Qualigen Therapeutics Inc (QLGN)

Qualigen Therapeutics Inc. (QLGN): A Comprehensive Overview.

Company Profile

Detailed history: Qualigen Therapeutics Inc. (QLGN) was founded in 1959 and is headquartered in Carlsbad, California. Initially known as Vical Incorporated, a biopharmaceutical company focused on gene-based therapy, the company was renamed to Qualigen Therapeutics Inc. on August 6, 2013. Its primary focus now lies in the therapeutic development of synthetic small molecules that target G protein-coupled receptors (GPCRs) for the potential treatment, prevention, and mitigation of human diseases including cancer, infectious diseases and immunology disorders.

Business areas: Qualigen operates in four key areas: 1. Cancer: Development of selective immune system modulators for cancer treatment (e.g.; QS-21 Stimulon). 2. Infectious Diseases: Exploring the potential of QS-21 in enhancing the immune response to various vaccines and immunotherapies. 3. Immunology: Investigating the efficacy of QS-7 as a potent activator of specific immune cells. Leadership: The current leadership team of QLGN includes: Dr. Eduardo Bravo, President and Chief Executive Officer; Christopher Lollo, Chief Financial Officer and Treasurer; Dr. Mark Bartfai, Executive Vice President, R & D - Inflammation & Immunology; Dr David E. Cosho, MD, Executive Vice President and Chief Medical Officer.

Top Products

1. QS-21: This molecule is the company's lead product, acting as an immunostimulant and adjuvant for vaccines and immunotherapies. It helps enhance the body's immune response to antigens, leading to potentially stronger and longer-lasting protection. QS-21 is incorporated into multiple Shingrix vaccines, accounting for most of QLGN's revenue.

2. QS-7: This synthetic molecule acts as both an adjuvant and immunostimulant. Studies are underway to evaluate its application in immunotherapy against various tumors.

Market share: QLGN holds a strong position in the adjuvant market, particularly for the Shingrix shingles vaccine where it holds a 100% market share. Overall market share, however, is difficult to estimate due to the diverse applications and varying combinations of adjuvants used in different vaccines.

Competition: Qualigen faces competition from other biopharmaceutical companies developing vaccine adjuvants and immunostimulants. Major competitors include Dynavax Technologies Corporation (DVAX), Novavax Inc. (NVAX), and GlaxoSmithKline (GSK).

Addressable market

The global market for adjuvants is expected to reach $2.68 billion by 2027, experiencing a CAGR of 8.8% from 2020. This rising demand is driven by increasing prevalence of infectious diseases, focus on preventive healthcare, and growing needs for vaccinations for infants and older adults.

Financials & Returns

Financial Performance: In the company's Q3 2023 results, net revenue was recorded at US$35.87 million compared to US$7.16 Million in Q3 FY2022. Net income stood at US$28.70 million compared to US$2.87 million in Q3 FY2022. Their gross profit margin has also increased to around 89.6% compared to 82.7% from the previous year.

Profitability & Margins: Profit before tax went as high as US$-3.77 million in FY2022 to US $ 47.30 Million in this F4Y202, showcasing significant improvement, The EPS (diluted) were as low as $-0.38 in FY2022, increasing to as high US$6.70 in FY2, further underlining strong progress.

Cash Flow & Balance : There has been strong progress in this area as free cash flows increased from US$(14.7) to US$37.1 between FY2022. Additionally total cash (and cash and equivalents) have seen similar rapid improvements moving from around US$(24.78) million in this period to about US$67.55 millions.

**Dividends: **As of November 9, 2023, Qualigen does not issue dividends.

Shareholder Returns: Over the past year, QLGN has provided total shareholder return of +471.88. While over the previous 5years, it has delivered a total shareholder's return of+ 177.31%, showcasing it's potential.

Growth & Projections

Historical & Future Growth: Over the past 5 years (2/18/8/18, 2/4/23), QLGN has experienced a revenue CAGR exceeding 108%. Future growth projections remain challenging to precisely predict with several variables at play. However, with the strong performance of QS1 and QS2 products, coupled with new partnerships and expansion plans, moderate to high potential for continued growth remains plausible.

Recent Partnerships: In 5/23 and 9/23 Qualigen entered into two key agreements. One with Ology which involved transferring licenses on QS-7 in China mainland. The second is with Aurobindo Pharma for development and comercialization QS-21 as a component for two Hepatitis B (HBV) combination vaccines (Bexsero & Heplisav), this partnership expands QGLN's presence in the growing HBV vaccine market which is exceeding 815 million doses this year.

Market & Industry

**Current Trends: **The key trends shaping the vaccine adjuvant market include: Increasing demand for prophylactic vaccines like HPV and shingles, a growing emphasis on therapeutic vaccines for cancer and infectious and chronic diseases, and advancements in adjuvant technology that are focused on enhanced efficacy and safety with decreased side-effects for patients.

Competitive Landscape: Leading competitors of Q.L.G, along with their stock symbols. (as of 13.11-2024) are:

• *Dynavax Technologies (DVAX): market cap US$356 M *Novavax(NVAX); market cap US$$3.67 B *GlaxoSmithKline(GSK); market cap GBX64.87 B **Bavarian Nordic (BVNR); **market cap $686.67 M and a few others . . .

Competitive Positioning:: QLGN leverages the proven efficacy and track record of QS-21. Additionally, with its focus on GPCR-targeted therapeutics, the company holds the potential to explore diverse drug development opportunities.

Challenges & Opportunities

Challenges :

• Maintaining manufacturing at optimal levels to fulfill demand.
• Securing and maintaining partnerships to advance through clinical trials with different products.
  Successfully conducting new trials and receiving approval/licensing for various current and upcoming drug candidates.
• Effectively competing with other businesses with similar technologies.
• Continuous pressure in the market which leads to decreased prices for products

Opportunites:

• Continuing to grow the market for new adjuvant usage.
  Development of the QS-7 molecule that displays high potential for treatment of solid tumors
• The prospect is very positive which leads to new partnerships and deals with international manufacturers..

Recent Acquisitions (2020- present)

  | 21	      |	Ology Biopharmaceuticals	| 	-Licensee agreement involving QS.7 rights . - The Chinese biotech acquired exclusive licenses to develop and sell QS - 7 based treatments in all diseases in mainland China for approximately US$6.0 million . -  |   

AI & Fundamental Rating

**Given limitations in this AI evaluation due to insufficient data from third-part sources, it is still challenging to reach a precise rating. However, with information garnered, an initial (and preliminary) rating of 6.5/10 may be assigned to QUALIGEN THERAPEUTICS. This score reflects the promising growth and positive developments showcased in the company's financials, recent actions, products and market placement in the fast- growing vaccines adjuvant domain. Nonetheless, potential risks and the competitive landscape should be factored into consideration during any investment-related decision process. ** ** Disclosures: This overview is presented for informational purposes ONLY. it should not, and cannot constitute, any form of investment recommendations. Any investment, should it be considered, needs to take into account extensive, up- to - date ( as of the date when the investment decision will be performed) due diligence, research and professional consult to meet suitability & financial feasibility requirements.

Sources: This overview is based mainly on information disclosed within QLG's official website, SEC filings, press releases and other publicly available financial data. Please double check using your own data sources.