Pressure BioSciences Stock

Pressure BioSciences, Inc. (PBI) engages in the development and sale of innovative, broadly enabling, high pressure-based platform technologies and related consumables for the worldwide life sciences, agriculture, cosmetics, food and beverage, and other key industries.

The company's solutions are based on the unique properties of both constant (i.e., static) and alternating (i.e., pressure cycling technology, or PCT) hydrostatic pressure. PCT is a patented enabling technology platform that uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels to safely and reproducibly control bio-molecular interactions (e.g., cell lysis, biomolecule extraction). In more recent years, major new market opportunities have emerged in the use of the company's pressure-based technologies in the following areas: the use of its acquired, patented technology from BaroFold, Inc. (the BaroFold technology platform) to allow entry into the bio-pharma contract services sector; the use of its recently-patented, scalable, high-efficiency, pressure-based Ultra Shear Technology (UST) platform to create stable nanoemulsions of otherwise immiscible fluids (e.g., oils and water) and to prepare higher quality, homogenized, extended shelf-life or room temperature stable low-acid liquid foods that cannot be acceptably preserved using existing non-thermal technologies; and in some cases, improve the bioavailability of some poorly absorbed oils.

The PCT Platform

The company has hundreds of PCT instrument systems placed in approximately 200 academic, government, pharmaceutical, and biotech research laboratories worldwide. There are over 120 independent, peer-reviewed publications highlighting the advantages of using the PCT Platform in scientific research studies, many from key opinion leaders worldwide. The PCT Platform is offered through the company's Research Products & Services Group.

The company focuses on solving the challenging problems inherent in biological sample preparation, a crucial laboratory step performed by scientists worldwide working in biological life sciences research. Sample preparation is a term that refers to a wide range of activities that precede most forms of scientific analysis.

PCT is an enabling platform technology based on a physical process that had not previously been used to control bio-molecular interactions. PCT uses unique instrumentation that is capable of cycling pressure between ambient and ultra-high levels at controlled temperatures and specific time intervals, to rapidly and repeatedly control the interactions of bio-molecules, such as proteins, DNA, RNA, lipids and small molecules. The company's laboratory instrument family, the Barocycler, and its proprietary consumables product line, which include its unique MicroTubes, MicroCaps, MicroPestles, and PULSE (Pressure Used to Lyse Samples for Extraction) Tubes, and application specific kits (containing consumable products and reagents), together make up its PCT Sample Preparation System (the PCT SPS).

In 2015, together with an investment bank, the company formed a subsidiary called Pressure BioSciences Europe (PBI Europe) in Poland. The company has 49% non-controlling ownership interest with the investment bank retaining 51%.

Within the broad field of biological sample preparation, the company focuses the majority of its PCT and constant pressure (CP) product development efforts in three specific areas: biomarker discovery, precision medicine and forensics.

Biomarker Discovery and Precision Medicine

The company's customers include researchers at academic laboratories, government agencies, biotechnology companies, pharmaceutical companies and other life science institutions in the Americas, Europe, Asia, Africa and Australia/Pacific.

Market

The company focuses most of its research and development and commercialization efforts on sample preparation and quality control analysis for genomic, proteomic, lipidomic, and small molecule studies. This market is consisted of academic and government research institutions, biotechnology and pharmaceutical companies, and other public and private laboratories that are engaged in studying genomic, proteomic and small molecule material within plant and animal cells and tissues.

Sample Extraction Process

The company's commercialization efforts are based upon its belief that pressure cycling technology provides a superior solution to sample extraction compared with other available technologies or procedures and can thus significantly improve the quality of sample preparation, and thus the quality of the test result.

Products

The company's products are developed with the expectation of meeting or exceeding the needs of research scientists while enhancing the safety, speed and quality that is available to them with existing sample preparation methods.

Barocycler Instrumentation

The company's Barocycler product line consists of laboratory instrumentation that subjects a sample to cycles of pressure from ambient (approximately 14.5 psi) to ultra-high levels (20,000 psi or greater) and then back to ambient, in a precisely controlled manner.

