On November 17, 2020 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Phase 1 MELANI-01 trial evaluating the UCARTCS1 product candidate for the treatment of patients with relapsed or refractory multiple myeloma (MM) (Press release, Cellectis, NOV 17, 2020, View Source [SID1234571264]).

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Cellectis worked closely with the FDA over the past months, to address the agency’s requests, which include adjustments to the MELANI-01 clinical protocol designed to enhance patient safety. Cellectis continues to work with the clinical site staff and investigators to efficiently obtain the required local approvals to reopen the trial and resume patient enrollment.

"We remain confident in the potential clinical benefit of UCARTCS1 product candidate for patients with relapsed/refractory multiple myeloma, a widely unmet medical need that Cellectis will continue to address. The safety of patients enrolled in our clinical trials remains our priority, and we are committed to resuming the clinical development of this promising program," said Carrie Brownstein, MD, Chief Medical Officer, Cellectis.

Patient enrollment is ongoing in Cellectis’ two other proprietary Phase 1 dose escalation trials: AMELI-01 evaluating UCART123 in relapsed and refractory acute myeloid leukemia and BALLI-01 evaluating UCART22 in relapsed and refractory B-cell acute lymphoblastic leukemia.

About MELANI-01
MELANI-01 is a Phase 1 open-label First-In-Human dose escalation clinical study evaluating UCARTCS1 product candidate for the treatment of patients with relapsed or refractory multiple myeloma (MM). UCARTCS1 is an allogeneic, off-the-shelf, gene-edited T-cell product candidate designed for the treatment of CS1/SLAMF7-expressing hematologic malignancies. CS1 (SLAMF7) is highly expressed on MM tumor cells. Learn more about the ongoing clinical trials at www.clinicaltrials.gov

About Multiple Myeloma (MM)

Multiple myeloma is a cancer that affects a type of white blood cells called plasma cells that are specialized mature B-cells, which secrete antibodies to combat infections. Multiple myeloma is characterized by the uncontrolled proliferation of neoplastic plasma cells in the bone marrow, where they overcrowd healthy blood cells. Although MM is a chronic disease and an exact cause has not yet been identified, researchers have made significant progress over the years in managing the disease through better understanding MM’s pathophysiology. The progress in finding a cure needs to be continued as The American Cancer Society estimates that 32,270 new cases of MM will be diagnosed, and 12,830 deaths are expected to occur in 2020 in the U.S. alone.

On November 17, 2020 Medtronic plc (NYSE:MDT) reported that it will report financial results for its second quarter of fiscal year 2021 on Tuesday, November 24, 2020 (Press release, Medtronic, NOV 17, 2020, View Source [SID1234571291]). A news release will be issued at approximately 5:45 a.m. Central Standard Time (CST) and will be available at View Source The news release will include summary financial information for the company’s second quarter of fiscal year 2021, which ended on Friday, October 30, 2020.

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Medtronic will host a webcast at 7:00 a.m. CST to discuss financial results for its second quarter of fiscal year 2021. The webcast can be accessed at View Source on November 24, 2020.

Within 24 hours of the webcast, a replay and transcript of the prepared remarks will be available by clicking on the Investor Events link at View Source.

Looking ahead, Medtronic plans to report its fiscal year 2021 third and fourth quarter results on Tuesday, February 23, 2021, and Thursday, May 27, 2021, respectively. For these events, confirmation and additional details will be provided closer to the specific event.

On November 17, 2020 Perrigo Company plc (NYSE; TASE: PRGO), reported that CEO and President, Murray S. Kessler and CFO, Ray Silcock, will present at the Morgan Stanley Global Consumer & Retail Conference at 1:00 PM EST on Tuesday, December 1, 2020 (Press release, Perrigo Company, NOV 17, 2020, View Source [SID1234571230]). Interested parties can access the presentation webcasts at View Source

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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 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the patient’s body, reported a business update for the third quarter of 2020 (Press release, Cue Biopharma, NOV 17, 2020, View Source [SID1234608289]).

