Easier to read! Thanks Berk! Board of director
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Posted On: 05/30/2024 8:40:06 PM
Easier to read! Thanks Berk!
Board of directors. So to Jump Right In, I'll like to ask Mitch Cohen to start and provide a brief overview of cyanine's current financial position. Mitch Thank you, Jay and good afternoon everyone. First, it's been a pleasure working with you and the rest of the good people excited on.
As we come to the close of our fiscal year, I'd like to say that the company has made significant strides to reduce its cash burn rate. And by reducing operating expenses and the workforce to preserve its resources and utilize them where they are most needed. This transformation consisted of reducing our force of full-time, by approximately 70 percent.
Adding five part-time employees and leveraging experienced Consultants and advisors on a part-time basis. By restructuring our Workforce and elected to retain specialized Consultants that are possible. We believe we have enhanced our regulatory, clinical, and medical capabilities And further assemble the team that places the company in the best position to be successful.
As the home was lifted, our team now stands ready to implement the best strategies to maximize shareholder value in the near and long term. In fact, we have already devoted some of our resources towards advancing, some of the prospects that Jay will be talking about shortly. The team is also busy preparing budgets and getting quotes from prospective cros for the upcoming trials.
Again, we'll be talking about them further and later in the conference call. And with those brief comments, I'll turn it back over to Jay. Uh, thank you Mitch. Um, And up next, I'd like to ask Tyler to cover several legal matters. Including the recent Samsung agreement The ongoing amorex litigation effort and a brief comment on our IP position uh, Tyler.
Thanks Jay. Um so as always we are very much restricted on what we can share by way of legal regulatory and I.T matters. But we did want to make a point to share what we can at this time. And we do think it's important. So, first and foremost, and mostly, by way of a recap, we were very pleased with the recent result in the Samsung dispute.
Uh needless to say, the Samsung this resolution removes significant short-term pressure on the company and also allows us to now use our immediate resources and funds to get back into the clinic and all those related preparations. Um, we, we appreciate Samson's willingness to come to an agreement in the end and also in that it was structured in a way that allows them to be repaid in line with the future success of cytodine.
Um, Add to the amarex. Litigation we are very much aware of the overwhelming investor interest in this proceeding but there's not much we can say as it relates to this pending litigation matter. Um so what I'll do is I'll just do a recap of what we can right? Um as this goes in our recent SEC filings, the arbitration is set to commence, November 11th 2024 That arbitration proceeding itself can sometimes last multiple weeks.
Uh typically an award is issued by the arbitrator approximately 30 to 60 days after the conclusion of the arbitration proceeding. So again you have an arbitration proceeding, a couple weeks, maybe 30 to 60 days thereafter. Your you potentially seen a ward from the arbitrator, okay, the company. What's been going on recently, the company has been working recently often on a number of Discovery objectives in the litigation.
And we continue to collect evidence for our claims and make preparations for the arbitration later this year. Uh, we also and this was disclosing filings as well. We remain open to settlement offers from Amarex and we, in fact, remain in settlement discussions with them at this time. Uh as the wind you could potentially see a development on that front.
The case could theoretically settle at any time before the conclusion of the arbitration proceedings. Uh, but at this time, we really we simply remain committed to maximizing the result for the company and and that could be whether through settlement or arbitration again, focus on maximizing, the result for the company.
Um, and then uh the the typical lawyer close off as this is an ongoing litigation matter, we cannot comment further at this time. Uh finally, as to the company's IP position. Uh this is a topic that is both a confidential legal matter as we already filed a pending application.
But it's curious too as it also involves future strategy and related confidential developments on that front. Um, so again, we'll share what we can at this time and always excited to talk IP. Um, first perhaps needless to say, as a pre-revenue biotech company, our IP portfolio is our asset.
Our IP is the record of what we've been able to accomplish and what we have to show for it at any given time. So considering that, considering this concept rather, we do not short our review and Analysis of all things, IP. We actively work with and meet with outside IP Council to both review, current applications and look forward to prospective developments.
Outdoor current development profile and where things stand the best source of information is always Uh, I'll qualify this a little bit later, but the best sorts of information is likely our FCC filings and a simplified IP report can be found in our form 10K, as well as certain pending registration statements that we we will file from time to time.
At this time. We do believe we are in a good position with IP although certain patents relating to the underlying antibody itself. Started to expire in 2023 preparations were made. Well, in advance of those expirations, and we have numerous patents, that cover our development initiatives, that will not start to expire until 2031 2035 2040 and 2043 respectively.
Uh and again more information on all that available in our FCC filing. So I'm not just rattling off random dates for you guys. We also regularly conduct in-depth discussions of research and marketing plans with IEP Council to ensure that new IP is protected in a timely and strategic matter.
Manner. Additionally the company is very much aware of in making plans regarding the exclusivity period following any prospective approval by the FDA, we get a lot of questions about this. Again should we be fortunate enough to achieve an approval with the FDA in the future? There would be an accompanying Market exclusivity period as to the use of Laura on the map in Commerce at that time.
