Q3 2023 T2 Biosystems Inc Earnings Call
Speaker 1: a point four million dollar sepsis
Yeah.
Sepsis test backwater.
Speaker 1: a point three million dollar reduction in international t-2dx instrument sales
A $3 million reduction in international <unk> Dx instrument sales and.
Speaker 1: and a $0.3 million reduction in COVID-19 testing.
A $3 million reduction in COVID-19 test sales.
Speaker 1: The sepsis test backorder directly impacted T2DX instrument and sepsis test demand during the third quarter and led to performance below our expectations.
The sepsis test back order directly impacted <unk> instrument and sepsis test demand during the third quarter and led to performance below our expectations.
Speaker 1: I'll discuss the actions we took and the progress made to address the backorder during our operations.
I'll discuss the actions, we took and the progress made to address the back order during our operations update.
Speaker 1: However, I'm pleased to report that as of today, we have already resolved the majority of the backorder that existed as of September 30.
However, I'm pleased to report that as of today, we have already resolved the majority of the back order that existed as of September 30.
Speaker 1: We expect fourth quarter 2023 sepsis and related product revenue of $2.4 million.
We expect fourth quarter, 2023, sepsis and related product revenue of $2 4 million representing.
Speaker 1: representing a sequential quarterly increase of 60% compared to the third quarter of 2023.
Representing a sequential quarterly increase of 60% compared to the third quarter of 2023.
Speaker 1: As a result of the sepsis test backorder, we expect total 2023 sepsis and related product revenue of $7.5 million, representing a decline of 10% compared to 2022.
As a result of the such as test back order, we expect total 2023, sepsis and related product revenue of $7 $5 million representing.
Representing a decline of 10% compared to 2022.
Speaker 1: As we have previously disclosed, there will be no BARDA revenue in the fourth quarter of 2020.
As we have previously disclosed there will be no BARDA revenue in the fourth quarter of 2023.
Speaker 1: We are very pleased with the recent progress in strengthening our balance.
We are very pleased with our recent progress in strengthening our balance sheet.
Speaker 1: As of September 30th, 2023, cash and cash equivalents totaled $24.3 million.
As of September 32023, cash and cash equivalents totaled $24 3 million.
Speaker 1: including proceeds raised to our ATM facility during the quarter.
<unk> proceeds raised through our ATM facility during the quarter.
Speaker 1: We reduced our debt and quarterly interest payments by converting $10 million, or approximately 20% of the CRG term loan to equity.
We reduced our debt and quarterly interest payments by converting $10 million or approximately 20% of the <unk> term loan to equity.
Speaker 1: We also implemented operating expense reductions at the end of the second quarter and headcount reductions throughout the first half of the year, which we have held at under 100 full-time employees.
We also implemented operating expense reductions at the end of the second quarter.
And head count reductions throughout the first half of the year.
Which we have held at under 100 full time employees.
Speaker 1: As we advance our mission, we remain focused on three corporate priorities.
As we advance our mission, we remain focused on three corporate priorities.
One accelerating our sales too.
Speaker 1: two, enhancing our operations, and three, advancing our pipeline. We'll discuss each of these priorities in more detail.
Two enhancing our operations and three advancing our pipeline.
We will discuss each of these priorities in more detail.
Starting with our first priority accelerating our sales.
Speaker 1: Commercially, we're focused on expanding the installed base of T2DX instruments and increasing sepsis test utilization in existing and new hospital occasions.
Commercially we are focused on expanding the installed base of <unk> instruments, and increasing sepsis test utilization in existing and new hospital accounts.
Speaker 1: In the third quarter, we executed contracts for five T2DX instruments, including two in the US and three in the US.
In the third quarter, we executed contracts for five <unk> Dx instruments, including two in the U S and three outside the U S.
Speaker 1: We achieved total revenue of $1.5 million, comprised entirely of sepsis and related product revenue.
We achieved total revenue of $1 $5 million comprised entirely of sepsis and related product revenue.
Sepsis test panel revenue was $1 1 million and we ended the quarter with a $380000 back order.
Speaker 1: and we ended the quarter with a $380,000 backorder. Demonstrating continue to increase its content with the broader spread of income technology
Demonstrating continued demand for our products.
Speaker 1: Our commercial team is targeting new hospital accounts while working with existing accounts to increase their sepsis testing.
Our commercial team is targeting new hospital accounts, while working with existing accounts to increase their substance testing volumes.
Speaker 1: We have integrated the sales, medical affairs, and service teams to educate and align key stakeholders on broader sepsis testing protocols.
We have integrated the sales medical affairs and service teams to educate and aligned key stakeholders on broader sepsis testing protocols.
Speaker 1: Annualized U.S. sepsis test utilization during the third quarter was $108,000 per instrument, which was impacted by the sepsis test backorder.
Annualized U S sepsis test utilization during the third quarter was $108000 per instrument, which was impacted by the Subsys test backward.
We believe our integrated commercial approach.
Speaker 1: and clearing a substantial portion of the backorder can drive deeper penetration within each account over the near period.
And declaring a substantial portion of the back order can drive deeper penetration within each account over the near term.
Speaker 1: And a number of hospital accounts annualized utilization is well above the $200,000 goal we expect to achieve an annualized basis over time across our US installed.
And a number of hospital accounts annualized utilization is well above the $200000 goal, we expect to achieve on an annualized basis over time across our U S installed base.
Speaker 1: As a testament to our commercial team's strong efforts in increasing education and identifying use cases.
As a testament to our commercial team's strong efforts and increasing education and identifying use cases, our customers have continuously demonstrated their support by presenting case studies highlighting the benefits of our products at industry conferences.
Speaker 1: Our customers have continuously demonstrated their support by presenting case studies, highlighting the benefits of our products at industry.
Speaker 1: During the September sepsis Alliance summit Butler hospital presented on the critical need our products fill an accelerating pathogen identification.
During the September Sepsis Alliance Summit Butler Hospital presented on the critical need our products, Phil and accelerating pathogen identification time, enabling a rapid diagnosis with independent species identification.
Speaker 1: enabling a rapid diagnosis with independent species identification.
Speaker 1: As we discussed on the previous call, Butler Hospital has developed a protocol to trigger the use of the T2 bacteria panel and have shown that the T2 bacteria panel allowed for targeted therapy as much as 37 hours faster than blood culture-based methods. At the upcoming ID week conference in Boston, we will be discussing the use of T2 bacteria in the T2 bacteria panel.
As we discussed on the previous call Butler Hospital has developed a protocol to trigger the use of the T. Two bacteria panel and have shown that the key to bacteria panel allowed for targeted therapy.
As much as 37 hours faster than blood culture based methods.
At the upcoming <unk> conference in Boston.
Morrow October 13th.
Speaker 1: Hospital experiences with T2 Candida and T2 Bacteria will be presented by infectious disease pharmacists from the University of Louisville Health System and Robert Wood Johnson University Hospital.
