Q4 2019 Earnings Call

Include but are not limited to statements regarding the company's plans and expectations for its lead CB 4211 drug candidate programs including but not limited to expect expectations regarding the timing and progression of the CV 4211 clinical trial and the expected timing of delivery of data the therapeutic and Commercial potential of the companies lead.

Welcome to the visor and Conference Center. The next available. Comfort specialist will be with you momentarily.

Song Conference Center, this is Diana. Which car would you like?

I'm sorry.

Okay. Thank you. And may I have your name, please?

And your company please David?

All right. Thank you so much. I'll transfer you to call you.

Operation forward-looking statements are based on current expectations project projections and interpretations that involve a number of risks and uncertainties that could cause actual results to differ materially from those anticipated by Khobar these risks and uncertainties are described in our registration statements reports and other filings with the Securities and Exchange Commission and a bath Canadian Securities Regulators, which are available on our website at sec.gov as well as in the safe harbor statement including with today's press release you are caution caution that such statements are not guarantees of future performance and that our actual results May differ materially from those set forth in the forward-looking statements. Khobar does not take any obligation to update publicly or revise any forward-looking statements or information whether as a result of new information future events, or otherwise now, I'd like to turn the call over.

To just be you know, Colbert's to financial Financial Officer Jeff.

Nike Jordan

well now go to the agenda.

next slide

When the slide comes up, there's a forward-looking statements that Jordan just reviewed and here's our agenda for our fourth-quarter discussion today.

Okay, next slide, please.

Want to thank everyone for joining us this afternoon. I will now provide you with a summary of our financial results the fourth quarter ended December 31st, 2019 compared to the fourth quarter ended December 31st, 2018 total operating expenses and Q4 2019 with 3570000 dollars as compared to $496,000 in Q4 2013 a decrease of approximately $526,000.

Operating expenses included non-cash expenses of $638,000 for the quarter ended December 31st, 2019 and $944,000 for the quarter ended December 30th, 2018. Net up and non-cash expenses total operating expenses in Q4 2019 with 2932000 dollars as compared to 3152000 Min the decrease of approximately $220,000 non-cash operating expenses include stock-based compensation and depreciation and amortization costs.

Research and development expenses were 1 million eight hundred ninety-eight thousand dollars in Q4 2019 compared to two million $86,000 in the prior-year. A decrease approximately $188,000 decrease in research and development expenses was primarily due to the timing of preclinical and clinical costs incurred in the prior year. These increases were partially offset by an increase in expenses related to our continuing development of peptides.

General and administrative expenses were 1672000 dollars in Q4 2019 compared to two million $10,000 in the prior-year. The decrease of approximately $330,000 decrease in general administrative expenses was primarily due to non-cash stock-based compensation and Severance costs related to determination of our former CEO and the prior-year. Partially offset by an increase in payroll related cruel's legal fees and dno insurance premiums incurred in the current year.

For the quarter ended December 31st, 2019. Copa reported net loss of 3717000 dollars or nine cents per basic and diluted share compared to a net loss. The quarter ended December 31st, 2018, a 4190000 dollars or $0.10 per basic and diluted share net loss included in non-cash expenses of $743,000 for the quarter ended December 31st, 2019 and 1 million $49,000 for the quarter ended December 31st, 2018, excluding the non-cash expenses. Colburn net loss is 2974000 dollars the quarter ended December 31st, 2019 as compared to three million $141,000 for the quarter ended December 31st, 2018.

Moving to the balance sheet as of December 31st, 2019 Cobra had twelve point six million dollars in cash and cash equivalents compared to twenty two point two million in cash and Investments as of December 13th, 2018 the cash burn for the quarter ended December 31st. 2019 was approximately 2.2 million dollars.

We estimate that based on our cash and Investments balance as of December 31st, 2019. We have sufficient Capital to finance our operations into the first quarter of 2020. This revised page is a result of delaying certain expenses, which we do not expect materially affect our R&D programs subsequent to the year-end the company decided to extend our operation data certain of the warrants that were issued as part of the company's private offering completed in July 2017. The expiration date of these warrants was extended from June 30th, 2020 to September 30th, 2021, but the balance of the terms and conditions of the warrants remaining unchanged holders of these warrants should expect to receive paperwork in the next month or two from the company.

