On May 14, 2020 Applied DNA Sciences Inc. (Nasdaq: APDN) ("Applied DNA" or the "Company") a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, reported consolidated financial results for the fiscal second quarter and the six months ended March 31, 2020 (Press release, Applied DNA Sciences, MAY 14, 2020, View Source [SID1234558023]).

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"Continued execution on our strategic priorities in our second fiscal quarter resulted in an expansion of our linear DNA story to include COVID-19 vaccine candidate and diagnostic kit programs and the addition of new development customers. These new development customers, several of which are leaders in the field of gene and redirected-cell therapies, demonstrate broadening interest and adoption of our proprietary linear DNA approach to preclinical biotherapeutics and diagnostics development and further validate linear DNA as a viable alternative for plasmid DNA," stated Dr. James A. Hayward, president and CEO of Applied DNA.

"Most of our activities during the quarter were devoted to our COVID-19 development programs that serve to also elevate the profile of our PCR-based LinearDNA platform to the biopharma industry as a powerful, large-scale tool for the rapid manufacture of DNA-based therapeutics," continued Dr. Hayward. "The global focus on the pandemic and the speed with which vaccine candidates are being developed are laying bare the limitations of modern vaccine development that are almost-exclusively reliant on plasmid-based technologies that are often slow and require much more downstream processing. Because our linear DNA approach does not require bacterial fermentation and has the added advantage of essentially no risk of contamination by genes for antibiotic resistance and other genetic contaminants, we believe our platform is well suited for such DNA-based therapeutics as engineered T cells, gene therapies, RNAi, and vaccines, such as for COVID-19 or future emerging infectious diseases. One new development customer, a global Top-20 pharmaceutical manufacturer, is evaluating the full scope of our platform to potentially serve as a foundational tool for their future genetic therapy pipeline. As the industry comes to terms with the limitations of plasmid-based technologies in terms of production speed and risk, we believe this will set the stage for a paradigm shift towards the rapid manufacturing of linear DNA vaccines with our LinearDNA platform as the accelerator."

Concluded Dr. Hayward, "Looking ahead, we remain focused on driving interest and building demand for our linear DNA approach across certain highly-regulated markets, such as drug development, that we believe offer a path to higher and more recurring revenue. Takis Biotech ("Takis") has initiated preclinical animal trials of our LinearDNA version of their vaccine candidates that we believe will demonstrate similar, robust immune responses to their plasmid-based constructs, but with the added advantage of speed and scalability to manufacture for global use. Concurrently, we are preparing for the possibility for Takis to progress to human trials this fall by readying our facility for compliance with the FDA’s cGMP regulations that govern the quality of biologics for human use. We have also developed our Linea COVID-19 high-throughput and high-sensitivity SARS-CoV-2 detection kit to enable mass-testing that can be a crucial tool in the toolbox of health systems and governments in the fight to further ‘flatten the curve’. Having received Emergency Use Authorization from the FDA today, we are now focused on the commercialization of our kit to assist frontline workers leading the charge against the pandemic. Pharmaceutical molecular tagging is another target market and one where the FDA has granted us entry into its Emerging Technology Program that gives us a path to drive the industry’s adoption of our authentication technologies and mitigate participation of counterfeit and adulterated drugs in the legitimate pharmaceutical supply chain. We will continue to build our business development pipeline and execute on our strategy to advance and prove the capabilities of linear DNA to drug developers and the broader pharmaceutical industry."

Fiscal Second Quarter 2020 Financial Results:

·Revenues decreased 29% for the second quarter of fiscal 2020 to $552 thousand, compared with $778 thousand reported in the same period of the prior fiscal year and decreased 13% from $634 for the first quarter of fiscal 2020. This decrease in revenues year over year is due to a decrease of $305 thousand in service revenues, offset by an increase of $79 thousand in product revenues. The decrease in service revenues is primarily attributable to a decrease from a government contract award that ended during the second half of fiscal 2019 and a decline in precommercial feasibility projects in both textiles and cannabis. The increase in product revenues was primarily related to an increase in biopharmaceutical revenues during the quarter ended March 31, 2020.

·Total operating expenses decreased to $3.1 million for the second fiscal quarter of 2020, compared with $3.3 million in the prior fiscal year’s second quarter. This decrease is attributable to a decrease in professional fees of approximately $183 thousand due to reduced legal fees. To a lesser extent, the decrease relates to a reduction of approximately $64 thousand in travel fees as result of travel restrictions associated with COVID-19. This decrease was offset by an increase in research and development expenses of $52 thousand.

