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T2 Biosystems T2SARS-CoV-2™ Panel Proves Effective Amid Global Rise in Variants of the SARS-CoV-2 Virus
BY GlobeNewswire
— 6:19 PM ET 01/11/2021
Panel can detect multiple variants of the SARS-CoV-2 virus, including those most recently identified in the United Kingdom, South Africa, and the U.S.
LEXINGTON, Mass., Jan. 11, 2021 (GLOBE NEWSWIRE) -- T2 Biosystems ( TTOO
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), Inc. , a leader in the rapid detection of sepsis-causing pathogens, today announced that its T2SARS-CoV-2™ Panel—a molecular diagnostic test that detects SARS-CoV-2, the virus responsible for COVID-19 infections—is capable of detecting the multiple variants of the SARS-CoV-2 virus most recently identified in the United Kingdom, South Africa, and the United States.
“As new strains of the COVID-19 virus emerge, it is critical that we ensure our technology continues to be an effective diagnostic solution during the ongoing pandemic,” said T2 Biosystems’ President and CEO, John Sperzel. “I’m proud that we can confidently say, after extensive analysis, that our T2SARS-CoV-2 Panel, which has demonstrated clinical sensitivity of 95 percent and specificity of 100 percent, can continue to help impact lives by detecting multiple variants of the SARS-CoV-2 virus.”
Both the variants identified in the United Kingdom (B.1.1.7) and South Africa (B.1.351) contain multiple mutations, most reflected in the S gene, which encodes the spike protein. To confirm that the T2SARS-CoV-2 Panel would detect these variants and other potential mutations of SARS-CoV-2 viruses, an in silico analysis was performed using genome sequences available in the National Center for Biotechnology Information (NCBI) nucleotide database and GISAID database.
Over 42,000 genome sequences for SARS-CoV-2 were evaluated for alignment with primer and probe sequences from T2SARS-CoV-2 Panel. This analysis demonstrated that the T2SARS-CoV-2 Panel should detect 99.99% of all SARS-CoV-2 viruses based on sequence alignments. A specific analysis of sequences for B.1.1.7 and B.1.351 variants confirmed that the T2SARS-CoV-2 Panel should be able to detect these variants.
The T2SARS-CoV-2 Panel provides results in under two hours utilizing an upper respiratory swab sample. The test runs on the Company’s FDA-cleared and fully-automated T2Dx® Instrument, which is capable of performing seven tests simultaneously and up to sixty samples per day.
The same T2Dx Instrument is also capable of running the FDA-cleared T2Bacteria® Panel and T2Candida® Panel. These panels are the only FDA-cleared assays for the detection of sepsis-causing bacterial and fungal pathogens directly from whole blood in three to five hours, without the need to wait days for blood culture results. By providing quicker results, the panels enable clinicians to target therapy faster for their patients suspected of sepsis, often before the second dose of antimicrobial medicine is administered, leading to better patient outcomes, improved antimicrobial stewardship, and reductions in length of stay in the hospital.
These additional panels remain especially clinically relevant during the pandemic, as data suggests that the COVID-19 virus can lead to sepsis, and death.
PLYMOUTH MEETING, Pa. and SUZHOU, China, Jan. 4, 2021 /PRNewswire/ – INOVIO (NASDAQ: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, and Advaccine Biopharmaceuticals Suzhou Co., Ltd. (“Advaccine”), an emerging biotech company with next-generation technology in vaccines, both preventive and therapeutic, today announced that they have entered into a collaboration and license agreement for COVID-19 DNA vaccine candidate INO-4800.
Under the collaboration and license agreement, Advaccine will have the exclusive right to develop, manufacture and commercialize INO-4800 within Greater China, inclusive of Mainland China, Hong Kong, Macao, and Taiwan. Advaccine will license its plasmid manufacturing process for use with INO-4800 and other INOVIO pipeline product candidates to INOVIO with the right to sublicense to INOVIO’s manufacturing partners. Additionally, Advaccine will provide its clinical data to INOVIO in support of INOVIO’s global INO-4800 regulatory filings and INOVIO will provide its INO-4800 clinical data for Advaccine to incorporate into its marketing applications in Greater China. Advaccine will make to INOVIO an upfront payment of $3.0 million as well as pay an aggregate of $108.0 million upon the achievement of specified development and sales-based milestones for INO-4800 in Greater China. INOVIO will be entitled to receive a royalty equal to a high single-digit percentage of annual net sales in each region within Greater China.
