On March 26, 2020 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology company developing next-generation antisense oligonucleotide (ASO) therapies using its scalable PATrOL platform to address genetic diseases, reported its financial results for the three month period ended December 31, 2019 (Press release, Ohr Pharmaceutical, MAR 26, 2020, View Source [SID1234555869]).

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"We continue to advance the development of our neurological and neuromuscular programs, which have not been significantly impacted by the COVID-19 pandemic. Next week, we plan to announce the results from a pharmacokinetic study in non-human primates, as well as pharmacodynamic data in patient-derived cell lines. We also expect to receive additional data from in vivo mouse pharmacokinetic studies later in the second calendar quarter of 2020 and present those results in a peer-reviewed publication or at a scientific conference in the second half of the calendar year," said Dietrich A. Stephan, Ph.D., chief executive officer of NeuBase.

"Recent FDA approvals in the RNA therapeutics industry continue to confirm the broad utility of the gene silencing approach, with neutral backbone ASOs now representing a significant portion of approved RNA-based drugs. We believe that the differentiated features of our PATrOL platform bodes well for our participation in the industry as we help fulfill the promise of scalable drug development using genetic sequence-based drugs. As previously announced, we plan to initially focus on Huntington’s disease and myotonic dystrophy to address the critical unmet needs of the patients impacted by these diseases, and then expand our development pipeline into other high value disease targets and cancer," concluded Dr. Stephan.

First Fiscal Quarter of 2020 and Recent Operating Highlights

·U.S. Patent and Trademark Office issued NeuBase a foundational patent covering proprietary DNA and RNA binding technology, which enables PATrOL-based therapies to target the secondary structures of DNA and RNA
·Cancer biologist and RNA therapeutics pioneer, Steven Dowdy, Ph.D., appointed to the NeuBase Scientific Advisory Board

Financial Results for the Fiscal Quarter Ended December 31, 2019:

·For the three month period ended December 31, 2019, the Company reported a net loss of approximately $4.5 million, or a net loss of $0.26 per share, compared with a net loss of approximately $1.5 million, or a net loss of $0.25 per share, for the same period last year.
·For the three month period ended December 31, 2019, total operating expenses were approximately $3.8 million, consisting of approximately $2.6 million in general and administrative expenses and $1.2 million of research and development expenses. This compares with total operating expenses of $1.5 million for the same period last year, which was comprised of approximately $0.4 million in general and administrative expenses and $1.1 million in research and development and research and development-licenses acquired expenses.
·At December 31, 2019, the Company had cash and cash equivalents of approximately $7.7 million, compared with cash and cash equivalents of approximately $10.3 million at September 30, 2019. The Company believes that its current cash balance will provide sufficient capital to fund operations through the end of fiscal year 2020.

On March 26, 2020 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the fourth quarter and year ended December 31, 2019 (Press release, Celldex Therapeutics, MAR 26, 2020, View Source [SID1234555867]).

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"We are pleased that Celldex entered 2020 with significant momentum, following exciting data in late 2019 from the CDX-1140 program that suggest this candidate is a best in class CD40 agonist," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "We are actively recruiting patients across multiple expansion cohorts to further explore potential indications and new combination approaches. We also continue to advance the Phase 2 program of our ErbB3 inhibitor, CDX-3379, exploring a potential biomarker strategy in head and neck squamous cell carcinoma."

"Last month, we completed dosing in the Phase 1 healthy volunteer study of our KIT inhibitor, CDX-0159, which we intend to study in mast cell driven disorders. In addition to demonstrating a favorable safety profile, if CDX-0159 is able to decrease tryptase levels in healthy volunteers, a surrogate for systemic mast cell load, we believe this drug candidate could have significant potential in mast cell driven diseases. Based on the promising results observed to date, we have expanded development of CDX-0159 and are planning to initiate studies in chronic urticaria. We are also preparing to advance CDX-527, the first candidate from our bispecific platform, into the clinic."