Hospital experiences with T to Canada and tissue bacteria will be presented by infectious disease pharmacists from the University of Louisville Health system, and Robert Wood Johnson University Hospital.
Speaker 1: Creating additional reference accounts like these hospital users is an important part of our commercial strategy.
Creating additional reference accounts like these hospital users is an important part of our commercial strategy.
Speaker 1: We're grateful for our strong customer support as they spread more awareness around our instruments, clinical and economic benefits.
We're grateful for our strong customer support as they spread more awareness around our instruments clinical and economic benefits.
Speaker 1: We continue to add to the clinical library, and this past quarter have been conducting studies to advance the capability to test in new ways.
We continue to add to the clinical library.
In this past quarter had been conducting studies to advance the capability to test in new ways.
Speaker 1: As a reminder, we announced a clinical collaboration with Vanderbilt University Medical Center during the second quarter to implement and evaluate our FDA-Clear T2DX instrument and T2 bacteria panel in a clinical setting.
As a reminder, we announced a clinical collaboration with Vanderbilt University Medical center during the second quarter to implement and evaluate our FDA cleared <unk> Dx instrument and tissue bacteria panel in a clinical setting.
Speaker 1: included in the clinical collaboration is a perspective study that will assess the capabilities of the T2 bacteria panel to improve clinical interventions and antibiotic usage for patients with a bloodstream. And
Included in the clinical collaboration is a prospective study that will assess the capabilities of the T. Two bacteria panel to improve clinical interventions and antibiotic usage for patients with a bloodstream infection.
Speaker 1: The T2DX instrument has been installed at Vanderbilt. The IRB has been approved, and patient enrollment is expected to begin next.
The key to Dx instruments has been installed at Vanderbilt.
<unk> has been approved and patient enrollment is expected to begin next month.
Speaker 1: We look forward to discussing future updates on this collaboration and clinical evidence once available.
Look forward to discussing future updates on this collaboration and clinical evidence once available.
Speaker 1: Bolstering our efforts is the increasing awareness of sepsis as a public health emergency. In September , we...
Bolstering our efforts is the increasing awareness of sepsis is a public health emergency.
In September we promoted sepsis awareness month.
Speaker 1: September is recognized as a month to reflect upon the fact that sepsis takes a life every 90 seconds in the United States.
September is recognized as a month to reflect upon the fact that sets US takes a life every 90 seconds in the United States.
Speaker 1: Thomas Heyman, CEO of SEPSA's Alliance, stated, quote, SEPSA is a public health crisis that no one is talking about. And...
Thomas Hayman CEO of Sepsis Alliance stated quote sepsis is a public health crisis that no one is talking about <unk>.
Speaker 1: We appreciate the work Sepsis Alliances is doing to raise awareness and educate people regarding sepsis.
We appreciate the work sepsis alliance is doing to raise awareness and educate people regarding sepsis.
Speaker 1: We commend Massachusetts Governor Morah Healy for recognizing the patient impact of sepsis and for issuing a proclamation to recognize September as sepsis awareness month in Massachusetts.
We commend, Massachusetts, Governor Moura Healey for recognizing the patient impact of sepsis and for issuing a proclamation to recognize September as sepsis awareness month in Massachusetts.
Speaker 1: We also applaud the United States Centers for Disease Control and Prevention, or CDC, for taking action to streamline U.S. Hospital's SEPSA program guidelines. Through their hospital's SEPSA's program guidelines.
We also applaud the United States centers for disease control and prevention or CDC, we're taking action to streamline U S hospitals sepsis program guidelines through their hospital sepsis program core elements.
Speaker 1: Program is designed to help hospitals to implement monitor and optimize census programs through seven elements. Hospital leadership commitment.
The program is designed to help hospitals to implement monitor and optimize sepsis programs through seven elements hospital leadership commitment accountability.
Speaker 1: accountability, multi-professional expertise, action, tracking, reporting, and education.
Multi professional expertise.
Actions tracking reporting and education.
Speaker 1: By establishing these core elements, they aim to improve upon old disjointed processes that have failed patients and created a massive burden for our health care.
By establishing these core elements they aim to improve upon old disjointed processes that have failed patients and created a massive burden for our health care system.
Speaker 1: It's extremely encouraging to have these additional stakeholders prioritizing awareness and calling for action to combat the public health threat of sep.
It's extremely encouraging to have these additional stakeholders prioritizing awareness and calling for action to combat the public health threat of sepsis.
Speaker 1: Our message is being amplified by these external voices and we expect this to stimulate additional conversations with potential customers and advance current dialogue.
Our message is being amplified by these external voices and we expect this to stimulate additional conversations with potential customers and.
In advanced current dialogues.
Speaker 1: It's clear the significant change is required for how we manage patients suspected of substance.
It is clear the significant changes required for how we manage patients suspected of sepsis.
Speaker 1: Reconfident, the growing public recognition can be a catalyst for positive change and that adoption of our substance products in U.S. hospitals will advance the standard of care.
Confident the growing public recognition can be a catalyst for positive change and that adoption of our sepsis products in U S hospitals will advance the standard of care.
Speaker 1: Following the FDA approval of the T2 Biothread panel, we immediately shifted our focus with this product toward commercialization.
Following the FDA approval of the <unk> bio threat panel, we immediately shifted our focus with this product towards commercialization.
Speaker 1: We believe there are multiple opportunities to sell the T2 Biosphere Panel, including to the US Laboratory Response Network, State or Public Health Labs.
We believe there are multiple opportunities to sell the <unk> bio threat panel <unk>.
Including to the U S Laboratory response network.
State or public health labs.
The U S strategic national stockpile.
Speaker 1: other government agencies, for example, CDC, NIH, and Department of Defense, and international governments that are US allies.
Other government agencies for example, CDC NIH and department of Defense.
And international governments that are U S allies.
Speaker 1: Given the ongoing wars in Europe and the Middle East, we believe the global population is at an increased risk for exposure to bioterrorism.
Given the ongoing wars in Europe , and the Middle East We believe the global population is at an increased risk for exposure to bioterrorism.
Speaker 1: We're proud to have developed a test to protect Americans from the consequences of deliberate or naturally occurring outbreaks of certain biopsy pathogens.
We're proud to have developed a test to protect Americans from the consequences of deliberate or naturally occurring outbreaks of certain bio threat pathogens.
Moving to our second priority enhancing our operations.
Speaker 1: On our last call, we discussed numerous steps we had taken to enhance our operations, including our cost structure, balance sheet, supply chain, and manufacturing.
On our last call. We discussed numerous steps, we have taken to enhance our operations, including our cost structure balance sheet supply chain and manufacturing.
Speaker 1: Since our last call and the close of the third quarter, we have made significant progress addressing our manufacturing processes aimed at resolving the sepsis test panel backwards.
Since our last call and the close of the third quarter, we have made significant progress addressing our manufacturing processes aimed at resolving the sepsis touch panel backorder.
