Q3 2024 SIGA Technologies Inc Earnings Call
Operator: Please go ahead. Good afternoon, everyone, and thank you for joining today's call and the review of our business results for the third quarter of 2024.
Good afternoon, everyone and thank you for joining today's call and the review of our business results for the third quarter 2024, I'm joined by Dan <unk>, Our Chief Financial Officer, and we appreciate this opportunity to provide an update on our company. After the update will be happy to answer your questions.
Sam: I am joined by Dan Luckshire, our Chief Financial Officer, and we appreciate this opportunity to provide an update on our company. After the update, we'll be happy to answer your questions. I'm pleased to share that with 122 million of procurement orders secured in the third quarter, SIGA continues to sustain its strong business momentum. These new orders position us well to extend our strong year-to-date revenue performance, which is outpacing revenues in the comparable period last year. Additionally, I would like to note that our product sales so far this year include a diverse mix of revenue sources.
I'm pleased to share that with 122 million a procurement order secured in the third quarter due to continued just staying its strong business momentum.
These new orders position us well to extend our strong year to date revenue performance, which is outpacing revenues in the comparable period last year.
Additionally, I would like to note that our product sales. So far this year include a diverse mix of revenue sources.
Sam: led by oral and IV T-pox deliveries to the U.S. Strategic National Stockpile. Internationally, year-to-date sales include deliveries to new customers, one of which represents our first sales of oral teapots in Africa in response to a request from the Ministry of Health in Morocco. At the end of the third quarter, Outstanding Procurement Orders were $146 million. This significant balance of outstanding orders positions us to recognize substantial revenues in the fourth quarter of 2024 and into 2025, demonstrating the continued strong demand for TPOC. Please note that this outstanding order balance includes most of the $112.5 million order from the U.S.
Led by oral and IV cheap past deliveries to the U S strategic national stockpile.
Internationally year to date sales include deliveries two new customers, one of which represents our first sale of oral T. Pax in Africa in response to a request from the Ministry of Health in Morocco.
At the end of the third quarter outstanding procurement orders for 146 million.
This significant balance of outstanding orders positions us to recognize substantial revenues in the fourth quarter of 'twenty 'twenty four and into 2025.
Demonstrating the continued strong demand for T box.
Please note that this outstanding order balance includes most of the $112 5 million order from the U S government under the 19 see contract announced in July, which we began shipping towards the end of September and continued into October.
Sam: government under the 19C contract announced in July, which we began shipping towards the end of September and continued into October. We believe year-to-date sales, as well as the outstanding orders built over the past several months, underscore our company's financial strength and resilience. Our focus continues to be on SIGA's long-term performance as we have multiple strategic opportunities to drive and expand our revenue base and earnings over time. Looking forward, we believe securing a new contract for the continuing supply of teapots to the Strategic National Stockpile, or SNS, represents a significant opportunity to enhance our company's momentum and long-term earnings potential, as well as do our part to advance our nation's public health preparedness.
We believe year to date sales as well as the out any or has built over the past several months underscore our company's financial strength and resilience.
Our focus continues to be on Chico's long term performance as we have multiple strategic opportunities to drive and expand our revenue base and earnings over time.
Looking forward, we believe securing a new contract for the continued supply of cheap talks to the strategic national stockpile or S. N. S represents a significant opportunity to enhance our company's momentum and long term earnings potential as well as do our part to advance our nation's public health preparedness we.
Sam: We believe our ongoing productive conversations with a wide range of government officials positions us well as we prepare for the administration of strategic preparedness and response, known as ASPR, to take the first step in a process which we expect to result in a new contract for TPP. As a reminder, ASPR is within the U.S. Department of Human Services, or HHS, and houses the Center for the Biomedical Advanced Research and Development Authority, or BARDA, and the SNS. We believe our dedicated team is well prepared to support this crucial public health initiative. And based on these conversations, we are confident in the U.S.
We believe our ongoing productive conversations with a wide range of government officials positions us well as we prepare for the administration of strategic preparedness and response known as Aspira to take the first step in a process, which we expect to result in a new contract for T pox.
As a reminder, as far as within the U S Department of human services or.
Our HHS and houses a center for the biomedical advanced research and development authority or BARDA and the SLS.
We believe our dedicated team is well prepared to support this crucial public health initiatives.
And based on these conversations we are confident in the U S government's enduring commitment to maintaining robust public health preparedness and the supply of anti viral therapies to treat smallpox.