"In closing, our mission at Celldex is focused on combatting devastating diseases. With the COVID-19 pandemic unfolding around the world, we have embraced the importance of public health guidelines while implementing operational plans aimed at minimizing disruptions to our core programs and protecting the health of our staff and the communities around us. We have observed that many medical and scientific conferences have canceled, delayed or made modifications to their format. We are following this closely and we may elect to report data outside of these settings if necessary. As always, we look forward to reporting on our progress, including updates across our clinical programs over the course of the year."

Recent Pipeline Highlights:

CDX-1140—a potent CD40 agonist that Celldex believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile.

In the Phase 1 dose-escalation study of CDX-1140 in patients with recurrent, locally advanced or metastatic solid tumors and B cell lymphomas both the monotherapy and combination with CDX-301 dose escalation portions of the trial are complete with an identified maximum tolerated dose (MTD) and recommended Phase 2 dose of CDX-1140 at 1.5 mg/kg—one of the highest systemic dose levels in the CD40 agonist class. Expansion cohorts are actively recruiting including:

— CDX-1140 with KEYTRUDA (pembrolizumab) in patients who have progressed on checkpoint therapy; and,

— CDX-1140 with CDX-301 in patients with head and neck squamous cell carcinoma (HNSCC).

In addition, a combination of CDX-1140 with chemotherapy in first line metastatic pancreatic cancer is planned.

Interim data from the dose escalation portion of the Phase 1 study were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting in November 2019. CDX-1140 achieved one of the highest systemic dose levels (1.5 mg/kg) in the CD40 agonist class. Clinical activity in both the monotherapy arm and the combination arm with CDX-301 was observed, including tumor necrosis in two patients with head and neck cancer, a RECIST partial response in gastroesophageal cancer and stable disease. CDX-1140 was associated with manageable immune-related adverse events.
CDX-3379—a differentiated human monoclonal antibody designed to block the activity of ErbB3 (HER3). ErbB3 is expressed in many cancers, including HNSCC and is believed to be an important receptor regulating cancer cell growth and survival as well as resistance to targeted therapies.

Enrollment continues in the Phase 2 study of CDX-3379 in advanced HNSCC in combination with Erbitux (cetuximab) in Erbitux-resistant patients who have been previously treated with or are ineligible for checkpoint therapy.

Data presented at the 2019 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2019 suggested that observed antitumor activity with CDX-3379 might be associated with somatic mutations in the FAT1 and NOTCH1, NOTCH2 or NOTCH3 (NOTCH1-3) genes—genes associated with tumor suppression. Based on these biomarker observations and the clinical activity observed in the ongoing Phase 2 study, the study was expanded (n= ~45 patients, including at least 15 patients with FAT1 mutations) to allow for an evaluation of the utility of biomarkers for patient selection.
CDX-0159—a monoclonal antibody that specifically binds the KIT receptor and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells. In certain inflammatory diseases, such as chronic urticarias, mast cell degranulation plays a central role in the onset and progression of the disease.

Dosing was recently completed in the ongoing Phase 1 single ascending dose escalation study of CDX-0159 in healthy subjects. This study is designed to evaluate the safety profile, pharmacokinetics and pharmacodynamics of CDX-0159 and to select a dose for further study in mast cell driven diseases. The Phase 1 study also evaluates plasma tryptase levels in healthy subjects. Tryptase is an enzyme synthesized and secreted by mast cells and decreases in plasma tryptase levels reflect a systemic reduction in mast cell burden, even in healthy volunteers. If CDX-0159 is able to decrease systemic mast cell load in healthy volunteers, Celldex believes the drug candidate could have significant potential in mast cell driven diseases. Based on promising results observed to date, Celldex has expanded development of CDX-0159.

— The Company intends to further study CDX-0159 in chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CINDU), both mast cell-related diseases, and plans to initiate studies by year end. CSU presents as itchy hives, angioedema or both for at least six weeks without a specific trigger; multiple episodes can play out over years or even decades. About 50% of patients with CSU achieve symptomatic control with antihistamines or leukotriene receptor antagonists. Omalizumab, an IgE inhibitor, provides relief for roughly half of the remaining antihistamine/leukotriene refractory patients. Consequently, there is a need for more effective later line therapies. CINDUs are forms of urticaria that have an attributable cause or trigger associated with them, typically resulting in hives or wheals. Celldex is exploring cold-induced and dermographism-induced (scratching the skin) urticarias.