Dr. J. Joseph Kim, President and Chief Executive Officer of INOVIO, said, “INOVIO’s partnership with Advaccine enables us to leverage their deep expertise, capabilities and network across the region – making it possible to rapidly produce and if and when approved, distribute our vaccine candidate to more people across Greater China. This agreement also provides INOVIO with an Asian manufacturing partner with a near-term focus on INO-4800 and a long-term manufacturing resource potentially for other INOVIO products. We are grateful for Advaccine joining our global manufacturing coalition as a dedicated resource for Greater China and look forward to our continued partnership in the fight against COVID-19.”
Dr. Bin Wang, Founder and Chairman of Advaccine, said, “We are proud to build upon our current partnership with INOVIO and join their global manufacturing consortium. Advaccine will leverage its innovative large-scale DNA plasmid manufacturing process developed over years — our GMP manufacturing facility in Suzhou has the capacity to produce over one hundred million doses of DNA vaccine per year. Given the strong safety profile and robust immune responses observed in the U.S. and China clinical trials of INO-4800, we are confident in the vaccine candidate and are fully committed to the manufacturing of INO-4800 for Greater China. INO-4800 is projected to be stable at room temperature for over a year, at 37oC for more than a month, and with a five-year projected shelf life at normal refrigeration temperature. INO-4800 does not need to be frozen during transport or storage – a critical element when considering the feasibility of distribution in Greater China and globally.”
INOVIO and Advaccine have been working together to advance the clinical development of INO-4800 in China, having all 640 subjects dosed for the first vaccination in Phase 2 clinical trial in China. The Phase 2 clinical trial of INO-4800 in China has enrolled both adults who are 18-59 years old and older adults (60 years and older) with the primary endpoints of evaluating safety and immunogenicity within the Chinese population. The dosing regimen involves two vaccinations at 0 and 28 days with either 1.0 mg or 2.0 mg dosing levels, similar to the independently run Phase 2 segment of INOVIO’s Phase 2/3 clinical trial for INO-4800 in the U.S, called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy).
INOVIO also recently announced it has started dosing of subjects in the Phase 2 segment of INNOVATE. For more information about the INNOVATE clinical trial, see www.clinicaltrials.gov, identifier NCT04642638.
About the INO-4800 “INNOVATE” Phase 2/3 Clinical Trial
The lead Principal Investigator for INNOVATE is Dr. Pablo Tebas, Professor of Medicine at the Hospital of the University of Pennsylvania. The Phase 2 segment of the clinical trial is designed to evaluate safety, tolerability and immunogenicity of INO-4800 in a 2-dose regimen (1.0 mg or 2.0 mg), in a three-to-one randomization (in a planned total of 400 subjects) to receive either INO-4800 or placebo, to confirm the more appropriate dosing level for each of three age groups (18-50 years, 51-64 years and 65 years and older) for the subsequent Phase 3 efficacy evaluation. The company strives to ensure diversity in enrollment, targeting specific populations that are working or residing in environments with high risk of exposure to SARS-CoV-2, for whom exposure may be relatively prolonged or for whom personal protective equipment (PPE) may be inconsistently used, especially in confined settings.
The INNOVATE trial is funded by the U.S. Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in coordination with the Office of the Assistant Secretary of Defense for Health Affairs (OASD (HA)) and the Defense Health Agency (DHA). In the planned Phase 3 segment of the trial, INOVIO intends to enroll healthy men and non-pregnant women 18 years and older, to evaluate the efficacy of the proposed dosing level(s) for each age group based on the data from the Phase 2 evaluation. Participants will be enrolled in a one-to-one randomization to receive either INO-4800 or a placebo. The Phase 3 segment will be case-driven with the final number of enrollees to be determined by the incidence of COVID-19 during the Phase 3 segment. The primary endpoint of the Phase 3 segment will be virologically confirmed COVID-19 disease.
Happy New Year AMA!!! Hope 2021 is better on everybody. Been a rough year that’s for sure.....
Happy New Year BR!
Merry Christmas AMA
INO-4800 DNA Coronavirus Vaccine
Fact checked by Robert Carlson, MD
Fact checked by Danielle Reiter, RN
INO-4800 DNA Vaccine Description
INO-4800 is a DNA vaccine candidate matched to the novel coronavirus SARS-CoV-2, which causes the COVID-19 disease in humans.
INOVIO's INO-4800 is the only nucleic-acid based vaccine that is stable at room temperature for more than a year and does not require to be frozen in transport or for years of storage, which are important factors when implementing mass immunizations to battle the current pandemic, says INOVIO.