Sam: government's enduring commitment to maintaining robust public health preparedness and a supply of antibiotherapies to treat smallpox. Importantly at SIGA we believe that the effective pandemic preparedness requires both vaccines and antivirals as neither alone can fully address the complexity of an outbreak. While vaccines play an important role preventing disease and building immunity, they may not be immediately available or effective for everyone. Antivirals, meanwhile, offer a critical line of defense by treating infections in real time and reducing the severity and spread of illness. Together, these tools provide a comprehensive approach to managing a pandemic, ensuring both preventive measures and timely treatments are available.
Speaker Change: Importantly at Seeger, we believed that the effects of pandemic preparedness requires both vaccines and anti virals as neither alone can fully address the complexity of an outbreak.
Speaker Change: While vaccines play an important role preventing disease and building immunity. They may not be immediately available or effective for everyone.
Speaker Change: Anti Virals. Meanwhile, offer a critical line of defense by treating infections in real time, and reducing the severity and spread of illness.
Speaker Change: Together these tools provide a comprehensive approach to managing a pandemic, ensuring both preventive measures and timely treatments are available.
Sam: We anticipate working towards a new comprehensive long-term agreement spanning five to 10 years. As a frame of reference, our last contract, executed in 2018, was valued at $546 million. Given the many changes anticipated to take place over the coming weeks in the federal government, the exact timing of the necessary steps remain to be determined. Please keep in mind that health security is a bipartisan issue with strong alignment across both parties and transcends elections and political consideration. This has been reinforced by our experience with administrations from both parties. In fact, our last two contracts were awarded under different administrations, specifically President Obama and President Trump.
Speaker Change: We anticipate working towards a new comprehensive long term agreement spanning five to 10 years.
Speaker Change: As a frame of reference our last contract executed in 2018 was valued at 546 million.
Speaker Change: Given the many changes anticipated to take place over the coming weeks and the federal government. The exact timing of the necessary steps remain to be determined.
Speaker Change: Please keep in mind that helps security is a bipartisan issue with strong alignment across both parties and transcends elections and political considerations.
Speaker Change: This has been reinforced by our experience with the administration's from both parties.
Speaker Change: In fact, our last two contracts were awarded under different administrations, specifically, President Obama and President Trump.
Sam: In summary, we're targeting the issuance of a new S&S contract in 2025, which we expect would include initial order under such contract. Such a contract would further our shared goal of protecting public health through continued partnership with the U.S. government.
Speaker Change: In summary, we're targeting the issuance of a new S. N S contract in 2025, which we expect would include initial order until under such contract.
Speaker Change: Such a contract with further our shared goal of protecting public health their continued partnership with the U S government.
Sam: Shifting gears, I'm pleased to share that we've recently announced an exclusive license to the portfolio of our preclinical, fully human, monoclonal antibodies from the Vanderbilt University that have the potential to treat a broad range of orthopoxviruses, including smallpox and mpox. This portfolio of monoclonals expands our pipelines, complements our TPOX franchise, and offers the potential for development of additional therapies in this space. Further, it opens the door to new long-term growth opportunities in collaboration with government partners to offset development investments. The U.S. Department of Defense is currently funding the development of these monoclonals through phase one via a third-party contract manufacturing organization with proven expertise in biologics development and manufacturing.
Speaker Change: Shifting gears I'm pleased to share that we recently announced an exclusive license to the portfolio of our preclinical fully human monoclonal antibodies from the Vanderbilt University that has the potential to treat a broad range of orthopoxvirus is including smallpox and pox.
Speaker Change: This portfolio of monoclonal as it expands our pipelines complements our T. Pax franchise and offers the potential for development of additional therapies in this space.
Speaker Change: Further it opens the door to new long term growth opportunities in collaboration with government partners to offset development of aspects.
Speaker Change: The U S Department of Defense is currently funding the development of these monoclonal <unk> through phase one by a third party contract manufacturing organization with proven expertise in biologics development and manufacturing.
Sam: Assuming the data are positive on these future studies, we plan to explore collaborations with government stakeholders and with their input pursue the development of these monoclonals to meet the needs of patients and public health. Our efforts will strive to develop this portfolio over the next several years efficiently, without requiring significant use of the company's cash resources to progress. The license marks an important step forward in our strategy to leverage our existing capabilities to create new opportunities for growth over the long term. Regarding the TPOX post-exposure prophylaxis program for smallpox or PEP, we continue to collaborate with the CDC in consultation with the FDA to complete the analysis of samples collected to support the study's immunogenicity objectives.