I will now turn the call over to Steve Steve. Thanks, Jeff. Good afternoon everyone and thank you for joining us today.

Before I get started with the overview, I wanted to know that there's been a lot of news on the potential impact of the nineteen disease on businesses and like most company that we are monitoring the situation. It is not possible at this time to estimate the impact. If any that Cove in nineteen could have on our business office, he could impede some of our activities for example, our clinical trial recruitment testing monitoring and related activities. Hopefully, this will not happen but we are monitoring the situation closely and would update the shareholders if needed in the meantime We are continuing our efforts in adapting to the changing conditions in particular. We just announced that Khobar will be meeting with investors at the Roth Conference next week. Which brought

converted to virtual meeting

So we will keep moving forward next slide.

We have made substantial progress recently. We were up from three programs last summer to five programs in January. We announced the discovery of cxcr4 Inhibitors. It is an important pathway for cancer and genetic diseases. And this is our second oncology program and an area where many companies are looking for new approaches in December. We announced positive preclinical results in the anti-fibrotic area which supported our earlier novel prophylactic results and it raises our confidences compound could have positive clinical benefits. Why are we finding such potent peptides in the mitochondria DNA?

These peptides have been part of the mitochondrial genome for Millennia and their function has been honed to a particular task as a result certain peptides are highly evolved regulated key biological functions.

The breadth of our technology platform continues to expand we have one program in Nash and obesity to in cancer one and fibrosis and 1000 type 2 diabetes and all of this supports the potential for the platform to produce additional novel peptides ninja hi.

So we see ourselves as the leader in developing Therapeutics from mitochondrial DNA this kind of the Cornerstone slide for Khobar and there may be some review or some of you to know the story will beginning with item one. The discovery Behind Bars technology is the finding that the mitochondria am more than powerhouses of the cell that we learned in Biology class and generate signals that affects cells organs and systems across the bottom.

And based on the last decade of research mitochondria dysfunction underlies multiple chronic and age-related diseases like Nash and obesity Gene. Some of the others cold war is discovered over a hundred peptides encoded in the mitochondria genome as a result. We believe we have a platform technology capable of producing multiple shots on goal. So imagine a hundred Keys up on the wall, and we're bringing them down one at a time to find out what they do.

CB 4211 is the first mitochondria based therapeutic to be evaluated in a clinical study in humans. We believe that CB 42 is the first of a number of candidates that our technology platform will identify for advancement into the clinic the data readout for this program is expected in the third quarter of 2020. Our chief science officer can Conde we'll discuss this further in his section in parallel. We generated an entirely new program a cxcr4 inhibitor and are continuing to progress on our evaluation of additional novel peptides targeting fiber optic diseases among oncology and type 2 diabetes. We plan to nominate one of these programs for ind-enabling studies leading to the clinic in dog.

2020

As we are leaders in development of mitochondrial based Therapeutics r i p o r i p portfolio is significant and continues to expand and we have an experienced management team as well leveraged by preclinical and clinical research organizations outside experts and world-class Founders. This provides strong talent and bread on a timely basis with financial efficiency.

As Jeff stated we had twelve point six million at the end of the fourth quarter. We've been spending less than a million dollars monthly the last quarter off and expect our Runway to take us into the first quarter of 2021. We think it is prudent to plan on maintaining our current burn rate and at the same level as the last few months until we raise additional funds we continue to prioritize our platform the spending on our platform, which we will discuss more later next slide, please.

So we've been talking about mitochondria medicine. What is it? There's a growing awareness and recognition of the role of mitochondria. Not only in producing energy wage in sales, but also in communicating among cells and in regulating and orchestrating the biological processes and systems that maintain a healthy balance that respond to disease and damaged replace aging cells and adapted the changing environmental and energy requirements off. This expanded is systemic roll for mitochondria how it affects how aging and disease and the therapeutic approaches to address its medical needs is collectively what we're we've been referring to as the new Arena of mitochondrial medicine. It also includes behaviors and the very significant.

Control of mitochondrial dysfunction in diseases as we've talked about for example with Nash where mitochondrial dysfunction starts with obesity and liver Fat Shack immune and inflammatory processes and progresses to cirrhosis fibrosis and potentially cancer.