The INO-4800 vaccine contains the plasmid pGX9501, which encodes for the full length of the Spike glycoprotein of SARS-CoV-2.
Inovio's proprietary platform hand-held smart device called CELLECTRA® is leading the way forward for activation immunotherapy. CELLECTRA uses a brief electrical pulse to open small pores in the cell reversibly to allow the plasmids to enter.
This one-of-a-kind platform delivers optimized DNA into cells, where it is translated into proteins that activate an individual's immune system to generate a robust targeted T cell and antibody response.
Once inside the cell, the plasmids begin replicating, thereby strengthening the body's own natural response mechanisms.
The advantages of INOVIO's DNA medicine platform are how fast DNA medicines can be designed and manufactured, the stability of the products which do not require freezing in storage and transport, and the robust immune response, safety profile, and tolerability that have been demonstrated in clinical trials.
Inovio is aiming to significantly expand the therapeutic range of monoclonal antibodies with its DNA-encoded monoclonal antibody technology. With dMAb, Inovio encodes DNA to express a monoclonal antibody. Injection of the DNA plasmid into a patient generates robust in vivo monoclonal antibody production.
This approach has the potential to generate in vivo production of therapeutic antibodies. Inovio's DNA medicines are not interfering with or changing in any way an individual's own DNA.
DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body. INOVIO states 'DNA medicines do not interfere with or change in any way an individual's own DNA.'
Published in Nature Communications on May 20, 2020, a new report focuses on immune studies in animals, which show induction of functional antibody responses and T-cell responses following immunization. This preliminary dataset identifies INO-4800 as a potential COVID-19 vaccine candidate, supporting the further translational study.
In addition to positive interim Phase 1 data published on June 30, 2020, INO-4800 has been shown to protect mice in SARS-CoV-2 viral challenge studies, where vaccination with INO-4800 prevented viral replication in the lungs of animals challenged with SARS-CoV-2.
On July 29, 2020, bioRxiv published a non-peer-reviewed study that showed INO-4800 reduced viral load in both the lower lungs and nasal passages in macaques that received two doses of INO-4800 (1 mg) four weeks apart and then was challenged with the live virus 13-weeks after the second dose (study week 17).
"While the pathophysiologic profile of SARS-CoV-2 is not completely understood, research and clinical studies suggest that both T cell and antibody immune responses will be important for protection in both mild and serious infections."
"Leveraging our previous expertise in MERS with INO-4700, where we demonstrated significant antibody and cellular responses, the breadth, and profile of the responses observed to date with INO-4800 targeting SARS-CoV-2 provide a promising read towards further development and addressing the existing public health threat," said Dr. Kate Broderick, Senior Vice President of R&D at INOVIO.
On October 8, 2020, npj Vaccines published an article titled "Experimental and in silico evidence suggests vaccines are unlikely to be affected by D614G mutation in SARS-CoV-2 spike protein." Researchers at the Commonwealth Scientific and Industrial Research Organization (CSIRO), Australia's national science research agency, and INOVIO reported that INO-4800 vaccination in a preclinical model was able to neutralize SARS-CoV-2 viruses with 'D614G' mutation (Aspartate-to-Glycine change at position 614) of the spike protein, which has become the dominant variant in the global COVID-19 pandemic.
Furthermore, INO-4800 is currently being tested in a ferret challenge model as well as in NHP challenge studies as part of the US government's Operation Warp Speed.
INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to protect and treat people from infectious diseases. INOVIO's DNA medicines are transient, and do not interfere with or change in any way an individual's own DNA. The advantages of INOVIO's DNA medicine platform are how fast DNA medicines can be designed and manufactured; the stability of the products, which do not require freezing in storage and transport; and the consistent immune response, safety profile, and tolerability that have been observed in clinical trials with multiple products.
INO-4800 DNA Vaccine Indication
INO-4800 is a DNA vaccine candidate designed to prevent novel coronavirus SARS-CoV-2 from infecting humans, which causes COVID-19 disease.
No pediatric vaccine efficacy has been disclosed.
INO-4800 DNA Vaccine Dosage
Participants will receive one ID injection of 1.0 milligram (mg) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit. INO-4800 will be administered ID on Day 0 and Week #4. EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0 and Week #4.
INO-4800 is the only nucleic-acid-based vaccine that is stable at room temperature for more than a year and does not need to be frozen in the transport of storage, which is important factors when implementing mass immunizations, says the company.
