Full Year 2024 Tivic Health Systems Inc Earnings Call - Pre Recorded

Prepared remarks, this call is being webcast and the replay will be available on the IR section of the company website for three months.

Before we begin let me remind you that today's call.

Management will make various forward looking statements investors are cautioned that these forward looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results or outcomes to differ materially from those indicated by our forward looking statements.

Please read the Safe Harbor statement contained in the press release, we issued today.

As well as those contained in Tibet <unk> filings with the SEC, including its annual report on Form 10-K of the year end December 31 2024 to.

To be filed with the FCC on or about March 'twenty, one 'twenty 'twenty four.

Under the heading risk factors as well as the company's other filings with the SEC.

On today's call with Civic Health, Chief Executive Officer, Jennifer Ernst and interim Chief Financial Officer, Lisa, We'll now let me turn the call over to Jennifer.

Thank you for that introduction I'm, Jennifer I'm, the CEO of Catholic Health and welcome to our 2024 year end corporate update.

Lisa: Well Theres a formally a look back at 2024 I have to say that much of what we did in 2024 has culminated in the last few weeks and considerably reshaped the company.

Lisa: We have advanced our vagus nerve stimulation program and in February of 2025, we announced that we've acquired worldwide exclusive rights to a phase III immuno modulator, sorry drug candidates.

Lisa: So I'd like to spend a portion of that is the front end I'll tell you more about the drug candidate itself will talk with you a little bit more about the vagus nerve work and how this represents a very very different company than it has been over the last year and a half.

Operator: Welcome to Tivic Health Systems year-end 2024 financial results and operational update conference call.

Welcome to Vic Health systems year end, 'twenty 'twenty, four financial results and operational update conference call.

Lisa: Now to say that we reshape the company in the last several weeks really is quite an understatement.

Operator: This call has been pre-recorded and the questions you have submitted in advance will be answered following the prior remarks.

Lisa: We announced that we've acquired worldwide exclusive rights to.

This call has been prerecorded and the questions you have submitted a batch will be answered following prepared remarks. This call is being webcast and the replay will be available on the IR section of the company website for three months.

Lisa: Phase three immuno modular Tory drug candidates.

Operator: This call is being webcast and the replay will be available on the IR section of the company website for three minutes. Before we begin, let me remind you that today's call Management will make various forward-looking statements. Investors are cautioned that these forward-looking statements are based on current expectations and are subject to risk and uncertainties that could cause actual results or outcomes to differ materially from those indicated by our forward-looking statements.

Lisa: 140 million as previously done invested in the candidate this.

Lisa: This is a toll like receptor will go into a little bit more about what that what T. A toller agonist is about.

Before we begin let me remind you that today's call.

Management will make various forward looking statements investors are cautioned that these forward looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results or outcomes to differ materially from those indicated by our forward looking statements.

Lisa: As an immunotherapy drug candidate called Intel Ahmad and we acquired a license for this clinical asset from sort of Taro biopharma.

Lisa: With US license, we not only got exclusive rights to the first indication for until about it but also to five additional indications.

Operator: Please read the Safe Harbor Statement contained in the press release we issued today. as well as those contained in Tivic Health's filings with the SEC, including its annual report on Form 10-K of the year-end December 31, 2024. to be filed with the SEC on or about March 21st, 2024. under the heading Risk Factors, as well as the company's other filings with the SEC.

Please read the Safe Harbor statement contained in the press release, we issued today.

As well as those contained in civic helps filings with the FCC, including its annual report on Form 10-K of the year end December 31, 2024 to be filed with the FCC on or about March 21st 2024.

Lisa: And two an additional molecular structure called enter Alaska. So we now have two drug candidates in the pipeline. In addition to the vagus nerve stimulation work that you've heard me talk about before.

Lisa: By adding a newly licensed to Golar foot tall or five agonist to the to the pipeline as it gives us a late stage drug candidate for.

Under the heading risk factors as well as the company's other filings with the SEC.

Operator: on today's call with Tivic Health Chief Executive Officer Jennifer Ernst and Interim Chief Financial Officer Lisa Wolfe.

Speaker Change: Today's call with Civic Health's, Chief Executive Officer, Jennifer Ernst and interim Chief Financial Officer, Lisa will now, let me turn the call over to Jennifer.

Lisa: For treating acute radiation syndrome, it's also called E. R. S.

Jennifer Ernst: Now let me turn the call over to Jennifer. Thank you for that introduction. I am Jennifer Ernst, the CEO of Tivic Health, and welcome to our 2024 Year-End Corporate Update. Now, while this is formally a look back at 2024, I have to say that much of what we did in 2024 has culminated in the last few weeks and considerably reshaped the company. We have advanced our Vegas nerve stimulation program, and in February of 2025, we announced that we've acquired worldwide exclusive rights to a phase three immunomodulatory drug candidate. So I'd like to spend a portion of this, this front end, I'll tell you more about the drug candidate itself.

Lisa: But importantly, we believe that this lays the foundation for building a biopharmaceutical capacity within Tyvek and that is what I am tremendously excited about to talk with you about today.

Speaker Change: Thank you for that introduction I'm, Jennifer I'm, the CEO of terrific Hal and welcome to our 2024 year end corporate update no.

Lisa: We are creating a robust pipeline that combines both biologic and bio electronic medicine to focus on immune dysregulation.

Speaker Change: Well, there's a formally a look back at 2024 I have to say that much of what we did in 'twenty 'twenty. Four is culminated in the last few weeks and I'm certainly reshape the company.

Lisa: So the pharmaceutical component with license is an excellent complement to our work on noninvasive vagus nerve stimulation, we've moved to that work forward throughout the year and we are seeing increasingly positive signals that we can regulate immune and autonomic system functions with a noninvasive neuro stimulation device.

Speaker Change: We have advanced our vagus nerve stimulation program and in February of 2025, we announced that we've acquired worldwide exclusive rights to a phase III immuno modular Tory drug candidate.

Speaker Change: So I'd like to spend a portion of the front of it and I'll tell you more about the drug candidate itself well talk with you a little bit more about the vagus nerve work and how this represents a very very different company than it has been over the last year and a half.

Lisa: So between the progress we've made internally.

Jennifer Ernst: We'll talk with you a little bit more about the vagus nerve work and how this represents a very, very different company than Tivic has been over the last year and a half. Now, to say that we reshaped the company in the last several weeks really is quite an understatement. we announced that we've acquired worldwide exclusive rights to a phase three immunomodulatory drug candidate. Over $140 million has previously been invested in the candidate. This is a toll-like receptor, and we'll go into a little bit more about what the toll or agonist is about. It's an immunotherapy drug candidate called Intelimod, and we acquired a license for this clinical asset from Statero BioPharm.

And the comprehensive agreement, we've entered with deter our Biopharma, we are aggressively accelerating the strategic transformation of this company into a diversified therapeutics company.

Speaker Change: Oh to say that we reshape the company in the last several weeks really is quite an understatement.

Lisa: A diversified company with multiple shots on goal.

Lisa: So let me spend.

Speaker Change: We announced that we've acquired worldwide exclusive rights to us.

Lisa: A little bit the time now to explain what we licensed and how it positions tip it going forward.

Speaker Change: These three immuno modular Tory drug candidates.

Lisa: We all know our immune system is our bodies defense system.

Speaker Change: Over 140 million as previously done invested into Canada.

Lisa: And one part of our immune system or these toll like receptors. There basically like security sensors that are part of that body is defense system.

Speaker Change: This is a toll like receptor.

Speaker Change: Little bit more about what that was.

Speaker Change: T. A toller agonist is about.

Lisa: People are five and protection particular recognizes a specific enemy flagged all pledge Alan the protein that's found in many bacteria.

Speaker Change: Therapy drug candidate called Intel Ahmad and we acquired a license for this clinical asset turns to Terra biopharma.

Jennifer Ernst: With this license, we not only got exclusive rights to the first indication for Entelabot, but also to five additional indications and to an additional molecular structure called Entelasta. So we now have two drug candidates in the pipeline in addition to the vagus nerve stimulation work that you've heard me talk about before. By adding a newly licensed TLR5 agonist to the pipeline, this gives us a late-stage drug candidate for treating acute radiation syndrome. It's also called ARS. But importantly, we believe that this lays the foundation for building a biopharmaceutical capacity within Tivic. And that is what I am tremendously excited about to talk with you about today.

Speaker Change: With this license we not only got exclusive rights to the first indication for until about it but also to five additional indications and two an additional molecular structure called into Alaska. So we now have two drug candidates in the pipeline. In addition to the vagus nerve stimulation work that you've heard me talk about before.

Lisa: And when the receptor detects that flag it triggers an immune response to fight off of them dating bacteria.

