Pressure Biosciences Inc ( PBIO - OTCQB ) - Medical Device

Q1 RESULTS - Conference Call

Shares Double In 3 Months - Serious Investors Only

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These shares have doubled since the start of 2019 advancing recently to over $3.90. A superior management team and an evolving product mix drives this company to new highs . Medical Device stocks have had a steady rebound since Dec 2019 and are expected to continue their strong advance .  Stock Watch

Pressure BioSciences  made a major acquisition in 2017 giving the company a much greater reach. Pressure Bio's devices can be found in the laboratories of such outstanding institutions as Harvard , Stamford, Cedars Sinai, NIH, CDC, and the USDA .

We urge serious investors to place these shares on their BUY LIST     Biotech Company Roars Ahead On Huge Volume

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PBIO                                                                                                           MED DEVICE ETF

 

Pressure BioSciences, Inc. Reports First Quarter 2019 Financial Results and Provides Business Update

Q1 Revenue from Newly Created BioPharma and UST Contract Services
Significantly Exceeds Services Revenue for All Quarters of 2018 Combined

Investor Conference Call Scheduled for Thursday, May 16, 2019 at 4:30 PM EST

SOUTH EASTON, MA / ACCESSWIRE / May 16, 2019 / Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" or the "Company"), a leader in the development and sale of broadly enabling, pressure-based instruments, consumables, and platform solutions to the worldwide life sciences industry, today announced financial results for the quarter ended March 31, 2019, provided a business update, and offered limited guidance for FY2019.

Financial Results: Q1 2019 vs. Q1 2018 (Rounded to nearest hundred except earnings per share)

Total revenue for Q1 2019 was $510,000 compared to $611,000 for the same period in 2018, a 16% decrease. Revenue from our new, proprietary Biopharma (BaroFold platform) and Ultra Shear Technology (UST platform) contract services accelerated as expected, with combined revenue of $238,000 in Q1 2019 compared to no services revenue in Q1 2018 and revenue of $202,000 for all of 2018. Sales of both instruments and consumables decreased in Q1 2019 compared to the same quarter of 2018. Overall, products and services revenue was $510,000 for the first quarter of 2019 compared to $585,000 for the same quarter of 2018, a 13% decrease. There was also no grant revenue in Q1 2019 compared to grant revenue of $25,000 in Q1 2018.

Operating loss for Q1 2019 was $1,397,000 compared to $1,108,000 for the same period in 2018, an increase of 26%. This increase was primarily driven by non-cash stock compensation relating to stock option repricing; costs relating to the hire of our first Chief Commercial Officer; and increased utilization of contracted investor and public relations services.

Loss per common share - basic and diluted- was $(2.01) for Q1 2019 compared to loss per common share of $(1.64) for the same period in 2018.

Mr. Richard T. Schumacher, President and CEO of PBI, said: "We believe this disruption in our long trend of increasing quarterly products and total revenue on a year-over-year basis was an anomaly, relating to a combination of several factors: (i) the December 2018 retirement of Dr. Nate Lawrence, our VP of Marketing and Sales for many years; (ii) the loss of several field sales representatives during the second half of 2018; (iii) the beginning of a shift in the focus of our sales strategy from individual academic users and opinion leaders towards more lucrative and efficient long-term growth relationships with biopharmaceutical companies; and (iv) increasing strategic focus and resources on our two new growth areas: contract services related to the BaroFold and UST platforms. The convergence of these factors on decreasing Q1 2019 revenue was unfortunate, but we believe short term in nature."

Mr. Schumacher continued: "As previously announced, we are moving quickly with new business leadership under Dr. Bradford Young and are actively recruiting sales representatives to fill out our team. We believe strongly that the deliberate shift in our sales strategy and new emergent contract services area will both result in increased revenue growth through the current fiscal year."