Speaker 1: At the end of the third quarter, the Texas test failed back order was $380,000.
At the end of the third quarter, the sepsis test panel Backorder was $380000 and I'm pleased.
Speaker 1: And I'm pleased to report that we cleared the majority of the back order in early October .
To report that we've cleared the majority of the back order in early October .
Speaker 1: We expect to clear the remainder of it this quarter, and we expect to finish 2023 with zero back.
We expect to clear the remainder of it this quarter and we expect to finish 2023 with zero back order.
Speaker 1: The back order was caused by a number of factors, including raw materials, personnel changes, processes, and equipment.
The Backorder was caused by a number of factors, including raw materials personnel changes processes and equipment.
Speaker 1: We attribute the recent manufacturing improvements to the key measures we have previously implemented, including hiring a new vice president of operations, advanced procurement of raw materials, process improvements, and investments in equipment.
We attribute the recent manufacturing improvements to the key measures, we've previously implemented including hiring a new vice president of operations advanced procurement of raw materials.
Process improvements and investments in equipment.
Speaker 1: The demand for our census test panels within the US and international markets remains strong.
The demand for our sepsis test panels within the U S and international markets remains strong.
Moving to our third priority advancing our pipeline.
Speaker 1: Our new product development priorities have targeted three areas. Tutsus, bioterism, and line-
Our new product development priorities have targeted three areas sepsis bioterrorism and Lyme disease.
Speaker 1: These represent areas of significant unmet medical need in which rapid detection can lead to faster targeted antimicrobial treatment and improve patient out.
These represent areas of significant unmet medical need and which rapid detection can lead to faster targeted antimicrobial treatment and improve patient outcomes.
Speaker 1: We've been advancing five new products intended to expand the test menu on our FDA-clear T2DX instrument and drive
We've been advancing five new products intended to expand the test menu on our FDA cleared <unk> Dx instrument.
And drive increased adoption.
Speaker 1: including the Titu Bio Threat panel, the addition of the Asmita Bacchid Balmanea to our FDA-Clear Titu Bacchuria panel.
Including the <unk> bio threat panel the.
The addition of acinetobacter by <unk> to our FDA cleared <unk> bacteria panel.
Speaker 1: The teacher resistance panel, the teacher line panel, and the candidate or a...
The teacher resistance panel, the <unk> panel and a candida Auris test.
Speaker 1: Each new test panel or test represents a differentiated solution to rapidly identify harmful pathogens and potentially allow clinicians to achieve faster, targeted antimicrobial.
Each new test panel or test represents a differentiated solution to rapidly identify harmful pathogens and potentially allow clinicians to achieve faster targeted antimicrobial therapy.
Speaker 1: The T2 Biotrite Panel is a direct from blood molecular diagnostic test. It runs on the FDA-Clear T2DX instrument and simultaneously detects six biopryt pathogens.
The <unk> panel is a direct from blood molecular diagnostic test it runs on the FDA cleared <unk> Dx instrument and simultaneously detects six bio threat pathogens in four hours, including the organisms that cause anthrax from Arabia Glanders melioidosis.
Speaker 1: including the organisms that cause anthrax, fileramia, glanders, meliodosis, plague, and ty-
Flag and typhus.
Speaker 1: not treated promptly infections with the pathogens included on the T2 biothrapp panel can result in mortality rates of 40 to 90%.
If not treated promptly infections with the pathogens included on the tissue bio threat panel can result in mortality rates of 40% to 90%. According to medical aspects of biological warfare, and the center for food security and public health.
Speaker 1: according to medical aspects, a biological warfare and the Center for Food Security and Public.
Speaker 1: The T2 biopsypanical clinical evaluation assess the sensitivity and specificity to detect targets in blood samples containing a range of bacterial concentrations. The positive percent of...
The <unk> bio threat panicle clinical evaluation assess the sensitivity and specificity to detect targets and blood samples containing a range of bacterial concentrations.
Positive percent agreement or sensitivity for all targets at 1% to three times the limit of detection was 100% for all targets, except for instance, seller for Laurentus, which was 94, 3%.
Speaker 1: For all targets at one to three times the limit of detection was 100% for all targets except Francescella Filorences which was 94.3%.
Speaker 1: The negative percent agreement or specificity for all six targets in healthy and febrile blood containing no bacteria was 100%. We believe this represents us. We believe this represents us.
The negative percent agreement or specificity for all six targets and healthy and federal blood containing no bacteria once 100%.
We believe this represents unparalleled performance.
Speaker 1: As expected, we received FDA 510K clearance for the T2 biopsyp panel during the third quarter of 2023, which allows us to market and sell the-
As expected we received FDA five 10-K clearance for the <unk> panel during the third quarter of 2023.
Which allows us to market and sell the test in the U S.
Speaker 1: The FBA-15K clearance marks a major milestone in our collaboration with the US government, specifically Barta, and our commitment to protect Americans from the consequences of deliberate or naturally occurring outbreaks of these biotrat patients.
The FDA five 10-K clearance marks a major milestone in our collaboration with the U S government.
Specifically BARDA and our commitment to protect Americans from the consequences of deliberate or naturally occurring outbreaks of these bioterror pathogens.
Speaker 1: It's important to note that the T2 biotrug panel is the first and only FDA-cleared product able to simultaneously detect these six pi-priority biotrug pass.
It is important to note that the <unk> bio threat panel is the first and only FDA cleared product able to simultaneously detect.
These six high priority bio threat pathogens.
Speaker 1: and the only FDA-cleared multi-target bioprop product developed and manufactured by a US-owned
And the only FDA cleared multi target bio threat product developed and manufactured by a U S owned company.
Speaker 1: We believe these facts will be important in discussions regarding purchases of the T2 biopsy panel which we intend to sell to commercial markets and governments.
We believe these facts will be important in discussions regarding purchases of the <unk> panel, which we intend to sell to commercial markets and governments.
Speaker 1: The expanded T2 bacteria panel to include detection of Acneeter-Vacter-Bomaniye is a direct from blood molecular diagnostic test designed to run on the FDA-cleared T2DX instrument and provide results in just three to five hours without the need to wait days for a positive blood.
The expanded T. Two bacteria panel to include detection of Acinetobacter <unk> is a direct from blood molecular diagnostic test designed to run on the FDA cleared <unk> Dx instrument and provide results in just three to five hours without the need to wait days for a positive blood culture.
Speaker 1: Adding S. Need a Bacter Balmani A Detection to our FDA-Clear T2 Vecturia Panel will expand our detection capabilities to approximately 75% of all substance-causing bacterial pathogens commonly found in blood.
Adding acinetobacter belmonte, a detection to our FDA cleared <unk> bacteria panel will expand our detection capabilities to approximately 75% of all sepsis, causing bacterial pathogens, commonly found in blood culture.
Speaker 1: Acne de Bacter Belmaneate can cause bloodstream infections, especially in critical patients, which can range from benign transit bacteria to septic shock. And it's been reported to have a crude ICU mortality rate of 34% to 43%.