Lisa: How is that helpful to us and told him on his appeal RFID the toll toll receptor five agonist. It accelerates. The same mechanism is that bacteria would in order to boost the immune system as a protective measure.

Speaker Change: By adding a newly licensed T L Arafat terrified agonist to the to the pipeline which gives.

Lisa: And Tom on what was originally developed.

Lisa: Developed as a radio protected drug for acute radiation syndrome.

Speaker Change: It gives us a late stage drug candidate.

Lisa: That occurs when high dose radiation exposure occurs and so I would think of nuclear accidents or attacks or dirty bombs.

Speaker Change: We're treating acute radiation syndrome, it's also called E. R. S.

Speaker Change: But importantly, we believe that this lays the foundation for building a biopharmaceutical capacity within topic and that is what I am tremendously excited about to talk with you about today.

Lisa:

Lisa: Obviously defense agencies have been a major proponent in this.

Lisa: There are limited FDA approved options for acute radiation syndrome, and they don't treat all of the factors that are associated with the condition.

Jennifer Ernst: We are creating a robust pipeline that combines both biologic and bioelectronic medicine to focus on immune dysregulation. So the pharmaceutical component we've licensed is an excellent complement to our work on non-invasive vagus nerve stimulation. We've moved that work forward throughout the year, and we are seeing increasingly positive signals that we can regulate immune and autonomic system functions with a non-invasive neurostimulation device. So between the progress we've made internally... and the comprehensive agreement we've entered with Stutterer Biopharma, we are aggressively accelerating the strategic transformation of this company into a diversified therapeutics company. a diversified company with multiple shots on goal.

Speaker Change: We are creating a robust pipeline that combines the biologic and bio electronic medicine to focus on immune dysregulation.

Lisa: And Palomar is positioned to fill a critical math and provide several potential advantages over the existing treatments for.

Speaker Change: So the pharmaceutical component with license is an excellent complement to our work on noninvasive vagus nerve stimulation, we've moved to that work for them throughout the year and we are seeing increasingly positive signals that we can regulate immune and autonomic system functions with a noninvasive neuro stimulation device.

Lisa: For example in telephone only requires one dose to become highly active on other drugs that are approved today require multiple doses. It also has shown improvements in the Gi tract function something that none of the other drugs that are in market today have done and there has shown the potential to be used prophylactic like as a means to prevent radio.

Speaker Change: So between the progress we've made internally.

Speaker Change: And the comprehensive agreement with Amtrust deter our Biopharma, we are aggressively accelerating the strategic transformation of this company into a diversified therapeutics company.

Lisa: Asian damage rather than just repair it.

Lisa: So and tell him on was funded.

Lisa: Extensively by the U S government through agencies like BARDA and the department of defense.

Speaker Change: A diversified company with multiple shots on goal.

Lisa: As I mentioned before they get original developer spent over 140 million in its development with significant support from those agencies.

Jennifer Ernst: So let me spend a little bit of time now to explain what we licensed and how it positions Tivic going forward. We all know our immune system is our body's defense. And one part of our immune system are these toll-like receptors. They're basically like security sensors that are part of that body's defense. PLR-5, in particular, recognizes a specific enemy with a flag called plagella and the protein that's found in many bacteria. And when the receptor detects that flag, it triggers an immune response to fight off an invading bacteria. Now, how is that helpful to us?

Speaker Change: So let me spend.

Speaker Change: Although the time now to explain what we licensed and how it positions topic going forward.

Lisa: With the development of them tell them on those those types of agencies are likely to be the key potential customers. This is the type of drug that nation states as well as military defense agencies will stockpile and keep on hand to have for emergency situations.

Speaker Change: You all know our immune system is our bodies defense system.

Speaker Change: And one part of our immune system of these toll like receptors. There basically like security sensors that are part of that body is decided system.

Speaker Change: Pillar five in.

Speaker Change: Particular recognizes a specific enemy that's a slide called pledge Alan the protein that's found in many bacteria.

Lisa: And how long a lot has already been tested extensively for acute radiation syndrome as I said earlier phase three drug all we have to face into now is a validation of the manufacturing.

Speaker Change: And when the receptor detects that flag it triggers an immune response to fight off of them dating back here yes.

Lisa: So what is a R S.

Speaker Change: How is that helpful to us.

Lisa: Acute radiation syndrome is the name for a cluster of policies develop soon after exposure to toxic doses of ionizing radiation.

Jennifer Ernst: Entolamide is a TLR5, a Toll Receptor 5 agonist. It activates the same mechanism as that bacteria would in order to boost the immune system as a protective measure. Now entalamide was originally developed as a radioprotective drug for acute radiation symptoms. That occurs when high-dose radiation exposure occurs. So think of nuclear accidents or attacks or dirty bombs. Obviously, defense agencies have been a major proponent in this. There are limited FDA-approved options for acute radiation syndrome, and they don't treat all of the factors that are associated with the condition. Intelimod is positioned to fill a critical gap and provide several potential advantages over the existing treatment.

Speaker Change: Told him on his appeal RFID to talk toll receptor five I guess, you know accelerates. The same mechanism is that bacteria would in order to boost the immune system as a protective measure.

Lisa: Radiation disrupts the DNA.

Lisa: Destroys rapidly dividing cells like those that are found in the bone marrow and in the intestines.

Speaker Change: Oh and tell him on what was originally developed as a radio protected drug for acute radiation syndrome.

Lisa: And it triggers mouth of inflammation.

Lisa: The effects that you see depending on the dose they can depend on the duration.

Speaker Change: It occurs whether high dose radiation exposure occurred since I was think of nuclear accidents or attacks or dirty bombs.

Lisa: But generally within minutes to hours, sometimes like nausea, vomiting, diarrhea, headache, and fatigue began developing those are the first signs of the cellular level of damage that is occurring in response to the radiation.

Speaker Change:

Speaker Change: Obviously defense agencies have been a major proponent in this.

Speaker Change: There are limited FDA approved options for acute radiation syndrome, and they don't treat all of the factors that are associated with the condition.

Lisa: In hours to days following that may appear to be an improvement, but the overall cell damage continues to spread.

Speaker Change: And Palomar is positioned to fill a critical math and provides several potential advantages over the existing treatments.

Lisa: It often fatal and due to the immune collapse to organ failure and to radiation induced infections, because the entire immune system against the shut down.

Jennifer Ernst: For example, the telomone only requires one dose to become highly active. Other drugs that are approved today require multiple doses. It also has shown improvements in the GI tract function, something that none of the other drugs that are in market today have done. And there is shown the potential to be used prophylactically as a means to prevent radiation damage rather than just repair it. So Intellimod was funded extensively by the U.S. government through agencies like BARDA and the Department of Defense. As I mentioned before, the original developer spent over $140 million in its development with significant support from those agents.

Speaker Change: Example, and tell them that only requires one dose do they get them highly active.

Lisa: The body has no way to protect itself.

Speaker Change: Other drugs that are approved today require multiple doses. It also has shown improvements in the Gi tract function something that none of the other drugs that are in market today have done.

Lisa: Acute radiation syndrome can.

Lisa: Can be lethal within hours or days.

Lisa: The emergency treatments like and tell them that aims to be to protect those critical tissues and improve survival rates can and tell them that has been shown to have a three X increase in survival rates.

Speaker Change: And there is showing the potential to be used prophylactically as a means to prevent radiation damage rather than just repair it.

Speaker Change: So in Telemark was funded.

Speaker Change: Extensively by the U S government through agencies like BARDA and the department of defense.

Lisa: When tested in animal models.

Lisa: But the drugs that are available today like neupogen and Neulasta they've been approved for treatment of they are S. Due to their ability to support the bone marrow repair.

Speaker Change: As I've mentioned before they get original developer spent over 140 million in its development with significant support from those agencies.

Lisa: But studies have been quelimane has shown improvement in both the bone marrow and the Gi tract.

Jennifer Ernst: With the development of Intelimod, those types of agencies are likely to be the key potential customers. This is the type of drug that nation-states as well as military defense agencies will stockpile and keep on hand to have for emergency situations. And Telamod has already been tested extensively for acute radiation syndrome. As I said earlier, phase three drug, all we have to face into now is the validation and manufacturing.

Speaker Change: With the development of them tell them on those those types of agencies are likely to be the key potential customers. This is the type of drug that nation states as well as military defense agencies, well stockpile and keep on hand to have for emergency situations.

Lisa: And again as I said potentially being used as a standalone treatment not necessarily requiring the additional medical support but can be improved if used in conjunction with existing drugs. So these are the types of studies that we will continue to advance and demonstrate.