INO-4800 DNA Vaccine Development News
November 9, 2020 - INOVIO confirmed it has responded to the US FDA to address the questions related to the partial clinical hold on INOVIO's Investigational New Drug Application for the Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800.
October 2, 2020 - Local media reported Inovio Pharmaceuticals has dropped its appeal of an injunction ruling in its dispute with a former contract manufacturer. "Inovio has decided to focus its efforts on winning the entire case at trial," said Jeff Richardson, a spokesman for the company.
September 28, 2020 - INOVIO announced that the U.S. FDA has notified the company it has additional questions about the company's planned Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800, including its CELLECTRA® 2000 delivery device to be used in the trial. Until the FDA's questions have been satisfactorily addressed, INOVIO's Investigational New Drug Application for the Phase 2/3 trial is on partial clinical hold. The company is actively working to address the FDA's questions and plans to respond in October, after which the FDA will have up to 30 days to notify INOVIO of its decision as to whether the trial may proceed.
September 8, 2020 - INOVIO announced that Thermo Fisher Scientific has signed a letter of intent to manufacture INOVIO's DNA COVID-19 vaccine candidate INO-4800. With its consortium of third-party manufacturers, INOVIO plans to have 100 million doses of INO-4800 manufactured in 2021, subject to FDA approval of INO-4800 for use as a COVID-19 vaccine. Thermo Fisher Scientific will join existing partners Richter-Helm BioLogics and Ology Biosciences in INOVIO's global manufacturing consortium.
July 30, 2020 - Published on the non-peer-reviewed online preprint site bioRxiv, INO-4800 reduced viral load in both the lower lungs and nasal passages in macaques that received two doses of INO-4800 (1 mg) four weeks apart and then were challenged with live virus 13 weeks after the second dose (study week 17). The reduced viral loads following exposure to SARS-CoV-2 infection at this timeframe demonstrate an important durable impact mediated by INO-4800. This is the first time vaccine protection in non-human primates was reported from memory immune responses as previously reported monkey vaccine challenge studies were conducted at the time near their peak immune responses (1-4 weeks from their last vaccination).
July 15, 2020 - Seoul National University Hospital said that it has administered the first dose of INO-4800, Inovio's Covid-19 vaccine, to a patient in his 40s.
July 10, 2020 - Inovio Pharmaceuticals Inc. could be embroiled in a prolonged legal battle with its Blue Bell, Pennsylvania-headquartered subcontractor VGXI, Inc after the subcontractor sued the company.
June 30, 2020 - INOVIO announced positive interim clinical data of its vaccine candidate against novel coronavirus (SARS-CoV-2), from the first two Phase 1 clinical trial cohorts. In addition, INO-4800 has been selected to participate in a non-human primate challenge study as part of the U.S. government's Operation Warp Speed. Furthermore, INOVIO has expanded its Phase 1 trial to add older participants in additional cohorts and plans to initiate a Phase 2/3 efficacy trial this summer upon regulatory concurrence.
June 23, 2020 - INOVIO announced it has received $71 million funding from the U.S. DoD to support the large-scale manufacture of the company's proprietary CELLECTRA® 3PSP smart device and the procurement of CELLECTRA® 2000 devices, which are used to deliver the INO-4800 vaccine candidate directly into the skin, where the vaccine prompts the body's immune system to drive a robust immune response.
June 4, 2020 - INOVIO and Seoul National University Hospital announced a partnership to start a Phase 1/2 clinical trial of INOVIO's COVID-19 vaccine INO-4800 in South Korea. The 2-stage trial of INO-4800, the first clinical study of the COVID-19 vaccine in Korea, will assess the safety, tolerability, and immunogenicity of the candidate vaccine in 40 healthy adults aged 19-50 years, and will further expand to enroll an additional 120 people aged 19-64 years.
June 3, 2020 - Inovio Pharmaceuticals, Inc. filed a complaint in the Court of Common Pleas of Montgomery County, Pennsylvania seeking, among other requests for emergency relief, to compel VGXI, Inc. and GeneOne Life Science, Inc. (together, “VGXI”) to facilitate the transfer of manufacturing methods, using VGXI’s technology, under the parties’ existing supply agreement (the “Supply Agreement”).
May 20, 2020 - The Wistar Institute announced a study reporting initial immunogenicity of a synthetic DNA vaccine for SARS-CoV-2 developed in collaboration with Inovio Pharmaceutical, Inc., and other scientists. Published in Nature Communications, the report focuses on immune studies in animals, which show induction of functional antibody responses and T-cell responses following immunization. This preliminary dataset identifies INO-4800 as a potential COVID-19 vaccine candidate, supporting the further translational study.