Uh, again with our iip Council, we are constantly reviewing and planning strategically around that concept. Finally, we also hope for and anticipate ongoing IEP development in the coming months and updates. In this regard, will be provided. Be a public statement and or SEC filings. So again any updates as to new IP or related developments will only be made via public statements and or the SEC filings.
Finally, for additional information that's already publicly available. Uh, outdoor IP portfolio. Please feel free to visit the uspto website. That's the US patent and trademark office their website. It has a search database where you're able to identify and isolate bicyedine and review our pet or pending patent in our IP portfolio.
Okay. And and that's it for the legal uh regulatory and IP front today. I want to thank you all for your time and and know that we're all working hard with the hope to convey additional updates on our legal regulatory and ID front in the very near future, back to you Jay Now thank you Tyler and I just want to say in the most heartfelt way that it has been a particular pleasure to work along.
Silent alongside Tyler and Mitch on the management team. These last few months, as we have started writing a new chapter to the society. Hein story. And next, I'd like to provide an update on cyanine's overall corporate strategy going forward. So as we noted in our recent shareholder letter over the next six months we expect to commence at least one and potentially two clinical trials.
Uh, those prospective trials in order of priority are first a phase two study of Laura Lamab in patients, with relapsed refractory. What's called micro satellite stable? Colorectal cancer. Basically, third line colon cancer and second study a phase two study exploring Laura on the map's effect on inflammation. Uh, the company's priority will be the oncology trial.
Uh which of it is successful, will put us on track towards a commercial approval of we're on the map in that indication So the oncology study of around the map will involve patients with relapsed colorectal cancer. Uh, colon cancer is among the most common and deadly forms of cancer and unfortunately appears to be increasing in incidence especially among younger people for reasons that are unknown.
Uh, our protocol built on the published pre-clinical work of Dr. Dan Linder at the Cleveland Clinic, who demonstrated that Lauren lemab. Inhibited metastasis in a humanized Mouse model of colon cancer. As well as the unpublished. Clinical observation that four of six patients with colon cancer in our prior basket trial, had either stable, or partially responsive disease up to 11 months after starting around the map.
Uh, so that's the basis and rationale for the study and the proposed clinical study uh, will evaluate when we're on the map in patients with colorectal cancer. Who've received at least one, but no more than two previous lines of treatment, the study will paralleurolamab with an established Salvage regimen and compare both 350 and 700 milligram dose levels.
Uh, sideline is uh, currently in the process of discussing. The proposed protocol design with the FDA. We're conducting related budgeting and planning our related fundraising efforts and I look forward to providing further details on this study. As we confirm our clinical investigators and finalize. The clinical protocol of the next several months as previously noted starting the oncology study and related fundraising is a top priority of the company.
At this time, Our second priority is the inflammation study. Uh, following the company's recent Communications with the FDA. I believe there are two foundational. Lauren, Lamab questions. That decided I needs to address. Uh, first question, uh, after discussing, with our key opinion leaders, we need to clarify the specific effect of blocking ccr5.
With laranglemab on Downstream signaling and biomarkers of inflammation. And second, we need to determine what is the optimal dose of around the map to use in the non-hiv and non-antiviral setting. I believe that addressing these questions will provide a framework for the FDA to understand any future clinical efficacy claims cited on makes and help the company accelerate the advancement of larolamount.
To provide a rationale for the inflation study, we reviewed data from cyanide's prior, Nash math, study where we looked at the effect of Laura, on the map in the subgroup of patients, that entered that study with inflammation as indicated by elevated levels of C-reactive protein and Baseline Elevated levels of C-reactive protein or CRP is widely.
Understood to be a key marker of chronic inflammation and associated with heart attacks strokes and other inflammatory illnesses. The re-analysis of our data indicated, a very important dose-dependent reduction in C-reactive protein. When Laurel on the map was dosed at both 350 and 700 mg compared to Placebo. Indeed, the main goal of our inflammation study will be to statistically, confirm that Lauren, Lamab.
Lowers levels of fee-reactive protein, as well as other key markers of inflammation. So follow in consultation with industry experts and mindful of the fda's prior feedback. We further revised the inflammation. Protocol, the study will now enroll 90 HIV positive. Subjects, who have chronic inflammation as demonstrated by an elevated level of high sensitivity, CRP at a pre-screening.
Visit confirmed at a screening visit at least two weeks apart. Uh, these study participants will be created for six months with weekly subcular on the map at either 350 or 700 milligrams or Placebo. And as just mentioned, the primary endpoint will be reduction in C-reactive protein with a host of other inflammatory biomarkers evaluated, a secondary endpoints Dr.
Otto Yang from UCLA. Have kindly agreed to be the lead investigator. For the trial. And the revised protocol will be submitted to the FDA in the next several weeks, which in turn will start a 30-day review, period. As noted in the recent shareholder letter, I believe it is imperative.
The company generate unassailable results in the clinic and I believe the above two trials can accomplish this In addition to these two core clinical studies, I'm pleased to announce two other exciting clinical initiatives First, we are in discussion with the American foundation for AIDS research. To partner and co-sponsor a study called latch led by investigators at Oregon Health Sciences University and the University of Washington, Latch stands for Lauren lemab and allogenic stem cell transplant to cure HIV.