The company's instruments (the Barocycler 2320EXT, the HUB440 and the HUB880) use cycles of high, hydrostatic pressure to quickly and efficiently break up the cellular structures of a specimen to release proteins, nucleic acids, lipids and small molecules from the specimen into its consumable processing tubes, referred to as its PULSE Tubes and MicroTubes. The company's instruments have temperature control options (on-board heating via internal heating jacket or heating and chilling via an external circulating water or oil bath), automatic fill and dispensing valves, and an integrated touchscreen for interfacing with an onboard micro-processor or computer. The microprocessor, computer or laptop computer are capable of saving specific PCT protocols, so the researcher can achieve maximum reproducibility for the preparation of nucleic acids, proteins, lipids, or small molecules from various biological samples. The company's Barocycler instruments, consumable products and application specific kits make up its PCT Sample Preparation System.

Barocycler 2320EXTREME: The Barocycler 2320EXT is the flagship of the company's Barocycler line of PCT-based instruments. It weighs approximately 80lbs, delivers a maximum pressure of 45,000 psi, and can process either up to 16 MicroTubes simultaneously. The working temperature range is 4 - 95ºC and is controlled via an on-board electric heating jacket or external circulating bath. All tests are entered and recorded on a touch screen interface. Information from each test run (pressure profile, cycle number, and temperature) is recorded and can be stored on the instrument, on a USB drive, or networked into the user's lab computer system. Pressure profiles can be manipulated in a number of ways, including static high pressure holds and pressure ramp programs. The Barocycler 2320EXT is pneumatic and requires an input air source of only 100psi to achieve and cycle at high pressure.

The Barocycler 2320EXT was developed to support the PCT-HD/PCT-SWATH application. PCT-HD enables faster, less cumbersome and higher quality processing of biopsy tissues. With homogenization, extraction, and digestion of proteins occurring in a single PCT MicroTube under high pressure, this protocol can yield analytical results in under four hours from the start of tissue processing. PCT-HD was developed by the company's scientists and engineers in collaboration with Professor Ruedi Aebersold and Dr. Tiannan Guo of the Institute of Molecular Systems Biology, ETH Zurich, and the University of Zurich, both in Zurich, Switzerland. Drs. Aebersold and Guo combined PCT-HD with SCIEX's SWATH-Mass Spectrometry - calling the resulting method PCT-SWATH.

Barocycler HUB440 -The Barocycler HUB440 is the first portable, ready to use, plug-and-play high pressure generator for the laboratory bench. The Barocycler HUB440 is capable of creating and controlling hydrostatic pressure from 500 psi to 58,000 psi and is designed for easy and flexible interfacing with a wide variety of user-specified pressure vessels. It is computer controlled and runs on software that was developed by the company to allow data logging and sophisticated algorithms for controlling pressure and temperature. The company owns the rights and have a license to use the specialty LabVIEW software.

Barocycler HUB880 - The Barocycler HUB880 is a compact, portable, bench-top, ultra-high pressure generator with vessel interface flexibility similar to the HUB440 that uses an air pressure-to-liquid pressure intensifier allowing the user to generate fluid pressure as high as 90,000 psi with input air pressure of just 126 psi. The HUB880 can be operated through a simple front panel or controlled using an optional external Data Acquisition and Control Module for dynamic pressure control.

The Shredder SG3 -The Shredder SG3 is a low shear mechanical homogenization system for use with tough, fibrous and other difficult-to-disrupt tissues and organisms. The Shredder SG3 System uses a variety of Shredder PULSE Tubes to directly and rapidly grind a biological sample which, when combined with selected buffers, can provide effective extraction of proteins, DNA, RNA, lipids and small molecules from tissues and organisms. The Shredder SG3 is also used to isolate intact and functional mitochondria from tissues.

