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Zimmer Biomet to Present at 2020 Evercore ISI HealthCONx Conference and Piper Sandler 32nd Annual Virtual Healthcare Conference

On November 17, 2020 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal care, reported that President and CEO Bryan Hanson and Executive Vice President and CFO Suky Upadhyay will be presenting at the 2020 Evercore ISI HealthCONx Conference on Tuesday, December 1, 2020, at 10:30 a.m. Eastern Time (Press release, Zimmer Holdings, NOV 17, 2020, https://www.prnewswire.com/news-releases/zimmer-biomet-to-present-at-2020-evercore-isi-healthconx-conference-and-piper-sandler-32nd-annual-virtual-healthcare-conference-301173015.html [SID1234571296]). Additionally, Executive Vice President and CFO Suky Upadhyay will be presenting at the Piper Sandler 32nd Annual Virtual Healthcare Conference Wednesday, December 2, 2020, at 11:00 a.m. Eastern Time.

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Live webcasts of the presentations can be accessed via Zimmer Biomet’s Investor Relations website at https://investor.zimmerbiomet.com. The webcasts will be archived for replay following the conference.

CNS Pharmaceuticals Announces FDA Filing of IND for its Brain Cancer Drug Berubicin

On November 17, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported that it has submitted an Investigational New Drug (IND) application, which has been accepted for review, to the U.S. Food and Drug Administration (FDA) for Berubicin in the treatment of Glioblastoma Multiforme (GBM) (Press release, CNS Pharmaceuticals, NOV 17, 2020, View Source [SID1234571295]). The Company plans to evaluate the efficacy of Berubicin in a Phase 2 Trial for adults with GBM who have failed first-line therapy and commence the trial within the first quarter of 2021, pending the FDA’s acceptance of the Company’s filing.

"Our laser focus from the beginning has been to start the next phase of the investigation of Berubicin for the treatment of this deadly disease as quickly as possible," commented John Climaco, CEO of CNS Pharmaceuticals. "Our team has worked tirelessly for the past year, making several inroads on our manufacturing and clinical efforts to achieve this important milestone. We believe we are optimally positioned to continue to execute our plan and initiate our Phase 2 trial in the first quarter of 2021. We continue to build on the positive results Berubicin demonstrated in the Phase 1 study in high grade gliomas and look forward to advancing its clinical development in these patients, with the end goal of addressing the unmet medical need of better treatment for patients diagnosed with GBM."

The planned Phase 2 trial will evaluate the efficacy of Berubicin in patients with GBM who have failed primary treatment for their disease, and results will be compared to the current standard of care, with 2 to 1 randomization of the 243 patients to Berubicin or Lomustine. The trial will include an interim analysis that will evaluate the comparative effectiveness of these treatments. The trial’s adaptive design is intended to allow this interim analysis of the data to demonstrate meaningful differences in efficacy between treatments and then to allow an adjustment to the size of the patient population in the trial for maximum efficiency in terms of time in development. Based on this, the trial has the potential to provide data to the FDA that may allow an expedited pathway for development. However, there can be no assurance that the FDA will support any potential request for an expedited pathway to approval or further development.

Results from Study Using Biocept’s Target Selector™ Testing to Monitor Breast Cancer Disease Progression to be Presented at 2020 SABCS®

On November 17, 2020 Biocept, Inc. (Nasdaq: BIOC), a leading commercial provider of molecular diagnostic assays, products and services designed to provide physicians with clinically actionable information to improve patient outcomes, reported that results from a prospective study using Target Selector testing to monitor disease progression in patients with metastatic breast cancer will be featured in a poster presentation at the virtual 2020 San Antonio Breast Cancer Symposium (SABCS) on December 9, 2020 (Press release, Biocept, NOV 17, 2020, View Source [SID1234571294]).

Vered Stearns, M.D., professor of oncology, breast cancer research chair in oncology, and director of the Women’s Malignancies Disease Group at Johns Hopkins University School of Medicine/Johns Hopkins Kimmel Cancer Center, will present "HER2 expression in matched metastatic tumor and circulating tumor cells (CTCs) in breast cancer: implications for profiling and monitoring of HER2 status to help guide anti-HER2 therapy." Following Dr. Stearns’ presentation, Biocept plans to announce the study results and to post the presentation here.

Despite improvements in early detection, one in eight women in the U.S. (12%) will develop invasive breast cancer over the course of her lifetime. Approximately 20% of breast cancers test positive for the HER2 protein and, during treatment and with disease progression, the HER2 receptor may convert from positive to negative.

"Once breast cancer metastasizes, it may be difficult to access multiple metastatic sites or to perform serial tissue biopsies to determine whether HER2 conversion has occurred," said Dr. Steans. "This prospective study was designed to evaluate the use of liquid biopsy compared with tissue biopsy for analysis of HER2 status over time."