Speaker Change: Assuming the data are positive on these future studies, we plan to explore collaborations with government stakeholders and with their input pursue the development of these monoclonal to meet the needs of patients and public health.
Speaker Change: Our efforts will strive to develop this portfolio over the next several years efficiently without requiring significant use of the company's cash resources to progress.
Speaker Change: The license marks an important step forward in our strategy to leverage our existing capabilities to create new opportunities for growth over the long term.
Speaker Change: Regarding the T. Pax post exposure prophylaxis program for smallpox or pet we continue to collaborate with the C. D. C. In consultation with the F. D. A to complete the analysis of samples collected to support the study's Immunogenicity objective.
Sam: The CDC recently began gearing up to perform the reanalysis and is targeted to complete its work in the first half of 2025. As such, we are planning for an FDA submission of the PEP indication in the third quarter of 2025. As we announced on August 15th, the National Institute of Allergy and Infectious Diseases, or NIAID, shared top-line results from a preliminary analysis from the PALM-007 trial. While the study did not meet its primary endpoint of a statistically significant improvement in time-to-lesion resolution within 28 days for MPOX patients in the Democratic Republic of Congo who were treated with ticuvirumab versus placebo, the results from this trial was not surprising due to the humanitarian considerations of the study design.
Speaker Change: The CDC recently began gearing up to perform the reanalysis and is targeted to complete its work in the first half of 2025.
Speaker Change: As such we are planning for that and FDA submissions of the Pep indication in the third quarter of 2025.
Speaker Change: As we announced on August 15th to National Institute of allergy and infectious diseases or NIAD share top line results from our preliminary analysis from the palm.
Speaker Change: Yourself and trial.
Speaker Change: While the study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution within 28 days for <unk> patients in the Democratic Republic of Congo.
Speaker Change: Retreated with who were treated with ticket versus placebo. The results for this trial was not surprising due to the humanitarian considerations of the study design.
Sam: Nonetheless, we are encouraged by the data showing ticuvirumab's potential benefit in two important patient groups. First, those patients treated early, and second, those with severe disease. We believe additional trials are warranted to explore the potential benefits of TPOX as an MPOX treatment in these and possibly other patient populations. Several additional mPoC studies are currently being conducted by trial sponsors around the world and are expected to help inform a deeper understanding of the potential of ticovirumat to benefit mPoC patients. Four trials are currently enrolling patients, including STOMP, UNITY, Platinum, Canada, and Epoxy. The largest of these is DOMPS, sponsored by NIAID, and is enrolling patients primarily in the U.S.
Speaker Change: Nonetheless, we are encouraged by the data showing took a fair amount of potential benefit in two important patient groups first those patients treated early and second those with severe disease. We believe additional trials are warranted to explore the potential benefits of T. Pax as an impasse treatment and these and possibly other.
Speaker Change: Populations.
Speaker Change: Several additional and Tox studies are currently being conducted by trial sponsors around the world and are expected to help us form a deeper understanding of the potential of Chico very much does that benefit and pox patients.
Speaker Change: For trials are currently enrolling patients, including stop unity Platinum, Canada and epoxy.
Speaker Change: The largest of these is stop sponsored by NIAD and is enrolling patients primarily in the U S and South America, it's progressing well with about 670 patients enrolled as of the first week of October up from 515 reported in our last call.
Sam: and South America. It's progressing well, with about 670 patients enrolled as of the first week of October, up from 515 reported in our last call. I would highlight that TPox has demonstrated a strong safety profile and is well tolerated by patients. This is supported by preclinical safety and toxicology studies in numerous animal models, including epoxy-infected non-human primates, phase 3 clinical data with healthy volunteers, and clinical observations in disease patients. Additionally, more than 2,000 mPox patients have participated in clinical trials to assess the efficacy of T-Pox for mPox treatment, and more than 8,000 patients have been administered T-Pox for compassionate use as the preferred antiviral to treat mPox disease.
Speaker Change: I would highlight the Chipotle has demonstrated a strong safety profile and is well tolerated by patients.
Speaker Change: This is supported by preclinical safety and toxicology studies in numerous animal models.
Speaker Change: I've talked to in fact, it nonhuman primates phase III clinical data with healthy volunteers and clinical observations in disease patients.