Acinetobacter Bombardier can cause bloodstream infections, especially in critically ill patients, which can range from benign transit bacteremia to septic shock.
And it has been reported to have accrued ICU mortality rate of 34% to 43%.
Speaker 1: As needed, back to infections rarely occur outside of healthcare settings in the United States, and can disproportionately impact those with weakened immune systems, chronic lung disease, or diabetes.
Acinetobacter infections rarely occur outside of health care settings in the United States and can disproportionately impact those with weakened immune systems.
Lung disease or diabetes.
Speaker 1: As needed, Dr. Balmaniye can be resistant to many antibiotics, including carbohydrates, which highlights the importance of rapid detection and targeted antimicrobial treat.
Acinetobacter by 98 can be resistant to many antibiotics, including carbo patents, which highlights the importance of rapid detection and targeted antimicrobial treatment.
Speaker 1: Today we issued a press release to announce that we have filed an FDA submission for 510K clearance to add ASNeeda Bakker Balmaneye to the T2 bacteria panel. As scheduled.
Today, we issued a press release to announce that we have filed an FDA submission for five 10-K clearance to add acinetobacter <unk> 98 to the T. Two bacteria panel as scheduled.
Speaker 1: As a reminder, the CE Marked version of the T2 bacteria panel, which we sell in certain international markets, already includes the detection of S-Needa back up on us.
As a reminder, the CE marked version of the <unk> bacteria panel, which we sell in certain international markets.
<unk> includes the detection of Acinetobacter Beaumont yet.
Speaker 1: The Teaching Resistance panel is a direct from the blood molecular diagnostic test designed to run on the FDA-cleared T2DX-
The teacher resistance panel is a direct from blood molecular diagnostic test designed to run on the FDA cleared <unk> instrument and simultaneously detect 13 antibiotic resistance genes known to cause antibiotic resistant infections in just three to five hours.
Speaker 1: Simultaneously detect 13 antibiotic resistance genes known to cause antibiotic resistant infections in just three to five hours without the need to wait days for a positive blood...
Without the need to wait days for a positive blood culture.
Speaker 1: The Teacher Resistance panel, which is marketed and sold in Europe under CE Mark, detects resistance genes that may confer resistance to common antimicrobials, such as carbon pentoms, met the system.
The teacher resistance panel, which is marketed and sold in Europe under CE, Mark detect resistance genes that may confer resistance to common at the macrobius such as <unk>.
The selling and vancomycin.
Speaker 1: We have advanced the US clinical trial, including completing patient enrollment, and we plan to file an FDA submission for 510K clearance after completing additional internal testing, including stability testing, which we expect to occur in the first quarter of 2024.
We have advanced the U S clinical trial, including completing patient enrollment and we plan to file an FDA submission for five 10-K clearance.
After completing additional internal testing, including stability testing, which we expect to occur in the first quarter of 2024.
Speaker 1: As a reminder, the Keyto Resistance panel was granted breakthrough device designation by the FDA, which provides for a prioritized review process upon FDA submission.
As a reminder, the teacher resistance panel was granted breakthrough device designation by the FDA.
Which provides for a prioritized review process upon FDA submission.
Speaker 1: The T2 line panel is a direct-from-blood molecular diagnostic test designed to run on the FDA-cleared T2DX instrument and detect Boralia Bidolfry, the bacteria that is the major cause of Lyme disease in the US.
The tissue line panel as a direct from blood molecular diagnostic test designed to run on the FDA cleared <unk> Dx instrument and detect borrelia Bergdorf rock the bacteria that is the major cause of Lyme disease in the U S.
Speaker 1: The KITU line panel is intended to test individuals with signs and symptoms of Lyme disease and aid in the diagnosis of early Lyme.
The key July panel is intended to test individuals' with signs and symptoms of Lyme disease.
And aid in the diagnosis of early line disease.
Speaker 1: And we believe it will provide a significant advantage over currently recommended serological testing. It requires the presence of anabond.
And we believe it will provide a significant advantage over currently recommended serological testing that requires the presence of antibodies.
Speaker 1: which can take the body two to six weeks to create post-intim-
Which can take the body two to six weeks to create post infection.
Speaker 1: In 2022 our T2Line panel was named a winner in the line innovation accelerator or LIMAT.
In 2022, our tissue line panel was named a winner in the line innovation accelerator for Wimax.
Speaker 1: partnership between the US Department of Health and Human Services and the Stephen and Alexandra Cohen Foundation.
<unk> shipped between the U S Department of health and human services and the Stephen Alexandra Cowen Foundation.
Speaker 1: The largest public-private partnership for Lyme disease that plans to award up to $9 million to future award.
The largest public private partnership for Lyme disease, the plans to award up to $9 million to future Award winners.
Speaker 1: We recently received additional interim funding from LIMX and submitted a Phase II progress report, which will be evaluated for moving to Phase III of the accelerators.
We've recently received additional interim funding from Wimax and submitted a phase II progress report, which will be evaluated for moving to phase III of the accelerator.
Speaker 1: We also received FDA breakthrough device designation for the T2 line panel, which allows for a prioritized review process upon submission to the FDA.
We also received FDA breakthrough device designation for the <unk> panel, which allows for a prioritized review process upon submission to the FDA.
Speaker 1: We completed the early assay development for the T2Line panel and we established a preliminary level of detection or LOD of two CFU per ML.
We've completed the early assay development for the <unk> panel and we established a preliminary level of detection or LOE date of two <unk> per ml.
Speaker 1: We're in discussions regarding the potential to initiate commercialization of the T2LIME panel as a laboratory-developed test.
We're in discussions regarding the potential to initiate commercialization of the <unk> panel as a laboratory developed test and subsequently plan to commence a U S clinical trial to support submission for five 10-K clearance to the FDA.
Speaker 1: Subsequently plan to commence a US clinical trial to support submission for 510K clearance to the FDA.
Speaker 1: The Candidora test is a direct from blood molecular diagnostic test designed to run on the FDA-queered T2DX instrument and detect Candidora species in just three to five hours without the need to wait days for a positive blood test.
The Candida Auris test as a direct from blood molecular diagnostic test designed to run on the FDA cleared <unk> Dx instrument and detect candida auris species in just three to five hours without the need to wait days for a positive blood culture.
Speaker 1: Canada, ORIS is a multi-drug-resistant fungal pathogen that has a mortality rate up to 60%. And it's recognized as a serious global health threat by the CDC and the World Health Organization.
Candida Auris is a multi drug resistant fungal pathogen that has a mortality rate up to 60%.
It is recognized as a serious global health threat by the CDC and the World Health Organization, Canada.
Speaker 1: Canada Auras is difficult to identify with standard laboratory methods, which can lead
Candida Auris is difficult to identify what standard laboratory methods.
Which can lead to inappropriate treatment.
Speaker 1: The CDC estimates the costs associated with US Spungle diseases in general are its highest $48 billion annual.