"The ability to monitor changes in tumor alterations can provide critical information for physicians in reassessing options over the course of treating patients with metastatic breast cancer," said Michael Nall, President and CEO of Biocept. "We believe that our Target Selector is among the most sensitive blood-based tests for identifying HER2 amplification. It is highly gratifying to conduct this study with Dr. Stearns, a recognized leader in breast cancer research, and to have these results presented at the SABCS."

About SABCS
Since 1977 the San Antonio Breast Cancer Symposium (SABCS) has been the leading scientific conference for basic scientists, physician-scientists, clinical investigators and breast care providers, and advocates seeking an exchange of new information in experimental biology, etiology, prevention, diagnosis, and therapy of premalignant breast disease and breast cancer. Founded, owned, and operated by UT Health San Antonio, the symposium has grown to a five-day event attended by an international audience of academic investigators and private physicians from over 80 countries to attain information through abstract presentations, panel discussions, research findings, and state-of-the-art educational sessions. UT Health San Antonio, the American Association for Cancer Research (AACR) (Free AACR Whitepaper), and Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine support SABCS, which provides education and accessibility to the latest information regarding the prevention, diagnosis, and treatment of premalignant breast cancer and breast disease. For more information about the symposium, please visit www.sabcs.org.

OS Therapies Acquires All Indications for OST-HER2 (Listeria monocytogenes) in Solid Tumors, Including Canines

On November 17, 2020 OS Therapies, a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat and cure Osteosarcoma (OS) and other deadly cancers in children and adults, reported the acquisition of all indications for OST-HER2 (Listeria monocytogenes), including Canine (Press release, OS Therapies, NOV 17, 2020, View Source [SID1234571293]). The technology that was developed and extensively tested at University of Pennsylvania, has been provisionally approved by the USDA for Osteosarcoma in canines. Phase I and Phase III trials conducted in canines have had very positive results.

OS Therapies believes now is the time to see if the technology works in humans as well as it does in Canines. The AOST-2121 clinical trial sponsored by OS Therapies and in coordination with the Children’s Oncology Group (COG) will be the first trial of OST-HER2 in Adolescents and Young Adults (AYA) with Osteosarcoma, a deadly and debilitating bone cancer. That trial is scheduled to start in early 2021.

"We are extremely excited to have the Intellectual Property (IP) for all indications of this very promising technology targeting HER2 solid tumors," said Paul Romness, CEO of OS Therapies. "It will ensure innovation and development across the platform technology, hopefully treating solid tumors in humans, as well as our four-legged friends…"

Pressure BioSciences, Inc. Reports Third Quarter 2020 Financial Results and Provides Business Update

On November 17, 2020 Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" or the "Company"), a leader in the development and sale of broadly enabling, pressure-based instruments, consumables, services, and platform solutions to the worldwide life sciences and other industries, reported financial results for the third quarter ended September 30, 2020, provided a business update, and offered limited guidance for FY2021 (Press release, Pressure BioSciences, NOV 17, 2020, View Source [SID1234571292]).

Mr. Richard T. Schumacher, President and CEO of PBI, commented: "We are delighted with the results of the third quarter 2020, particularly in the measurable progress made in three important areas: (i) key operational and technical projects (see highlight bullets below); (ii) revenue increases in our products and services offerings; and (iii) important restructuring improvements in the reduction of onerous, variable-rate convertible debt. As previously reported, the Company’s first and second quarter 2020 results were substantially impacted by business interruptions and/or distractions for PBI clients and prospects. However, third quarter 2020 results demonstrated a dramatic recovery, with Q3 total revenue exceeding the revenue of Q1 and Q2 2020 combined and topping all previous quarterly revenue results since Q4 2018. Similarly, instrument sales in Q3 2020 exceeded instrument sales in Q1 and Q2 2020 combined, and contracted services revenue for our Ultra Shear Technology ("UST") nanoemulsions and BaroFold biopharmaceutical protein refolding and recovery platforms in Q3 2020 also exceeded revenue for the same services in Q1 and Q2 2020 combined."

Mr. Schumacher continued: "We have been especially proud of our strong progress in the restructuring and reduction of onerous, variable-rate convertible debt and the consequential improvement in our investment grade profile. On December 31, 2019 we carried approximately $5.4 million of very expensive, variable-rate convertible debt on our books. We successfully reduced this onerous debt to approximately $1.7 million by Sept 30, 2020 through a combination of cash and conversion into PBIO common stock at a value of $2.50/share. We also carried about $1.1M in merchant cash advances ("MCAs") on December 31, 2019; MCA balances were reduced to $0 by September 30, 2020, primarily through a combination of cash, conversion of debt into stock at a value of $2.50/share, and warrant awards with a $3.50 exercise price. Cash for the debt paydowns and restructurings above was sourced from friendly, long-term investors who we anticipate, based on past performance, will likely convert their safer, less onerous fixed-rate loans into equity in the near future."