May 11, 2020 - INOVIO's President and Chief Executive Officer Dr. J. Joseph Kim said U.S. Phase 1 clinical trial for COVID-19 vaccine candidate INO-4800 completed enrollment with 40 healthy volunteers; preliminary results expected in late June 2020. The Phase 2/3 efficacy trial for INO-4800 'to start this summer upon regulatory approval.'
April 30, 2020 - INOVIO announced it has entered into an agreement to expand its manufacturing partnership with the German contract manufacturer Richter-Helm BioLogics GmbH & Co. KG, to support large-scale manufacturing of INOVIO's investigational DNA vaccine INO-4800, which currently is in Phase 1 clinical testing in the U.S. for COVID-19 and could potentially advance to Phase 2/3 efficacy trials this summer. The agreement is being partly funded by an initial grant of $1.3 million from the Coalition for Epidemic Preparedness Innovations (CEPI), which brings CEPI's total support to date for the development of INO-4800 to $17.2 million.
April 28, 2020 - INOVIO announced that its Phase 1 clinical trial for COVID-19 DNA vaccine INO-4800 is fully enrolled with all 40 healthy volunteers receiving their first dose, with interim immune responses and safety results expected in late June 2020. The 40 healthy volunteers now enrolled at sites at the University of Pennsylvania, and a clinic in Kansas City, MO, will receive 2-doses of INO-4800, four weeks apart. The Phase 1 study is designed to assess the safety profile and immunogenicity of INO-4800 in support of advancing rapidly to a Phase 2/3 efficacy trial, which is planned to potentially initiate this summer.
April 16, 2020 - The International Vaccine Institute (IVI) announced that the Coalition for Epidemic Preparedness Innovations has granted $6.9 million funding to INOVIO to work with IVI and the Korea National Institute of Health (KNIH) for a Phase 1/2 clinical trial of INOVIO's COVID-19 vaccine candidate (INO-4800) in South Korea. IVI will conduct the trial in parallel to INOVIO's Phase 1 INO-4800 study currently underway in the US since April 6, 2020, with 40 healthy adults receiving the vaccine candidate and eventually expanding to older adults.
April 6, 2020 - INOVIO Pharmaceuticals, Inc. announced that the U.S. FDA has accepted the company's Investigational New Drug application for INO-4800, its DNA vaccine candidate designed to prevent COVID-19 infection, paving the way for Phase 1 clinical testing of INO-4800 in healthy volunteers beginning this week. The first dosing is planned for today.
March 24, 2020 - Ology Bioservices Inc. and Inovio Pharmaceuticals Inc. announced today that the US DOD has awarded Ology Bioservices with a contract valued at $11.9 million to work with Inovio on DNA technology transfer to rapidly manufacture DNA vaccines such as (INO-4800).
March 12, 2020 - INOVIO Pharmaceuticals, Inc. announced that it has received a new $5 million grant from the Bill & Melinda Gates Foundation to accelerate the testing and scale-up of CELLECTRA® 3PSP proprietary smart device for the intradermal delivery of INO-4800, a DNA vaccine for COVID-19 disease. Inovio said its Cellectra 3PSP device is a small, hand-held and portable device that runs on AA batteries and can be used to inject a vaccine. It was originally developed using $8.1 million in funding from the medical arm of the U.S. Defense Threat Reduction Agency’s Medical CBRN Defense Consortium. Inovio reiterated that it expects to deliver 1 million doses of INO-4800 by year-end 2020.
March 3, 2020 - Inovio Pharmaceuticals, Inc. announced an accelerated timeline for developing its DNA vaccine INO-4800. We plan to begin human clinical trials in the U.S. in April and soon thereafter in China and South Korea, where the outbreak is impacting the most people. We plan on delivering one million doses by year-end 2020 with existing resources and capacity.
January 30, 2020, Beijing Advaccine Biotechnology announced a collaboration with Inovio Pharmaceuticals, Inc. to advance the development in China of the INO-4800 vaccine candidate, which is targeted against the novel coronavirus named 2019-nCoV.
January 23, 2020, Inovio Pharmaceuticals, Inc. said in a press release that the Coalition for Epidemic Preparedness Innovations funding of $9 million dollars will support Inovio's preclinical and clinical development through Phase 1 human testing of INO-4800, its new coronavirus vaccine candidate matched to the outbreak strain. Inovio's collaborators for this coronavirus vaccine development include the Wistar Institute, VGXI, a fully owned subsidiary of GeneOne Life Science, and Twist Bioscience.