— A review of the CDX-0159 early development program was presented at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting in November 2019 in the Distinguished Industry Oral Abstract Session.
Celldex continues to advance a robust preclinical portfolio and data from the Company’s CDX-527 bispecific candidate were presented in November at SITC (Free SITC Whitepaper) 2019. CDX-527 uses Celldex’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway. The data presented at SITC (Free SITC Whitepaper) demonstrate that CDX-527 is more potent at T cell activation and anti-tumor immunity than the combination of parental monoclonal antibodies. Celldex plans to initiate a Phase 1 study in the second half of 2020.

Fourth Quarter and Twelve Months 2019 Financial Highlights and 2020 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2019 were $64.4 million compared to $72.9 million as of September 30, 2019. The decrease was primarily driven by fourth quarter cash used in operating activities of $11.0 million, partially offset by $2.4 million in net proceeds from sales of common stock under the Cantor agreement. At December 31, 2019, Celldex had 17.0 million shares outstanding.

Revenues: Total revenue was $0.9 million in the fourth quarter of 2019 and $3.6 million for the year ended December 31, 2019, compared to $1.8 million and $9.5 million for the comparable periods in 2018. The decrease in revenue was primarily due to lower revenue from the collaboration agreement with Bristol-Myers Squibb Company and the contract manufacturing and research and development agreements with the International AIDS Vaccine Initiative and Rockefeller University.

R&D Expenses: Research and development (R&D) expenses were $10.3 million in the fourth quarter of 2019 and $42.7 million for the year ended December 31, 2019, compared to $11.2 million and $66.4 million for the comparable periods in 2018. The decrease in R&D expenses was primarily due to lower clinical trial, personnel and contract manufacturing costs.

G&A Expenses: General and administrative (G&A) expenses were $3.2 million in the fourth quarter of 2019 and $15.4 million for the year ended December 31, 2019, compared to $4.3 million and $19.3 million for the comparable periods in 2018. The decrease in G&A expenses was primarily due to lower personnel and commercial planning costs and lower lease restructuring expense.

Intangible Asset and Goodwill Impairments: During the first quarter of 2018, the Company recorded $18.7 million in non-cash impairment charges related to fully impaired glembatumumab vedotin-related intangible assets and $91.0 million in goodwill impairment charges as the carrying value of the Company’s net assets exceeded the Company’s fair value by an amount in excess of the goodwill asset.

Changes in Fair Value Remeasurement of Contingent Consideration: During the year ended December 31, 2019, the Company recorded a $1.3 million gain on the fair value remeasurement of contingent consideration primarily due to changes in discount rates, the passage of time and updated assumptions for the varlilumab program.

Net Loss: Net loss was $10.4 million, or ($0.64) per share, for the fourth quarter of 2019 and $50.9 million, or ($3.51) per share, for the year ended December 31, 2019, compared to a net loss of $9.4 million, or ($0.81) per share, and $151.2 million, or ($14.48) per share, for the comparable periods in 2018.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2019 are sufficient to meet estimated working capital requirements and fund planned operations into the first quarter of 2021. This guidance excludes anticipated proceeds from future sales of common stock under the Cantor agreement or other potential fundraising.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA. Erbitux is a registered trademark of Eli Lilly & Co.

On March 26, 2020 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, reported financial results for the fourth quarter and year ended December 31, 2019 (Press release, Apollo Endosurgery, MAR 26, 2020, View Source [SID1234555866]). The Company will hold a conference call today at 3:30 p.m. CT / 4:30 p.m. ET to discuss its results.