Lisa: In addition to the Eros application for which this drug is ready to move into manufacturing.

Speaker Change: And how long a lot has already been tested extensively for acute radiation syndrome as I said earlier phase three drug all we have to face into now is a validation of the manufacturing.

Lisa: So the phase III studies have been completed for <unk>. There are no human studies remaining for us to do for them telling them on.

Jennifer Ernst: So what is ARS? Acute radiation syndrome is the name for a cluster of pathologies that develop soon after exposure to toxic doses of ionizing radiation. Radiation disrupts the DNA. destroys rapidly dividing cells like those that are found in the bone marrow and in the intestine. and it triggers massive inflammation. So the effects that you see depend on the dose, depend on the duration. But generally, within minutes to hours, symptoms like nausea, vomiting, diarrhea, headache, and fatigue begin developing. Those are the first signs of the cellular level of damage that is occurring in response to radiation.

Speaker Change: So what is a R S.

Speaker Change: Radiation syndrome is the name for a cluster of pathologies that develop soon after exposure to toxic doses of ionizing radiation.

Lisa: Our next step is to move into manufacturing validation and for that we will require wrapping up the manufacturing a certain amount of biotech biological testing in animals.

Speaker Change: Radiation disrupts the DNA.

Lisa: And then into a BLA application, our biologics license application with the F D. A.

Speaker Change: Destroys rapidly dividing cells like those that are found in the bone marrow and in the intestine.

Speaker Change: And it triggers a mouse inflammation. So the effects that you see depending on the dose they said depending on the duration, but.

Lisa: This particular asset.

Lisa: Has been significantly de risked, meaning political will be able to capitalize on capitalize on it.

Speaker Change: But generally within minutes to hours, sometimes like nausea, vomiting, diarrhea, headache, and fatigue began developing those are the first signs of the cellular level of damage that is occurring in response to the radiation.

Lisa: Much less capital intensive pathway than if we were attempting to for sample develop a drug from scratch.

Lisa: A R S. Though is only one indication.

Jennifer Ernst: In hours the days following, there may appear to be an improvement, but the overall cell damage continues to spread. It is often fatal due to the immune collapse, to organ failure, and to radiation-induced infection because the entire immune system begins to shut down and the body has no way to protect itself. Acute radiation syndrome can be lethal within hours or days. So emergency treatments like Intelimod aims to be to protect those critical tissues and improve survival rates. Intelimod has been shown to have a 3X increase in survival rates when tested in animal models. The drugs that are available today, like Nupagent and Lasta, have been approved for treatment of ARS due to their ability to support the bone marrow repair.

Speaker Change: In hours to days following the may appear to be an improvement, but the overall cell damage continues to spread.

Lisa: Soon system Dysregulation in area, we have been familiar with because of our history of working with the immune system through both the sinus and nasal passages them through the VNS work, we've been doing now immune system Dysregulation is a very common issue for patients that undergo medical radiation treatments.

Speaker Change: There's often fatal and due to the immune collapse, Oregon failure and to radiation induced infections, because the entire immune system to get us to shut down.

Speaker Change: And the body has no way to protect itself.

Lisa: That is part of the area, where we see expansion opportunity. So our next steps and Palomar.

Speaker Change: The acute radiation syndrome can.

Speaker Change: Can be lethal within hours or days.

Lisa: You'll hear about through the course of this year is to commence the validation of the manufacturing process.

Speaker Change: The emergency treatments like and tell him out aims to be to protect those critical tissues and improve survival rates can tell them that has been shown to have a three X increase in survival rates went.

Lisa: The first lot manufacturing bioequivalence equivalency testing.

Lisa: And then we will file and make a request to the FDA to market a biologic product in the United States typically expected to take approximately 18 months thereafter.

Speaker Change: When tested in animal models.

Speaker Change: But the drugs that are available today like neupogen and Neulasta had been approved for treatment of the R. S. Due to their ability to support the bone marrow repair that.

Lisa: The FDA will use that in the information we provide the testing results we presented from the manufacturing.

Jennifer Ernst: But studies in Telamon have shown improvement in both the bone marrow and the GI tract. And again, as I said, potentially being used as a stand-alone treatment, not necessarily requiring the additional medical support, but can be improved if used in conjunction with existing drugs. So these are the types of studies that we will continue to advance and demonstrate in addition to the ARS application for which this drug is ready to move into manufacturing. The Phase 3 studies have been completed for Intelimod. There are no human studies remaining for us to do for Intelimod. Our next step is to move into manufacturing validation.

Speaker Change: But studies in Colorado, that's shown improvement in both the bone marrow and the Gi tract.

Lisa: What we presented in the BLA to ensure that the biologic processes meet rigorous safety purity and potency standards.

Speaker Change: And again as I said potentially being used as a standalone treatment not necessarily requiring the additional medical support but can be improved interest in conjunction with existing drugs.

Lisa: We expect or hope to be able to then begin marketing the biologic compound in the United States, if and when the FDA issues. The biologics license. This means if all goes as planned we may be seeing first orders with them about two years.

Speaker Change: Types of studies that we will continue to advance and demonstrate.

Speaker Change: In addition to the Arris application for which this drug is ready to move into manufacturing.

Lisa: The prior to FDA approval. We may also have some opportunities to market and tell him on for emergency use in other parts of the world.

Speaker Change: So the phase III studies have been completed for <unk>. There are no human studies remaining for us to do for <unk>.

Lisa: So this represents as a drug candidate a significant revenue opportunity within a relatively short window compared to other.

Speaker Change: Our next step is to move into manufacturing validation and for that we will require wrapping up the manufacturing a certain amount of biotech biological testing in animals.

Jennifer Ernst: And for that, we will require wrapping up the manufacturing, a certain amount of biological testing in animals. and then into a BLA application or biologics license application with the FDA. this particular asset. has been significantly de-risked, meaning Tivic will be able to capitalize on it on a much less capital-intensive pathway than if we were attempting to, for example, develop a drug from scratch.

Lisa: Other drug candidates.

Lisa: Now we are also seeing a number of exciting opportunities to potentially expand our pipeline to adjacent indications.

Speaker Change: And then into a BLA application, our biologics license application with the F D. A.

Lisa: Some of the indications related to chronic radiation toxicity and again immune system Dysregulation I think they're seeing an aging populations, they're seeing among those individuals' are receiving radiation treatments.

Speaker Change: This particular asset.

Speaker Change: Has been significantly de risked, meaning critical to be able to capitalize and capitalize on it.

Speaker Change: Much less capital intensive pathway than if we were attempting to for sample develop a drug from scratch.

Lisa: And even among health care professionals that administer those radiation treatments.

Lisa: So listen for the Euro for words like immuno senescence misses the gradual age related decline.

Jennifer Ernst: ARS, though, is only one indication. Immune system dysregulation, an area we have been familiar with because of our history of working with the immune system through both the sinus nasal passages and through the VNS work we've been doing. Now, immune system dysregulation is a very common issue for patients that undergo medical radiation treatment. That is part of the area where we see expansion opportunity. So our next steps in Telemud, what you'll hear about through the course of this year, is to commence the validation of the manufacturing process. includes a first lot manufacturing, bioequivalency testing. And then we will file and make a request to the FDA to market a biologic product in the United States, typically expected to take approximately 18 months.

Speaker Change: A R S. Though is only one indication.

Speaker Change: Soon system Dysregulation in area, we have been familiar with because of our history of working with the immune system through both the Sino nasal passages am through the VNS work, we've been doing now immune system Dysregulation is a very common issue for patients that undergo medical radiation treatments.

Lisa: And our immune system function.

Lisa: <unk> is being tested in a randomized controlled trial for age related immune system dysfunction at the minute.

Lisa: Oh clinics.

Mr Pena: Mr Pena.

Mr Pena: And lymphocyte exhaustion exhaustion neutral opinion is a condition characterized by abnormally low numbers of neutrophils or white blood cells.

Speaker Change: That is part of the area, where we see expansion opportunity. So our next steps and Palomar.

Mr Pena: That can result from chemotherapy radiation bone marrow disorders, and certain autoimmune conditions.

Speaker Change: What you'll hear about through the course of this year is to commence the validation of the manufacturing process.

Mr Pena: And lymphocyte exhaustion similarly, as a condition that occurs when immune cells, particularly T cells become less effective after being exposed to infection to cancer or to cancer treatments.

Speaker Change: The first lot manufacturing bioequivalence equivalency testing.

Speaker Change: And then we will file a request to the FDA to market a biologic product in the United States typically expected to take approximately 18 months thereafter.

Mr Pena: So I told him out has been tested on humans and demonstrated utility in healthy patients and count the cancer patients.