INO-4800 DNA Vaccine Clinical Trial Information
ClinicalTrials.gov Identifier: NCT04336410 - Last Update Posted: September 21, 2020.
April 2020 - Human clinical trials begin with 40 healthy adult volunteers in Philadelphia, PA (University of Pennsylvania) and Kansas City, MO (at the Center for Pharmaceutical Research), where screening of potential participants has already begun. This is an open-label trial to evaluate the safety, tolerability, and immunological profile of INO-4800 administered by intradermal injection followed by electroporation using CELLECTRA® 2000 device in healthy adult volunteers.
Each participant will receive 2-doses of INO-4800 four weeks apart, and the initial immune responses and safety data from the study are expected by late summer.
94% of Phase 1 trial participants demonstrated overall immune responses at Week 6 after two doses of INO-4800 in trial with 40 healthy volunteers in preliminary analyses.
Through Week 8, theINO-4800 regimen was deemed safe and well-tolerated with no serious adverse events; all reported adverse events were grade 1 in severity.
In a preclinical animal challenge study, INO-4800 provided full protection against SARS-CoV-2 replication in the lungs in mice challenged with the virus
The Phase 2/3 efficacy trial for INO-4800 'to start this summer upon regulatory approval.'
ClinicalTrials.gov Identifier: NCT04447781 - Last Update Posted: August 19, 2020.
This is a phase I/IIa trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA® 2000 device in healthy adults aged 19 to 64 years in the Republic of Korea.
INO- 4800 contains the plasmid pGX9501, which encodes for the full length of the Spike glycoprotein of SARS-CoV-2.
The primary objective of this trial is to evaluate the tolerability, safety, and immunogenicity of INO-4800 administered by ID injection followed by EP in healthy adults in the Part A and Part B. Enrollment into Part A, and Part B will proceed sequentially.
Updated11/09/2020 - 21:15
INO up 35%. FDA approval and CEPI funding coming
Are you aware of TPTW? Might be ready to turn around.
T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens, today announced financial results for the third quarter ended September 30, 2020.
Recent Highlights
Achieved record quarterly revenue of $5.2 million, including product revenue of $3.8 million, representing growth of 213% and 219% respectively, compared to the prior year period
Sold record 32 T2Dx® Instruments in the third quarter, including 28 instruments in the U.S., an increase of 167% compared to the prior year period
Increased T2Bacteria® and T2Candida® Panel revenue by 70% and 38% respectively, compared to the prior year, demonstrating significant growth in the sepsis portfolio
Received Emergency Use Authorization (EUA) for the T2SARS-CoV-2® Panel molecular diagnostic test run on the FDA-cleared T2Dx Instrument to detect the virus responsible for COVID-19
Completed all milestones in the base phase of the product development contract awarded by BARDA, leading to the subsequent exercise of the first contract option valued at $10.5 million
Received New Technology Add-on Payment (NTAP) extension for the T2Bacteria Panel from the U.S. Centers for Medicare & Medicaid Services (CMS) for fiscal year 2021
“The third quarter was transformational for T2 Biosystems as we continue our growth as a commercially driven, customer-focused company. We achieved record sales during the quarter, grew our U.S. installed base of T2Dx Instruments by nearly 70 percent, saw strong demand at U.S. hospitals for our COVID-19 diagnostic test, and have commitments from new customers to adopt our products that have positioned us for long-term success,” stated John Sperzel, President and CEO of T2 Biosystems. “We remain committed to our three corporate priorities – accelerating sales, improving operations, and advancing our pipeline – and look to build on our momentum during the fourth quarter of 2020.”
Third Quarter 2020 Financial Results
Total revenue for the third quarter of 2020 was $5.2 million, an increase of 213% compared to the prior year period. Product revenue for the third quarter of 2020 was $3.8 million, an increase of 219% compared to the prior year period, driven by increased test panel and instrument sales. Research and contribution revenue for the third quarter of 2020 was $1.5 million, an increase of 198% compared to the prior year period, driven by increased activity under the BARDA contract.
Costs and operating expenses for the third quarter of 2020 were $15.9 million, an increase of $1.9 million compared to the prior year period, driven by increased cost of product revenue from increased sales and offset by lower research and development and selling, general and administrative expenses.
Net loss for the third quarter of 2020 was $11.3 million or a loss of $0.08 per share, compared to a net loss of $14.2 million or a loss of $0.31 per share in the prior year period.