And type 2 diabetes has an even longer list of Downstream diseases around the body driven by mitochondrial dysfunction when mitochondria don't function properly disease has become increasingly systemic another aspect of mitochondrial medicine.

next slide

we've seen the evidence of this in our own research and development activities are earlier peptide research demonstrated therapeutic potential for metabolic diseases inflammation and cancer n RCB 4211 peptide targets Nash and obesity. Both metabolic diseases together with the information that leads to fibrosis and our more recent research and studies with our newer cxcr4 anti-fibrotic immunotherapeutic wage type two diabetes peptides Target and even more diverse set of diseases all with peptides originating within the mitochondrial genome this diversity illustrates, the broad roles of mitochondria and mitochondrial of dysfunction and further supports our belief in the potential.

all of our library of

Mitochondrial peptides to address the therapeutic needs of a very wide range of diseases.

We also believe it continues to position Khobar as a first-mover in leader in this incredibly important new Arena of mitochondrial medicine off now our chief science officer King Hyundai will share our clinical and preclinical progress Ken. Thank you. Steve all analogy of a brief update on a warranty programs beginning with our CB 4211 clinical program next slide player.

So Stevie 4211 is currently in Phase 1 clinical testing as a potential treatment for National be City the phase one stage of the study is complete and involved a double-blind placebo-controlled single sending dose multiple ascending dose assessment of safety tolerability and pharmacokinetics in healthy adults to select the most appropriate dose for the phase 1B stage. No significant safety or tolerability issues were observed in the phase one after restarting the study the ongoing phase one be part of the study is a double-blind placebo-controlled evaluation of one dose level of c v 4211 even once a day, you know be subjects with nafld. This phase is designed to assess potential effects of birth to 11 on liver fat body weight and various biomarkers that are relevant to Nash obesity and metabolic disease the phase 1B stage is currently recruiting wage.

We have added three new clinical sites to the study in order to expedite enrollment. We made this change when it appeared that our single site would be unlikely to enroll subjects fast enough was still meeting all of the revised study entry criteria, all for clinical sites are now open and recruiting and with the addition of these new sites, we expect availability of top-line activity data in the third quarter of 2020, but the final timing will continue to be a function of the enrollment rate. We will be updating the clinicaltrials.gov record to reflect the site changes, but we will not be providing patient by patient details on enrollment as a reminder that study is blinded and Analysis of data from both stages of the study will only occur when the database is finally locked and the study is unblinded after completion of the phase one be staged.

As stated on the last quarterly coal, we expect to provide updates on the progress of the study at significant Milestones. If the study goes as planned the next such Milestone would likely be the end of dosing in the last obese nafld subject and we will update our progress on the next investor call next slide, please.

Now let's talk about what is next for CB 4211. We plan to complete the ongoing phase 181b study with readouts for National be city as we said in the third quarter of 2025. What we do next will depend on what we see from the phase 1B data in terms of Trends in liver fat reduction by MRI PDF and Trends in biomarkers. This is a small study involving four weeks of treatment. So we will not be looking for the same outcomes as a larger phase two study with a longer duration of 12 or 16 weeks.

in planning the

Development path for CB 4211 in Nash. There are a number of factors that need to be considered based on the phase 1B outcome. We will need to select the best dose regimen or regimens to take forward off the study design and duration and we need to understand how the regulatory landscape is evolving around the most appropriate primary and secondary endpoint. We will need to select appropriate patient population for our drug the right stage of fibrosis to study and carefully consider the potential contribution of diabetes and other comorbidities in the National wage population.

We also need to conclude the process of phase do preparations which includes manufacturing toxicology Etc.

It may be advantageous for us to consider running an additional short phase 1B study specifically in a diabetic population on a glp-1 Agonist to take full advantage of a potential Synergy with CB 4211 and help differentiate our product. So as we progress in development, we will also continue to refine our formulation towards a final commercial form.

Now we're looking at all of these factors and independent of the Nash outcome. We also continue to look at the potential for c v 4211 in obesity and other alternative indications off next slide, please.