Jennifer Ernst: The FDA will use the information we provide, the testing results we present from the manufacturing, what we present in the BLA, to ensure that the biologic processes meet rigorous safety, purity, and potency standards. We expect or hope to be able to then begin marketing the biologic compound in the United States if and when the FDA issues the biologic license. This means if all goes as planned, we may be seeing first orders within about two years. So prior to FDA approval, we may also have some opportunities to market Intelemon for emergency use in other parts of the world.

Speaker Change: The afternoon will use that in the information we provide the testing results we presented for the manufacturing.

Mr Pena: For the treatment of neutral pinion lymphocyte exhaustion.

Mr Pena: Finally, chronic radiation syndrome. So the types of cases, where conditions that are caused by the long term exposure to low levels of radiation and that's what we would see in the medical treatment area people that are on X rays around C. T scans people to work around nuclear residue or makes to me experienced occupational exposure.

Speaker Change: What we presented in the BLA to ensure that the biologic processes meet rigorous safety purity and potency standards.

Speaker Change: Yeah.

Speaker Change: We expect or hope to be able to do that and began marketing the biologic compound in the United States, if and when the FDA issues. The biologics license. This means if all goes as planned we may be seeing first orders with them about two years.

Mr Pena: The trade long term chronic syndrome.

Speaker Change: The prior to FDA approval. We may also have some opportunities to market and tell him on for emergency use in other parts of the world.

Mr Pena: We have a second compound we would advance the second licensed compound into laughter through the clinical and regulatory trials.

Jennifer Ernst: So this represents, as a drug candidate, a significant revenue opportunity within a relatively short window compared to other drug candidates.

Speaker Change: So this represents as a drug candidate a significant revenue opportunity.

Speaker Change: So leading the ramp up of this biopharma activity within civic I am thrilled to have brought on board Michael Okay. Handley, Mike is the former Chief Executive Officer, President and Chairman to Terra Biopharma ran tomorrow and polymer was previously held.

Speaker Change: Within a relatively short window compared to.

Speaker Change: Other drug candidates.

Jennifer Ernst: Now, we are also seeing a number of exciting opportunities to potentially expand our pipeline to adjacent indications. Some of the indications related to chronic radiation toxicity and, again, immune system dysregulation, I think that are seen in aging populations, they're seen among those individuals are receiving radiation treatments, and even among health care professionals that administer those radiation treatments. So listen through the year for words like immunosenescence. This is a gradual age-related decline in our immune system function. Intelinod is being tested in a randomized controlled trial for age-related immune system dysfunction at the Mayo Clinic. Neutropenia and Lymphocyte Exhaustion.

Speaker Change: Now we are also seeing a number of exciting opportunities to potentially expand our pipeline to Jason indications.

Speaker Change: Some of the indications related to chronic radiation toxicity and again immune system Dysregulation I think they're seeing an aging populations, they're seeing among those individuals' are receiving radiation treatments.

Speaker Change: He has been absolutely instrumental in the launch of 17 drug candidates and has had to exit some multiple strategic buyers.

Speaker Change: Mike has joined as our Chief operating officer.

Speaker Change: With him his experience in Neuromodulation and in drug development to the table.

Speaker Change: And even among health care professionals that administer those radiation treatments.

Speaker Change: So listen for the Euro for words like immuno senescence missiles, the gradual age related decline.

Speaker Change: He has also been having ahead of the president out there he.

Speaker Change: He is the president of <unk> Biopharma.

Speaker Change: As we began to build that program out. So I believe we believe that Mike is the perfect leader to head up with newly formed area.

Speaker Change: In our immune system function.

Speaker Change: <unk> is being tested in a randomized control trial for age related immune system dysfunction at the minute.

Speaker Change: So he'll be tasked with leading and tell him on through the remaining steps toward the potential regulatory approval and commercialization.

Speaker Change: Oh clinics.

Speaker Change: Mr Kenya.

Speaker Change: And then society Sasha exhaustion neutropenia as a condition characterized by abnormally low numbers of neutrophils or white blood cells.

Jennifer Ernst: Now, neutropenia is a condition characterized by abnormally low numbers of neutrophils or white blood. that can result from chemotherapy, radiation, bone marrow disorders, and certain autoimmune conditions. and lymphocyte exhaustion, similarly as a condition that occurs when immune cells, but particularly T cells, become less effective after being exposed to infection, to cancer, or to cancer treatment. The telemod has been tested on humans and demonstrated utility in healthy patients and cancer patients. for the treatment of neutropenia and lymphocyte exhaustion. Finally, chronic radiation syndrome, so the types of cases where conditions that are caused by the long-term exposure to low levels of radiation, and that's what we would see in the medical treatment area, people that run x-rays, that run CT scans, people that work around nuclear residue or may experience occupational exposure.

Speaker Change: And we'll also direct future biotech pipeline development activity and weather.

Speaker Change: That is through continued organic development licensing.

Speaker Change: That can result from chemotherapy radiation bone marrow disorders, and certain autoimmune conditions.

Speaker Change: Or additional inorganic opportunities that we were able to identify.

Speaker Change: And lymphocyte exhaustion similarly, as a condition that occurs when immune cells, particularly T cells become less effective after being exposed to infection to cancer or to cancer treatments.

Speaker Change: Okay.

Speaker Change: The work, we will be pursuing in this new biopharma capability.

Speaker Change: He is an ideal complement to our current focus on bio electronics.

Speaker Change: So the total amount has been tested on humans and demonstrated utility in healthy patients and cat cancer patients for.

Speaker Change: Where are we are developing AR. So I want to segue now to talk a little bit more about the noninvasive vagus nerve stimulation work that we're doing.

Speaker Change: For the treatment of neutropenia in lymphocyte exhaustion.

Speaker Change: We are developing a noninvasive.

Speaker Change: Finally, chronic radiation syndrome. So the types of cases work conditions that are caused by the long term exposure to low levels of radiation and that's what we would see in the medical treatment area people that run X rays around C. T scans people to work around nuclear residue or makes me experienced occupational exposure.

Speaker Change: Cervical that means the neck.

Speaker Change: Next stimulation device for vagus nerve activation.

Speaker Change: This is a device that we expect will be able to treat key indications that affect large populations or impacted by that.

Speaker Change: We're active immune systems.

Speaker Change: Earlier I said.

Speaker Change: And told them on until after on the biologics we have licensed.

Jennifer Ernst: To treat long-term chronic syndrome, we have a second compound. We would advance the second licensed compound, Entelasta, through the clinical and regulatory trial.

Speaker Change: So treat long term chronic syndrome.

A powerful effect on activating an immune system that is under active.

Speaker Change: We have a second compound who had advanced the second licensed compound into laughter through the clinical and regulatory trials.

Speaker Change: But there are a number of conditions, such as heart diseases, neurologic diseases and autoimmune diseases.

Jennifer Ernst: Leading the ramp-up of this biopharma activity within Tivic, I am thrilled to have brought on board Michael K. Hanley. Mike is a former Chief Executive Officer, President and Chairman of Statara Biopharma, where Enz Holomad was previously held. He has been absolutely instrumental in the launch of 17 drug candidates and has had exits to multiple strategic buyers. Mike has joined Tivic as our Chief Operating Officer. that brings him his experience in neuromodulation and in drug development to the table. He is also the president of Tivic Biopharma as we begin to build that program out. So I believe, we believe that Mike is the perfect leader to head up this newly formed area.

Speaker Change: So leading the ramp up of this biopharma activity within civic I am thrilled to have brought on board Michael to Handley, Mike is the former Chief Executive Officer, President and chairman to Terra Biopharma, where anthem out and saw a man was previously held.

Speaker Change: In which the immune system is over active.

Speaker Change: Opposite direction.

Speaker Change: So with our with the complement of both the biologic <unk>.

Speaker Change: And the bio electronic approaches we have the ability to bring the immune system and the homeostasis, whether it is <unk>.

Speaker Change: He has been absolutely instrumental in the launch of 17 drug candidates and has had to exit some multiple strategic buyers.

Speaker Change: Arctic or overactive.

Speaker Change: So each of these two programs together, we'll work to address illnesses that are caused by the immune and autonomic system Dysregulation.

Speaker Change: Mike has joined as our Chief operating officer.

One through the neuro stimulation pathways.

Speaker Change: Things in his experience in Neuromodulation and in drug development to the table.

Speaker Change: One through the body's molecular pathways.

Speaker Change: I believe that we are highly highly unique in being able to bring both solutions together as either individual candidates.

Speaker Change: He has also been having ahead of the president.

Speaker Change: He is the president of terrific Biopharma.

Speaker Change: As we began to build that program out. So I believe we believe that Mike is the perfect leader to head up this newly formed area.