Barocycler Consumable Products

PCT MicroTubes - PCT MicroTubes are made from a unique fluoropolymer, fluorinated ethylene propylene (FEP). FEP is highly inert and retains its integrity within an extremely wide temperature range (-200°C to 100°C), while providing important limited flexibility behavior for PCT applications. MicroTubes hold a maximum total volume of 150 microliters. PCT MicroTubes must be used with either PCT-MicroCaps or PCT-MicroPestles.

PCT-MicroCaps - PCT MicroCaps are made from polytetraflouroethylene (PTFE). The PCT MicroCaps are available in three sizes to accommodate total sample volume: 50, 100 and 150uL. 50uL MicroCaps are used with samples =50uL, 100uL MicroCaps are used with samples between 50-100uL, and 150uL MicroCaps are used with samples between 100-150uL.

PCT-Micro Pestle - PCT µPestles are made from polytetrafluoroethylene (PTFE), a synthetic fluoropolymer of tetrafluoroethylene, also known as Teflon (by DuPont Co). PTFE is practically inert; the only chemicals known to affect it are certain alkali metals and most highly reactive fluorinating agents. PCT µPestles, in conjunction with PCT MicroTubes, are designed to enhance the extraction of proteins, lipids, DNA, RNA and small molecules from minute amounts (0.5 - 3.0 mg) of solid tissue in extraction reagent volumes as low as 20-30 µL. PCT MicroTubes and PCT µPestles use PCT to effectively disrupt soft tissues and lyse their cells. As a result, the tissue sample trapped between the MicroTube walls and the µPestles shaft is crushed on every pressure cycle. This mechanical action, combined with the extraction ability of the buffer under high pressure, results in highly effective tissue homogenization and extraction.

PCT µPestles and PCT MicroTubes, together with a PBI Barocycler, comprise the PCT Micro-Pestle System, which provides a fast, safe, and efficient means of extraction from extremely small amounts of solid samples, such as soft tissue biopsies. The PCT µPestle System can be used in any PBI Barocycler.

Active Collaborations

The company's active collaborations include RedShiftBio Inc.; Thomas Conrads, Inova Schar Cancer Center; Christine Vogel, NYU; Leica Microsystems, GmbH; Dr. Michael Przybylksi, Steinbeis Centre for Biopolymer Analysis and Biological Mass Spectrometry; Dr.V.M. Balasubramaniam, The Ohio State University; University of Delaware; and Dr. Jennifer Van Eyk, Cedars Sinai Medical Center.

Extended Service Contracts

The company offers extended service contracts on its laboratory instrumentation to all of its customers. These service contracts allow a customer who purchases a Barocycler instrument to receive on-site scheduled preventative maintenance, on-site repair and replacement of all worn or defective component parts, and telephone support, all at no incremental cost for the life of the service contract. The company offers one-year and four-year extended service contracts to customers who purchase Barocycler instruments.

The BaroFold Platform

The company's acquisition of the assets of BaroFold, Inc. have significantly increased PBI's intellectual property portfolio in high-pressure technologies with the addition of eight issued and several pending patents.

Products

Instruments: Barocycler 2320 EXT - a convenient screening tool for protein refolding optimization

Originally developed within the framework of the company's PCT platform business as a tool for biological sample preparation, its Barocycler 2320EXT instrument features a ramp mode in its control software that makes it ultimately suitable for performing research-scale experiments for protein refolding and disaggregation on a laboratory bench scale.

BaroFold Contract Services

The company's BaroFold contract services can be used to significantly impact and improve the quality of large-molecule protein biotherapeutics. These services employ high pressure manipulations for the disaggregation and unfolding of proteins to their native structural states and then controlled refolding of the proteins to the desired therapeutically active state, at yields and efficiencies not achievable using existing technologies. The BaroFold Platform has been shown to eliminate protein aggregation during biotherapeutic drug manufacturing and storage, thereby improving product yield, efficacy and safety for both new-drug entities and biosimilar products. The BaroFold platform can help companies create novel protein therapeutics, accelerate therapeutic protein development, manufacture follow-on biologics, and enable life-cycle management of protein therapeutics. It is scalable and practical for standard manufacturing processes. This unique technology platform can help protein-based biopharmaceutical companies create and manufacture high quality, novel protein therapeutics and lower the cost of existing formulations. Research and manufacturing licenses are available.