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Highlights
•Fourth quarter U.S. OverStitch Endoscopic Suturing System ("ESS") sales increased 33% to $4.4 million
•Fourth quarter U.S. Endoscopy sales increased 31% to $5.6 million
•Worldwide ESS sales for the full year 2019 increased 21% (23% in constant currency) to $28.3 million, representing 63% of our Endoscopy sales
•Fourth quarter Orbera Intragastric Balloon System ("IGB") sales increased 23% in the U.S. and 11% (13% in constant currency) worldwide
Todd Newton, CEO of Apollo, said, "The Endoscopic Suturing market developed rapidly in 2019 as evidenced by Apollo’s 36% revenue growth for ESS products in the U.S. and 21% growth worldwide. Clinical publications providing evidence of the many applications for our ESS technology continued to expand during 2019, and Apollo’s new single channel OverStitch device introduced in November 2018 is taking our technology to a broader group of physicians and locations. Our strategy in the near term is to withstand the unprecedented challenges presented by the COVID-19 pandemic, and then return our focus as swiftly as possible to increasing the user base of our technology and to improve our operating efficiency as we continue to scale the business."
Due to unprecedented global economic conditions and uncertainty resulting from the COVID-19 pandemic, the Company will not be providing an outlook for 2020 at this time. We are closely monitoring the global impact to the health systems where we conduct business and the slowdown in business activity related to COVID-19, and hope to provide better clarity about our outlook for 2020 on our first quarter results call. In response to the rapidly changing conditions resulting from the COVID-19 pandemic, we have taken steps to limit business activities, to limit spending and maintain only key business functions in order to continue to fulfill product orders and support our customers while also taking proactive measures to protect the health and safety of our employees and their families consistent with local guidelines.
U.S. ESS product sales increased 33% to $4.4 million in the fourth quarter of 2019 and 36% to $14.9 million in the full year of 2019. Outside the U.S. ("OUS") ESS product sales decreased 15% (13% in constant currency) to $3.0 million for the fourth quarter of 2019 due primarily to the timing of distributor orders, while increasing 8% (13% in constant currency) to $13.4 million in the full year of 2019. Worldwide, ESS product sales increased 8% (9% in constant currency) and 21% (23% in constant currency) for the fourth quarter and full year of 2019, respectively.
U.S. IGB sales increased 23% to $1.2 million for the fourth quarter of 2019 and decreased 4% to $5.2 million for the full year of 2019. OUS IGB product sales increased 7% (9% in constant currency) to $3.1 million and decreased 5% (2% in constant currency) to $11.7 million for the fourth quarter and full year of 2019, respectively. Our efforts to expand IGB therapy in the U.S. market and advance twelve-month therapy OUS improved in the fourth quarter leading to reported growth in both regions and lifting our full year results close to break even with the prior year. Worldwide, IGB sales increased 11% (13% in constant currency) and decreased 5% (3% in constant currency) for the fourth quarter and full year of 2019, respectively.
Worldwide Endoscopy product sales increased 9% (10% in constant currency) and 10% (12% in constant currency) for the fourth quarter and full year of 2019, respectively. ESS product sales represented 64% and 63% of total Endoscopy sales for the fourth quarter and full year of 2019, respectively. In the U.S., Endoscopy sales increased 31% to $5.6 million and 22% to $20.1 million for the fourth quarter and full year of 2019, respectively.
The divestiture of our Surgical products in December of 2018 reduced total revenues by $4.1 million and $13.7 million for the fourth quarter and full year of 2019, respectively. We divested the Surgical products line in order to strengthen Apollo’s focus on our Endoscopy products, which we believe have high growth potential.
Gross margin for the fourth quarter of 2019 was 49%, compared to 47% for the fourth quarter of 2018. Gross margin for the full year of 2019 decreased to 51% compared to 55% for the full year of 2018 as a result of a greater proportion of our overall product sales coming from our ESS products, which realize a lower gross margin than our other products. Management has previously discussed its ongoing gross margin improvement initiative.