Speaker Change: Additionally, more than 2000, and Ponca patients had participated in clinical trials to assess the efficacy of T box for <unk> treatment in more than 8000 patients have been administered T parks, where capacity at us as the preferred anti viral to treat and pox disease.
Sam: Furthermore, T-pox has demonstrated effectiveness as an antiviral and pet treatment for survival and reduction of body lesions and viral load in non-human primates infected with lethal amounts of M-pox virus. Additionally, T-pox has been shown to improve survival and reduce lesions in non-human primates infected with smog. Based on the totality of the scientific evidence, we believe this diverse and expansive collection of data sources highlights why TPOX has received regulatory approval for smallpox in the U.S. and Canada and regulatory approval in the EU and the U.K. for a broad orthopox label, including smallpox and mpox. In Japan, we are actively engaged in discussions with our partner, Japan Biotechnology Pharma, and regulators regarding the pending new drug application for TPOX to treat smallpox, mpox, cowpox, and complications due to the Zinnia virus.
Speaker Change: Furthermore, T Fox has demonstrated effectiveness as an anti viral and pet treatment for survival and reduction of body lesions and viral load in nonhuman primates infected with lethal Mt.
Speaker Change: In pox virus.
Speaker Change: Additionally, T parks has been shown to improve survival reduced lesions in nonhuman primates infected with smallpox.
Speaker Change: Based on the totality of the scientific evidence we believe this diverse and an expansive collection of data sources highlights why T. Pax has received regulatory approval for smallpox in the U S and Canada and a regulatory approval in the EU and the U K for broad ortho Pax label, including smallpox and pox.
Speaker Change: In Japan, we are actively engaged in discussions with our partner, Japan, biotech know pharma and regulators regarding the pending new drug application for <unk> to treat smallpox and pox cowpox and complications due to the Sydney a virus.
Sam: Based on the standard review timeline, we expect a final regulatory decision by early next In summary, this is an exciting and dynamic time for SIGA. We are strong, resilient, and profitable. Our strategy and prudent capital management is delivering solid results. and we believe make us well positioned for the future. Additionally, our TPOX franchise meets a critical need for smallpox preparedness, and our team has the expertise to drive long-term results, which we believe will produce sustainable growth and shareholder value over time.
Speaker Change: Based on the standard review time line, we expect a final regulatory decision by early next year.
Speaker Change: In summary, this is an exciting and dynamic time for CECO, we are strong resilient and profitable ours.
Speaker Change: Our strategy and prudent capital management is delivering solid results.
Speaker Change: And we believe make us well positioned for the future.
Speaker Change: Additionally, our T. Pax franchise meets a critical need for smallpox preparedness and our team has the expertise to drive long term results, which we believe will produce sustainable growth and shareholder value over time.
Dan Luckshire: With that, I'll turn it over to Dan to review the financial results in more detail. Thanks, Sam. As noted earlier in the call, SIGA's product sales for the nine-month end of September 30, 2024 continued to outpace product sales for the comparable period in 2023. Product revenue for the nine-month end of September 30, 2024 was $53 million. Other than this amount, $9 million is related to the third quarter. In the third quarter, there is an $8 million oil teapot delivery to the U.S. Strategic National Stockpile, or S&S. and a $1 million of international. The $8 million World Cheap Hacks delivery represents the first delivery to the S&S in connection with the $112.5 million order.
Speaker Change: With that I'll turn it over to Dan to review the financial results in more detail.
Speaker Change: Thanks, Dan.
Dan: As noted earlier in the call.
Speaker Change: Biggest product sales for the nine months ended September 32024 continue to outpace product sales for the comparable period in 2023.
Speaker Change: Product revenue for the nine months ended September 30 of 2020 was $53 million.
Speaker Change: All of this amount $9 million is related to the third quarter.
Speaker Change: In the third quarter, there was an $8 million royalty Pax deliveries to the U S strategic national stockpile.
Speaker Change: Yes.
Speaker Change: $1 million of international sales.
Speaker Change: 8 million Diavik royalty Pax delivery represents the first delivery to the us and us in connection with the $112 5 million dollar order.
Andrew the 19th fee contract, which was announced in July.
Speaker Change: International sales amount includes the first sell to Africa.
Dan Luckshire: With respect to product revenues for the nine months ended September 30, 2024, the $53 million amount comes from a diverse mix, including 23 million dollars of oil cheapox sales and 17 million of IV cheapox sales to the U.S. government under the 19C contract. 12 million dollars of international world teapot sales to 12 countries. and $1 million of world teapot sales to the U.S. Department In addition to product-related revenue.