The proposed study will evaluate the use of Laura on the map to facilitate an HIV cure. In the HIV positive subjects, undergoing stem cell transplantation, Previous reports of HIV. Positive patients achieving a cure have occurred. When those rare homozygous ccr5, double negative individuals have been identified to provide donor stem cells for the transplantation.
This study will evaluate the possibility that larolamap could extend the list of potential donors to include the much larger pool of ccr5, positive individuals. Administered following transplantation for six months during the engraftment period, to protect the HIV negative, donor cells from becoming HIV infected. The hope is that those donor cells now protected from HIV.
Infection will then eliminate HIV from the reservoir of the transplant recipient. If successful, this study would obviously bring about much needed positive attention to both Laura on the map and Cydonide. We're exploring this partnership with amfar to jointly co-sponsor and fund the research aspects of the latch study. Which importantly will not require us to cover the cost of the transplant itself.
I'm also pleased to confirm that Saturday night is collaborating on an exploratory investigator initiated pilot study of Lauren Lamabin patients with Alzheimer's disease. Saturday night is fortunate to be working on this project with a highly experienced investigator and a leading academic Medical Center. The study proposes to enroll 20 patients, with mild to moderate Alzheimer's disease, who are treated with Laura on the map at either 350 or 700 milligrams weekly and followed for 12 weeks with a primary neuroradiology endpoint.
I look forward to providing additional details on future calls but it's important to note that we have already identified an external source of funding for this study. Lastly, I'm pleased to announce that cyto 9 is following up on the results of our prior Nash study, which demonstrated a statistically significant benefit of the wrong, the map at the 350, milligram dose though not at the 700 milligram dose level.
In order to clarify the optimal dosing regimen for Nash, are now Mash and efficiently, evaluate the potential for combination therapy. We have contracted with the lab to perform a pre-clinical mouse study, evaluating both 350 and 700, milligram dose levels alone, and in combination with Reset metron, a drug recently approved by the FDA for the treatment of mash.
The study will evaluate larala map with, and without rest metarom in both preventing, as well as reversing liver fibrosis. The results of this study should be available in the fall and will, hopefully then enable us to pursue Partnerships evaluating combination therapy in the math space. Before closing with a discussion of Publications and projected timelines.
I'd like to switch gears and touch on cyanine's efforts to develop longer acting forms of Lauren lemap. Dr. Scott Hansen, has been working in the lab in his lab to evaluate the various long-acting candidates and it's kindly agreed to join us on the call today. Scott. Thank you. Jay uh if any of you listening have heard me speak before, I'm very passionate about larger map and absolutely believe it can help people and I promise we as a company are working hard to make that happen.
For me, this all began during the pandemic and calling your mind. Jonas Sasha asked me to help out with cytodine cd15 trial. I knew nothing of LaRonia map at the time, but because it was a covid-19 study at the height of the pandemic and my academic lab was capable of in taking clinical trials material, I was happy to help out my role in this project was to perform the receptor occupancy essay, as well as run various biomarker analyzes.
The First Data I analyzed from this trial, I was instantly amazed how laronymad was changing the immune cell landscape and treated patients. The mouse immunologists like to call these changes. Macrophage polarization, but what I was observing was much more nuanced and robust. I was observing near complete. Immune modulation, almost all major, immune cell classes, including T, and B cells, not just macrophage polarization and after making this observation, I knew from that day that this molecule could be useful as a therapeutic including treatment for various cancers and neuroinflammatory disorders.
So when Cyrus Armand asked me to join the company in a more formal capacity, it was very easy for me to say, yes. As I said earlier, I believe this molecule can help and will help people. But enough about me, I think what most people are interested in hearing about is what we've been up to this past year.
I'm delighted to say that the Personnel auditions Tanya and the board have made to the company. In my opinion, have been amazing. We all worked super well together and because of this, we were finally able to get laranye Bob off the clinical hold, but more importantly, for the sake of getting the Roger Mabad into the people where it should be for the first time Jay and Cyrus greenlighted, a deep dive into the data from our past clinical trials.
I think you heard Jay speak of this a little earlier of re-analyzing. The Nash data. This is this is part of that. You may ask why that is so important. Well, I believe we are currently making sound and up-to-date plans based off our actual clinical data and we have lots of it.
And we're using these data to drive our decisions of where we feel Iran Yamab can be most impactful which hopefully will equate to the quickest path to approval and viable partnerships. I think Jay did a great job, outlining firedine's future and why we are devoting our resources to these specific areas and I can confidently.
Tell you those decisions were based off of actual data from our trials. Compensation from statisticians, reviewing that data and expert opinions from the scientific. And and the work that I've done in the lab related to the mechanism of action, we have lots of data in the lab. Now finally, I'm very excited to share with you some exciting things happening in our pre-clinical programs.
First and I think Jay concluded. His first section of his talk on. This is to protect and expand our IP portfolio. We are working with a local generative AI company to design and create not only a longer lasting laranyamab, but possibly a more potent molecule that can be used in pre-exposure prophylaxis or prep a space where we think in combination with a long-acting antiretroviral, will have huge impacts for the HIV.
