AJNA BioSciences

AJNA BioSciences

[Closed for Investment] AJNA BioSciences, with a valuation of $40 million, is raising funds on Wefunder. The company is revolutionizing the pharmaceutical industry with its botanical drugs. AJNA BioSciences is on its way to develop FDA-approved drugs from plant medicine and treat conditions, including Autism Spectrum Disorder and Generalized Anxiety Disorder. The company is led by world-class scientists from John Hopkins, NYU, and Harvard Medical and has two botanical drugs in clinical trials. Joel Stanley founded AJNA BioSciences in April 2021. The current crowdfunding campaign has a minimum target of $50,000 and a maximum target of $1.24 million. The campaign proceeds will be used for continued improvement in two new drugs, laboratory capacity expansion, and general corporate expenses.

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Investment Overview

Raised this Round:
$1,234,236 - RegCF
$4,169,232 - Total

Deal Terms

Total Commitments ($USD)

Platform
Wefunder
Start Date
06/21/2024
Close Date
10/03/2024
Min. Goal
$50,000
Max. Goal
$1,235,000
Min. Investment

$250

Security Type

Equity - Preferred

Series

Seed

SEC Filing Type

RegCF / RegD 506(c)    Open SEC Filing

Price Per Share

$1.73

Early Bird Valuation

$31,582,371

Pre-Money Valuation

$40,000,801

Company & Team

Company

Year Founded
2021
Industry
Healthcare & Pharmaceuticals
Tech Sector
HealthTech
Distribution Model
B2C
Margin
Low
Capital Intensity
High
Location
Littleton, Colorado
Business Type
Growth
Company Website
Visit Website

Team

Employees
9
Prior Founder Exits?
Yes
Founder Name
Joel Stanley
Title
CEO

Financials

as of Fiscal Year 2023
 Revenue +910% YoY
$4,558,657
 Monthly Burn
$66,366
 Cash on Hand
$728,089

Summary Profit and Loss Statement

FY 2023 FY 2022

Revenue

$4,558,657

$415,364

COGS

$4,558,657

$415,364

Tax

$30,000

$0

 

 

Net Income

$9,380,650

$-4,066,700

Summary Balance Sheet

FY 2023 FY 2022

Cash

$984,298

$532,128

Accounts Receivable

$0

$415,364

Total Assets

$13,476,027

$3,003,351

Short-Term Debt

$9,611,654

$1,176,130

Long-Term Debt

$715,011

$8,180,430

Total Liabilities

$10,326,665

$9,356,560

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Synopsis

AJNA BioSciences is dedicated to advancing the field of plant-based pharmaceuticals. The company focuses on developing FDA-approved botanical drugs aimed at treating conditions such as Autism Spectrum Disorder (ASD) and Generalized Anxiety Disorder (GAD). The company is led by a team of scientists from prestigious institutions like Johns Hopkins, NYU, and Harvard Medical and has two botanical drugs currently in clinical trials. AJNA BioSciences primarily serves patients suffering from ASD and GAD, as well as healthcare providers looking for alternative treatment options.

AJNA BioSciences addresses the limited availability of effective and safe medications for conditions like Autism Spectrum Disorder and Generalized Anxiety Disorder. Traditional pharmaceutical treatments for these conditions often come with significant side effects and may not be effective for all patients. For instance, existing drugs for ASD can cause intense side effects, and many antidepressants prescribed for GAD have adverse long-term impacts, including sexual dysfunction, weight gain, and sleep disturbances.

AJNA BioSciences offers a solution by developing botanical drugs derived from plant medicine. The company's first drug candidate, AJA001, is a full-spectrum cannabis-derived medication designed to alleviate symptoms of irritability and aggression in patients with Autism Spectrum Disorder. This drug utilizes patented hemp genetics to optimize bioavailability and is progressing toward Phase 2 clinical trials. The second drug candidate, AJAO02, is a psilocybin-based antidepressant intended as a natural alternative to traditional antidepressants for treating Generalized Anxiety Disorder. This drug is in preparation for phase 1 clinical trials, with Phase 2 expected to commence in the second half of 2025.

Families and caregivers of individuals with Autism Spectrum Disorder and Generalized Anxiety Disorder often struggle to find medications that effectively manage symptoms without causing severe side effects. AJNA BioSciences' approach of using plant-based medicine offers a more natural treatment alternative, potentially reducing the burden of side effects and improving the quality of life for patients. This concept is akin to the growing preference for natural and holistic remedies in everyday health and wellness, where people seek effective and gentle treatments on the body.

