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]).

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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.

On November 17, 2020 Hologic, Inc. (Nasdaq: HOLX) reported that its new Genius Digital Diagnostics System is now CE marked in Europe (Press release, Hologic, NOV 17, 2020, View Source [SID1234571171]). Genius Digital Diagnostics is the first digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced digital imaging to help cytotechnologists and pathologists identify pre-cancerous lesions and cancer cells in women.

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For more than 30 years, Hologic has developed and brought to market new advances in cervical cancer screening, including the first liquid-based cytology technology, the ThinPrep Pap Test, and the first FDA-approved mRNA-based HPV test, the Aptima HPV Assay. Hologic is redefining cervical cancer screening yet again by introducing Genius Digital Diagnostics for laboratories. The system can rapidly analyze all cells on a ThinPrep Pap test slide, narrowing tens of thousands of cells down to a gallery view of the most diagnostically relevant images. This will help provide healthcare providers with the critical information they need to guide earlier detection and better treatment decisions for the patients they serve.

"Application of AI requires digital images that are of exceptional quality," said Kevin Thornal, president, Diagnostic Solutions Division at Hologic. "Our teams developed a breakthrough imaging technology that converts physical glass cytology slides into digital images with superior clarity. From this digitalization, advanced image analysis and improved standardization are now achievable."

Genius Digital Diagnostics enables a more seamless and dynamic collaboration across laboratories within a network, connecting pathologists with remote review so each patient can benefit from the collective knowledge of geographically dispersed experts when needed. Digital case review promises to enhance the experience for lab partners by improving workflow and accelerating review time.

"As a part of our development process, we collaborated with cytotechnologists and pathologists to ensure we were developing a new system to meet their needs," said Michael Quick, vice president, R&D and Innovation at Hologic. "We’re always innovating so we can help our lab partners detect more diseases and save more lives every day."

Hologic now offers the first CE-marked comprehensive cervical cancer screening portfolio from sample collection to digital diagnosis. Genius Digital Diagnostics consists of a digital imager for image acquisition, an AI algorithm for analyzing images, an image management server for storing images, and a review station for case review. The complete system is scalable, designed to fit the present and future needs of laboratories.

On November 17, 2020 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that, as part of its ongoing collaboration with STORM Therapeutics ("STORM"), the leading biotechnology company focused on the discovery and development of small molecule therapies modulating RNA epigenetics, STORM has selected STC-15 as a first-in-class development candidate (Press release, Evotec, NOV 17, 2020, View Source;announcements/press-releases/p/evotec-and-storm-therapeutics-leverage-indigo-platform-to-progress-oncology-project-towards-clinical-studies-5998 [SID1234571192]). STORM will now use INDiGO, Evotec’s unique integrated, accelerated IND-enabling platform, to progress STC-15 towards an IND application in 2021.

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STORM discovered STC-15, an orally bioavailable, small molecule inhibitor of the enzyme METTL3 targeting modulation of RNA epigenetics, an entirely new mechanism of action, to treat acute myeloid leukaemia ("AML") and other solid and haematological cancers with the support from Evotec’s pre-clinical drug discovery engine.

STORM leads the global field of RNA modulation having demonstrated in vivo proof of concept activity of the first RNA methyltransferase inhibitor in relevant animal models for myeloid and solid tumours. METTL3 is one of two programmes from the STORM platform that have already shown in vivo activity.

Dr Craig Johnstone, Chief Operating Officer of Evotec, commented: "The relationship with STORM goes from strength to strength and is a great example of Evotec’s ability to support the exploration of novel and exciting biology to maximise innovation, but also execute efficiently with rapid and seamless integration from target through to IND."

Dr Keith Blundy, Chief Executive Officer of STORM Therapeutics, added: "STC 15 was identified with support from Evotec and is a highly potent and selective METTL3 inhibitor that is effective in leukaemia cells refractory to chemotherapy treatment. This patient population will be incorporated into the initial clinical trials aiming to accelerate clinical proof of concept for patients with limited other options in addition to exploring combinations with standard of care. STORM’s vision is to become the world’s first company to deliver a disease-modifying agent that works by targeting RNA-modulating enzymes. Evotec has enabled us to rapidly and successfully progress our work resulting in a first-in-class development candidate, with more to follow."

On November 17, 2020 Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, reported results for its first quarter ended September 30, 2020 (Press release, Palatin Technologies, NOV 17, 2020, View Source [SID1234571232]).