I'm currently testing 17, new variants of laurania map. It's really early in this process, but some of these monu molecules are showing extreme promise in my in vitro assays. Um, making sure that the function of lauranya mab is not altered, but preserved, and these data are very exciting and get very, very early, but very promising.
I'm very excited about this endeavor and I feel it will be a game changer for cydodine and will help preserve the company's future. Lastly, I feel another game changer for cytodine, is the latch trial Jay mentioned earlier in his presentation. This is something very exciting for us as a company and me, personally, I became a scientist, not only to move science forward, but to also try to save life, Dr.
Jonah Sasha's. Work with laronda mab and stem cell transplant in the non-human primate model really made this trial possible for us. He demonstrated that you can pharmacologically knock out pcr5, with the running map, essentially creating that Delta 32 phenotype. That Jay mentioned, the phenotype has facilitated HIV care in the setting of stem cell cell transplantation.
This isn't a therapy Obviously this isn't a therapy for everyone living with HIV but for those that it makes sense for We Believe LaRonia map can help cure people of HIV and that would be pretty remarkable and something we can all be very proud of. I can go on and on about my excitement about this molecule, but for the sake of time, I'm going to hand the mic back over to Jay.
Thank you for listening to me today. It was my pleasure to be here, and I'm happy to be part of all this Thank you, Scott. Um, it really has been a pleasure getting to know you better and working with you and uh appreciating the enthusiasm you bring to this work.
Um it is also exciting to be working on the various early stage clinical trials, That I outlined with our current formulation over on the map knowing that a longer acting and more convenient formulation of the drug could be available to patients down the road. So moving on now, as promised on prior calls, cyanide is also continuing to aggressively pursue publication of our clinical data for peer review.
Uh importantly the clinical endpoint data from the cd15. Long covid trial was recently published in the Journal of Infection that study enrolled. 56 patients, with long covid who were treated for eight weeks with either Lauren Lamab or Placebo. And the study results showed clinical Improvement in 19 of the 24 endpoints that were evaluated.
Um and so that data is now posted on our website and has been brought to the attention of colleagues at the recover program at NIH, overseeing studies in long covid. In addition to that. Now publish data we have two manuscripts from our studies of patients with triple negative breast cancer.
A manuscript from our study of HIV positive patients with multi-drug resistant virus and a manuscript from our study of patients, with mild to moderate covid-19 that have all been submitted from publication and are currently undergoing peer review. In addition a manuscript detailing results from both our pre-clinical and clinical studies of Laura, on the map in Mash is undergoing final internal review and will be submitted shortly.
So at this point, I would again like to pause and ask Tanya erbach, our chair of the board of directors. To join the call and say a few words, Tanya Thank you. Jay. On behalf of the board. I'm really delighted to be here today and to extend our Collective appreciation for the dedication and hard work, demonstrated by Jay, and the team over the past several months.
As outlined by J, significant progress has been achieved in identifying and pursuing our corporate objectives setting, an exciting trajectory for the future. Jay has proven to be an outstanding leader serving as a unifying Force within the team, and earning, everyone's respect with his tireless, work ethic, wisdom and humility.
We were particularly pleased when he accepted the longer-term role of Chief executive officer, a testament to his dedication and vision. Throughout the past months, the board has been deeply engaged in a comprehensive review of our corporate strategy in collaboration with management and key advisors Each director officer and outside consultant has played a crucial role in this process and I want to express sincere gratitude for their combined contributions and commitment.
The resulting corporate strategy has been met with satisfaction by the board and we are enthusiastic about the objectives set forth by Jay and the team. We see promising opportunities ahead, particularly with respect to Laura, on the map's prospects in oncology and other growth prospects that could yield significant value.
While we acknowledge that, as Jay says, there is still work to be done. We do want to recognize that he and the team have been able to accomplish over the past several months, as we anticipate the future, we are eager to witness a continued advancements and achievements, that lie ahead in the remainder of the calendar year, Thank you again JCU.
And the team and I'll hand it back to you. Uh, thank you Tanya. And I I genuinely appreciate the way you and the board have supported me and management and all of our team. Uh, during this critical transition for cy9. Um, lastly, I would like to brief the comment on the projected timelines for the various programs, I discussed.
As I mentioned previously, we are currently discussing, uh, with FDA. Uh, issues around our colorectal, cancer study, and hope to start enrolling patients before the end of the year. We have finalized the inflammation study and we'll be submitting that to FDA this week or next week and hope to start enrolling patients as well in 2024.
The timelines for the latch study, uh, and the pilot study in Alzheimer's disease, involve academic institutions. So both are more likely to start early in 2025, And the results of the pre-clinical study of Lauren Lamab and Mash that I described should be available in the fall, which hopefully will give us the data to start pursuing a partnership before the end of the year.
And lastly, after someone unavoidable delays, the pre-clinical study of laramab and a mouse model of glioblastoma at my father's lab at Einstein monastery, Medical Center in New York, is now underway and we look forward to reviewing those results by the end of the year. In closing, I would just like to say that is truly an honor to serve as cyan CEO at what remains a critical critical, juncture for the company.
I want to again, thank the many shareholders who have graciously reached out to express their support and good wishes. We're genuinely pleased by the recent progress here at 79 we know there's more work to do and we look forward to keeping you informed as further events unfold till then stay safe and thank you for your patience and support.