Next Section: Price

Price

AJNA BioSciences is offering Preferred Equity in its current funding round. The pre-money valuation for this round is set at $40 million, with shares priced at $1.73 each. This valuation reflects the company's already raised $25M and significant progress in developing its two drugs.

Investing in Preferred Equity offers advantages over Common Equity, including priority in dividend payments and liquidation preferences. Specifically, AJNA BioSciences has a 1x liquidation preference, meaning that in the event of a liquidation, preferred shareholders are entitled to receive their initial investment before any distributions are made to common shareholders. This provides a level of downside protection for investors. However, it is essential to note that Preferred Equity may also come with restrictions on voting rights, which could limit investors' influence on company decisions.

Analyzing ANJA BioSciences exit potential involves considering the broader market for plant-based pharmaceuticals and the company's ability to scale its operations. Startups in this sector have seen significant interest due to the growing demand for natural and holistic treatment options. To achieve a 10x return on investment, AJNA BioSciences would need to reach a post-exit valuation of approximately $400 million, not accounting for dilution.

For AJNA BioSciences to reach such a valuation, several factors must align. The company would need to successfully navigate its clinical trials to secure FDA approvals for its drug candidates and either exit (sell) or commercialize the drug. AJNA plans to establish commercialization partnerships as each drug advances in the approval process. This could include partial or full exits of each drug and its future revenues or marketing rights. Such M&A is common between emerging drug developers and larger pharmaceutical companies and substantially helps with scaling production and distribution, as well as achieving significant market penetration, which is crucial if a drug is to be a “blockbuster.” 

In summary, while investing in AJNA BioSciences through Preferred Equity offers certain protections and potential for high returns, it also comes with risks typical of the pharmaceutical industry, including regulatory hurdles and the need for substantial market adoption. Investors should weigh these factors carefully when considering participation in this funding round.

Next Section: Market

Market

The plant-based Active Pharmaceutical Ingredients (APIs) market is experiencing significant growth, driven by several key factors.  One of the primary drivers is the increasing awareness and interest in plant-based medicines. With nearly half of all conventional pharmaceuticals being single compounds derived from natural sources, there is a growing trend toward leveraging medicinal compounds in nature. AJNA BioSciences is one of the first companies to pioneer botanical drugs that capture more than one molecule, but rather the full spectrum of medicinal compounds in any plant species. This trend is further propelled by advancements in genomics and biotechnology, which have enhanced plant bioactive molecules' extraction, characterization, and utilization.

The prevalence of chronic diseases such as Autism Spectrum Disorder and Generalized Anxiety Disorder is another critical market driver. These conditions affect millions of individuals globally, creating a substantial demand for effective and safe treatment options. AJNA BioSciences' focus on developing botanical drugs for these conditions positions the company well to tap into this growing need.

Additionally, the COVID-19 pandemic has sparked interest in developing drugs on platforms other than mammalian cells. Plant-based medications have gained popularity during this period, as evidenced by Health Canada's approval of the plant-based COVID-19 Vaccine, COVIFENZ, in February 2022. This trend underscores the potential for botanical drugs to address emerging healthcare challenges.

However, the market for botanical drugs and plant-based APIs has challenges. The regulatory framework associated with these drugs is still evolving, and robust scientific evidence is needed to establish their safety and efficacy. Meeting statutory criteria for herbal medication research can be challenging, and the quality of trial medicines must be consistent across batches to gain regulatory approval. These regulatory uncertainties could impact the growth trajectory of companies like AJNA BioSciences.

The US plant-based API market is valued at approximately $9.3 billion, with a growth rate of 6.2% annually. This market size indicates substantial opportunities for AJNA BioSciences, although the company currently targets a niche within this broader market. Specifically, AJNA BioSciences' products cater to individuals suffering from Autism Spectrum Disorder and Generalized Anxiety Disorder, which together represent a significant portion of the addressable market.

Next Section: Team

Team

The team at AJNA BioSciences comprises individuals with extensive experience and expertise in botanical drug development and the broader pharmaceutical industry. The leadership team is particularly notable for its background in scientific research and business operations, which is crucial for the company's success in developing and commercializing plant-based pharmaceuticals.

Joel Stanley serves as the CEO and Co-Founder of AJNA BioSciences. He is a recognized leader in botanical drug innovation and has a proven track record in the CBD industry. Notably, Stanley scaled Charlotte's Web, a leading CBD category company, from inception to an IPO, achieving $75 million in annual revenue. His experience scaling operations and navigating regulatory landscapes directly relates to AJNA BioSciences' goals of developing FDA-approved drugs.