Total operating expenses decreased $11.2 million to $12.7 million for the fourth quarter of 2019 and decreased $24.1 million to $49.2 million for the full year of 2019 compared to the same periods of 2018. Excluding the one-time $7.8 million loss on divestiture of our Surgical products in December of 2018, the subsequent reduction in intangible asset amortization expense of $1.2 million and $5.0 million for the fourth quarter and full year of 2019, respectively resulting from this divestiture and a one-time $5.6 million settlement gain reported in the first quarter of 2019, total operating expenses decreased $2.3 million and $5.7 million for the fourth quarter and full year of 2019, respectively. This reduction in recurring operating expenses was the result of lower U.S. direct to consumer advertising and lower clinical trial costs as enrollment or other milestones were reached on the clinical studies that the Company is funding.
Net loss for the fourth quarter of 2019 was $7.2 million compared to $18.4 million for the fourth quarter 2018. For the full year, net loss was $27.4 million in 2019 compared to $45.8 million in 2018.
Cash, cash equivalents and restricted cash were $30.9 million as of December 31, 2019.
Conference Call
Apollo will host a conference call on March 26, 2020 at 3:30 p.m. Central Time / 4:30 p.m. Eastern Time to discuss Apollo’s operating results for the fourth quarter and year ended December 31, 2019.
To participate in the conference call dial 844-369-8770 for domestic callers and +1-862-298-0840 for international callers. A live webcast of the conference call will be made available on the "Events and Presentations" section of our Investor Relations website: ir.apolloendo.com.
A replay of the webcast will remain available on Apollo’s website, www.apolloendo.com, following the call.
Non-GAAP Financial Measures
To supplement our financial results, we are providing a non-GAAP financial measure, percentage revenue change in constant currency, which removes the impact of changes in foreign currency exchange rates that affect the comparability and trend of revenues compared to the same period of the prior year. Percentage revenue change in constant currency is calculated by translating current foreign currency sales at last year’s exchange rate. This supplemental measure of our performance is not required by, and is not determined in accordance with GAAP.
We believe the non-GAAP financial measure included herein is helpful in understanding our current financial performance. We use this supplemental non-GAAP financial measure internally to understand, manage and evaluate our business, and make operating decisions. We believe that making non-GAAP financial information available to investors, in addition to GAAP financial information, may facilitate more consistent comparisons between the company’s performance over time with the performance of other companies in the medical device industry, which may use similar financial measures to supplement their GAAP financial information. However, our non-GAAP financial measure is not meant to be considered in isolation or as a substitute for the comparable GAAP metric.

On March 26, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported its financial results for the fourth quarter and full year ended December 31, 2019 and provided an update on recent developments (Press release, IGM Biosciences, MAR 26, 2020, View Source [SID1234555865]).

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"2019 was a transformational year for IGM. The many highlights of the year included our successful initial public offering and the initiation of our first-in-human trial for our lead product candidate, IGM-2323, a CD20 x CD3 bispecific IgM antibody, in patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL)," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We expect continued progress in 2020, with the filing of an Investigational New Drug application (IND) with the Food and Drug Administration (FDA) for our second product candidate, IGM-8444 and the presentation of initial data from our clinical trial of IGM-2323. With thanks to the IGM team, we believe we are well positioned to remain the global leader in the research and development of engineered therapeutic IgM antibodies."

Recent Highlights and Pipeline Updates

IGM-2323 – Phase 1 trial initiated: In October 2019, IGM announced dosing of the first patient in its Phase 1 clinical trial evaluating IGM-2323 in patients with relapsed/refractory B cell NHL. This Phase 1 clinical trial represents the first-in-human application of IGM Biosciences’ engineered IgM antibody technology. IGM expects to report initial data from this Phase 1 trial in the second half of 2020.

IGM-8444 – IND filing planned: IGM expects to file an IND application with the FDA for IGM-8444 in 2020, initially for the treatment of patients with solid tumors. IGM-8444 is an IgM antibody targeting the Death Receptor 5 (DR5) protein, which is broadly expressed on a broad range of solid and hematologic malignancies.