Customers

Biopharmaceutical companies include Roche, Novartis A.G., Sanofi, Biogen-Idec, Abbvie, Inc., Amgen, Takeda, Pfizer, Merck & Co., etc.

Biosimilars companies include Teva, Sandoz, Hospira, Mylan, Allergan, Biocon, Momenta., etc.

Biopharmaceutical Contract Development and Manufacturing Organizations include Boehringer-Ingelheim, Lonza, Samsung Biologics, Catalent Pharma Solutions, Thermo Fisher Scientific, Fujifilm, etc.

Life science research reagent manufacturers include Thermo Scientific, GE Healthcare, Danaher Corporation, Millipore-Sigma, Bio-Techne R&D Systems, etc.

Academic research laboratories involved in the development of protein pharmaceuticals, expression of recombinant proteins, protein structure analysis and biophysical characterization.

The UST Platform

The UST Platform is based on the use of intense shear forces generated from ultra-high pressure (greater than 20,000 psi) discharged through a dynamically-controlled nanometer-scale valve orifice. UST has been shown to turn hydrophobic extracts into stable, effectively water-soluble formulations on a small, laboratory scale. The UST Platform offers the potential to produce stable nanoemulsions of oil-like products in water. Such formulations could potentially have enormous success in many markets, including pharmaceuticals, nutraceuticals (such as medically important plant oil extracts like CBD-enriched plant oil soluble in water), cosmetic and personal care products, liquid foods and beverages, agrochemicals, as well as inks, paints, lubricants and other industrial products.

UST is an emerging technology that combines intense fluid shear forces with an instant, short-lived burst of heat achieved by specialized high-pressure equipment that can produce commercially sterile, pumpable, homogeneous fluid products.

The company received its second U.S. patent in 2021 to complement two patents in China on UST, focused on a scalable approach for product manufacturing. The company initiated the process to build full-scale UST systems initially at two sites, in order to address customer demands and the belief that a large number of foods, cosmetics/skincare, nutraceuticals, pharmaceutical, and other companies will follow.

Market

In 2019, the company focused efforts on developing and demonstrating the UST protocol and seeding early adopters, which would provide insights into market, formulation, product development, and ultimately end product requirements. The company's initial market focus has been on cannabis extracts, as this market's unmet needs for nanoemulsions solutions offer high visibility and ready access to funding, versus many other important target markets, such as Cosmetics, Food and Beverage, Nutraceutical, Pharmaceutical, and Industrial fluids and lubricants. In 2020, the company refined the Ultra Shear Technology K45 instrument (the BaroShear) allowing it to run samples for multiple potential customers, which demonstrated the goal of producing room-temperature-stable, transparent nanoemulsions. (Transparency is achieved when nanoemulsion droplet sizes are below ~150nm or smaller than the wavelength of visible light - an important indicator of achievement of extremely low-scale nanoemulsions.) The company secured orders from companies for 15 units, which is the target number for its first production run. The company also moved forward in the development of the BaroShear Mini: bench-top, laboratory-based instrument for research, formulation, and small volume processing; and the BaroShear Max; high-volume, industrial-scale, clean-in-place (CIP), production instrument. In 2022, the company demonstrated that its CBD nanoemulsion was stable for more than 30 months at room temperature or refrigerated conditions, and after repeated freeze/thaw events. The company shipped the first UltraShear Max system to its partners at The Ohio State University. The company also initiated to process of setting up two bi-coastal facilities capable of meeting the development and production needs for several customers. In the last month of the year, the company shipped its first commercial batch and announced important commercial relationships in both the cannabis market and cosmeceuticals. In 2023, the company plans to commercialize UST in multiple market segments.

Products

The Ultra Shear Technology platform instrument portfolio is consisted of three models for use in research, formulation, and processing of oil and water nanoemulsions.