Orrin Devinsky, the Chief Medical Advisor, brings a wealth of medical expertise to the team. Devinsky is a distinguished neurologist specializing in epilepsy and behavioral disorders. He holds positions as a Professor of Neurology, Neurosurgery, and Psychiatry at NYU School of Medicine and serves on the Board of Directors of the Epilepsy Foundation. His medical insights and experience with clinical trials, including being Principal Investigator on the only FDA-approved CBD drug, are invaluable for guiding AJNA BioSciences through the rigorous drug development and approval process.

Scott Hansen, the Vice President of Lab Operations and quality, is an expert in pharmaceutical operations with a focus on quality systems. He has held leadership roles in quality and regulatory affairs at companies like Agricor/Botanacor and Charlotte's Web. Before his time in natural products, he spent over two decades in Quality Control at Sandoz Pharmaceutical. His background ensures that AJNA BioSciences maintains high standards in its laboratory operations and meets regulatory requirements, essential for the company's credibility and success.

Bob Judge, the Vice President of Finance, has extensive experience in financial management and private equity. He has served as CFO and COO at Timberline Industries and CEO at Lane Industries and Lane Pursuits. His expertise in overseeing financial operations and securing venture capital investments is critical for AJNA BioSciences as it seeks to manage its burn rate and secure additional funding for ongoing projects.

The team's collective experience aligns well with AJNA BioSciences' goals of developing and commercializing botanical drugs. Their backgrounds in scientific research, clinical trials, regulatory affairs, and financial management provide a strong foundation for the company's ambitious objectives.

Next Section: Differentiation

Differentiation

AJNA BioSciences differentiates itself in the highly competitive pharmaceutical industry through its focus on developing FDA-approved botanical drugs for conditions such as Autism Spectrum Disorder (ASD) and Generalized Anxiety Disorder (GAD). This differentiation is particularly relevant compared to industry competitors like Risperdal, Abilify, and Lexapro, which are established pharmaceutical treatments for similar conditions.

Risperdal and Abilify are commonly prescribed for ASD, while Lexapro is a widely used antidepressant for GAD. These drugs are produced by large pharmaceutical companies with extensive resources and market reach. Regarding company size, AJNA BioSciences is significantly smaller and in an earlier stage of development than these established players. However, AJNA BioSciences aims to offer a unique value proposition through its plant-based drug formulations, perceived as more natural alternatives with potentially fewer side effects.

When evaluating product quality, AJNA BioSciences leverages its team of world-class scientists from institutions like Johns Hopkins, NYU, and Harvard Medical to ensure rigorous research and development processes. The company's botanical drugs are designed to meet FDA approval standards, a critical quality benchmark in the pharmaceutical industry. In contrast, traditional pharmaceutical drugs like Risperdal, Abilify, and Lexapro have well-documented efficacy. Still, they are also associated with significant side effects, which AJNA BioSciences aims to mitigate with its plant-based approach.

AJNA BioSciences' products are still in the clinical trial, so specific pricing details are unavailable. However, the company’s focus on optimizing bioavailability and leveraging patented hemp genetics suggests a potential for competitive pricing once the products reach the market. Traditional pharmaceuticals, on the other hand, often come with high costs due to extensive R&D and marketing expenses.

The customer demographics for AJNA BioSciences' products primarily include individuals suffering from Autism Spectrum Disorder (ASD) and Generalized Anxiety Disorder (GAD). These demographics span a wide age range, from children and adolescents with ASD to adults experiencing GAD. Additionally, caregivers and healthcare providers seeking alternative treatment options that offer a more natural profile are key target customers. The company's botanical drugs appeal to those looking for effective treatments with potentially fewer side effects than conventional pharmaceuticals.

Next Section: Performance

Performance

AJNA BioSciences is a pre-revenue company, with the recorded revenue on its income statement coming from its Joint Venture with BAT and Charlotte’s Web for the ASD drug (AJA001). In terms of the development of AJA001, AJNA has completed Phase I of FDA clearance and is seeking a Phase II entrance early next year. 

The company's monthly burn rate is approximately $66.4k, while its most recent cash is about $728k. This indicates that AJNA BioSciences has a comfortable ten-month runway.

AJNA BioSciences has also raised $25 million in prior funding rounds, including $15 million from British American Tobacco and $10.1 million from a private round involving PhiFund Ventures. This substantial capital infusion has enabled the company to advance its drug development programs and expand its laboratory capacity. However, given the capital-intensive nature of pharmaceutical development, the need for continuous investment remains.