The CDC estimates the costs associated with U S fungal diseases in general are as high as $48 billion annually.
Speaker 1: and it's called on public health professionals to help lower the burden of fungal disease by continuing to wear a awareness of the lifesaving benefits of early detection and proper treatment.
And it's called on public health professionals to help lower the burden of fungal disease by continuing to raise awareness of the lifesaving benefits of early detection and proper treatment.
Speaker 1: As a reminder, we currently market and sell the T2 candidate panel. The only FDA-clear diagnostic test able to detect sepsis-causing candidate pathogens directly from blood in just three to five hours without the need to wait days for a positive blood.
As a reminder, we currently market and sell the <unk> Candida panel the only FDA cleared diagnostic test able to detect sepsis, causing Canada pathogens directly from blood in just three to five hours without the need to wait days for a positive blood culture.
Speaker 1: The T2 Canada panel runs on the FDA-Clear T2DX instrument, and simultaneously detects five candidates.
<unk> Candida panel runs on the FDA cleared <unk> instrument and simultaneously.
<unk> five candida species, including Candida albicans, Senator <unk>, Canada, perhaps losses, Canada crew, Ci and Canada, Nevada.
Speaker 1: including candidate albagams, candidate tropicalis, candidate perhaps losas, candidate cruciai, and candidate glibata, which causes over 90% of people.
Which causes over 90% of candidate blood infections.
Speaker 1: Rapid detention of these pathogens, as well as Canada or us, is essential to getting infected patients on tartarled antifungal therapy and improving patient outcomes.
<unk> detention of these pathogens as well as Candida Auris is essential to getting infected patients on targeted antifungal therapy and improving patient outcomes.
Speaker 1: During the third quarter of 2023, we received FDA breakthrough device designation for the Canada or
During the third quarter of 2023, we received FDA breakthrough device designation for the Candida Auris test, which provides greater and more frequent access to the FDA and may accelerate our path to FDA clearance.
Speaker 1: which provides greater and more frequent access to the FDA and may accelerate our path to FDA clearance.
Regarding our longer term product development initiatives.
Speaker 1: While we met all milestones set forth in the Barta contract related to the next generation instrument and comprehensive success panel or AMR panel, Barta informed us that our milestone-based product development contract ended on September 15, 2023, upon the expiration of option three.
While we met all milestones set forth in the BARDA contract related to the next generation instrument and comprehensive sepsis panel for Ahmar panel BARDA informed us that are milestone based product development contract ended on September 15th 2023.
On the exploration of option three.
Speaker 1: Following the recent FDA 510K clearance for the teacher bio-threat panel and the recently completed patient enrollment for the teacher resistance panel, Barta has decided not to fund additional product development under this.
Following the recent FDA five 10-K clearance for the <unk> panel and the recently completed patient enrollment for the teacher resistance panel BARDA has decided not to fund additional product development under this contract.
Speaker 1: We may apply for additional bar of funding under new contract soliciting.
We may apply for additional BARDA funding under new contract solicitations.
Speaker 1: Earlier today, we issued a press release announcing a reverse stock split at a 1-100 ratio.
Earlier today, we issued a press release announcing a reverse stock split at a one to 100 ratio effective today October 12, 2023 and to begin trading on a split adjusted basis when the market opens Tomorrow October 13 2023.
Speaker 1: effective today October 12, 2023. And to begin trading on a split adjusted basis when the market opens tomorrow, October 15, 2020.
Speaker 1: The portion of the adjustments will be made to the number of shares of common stock reserved for issuance under the company's equity incentive plans and the number of shares of common stock subject to outstanding warrants, convertible preferred and series A stock held by CRG servicing LLC and equity awards, as well as the applicable share.
Proportional adjustments will be made to the number of shares of common stock reserved for issuance under the company's equity incentive plans and the number of shares of common stock subject to outstanding warrants convertible preferred series a stock held by <unk> servicing LLC and equity awards as well as the applicable share price.
Speaker 1: The reverse stock split will not affect the number of authorized shares of the company's common stock or the par value of the common.
The reverse stock split will not affect the number of authorized shares of the company's common stock or the par value of the common stock.
Speaker 1: As a reminder, NASDAQ Capital Market Listing Rules require the company to maintain a market value of listed securities of at least $35 million, and a minimum bid price.
As a reminder.
<unk> that capital market listing rules require the company to maintain a market value of listed securities of at least $35 million.
And a minimum bid price of $1.
Speaker 1: On July 6, 2023, we participated in an appeal hearing with the NASDAQ that led to a formal response approving our appeal and granting an extension to regain compliance until November 20, 2020.
On July six 2023, we participated in an appeal hearing with the NASDAQ that led to a formal response approving our appeal and granting an extension to regain compliance until November 22023.
Speaker 1: Previously reported we regained compliance with the market value of listed securities requirement on August 7, 2023.
As previously reported we regained compliance with the market value of listed securities requirement on August seven 2023.
Speaker 1: While we have seen an increase in our stock price since the July 6th NASDAQ hearing, our stock price has not increased enough to achieve the minimum bid price organically.
While we have seen an increase in our stock price since the July 6th NASDAQ hearing our stock price has not increased enough to achieve the minimum bid price organically.
Speaker 1: Therefore, our Board of Directors has decided to affect the reverse stock split to bring the company into compliance
Therefore, our board of directors has decided to effect the reverse stock split to bring the company into compliance with the minimum bid price and.
And maintain our NASDAQ listing.
Speaker 1: We believe it's in the best interest of the company and our stockholders to maintain our NASSET listing for several reasons. One, to maintain the...
We believe it's in the best interest of the company and our stockholders to maintain our NASDAQ listing for several reasons one to maintain liquidity for the stock.
Speaker 1: to the broadening opportunities for future access to capital. Three to attract.
Two to broaden the opportunities for future access to capital.
Three to attract and compensate employees.
Speaker 1: and pour to pursue potential mergers and aqua-
And four to pursue potential mergers and acquisitions.
Speaker 1: I also want to clarify how this impacts the actions we have taken to reduce our debt and quarterly interest.
I also want to clarify how this impacts the actions we have taken to reduce our debt and quarterly interest payments.
Speaker 1: In July , we announced the conversion of $10 million for approximately 20% of our turn loan with CRG servicing, LLC or CRG.
In July we announced the conversion of $10 million for approximately 20% of our term loan with <unk> servicing LLC or <unk>.
Speaker 1: into 48 million, 345,798 shares of common stock, which CRG sold during September , 2020.
Into 48 million 345798 shares of common stock.
<unk> sold during September 2023.
Speaker 1: Additionally, CRG is entitled to convert 93 million, 297,259 shares of Series B convertible stock into shares of common.
Additionally, <unk> is entitled to convert $93 million.
297259 shares of series B convertible stock into shares of common stock.
Speaker 1: As a result of the reverse stock split announced today, the Series B convertible preferred stock would convert to 932,973 shares.