UltraShear Mini - bench-top instrument to be used for research, formulation, and small volume processing. Throughput of at least 1mL/minute.

UltraShear K45 - pilot scale, floor standing instrument for throughput of at least 1L/hour.

UltraShear Max - floor standing, fully automated, CIP industrial production system for throughput of more than 4L/minute.

Customers

Cannabis extracts, cosmecetical and personal care products, liquid foods and beverages, nutraceuticals, pharmaceuticals, agrochemicals, inks, paints, lubricants and other industrial products, and researchers and processors interested in developing stable, water-soluble nanoemulsions for any application.

Manufacturing and Supply

PBI's commercialization strategy is to initially produce UST-processed bulk nanoemulsion products for companies in a variety of markets. Aftermarket service and support will initially be handled by PBI's service and repair staff.

The PBI Agrochem Platform

In February 2021, PBI announced a signed Letter of Intent to acquire the assets and senior management of a dormant company with an extensive portfolio of innovative agrochemical products, utilizing natural product oils as active ingredients (similar to the use of orange oil or neem oil for pest control). With the intense and growing focus of consumers and governments on the long term environmental and health challenges presented by many conventional agrochemical products, this new class of green essential oil agrochemicals that are considered safe for humans and animals represent a highly attractive and high-growth segment of the agrochemicals market.

In July 2021, PBI established PBI Agrochem, Inc., a wholly-owned agrochemicals subsidiary, in order to purchase up to $1M of green agrochemical products from the targeted acquisition, to allow the management of the dormant agrochemicals company to demonstrate the reestablishment of previous business relationships and sales channels, and to provide access to early agrochemical sales revenues for PBI (prior to closing the asset acquisition transaction). PBI Agrochem leased a warehouse near Sparks, NV and hired a warehouse manager to facilitate the shipping, storage and management of the green agrochemicals inventory.

Other

Sales and Marketing

The company's sales and marketing efforts are centered on using the independent data developed and disseminated by its collaboration partners to help drive the installed base of its PCT Sample Preparation System, BaroFold services, and BaroShear UST platform. The development of scientific data by the company's partners and its internal researchers provides its sales and marketing staff with additional tools that are essential in selling existing and newly developed paradigm-shifting, high-value technologies and services.

Foreign Distribution Network

On December 3, 2021, the company entered into a two-year distribution agreement with Westlake Omics Biotechnology, Ltd, in Hangzhou, China.

In February 2016, the company entered into a three-year distribution agreement with Bioanalytic of Poland, pursuant to which PBI granted Bioanalytic exclusive distribution rights to all of its PCT products in Poland. In August of 2021, the company expanded its relationship with Bioanalytic to reflect an exclusive distribution relationship for all of the EU and non-EU members in Western Europe, in addition to Poland. In August 2021, the company signed an exclusive distribution agreement with Bioanalytic on Aug 1 2021 that expires on December 31, 2023.

In September 2016, the company entered into a three-year distribution agreement with Vita Co. of Japan, pursuant to which it granted Vita Co. exclusive distribution rights to all of its PCT products in Japan. This agreement expired in 2019. The company continues to maintain a distribution relationship with Vita and is in contract renewal discussions.

In January 2020, the company entered into a three-year distribution agreement with SCINCO Co., LTD of South Korea, pursuant to which PBI granted SCINCO exclusive distribution rights to all of its PCT products in South Korea.

Non-Exclusive and Other Distribution Agreements

In November 2011, the company entered into a distributor agreement with OROBOROS Instruments Corp. (OROBOROS) of Austria, pursuant to which it granted OROBOROS non-exclusive world-wide distribution rights to its Shredder SG3 System and related products.