Next Section: Risk

Risk

Investing in AJNA BioSciences presents several specific risks that potential investors should consider. While the company's mission to develop plant-based pharmaceuticals offers promising opportunities, this venture presents unique challenges.

One of the critical risk factors for AJNA BioSciences is the regulatory environment. Developing FDA-approved drugs from plant medicine involves navigating complex and stringent regulatory pathways. Any delays or obstacles in obtaining FDA approval for their drug candidates could significantly impact the company’s timeline and financial projections. This regulatory risk is compounded by the fact that the company is dealing with Schedule 1 substances, which have additional layers of regulatory scrutiny. However, AJNA does possess a DEA Schedule 1 Bulk Manufacturing License to mitigate some of the regulatory hurdles in working with these Schedule 1 substances.

The company’s reliance on a niche market also introduces adoption risk. While there is growing interest in plant-based medicines, accepting and integrating botanical drugs into mainstream medical practices may take time. This early-to-market risk means that AJNA BioSciences must invest heavily in education and marketing to gain traction among healthcare providers and patients.

AJNA BioSciences operates in a highly competitive landscape with established pharmaceutical companies offering traditional treatments for Autism Spectrum Disorder and Generalized Anxiety Disorder. Competing against well-funded and recognized brands such as Risperdal, Abilify, and Lexapro poses a significant challenge. The company must demonstrate superior efficacy and safety profiles for its botanical drugs to convince prescribers and patients to switch from conventional medications.

Next Section: Bullish Outlook

Bullish Outlook

AJNA BioSciences' bullish outlook is supported by several key factors contributing to its potential for significant growth and market success.

Firstly, the market opportunities and growth potential for Botanical Drugs and plant-based Active Pharmaceutical Ingredients (APIs) are substantial. The US market for plant-based APIs is valued at approximately $9.3 billion, with an annual growth rate of 6.2%. This growing demand for natural and holistic treatment options presents a favorable environment for AJNA BioSciences to expand its market share. The increasing prevalence of conditions like Autism Spectrum Disorder (ASD) and Generalized Anxiety Disorder (GAD) further underscores the need for effective and safe treatment alternatives, which AJNA BioSciences aims to provide with its botanical drugs.

AJNA BioSciences has several unique strengths and competitive advantages. A team of world-class scientists from Johns Hopkins, NYU, and Harvard Medical leads the company. This scientific expertise is crucial for rigorously developing and testing their botanical drugs. Additionally, the company’s ability to develop FDA-approved drugs from plant medicine sets it apart from many competitors in the pharmaceutical industry. Using patented hemp genetics for optimized bioavailability in its drug candidates further enhances the company's competitive positioning. Pending successful commercialization and/or exits of these first two drug candidates, AJNA will be poised to continue to disrupt the conventional/synthetic drug market with more efficacious botanical drugs. 

Another positive factor is the company's strong leadership and notable achievements. CEO Joel Stanley has a proven track record of scaling operations, having previously led Charlotte's Web from inception to an IPO. The involvement of distinguished medical professionals like Orrin Devinsky, who brings extensive clinical trial and neurological expertise, adds credibility to AJNA BioSciences' drug development efforts. Their state-of-the-art laboratory, equipped with advanced tools for botanical analysis, positions the company well to continue its innovative work.

AJNA BioSciences has also secured significant partnerships and funding. The company has raised $25 million in prior rounds, including $15 million from British American Tobacco, which invested in their lead drug AJA001. This substantial financial backing provides a solid foundation for ongoing research, development, and commercial activities. The company's ability to maintain a positive net income of $9.4 million in the most recent fiscal year demonstrates financial stability and prudent management.

Next Section: Bearish Outlook

Bearish Outlook

AJNA BioScience's bearish outlook is influenced by several key factors that present potential growth and financial sustainability challenges.

Firstly, the regulatory environment for developing FDA-approved botanical drugs is highly complex and stringent. AJNA BioSciences must navigate multiple layers of regulatory scrutiny, especially since its products involve Schedule 1 substances. Any delays or obstacles in obtaining FDA approval can significantly impact the company’s timeline and financial projections. This regulatory hurdle is a significant growth inhibitor, requiring substantial time and financial resources.

Regarding market challenges, AJNA BioSciences operates in a highly competitive landscape. The pharmaceutical market for conditions such as Autism Spectrum Disorder and Generalized Anxiety Disorder is dominated by established companies with well-known brands like Risperdal, Abilify, and Lexapro. These competitors have extensive research, development, and marketing resources, which can overshadow AJNA's efforts. Additionally, traditional pharmaceuticals have a long history of proven efficacy, making it difficult for new entrants to gain market share, especially in a market that is slow to adopt new, unproven treatments.