Speaker Change: With respect to product revenues for the nine months ended September 30 of 'twenty 'twenty four the 53 billion dollar amount comes from a diverse mix including twice.
Speaker Change: $23 million once you park sales and $17 million of IV G box sales.
Speaker Change: The U S government under the 19 fee contract.
Speaker Change: $12 million of International War to park sales to 12 countries.
Speaker Change: And $1 million of royalty park sales to the U S Department of defense.
Speaker Change: In addition to product related related revenues.
Dan Luckshire: The company also has had research and development revenue. For the three and nine months ended September 30th, 2024, research and development revenues were $1 million and $4 million, respectively. Pre-taxed operating income. which excludes interest income and taxes was half a million dollars for the three months ended September 30th, 2024. For the nine months into September 30th, pre-tax operating income was $13 million. In comparison, there is a pre-tax operating loss for the 3 and 9 month end of September 30, 2023 of $1 million and $8 million respectively. Net income for the three months into September 30, 2024 was $1 million.
Speaker Change: Company also has had research and development revenue.
Speaker Change: For the three and nine months ended September 32020 for research and development revenues were $1 million and $4 million respectively.
Speaker Change: Pretax operating income.
Speaker Change: Which excludes interest income and taxes.
Speaker Change: Half a million dollars for the three months ended September 32024.
Speaker Change: For the nine months ended September 30th pretax operating income was $13 million.
Speaker Change: In comparison, there was a pretax operating loss for the three and nine months ended September 32023 of $1 million and $8 million respectively.
Speaker Change: Net income for the three months ended September 30 of 'twenty 'twenty four it was $1 million.
Dan Luckshire: For the nine months ended September 30th, that income was $13 million. In turn, fully diluted income per share for the three months ended September 30th, 2024 was $0.02. And for the nine months into September 30th, fully diluted income per share was $0.19. At September 30, 2024, the company continued to maintain a strong balance sheet with a cash balance of $99 million and no debt. I would like to note that the company has maintained a strong balance sheet while also returning substantial cash to shareholders. As a quick reminder, on April 11th, SIGA paid a cash dividend of $0.60 per share, which amounted to a $43 million payment to shareholders.
Speaker Change: For the nine months ended September 30th net income was $13 million.
Speaker Change: In turn fully diluted income per share for the three months ended September 32024 with two shifts.
Speaker Change: And for the nine months ended September 30th fully diluted income per share was <unk> 19 cents.
Speaker Change: At September 30th 'twenty to 'twenty four.
Speaker Change: Company continues to maintain a strong balance sheet with a cash balance of $99 million and no debt.
Speaker Change: I would like to note that the company has maintained a strong balance sheet, while also returning substantial cash to shareholders.
Speaker Change: A quick reminder, on April 11th they could pay the cash dividend of <unk> 60 per share which.
Speaker Change: Which amounted to a 43 million dollar payment to shareholders.
Dan Luckshire: Looking forward, as Zem mentioned earlier in the call, we are well positioned for substantial revenues in the fourth quarter and into 2025, in light of our outstanding order balance of $146 million as of September 30. As such, we believe 2024 is lining up to be another year of strong product revenue performance.
Speaker Change: Looking forward as I mentioned earlier in the call we are well positioned for substantial revenues in the fourth quarter and into 2025 and in light of her outstanding order balance of $146 million as of September 30th.
Speaker Change: As such we believe 'twenty 'twenty four is lining up to be another year of strong product revenue performance.
Dan Luckshire: This concludes the financial update.
Speaker Change: This concludes the financial update at this point I will turn the call back to Jim.
Sam: At this point, I will turn the call back to Zim.
Operator: Thank you, Dan. With that, we would like to open the call for questions. Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the one on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by 2. And if you are using a speakerphone, please lift the handset before pressing any key. One moment, please, for your first question.
Thank you Dan with that we would like to open the call for questions.
Speaker Change: Thank you.
Speaker Change: Ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press the star followed by the one on your Touchtone phone you will hear a prompts that you had has been waste.
Speaker Change: Should you wish it came from the polling process. Please press star followed by two and.
And if you are using a speaker phone please lift the handset before pressing any case.
Speaker Change: One moment. Please for your first question.
Jyoti Prakash: Your first question comes from Jyoti Prakash at Edison Group.