Board of directors. So to Jump Right In, I'll like to ask Mitch Cohen to start and provide a brief overview of cyanine's current financial position. Mitch Thank you, Jay and good afternoon everyone. First, it's been a pleasure working with you and the rest of the good people excited on.
As we come to the close of our fiscal year, I'd like to say that the company has made significant strides to reduce its cash burn rate. And by reducing operating expenses and the workforce to preserve its resources and utilize them where they are most needed. This transformation consisted of reducing our force of full-time, by approximately 70 percent.
Adding five part-time employees and leveraging experienced Consultants and advisors on a part-time basis. By restructuring our Workforce and elected to retain specialized Consultants that are possible. We believe we have enhanced our regulatory, clinical, and medical capabilities And further assemble the team that places the company in the best position to be successful.
As the home was lifted, our team now stands ready to implement the best strategies to maximize shareholder value in the near and long term. In fact, we have already devoted some of our resources towards advancing, some of the prospects that Jay will be talking about shortly. The team is also busy preparing budgets and getting quotes from prospective cros for the upcoming trials.
Again, we'll be talking about them further and later in the conference call. And with those brief comments, I'll turn it back over to Jay. Uh, thank you Mitch. Um, And up next, I'd like to ask Tyler to cover several legal matters. Including the recent Samsung agreement The ongoing amorex litigation effort and a brief comment on our IP position uh, Tyler.
Thanks Jay. Um so as always we are very much restricted on what we can share by way of legal regulatory and I.T matters. But we did want to make a point to share what we can at this time. And we do think it's important. So, first and foremost, and mostly, by way of a recap, we were very pleased with the recent result in the Samsung dispute.
Uh needless to say, the Samsung this resolution removes significant short-term pressure on the company and also allows us to now use our immediate resources and funds to get back into the clinic and all those related preparations. Um, we, we appreciate Samson's willingness to come to an agreement in the end and also in that it was structured in a way that allows them to be repaid in line with the future success of cytodine.
Um, Add to the amarex. Litigation we are very much aware of the overwhelming investor interest in this proceeding but there's not much we can say as it relates to this pending litigation matter. Um so what I'll do is I'll just do a recap of what we can right? Um as this goes in our recent SEC filings, the arbitration is set to commence, November 11th 2024 That arbitration proceeding itself can sometimes last multiple weeks.
Uh typically an award is issued by the arbitrator approximately 30 to 60 days after the conclusion of the arbitration proceeding. So again you have an arbitration proceeding, a couple weeks, maybe 30 to 60 days thereafter. Your you potentially seen a ward from the arbitrator, okay, the company. What's been going on recently, the company has been working recently often on a number of Discovery objectives in the litigation.
And we continue to collect evidence for our claims and make preparations for the arbitration later this year. Uh, we also and this was disclosing filings as well. We remain open to settlement offers from Amarex and we, in fact, remain in settlement discussions with them at this time. Uh as the wind you could potentially see a development on that front.
The case could theoretically settle at any time before the conclusion of the arbitration proceedings. Uh, but at this time, we really we simply remain committed to maximizing the result for the company and and that could be whether through settlement or arbitration again, focus on maximizing, the result for the company.
Um, and then uh the the typical lawyer close off as this is an ongoing litigation matter, we cannot comment further at this time. Uh finally, as to the company's IP position. Uh this is a topic that is both a confidential legal matter as we already filed a pending application.
But it's curious too as it also involves future strategy and related confidential developments on that front. Um, so again, we'll share what we can at this time and always excited to talk IP. Um, first perhaps needless to say, as a pre-revenue biotech company, our IP portfolio is our asset.
Our IP is the record of what we've been able to accomplish and what we have to show for it at any given time. So considering that, considering this concept rather, we do not short our review and Analysis of all things, IP. We actively work with and meet with outside IP Council to both review, current applications and look forward to prospective developments.
Outdoor current development profile and where things stand the best source of information is always Uh, I'll qualify this a little bit later, but the best sorts of information is likely our FCC filings and a simplified IP report can be found in our form 10K, as well as certain pending registration statements that we we will file from time to time.
At this time. We do believe we are in a good position with IP although certain patents relating to the underlying antibody itself. Started to expire in 2023 preparations were made. Well, in advance of those expirations, and we have numerous patents, that cover our development initiatives, that will not start to expire until 2031 2035 2040 and 2043 respectively.
Uh and again more information on all that available in our FCC filing. So I'm not just rattling off random dates for you guys. We also regularly conduct in-depth discussions of research and marketing plans with IEP Council to ensure that new IP is protected in a timely and strategic matter.
Manner. Additionally the company is very much aware of in making plans regarding the exclusivity period following any prospective approval by the FDA, we get a lot of questions about this. Again should we be fortunate enough to achieve an approval with the FDA in the future? There would be an accompanying Market exclusivity period as to the use of Laura on the map in Commerce at that time.
Uh, again with our iip Council, we are constantly reviewing and planning strategically around that concept. Finally, we also hope for and anticipate ongoing IEP development in the coming months and updates. In this regard, will be provided. Be a public statement and or SEC filings. So again any updates as to new IP or related developments will only be made via public statements and or the SEC filings.