Additionally, AJNA BioSciences faces adoption risks. The company is early to market with its botanical drug formulations, and there is uncertainty regarding the acceptance and integration of these drugs into mainstream medical practices. The company's reliance on a niche market for plant-based medicines means that extensive education and marketing efforts are needed to drive adoption, which can be time-consuming and costly.

Next Section: Executive Summary

Executive Summary

AJNA BioSciences is a company focused on developing FDA-approved botanical drugs to treat conditions such as Autism Spectrum Disorder (ASD) and Generalized Anxiety Disorder (GAD). The primary customers include individuals suffering from these conditions and healthcare providers seeking alternative treatment options.

The plant-based Active Pharmaceutical Ingredients (APIs) market is valued at approximately $9.3 billion and growing at an annual rate of 6.2%. Key drivers include rising awareness and interest in plant-based medicines, the prevalence of chronic diseases, and advancements in genomics and biotechnology. While these trends present growth opportunities, regulatory uncertainties and market adoption risks could impact the company's trajectory.

Investing in AJNA BioSciences presents several unique risks, including regulatory challenges, early market adoption risks, and high competition from established pharmaceutical companies. The company's high burn rate and limited runway also pose financial risks that must be managed effectively.

On the bullish side, AJNA BioSciences benefits from a growing market for plant-based medicines, a strong scientific team, and significant prior funding. The company's innovative approach to botanical drug development positions it well to capture market share in the pharmaceutical industry.

Conversely, the bearish outlook highlights regulatory uncertainties, financial sustainability concerns, and the competitive landscape. The company's high valuation and need for continuous funding add layers of risk that investors must consider.

In conclusion, AJNA BioSciences presents a compelling investment opportunity with significant potential upside, driven by market trends and the company's unique approach to botanical drugs. However, investors should weigh the substantial risks and challenges associated with regulatory approvals, financial management, and market competition before making an investment decision.

Why We Invested

After an in-depth analysis of AJNA Biosciences, Kingscrowd Capital has decided to invest $10,000 in the company’s current Wefunder round.

There are several reasons we are excited about AJNA BioSciences. First and foremost, AJNA is one of the only players in the botanical/plant-based pharmaceutical space, with deep expertise in getting plant-based treatments through FDA approval. The company is advised by Dr. Jinhui Dou, PhD, who spent decades in the FDA and the primary author of the official Botanical Drug Development Guidance that AJNA follows to bring its botanical treatments through the FDA. AJNA’s deep expertise in botanical standardization and chemistry, manufacturing, and controls positions AJNA perfectly as a leader in this space. If AJNA can become one of the first pharmaceutical companies to bring a plant-based botanical drug to market, the company’s value will increase substantially. 

Additionally, we believe that plant-based pharmaceuticals have massive potential and are only just beginning to gain FDA acceptance. AJNA is far ahead of the curve as no known oral systemic botanical drugs are entering Phase II, giving AJNA a huge head start with its cannabinoids and botanical drugs.  

Finally, we are particularly impressed with AJNA's structure for its AJA001 lead candidate. The company has structured this as a Joint Venture with British American Tobacco (who invested $15 million) and Charlotte’s Web. Using this JV structure for AJA001 and future drug indications allows large institutional investors to invest directly into one of the many drug development pathways under the AJNA BioSciences umbrella. This is often more enticing for investors who want to support the development of a specific drug indication than the overall AJNA portfolio. This opens the door for substantial capital injections from institutional investors and allows AJNA to exit specific drug indications down the line via acquisition or royalties. 

Overall, we are very excited about AJNA BioSciences' growth prospects and are particularly impressed with the deep expertise of the company's clinical FDA team. At its current valuation, this is a great entry point for KC Capital, and we are excited to join AJNA on its journey to revolutionize the pharmaceutical industry with plant-based botanical treatments.

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Company Funding & Growth

Funding history

Total Prior Capital Raised
$25,000,000
VC Backed?
Yes
Close Date Platform Valuation Total Raised Security Type Status Reg Type
10/03/2024 Wefunder $40,000,801 $4,169,232 Equity - Preferred Funded RegCF / RegD 506(c)
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AJNA BioSciences on Wefunder 2024
Platform: Wefunder
Security Type: Equity - Preferred
Valuation: $40,000,801
Price per Share: $1.73

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