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First Quarter Ended September 30, 2020 Financial Highlights

Net loss for the quarter was $(3.9) million, or $(0.02) per share, compared to a net loss of $(4.5) million, or $(0.02) per share for the comparable quarter of 2019;
Vyleesi gross sales for the period July 25 to September 30 amounted to $809,100. Recognized $(288,560) in Vyleesi product revenue, net of allowances and accruals;
Recognized no contract and license revenue for the quarter, compared to $97,379 for the comparable quarter of 2019;
Total operating expenses for the quarter were $3.7 million, including a $1.6 million gain on the license termination agreement, compared to $5.0 million for the comparable quarter of 2019;
As of September 30, 2020, the Company had $86.6 million in cash and cash equivalents and $5.0 million in accounts receivable, compared to $82.9 million in cash and cash equivalents and no accounts receivable as of June 30, 2020, with no outstanding debt.
Business Highlights and Updates

In July 2020, regained exclusive North American rights to market Vyleesi (bremelanotide injection), the first and only on demand treatment for premenopausal women suffering from acquired, generalized, hypoactive sexual desire disorder (HSDD), a condition affecting one in ten premenopausal women;
Vyleesi commercial activities: solidified the distribution network and procedures, improved contact with prescribers and healthcare providers through virtual meetings, increased insurance reimbursement coverage, and initiated a highly-selective digital marketing and telemedicine campaign to rebuild awareness and demand among pre-menopausal women with initial geo-targeting to top prescriber and digital locations;
Completed enrollment of a Phase 2 clinical study with PL9643 for the treatment of dry eye disease (DED). Data readout expected December 2020;
A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is targeted to start in the first half of calendar year 2021.
"We have made significant progress and improvement on Vyleesi commercial activities, specifically around insurance reimbursement and expanded coverage. This put us in the proper position as we initiated a targeted marketing digital campaign to raise condition and treatment awareness with premenopausal women," stated Carl Spana, Ph.D., President and CEO of Palatin.

"Despite the challenges posed by the ongoing viral pandemic, we are on track for data readout next month on our PL9643 Phase 2 clinical study in subjects with dry eye disease. Most people living with dry eye disease suffer from episodic flare-ups. These flares can be caused by a multitude of triggers and frequently are not sufficiently addressed by current therapies."

Programs Overview

Hypoactive Sexual Desire Disorder (HSDD) / Vyleesi (bremelanotide injection)

In July 2020, Palatin announced the mutual termination of its License Agreement with AMAG Pharmaceutical, Inc, for Vyleesi. Under the termination agreement, Palatin regained all North American development and commercialization rights for Vyleesi. AMAG made a $12.0 million payment to Palatin at closing and will make a $4.3 million payment to Palatin on March 31, 2021. Palatin assumed all Vyleesi manufacturing agreements, and AMAG transferred information, data, and assets related exclusively to Vyleesi, including existing inventory. AMAG is providing certain transitional services to Palatin for a period to ensure continued patient access to Vyleesi and regulatory compliance during the transition back to Palatin. Palatin is reimbursing AMAG for the agreed upon costs of the transition services.

Palatin is exploring its options to enhance the commercialization of Vyleesi, including discussions with potential collaboration partners that currently market female healthcare products. Palatin continues collaboration discussions for territories outside the currently licensed territories of China and Korea and anticipates executing multiple agreements through calendar year 2021.

The Company’s strategy implements an informed and highly targeted approach to marketing, focusing on telemedicine, social media, and digital advertising. The Company is committed to working with payers and healthcare professionals to ensure women with HSDD have continued and affordable access to Vyleesi. Vyleesi remains commercially available through specialty pharmacies Avella and BioPlus. Patients also can connect with a healthcare provider through telemedicine. Patients and healthcare providers can learn more about HSDD and Vyleesi at www.vyleesi.com.

Vyleesi is the first FDA-approved product for the as-needed treatment for premenopausal women who experience distress or interpersonal difficulty due to low sexual desire. This treatment is available as a subcutaneous self-injection in a prefilled disposable autoinjector pen for use in anticipation of a sexual encounter.

Anti-Inflammatory / Autoimmune Programs

Enrollment in a Phase 2 clinical study with PL9643 for the treatment of dry eye disease was completed in August 2020. Data readout is targeted for December of 2020. If results from the Phase 2 study support advancing to Phase 3, the Company will initiate a Phase 3 efficacy study as early as mid-calendar year 2021.

A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is targeted to start in the first half of calendar year 2021, with data readout potentially in the first half of calendar year 2022.