Speaker Change: Your first question comes from Chiyoda Prakash at Edison Group. Please go ahead.
Jyoti Prakash: Please go ahead. Hello, thank you for taking my questions. I have around three to four questions, so let me ask them one after the other.
Chiyoda Prakash: Hello. Thank you for taking my questions I have around three to four questions. So let me answer them one after the adult it's it's great to see that the deliveries under the BARDA order photo orderly about because I've started happening in Q4, well my question is related to the delivery of the.
Sam: It's great to see that the deliveries under the BADA order for oral teapots have started happening in Q4. My question is related to the deliveries of IV teapots, which seem to be more perfected in comparison to oral teapots. What are the reasons for this? Are there any particular supply chain related constraints? When can we see orders being delivered for IV teapots?
Chiyoda Prakash: I V D box, which you seem to be more protected our income batteries into water and tea Bulks. What are the reasons for this are there any particular supply chain related spend screens when can we see orders being delivered for IEP books.
Sam: Secondly, when can we expect the latest order from the Department of Defense to be delivered?
Chiyoda Prakash: Secondly, when can we expect the latest or daughter.
Chiyoda Prakash: Some of the department of defense to be delivered.
Chiyoda Prakash: Yeah.
Chiyoda Prakash: Yeah.
Sam: So, Jyoti, thank you so much for your first question. I will start by first giving you a little context between oral T-pox as well as the IV. Oral TPOCS is the predominant formulation of the U.S. government's stockpile, and in connection with its delivery activity, the timing and the cadence of the order activity is very, very different between the two formulations, whether it's orals or IV. The manufacturing process for IVs is much more complex than the oral process. for Teapots with the use of different vendors as well as some different raw materials. Given these differences, IV and oral TPOCs are on different schedules, with IV requiring longer manufacturing lead times than oral.
Speaker Change: So Chelsea. Thank you so much for your first question I will start by first giving you a little context between oral T Pax as well as the IV.
Speaker Change: Royalty Pax is the predominant formulation of the U S government stockpile and in connection with its delivery activity the timing and the cadence of the order activity is very very different between the two formulations, whether it's oral or IV.
Speaker Change: The manufacturing process for IV is it's much more complex than the oral process.
Speaker Change: For T Pax with the use of different vendors as well as some different raw materials.
Speaker Change: Given these differences IV and oral T Pax drive different schedules with IV, requiring logger boots manufacturing lead times and oral.
Sam: Lastly, product deliveries, whether it's IV or orals, are partially dependent on whether customers would like to take, when the customers would like to take delivery. As Dan mentioned, the timing of the orals from the last contract tranche has started in 2024 and will continue into 2025.
Speaker Change: Lastly product deliveries, whether it's the idea of R. R.
Speaker Change: Ah partially dependent on where the customers would like to take when the customers would like to take delivery as Dan mentioned, the timing of the world from the last contract charge. It has started in 2024 and will continue into 2025.
Speaker Change: Yeah.
Speaker Change: Okay.
Jyoti Prakash: Okay, that's helpful.
Speaker Change: Okay. That's helpful and just on the question on the deliveries under the department of Defense contract.
Sam: And just on the question on the deliveries under the Department of Defense contract. Hi, I think I Yeah, and I said that the deliveries have started in already this year and will continue into 2025. Thank you.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: Hi, I think I.
Speaker Change: Yeah, and I said that the deliveries.
Speaker Change: I've started and already this year and will continue into 2025.
Speaker Change: Oh, okay.
Jyoti Prakash: And the second question is related to your internationalization efforts. It's great to see you make your commercial foray into Africa. Just want to understand, since your amendment, agreement of your amendment with Meridian, what kind of traction opportunities or challenges are you seeing in the international market?
Speaker Change: Thank you and the second question is related to your order internationalization, that's why to wait to see you are making a commotion 42 also Paul just wanted to understand since you are the amendment agreement Amendment with me again, so what kind of traction opportunity what challenges are you seeing.
Speaker Change: And and then did actually markets.
Sam: So thank you.
Speaker Change: So thank you as a gentle reminder, for the broad audience, we had amended the meridian agreement effective in June 1st So that we could bring all the international marketing and sales in house, except for a few administrative and supportive activities provided by meridian.