·Net loss for the quarter ended March 31, 2020 was $3.0 million, or $0.79 per share, compared with a net loss of $2.7 million, or $3.22 per share, for the quarter ended March 31, 2019, an increase of 10%, and a net loss of $2.7 million, or $1.12 per share, for the quarter ended December 31, 2019.

·Excluding non-cash expenses, Adjusted EBITDA was negative $2.6 million and a negative $2.3 million for the quarters ended March 31, 2020 and 2019, respectively. See below for information regarding non-GAAP measures.

·Cash was $8.7 million at March 31, 2020 that includes the exercise of warrants associated with the November 15, 2019 underwritten public offering ("the offering") totaling approximately $2.8 million in net proceeds. Subsequent to March 31, 2020 the Company received a further $2.9 million of net proceeds through the exercise of warrants associated with the offering. There are a total of approximately 1.5 million warrants outstanding from the offering at May 14, 2020.

Six Months Ended March 31, 2020 Financial Results:

·Revenues decreased 29% for the first half of fiscal 2020 to $1.2 million, compared with $1.7 million reported in the same period of the prior fiscal year. This decrease in revenue year over year is due to a decrease of $472 thousand in service revenues and a decrease of $5 thousand in product revenues. The decrease in service revenues is primarily attributable to a decrease from a government contract award that ended during the second half of fiscal 2019.

·Total operating expenses decreased to $6.1 million for the six months ended March 31, 2020, compared with $7.2 million in the prior fiscal year’s first six months. This decrease is primarily attributable to decreases in payroll of approximately $272 thousand, attributable to headcount reductions, a decrease in stock-based compensation expense of approximately $262 thousand as well as decreases in legal and professional fees of $139 thousand, consulting fees of $121 thousand, reduced travel expenses of $110 thousand and research and development of $93 thousand.

·Net loss for the six-month period ended March 31, 2020 was $5.6 million, or $1.76 per share, compared with a net loss of $5.9 million, or $6.51 per share, for the six months ended March 31, 2019, an improvement of 5%.

·Excluding non-cash expenses, Adjusted EBITDA was negative $5.0 million and a negative $4.9 million for the six months ended March 31, 2020 and 2019, respectively. See below for information regarding non-GAAP measures.

Select Quarterly Operational Highlights:

Applied DNA progressed its COVID-19 development program that spans both vaccine development and clinical diagnostic kit development:

·On May 14, 2020, Applied DNA announced that it had received Emergency Use Authorization for its COVID-19 diagnostic Assay kit from the U.S. Food and Drug Administration ("FDA"). Clinical laboratories in the United States certified under Clinical Laboratory Improvement Amendments can immediately begin ordering and using the LineaTM COVID-19 assay kit to detect SARS-CoV-2, the virus that causes COVID-19;

·On May 5, 2020, the Company announced that it had applied to the U.S. FDA for Emergency Use Authorization for its COVID-19 diagnostic kit, Linea COVID-19, a RT-PCR-based, high-sensitivity and high-throughput COVID-19 diagnostic test;

·On May 4, 2020, Applied DNA and its COVID-19 development partner, Takis, announced that the first injections of their DNA vaccine candidates against the Spike protein (‘S’ gene) of the SARS-CoV-2 virus that causes the COVID-19 disease, have produced neutralizing antibodies in test animals. The studies were completed at the renowned Lazzaro Spallanzani National Institute for Infectious Diseases in Rome. These initial results were obtained using plasmids (the templates for LinearDNA) to baseline results; Applied DNA’s linear DNA dose-response trials begin in the week of May 4, 2020;

·On April 21, 2020, the Company signed an agreement with Stony Brook University Hospital to validate and implement the Company’s COVID-19 diagnostic test: Linea COVID-19. The diagnostic test targets the SARS-CoV-2 Spike (S) gene, which is also the subject of the Company’s COVID-19 vaccine development program;

·On April 15, 2020, Applied DNA announced that it had shipped five linear DNA versions of COVID-19 vaccine candidates to its drug development partner, Takis, to support the immediate start of preclinical animal testing. Shipment of the vaccine candidates follows Takis’ receipt of approval from Italy’s Ministry of Health to begin preclinical testing. Concurrent with Takis’ animal trials, Applied DNA is preparing for cGMP production of selected vaccine candidate(s) to support human trials scheduled to begin this fall; and

·On March 24, the Company announced that it had filed a provisional patent application with the U.S. Patent and Trademark Office for a diagnostic assay for COVID-19.