Speaker Change: Or in concert with each other overtime to be able to address the serious disease conditions that the world faces today.

Jennifer Ernst: So he'll be tasked with leading Intellimod through the remaining steps toward the potential regulatory approval and commercialization, and will also direct future biotech pipeline development activity, whether that is through continued organic development licensing or additional inorganic opportunities that we are able to identify.

Speaker Change: So he'll be tasked with leading and tell him on through the remaining steps towards a potential regulatory approval and commercialization.

Speaker Change: Yeah.

Speaker Change: So to say a little bit more than about the N C. D N S program.

Speaker Change: Andy will also direct future biotech pipeline development activity, whether that is through continued organic development licensing.

Speaker Change: I've mentioned before there are surgically approved implants.

Speaker Change: <unk> opened up the neck sticking unimplanted stimulated the vagus nerve.

Speaker Change: Or additional inorganic opportunities that we were able to identify.

Speaker Change: These have been approved for or are approaching approaching approval for diseases like epilepsy depression rheumatoid arthritis.

Speaker Change: Okay.

Jennifer Ernst: The work we will be pursuing in this new biopharma capability is an ideal complement to our current focus in bioelectronics.

Speaker Change: The work, we will be pursuing in this new biopharma capability is an ideal complement to our current focus in bio electronics.

Speaker Change: Our goal, though is to replace the need for that surgical approach with a noninvasive approach.

Jennifer Ernst: But where we are developing the, so I want to segue now to talk a little bit more about the noninvasive vagus nerve stimulation work that we are doing. We are developing a noninvasive for more information. This is a device that we expect will be able to treat key indications that affect large populations who are impacted by overactive immune.

Speaker Change: But where we are developing AR. So I want to segue now to talk a little bit more about the noninvasive vagus nerve stimulation works that we're doing.

Speaker Change: We're focused on vagus nerve treatments that can be done without having to put an implant in the body, but be able to deliver equal or superior efficacy compared to the existing treatments.

Speaker Change: We are developing a noninvasive.

Speaker Change: Cervical that means go neck and neck stimulation device for vagus nerve activation.

Speaker Change: So in previous studies earlier this year, we announced results of our heart rate variability studies with Feinstein Institute.

Speaker Change: This is a device that we expect will be able to treat key indications that affect large populations or impacted by.

Speaker Change: Showing that we were demonstrating significant changes in heart rate variability in the greenway function and an autonomic system function.

Speaker Change: Our active immune systems now earlier I said.

Jennifer Ernst: earlier I said. and Tolomod, and to LASTA and the biologics we advise. have a powerful effect on activating an immune system that is underactive. But there are a number of conditions, such as heart diseases, neurologic diseases, and autoimmune diseases, in which the immune system is overactive. at www.cdc.gov. and the bioelectronic approaches, we have the ability to bring the immune system into homeostasis, whether it is underactive or overactive. So each of these two programs together will work to address illnesses that are caused by the immune and autonomic system dysregulation. one through the neural stimulation pathways and one through the body's molecular pathways.

Speaker Change: And told them on into laughter and the biologics we have licensed.

Speaker Change: Have a powerful effect on activating an immune system that is under active.

Speaker Change: Impaired to the implants, we had data that was right on par with the implant or in some cases better.

Speaker Change: But there are a number of conditions, such as heart diseases, neurologic diseases and autoimmune diseases in.

Speaker Change: Certainly better than most anyone has seen from a non invasive device.

Speaker Change: In which the immune system is over access.

Speaker Change: Yeah. We currently are going through an optimization program, a sign saying with the Feinstein Institute.

Opposite direction.

Speaker Change: So with our with the complement of both the biologic <unk>.

Speaker Change: So just two weeks ago.

Speaker Change: We shared that the Feinstein Institute for medical research.

Speaker Change: And the bio electronics approaches we have the ability to bring the immune system into homeostasis, whether it is under active or overactive.

Speaker Change: Presented the first layer of the data that's coming out of that optimization study.

Speaker Change: Our data showed that personalizing, the vagus nerve stimulation.

Speaker Change: Each of these two programs together, we'll work to address illnesses that are caused by the immune and autonomic system Dysregulation.

Speaker Change: Personalizing it not just going at it with one frequency of personalizing the stimulation to the individual.

Speaker Change: One through the neuro stimulation pathways.

Speaker Change: A 400% increase in the effects that we saw.

Speaker Change: Won through the body's molecular pathways.

Jennifer Ernst: I believe that we are highly, highly unique in being able to bring both solutions together as either individual candidates or in concert with each other over time to be able to address the serious disease conditions that the world faces today.

Speaker Change: I believe that we are highly highly unique in being able to bring both solutions together.

Speaker Change: So between having demonstrated already incredibly compelling results earlier in the year.

Speaker Change: As either individual candidates.

Speaker Change: And then continuing to work in the optimization area.

Speaker Change: Or in concert with each other overtime to be able to address the serious disease conditions that the world faces today.

Speaker Change: We are seeing the opportunity you have for a profound effect with a non invasive treatment.

Jennifer Ernst: Let's just say a little bit more then about the NCVNS program. I've mentioned before, there are surgically approved implanters. These are open up the neck, stick in an implant, stimulate the vagus. These have been approved for, or are approaching approval for diseases like epilepsy, depression, rheumatoid arthritis. Our goal, though, is to replace the need for that surgical approach with a non-invasive approach. We're focused on vagus nerve treatments that can be done without having to put an implant in the body, but be able to deliver equal or superior in efficacy compared to the existing treatments. So, in previous studies, earlier this year, we announced results of our heart rate variability studies with the Feinstein Institute.

Speaker Change: Let's just say a little bit more than about the N C. D N S program.

Speaker Change: We believe that this data is significant because it signals a strong likelihood that we can better treat inflammatory cardiac and neurologic disorders.

Speaker Change: I've mentioned before there are surgically approved implants. These are open up the neck sticking on implants stimulated the vagus nerve.

Speaker Change: Without the need for invasive surgeries.

Speaker Change: Most importantly, we believe that the studies strongly validates our strategy of developing these personalized neuromodulation devices.

Speaker Change: These have been approved for our are approaching approaching approval for diseases like epilepsy depression rheumatoid arthritis.

Speaker Change: Non implantable devices and following some of the leaders that have already informed and educated the market on VNS stimulation with him who have educated the market on VNS with them implanted device.

Speaker Change: Our goal, though is to replace the need for that surgical approach with a noninvasive approach.

Speaker Change: We're focused on vagus nerve treatments that can be done without having to put an implant in the body.

Speaker Change: Being able to deliver equal or superior efficacy compared to the existing treatments.

Speaker Change: We hope to be able to demonstrate that we can replace those implanted devices with.

Speaker Change: With noninvasive approaches broadening the market, reducing the risk to patient and opening up new therapeutic category.

Speaker Change: So in previous studies earlier this year, we announced our results of our heart rate variability studies with Feinstein Institute.

Speaker Change: We expect to complete the data gathering phase of this optimization work with the Feinstein Institute sometime in the next month or two and.

Jennifer Ernst: showing that we were demonstrating significant changes in heart rate variability, in the brain wave function, and in autonomic system function. Compared to the implants, we had data that was right on par with the implant, or in some cases, better. certainly better than most anyone has seen from a non-invasive device. Now, we currently are going through an optimization program of fine. with the Feinstein Institute. for just two weeks ago. We shared that the Feinstein Institute for Medical Research presented the first layer of the data that is coming out of that optimization study. Our data showed that personalizing the vagus nerve stimuli personalizing it, not just going at it with one frequency, but personalizing the stimulation to the individual, offered a 400% increase in the effects that we saw.

Speaker Change: Showing that we were demonstrating significant changes in heart rate variability and the brainwave function.

Speaker Change: And I would expect to be reporting that data further in the further out in the course of this year and in Q2.

Speaker Change: And in autonomic system function.

Speaker Change: Impaired to the implants, we had data that was right on par with the implant or in some cases better.

Speaker Change: Progress during the last several weeks also included expanding our U S and international IP portfolio that we filed on these new novel modalities of stimulation, including the personalization.

Speaker Change: Certainly better than most anyone has seen from a non invasive device.

Speaker Change: Yeah. We currently are going through an optimization program of science day, with if Ive seen Institute.

Speaker Change: Adding additional IP on our state of the art method of personalizing, the vagus nerve stimulation that is received.

Speaker Change: So just two weeks ago.

Speaker Change: We shared that the Feinstein Institute for medical research.

Speaker Change: With a growing clinical data showing the tailoring keys stimulation parameters to each study subject result in meaningfully improved effect.

Speaker Change: Presented the first layer of the data that's coming out of that optimization study.