Recent Operational and Technical Highlights

Launch of our Revolutionary UST-Based System to Make High Quality, Stable, Water-Soluble Nanoemulsions

On target to launch our unique BaroShear K45 Nanoemulsification System by mid-2021
Novel, proprietary system designed to revolutionize the processing of immiscible liquids (like oils in water) into water-soluble, long-term stable, highly absorbable, innately bioavailable nanoemulsions
Resulting formulations could potentially have enormous success in many very large and rapidly growing markets, including high-value pharmaceuticals, cosmetics, nutraceuticals (such as CBD-infused products), liquid foods and beverages, as well as industrial products including inks, paints and lubricants
Announced receipt of purchase orders for twelve (12) BaroShear K45 nanoemulsification systems being manufactured for mid-2021 release
Completed build-out of our GMP-compliant manufacturing laboratory, an application development showcase for the BaroShear K45 and our industrial scale, high volume (2 liters/minute) UST-based nanoemulsification systems
Expansion of our Recently Launched BaroFold Contract Services Business

We entered into ongoing service agreements with two biopharma companies seeking to determine if our patented BaroFold platform could significantly impact and improve the quality of their early-stage protein therapeutics
We began discussions with potential CRO and CMO partners for the expansion of our BaroFold services
We continued to expand the PBIO contract services laboratory with additional specialized equipment and new methods/applications
Intellectual Property (Patents)

We were awarded the first U.S. patent for our revolutionary Ultra Shear Technology Platform.
We were awarded a pivotal U.S. patent for our best-selling, pressure-based consumable device, the PCT MicroPestle
Collaborations

We signed a worldwide, co-marketing alliance with Leica Microsystems (a Danaher company), integrating PBI’s Pressure Cycling Technology ("PCT") with their laser microdissection platform, prior to mass spec analyses. Leica and PBI believe that the combination of their proprietary technology platforms provides the potential to accelerate cancer R&D with an innovative and proprietary tumor processing workflow
Earlier this year, PBI and RedShiftBio demonstrated the potential of combining their proprietary technologies to enable a new tool for the development and production of biotherapeutics
Financial Results: Q3 2020 vs. Q3 2019 (rounded to nearest hundred except earnings per share)

Products and services revenues were $534,000 for the 2020 third quarter compared to $501,000 for the same quarter of 2019, a 7% increase. This increase was primarily attributable to increased sales of instruments, which totaled $312,700 in Q3 2020 compared to $185,800 in Q3 2019, an increase of 68%. Revenue from consumable products was $49,000 for the third quarter of 2020 compared to $112,000 for the same period in 2019, a 56% decrease. Contracted scientific services for BaroFold protein refolding applications and UST services provided revenue of $84,200 in Q3 2020, compared to $149,200 in Q3 2019, a decrease of 44%. These decreases in consumable product sales and scientific services were primarily attributable to the negative impact that the COVID-19 pandemic had on the operations of many of our customers.

Operating loss for Q3 2020 was $819,000 compared to $1,069,000 for the same period in 2019, a decrease in operating loss of 23%. This decrease was primarily due to lower investor relations services, stock-based compensation expenses, personnel costs, and marketing expenditures.

Loss per common share – basic and diluted– was $(1.02) for Q3 2020 compared to loss per common share of $(2.20) for the same period in 2019.

PBI’s Chairman of the Board, Mr. Jeffrey N. Peterson, offered an overview perspective: "The excitement of our early vision for PBI was based upon the anticipated broad potential of multiple, patented high-pressure technology platforms, now spanning the PCT platform for sample preparation, the BaroFold platform for protein refolding/recovery of biotherapeutics, and the UST platform for processing a new generation of extremely effective nanoemulsions. These unique and proprietary pressure-based platforms address numerous and diverse large market opportunities worldwide. The Company has successfully developed and poised these technologies for market readiness, rapid revenue growth, and a path to major revenue growth and profitability in 2021. We believe that the restructuring of PBI’s debt, already alleviating much of our onerous variable-rate convertible debt exposure, has dramatically repositioned the Company for new investment to eliminate the remaining onerous variable-rate debt, fund our UST platform inventory build for the twelve pre-orders already received for the new BaroShear K45 nanoemulsification system, and drive our conversion to profitability by late 2021."

Earnings Call

The Company will hold an Earnings Conference Call at 4:30 PM EDT on Tuesday, November 17, 2020. To attend this teleconference via telephone, Dial-in: (877) 407-8033 (North America), (201) 689-8033 (International). Verbal Passcode: PBIO Third Quarter 2020 Financial Results Call. Replay Number (877) 481-4010 (North America), (919) 882-2331 (International); Replay ID Number: 38901. Teleconference Replay Available for 30 days.