IGM-7354 – Next candidate announced: IGM nominated IGM-7354 as its third clinical candidate. IGM-7354 is a targeted IL-15 immune stimulating antibody which demonstrates another use of IGM’s novel J chain based bispecific technology. In this case, the immune stimulating IL-15 is displayed on the J chain of an anti-PD-L1 IgM antibody, which serves to display the immune stimulating IL-15 on the surface of PD-L1 positive cells, such as cancer cells. IGM expects to file an IND with the FDA for IGM-7354 in 2021.

Fourth Quarter and Full Year 2019 Financial Results

Cash and Investments: Cash and investments as of December 31, 2019 were $236.6 million.

Research and Development (R&D) Expenses: For the fourth quarter and year ended 2019, R&D expenses were $12.8 million and $35.3 million, respectively.
General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2019, G&A expenses were $3.2 million and $9.2 million, respectively.
Net Loss: For the fourth quarter of 2019, net loss was $14.8 million, or a loss of $0.49 per share. For the year ended 2019, net loss was $43.1 million, or a loss of $4.80 per share.
Shares Outstanding: Weighted-average shares outstanding for the fourth quarter of 2019 were 30.5 million and for the full year of 2019 were 9.0 million shares.
2020 Financial Guidance

IGM estimates non-GAAP operating expenses for 2020 of approximately $75 – $85 million, excluding estimated non-cash stock-based compensation expense of approximately $8 million. Including non-cash stock-based compensation expense, IGM estimates GAAP operating expenses for 2020 of $83 – $93 million. IGM also expects to end 2020 with a balance of over $140 million in cash and investments.

Conference Call and Webcast

IGM will host a conference call and webcast to discuss this announcement today, March 26, at 4:30 p.m. ET. To access the live call by phone please dial (866) 649-1996 (domestic) or (409) 217-8769 (international); the conference ID is 2991398. A live audio webcast of the event may also be accessed through the "Investors" section of IGM’s website at www.igmbio.com. A replay of the webcast will be available for 30 days following the event through 11:59p.m. ET on April 25, 2020.

On March 26, 2020 IntegraGen (Paris:ALINT), a company specializing in the transformation of data from biological samples into genomic information and diagnostic tools for oncology, reported Dana-Farber Cancer Institute will utilize the company’s MERCURY cloud-based software as part of their analysis and reporting process for sequencing data obtained from tumors of cancer patients (Press release, Integragen, MAR 26, 2020, View Source [SID1234555864]). Dana-Farber plans to utilize MERCURY to assist in the analysis of sequencing data obtained from small and large targeted gene sequencing panels as well as data derived from whole exome and genome sequencing.

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"Genomic profiling of tumors can assist in the identification of pathogenic molecular alterations which drive a patient’s cancer and enable the implementation of precision medicine-based approaches to treatment," stated Annette S. Kim M.D., Ph.D., Co-Director of the Dana-Farber Cancer Institute’s new Interpretive Genomics Program within the Department of Oncologic Pathology. The program is Co-Directed by Keith L. Ligon, MD PhD, Director of the Dana-Farber Center for Patient Derived Models. "MERCURY provides us with a tool to rapidly interpret large scale and complex genomic sequencing data with the added ability of customization to meet our specific analysis and reporting needs to support clinical research and clinical trials."

"IntegraGen is excited about Dana-Faber’s decision to utilize MERCURY and look forward to interacting with another world leader in cancer care related to the utilization of our cloud-based bioinformatic tools," said Larry Yost, General Manager of IntegraGen, Inc. "We are convinced that the use of MERCURY will aid in the better understanding of the etiology of a patient’s cancer and assist with the realization of the benefits of precision medicine by transforming large-scale sequencing data into actionable results. We are also looking forward to continuing the development and expansion of our genomic interpretation software tools in North America."

MERCURY is a user-friendly genomic interpretation tool for oncology designed to assist pathologists and oncologists to rapidly transform raw data obtained via high-throughput sequencing into a clinical molecular report for clinical and research use. The cloud-based tool minimizes the complexity, time and cost associated with the clinical interpretation and identification of variants that may be of interest in the therapeutic management of patients. MERCURY utilizes the Google Cloud technology to ensure a secure environment for data analysis and storage which is compliant with the latest information security requirements.