly and is highly dependent on specific therapeutic areas and product approvals. Precise figures are often proprietary or require extensive market research reports.

Opportunities & Challenges

Opportunities Risks
Successful clinical trial outcomes for its lead drug candidates, potentially leading to FDA approval and market entry. Clinical trial failures or delays, which could significantly impact the company's valuation and future prospects.
Strategic partnerships or collaborations with larger pharmaceutical companies to accelerate drug development and commercialization. Regulatory hurdles and challenges in obtaining FDA approval for its drug candidates.
Expanding its pipeline through the acquisition or licensing of new drug candidates or technologies. Competition from other companies developing similar therapies, which could limit market share and pricing power.
Growing demand for treatments for rare diseases, driven by increased awareness and improved diagnostic capabilities. Challenges in manufacturing and scaling up production of its drug candidates.
Favorable regulatory environment, such as accelerated approval pathways for drugs targeting unmet medical needs. Potential changes in the regulatory landscape that could make it more difficult or costly to develop and commercialize new drugs.

Industry Position

Applied Therapeutics is a biotechnology company operating in a highly competitive and dynamic industry. Its position is characterized by:

  • Focus on Rare Diseases: The company is concentrating its efforts on developing therapies for rare diseases with significant unmet medical needs. This strategy allows it to potentially benefit from orphan drug designations and accelerated approval pathways.
  • Pipeline Development: Applied Therapeutics is investing heavily in the development of its pipeline of drug candidates. The success of these programs is critical to the company's future growth and value creation.
  • Financial Resources: The company's financial position is an important factor in its ability to fund its research and development activities. Access to capital through equity offerings, debt financing, or partnerships is essential.

To gain more insights into the investors and stakeholders involved with Applied Therapeutics, you can explore: Exploring Applied Therapeutics, Inc. (APLT) Investor Profile: Who’s Buying and Why?

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