The Company’s LinearDNA platform for preclinical biotherapeutic (gene and redirected-cell therapies) and diagnostic applications development continued to shift towards broader adoption:

·On March 26, the Company announced that it had shipped CAR T amplicons proprietary to a new development customer, the biologics subsidiary of a U.S.-based, global biopharmaceutical company, for use in evaluating the use of linear DNA; and

·On March 20, Applied DNA announced the signing of a research agreement with a new development customer, a global Top-20 pharmaceutical manufacturer, to evaluate the full scope of the Company’s linear DNA platform to potentially improve the efficacy and safety of the customer’s CAR T therapy pipeline. The research agreement includes the Company’s patented technologies to maximize protein expression and unique linear DNA anti-CD19 CAR T construct for the treatment of acute lymphocytic leukemia.

The Company’s DNA tagging business for supply chain security continued to build awareness and adoption:

·On February 24, the Company announced the receipt of international patents on its Beacon secure optical molecular market technologies in China, Canada, and the U.S., each a key market for brand protection and assurance for Applied DNA;

·On February 20, Applied DNA received Pareve kosher certification for products within its SigNature and CertainT brands from Orthodox Union, the world’s largest and most widely recognized international kosher certification agency. Certification supports the Company’s business development efforts in the food, pharmaceutical, and dietary supplements markets to maximize adoption of its molecular-based tagging platform; and

·On February 19, the Company entered the dietary supplements market with a multi-year contract with Nutrition21, a trusted developer and supplier of novel and clinically substantiated branded ingredients for the nutritional supplement industry. Under the terms of the contract, the application of Applied DNA’s CertainT platform to Nutrition21’s leading sports supplement, Nitrosigine, offers Nutrition21 the certainty of its ingredients all the way through to their customers’ finished products and onto retail shelves and online stores. Separately, the two companies signed an additional agreement to enable Nutrition21 to represent the CertainT platform throughout Nutrition21’s extensive network in the dietary supplement market.

Fiscal Second Quarter 2020 Conference Call Information

The Company will hold a conference call and webcast to discuss its fiscal second quarter-end 2020 results on Thursday, May 14, 2020 at 4:30 PM EDT. To participate on the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, due to the large number of expected participants, not all questions may be answered.

To Participate:

·Participant Toll Free: 1-844-887-9402
·Participant Toll: 1-412-317-6798
·Please ask to be joined to the Applied DNA call

Live webcast: View Source

Replay (available 1 hour following the conclusion of the live call through May 21, 2020):

·Participant Toll Free: 1-877-344-7529
·Participant Toll: 1-412-317-0088
·Participant Passcode: 10141899
·Webcast replay: View Source

For those unable to attend the live call, a copy of management’s PowerPoint presentation will be available for review under the ‘Events and Presentations’ section of the company’s Investor Relations web site: View Source

On May 14, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the publication of two abstracts in connection with the upcoming ASCO (Free ASCO Whitepaper) Virtual Annual Meeting on May 29-31 (Press release, Oncolytics Biotech, MAY 14, 2020, View Source [SID1234558039]). The first abstract "("Multiple Myeloma Abstract"), which has been accepted as an electronic poster, reports on viral replication, tumor immune responses, and treatment safety in multiple myeloma patients treated with pelareorep in combination with carfilzomib (Kyprolis). The second abstract ("Pancreatic Cancer Abstract") reports on treatment tolerability and efficacy in pancreatic cancer patients treated with pelareorep, in combination with pembrolizumab (Keytruda).