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"We are very pleased with the progress we continue to make advancing CUE-101 through the ongoing Phase 1 monotherapy dose escalation trial," said Daniel Passeri, chief executive officer of Cue Biopharma. "We are encouraged by the datasets to date from this ongoing study, have completed dosing cohort 6, at 4mg/kg and were recently cleared by the Safety Review Committee to begin dosing cohort 7, at 8mg/kg."

Anish Suri, chief scientific officer and president of Cue Biopharma, added, "We believe that we remain well-positioned for continued execution of our development plans for our lead asset CUE-101, which is representative of our IL-2 based CUE-100 series, and the continued build-out of our pipeline via our proprietary protein engineering approach, as also exemplified by recent scientific presentations at the SITC (Free SITC Whitepaper) meeting last week."

Third Quarter 2020 Financial Results

Collaboration revenue was $704,000 and $984,000 for the three months ended September 30, 2020 and 2019, respectively.

Research and development expenses were $7.5 million and $5.3 million for the three months ended September 30, 2020 and 2019, respectively. This increase of approximately $2.2 million was due primarily to an increase in clinical trial activity, drug manufacturing costs, and stock-based compensation expense, offset by a decrease in travel expenses during the third quarter of 2020 as the COVID-19 pandemic continued to hamper business travel throughout the quarter.

General and administrative expenses were $3.3 million and $2.8 million for the three months ended September 30, 2020 and 2019, respectively. This increase of approximately $0.5 million was due primarily to increases in stock-based compensation and legal fees offset by a decrease in travel expenses for the third quarter of 2020.

"As of September 30, 2020, we had approximately $91.8 million in cash, cash equivalents and marketable securities, which we believe will allow us to support the clinical development of our lead asset CUE-101 into the second quarter of 2022," said Kerri-Ann Millar, chief financial officer of Cue Biopharma.

Recent News & Business Updates

Presented three posters highlighting the company’s clinical and pipeline progress at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 35th Anniversary Annual Meeting (SITC 2020). The posters include a clinical update on CUE-101, the lead drug candidate from the IL-2 based CUE-100 series and data supporting the potential of the Immuno-STAT (Selective Targeting and Alteration of T cells) platform to selectively engage and modulate targeted T cells within the body in a manner that could address a broad range of indications.

Entered into an amendment to the Global License and Collaboration agreement with LG Chem that extended the deadline for LG Chem to exercise its option for an additional Immuno-STAT program from November 6, 2020 to April 30, 2021.

Appointed Tamar Howson to the board of directors. Ms. Howson brings broad corporate and business development experience to the board, having held executive leadership positions in several global biopharmaceutical and pharmaceutical companies as well as her extensive board service.

Presented preclinical data focused on the in vivo detection of tumor antigen-specific T cells in a peer-reviewed paper published in Nature Methods titled, "In vivo detection of antigen-specific CD8 T cells by immuno-positron emission tomography." The study was co-authored by Steven C. Almo, Ph.D., co-founder of Cue Biopharma, professor and chair of biochemistry, professor of physiology & biophysics and the Wollowick Family Foundation chair in multiple sclerosis and immunology at Albert Einstein College of Medicine and Hidde Ploegh, Ph.D., a renowned expert in molecular immunology and a member of the program in cellular and molecular medicine at Boston Children’s Hospital.

Extended cash runway during the third quarter of 2020 through sales of shares of common stock under an ATM equity offering sales agreement for aggregate proceeds of $14.3 million, net of commissions paid, with Stifel Nicolaus & Company, Inc., who acted as sales agent.
Members of the Cue Biopharma executive management team will provide an update on the ongoing Phase 1 clinical trial of CUE-101 for the treatment of HPV+ HNSCC, technology platforms and pipeline progress, as well as updates on its strategic objectives and anticipated milestones today, Tuesday, November 17 at 4:30 p.m. EST.