As a result of the reverse stock split announced today the series B convertible preferred stock would convert to 932973 shares.
Speaker 1: In summary, we achieved important milestones across our three corporate priorities during the third quarter of 2020.
In summary, we achieved important milestones across our three corporate priorities during the third quarter of 2023.
Speaker 1: Conversely, we continue to increase our global T2DX instrument installed base, maintain strong demand for our
Commercially we continue to increase our global <unk> Dx instrument installed base.
Maintained strong demand for our sepsis test panels right.
Speaker 1: raise awareness of the value of our products directly and through key opinion leaders and clinical evaluations and prestigious hospitals like Vanderbilt University Medical.
Raise awareness of the value of our products directly and through key opinion leaders and clinical evaluations and prestigious hospitals like Vanderbilt University Medical Center.
Speaker 1: Operationally, we strengthen our balance sheet and we've made significant progress in our supply chain and manufacturing operations to address the sepsis test back.
Operationally, we strengthened our balance sheet and we've made significant progress in our supply chain and manufacturing operations to address the sepsis test back order.
Speaker 1: Scientifically, we received FDA 510K clearance for the T2 biothread panel, received FDA breakthrough device designation for the candidate AuraSKAS.
Scientifically we received FDA five 10-K clearance for the <unk> bio threat panel.
We received FDA breakthrough device designation for the Candida Auris test.
Speaker 1: File the FDA-510K submission to add detection of S-Needabacter Bamanie to the T2 bacteria panel and advance the T2 resistance panel toward FDA-510K.
The FDA five 10-K submission to add detection of acinetobacter by 98 to the teacher bacteria panel and advanced the teacher resistance panel toward FDA five 10-K submission.
Speaker 1: I'd like to turn the call back over to the operator to open the line for questions. Operator.
I'd like to turn the call back over to the operator to open the line for questions.
<unk>.
Speaker 2: Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone key.
Thank you at this time, we will be conducting a question and answer session.
If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.
Speaker 2: A confirmation tone will indicate your line as in the question queue. You may press star two if you would like to remove your question from the queue.
You May press Star two if you would like to remove your question from the queue.
Speaker 2: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Speaker 2: Once again, please press star one on your phone at this time if you wish to ask your question. Please hold.
Once again, please press star one on your phone at this time.
Just to ask a question.
Please hold while we poll for questions.
Speaker 2: And the first question today is coming from Kyle Mixen from Canacord. Kyle, your line is live.
And the first question today is coming from Kyle <unk> from Canaccord.
Your line is live.
Speaker 3: Hey guys, thanks for taking me questions. Congrats on the FDA news. I'm on my financials in the quarter. So last quarter, you exited with a back quarter of 350K.
Hey, guys. Thanks for taking the questions.
That's on the FDA news.
Financials within the quarter, So last quarter, you exited with a back order of 350 K.
Speaker 3: This is quarter, you ended with back quarter of 380. It's pretty close to net neutral. I just like wouldn't this quarter, like this result here be kind of a normalized quarter. I guess is that the wrong way to think about it. Just seems like the 380 with a headwind or a characterize the headwind's wondering if you can like dive into that a bit more. And secondly, this whole like you know, wagon revy recognition, the back quarter situation is that just a reminder, are you confident that can end soon or is that gonna just continue going forward? Thanks.
This quarter you ended with back order of creating it's pretty close to net neutral I just wouldn't this quarter. Like this result here would be kind of a normalized quarter I guess is that the.
The wrong way to think about it just seems like that's really what the headwind or characterize headwinds.
If you'd like.
Dive into that a bit more.
And secondly, this whole like wagon revenue recognition. The back order situation is that just to remind me are you confident that can end soon or is that going to just continue going forward. Thanks.
Speaker 1: Sure, thank you Kyle. John Sprig isn't available today, so I'm gonna take that question.
Sure. Thank you call John Sprague isn't available today, so I'm going to take that question the.
Speaker 1: The first thing on the back order at the end of the second quarter compared to the back order at the end of the third quarter.
The first thing on the back order at the end of the second quarter compared to the back order at the end of the third quarter.
Speaker 1: It's not really the same back order. So we cleared the majority of the back order that ended. We ended the second quarter with. Obviously we weren't able to make and ship enough products.
It's not really the same back orders. So we cleared the majority of the back order that ended we ended the second quarter with obviously, we werent able to make and ship enough product based on the demand that we had for the third quarter. So we ended the third quarter with a back order they happen to be of similar size, but thats more by coincidence then.
Speaker 1: based on the demand that we had for the third quarter. So we ended the third quarter with the back quarter. They happened to be of similar size, but that's more by coincidence than...
Speaker 1: then just one moving on to the next quarter. As far as the end date, we have already cleared the majority of the back order, that 380,000 that we ended Q3 with.
And then just one moving on to the next quarter as far as the end date, we have already cleared the majority of the back order that 380000 that we ended Q3 with <unk>.
Speaker 1: We expect to continue clearing that over the next week. We expect to have zero back order at the end of the fourth quarter. And we believe that the mitigations that we put in place to address it, both in the second quarter and in the third quarter are working. And we expect it to be completely resolved.
We expect to continue clearing that over the next week, we expect to have zero back order at the end of the fourth quarter and we believe that the mitigation that we put in place to address it both in the second quarter and in the third quarter are working.
And we expect it to be completely resolved this quarter.
Speaker 3: All right, great. Those were helpful. And maybe John , could you talk about the incremental market opportunity that this new pathogen provides that you announced in the press release with the FDA? Just, I think you mentioned like 75% of pathogen is now for bacteria, but what does that mean in terms of like dollars or just opportunity in general?
Alright, great that was very helpful.
Maybe John could you talk about the incremental market opportunity that this new pathogen provides that <unk> announced in the press release with the FTA.
I think you mentioned like 10, 5% of pathogen now for bacteria, but what does that mean in terms of dollars or just <unk>.
Opportunity in general.
Speaker 1: Well, I think it's really important, Kyle, and thanks for asking that question. One of the pushbacks that we get, certainly from competitors, but often also from customers, is why would I bring on a technology that can only identify five or, in the case of adding S-Needa-Bacter, six bacterial pathogens? How is that going to help me in my SEPSA protocols and manage my patients at risk of SEPSA? And interestingly, when we ask them to show us the positive blood cultures, positive bacteria.
Well I think it's really important call and thanks for asking that question one of the pushback that we get certainly from competitors, but often also from customers is a why would I bring on a technology that can only identify five or in the case of adding acinetobacter six backed.
<unk> pathogens like how is that going to help me in my sepsis protocols and manage my patients at risk of Sensus and interestingly when we ask them to show us the positive blood cultures positive bacterial blood cultures.
Speaker 1: Typically, what we see is the five pathogens, and now, of course, six, cover somewhere between 70 and 80% of the positive bacterial specimens that they see. They're generally surprised.