Dr. Bradford Young, PBI's Chief Commercial Officer, added: "We placed a large amount of effort and focus on our new BioPharma and UST contract services with very encouraging results. We will continue to emphasize these key strategic growth initiatives going forward. We believe the markets for our proprietary technology platforms are very large and that the need for our services and platform technologies will continue to grow as we begin to aggressively promote the benefits of our patented BaroFold and UST platforms for R&D and manufacturing. We anticipate that the growing use of these new services will also support increased sales of our PCT instruments and consumables."

Recent Operational and Technical Highlights

  • We released a video demonstrating the ability of our proprietary UST platform to create water-soluble CBD Oil that disperses instantly when infused into soft drinks, sports drinks, and beer for enhanced quality and absorption;
  • We announced the establishment of a Center of Excellence at Dr. Christine Vogel's laboratory at New York University's Center for Genomics and Systems Biology;
  • We announced a collaboration with The Steinbeis Centre for Biopolymer Analysis & Biomedical Mass Spectrometry, a world-renown German research organization, to develop a revolutionary method for optimizing disease-fighting antibodies;
  • We released scientific analyses confirming important benefits from processing CBD Oil with PBI's UST Platform: analyses showed UST-prepared CBD Oil solutions met challenging nanoemulsion specifications and exhibited minimal loss during processing;
  • We released a short video demonstrating the use of our prototype UST Platform to make water-soluble CBD Oil, offering a solution to CBD absorption issues in food and beverages.
  • We announced a collaboration with nutraceutical manufacturer NutraLife Biosciences for the development of high quality, water-soluble nanoemulsion-based nutraceuticals.
  • We announced that a record number of scientific papers citing the significant benefits of PBI's PCT technology platform were published in 2018, with several authored by global Key Opinion Leaders (KOLs).
  • We announced the commercial launch of our unique Biopharma contract services business, offering improved manufacturing, quality control, and remediation opportunities for highly valuable protein therapeutic candidates and products, opening key opportunities for us to serve an estimated $250 billion global market.

Earnings Call

The Company will hold an Earnings Conference Call at 4:30 PM EDT on Thursday, May 16, 2019. To attend this teleconference via telephone, Dial-in: (844) 602-0380 (North America), (862) 298-0970 (International). Verbal Passcode: PBIO First Quarter 2019 Financial Call and Business Update. Replay Number (877) 481-4010 (North America), (919) 882-2331 (International). Replay ID Number: 49215. Teleconference Replay Available for 30 days.

About Pressure BioSciences, Inc.

Pressure BioSciences, Inc. (OTCQB: PBIO) is a leader in the development and sale of innovative, broadly enabling, pressure-based solutions for the worldwide life sciences industry. Our products 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). Our primary focus is in the development of PCT-based products for biomarker and target discovery, drug design and development, biotherapeutics characterization and quality control, soil & plant biology, forensics, and counter-bioterror applications. Additionally, major new market opportunities have emerged in the use of our pressure-based technologies in the following areas: (1) the use of our recently acquired, patented technology from BaroFold, Inc. (the "BaroFold" technology) to allow entry into the bio-pharma contract services sector, and (2) the use of our recently-patented, scalable, high-efficiency, pressure-based Ultra Shear Technology ("UST") platform to (i) create stable nanoemulsions of otherwise immiscible fluids (e.g., oils and water) and to (ii) prepare higher quality, homogenized, extended shelf-life or room temperature stable low-acid liquid foods that cannot be effectively preserved using existing non-thermal technologies.

Forward Looking Statements

This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "could," "would," "expects," "plans," "intends," "anticipates," "believes," estimates," "predicts," "projects," "potential" or "continue" or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. In evaluating these statements, you should specifically consider various factors. Actual events or results may differ materially. The Company's financial results for the three months ended March 31, 2019 may not necessarily be indicative of future results. These and other factors may cause our actual results to differ materially from any forward-looking statement. These risks, uncertainties, and other factors include, but are not limited to, the risks and uncertainties discussed under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2018, and other reports filed by the Company from time to time with the SEC. The Company undertakes no obligation to update any of the information included in this release, except as otherwise required by law. Due to rounding, numbers presented throughout this and other documents may not add up precisely to the totals provided and percentages may not precisely reflect the absolute figures.

