Key Words: Venture Capital, Pharmaceutical Venture, Series A Funding, Private Equity, Investment, Investor,
Lipid nanoparticles (LNPs) have been developed as vehicles for small and large molecule delivery and are now a key component of COVID-19 mRNA vaccines. Vaccines against COVID-19 have been developed with unprecedented speed, but the bottleneck to releasing those vaccines was the manufacturing throughput and quality assurance.
T&TTM Scientific’s (T&T’s) breakthrough innovation and manufacturing technologies of LNP enables our Pharmaceutical Contract Development and Manufacturing Organization (CDMO) platform. Production of COVID-19 vaccines has taken place in Europe, and the manufacturing technology licensed and imported from Polymun. T&T team has met with US-HHS and gearing up to be able to help with COVID and future emergency vaccine manufacturing. T&T is building a strong organization with its platform for such manufacturing capabilities in the USA.
T&T lipid-based innovations are applicable beyond the COVID vaccines to a wide variety of pharmaceutics; examples are several approved novel drugs by the FDA that should work with T&T manufacturing platforms: GlaxoSmithKline’s Amprenavir as HIV antiviral, Roche Calcitriol as Calcium regulator, Cipro® antibiotics by Bayer, Johnson & Johnson’s Doxil for Ovarian Cancer, Pacira’s long-acting analgesic EXPAREL® (bupivacaine liposome injectable suspension), and several more (~22 total #drugs). LNPs in therapeutics and vaccines are rapidly growing after COVID vaccines proved their effectiveness as drug protection and delivery vehicles. T&T is also developing formulation lipid-based platforms to protect and deliver pharmaceutical agents (ProFECTTM + LNP library). Technically, LNPs maximize drug bioavailability, target specific tissues, controlling the release of the drug, minimalize immune response, and enable the delivery of traditionally difficult drugs such as biomolecules with sufficient drug loading capacity.
T&T market opportunity is broad, as LNPs provide efficient and effective delivery of most Active Pharmaceutical Ingredients (APIs) by protecting the APIs and targeting specific cells and tissues. T&T LNP scalable manufacturing technologies are proven by comprehensive CDMO clinical batches produced under an FDA compliance quality system. Our need is now capital to scale our broad and robust infrastructure and process to meet demands, sales pipeline and capture the rapidly growing market and manufacture in the US with domestic technologies.
T&T was founded by two friends, lab-mates, and Ph.D. graduates, Dr. Nima Tamaddoni, and Dr. Graham Taylor, from the University at Tennessee in Mechanical Engineering and Biomedical Engineering, respectively. The company’s first product was the world’s first fully assembled and disposable liposomes and LNPs extruder, NanoSizerTM MINI, and STERILE. This device saved 90%+ time and eliminated the chance of contamination of precious pharmaceutical ingredients for doctors and scientists in academic and pharmaceutical labs in over 60 countries. Further, the two developed fully automated extrusion equipment to manufacture small to large-scale lipid-based pharmaceutics, which has already been used to make clinical materials.
In 2018, T&T Scientific offered a range of services to produce drug products that are used in clinics utilizing its own manufacturing technologies. The company is registered as a contract pharmaceutical manufacturer with the US Food and Drug Administration (FDA Registration # 3015266446). T&T has CDMO contracts in North America, Europe, and Asia, for GMP pharmaceutical manufacturing.
In 2019, T&T started developing solvent injection technologies and launched at the end of 2020 with NanoSizerTM FLOW Blink, a small-scale benchtop solvent injection technology. During this time, the team has been developing scaled-up systems to be used only in-house for contract manufacturing services of vaccines, therapeutics of clinical and commercial batches. T&T’s service pharmaceutical manufacturing platform, including services and products, enables a unique competitive advantage in this landscape with speed, price, quality, and comprehensive offerings.
T&T was initially founded in late 2015 and immediately started to generate revenue with the growth of 300-1000%+ per year. T&T has grown its capabilities organically to the current 15,000sq. ft. facilities with five formulation and analytical laboratories and cleanroom spaces (ISO 5/7/8) for manufacturing, sterile filtration, and fill and finish of pharmaceuticals. Furthermore, T&T is currently in the process of expanding to 82,000 sq. ft. facilities to expand its manufacturing capacities, gearing up to scale to the manufacturing capacity that can respond to any unpredicted global outbreak such as COVID-19 vaccine manufacturing; and contribute to the world with existing and upcoming LNP, liposome, pharmaceuticals.
Market Opportunity: T&T seeks to capture 10% of the total $38.2B/yr LNP market within 3-5 years (Including CDMO, formulations and manufacturing technologies, fill/finish). T&T’s initial focus will be to capture a 10% CDMO $3.7B/yr market by growing its capacity and team to capture this limited and rapidly growing market and demand.
Use of funds: T&T Scientific seeks $22.8M to further focus on expanding in-house high throughput production capacities, fill/finish, and build the team, including new VP’s, analytical and formulation scientists, cleanroom manufacturing operators, automation and software engineers, quality control, and validation staff; and sales and marketing.