Sam: As a gentle reminder for the broad audience, we amended the Meridian agreement, effective in June 1, so that we could bring all the international marketing sales in-house, except for a few administrative and supportive activities provided by Meridian. This change has given us greater control to meet the needs of our global customers. Since amending the agreement, we have been spending considerable time strengthening and building our relationships with current as well as potential customers around the globe. We're all centered around the expanding of our international business. With the recent sale of Africa to the request of the Ministry of Health in Morocco, we believe our effort is off to a great start.
Speaker Change: This change has given us greater control to meet the needs of our global customers.
Speaker Change: Since many of the agreement we have been spending considerable time strengthening and building our relationships with current and as well as potential customers around the globe.
Speaker Change: We're all centered around the expanding of our international business.
Speaker Change: With the recent sale of Africa to the request from the Ministry of Health in Morocco, We believe our effort is off to a great start.
Sam: Bringing the effort in-house has definitely enhanced our depth of dialogue with international customers and we expect it will help our ongoing efforts to pursue sales opportunities over the immediate and long-term horizon. We have not experienced any challenges at this point in this transition.
Speaker Change: Bringing the effort in house has definitely enhance our death in dialogue with international customers and we expect it will help our ongoing efforts to pursue sales opportunities over the immediate and long term horizon, we have not experienced any challenges at this point when this transition.
Jyoti Prakash: Perfect.
Speaker Change: Perfect.
Sam: And moving on, it's great to see that you've been licensed to new pre-clinical program. Can you provide us some more details on the deal economics and when can we expect this program to enter clinical studies? And how do you plan to develop this as a monotherapy or a combination therapy with TPOC?
Speaker Change: Moving on it's great to see that you can license to new.
Speaker Change: I'm Gonna go program can you provide us some more details on the deal economics and when can we expect this program to enter clinical studies and how do you plan to do my 11th this as a mono therapy artist nation to be with deep walks.
Sam: Sure, thank you for asking. We're extremely excited about the recent end license of the monoclonal antibody portfolio from Vanderbilt. And we're excited about this opportunity to expand our pipeline and strengthen our ability to be in the orthopox space. These antibodies, we believe, have a potential to treat a broad spectrum of orthopoxviruses, which is inclusive of smallpox and mpox. And we would look to develop them from a therapeutic as well as a prophylactic consideration. We've demonstrated PROMIS in preclinical models and could potentially use as a standalone treatment or in the combination with TPOC. Given our capabilities in clinical development as well as partnerships in the U.S.
Speaker Change: Sure. Thank you for asking we're extremely excited about the recent and license of the monoclonal antibody portfolio from Vanderbilt and we're excited about this opportunity to expand our pipeline and strengthen our ability to be in the orthopedic space.
Speaker Change: These antibodies, we believe has the potential to treat a broad spectrum of Orthopods viruses, which is inclusive of smallpox and anthrax.
Speaker Change: And we would look to develop them from a therapeutic as well as a prophylactic consideration.
Speaker Change: We've demonstrated promise and preclinical models and could potentially use as a standalone treatment or in the combination with T box.
Speaker Change: Given our capabilities in clinical development as well as partnerships in the U S. Government agencies, we believe we're best suited to maximize the potential of these therapies in a cost effective manner.
Sam: government agencies, we believe we are best suited to maximize the potential of these therapies in a cost-effective manner. In fact, the DoD has recently funded the development through a third party with monoclonal antibody manufacturing expertise through Phase 1.
Speaker Change: In fact, the D. O D has recently funded the development through a third party with monoclonal antibody manufacturing expertise there is phase one.
Sam: As we work through the clinical development process, we will keep you posted. It's premature to talk about timing.
Speaker Change: As we worked through the clinical development process, we will keep you posted its premature to talk about timing.
Speaker Change: Yeah.
Jyoti Prakash: Excellent.
Speaker Change: Excellent and I have one final question.
Sam: And I have one final question. There have been recent media reports on some MPOX patients being resistant to TPOX. Can you provide your perspective on these reports and if that's a concern for SIGA?
Speaker Change: Seems to me Daddy boots on some and box patients being resistant to deep walks well can.
Can you provide you a perspective on these reports and if that's a concern unforeseeable.
Sam: Thank you for giving us an opportunity to weigh in on some of these reports as it relates to resistance. I always think it's important to think about considerations based on totality of data. I will first start with by saying that the preclinical evidence collected to date has shown no resistance to an animal treated with TPOX for an extended time frame. Additionally, CDC reports document only a small number of drug-resistant developing and patients receiving TPOX. Overall, it remains low at less than 1% in the patient population. This resistance has been primarily observed in a limited number of immunocompromised patients or those with advanced HIV who have received extended courses of treatment beyond the recommended duration.