For more information about PBI and this press release, please click on the following website link:

http://www.pressurebiosciences.com

Please visit us on Facebook, LinkedIn, and Twitter.

PRESSURE BIOSCIENCES, INC. AND SUBSIDIARY 
CONSOLIDATED STATEMENTS OF OPERATIONS 
UNAUDITED



For the Three Months
Ended
March 31,

2019
2018
Revenue:
Products, services, other
$
510,240
$
585,244
Grant revenue
-
25,530
Total revenue
510,240
610,774

Costs and expenses:
Cost of products and services
309,712
324,789
Research and development
264,704
324,976
Selling and marketing
188,215
274,468
General and administrative
1,144,421
794,605
Total operating costs and expenses
1,907,052
1,718,838

Operating loss
(1,396,812
)
(1,108,064
)

Other (expense) income:
Interest expense, net
(512,706
)
(872,328
)
Other expense
(104,845
)
(250,817
)
Impairment loss on investment
-
(4,730
)
(Loss) Gain on extinguishment of debt
(40,810
)
4,285
Total other expense
(658,361
)
(1,123,590
)

Net loss
(2,055,173
)
(2,231,654
)

Deemed dividends on beneficial conversion feature
(1,060,199
)
-
Preferred stock dividends
(355,610
)
-
Net loss attributable to common shareholders
(3,470,982
)
2,231,654

Net loss per share – basic and diluted
$
(2.01
)
$
(1.64
)

Weighted average common stock shares outstanding used in the basic and diluted net loss per share calculation
1,723,557
1,363,326


PRESSURE BIOSCIENCES, INC. AND SUBSIDIARY 
CONSOLIDATED BALANCE SHEETS



Unaudited
March 31,
2019
December 31,
2018
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
269,714
$
103,118
Accounts receivable
443,162
474,830
Inventories, net of $273,547 reserve at March 31, 2019 and at December 31, 2018
753,132
765,478
Prepaid expenses and other current assets
183,341
170,734
Total current assets
1,649,349
1,514,160
Investment in equity securities
16,643
16,643
Property and equipment, net
79,932
69,272
Right of use asset
122,792
136,385
Intangible assets, net
641,827
663,462
TOTAL ASSETS
$
2,510,543
$
2,399,922

LIABILITIES AND STOCKHOLDERS' DEFICIT
CURRENT LIABILITIES
Accounts payable
$
474,418
$
658,856
Accrued employee compensation
394,980
456,932
Accrued professional fees and other
1,172,115
1,112,995
Other current liabilities
1,584,507
1,233,325
Deferred revenue
36,952
20,623
Operating lease liability
63,614
59,799
Convertible debt, net of unamortized debt discounts of $239,675 and $156,180, respectively
4,504,188
4,000,805
Other debt, net of unamortized discounts of $10,011 and $9,118, respectively
944,374
852,315
Related party debt other
15,000
15,000
Total current liabilities
9,190,148
8,410,650
LONG TERM LIABILITIES
Operating lease liability, net of current portion
59,178
76,586
Deferred revenue
33,958
37,757
TOTAL LIABILITIES
9,283,284
8,524,993

