Business Description

Novatek Pharmaceuticals is a company with a team leading clinical investigations focused on development of immunomodulatory drugs related to cancers and infectious diseases. Empowering naturally derived immunotherapy that is effective across various cancer types, with the goal of effectively boosting the immune system and T cell population in patients while reducing the adverse effects of disease or cytotoxic therapies.

We primarily work with Nigella Sativa (Black seeds) a natural derivative incorporated within our proprietary drug NP-101. Clinical trials conducted in 2021 demonstrated that NP-101 has applications for immunotherapy and cancer treatment showcasing significant effect on T cells. The Novatek team has 100+ years of clinical research and pharmaceutical development experience, resulting in 400+ peer reviewed publications and a strong pharmaceutical pipeline.

Thymoquinone (TQ) is the main bioactive component in Black seeds that has a broad spectrum of therapeutic applications. TQ has many medical applications due to antiviral, anti-inflammatory, anti-fungal, antioxidant, antibacterial, anti-asthmatic, anticoagulant, and antihistamine properties. It has been studied as a hepatoprotective, anti-mutagenic, and antitumor therapy with a specific mechanism of action that lends TQ as an emerging pharmaceutical.

Key Product Features:

• Immune modulator drug
• Safe and tolerable
• Could be safely combined with cytotoxic (chemotherapy) and immunotherapy
• Thymoquinone (TQ) was found to possess organ protection capabilities against the toxic effects of cancer therapies on different organs including heart, liver, and kidney.

Current Status:

• GMP manufacturing is complete
• Published a small randomized phase II clinical trial in outpatient COVID-19
• Granted type B meeting by FDA to discuss potential of EUA
• Patent for COVID-19 treatment indication pending
• Oncology trial of high-grade neuroendocrine cancers is actively accruing
• Large randomized phase II-B (308 patients) clinical trial in outpatient COVID-19 is actively accruing
• 7 oncology trials in the pipeline for 2023

Problem

The current landscape of cancer therapy faces a significant challenge in the lack of effectiveness across different cancer types. Despite numerous treatment options available, there remains a critical need for innovative approaches that can provide meaningful clinical outcomes for patients. Novatek Pharmaceuticals recognizes this pressing problem and aims to address it through their groundbreaking immunomodulatory drug, NP-101.

Existing cancer therapies often exhibit limited efficacy and struggle to effectively combat various cancer types. This deficiency stems from the complex and heterogeneous nature of cancer, requiring novel strategies to stimulate the immune system and enhance the body’s natural defense mechanisms. Novatek’s NP-101 offers a promising solution to this problem by leveraging the therapeutic properties of thymoquinone and its associated compounds.

Solution

Novatek’s NP-101 offers a promising solution to this problem by leveraging the therapeutic properties of thymoquinone and its associated compounds. NP-101 is an enteric encapsulated GMP-manufactured oral drug that boosts the T-cell population. Through a rigorous clinical trial conducted in 2021, Novatek successfully demonstrated the statistically significant immunostimulatory effect of NP-101 on T-cells. This groundbreaking finding highlights the potential of NP-101 as an effective immunostimulatory drug, capable of enhancing the body’s immune response to fight against cancers and diseases.

By addressing the current lack of effective cancer therapies across different cancer types, Novatek Pharmaceuticals aims to revolutionize the field of oncology and improve patient outcomes. With their proprietary drug NP-101, they intend to provide a transformative solution that unlocks the full potential of the immune system, offering new hope and treatment possibilities for patients facing various cancer types.

Business Model

TBD

Market Projection

NP-101 may be used as an adjunct therapy to current immuno-oncology therapies and has the potential to become the gold standard in cancer treatment.

The global market for oncology drugs is over $182 B with an expected growth rate of 11.3% in the US alone.

Competition

We are a company that focuses on the potentially beneficial roles of NP-101 against cancer pathophysiology in the context of antioxidant, anti-inflammatory, immunomodulatory, epigenetic modulation, antiviral activity, docking studies on anti-COVID-19 activity, antibacterial and anticoagulant effects for the treatment of infectious diseases.

Traction & Customers

Novatek is not yet selling their product. However, in just two years, Novatek has brought NP-101 from concept to phase I/II trials. NP-101 began as a concept in 2020, underwent GMP Manufacturing and was in Phase II-A Outpatient COVID-19 trials in 2021. Then, in 2022 NP-101 was in Phase I/II Oncology Trials. In 2024, NP-101 will be in Phase II-B Outpatient COVID-19 trials.

Novatek has now accepted 3 proposals for pilot cancer studies:

1. Metastatic colorectal cancer at Houston Methodist Hospital
2. Operable liver cancer at the University of Florida
3. Solid Tumors at MD Anderson Cancer Center phase one program

Additionally, basket clinical trials with 4 different cancer types are currently in the pipeline for 2023 and will be conducted at Case Western Reserve University in Ohio.

Investors

Novatek has been bootstrapped to date with investments into the company made by the founders. Novatek is conducting this Regulation Crowdfunding offering as a way to bring investors interested in the company into the project.

Terms

The Company is offering up to 4,237,288 of Shares of Common Stock for up to $4,999,999.83 at $1.18 per share. The Company is attempting to raise a minimum amount of $49,998.96 in this Offering (the “Minimum Amount”). The Company must receive commitments from investors in an amount totaling the Minimum Amount by April 1, 2023 (the “Offering Deadline”) in order to receive any funds. If the sum of the investment commitments does not equal or exceed the Minimum Amount by the Offering Deadline, no Securities will be sold in the Offering, investment commitments will be cancelled and committed funds will be returned to potential investors without interest or deductions. The Company has the right to extend the Offering Deadline at its discretion. The Company will accept investments in excess of the Minimum Amount up to $4,999,999.83 (the “Maximum Amount”) and the additional Securities will be allocated at the Company’s discretion.

Risks

Please be sure to read and review the Offering Statement. A crowdfunding investment involves risk. You should not invest any funds in this offering unless you can afford to lose your entire investment.

In making an investment decision, investors must rely on their examination of the issuer and the terms of the offering, including the merits and risks involved. These securities have not been recommended or approved by any federal or state securities commission or regulatory authority. The U.S. Securities and Exchange Commission does not pass upon the merits of any securities offered or the terms of the offering, nor does it pass upon the accuracy or completeness of any offering document or literature.

These securities are offered under an exemption from registration; however, the U.S. Securities and Exchange Commission has not made an independent determination that these securities are exempt from registration.

Neither PicMii Crowdfunding nor any of its directors, officers, employees, representatives, affiliates, or agents shall have any liability whatsoever arising from any error or incompleteness of fact or opinion in, or lack of care in the preparation or publication of, the materials and communication herein or the terms or valuation of any securities offering.

The information contained herein includes forward-looking statements. These statements relate to future events or future financial performance and involve known and unknown risks, uncertainties, and other factors that may cause actual results to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties, and other factors, which are, in some cases, beyond the company’s control and which could, and likely will materially affect actual results, levels of activity, performance, or achievements. Any forward-looking statement reflects the current views with respect to future events and is subject to these and other risks, uncertainties, and assumptions relating to operations, results of operations, growth strategy, and liquidity. No obligation exists to publicly update or revise these forward-looking statements for any reason or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.