Finally, for additional information that's already publicly available. Uh, outdoor IP portfolio. Please feel free to visit the uspto website. That's the US patent and trademark office their website. It has a search database where you're able to identify and isolate bicyedine and review our pet or pending patent in our IP portfolio.
Okay. And and that's it for the legal uh regulatory and IP front today. I want to thank you all for your time and and know that we're all working hard with the hope to convey additional updates on our legal regulatory and ID front in the very near future, back to you Jay Now thank you Tyler and I just want to say in the most heartfelt way that it has been a particular pleasure to work along.
Silent alongside Tyler and Mitch on the management team. These last few months, as we have started writing a new chapter to the society. Hein story. And next, I'd like to provide an update on cyanine's overall corporate strategy going forward. So as we noted in our recent shareholder letter over the next six months we expect to commence at least one and potentially two clinical trials.
Uh, those prospective trials in order of priority are first a phase two study of Laura Lamab in patients, with relapsed refractory. What's called micro satellite stable? Colorectal cancer. Basically, third line colon cancer and second study a phase two study exploring Laura on the map's effect on inflammation. Uh, the company's priority will be the oncology trial.
Uh which of it is successful, will put us on track towards a commercial approval of we're on the map in that indication So the oncology study of around the map will involve patients with relapsed colorectal cancer. Uh, colon cancer is among the most common and deadly forms of cancer and unfortunately appears to be increasing in incidence especially among younger people for reasons that are unknown.
Uh, our protocol built on the published pre-clinical work of Dr. Dan Linder at the Cleveland Clinic, who demonstrated that Lauren lemab. Inhibited metastasis in a humanized Mouse model of colon cancer. As well as the unpublished. Clinical observation that four of six patients with colon cancer in our prior basket trial, had either stable, or partially responsive disease up to 11 months after starting around the map.
Uh, so that's the basis and rationale for the study and the proposed clinical study uh, will evaluate when we're on the map in patients with colorectal cancer. Who've received at least one, but no more than two previous lines of treatment, the study will paralleurolamab with an established Salvage regimen and compare both 350 and 700 milligram dose levels.
Uh, sideline is uh, currently in the process of discussing. The proposed protocol design with the FDA. We're conducting related budgeting and planning our related fundraising efforts and I look forward to providing further details on this study. As we confirm our clinical investigators and finalize. The clinical protocol of the next several months as previously noted starting the oncology study and related fundraising is a top priority of the company.
At this time, Our second priority is the inflammation study. Uh, following the company's recent Communications with the FDA. I believe there are two foundational. Lauren, Lamab questions. That decided I needs to address. Uh, first question, uh, after discussing, with our key opinion leaders, we need to clarify the specific effect of blocking ccr5.
With laranglemab on Downstream signaling and biomarkers of inflammation. And second, we need to determine what is the optimal dose of around the map to use in the non-hiv and non-antiviral setting. I believe that addressing these questions will provide a framework for the FDA to understand any future clinical efficacy claims cited on makes and help the company accelerate the advancement of larolamount.
To provide a rationale for the inflation study, we reviewed data from cyanide's prior, Nash math, study where we looked at the effect of Laura, on the map in the subgroup of patients, that entered that study with inflammation as indicated by elevated levels of C-reactive protein and Baseline Elevated levels of C-reactive protein or CRP is widely.
Understood to be a key marker of chronic inflammation and associated with heart attacks strokes and other inflammatory illnesses. The re-analysis of our data indicated, a very important dose-dependent reduction in C-reactive protein. When Laurel on the map was dosed at both 350 and 700 mg compared to Placebo. Indeed, the main goal of our inflammation study will be to statistically, confirm that Lauren, Lamab.
Lowers levels of fee-reactive protein, as well as other key markers of inflammation. So follow in consultation with industry experts and mindful of the fda's prior feedback. We further revised the inflammation. Protocol, the study will now enroll 90 HIV positive. Subjects, who have chronic inflammation as demonstrated by an elevated level of high sensitivity, CRP at a pre-screening.
Visit confirmed at a screening visit at least two weeks apart. Uh, these study participants will be created for six months with weekly subcular on the map at either 350 or 700 milligrams or Placebo. And as just mentioned, the primary endpoint will be reduction in C-reactive protein with a host of other inflammatory biomarkers evaluated, a secondary endpoints Dr.
Otto Yang from UCLA. Have kindly agreed to be the lead investigator. For the trial. And the revised protocol will be submitted to the FDA in the next several weeks, which in turn will start a 30-day review, period. As noted in the recent shareholder letter, I believe it is imperative.
The company generate unassailable results in the clinic and I believe the above two trials can accomplish this In addition to these two core clinical studies, I'm pleased to announce two other exciting clinical initiatives First, we are in discussion with the American foundation for AIDS research. To partner and co-sponsor a study called latch led by investigators at Oregon Health Sciences University and the University of Washington, Latch stands for Lauren lemab and allogenic stem cell transplant to cure HIV.