Speaker Change: Thank you forgive me us an opportunity to weigh in on on some of these reports as it relates to resistance I always think it's important to think about considerations based on totality of data I will first start with by saying that the preclinical evidence collected to date has shown no resistance in animals treated with tea.
Speaker Change: Fox for an extended time frame.
Speaker Change: Additionally, C. D. C report document only a small number of drug resistance developing in patients receiving T Park overall, it remains low at less than 1% in the patient population.
Speaker Change: This resistance has been primarily observed in a limited number of immunocompromised patients or those with advanced HIV whoever received extended courses of treatment beyond the recommended duration.
Sam: I think the recent report you're referring to is the October CDC Morbidity and Mortality Weekly Report. This is noted a small sample of patients with mild MPOC. Resistance to TPOX was reported in a few patients. This finding is potentially important and does warrant further investigation to guide future treatment protocols. However, I think it's important to note that the treatment history documentation was not collected to better understand these reports. And additionally, these reports omit important data related to the total number of specimens tested. patient profiles as well as treatment timing, making it difficult to reach a conclusion about Ticoverumab's efficacy in mpox treatment or overall detection of drug resistance.
Speaker Change: I think the recent report you're referring to is the October C. D C morbidity and mortality weekly reports.
Speaker Change: As noted a small sample of patients with mild and pox.
Speaker Change: Resistance T. Pax was reported in a few patients.
Speaker Change: This finding is potentially important it does warrant further investigation to guide future treatment protocols.
Speaker Change: I think it's important to note that cheap in history documentation was not collected to better understand these reports and additionally, these reports admit important data related to the total number of specimens tests.
Speaker Change: Patient profiles as well all treatment timing, making it difficult to reach conclusion about ticket fair amounts of efficacy and M Pax treatment or overall detection of drug resistance.
Sam: It's really important to note that the resistance of smallpox or mpox is less likely to occur compared to COVID-19 or influenza. For example, smallpox and mpox are DNA viruses which mutate less easily than RNA viruses, like the viruses that I just mentioned, COVID and influenza. This may attribute it to the low levels of resistance observed to date with ticovirumat. I would like to remind everyone that there is no demonstrated ticovirumat resistance to smallpox, and we have not identified that to date.
Speaker Change: It's really important to note that the resistance of smallpox and Pax is less likelihood of Kerr compare to COVID-19 or influenza.
Speaker Change: For example, a smallpox and Pax or DNA viruses, which mutate less easily that RNA viruses like the viruses that I just mentioned COVID-19 in influenza.
Speaker Change: It is mainly attributed to the low levels of resistance observed to date with ticket there Matt.
Speaker Change: I would like to Ryan everyone that there is no demonstrated check of ear about resistance to smallpox and and we have not identified that today.
Sam: Thank you.
Speaker Change: Thank you that's very helpful. That's all the questions on her all log congratulations on the quarter.
Jyoti Prakash: That's very helpful.
Jyoti Prakash: That's all the questions I have. Congratulations on the quarter.
Operator: Thank you. Thank you, ladies and gentlemen. As a reminder, if you have any questions, please press star 1.
Speaker Change: Thank you. Thank you.
Speaker Change: Thank you, ladies and gentlemen, as a reminder, if you have any questions. Please press star one.
Speaker Change: Yeah.
Operator: It appears we have no further questions.
Speaker Change: It appears we have no further questions I will turn the call back over for closing comments.
Sam: I will turn the call back over for closing comments. Thank you. Thank you so much for dialing in to SIGA's call and for your ongoing interest in our company.
Speaker Change: Okay.
Speaker Change: Thank you. Thank you so much for dialing in to see you guys call and for your ongoing interest in our company. We look forward to speaking to you again on our fourth quarter call have a good rest of the evening.
Operator: We look forward to speaking to you again on our fourth quarter call. Have a good rest of the evening.
Operator: Ladies and gentlemen, this concludes your conference for today. We thank you for participating and we ask that you please disconnect your line.
Ladies and gentlemen. This concludes your conference for today, we thank you for participating and we ask that you. Please disconnect your lines.
Speaker Change: Oh.
Speaker Change: Yeah.
Speaker Change: Oh.
Speaker Change: Yes.
Speaker Change: Oh.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.