Multiple Myeloma Abstract
Abstract ID: 8535
Session: Hematologic Malignancies-Plasma Cell Dyscrasia
Poster ID: 435
Abstract Title: Oncolytic virus pelareorep plus carfilzomib phase I trial in carfilzomib-refractory patients (NCI 9603): Responses with cytokine storm
Presenter: Craig Hofmeister, M.D., MPH, Associate Professor, Department of Hematology and Medical Oncology Emory University School of Medicine

•Reported selective infection of cancerous cells with pelareorep, with associated CD8+ and natural killer (NK) cell recruitment, PD-L1 upregulation, activated caspase-3 expression, and increased pelareorep protein production within myeloma cells.
•Two patients achieved unconfirmed partial responses, two patients had stable disease, and two patients had progressive disease. All patients had advanced and challenging to treat carfilzomib-refractory disease.
•Of the two responding patients, one patient developed a fever and grade 4 thrombocytopenia that resolved, and the other patient developed a cytokine storm, associated with rapid tumor lysis.
•Data supports the potential of future studies investigating pelareorep, carfilzomib, and immune checkpoint inhibitor combination therapy in multiple myeloma patients.
•Additional data to be presented at the poster session on May 29, 2020.

Pancreatic Cancer Abstract
Abstract ID: e16789
Abstract Title: Pembrolizumab in combination with the oncolytic virus pelareorep in patients progressing on systemic chemotherapy for advanced pancreatic adenocarcinoma, a Phase II study
Presenter: Devalingam Mahalingam, MD, Ph.D., Associate Professor of Medicine at Northwestern University Feinberg School of Medicine and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University

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•Preliminary data indicate that the combination of pelareorep and pembrolizumab resulted in tumor-specific replication, a high degree of T cell repertoire turnover, and the creation of new T cell clones in the peripheral blood during treatment.
•The treatment was found to be well tolerated, with most treatment-related adverse events being grade 1 or 2.
•One patient achieved a partial response and three achieved stable disease, with an overall disease control rate of 30% in evaluable patients.
•The study will not proceed to stage 2 in unselected patients, however further evaluation of the anti-tumor activity of pelareorep and anti-PD-1 therapy is now planned in biomarker defined pancreatic patients in a subsequent study.
•Detailed translational and biomarker data from this study will be published later in the year.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On May 14, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that its collaborator, Takeda Pharmaceutical Company Limited, received approval from the European Commission to extend the current conditional marketing authorization for ADCETRIS (brentuximab vedotin) to include treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL), in combination with CHP (cyclophosphamide, doxorubicin, prednisone) (Press release, Seattle Genetics, MAY 14, 2020, View Source [SID1234558056]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of peripheral T-cell lymphomas (PTCL), including sALCL. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on March 27, 2020.

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"The approval of ADCETRIS in combination with CHP for use in the European Union for patients with previously untreated sALCL represents a significant advance for patients who previously were treated with CHOP chemotherapy regimen that was often unsuccessful in leading to long-term remissions," said Clay Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. "The outstanding results from the ECHELON-2 phase 3 trial, which demonstrated superior progression-free survival and overall survival compared to CHOP, led to this important regulatory milestone. We are pleased that our partner Takeda is able to make this clinically meaningful therapeutic option available to patients in Europe."

The results from the ECHELON-2 phase 3 clinical trial were published in The Lancetin December 2018. The marketing authorization for ADCETRIS is valid in all countries of the European Union, Norway, Liechtenstein and Iceland. For further details about the European Commission decision, please visit the European Medicines Agency website: www.ema.europa.eu/ema.

About T-Cell Lymphomas

There are more than 60 subtypes of non-Hodgkin lymphomas which are broadly divided into two major groups: B-cell lymphomas, which develop from abnormal B-lymphocytes, and T-cell lymphomas, which develop from abnormal T-lymphocytes. There are many different forms of T-cell lymphomas, some of which are extremely rare. T-cell lymphomas can be aggressive (fast-growing) or indolent (slow-growing). PTCL accounts for approximately 10 percent of non-Hodgkin lymphoma cases in the U.S. and Europe and may be as high as 24 percent in parts of Asia.

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include three completed phase 3 trials: ECHELON-2 trial in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing cells.

ADCETRIS for injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions in 2013 for patients with (1) HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates and (2) sALCL after failure of at least one multi-agent chemotherapy regimen. Non-conditional approval was granted for (3) post-ASCT consolidation treatment of patients with HL at increased risk of relapse or progression in 2017, (4) adult patients with pcALCL or CD30-expressing MF who have received prior systemic therapy in 2018, (5) for previously untreated patients with Stage IV HL in combination with doxorubicin, vinblastine, and dacarbazine in 2019, and (6) for previously untreated adult patients with sALCL, peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumors express CD30, in combination with cyclophosphamide, doxorubicin, prednisone in 2019.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) for the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy, (5) for the treatment of adult patients with relapsed or refractory sALCL, and (6) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS has received marketing authorization by regulatory authorities in 73 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See U.S. important safety information, including Boxed Warning, below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