The proposed study will evaluate the use of Laura on the map to facilitate an HIV cure. In the HIV positive subjects, undergoing stem cell transplantation, Previous reports of HIV. Positive patients achieving a cure have occurred. When those rare homozygous ccr5, double negative individuals have been identified to provide donor stem cells for the transplantation.
This study will evaluate the possibility that larolamap could extend the list of potential donors to include the much larger pool of ccr5, positive individuals. Administered following transplantation for six months during the engraftment period, to protect the HIV negative, donor cells from becoming HIV infected. The hope is that those donor cells now protected from HIV.
Infection will then eliminate HIV from the reservoir of the transplant recipient. If successful, this study would obviously bring about much needed positive attention to both Laura on the map and Cydonide. We're exploring this partnership with amfar to jointly co-sponsor and fund the research aspects of the latch study. Which importantly will not require us to cover the cost of the transplant itself.
I'm also pleased to confirm that Saturday night is collaborating on an exploratory investigator initiated pilot study of Lauren Lamabin patients with Alzheimer's disease. Saturday night is fortunate to be working on this project with a highly experienced investigator and a leading academic Medical Center. The study proposes to enroll 20 patients, with mild to moderate Alzheimer's disease, who are treated with Laura on the map at either 350 or 700 milligrams weekly and followed for 12 weeks with a primary neuroradiology endpoint.
I look forward to providing additional details on future calls but it's important to note that we have already identified an external source of funding for this study. Lastly, I'm pleased to announce that cyto 9 is following up on the results of our prior Nash study, which demonstrated a statistically significant benefit of the wrong, the map at the 350, milligram dose though not at the 700 milligram dose level.
In order to clarify the optimal dosing regimen for Nash, are now Mash and efficiently, evaluate the potential for combination therapy. We have contracted with the lab to perform a pre-clinical mouse study, evaluating both 350 and 700, milligram dose levels alone, and in combination with Reset metron, a drug recently approved by the FDA for the treatment of mash.
The study will evaluate larala map with, and without rest metarom in both preventing, as well as reversing liver fibrosis. The results of this study should be available in the fall and will, hopefully then enable us to pursue Partnerships evaluating combination therapy in the math space. Before closing with a discussion of Publications and projected timelines.
I'd like to switch gears and touch on cyanine's efforts to develop longer acting forms of Lauren lemap. Dr. Scott Hansen, has been working in the lab in his lab to evaluate the various long-acting candidates and it's kindly agreed to join us on the call today. Scott. Thank you. Jay uh if any of you listening have heard me speak before, I'm very passionate about larger map and absolutely believe it can help people and I promise we as a company are working hard to make that happen.
For me, this all began during the pandemic and calling your mind. Jonas Sasha asked me to help out with cytodine cd15 trial. I knew nothing of LaRonia map at the time, but because it was a covid-19 study at the height of the pandemic and my academic lab was capable of in taking clinical trials material, I was happy to help out my role in this project was to perform the receptor occupancy essay, as well as run various biomarker analyzes.
The First Data I analyzed from this trial, I was instantly amazed how laronymad was changing the immune cell landscape and treated patients. The mouse immunologists like to call these changes. Macrophage polarization, but what I was observing was much more nuanced and robust. I was observing near complete. Immune modulation, almost all major, immune cell classes, including T, and B cells, not just macrophage polarization and after making this observation, I knew from that day that this molecule could be useful as a therapeutic including treatment for various cancers and neuroinflammatory disorders.
So when Cyrus Armand asked me to join the company in a more formal capacity, it was very easy for me to say, yes. As I said earlier, I believe this molecule can help and will help people. But enough about me, I think what most people are interested in hearing about is what we've been up to this past year.
I'm delighted to say that the Personnel auditions Tanya and the board have made to the company. In my opinion, have been amazing. We all worked super well together and because of this, we were finally able to get laranye Bob off the clinical hold, but more importantly, for the sake of getting the Roger Mabad into the people where it should be for the first time Jay and Cyrus greenlighted, a deep dive into the data from our past clinical trials.
I think you heard Jay speak of this a little earlier of re-analyzing. The Nash data. This is this is part of that. You may ask why that is so important. Well, I believe we are currently making sound and up-to-date plans based off our actual clinical data and we have lots of it.
And we're using these data to drive our decisions of where we feel Iran Yamab can be most impactful which hopefully will equate to the quickest path to approval and viable partnerships. I think Jay did a great job, outlining firedine's future and why we are devoting our resources to these specific areas and I can confidently.
Tell you those decisions were based off of actual data from our trials. Compensation from statisticians, reviewing that data and expert opinions from the scientific. And and the work that I've done in the lab related to the mechanism of action, we have lots of data in the lab. Now finally, I'm very excited to share with you some exciting things happening in our pre-clinical programs.
First and I think Jay concluded. His first section of his talk on. This is to protect and expand our IP portfolio. We are working with a local generative AI company to design and create not only a longer lasting laranyamab, but possibly a more potent molecule that can be used in pre-exposure prophylaxis or prep a space where we think in combination with a long-acting antiretroviral, will have huge impacts for the HIV.
I'm currently testing 17, new variants of laurania map. It's really early in this process, but some of these monu molecules are showing extreme promise in my in vitro assays. Um, making sure that the function of lauranya mab is not altered, but preserved, and these data are very exciting and get very, very early, but very promising.