Speaker Change: Our data showed the personalizing the vagus nerve stimulation.

Speaker Change: No actually it doesn't mean, the autonomic system, we believe that this combo as a key differentiator for introducing the new vagus nerve stimulation.

Speaker Change: Personalizing it not just going at it with one frequency of personalizing the stimulation to the individual.

Speaker Change: A 400% increase in the effects that we saw.

Speaker Change: So I have been a bit vague about exactly where we intend to apply these.

Speaker Change: We have completed on or working through the data from work, we engaged Fletcher state in Q3 and Q4 to do.

Jennifer Ernst: So, between having demonstrated already incredibly compelling results earlier in the year and then continuing the work in the optimization area. We are seeing the opportunity here for a profound effect with a non-invasive treatment. We believe that this data is significant because it signals a strong likelihood that we can better treat inflammatory, cardiac, and neurologic disorders without the need for invasive surgery. And most importantly, we believe that the study strongly validates our strategy of developing these personalized neuromodulation devices. non-implantable devices, and following some of the leaders that have already informed and educated the market on VNS stimulation, who have educated the market on VNS with an implanted device.

Speaker Change: So between having demonstrated already incredibly compelling results earlier in the year.

Speaker Change: And then continuing to work in the optimization area.

Speaker Change: As we prioritize the selection of the first indication. So we've been looking Wisconsin I'm looking at all of the market applications for BNS.

Speaker Change: We are seeing the opportunity you have for a profound effect with a non invasive treatment.

Speaker Change: Using that data about reimbursement about physician Receptiveness patients' receptiveness.

Speaker Change: We believe that the state is significant because it signals a strong likelihood that we can better treat inflammatory cardiac and neurologic disorders.

Speaker Change: Our confidence continues to grow as we work through that and prepare to move into the disease specific clinical trials.

Speaker Change: Without the need for invasive surgeries.

Speaker Change: So in the short term.

Speaker Change: In the short term, we will be prioritizing the advancement of an telemark towards revenue.

Speaker Change: Most importantly, we believe that the studies strongly validates our strategy of developing these personalized neuromodulation devices.

Speaker Change: I also expect though that we will begin entering these disease specific trials for the vagus nerve stimulation device.

Speaker Change: Non implantable devices and following some of the leaders that have already informed and educated the market on VNS stimulation with him who have educated the market on VNS with them implanted device.

Speaker Change: In 2025.

Speaker Change: So as we are securing our intellectual property on a global scale, maybe we have 16 issued patents and 11 patents pending.

Jennifer Ernst: And we hope to be able to then demonstrate that we can replace those implanted devices. with non-invasive approaches, broadening the market, reducing the risk to patients, and opening up new therapeutic categories. And we expect to complete the data gathering phase of this optimization work with the Feinstein Institute sometime in the next month or two, and I would expect to be reporting that data further out in the course of this year in Q2. Progress during the last several weeks also included expanding our U.S. and international IP portfolio. So we filed on these new novel modalities of stimulation, including the personalization.

Speaker Change: We hope to be able to demonstrate that we can replace those implanted devices with.

Speaker Change: We also now have exclusively licensed over 60 patents as part of our agreements with the terror Biopharma.

Speaker Change: With noninvasive approaches broadening the market, reducing the risk to patient and opening up new therapeutic category.

Speaker Change: This combination of a biologic and bio electronic immunotherapy pipeline represents a really truly transformational opportunity for the company.

Speaker Change: We expect to complete the data gathering phase of this optimization work was the Feinstein Institute sometime in the next month or two and.

Speaker Change: And it's an incredible opportunity and moment in time for our investors.

Speaker Change: And I would expect to be reporting that data further and further out in the course of this year and then in Q2.

Speaker Change: I just wanted to highlight that a compelling aspect of the clinical pipeline we've created.

Speaker Change: Progress during the last several weeks also included expanding our U S and international IP portfolio that we filed on these new novel modalities of stimulation, including the personalization.

Speaker Change: This comparative cost effectiveness in the world of Therapeutics Protiviti non invasive VNS device the cost to advance the treatment through U S. FDA approval is substantially lower than what it has to do so with a surgical implanted device.

Jennifer Ernst: additional IP on a state-of-the-art method of personalizing the vagus nerve stimulation that is received. With the growing clinical data showing that tailoring key stimulation parameters to each study subject results in meaningfully improved effect on the measures of the autonomic system, we believe that this combo is a key differentiator for introducing the new vagus nerve stimulation.

Speaker Change: Adding additional IP on our state of the art method of personalizing, the vagus nerve stimulation that is received.

Speaker Change: Companies that have developed the implanted therapeutics have been funded to the tune of hundreds of millions of dollars.

Speaker Change: With a growing clinical data showing the tailoring keys stimulation parameters to each study subject result in meaningfully improved effect.

Speaker Change: However, because of the significant because of this noninvasive approach and then take a look at the significant prior investment has already been.

Speaker Change: And then I was just doesn't go autonomic system. We believe that this combo is a key differentiator for introducing the new vagus nerve stimulation.

Speaker Change: Made for and tell them on the fact that there are no remaining human trials between here and revenue for the first indication.

Jennifer Ernst: So, I have been a bit vague about exactly where we intend to apply these. We have completed and are working through the data from work we engaged Fletcher Spaeth in Q3 and Q4 to do. as we prioritize the selection of the first indication. So we've been looking with confidence, looking at all of the market applications for VMS, using that data about reimbursement, about physician receptiveness, patient receptiveness. Our confidence continues to grow as we work through that and prepare to move into the disease-specific clinical trial. So in the short term, in the short term, we will be prioritizing the advancement of Intelimod towards revenue.

Speaker Change: So I haven't been vague about exactly where we intend to apply these.

Speaker Change: We have completed our working through the data from work, we engaged Fletcher state in Q3 and Q4 to do.

Speaker Change: Fantastic.

Speaker Change: Secure the option to license five additional indications for Telemark and its second generation drug into Alaska.

Speaker Change: As we prioritize the selection of the first indication. So we've been looking Wisconsin looking at all of the market applications for VNS yeah.

Speaker Change: This is an incredible moment for the company, we are a completely different company than we were six months ago.

Speaker Change: Are you using that data about reimbursement about physician receptiveness patients' receptiveness, our confidence continues to grow as we work through that and prepare to move into the disease specific clinical trials.

Speaker Change: Which finally brings me to a couple of other of our other updates important for investors.

Speaker Change: As we previously communicated we received a notice as last year from now think of the bid price deficiency.

Speaker Change: So in the short term.

Speaker Change: In February we presented our compliance plan to the NASDAQ hearings panel and subject to subsequently we received approval of our compliance plan.

Speaker Change: Yeah in the short term, we will be prioritizing the advancement of an telemark towards revenue.

Jennifer Ernst: I also expect, though, that we will begin entering these disease-specific trials for the vagus nerve stimulation device later in 2025. So, as we are securing our intellectual property on a global scale, today we have 16 issued patents and 11 patents pending. We also now have exclusively licensed over 60 patents as part of our agreements with Statara Biopharm. This combination of a biologic and bioelectronic immunotherapy pipeline represents a truly, truly transformational opportunity for the company. and it's an incredible opportunity and moment in time for our investors. I just want to highlight that a compelling aspect of the clinical pipeline we've created is its comparative cost effectiveness.

Speaker Change: I also expect though that we will began entering these disease specific trials for the vagus nerve stimulation device later in 2025.

Speaker Change: An extension of our review.

Speaker Change: Well I am pleased to say.

Speaker Change: As of today.

Speaker Change: So as we are securing our intellectual property on a global scale. They we have 16 issued patents and 11 patents pending.

Speaker Change: Today.

Speaker Change: We have traded above a dollar for 10 consecutive days.

Speaker Change: And we fully expect to be hearing from NASDAQ soon that we are in compliance with continued listing requirements.

We also now have exclusively licensed over 60 patents as part of our agreements with the terror Biopharma.

Speaker Change: This morning, we also announced that we've closed an equity line of credit and the amount of $25 million.

Speaker Change: This combination of a biologic and bio electronic immunotherapy pipeline represents a really truly transformational opportunity for the company.

Speaker Change: An equity line of credit we don't take it all at once this gives us a very flexible tool, though for funding the company through the stages of development.

Speaker Change: And it's an incredible opportunity and moment in time for our investors.

Speaker Change: If we were able to fully utilize even a portion of that line.

Speaker Change: I just wanted to highlight that a compelling aspect.

Speaker Change: We believe we have the commercialization ovens Palomar.

Speaker Change: The clinical pipeline. We've created is this comparative cost effectiveness in the world of Therapeutics Protiviti non invasive VNS device the cost to advance the treatment through U S FDA approval.