On May 14, 2020 Foundation Medicine, Inc. reported that new data supporting the clinical use of its portfolio of tissue and liquid comprehensive genomic profiling (CGP) tests will be presented at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program, which will be held from May 29 to May 31 (Press release, Foundation Medicine, MAY 14, 2020, View Source [SID1234558072]). The company and its collaborators will present a total of 22 studies, including two clinical symposia presentations and one poster discussion. The data highlight insights into the utility of liquid biopsy CGP testing to help inform treatment selection across a variety of advanced cancers and the predictive role of tumor mutational burden (TMB) as a genomic signature to optimize precision medicine approaches.

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Highlights of these presentations include:

new data demonstrating the use of liquid biopsy CGP to identify predictive and prognostic biomarkers to improve clinical outcomes for patients with advanced cancer, including metastatic breast cancer, non-small lung cancer (NSCLC) and prostate cancer;
additional evidence of the role of complex biomarkers and genomic signatures such as TMB may have in patient response to targeted therapies and immunotherapies; and
the clinical value of liquid biopsy as a tool for oncologists in various treatment settings, including the ability to identify resistance mechanisms across primary and metastatic tumors and enable precision medicine.
"At this meeting, we’ll share new data demonstrating the use of clinically relevant insights from our tissue and liquid comprehensive genomic profiling tests to inform treatment decision-making and improve patient outcomes through methods such as identifying resistance mechanisms," said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. "We’re at an important juncture in personalized medicine where pan-tumor complex signatures such as TMB and MSI are growing in their clinical importance, and our data show the unique ability of CGP to investigate these nuanced biomarkers of response and advance precision treatment approaches."

Clinical Validity of Liquid Biopsy Comprehensive Genomic Profiling

In a study conducted in collaboration with the Dana Farber Cancer Institute, researchers characterizing NSCLC cases found MET exon 14 skipping alterations present in 2.3 percent of tumor DNA samples, representing six major subtypes. The analysis of paired tumor and liquid biopsy samples identified potential acquired resistance mechanisms that may be critical to predicting response to MET inhibitors and identifying matched targeted therapy options, which have recently shown clinical efficacy for this subset of patients, demonstrating the importance of testing NSCLC patients for these alterations.

[Characterization of 1,387 NSCLCs with MET exon 14 (METex14) skipping alterations (SA) and potential acquired resistance (AR) mechanisms. Abstract #9511.]

In a retrospective analysis, researchers compared more than 325,000 tumor tissue samples to over 28,000 patient-matched plasma samples to understand the clinical validity of liquid biopsy CGP in detecting kinase fusions. Kinase gene fusions identified by tissue-based CGP were also detected by liquid biopsy CGP in temporally-matched plasma samples, with high positive percent agreement between tissue and liquid biopsies. The analysis of liquid biopsy samples also identified acquired alterations consistent with known mechanisms of resistance.

[Pan-tumor analyses of kinase fusions detected in circulating tumor DNA (ctDNA) and concordance with paired tissue. Abstract #3517. Poster #247.]

A clinically advanced prostate cancer study used CGP on pre-treatment primary tumor biopsy, post-treatment metastatic biopsy and liquid biopsy to uncover differences in genomic alterations and potential impact on treatment selection. The study demonstrated how systemic treatment resulted in genomic changes in metastases as the tumor evolves to survive. Given the variance between metastatic sites, liquid biopsy may capture a broader range of therapy opportunities for patients.

[Contrasting genomic profiles in post-systemic treatment metastatic sites (MET), pretreatment primary tumors (PT), and liquid biopsies (LB) of clinically advanced prostate cancer (PC). Abstract #5534. Poster #115.]

Complex Biomarkers as Predictor of Immunotherapy Response

In an analysis of the Phase III IMvigor130 study, researchers explored the potential predictive role of TMB, PD-L1 expression and T-effector gene expression biomarkers in patients with metastatic urothelial cancer. The results reinforce the potential predictive nature of biomarkers associated with response or resistance to atezolizumab monotherapy or atezolizumab in combination with platinum-based chemotherapy.

[Tumor, immune, and stromal characteristics associated with clinical outcomes with atezolizumab (atezo) + platinum-based chemotherapy (PBC) or atezo monotherapy (mono) versus PBC in metastatic urothelial cancer (mUC) from the phase III IMvigor130 study. Abstract #5011.]