Typically what we see is the five pathogens and now of course six cover somewhere between 70% 80% of the positive bacterial specimens that they see they're generally surprised by that.
Speaker 1: So the importance of adding S-Needabacter is we take our detention capabilities when you look at all the data that's out there from approximately 70% with five pathogens to approximately 75.
And so the importance of adding acinetobacter is we take our detention capabilities. When you look at all the data that's out there from approximately 70% with five pathogens to approximately 75.
Speaker 1: percent with six packages and the other thing that's really important just to remind everyone that
<unk> with six packages and the other thing Thats really important just to remind everyone that the pathogens that we have on our tissue bacteria panel were chosen for a reason one because we get pretty broad coverage with fiber now hopefully six targets, but also because those are the targets that are generally.
Speaker 1: The pathogens that we have on our TQ bacteria panel were chosen for a reason. One, because we get pretty broad coverage with five and now hopefully six targets, but also because those are the targets that are generally resistant to broad spectrum empiric antimicrobial or in this case, antibiotic treatment. So.
Our resistant to broad spectrum empiric anti microbial or in this case antibiotic treatment. So.
Speaker 1: We chose them for a reason, the resistant to broad spectrum, and because of that, they lead to the longest hospital stays, the greatest cost, and the worst patient.
We chose them for a reason the resistant to broad spectrum and because of that they lead to the longest hospital stays the greatest cost and the worst patient outcomes. So we're obviously super excited to add acinetobacter, we have it internationally and it has been an important part of driving adoption outside the U S.
Speaker 1: So we're obviously super excited to add Ashtonieta backer. We have it internationally and it has been an important part of driving adoption outside the US.
Speaker 3: Okay, that's interesting. Thanks, Sean. I'm on the instrument placement side. So five in the quarter executed.
Okay. That's interesting thanks, Sean.
The instrument placement side to five in the quarter executed.
Speaker 3: You know, annualized that's 20. You need to eat at 51, I guess, last year for the full year. Can you just toggle up the dynamics in terms of like demand for instruments or maybe bottle in that in terms of like shipment or something? And internationally, you actually had a stronger accord than domestic. I mean, there's a lot of macro headwinds kind of going on. I would have figured that might have been weaker, but I just wanted to give you the opportunity to kind of talk about the placement situation.
Annualized Thats 20, Indeed, you did 51, I guess last year for the full year.
Can you just talk about the dynamics in terms of like demand for instruments or maybe.
Bottlenecks in terms of like shipments or something and internationally actually had a stronger quarter than the domestic I mean, theres a lot of macro headwinds kind of going on I would have figured that might have been weaker but.
Just wanted to give you the opportunity to kind of talk about the.
Placement situation.
Speaker 1: Sure, I wouldn't read anything into the international demand versus domestic demand. I think at a high level it's generally easier to drive adoption in markets outside the US. The US is the strictest regulatory environment. That's why historically when you look at
Sure I wouldn't read anything into the international demand versus domestic demand I think at a high level, it's generally easier to drive adoption in markets outside the U S. U S has the strictest regulatory environment. That's why historically when you look at how most new companies introduce new <unk>.
Speaker 1: how most new companies introduce new products to the market, they start in Europe , and then they come to the US. So I think that's actually a positive. We're obviously disappointed with five instruments, but that's not where we expect to be. The back order absolutely impacted that.
Products to the market may start in Europe , and then they come to the U S. So I think that's actually a positive. We're obviously disappointed with five instruments, that's not where we expect to be back order absolutely impacted that.
Speaker 1: We, the other impact of a backorder is we couldn't get new customers to go live as fast as we wanted them to. So instruments that we shipped in Q2 were still backlogged in terms of going live, as well as instrumenting Q3 because we needed to take care of our existing customers first. So the backorder doesn't just
The other impact of a back order is we couldnt get new customers to go live as fast as we wanted them to so instruments that we shipped in Q2, we're still backlogged in terms of going live as well as instruments in Q3, because we needed to take care of our existing customers first so.
The back order doesn't just impact the potential sales in the quarter, but it also impacts going live with instruments and it impacts selling instruments to new customers or additional instruments to adjusting existing customers. So it impacted the whole business again, that's why we put so much emphasis on resolving it and while we can.
Speaker 1: the potential sales in the quarter, but it also impacts going live with instruments and it impacts selling instruments to new customers or additional instruments to existing customers. So it impacted the whole business. Again, that's why we put so much emphasis on resolving it and why we feel good about it being completely resolved in the fourth quarter.
Feel good about it being completely resolved in the fourth quarter.
Speaker 3: Okay, and there's one more I'm gonna hop by that, hop by half of that, the, Gross margins, that's a key metric that you've been trying to improve. You know, maybe to talk about how that progressed in the quarter, like we don't really have visibility into that, I think, here in the Specialties, and then, do the how does the back-order situation kind of impact that? Because we would think that maybe it's all test, such a test revenue, that's higher margins for current, so how do you always move in pieces sort of fit together, I guess, with Gross margin? And how is that improving?
Okay, and then one more and then I'll hop by that hop off after that.
Martin that's a key metric that <unk> been trying to improve.
Maybe just talk about how that progressed in the quarter like we don't really have visibility into that I think.
Here in the press release and then.
Does the <unk> situation kind of impact that because you would think that maybe it's all tests such as <unk> revenue. That's higher margin is recurring so how should we how does this how do you. All these moving pieces sort of fit together I guess with gross margin and how does that proven.
Speaker 1: So you're absolutely right Kyle, having lower test sales, which is the razor blade of the razor blade model, is not favorable when it comes to gross margins. We haven't finalized our Q3 results. There's obviously still subject to review. So we're not reporting on gross margin yet. We'll do that in the normal course in the first half of November .
So youre, absolutely right, having lower test sales, which is the razor blade of the razor Razorblade model.
Is not favorable when it comes to gross margins, we haven't finalized our Q3 results.
Obviously still subject to review.
No we're not reporting on gross margins, yet, we'll do that in the normal course in the first half of November .
Speaker 3: Okay, how about cash burn is that something you can kind of comment on possibly just giving it a possibility type metric I guess
Okay, how about cash burn is that something you can kind of comment on possibly just given its profitability type metric I guess.
Speaker 1: Well, we finished the quarter with 24.3 million in cash. We had finished Q2 with 16.1. We're obviously in a better task position. A balance sheet is strengthened also through the conversion of debt to equity and the lower interest payments that go along with that. So we feel much better this quarter with the cash position in the runway than where we were at the end of.
Well, we finished the quarter with $24 3 million in cash we had finished Q2 with $16. One we're obviously in a better cash position our balance sheet has strengthened also through the conversion of debt to equity.
And the lower interest payments that go along with that so we feel much better this quarter with the cash position and runway than where we were at the end of Q2 okay.
Speaker 3: Okay, he always more like a going forward type question, but that sounds good. All right. Thanks so much for the time. Appreciate it.
Yeah. It was more of a looking going forward type question, but that sounds good alright. Thanks, so much for the time I appreciate it.