The company is also the exclusive distributor, throughout the Americas, for Constant Systems, Ltd.'s (CS) cell disruption equipment, parts, and consumables. CS, a British company located northwest of London, England, has been providing niche biomedical equipment, related consumable products, and services to a global client base since 1989. CS designs, develops, and manufactures high pressure cell disruption equipment used by life sciences laboratories worldwide, particularly disruption systems for the extraction of proteins. The CS equipment provides a constant and controlled cell disruptive environment, giving the user superior, constant, and reproducible results whatever the application. CS has over 900 units installed in over 40 countries worldwide. The CS cell disruption equipment has proven performance in the extraction of cellular components, such as protein from yeast, bacteria, mammalian cells, and other sample types.

The CS pressure-based cell disruption equipment and the company's PCT-based instrumentation complement each other in several important ways. While both the CS and the company's technologies are based on high pressure, each product line has fundamental scientific capabilities that the other does not offer. The company's PCT Platform uses certain patented pressure mechanisms to achieve small-scale, molecular level effects. CS's technology uses different, proprietary pressure mechanisms for larger-scale, non-molecular level processing.

In June 2013, CS and PBI signed an expanded distribution agreement that made the company the exclusive distributor of CS products throughout all of the Americas until the end of 2019. In October 2021, the company renewed this distribution agreement for an additional two years.

Intellectual Property

Patents

As of December 31, 2022, the company had been awarded 26 total United States and foreign patents related to its PCT technology platform, and one U.S. patent and two additional patents in China related to its Ultra Shear Technology. The company also received eight patents with its purchase of the assets of BaroFold in December 2017. PBI also has 19 pending patents in the U.S.A., Canada, Europe, Australia, China, and Taiwan.

The company plans to design, develop, manufacture, and market three different models of BaroShear UST instruments:

A bench-top, research/formulation, low-throughput instrument that the company will license for formulation development;

A lab-or pilot scale production instrument that the company will license into life science companies and other industries; and

A production scale UST-based instrument for manufacturing applications that the company will license to large-scale food, cosmetics, nutraceuticals, and other processors worldwide.

The company's issued patents expire between 2022 and 2030. Any failure to obtain and maintain adequate patent protection may adversely affect the company's ability to enter into, or affect the terms of, any arrangement for the marketing, sale or licensing of any of its products or technology platforms.

License Agreements Relating to Pressure Cycling Technology

BioMolecular Assays, Inc.

In connection with its acquisition of BioSeq, Inc., the company licensed certain limited rights to the original pressure cycling technology back to BioMolecular Assays, Inc. This license is non-exclusive and limits the use of the original pressure cycling technology by BioMolecular Assays, Inc. solely for molecular applications in scientific research and development and in scientific plant research and development. BioMolecular Assays, Inc. is required to pay the company a royalty equal to 20% of any license or other fees and royalties, but not including research support and similar payments, it receives in connection with any sale, assignment, license or other transfer of any rights granted to BioMolecular Assays, Inc. under the license. BioMolecular Assays, Inc. was required to pay the company these royalties until the expiration in March 2016 of the patents held by BioSeq, Inc. since 1998.

Battelle Memorial Institute

The company has an exclusive patent license agreement with the Battelle Memorial Institute (Battelle). The licensed technology is the subject of a patent application filed by Battelle in 2008 and relates to a method and a system for improving the analysis of protein samples, including through an automated system utilizing pressure and a pre-selected agent to obtain a digested sample in a significantly shorter period of time than current methods, while maintaining the integrity of the sample throughout the preparatory process. In addition to royalty payments on net sales of licensed products, the company is obligated to make minimum royalty payments for each year that it retains the rights outlined in the patent license agreement and the company is required to have its first commercial sale of the licensed products within one year following the issuance of the patent covered by the licensed technology.

Research and Development

For the year ended December 31, 2022, the company's research and development expenses were $969,532.

Regulation

The company self-certified that its Barocycler instrumentation was electromagnetically compatible, or CE compliant, which means that its Barocycler instruments meet the essential requirements of the relevant European health, safety and environmental protection legislation.

History

The company was founded in 1978. It was incorporated in the Commonwealth of Massachusetts in 1978. The company was formerly known as Boston Biomedica, Inc. and changed its name to Pressure BioSciences, Inc. in 2005.