The Company continues its assessment and development work related to the treatment of patients with diabetic retinopathy, with an investigational new drug (IND) filing targeted for mid-calendar year 2021.

The Company currently anticipates filing an IND and commencing clinical trials with PL8177 for non-infectious uveitis, for which the FDA granted orphan drug designation, in the second half of calendar year 2021.

Palatin is advancing its COVID-19 development plan and is conducting all the required activities needed to file an IND and begin clinical studies with PL8177 as a treatment in COVID-19 patients. These activities will be completed in the fourth calendar quarter of 2020, allowing the Company to potentially file an IND with the FDA and initiate a clinical study of PL8177 for the treatment of COVID-19 patients early in the first calendar quarter of 2021.

The landscape for treating and conducting clinical studies in COVID-19 patients is rapidly evolving. This impacts the design, risk, and ability to conduct clinical studies in COVID-19 patients. Considering the risk and uncertainty of conducting COVID-19 clinical studies, the start of a PL8177 clinical study is subject to receiving external funding and operational support. The Company is in the process of applying to government programs that provide such support.

Natriuretic Peptide Receptor (NPR) System Program

PL3994, an NPR-A agonist, will be evaluated in a Phase 2A clinical study in heart failure patients with preserved ejection fraction. The proposed study is a collaboration with two major academic medical centers and is supported by an American Heart Association grant. Patient enrollment in the study has commenced and the first patient was dosed in November 2020.

Genetic Obesity Program

Palatin’s melanocortin receptor 4 (MC4r) peptide PL8905 and orally active small molecule PL9610 are currently under investigation for the treatment of rare genetic metabolic and obesity disorders. These programs are under internal evaluation for orphan designations, potential development, and licensing.

Conference Call / Webcast

Palatin will host a conference call and audio webcast on November 17, 2020 at 11:00 a.m. Eastern Time to discuss the quarter ended September 30, 2020 results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-800-353-6461 (US/Canada) or 1-334-323-0501 (international), conference ID 3383273. The audio webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and audio webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (US/Canada) or 1-719-457-0820 (international), passcode 3383273. The webcast and telephone replay will be available through November 24, 2020.

On November 17,2020 PharmaMar (MSE:PHM) and STADA Arzneimittel have reported a commercial licensing agreement for Yondelis (trabectedin) with the STADA Arzneimittel AG’s subsidiary in the United Arab Emirates named STADA MENA DWC-LLC (herein together referred to as "STADA") in Algeria, Bahrain, Egypt, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Qatar, Saudi Arabia, Tunisia, United Arab Emirates (UAE) and Yemen (Press release, PharmaMar, NOV 17, 2020, View Source;sid=2 [SID1234571268]).

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Under the terms of the license and commercialization agreement, PharmaMar will receive a non-disclosed upfront payment and will be eligible for additional remunerations, including a regulatory milestone payment. PharmaMar will retain exclusive production rights of trabectedin and will sell the product to STADA for its clinical and commercial use on an exclusive basis in the 15 MENA markets.

This new agreement follows PharmaMar’s announcement on August 26th, 2019, regarding the agreement entered into with Janssen Products LP (Janssen), by which PharmaMar recovered the commercialization rights of the product in more than 40 countries, formerly licensed to Janssen, where Yondelis has already been approved.

Yondelis is currently registered and marketed in several MENA countries for the treatment of soft tissue sarcoma and relapsed ovarian cancer. Through this licensing agreement, and once the marketing authorizations are formally transferred, STADA will be authorized to commercialize and distribute the product in MENA countries on an exclusive basis.

According to Luis Mora, Managing Director of PharmaMar’s Oncology Business Unit: "This new agreement with STADA will allow us to bring trabectedin to patients throughout the 15 MENA countries covered by the deal. We see STADA’s infrastructure and internal capabilities playing a key role in helping us to maximize the access to this unique drug for as many sarcoma and ovarian cancer patients as possible."

Carsten Cron, Executive Vice-President of Emerging Markets at STADA, commented: "This alliance with PharmaMar for the Yondelis unique treatment option for sarcoma and ovarian cancer significantly strengthens our specialty pharmaceuticals portfolio in the MENA region. This builds on our purpose of "Caring for people’s health as a trusted partner."

"The agreement," he added, "is also testament to how STADA is using its position as a go-to-partner for specialty pharmaceuticals, as well as for generics and consumer healthcare products, to build a broad oncology offering."