Thank you Tom.
Speaker 2: Thank you. The next question is coming from Ben Hainer from Alliance Global Partners. Ben, your line is live.
Thank you. The next question is coming from Ben Hayner from Alliance Global Partners. Ben Your line is live.
Speaker 4: Good afternoon, gentlemen. Thanks for taking the questions and congrats on the T2 bio-threat clearance.
Good afternoon, gentlemen, thanks for taking the questions and congrats on the Q2 bio threat clearance.
Speaker 4: It pushed off for me, you mentioned at our five-six potential...
First off for me you.
I don't know if its five six potential.
Speaker 4: potential customers for the Q2 biophrath panel. You know, how many of those institutions or agencies have you been in contact with, you know, our discussions come in there and any color that you can provide? Sure, Ben.
Potential customers for the <unk> panel.
How many of those institutions or agency.
In contact with.
The discussions coming there any any color you can provide.
Sure Ben.
First of all thanks for the question.
Speaker 1: The first thing I want to do is just, you know, three really important points about the T2 BIOS.
The first thing I want to do is just <unk>.
Three really important points about the <unk> panel.
Speaker 1: and he's really emphasized these. The first is that the targets, the six targets that are on our panel are unique.
And just really emphasize these the first is that the targets. The six targets that are on our panel are unique.
Speaker 1: The TDA Bio Threp Antel is the first and only FDA-clear product able to simultaneously detect those six high-priority bio-threp antelope.
The <unk> panels, the first and only FDA cleared product able to simultaneously detect those six high priority bio threat pathogens.
Speaker 1: There is another multi-target bioprack product that is manufactured by a French owned company. The three of the targets are similar to our panel, three of them are not. That product is entirely controlled by Department of Defense. ours is not. So we have unique targets. The second point I wanna make is that, we believe the performance of our product, sensitivity and specificity is unparalleled. The sensitivity was
There is a another multi target bio threat product that is manufactured by a French owned company.
Three of the targets are similar to our panel three of them are not that product is entirely controlled by department of defense or is this not so we have a unique targets. The second point I want to make is that we believe the performance of our product the sensitivity and specificity is unparalleled.
The sensitivity was 100%.
Speaker 1: on five targets and 94.3% on the other. And the specificity was 100% across all sick targets.
On five targets and 94, 3% on the other and the specificity was 100% across all sick targets.
Speaker 1: I've not seen that kind of performance in a multi-target molecular diagnostic test.
I have not seen that kind of performance in a multi target molecular diagnostic test.
Speaker 1: outside of BioFract, certainly not within. And then the third, which I think is really important, when we talk about procurement of this test or sales of this test to US government entities, this product is made...
Outside of biotech certainly not within and then the third which I think is really important when we talk about procurement of this test or sales of this test to U S government entities.
This product is made by U S owned company.
Speaker 1: It's the only FDA-clear multi-target pilot threat product developed and manufactured by a US-owned company. And with the Bi-America First Mandate, we think that's going to be important.
It's the only FDA cleared multi target bio threat product developed and manufactured by U S owned company and with the buy America first mandate, we think thats going to be important.
Speaker 1: So to your question about the target market opportunities, I mean, just to reiterate them, the US lab response network, it's about 30 labs across the United States that routinely test for these kind of pathogens and others. So that's a clear opportunity. State and public health labs, that's within the call point of our current commercial.
So to your question about the the target market opportunities I mean, just to reiterate them. The U S. Lab response network. Its about 30 labs across the United States routinely test for these kind of pathogens and others, So thats a clear opportunity.
State and public health labs, that's within the call point of our current commercial team the stockpile and other government agencies like CDC NIH Dod those are going to be more of a corporate account type sale that would be made by myself or others in the organization.
Speaker 1: the stockpile and other government agencies like CDC and IH DoD, those are going to be more of a corporate account type sale. They would be made by myself or others in the organization.
Speaker 1: international governments the same. They would have to be allies of course.
International governments and the same but they would have to be allies of course.
And we are actively engaged in those discussions.
Speaker 4: Okay. And I mean, is there any sort of timeline that is associated potentially with these things? I mean, is there are key processes that accept a cleared or anything from any of these folks that are any of these entities that you can kind of hang your hat on or investors can hang your hat on and say, you know, this is what is the potential out there.
Okay.
Yes.
Is there any sort of timeline that is associated potentially with these things I mean is there.
RFP processes, although that's updated cleared or anything from any of these folks that are hurting.
These entities that.
That you can kind of hang your head on our investors can hang their head on and say what is the potential out there.
Speaker 1: Well, I think the good thing is they're all a little bit different. The strategic stockpile, that's obviously a process, it's a government-led process. The LRN labs is probably a little less structured than that, but also it's a government-led process. State and public health labs, those could happen anytime, and as well as international governments. I think there's obviously a lot of emphasis on what's going on around the world and the threat of biotechism is real.
Well I think the good thing is they are all a little bit different the strategic stockpile. That's obviously a process. It's a government led process. The LR and labs is probably a little less structured than that but also it's a government led process state public health labs, those could happen anytime.
And as well as international governments I think there is there's obviously a lot of emphasis on what's going on around the world.
And the threat of bioterrorism terrorism Israel.
Speaker 4: Okay. That's fair enough. And then on the investments in equipment on the production side to kind of help deal with the back of the rows, significant investments in equipment and do those expand your production capacity or what's the right way to kind of wrap your head around the walls.
Okay.
That's fair enough and then on the industrial.
Equipment on the.
On the production side to kind of help deal with the back what are those.
Significant investments in equipment and do those expand your production capacity or what's the right way to kind of wrap your head around malls.
Speaker 1: I wouldn't consider them consistent. We're talking about piece of equipment that might cost $10,000.
I wouldn't consider them consistent we're talking about piece of equipment that might cost $10000.
Speaker 4: Okay, so it's not significant and don't think about it as really expanding capacity or anything like that.
Okay.
Thats again and don't think about it.
Really expanding capacity or anything like that.
That's correct.
Speaker 4: Okay, great. I think the back of our questions kind of been asked and answered. So I guess all good at that. Thanks a lot for taking the questions.
Okay great.
I think the bank.
Question is kind of been asked.
Answered so I guess I'll leave it at that thanks, a lot for taking my questions.
Thank you Ben I appreciate it.
Speaker 2: Thank you. They run a lot of questions at this time. I would now like to turn the call over to John Sparrow for closing our mark.
Thank you there were no other questions at this time I would now like to turn the call over to John <unk> for closing remarks.
Speaker 1: Thank you all for participating in our preliminary Q3 results report and business update. We look forward to updating as we go forward. Thank you and have a great night.
Thank you all for participating in our preliminary Q3 results report and business update we look forward to updating as we go forward.
You don't have a great night.
Speaker 2: Thank you, this does conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.
Thank you. This does conclude today's conference you may disconnect. Your lines at this time. Thank you for your participation.