Speaker Change: Ollie funded.

Jennifer Ernst: In the world of therapeutics, for Tivic's non-invasive BNS device, the cost to advance a treatment through U.S. FDA approval is substantially lower than what it is to do so with a surgical implanted device. companies that have developed the implanted therapeutics have been funded to the tune of hundreds of millions of dollars. However, because of this non-invasive approach, and then take a look at the significant prior investment that has already been made for Intelimod, the fact that there are no remaining human trials between here and revenue for the first syndication. and Tivic has secured the option to license five additional indications for Intelimod and its second generation drug Entelos.

Speaker Change: And as we move forward, we can strategically finance the rest of our programs. So I started this call.

Speaker Change: This is a transformational year for Tyvek and.

Speaker Change: It is substantially lower than what it has to do so with a surgical implanted device.

Speaker Change: And a lot of what we have worked on is coming to fruition right now.

Speaker Change: We started 2024 as a single product company with an O T C.

Speaker Change: Companies that have developed the implanted therapeutics have been funded to the tune of hundreds of millions of dollars.

Speaker Change: Product directly to consumers' needs.

Speaker Change: We now have a highly robust immunotherapy pipeline and I would encourage any investor who might be looking at civic.

Speaker Change: However.

Speaker Change: Because of the significant because the best Noninvasive approach and then take a look at the significant prior investment has already been <unk>.

Speaker Change: Go look at comparable companies.

Speaker Change: Made for Telemark. The fact that there are no remaining human trials between here and revenue for the first indication.

Speaker Change: In the market today, who are doing immuno therapeutics and the type of valuations that are present when you have this kind of pipeline.

Speaker Change: And so they can.

Speaker Change: How secure the option to license five additional indications for Telemark.

Speaker Change: So with that yes, we now go to our 'twenty 'twenty four numbers, but for me.

Speaker Change: And the second generation drug enter Alaska.

Jennifer Ernst: This is an incredible moment for the company.

Speaker Change: What is most exciting about civic today is looking forward to 2020 five and the foundation we have created.

Speaker Change: This is an incredible moment for the company, we are a completely different company than we were six months ago.

Jennifer Ernst: We are a completely different company than we were six months ago.

Jennifer Ernst: which finally brings me to a couple of other updates important for investors. As we previously communicated, we received the notices last year from NANOWTEC of a bid price deficient. In February, we presented our compliance plan to the NASDAQ hearings panel, and subsequently, we received approval of the compliance plan and extension of our review.

Speaker Change: No.

Speaker Change: Which finally brings me to a couple of other of our other updates important for investors.

Lisa: So let me turn now the call over to Lisa.

Lisa: More it on your own balance sheet, and our P&L data points.

Speaker Change: As we previously communicated we received a notice as last year from NASDAQ with the bid price deficiency.

Lisa: Thank you Jennifer for ease of listening all of the financial metrics I'll be reporting today compare the year ended December 31, 2024 to the prior year ended December 31, 2023, unless otherwise stated.

Speaker Change: In February we presented our compliance plan to the NASDAQ hearings panel and subsequent subsequently we received approval of our compliance plan.

Lisa: Revenue net of returns totaled <unk> 8 million compared to 1.2 million a year ago. The decline was primarily due to a decrease in unit sales of 41% associated with reductions in our overall marketing spend.

Speaker Change: Extension of our review.

Jennifer Ernst: I am pleased to say. as of today. We traded above $1 for 10 consecutive days, and we fully expect to be hearing from NASDAQ soon that we are in compliance with continued listing requirements.

I am pleased to say.

Speaker Change: As of today.

Speaker Change: As of today we.

Speaker Change: We have traded above a dollar for 10 consecutive days.

Speaker Change: And we fully expect to be hearing from NASDAQ soon that we are in compliance with continued listing requirements.

Lisa: Cost of sales decreased 12% to $8 million from 9 million in the prior year, primarily due to a 41% decrease in unit sales.

Jennifer Ernst: This morning, we also announced that we have closed an equity line of credit in the amount of $25 million. An equity line of credit, we don't take it all at once. This gives us a very flexible tool, though, for funding the company through the stages of development. if we were able to fully utilize even a portion of that line. We believe we have the commercialization of Intellimod fully funded.

Speaker Change: This morning, we also announced that we've closed the equity line of credit and the amount of $25 million.

Lisa: Cost of sales in 2024 included an inventory reserve of 354000, compared with 32000 and reserves for 2023.

Speaker Change: And equity line of credit we don't take it all at once this gives us a very flexible tool, though for funding the company through the stages of development.

Lisa: Disposal costs of 21000 were incurred in 2024 related to the move to a new logistics provider. The change in logistics providers. In August 2024 has resulted in cost savings and improved margins on a recurring basis.

Speaker Change: If we were able to fully utilize even a portion of that line.

Speaker Change: We believe we have the commercialization of and tell him on fully funded.

Jennifer Ernst: And as we move forward, we can strategically finance the rest of our programs. So I started this call saying this is a transformational year for Tivic. And a lot of what we have worked on is coming to fruition right now. We started 2024 as a single product company with an OTC product directed to consumers. We now have a highly robust immunotherapy pipeline, and I would encourage any investor who might be looking at Tivic to go look at comparable companies. in the market today who are doing immunotherapeutics and the type of valuations that are present when you have this kind of pipeline.

Speaker Change: And as we move forward, we can strategically finance the rest of our programs. So I started this call.

Lisa: We're exploring new opportunities to increase cash flow generated by the clear up business, we deployed a new ecommerce web infrastructure for clear up improving user experience and also upgraded the Tyvek health Investor Relations website.

Speaker Change: This is a transformational year for civic.

Speaker Change: And a lot of what we have worked on is coming to fruition right now.

Speaker Change: We started 2024 as a single product company with an O T C.

Lisa: Gross profit was 2000 compared with 287000 for the prior year the lower gross profit in 2024 was primarily due to the 354000 in inventory reserves recorded in 2024 compared to 32000 in 2023.

Speaker Change: Product directly to consumers.

Speaker Change: We now have a highly robust immunotherapy pipeline and I would encourage any investor who might be looking at civic to go lot of comparable companies.

Speaker Change: In the market today or doing immuno therapeutics and the type of valuations that are present, when you have this kind of pipeline.

Lisa: Total operating expenses were $5 7 million compared to $8 5 million for 2023.

Jennifer Ernst: But with that, yes, we now go to our 2024 numbers, but for me. What is most exciting about Tivic today is looking forward to 2025 and the foundation we have created now.

Speaker Change: So with that yes, we now go to our 'twenty 'twenty four numbers, but for me.

Lisa: We plan to increase our research and development investments in our vagus nerve platform in clinical applications.

Speaker Change: What is most exciting about civic today is looking forward to 2020 five and the foundation we have created.

Lisa: And to advance the development of Tyvek licensed T. L. R. Five agonist programs, specifically and telemark and into laughter.

Speaker Change: No.

Lisa Wolfe: Let me turn now the call over to Lisa to report on the U.S. Balance Sheet and our P&L data. Thank you, Jennifer.

Lisa: So let me turn now the call over to Lisa before it out of your S balance sheet and our P&L data points.

Lisa: Net loss for the year decreased to $5 7 million from $8 2 million for 2023.

Lisa: Thank you Jennifer for ease of listening all of the financial metrics I'll be reporting today compare the year ended December 31, 2024 to the prior year ended December 31, 2023, unless otherwise stated.

Lisa Wolfe: For ease of listening, all of the financial metrics I'll be reporting today compare the year ended December 31, 2024 to the prior year ended December 31, 2023, unless otherwise stated. Revenue net of returns totaled $0.8 million compared to $1.2 million a year ago. The decline was primarily due to a decrease in unit sales of 41 percent associated with reductions in our overall marketing spend. Cost of sales decreased 12% to $0.8 million from $0.9 million in the prior year, primarily due to a 41% decrease in unit sales. Cost of sales in 2024 included an inventory reserve of $354,000 compared with $32,000 in reserves for 2023.

Lisa: Cash and cash equivalents at December 31, 2024 totaled $2 million compared with $3 4 million at December 31, 2023.

Lisa: Revenue net of returns totaled <unk> 8 million compared to $1 2 million a year ago. The decline was primarily due to a decrease in unit sales of 41% associated with reductions in our overall marketing spend.

Lisa: The company had working capital of $2 4 million at December 31, 2024.

Lisa: We have no debt as of year end 2024 or 2023.

Lisa: We recently affected a reverse stock split one of the greatest challenges of drug and device development is the need for constant capital infusions over time until full commercialization occurred.