I'm very excited about this endeavor and I feel it will be a game changer for cydodine and will help preserve the company's future. Lastly, I feel another game changer for cytodine, is the latch trial Jay mentioned earlier in his presentation. This is something very exciting for us as a company and me, personally, I became a scientist, not only to move science forward, but to also try to save life, Dr.
Jonah Sasha's. Work with laronda mab and stem cell transplant in the non-human primate model really made this trial possible for us. He demonstrated that you can pharmacologically knock out pcr5, with the running map, essentially creating that Delta 32 phenotype. That Jay mentioned, the phenotype has facilitated HIV care in the setting of stem cell cell transplantation.
This isn't a therapy Obviously this isn't a therapy for everyone living with HIV but for those that it makes sense for We Believe LaRonia map can help cure people of HIV and that would be pretty remarkable and something we can all be very proud of. I can go on and on about my excitement about this molecule, but for the sake of time, I'm going to hand the mic back over to Jay.
Thank you for listening to me today. It was my pleasure to be here, and I'm happy to be part of all this Thank you, Scott. Um, it really has been a pleasure getting to know you better and working with you and uh appreciating the enthusiasm you bring to this work.
Um it is also exciting to be working on the various early stage clinical trials, That I outlined with our current formulation over on the map knowing that a longer acting and more convenient formulation of the drug could be available to patients down the road. So moving on now, as promised on prior calls, cyanide is also continuing to aggressively pursue publication of our clinical data for peer review.
Uh importantly the clinical endpoint data from the cd15. Long covid trial was recently published in the Journal of Infection that study enrolled. 56 patients, with long covid who were treated for eight weeks with either Lauren Lamab or Placebo. And the study results showed clinical Improvement in 19 of the 24 endpoints that were evaluated.
Um and so that data is now posted on our website and has been brought to the attention of colleagues at the recover program at NIH, overseeing studies in long covid. In addition to that. Now publish data we have two manuscripts from our studies of patients with triple negative breast cancer.
A manuscript from our study of HIV positive patients with multi-drug resistant virus and a manuscript from our study of patients, with mild to moderate covid-19 that have all been submitted from publication and are currently undergoing peer review. In addition a manuscript detailing results from both our pre-clinical and clinical studies of Laura, on the map in Mash is undergoing final internal review and will be submitted shortly.
So at this point, I would again like to pause and ask Tanya erbach, our chair of the board of directors. To join the call and say a few words, Tanya Thank you. Jay. On behalf of the board. I'm really delighted to be here today and to extend our Collective appreciation for the dedication and hard work, demonstrated by Jay, and the team over the past several months.
As outlined by J, significant progress has been achieved in identifying and pursuing our corporate objectives setting, an exciting trajectory for the future. Jay has proven to be an outstanding leader serving as a unifying Force within the team, and earning, everyone's respect with his tireless, work ethic, wisdom and humility.
We were particularly pleased when he accepted the longer-term role of Chief executive officer, a testament to his dedication and vision. Throughout the past months, the board has been deeply engaged in a comprehensive review of our corporate strategy in collaboration with management and key advisors Each director officer and outside consultant has played a crucial role in this process and I want to express sincere gratitude for their combined contributions and commitment.
The resulting corporate strategy has been met with satisfaction by the board and we are enthusiastic about the objectives set forth by Jay and the team. We see promising opportunities ahead, particularly with respect to Laura, on the map's prospects in oncology and other growth prospects that could yield significant value.
While we acknowledge that, as Jay says, there is still work to be done. We do want to recognize that he and the team have been able to accomplish over the past several months, as we anticipate the future, we are eager to witness a continued advancements and achievements, that lie ahead in the remainder of the calendar year, Thank you again JCU.
And the team and I'll hand it back to you. Uh, thank you Tanya. And I I genuinely appreciate the way you and the board have supported me and management and all of our team. Uh, during this critical transition for cy9. Um, lastly, I would like to brief the comment on the projected timelines for the various programs, I discussed.
As I mentioned previously, we are currently discussing, uh, with FDA. Uh, issues around our colorectal, cancer study, and hope to start enrolling patients before the end of the year. We have finalized the inflammation study and we'll be submitting that to FDA this week or next week and hope to start enrolling patients as well in 2024.
The timelines for the latch study, uh, and the pilot study in Alzheimer's disease, involve academic institutions. So both are more likely to start early in 2025, And the results of the pre-clinical study of Lauren Lamab and Mash that I described should be available in the fall, which hopefully will give us the data to start pursuing a partnership before the end of the year.
And lastly, after someone unavoidable delays, the pre-clinical study of laramab and a mouse model of glioblastoma at my father's lab at Einstein monastery, Medical Center in New York, is now underway and we look forward to reviewing those results by the end of the year. In closing, I would just like to say that is truly an honor to serve as cyan CEO at what remains a critical critical, juncture for the company.
I want to again, thank the many shareholders who have graciously reached out to express their support and good wishes. We're genuinely pleased by the recent progress here at 79 we know there's more work to do and we look forward to keeping you informed as further events unfold till then stay safe and thank you for your patience and support.
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