STOCKHOLDERS' DEFICIT
Series D Convertible Preferred Stock, $.01 par value; 850 shares authorized; 300 shares issued and outstanding on March 31, 2019 and December 31, 2018, respectively (Liquidation value of $300,000)
3
3
Series G Convertible Preferred Stock, $.01 par value; 240,000 shares authorized; 80,570 shares issued and outstanding on March 31, 2019 and December 31, 2018, respectively
806
806
Series H Convertible Preferred Stock, $.01 par value; 10,000 shares authorized; 10,000 shares issued and outstanding on March 31, 2019 and December 31, 2018, respectively
100
100
Series H2 Convertible Preferred Stock, $.01 par value; 21 shares authorized; 21 shares issued and outstanding on March 31, 2019 and December 31, 2018, respectively
-
-
Series J Convertible Preferred Stock, $.01 par value; 6,250 shares authorized; 3,458 shares issued and outstanding on March 31, 2019 and December 31, 2018, respectively
35
35
Series K Convertible Preferred Stock, $.01 par value; 15,000 shares authorized; 6,880 shares issued and outstanding on March 31, 2019 and December 31, 2018, respectively
68
68
Series AA Convertible Preferred Stock, $.01 par value; 10,000 shares authorized; 7,059 and 6,499 shares issued and outstanding on March 31, 2019 and December 31, 2018, respectively
71
65
Common stock, $.01 par value; 100,000,000 shares authorized; 1,768,492 and 1,684,182 shares issued and outstanding on March 31, 2019 and December 31, 2018, respectively
17,685
16,842
Warrants to acquire common stock
20,706,539
19,807,247
Additional paid-in capital
40,640,273
39,777,301
Accumulated deficit
(68,138,321
)
(65,727,538
)
Total stockholders' deficit
(6,772,741
)
(6,125,071
)
TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT
$
2,510,543
$
2,399,922

SOURCE: Pressure BioSciences, Inc.


 

Corporate Overview And Discussion From 10K

     We are focused 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. Sample preparation is often complex, time-consuming and, in our belief, one of the most error-prone steps of scientific research. It is a widely-used laboratory undertaking – the requirements of which drive what we believe is a large and growing worldwide market. We have developed and patented a novel, enabling technology platform that can control the sample preparation process. It is based on harnessing the unique properties of high hydrostatic pressure. This process, which we refer to as PCT, uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels i.e., 20,000 psi or greater to safely, conveniently and reproducibly control the actions of molecules in biological samples, such as cells and tissues from human, animal, plant and microbial sources

      PCT is an enabling platform technology based on a physical process that had not previously been used to control bio-molecular interactions. PCT uses internally developed 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. Our laboratory instrument family, the Barocycler®, and our internally developed consumables product line, which include our unique MicroTubes, MicroCaps, MicroPestles, BaroFlex and PULSE® (Pressure Used to Lyse Samples for Extraction) Tubes, and application specific kits (containing consumable products and reagents), together make up our PCT SPS.

In 2015, together with an investment bank, we formed a subsidiary called Pressure BioSciences Europe (“PBI Europe”) in Poland. We have 49% ownership interest with the investment bank retaining 51%. PBI Europe has never had any operating activities and we cannot reasonably predict when operations will commence. Therefore, we don’t have control of the subsidiary and did not consolidate them in our financial statements.

 

Patents

 

PBI has 14 United States granted patents and one foreign granted patent (Japan: 5587770, EXTRACTION AND PARTITIONING OF MOLECULES) covering multiple applications of PCT in the life sciences field. PBI also has 19 pending patents in the USA, Canada, Europe, Australia, China, and Taiwan PCT employs a unique approach that we believe has the potential for broad use in a number of established and emerging life sciences areas, which include, but are not limited to:

 

Biological sample preparation

Pathogen inactivation

Protein purification

Control of chemical reactions particularly enzymatic and

Immunodiagnostic

 

 

 

 

We are also the exclusive distributor, throughout the Americas for Constant System’s cell disruption equipment, parts, and consumables. CS, a British company located several hours 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 required 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 our PCT-based instrumentation complement each other in several important ways. While both the CS and our technologies are based on high pressure, each product line has fundamental scientific capabilities that the other does not offer. Our 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 a number of routine laboratory applications, such as protein extraction, both effects can be critical to success. Therefore, for protein extraction and a number of other important scientific applications, we believe laboratories will benefit by using the CS and our products, either separately or together.

 

Primary Fields of Use and Application for PCT

 

Sample preparation is widely regarded as a significant impediment to research and discovery and sample extraction is generally regarded as one of the key parts of sample preparation. The process of preparing samples for genomic, proteomic, lipidomic, and small molecule studies includes a crucial step called sample extraction or sample disruption. This is the process of extracting biomolecules such as nucleic acid i.e., DNA and/or RNA, proteins, lipids, or small molecules from the plant or animal cells and tissues that are being studied. Our current commercialization efforts are based upon our belief that pressure cycling technology provides a superior solution for sample extraction when compared to other available technologies or procedures and thus might significantly improve the quality of sample preparation, and thus the quality of the test result.