Lisa: Cost of sales decreased 12% to $8 million from 9 million in the prior year, primarily due to a 41% decrease in unit sales.

We've taken preemptive actions to solidify a promising future for cubic and its shareholders, which included the shareholders' approval of a 17 for one reverse stock split which went into effect on March 7th.

Lisa: Cost of sales in 2024 included an inventory reserve of 354000, compared with 32000 and reserves for 2023.

Lisa Wolfe: Disposal costs of $21,000 were incurred in 2024 related to the move to a new logistics provider. The change in logistics providers in August 2024 has resulted in cost savings and improved margins on a recurring basis.

Lisa: Disposal costs of 21000 were incurred in 2024 related to the move to a new logistics provider. The change in logistics providers. In August 2024 has resulted in cost savings and improved margins on a recurring basis.

Lisa: The objective of this action is to gain compliance with exchange listing requirements by potentially increasing the market price of <unk> common stock and making it more attractive to investors.

Lisa: We feel confident that with the progress we've made on meeting NASDAQ requirements and reshaping the company to become a more diversified organization, we are well positioned for growth opportunities ahead.

Lisa Wolfe: We're exploring new opportunities to increase cash flow generated by the ClearUp business. We deployed a new e-commerce web infrastructure for ClearUp, improving user experience, and also upgraded the Tivic Health Investor Relations website. Gross profit was $2,000 compared with $287,000 for the prior year. The lower gross profit in 2024 was primarily due to the $354,000 in inventory reserves recorded in 2024 compared to $32,000 in 2023.

Lisa: We're exploring new opportunities to increase cash flow generated by the clear up business.

Lisa: We deployed a new ecommerce web infrastructure for clear at improving user experience and also upgraded the Tyvek health Investor Relations website.

Jennifer Ernst: Now, let me turn the call back to Jennifer for closing remarks.

Jennifer Ernst: Hey, Thank you Lisa.

As we start 2025.

Lisa: Gross profit was 2000 compared with 287000 for the prior year.

Speaker Change: <unk> is a completely different company than we were a year ago.

Lisa: The lower gross profit in 2024 was primarily due to the 354000 in inventory reserves recorded in 2024 compared to 3202023.

Speaker Change: I look forward to this year more than I have any other year in our company's history.

Speaker Change: We continue with a determined focus on achieving the upcoming key milestones those associated with the Intel them on commercialization and with advancing our VNS programs in particular, I mean, we view 2025, a year of growth and progress, but we'll continue to reshape pivot we will continue to move the company closer to securing regular.

Lisa Wolfe: Total operating expenses were $5.7 million compared to $8.5 million for 2023. We plan to increase our research and development investments in our Vagus Nerve platform and clinical applications and to advance the development of Tivic's licensed TLR-5 agonist programs, specifically Intolimod and Intolastis. Net loss for the year decreased to $5.7 million from $8.2 million for 2023. Cash and cash equivalents at December 31, 2024 totaled $2 million, compared with $3.4 million at December 31, 2023. The company had working capital of $2.4 million at December 31, 2024. We have no debt as of year-end 2024 or 2023.

Lisa: Total operating expenses were $5 7 million compared to $8 5 million for 2023.

Lisa: We plan to increase our research and development investments in our vagus nerve platform and clinical applications.

Speaker Change: Tori approvals for what we expect will be life changing treatments for patients in need.

Lisa: And to advance the development of Tyvek licensed T. L. R. Five agonist programs, specifically and Telemark and into Alaska.

Speaker Change: And on a final note I invite you to visit our newly updated Investor website web pages, where we have updated our clinical pipeline and investor deck to capture the broadened opportunities for product development and expansion.

Lisa: Net loss for the year decreased to $5 7 million from $8 2 million for 2023.

Lisa: Cash and cash equivalents at December 31, 2024 totaled $2 million compared with $3 4 million at December 31, 2023.

Speaker Change: There you can also sign up to receive company news and finally and alerts that will help you stay informed of.

The exciting progress that doesn't have us in real time.

Lisa: The company had working capital of $2 4 million at December 31, 'twenty 'twenty four.

Speaker Change: I look forward to communicating with you.

Speaker Change: Very soon as we come back for the next earnings call.

Lisa: We have no debt as of year end 2024, or 2023, we recently affected a reverse stock split one of the greatest challenges of drug and device development is the need for constant capital infusions over time until full commercialization occurred.

Speaker Change: And thank you so much I wanted to offer my thanks to our team to our investors and also to craft capital who brought this incredible opportunity to us.

Lisa Wolfe: We recently affected a reverse stock split. One of the greatest challenges of drug and device development is the need for constant capital infusions over time until full commercialization occurs. We've taken preemptive actions to solidify a promising future for Tivic and its shareholders, which included the shareholders' approval of a 17 for one reverse stock split, which went into effect on March 7th. The objective of this action is to gain compliance with exchange listing requirements by potentially increasing the market price of Tivic's common stock and making it more attractive to investors. We feel confident that with the progress we've made on meeting NASDAQ requirements and reshaping the company to become a more diversified organization, we are well positioned for growth opportunities ahead.

Speaker Change: To help US build this company going forward. So I want to thank all of our collaborators across this process of a transformation and turning to Vic now into a diversified therapeutics company.

Lisa: We've taken preemptive actions to solidify a promising future for cubic and its shareholders, which included the shareholders' approval of a 17 for one reverse stock split which went into effect on March 7th.

Speaker Change: Thank you.

Lisa: The objectives of this action is to gain compliance with exchange listing requirements by potentially increasing the market price of <unk> common stock and making it more attractive to investors.

Speaker Change: That does conclude today's teleconference. We thank you for your participation.

Speaker Change: Disconnect your lines at this time.

Lisa: We feel confident that with the progress we've made on meeting NASDAQ requirements and reshaping the company to become a more diversified organization, we are well positioned for growth opportunities ahead.

Jennifer Ernst: Now let me turn the call back to Jennifer for closing remarks. Thank you, Lisa.

Jennifer Ernst: Now, let me turn the call back to Jennifer for closing remarks.

Jennifer Ernst: Thank you Lisa.

Jennifer Ernst: Now, as we start 2025, Tivic is a completely different company than we were a year ago. I look forward to this year more than I have any other year in the company's history. We continue with a determined focus on achieving the upcoming key milestones, those associated with the Intellimod commercialization and with advancing our VNS programs in particular. And we view 2025 as a year of growth and progress that will continue to reshape Tivic. We will continue to move the company closer to securing regulatory approvals for what we expect will be life changing treatments for patients in need.

Speaker Change: As we start 2025.

Speaker Change: <unk> is a completely different company than we were a year ago.

Speaker Change: I look forward to this year more than I have any other year in our company's history.

Speaker Change: We continue with a determined focus on achieving the upcoming key milestones those associated with the Intel them on commercialization and with advancing our VNS programs in particular, I mean, we view 2025, a year of growth and progress, but we'll continue to reshape Tyvek. We will continue to move the company closer to securing regular.

Speaker Change: Tori approvals for what we expect will be life changing treatments for patients in need.

Jennifer Ernst: And on a final note, I invite you to visit our newly updated investor website, web pages where we have updated our clinical pipeline and investor deck to capture the broadened opportunities for product development and expansion. Well, there you can also sign up to receive company news and filing alerts that will help you stay informed of the exciting progress that is ahead of us in real time. So I look forward to communicating with you very soon as we come back for the next earnings call.

Speaker Change: And on a final note I invite you to visit our newly updated Investor website web pages, where we have updated our clinical pipeline and investor deck to capture the broadened opportunities for product development and expansion.

Speaker Change: There you can also sign up to receive company news and finally and alerts that will help you stay informed of the exciting progress. It is ahead of us in real time.

Speaker Change: I look forward to communicating with you very soon as we come back for the next earnings call and thank you. So much I wanted to offer my thanks to our team.

Jennifer Ernst: And thank you so much. I want to offer my thanks to our team, to our investors, and also to Kraft Capital, who brought this incredible opportunity to us. to help us build this company going forward. So I want to thank all of our collaborators across this process of a transformation and turning Tivic now into a diversified therapeutics company.

Speaker Change: So our investors and also to craft capital, who brought this incredible opportunity to us.

Speaker Change: To help US build this company going forward. So I want to thank all of our collaborators across this process of a transformation and turning civic now into a diversified therapeutics company.

Operator: Thank you.

Speaker Change: Thank you.

Operator: And with that, that does conclude today's teleconference. We thank you for your participation. You may disconnect your lines.

Speaker Change: That does conclude today's teleconference. We thank you for your participation.

Speaker Change: Disconnect your lines at this time.

Speaker Change: Okay.

Speaker Change: [music].

Operator: tempted to say how drunk I am