Total cash, cash equivalents, current and long-term marketable securities, and restricted cash were $61.8 million as of September 30, 2020.
2020 Financial Outlook
The Company has increased its expectation of full year 2020 total revenue to be between $19.0 million to $20.0 million, including product revenue between $13.0 million to $14.0 million and research and contribution revenue of approximately $6.0 million. In the U.S., a minimum of 60 T2Dx Instrument are expected to be sold in the second half of 2020.
Fourth Quarter 2020 Financial Outlook
The Company expects fourth quarter 2020 total revenue to be between $8.7 million to $9.7 million, including product revenue between $7.2 million to $8.2 million and research and contribution revenue of approximately $1.5 million. In the U.S., a minimum 32 T2Dx Instruments are expected to be sold in the fourth quarter of 2020.
Webcast and Conference Call Information
T2’s management team will host a conference call today, November 4, 2020, beginning at 4:30pm ET. Investors interested in listening to the call may do so by dialing 877-407-9208 for domestic callers or 1-201-493-6784 for International callers. A live and recorded webcast of the call will be available on the “Investors” section of the Company’s website at www.t2biosystems.com.
About T2 Biosystems
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, T2Candida® Panel, the T2Bacteria® Panel, the T2Resistance™ Panel, and the T2SARS-CoV-2™ Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the T2Cauris™ Panel, and T2Lyme™ Panel, as well as additional products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers, and biothreat pathogens.
INO on alert. ER after hours November 9th
Ama! I'm an investing nobody, but this was always one of my favorite boards. I was sad when it went dormant. Nice to see you posting.
Jim The Nut Cramer...On INO: Amid the FDA halting the company's COVID-19 vaccine trial, Cramer says "there are better fish to fry" in this industry and would get out of that company.
What a putz. It was not halted. It was paused for the device not the medicine. If he says sell that means BUY!!!
T2 Biosystems (TTOO)
Moving on to another player in the diagnostic space, T2 Biosystems manufactures molecular diagnostic instruments and test panels. While the company has struggled in the past, Leerink argues that its $1.33 share price presents an opportunity to get in on this turnaround story.
Firm analyst Puneet Souda, who also covers HTGM, points out that part of the excitement surrounding this name is related to its COVID-19 testing solution (sepsis rule-out test). During its Q2 2020 earnings call, TTOO stated that there has been serious demand for the test, with it specifically seeing increased use from hospitalized patients who have a greater risk of developing secondary co-infections such as sepsis.
It should be noted that TTOO has partnered with Hackensack Meridian Health to develop and validate the COVID-19 assay on the T2Dx platform. The system can provide results in less than two hours, with clinical data demonstrating a sensitivity of 95% and specificity of 100%. As for the daily throughput, it lands at 60-80 tests. With all of the necessary filings submitted to the FDA for Emergency Use Authorization (EUA) approval, TTOO has started selling the test to clinical labs.
Expounding on this, Souda commented, “Management expects all 60 placements in the 2020 financial guidance to be entirely driven by COVID demand and has solid visibility into 2H – impressive in our view given the lack of instrument adoption in 1H20. TTOO hopes to leverage current COVID-19 demand to increase T2Dx install base and expand sepsis-related revenue over time – as the pandemic inevitably subsides.”
Given that the COVID test is expected to provide a significant near-term revenue boost, management reinstated its FY20 revenue guidance of $18-$20 million, which is above the consensus estimate.
If that wasn’t enough, Souda calls the efforts of newly appointed CEO John Sperzel encouraging, who is working to execute on his top priorities. These include accelerating sales growth through a focus on utilization, reducing TTOO's cost structure and advancing the product pipeline.
Specifically looking at utilization, in Q2, TTOO’s U.S. annuity per system increased 51% quarter-over-quarter, from $50,000 per system to over $75,000 per system, due to rising demand for its FDA-approved fungal candida test. This doesn’t factor in any benefit from the COVID tests.
On top of this, TTOO strengthened its balance sheet, with its pro-forma cash position now coming in at $69 million. As its pipeline also includes a Lyme disease test, a testing instrument and several other test panels, Souda likes what he’s seeing.
To this end, Souda sides with the bulls. Along with an Outperform (i.e. Buy) rating, he keeps a $3 price target on the stock. This target puts the upside potential at 123%.
Are other analysts in agreement? They are. Only Buy ratings, 4 to be exact, have been published in the last three months. Therefore, the message is clear: TTOO is a Strong Buy. With a $3.25 average price target, shares could soar 152% in the next year.