The following is a list of select abstracts that will be presented at the meeting. To access all abstracts being presented by Foundation Medicine and its collaborators, please visit: meetinglibrary.asco.org.

Abstract #

Title

Collaborator

Clinical Science Symposia

9511

Characterization of 1,387 NSCLCs with MET exon 14 (METex14) skipping alterations (SA) and potential acquired resistance (AR) mechanisms

Dana Farber Cancer Institute

5011

Tumor, immune, and stromal characteristics associated with clinical outcomes with atezolizumab (atezo) + platinum-based chemotherapy (PBC) or atezo monotherapy (mono) versus PBC in metastatic urothelial cancer (mUC) from the phase III IMvigor130 study

Poster Discussion

3517

Pan-tumor analyses of kinase fusions detected in circulating tumor DNA (ctDNA) and concordance with paired tissue

Poster Presentations

1050

Patient-matched tissue and liquid biopsies identify shared and acquired genomic alterations in breast cancer

5534

Contrasting genomic profiles in post-systemic treatment metastatic sites (MET), pretreatment primary tumors (PT), and liquid biopsies (LB) of clinically advanced prostate cancer (PC)

TPS2087

A multi-stakeholder platform to prospectively link longitudinal, real-world clinico-genomic, imaging and outcomes data for patients with metastatic lung cancer

Flatiron Health

3060

Characteristics and outcomes of real-world (RW) patients (pts) with microsatellite instability-high (MSI-H) solid tumors treated with pembrolizumab monotherapy (P) after FDA approval

Flatiron Health

9591

Real-world (RW) outcomes for non-small cell lung cancer (NSCLC) patients (pts) with EGFR exon 19 deletions (x19del) stratified by deletion size

Flatiron Health

3622

Increased tumor purity and improved biomarker detection using precision needle punch enrichment of specimen paraffin blocks: method validation and implementation in a prospective clinical trial

3620

Pan-cancer analysis of FGFR1-3 genomic alterations to reveal a complex molecular landscape

5527

Association of BRCA alteration (alt) type with real-world (RW) outcomes to PARP inhibitors (PARPi) in patients (pts) with metastatic castrate resistant prostate cancer (mCRPC)

On May 14, 2020 BioLife Solutions, Inc. (NASDAQ: BLFS) ("BioLife" or the "Company"), a leading developer and supplier of a portfolio of class-defining bioproduction tools for cell and gene therapies, reported financial results for the three months ended March 31, 2020 (Press release, BioLife Solutions, MAY 14, 2020, View Source [SID1234558088]).

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Total revenue for the first quarter of 2020 was $12.2 million, a 111% increase over the first quarter of 2019 and a 47% increase over the fourth quarter of 2019. Revenue growth was driven by significantly higher revenue from biopreservation media, which increased 50% year-over-year and 67% sequentially, and accounted for approximately 71% of total revenue. Sales of BioLife’s ThawSTAR, evo and Custom Biogenic Systems (CBS) freezer products accounted for the balance of revenue and were in line with management’s expectations.

The Company also announced an agreement for a strategic capital investment by Casdin Capital for the purchase of $20 million of primary common shares at $10.50 per share. Casdin also intends to purchase an additional $5 million of secondary common shares from an existing investor on the same terms.

Mike Rice, BioLife’s CEO, remarked, "On the heels of significantly increased demand for our products from existing customers, 40 new customers, and 13 new US FDA Master File requests, we believe it is the right time to accelerate our ongoing growth strategy. We are fortunate to have a growth equity partner in Casdin Capital that enabled us to strengthen our balance sheet to aggressively grow our portfolio of high value tools and services targeting the cell and gene therapy market. Through a combination of internal innovation, and acquisitions, co-investments and licensing of external assets, BioLife is on target to expand its business substantially over the next few years."

"Casdin Capital continues to demonstrate confidence in management and our business plan. Casdin has been a key shareholder and partner in identifying and co-investing in acquisition targets that support our strategy to further consolidate the bioproduction tools space," he added.