 

Within the broad field of biological sample preparation, in particular sample extraction, we focus the majority of our PCT and constant pressure (“CP”) product development efforts in three specific areas: biomarker discovery (primarily through mass spectrometric analysis), forensics, and histology. We believe that our existing PCT and CP-based instrumentation and related consumable products fill an important and growing need in the sample preparation market for the safe, rapid, versatile, reproducible and quality extraction of nucleic acids, proteins, lipids, and small molecules from a wide variety of plant, animal, and microbiological cells and tissues.

 

Biomarker Discovery - Mass Spectrometry

 

A biomarker is any substance (e.g., protein, DNA) that can be used as an indicator of the presence or absence of a particular disease-state or condition, and/or to measure the progression and effects of therapy. Biomarkers can help in the diagnosis, prognosis, therapy, prevention, surveillance, control, and cure of diseases and medical conditions.

 

A mass spectrometer is a laboratory instrument used in the analysis of biological samples, often focused on proteins, in life sciences research. It is frequently used to help discover biomarkers. According to a recently published market report by Transparency Market Research, “Spectrometry Market (Atomic, Molecular and Mass Spectrometry) - Global Scenario, Trends, Industry Analysis, Size, Share & Forecast 2011 – 2017, the global spectrometry market was worth $10.2 billion in 2011 and is expected to reach $15.2 billion in 2017, growing at a compound annual growth rate of 6.9% from 2011 to 2017. In the overall global market, the North American market is expected to maintain its lead position in terms of revenue until 2017 and is expected to have approximately 36.2% of the market revenue share in 2017, followed by Europe. We believe PCT and CP-based products offer significant advantages in speed and quality compared with current techniques used in the preparation of samples for mass spectrometry analysis.

 

Forensics

 

The detection of DNA has become a part of the analysis of forensic samples by laboratories and criminal justice agencies worldwide in their efforts to identify the perpetrators of violent crimes and missing persons. Scientists from the University of North Texas and Florida International University have reported improvements in DNA yield from forensic samples (e.g., bone and hair) when using the PCT platform in the sample preparation process. We believe that PCT may be capable of differentially extracting DNA from sperm cells and female epithelial cells captured in swabs collected from rape victims and subsequently stored in rape kits. We also believe that there are many completed rape kits that remain untested for reasons such as cost, time and quality of results. We further believe that the ability to differentially extract DNA from sperm and not epithelial cells could reduce the cost of such testing, while increasing the quality, safety and speed of the testing process.

 

Histology

 

The most commonly used technique worldwide for the preservation of cancer and other tissues for subsequent pathology evaluation is process them into formalin-fixed, paraffin-embedded (“FFPE”) tissue samples. We believe that the quality and analysis of FFPE tissues is highly problematic, and that PCT offers significant advantages over current processing methods, including standardization, speed, biomolecule recovery, and safety.

 

 Our customers include researchers at academic laboratories, government agencies, biotechnology companies, pharmaceutical firms, and other life science institutions in the North, Central, and South America; Europe, and Asia. Our goal is to continue aggressive market penetration in these target groups. We also believe that there is a significant opportunity to sell and/or lease additional Barocycler® instrumentation to additional laboratories at current customer institutions.

 

 If we are successful in commercializing PCT in applications beyond our current focus area of genomic, proteomic, lipidomic, and small molecule sample preparation, and if we are successful in our attempts to attract additional capital, our potential customer base could expand to include hospitals, reference laboratories, pharmaceutical manufacturing plants and other sites involved in each specific application. If we are successful in forensics, our potential customers could be forensic laboratories, military and other government agencies. If we are successful in histology (extraction of biomolecules from FFPE tissues), our potential customers could be pharmaceutical companies, hospitals, and laboratories focused on drug discovery or correlation of disease states.

 

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