Spec plays TTOO $1.95 and SNRE $12
NY Times article on INO
https://www.nytimes.com/2020/06/13/science/vaccine-coronavirus-inovio.html
$PCTL +88.24% today. Vol 80.5M shares, $4.34M traded!
Last 0.064
A New Disruptive Technology in the
World of Hospital Disinfection
https://pctcorphealth.com/
Thanks!........plenty more where that came from .......
z
Nice chart Zardiw!
$PCTL +66.67% today. Vol 40.75M shares, $1.4M traded! Last 0.04
$PCTL PCT Corp is engaged in making disinfection and decontamination products used in hospitals, crop farms and range of other applications. It sells its products in the United States and UK.
https://insiderfinancial.com/what-is-exciting-about-pct-ltd-otcmktspctl/179688/
Watching MCOA, COHO, CWNR (Shell sale)
Correction coming I agree.... Been 12 years since last one we are due. Writing is on the wall
Even if the Fed cuts rates to zero, market bear David Rosenberg predicts a recession is less than 12 months away
Market is underestimating the odds of more interest rate cuts: David Rosenberg
Despite the Federal Reserve’s latest efforts to boost the economy, long-time market bear David Rosenberg warns a recession is coming.
The Gluskin Sheff chief economist and strategist predicts economic growth in the U.S. will turn negative sooner than most investors anticipate — setting the stage for a painful market pullback.
“There’s a recession coming in the next 12 months,” he said last Thursday on CNBC’s “Futures Now.
The Fed lowered its benchmark interest rate last Wednesday by a quarter point. Fed Chairman Jerome Powell signaled rates would only be cut again if there’s new evidence the economy is softening. However, Powell said he didn’t expect that to happen.
“The only reason that he said that he’s optimistic on the outlook is because of exactly what the Fed is doing which is breathing stimulus back into the economy,” said Rosenberg, who came into 2019 with a recession warning and has been known as a perma-bear on Wall Street for decades.
Yet, U.S. growth hasn’t gone negative this year. Plus, the S&P 500 and Dow are up more than 19% and 15%, respectively.
But according to Rosenberg, it’s just a matter of time until economic data sours and Powell is forced to resume easing in the coming months.
“I think that they’ll go in October and December and through 2020,” he added.
Whether the Fed cuts all the way to zero or not, Rosenberg speculates the outcome will be the same: Recession.
“The economy is already slowing down,” Rosenberg said. “Earnings are actually contracting.”
$WWIO Mikey doesn’t like it anymore
Yea, waiting for housing market crash to come again.
Regional bank mergers coming imo. The first was today.
Short the market. Big drop coming
Looking for another life changer.Happy Holidays
What's hot Boiler?
WRFX .0013 up 160% how can you not invest in a co with a team like this>
Mick Davis https://www.linkedin.com/in/mickdavis/
Ron Pitcock https://www.linkedin.com/in/rpitcock/
Lol, thanks buddy
Boiler, nice pic!
Good to see you back AMA!!!
Best Buy: It's Not Getting Better
Amazon is the second-largest consumer electronics retailer in the country after Best Buy, and it’s gunning for the top spot, according to Quartz. In June 2016, Amazon surpassed Walmart in electronics sales, putting it in second place. At the same time, Best Buy’s market share is shrinking. Sales of TVs, headphones, laptops, and other electronic gadgets at Amazon grew 28% in 2015, compared to single-digit growth at Apple and Best Buy. But the brick-and-mortar electronics store is trying to fend off its biggest competitor by improving its e-commerce offerings. And it seems to be having some success, so the end might not be nigh for this chain.
Why it’s now time to break from the stock market’s herd
https://www.marketwatch.com/story/why-its-now-time-to-break-from-the-stock-markets-herd-2017-11-29
It's Time to Break Up General Electric
https://money.usnews.com/investing/stock-market-news/articles/2018-01-16/break-up-general-electric-company-ge
ONCI - gonna run, volume alert 94M traded today. 30M in the last 15 minutes in 7 and 8M chunks... ~$40k per hit.
https://ih.advfn.com/stock-market/USOTC/on4-communications-inc-ONCI/trades
$ASTI has REAL products on Walmart, Amazon and many other major stores: https://www.amazon.com/s/ref=nb_sb_noss_2?url=search-alias%3Daps&field-keywords=ascent+solar
Woof woof! Up 150%
ATTBF-- Holy Moly!
AMA's Stock Market Insights
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