Key Accomplishments in the First Quarter of 2020

Biopreservation media revenue increased 50% from Q1 2019 and increased 67% from Q4 2019, as numerous customers placed replenishment and safety stock orders to ensure their clinical development programs could continue unabated during the COVID-19 pandemic.
Gained 40 new customers including 16 using biopreservation media, 6 using ThawSTAR products, 10 using evo cold chain management solutions and 8 that placed initial orders for CBS freezers and related accessories.
Processed 13 new U.S. FDA Drug Master File cross-reference requests, indicating the planned use of CryoStor or HypoThermosol in human clinical trials of new cell or gene therapies.
Granted three new patents for BioLife’s cold chain technologies. The Company’s intellectual property estate now includes 50 issued and 34 pending patents.
Financial Highlights for the First Quarter 2020

REVENUE

Total revenue of $12.2 million
Biopreservation media revenue of $8.7 million
Automated thawing product revenue of $394,000
evo cold chain management rental revenue of $438,000
CBS freezer and related accessories revenue of $2.7 million
GROSS MARGIN

Gross margin (GAAP) for the first quarter of 2020 was 57.8% compared with 71.5% for the first quarter of 2019. Adjusted gross margin (non-GAAP) for the first quarter of 2020 was 64.1% compared with 71.5% for the first quarter of 2019.
OPERATING EXPENSE

Operating expense (GAAP) for the first quarter of 2020 was $11.8 million compared with $5.2 million in the first quarter of 2019. Adjusted operating expense (non-GAAP) for the first quarter of 2020 was $6.4 million compared with $3.3 million in the first quarter of 2019.
OPERATING PROFIT

Operating profit (GAAP) for the first quarter of 2020 was $370,000 compared with $566,000 for the first quarter of 2019. Adjusted operating profit (non-GAAP) was $1.4 million for the first quarter of 2020 compared with $774,000 for the first quarter of 2019.
NET INCOME/(LOSS)

Net income (GAAP) for the first quarter of 2020 was $22.3 million compared with a net loss of $19.2 million for the first quarter of 2019. Net income (GAAP) for the first quarter of 2020 included other income of $21.9 million related to the change in fair value of outstanding warrants, and the net loss for the first quarter of 2019 included other expense of $19.7 million related to the change in fair value of outstanding warrants. Adjusted net income (non-GAAP) was $1.4 million for the first quarter of 2020 compared with $942,000 for the first quarter of 2019.
EARNINGS/(LOSS) PER SHARE

Earnings per basic share (GAAP) for the first quarter of 2020 were $0.87 compared with a loss per basic share of $1.03 for the first quarter of 2019. Adjusted fully diluted EPS (non-GAAP) for the first quarter of 2020 was $0.06 compared with $0.04 for the first quarter of 2019 on a fully diluted basis.
ADJUSTED EBITDA

Adjusted EBITDA, a non-GAAP financial measure for the first quarter of 2020 was $2.9 million compared with $1.4 million for the first quarter of 2019.
Roderick de Greef, BioLife Chief Financial Officer and Chief Operating Officer, remarked, "Based on higher-than-expected revenue, our Q1 results demonstrate the operating leverage we can realize, as evidenced by achieving adjusted EBITDA of $2.9 million or 24% of total revenue."

Withdrawal of 2020 Financial Guidance

Due to uncertainty regarding the impact of COVID-19 on BioLife and its customers, on May 1, 2020 the Company withdrew its financial guidance for 2020.

Investment by Casdin Capital

The Company executed a securities purchase agreement with existing shareholder Casdin Capital, a New York based life science focused investment firm with approximately $1 billion in assets under management. The agreement specifies the purchase of $20 million of BioLife Solutions common shares at $10.50 per share. The transaction was negotiated over the last several weeks, and the 30-day volume weighted average price was $11.32 as of market close yesterday. Casdin also intends to purchase an additional $5 million of BioLife Solutions common shares from a long-term shareholder at the same terms.

Conference Call & Webcast

The Company will discuss first quarter 2020 financial results today after market close on a conference call and live webcast at 4:30 p.m. ET (1:30 p.m. PT). Management will provide an overview of the Company’s financial results and a general business update.

To access the webcast, log onto the Investor Relations page of the BioLife Solutions website at View Sourceearnings." target="_blank" title="View Sourceearnings." rel="nofollow">View Source Alternatively, you may access the live conference call by dialing (844) 825-0512 (U.S. & Canada) or (315) 625-6880 (International) with the following Conference ID: 2085346. A webcast replay will be available approximately two hours after the call and will be archived on View Source for 90 days.