So now let's talk about the rest of our pipeline. We have made great progress over the last year and now we have four programs in the preclinical peptide stage. The first of these is an exciting new program. That was only recently announced analogs for cancer and other indications now analogs are a family of peptides that are highly potent an elective Inhibitors of the CXC chemokine receptor type four or cxcr4. This is a key chemokine receptor that regulates the growth and metastasized tumors as well as the movement of immune cells within the body.

The in vitro activity of this family of peptides was demonstrated in cell-based assays and has also been successfully translated to the in Vivo setting in an initial Mouse model of a greyish melanoma and we will discuss the data in more detail in the next few slides the second program announced on our last quarterly call is analog peptides byproduct diseases. We previously shared data on the efficacy of MBT 2 and a prophylactic Mouse model of idiopathic pulmonary fibrosis, or ipf and Thursday December. We announced that we had further demonstrated the efficacy of MBT 2 in a therapeutic model of ipf where fibrosis is already established before the treatment is started off will also show some of those data today.

the 3rd

Program discussed in our last call is the MBT 3 family of peptide analogs with potential for cancer immunotherapy enhancing the killing of cancer cells by human immune cells in vitro. And the final program on the list is CB 5064 analogs for type 2 diabetes this family of peptides interacts with the April in receptor off a key receptor involved in energy homeostasis cardiovascular function and other processes. We previously presented data on the CB 5064 family as a 2019 American Diabetes Association meeting now on today's call. I'll focus on the two newest programs the cxcr4 antagonist and the anti-fibrotic peptide both of which have generated considerable Interest next slide Loop.

Now chemokine receptor are proteins that are found on the surface of cells that sense a corresponding chemical signal or chemo kiyon Nae send a message within the cell that can make the cell move towards the source to cxcr4 receptor in particular plays a key role in tumor growth Invasion angiogenesis metastasis, and in the resistance of cancer cells to therapy. It also regulates the Homing and retention of stem cells and malignant cells within the bone marrow. This receptor is overexpressed in 75% of human tumors in the sending of cancer inhibition of cxcr4 needs the mobilization of immune cells enhances the effect of chemotherapy and immunotherapy in various cancers.

And reduces the development of metastatic tumors by blocking the ability of tumor cells to evade immune surveillance.

Now Beyond this inhibition of cxcr4 also has potential for mobilizing stem cells so that they can be harvested for transplantation and it offers a potential for treatment of a phone number of Orphan indications where cxcr4 is dysregulated.

What Cobalt has discovered is a novel Family of peptides that are cxcr4 antagonists the m b t v analogs these novel peptides represent the first Inhibitors Thursday are 4 to be based on a peptide encoded in the mitochondrial genome and that potentially offers a lower risk of off-target effects.

Power and b t v and logs are highly potent. They're able to inhibit cxcr4 at very low concentrations down in the loan animal arranged and they're highly selective to the cxcr4 time. As I said, we've already successfully expanded on this in vitro potency and we have demonstrated efficacy in an initial model in Vivo. We showed that MBT 5001 was effective at enhancing chemotherapy in an aggressive Mouse melanoma model reducing the growth of tumors. In fact, the combination of MBT 5000 log one with the chemotherapeutic temozolomide significantly reduced mean to my volume by 61%

versus only Thirty

8% for treatment with temozolomide alone. So let's look at those data in more detail next flight.

Okay, and this slide we see on the left the growth of the tumor is over time after implantation in the mice and presented here as the average of eight to ten animals for each track on the right. You see the individual tumor sizes at day 11:00 of the study now the black line and the dots that are black or treatment with Placebo or vehicle control and you can see that the tumors grew rapidly. You can see from the blue line that this particular aggressive tumor type does not respond to immune checkpoint Inhibitors like the dead body, which is the male equivalent of the human drug keytruda. The green line is treatment with a chemotherapeutic agent temozolomide alone.

And they said that resulted in about a 31% reduction in the tumor volume compared to vehicle.

Now treatment with m b t v analog one alone had a modest effect on tumor growth in the pink line as expected. But when this particular peptide was combined with TJ, the purple line is significantly enhance the tumor affect anti-tumor effect resulting a 61% reduction in tumor growth compared to vehicle.

This appears to be the result of the peptide successfully blocking cxcr4 reducing the ability of the tumor to grow and invade and allowing the chemotherapy to be more effective next slide, please.

On this slide. We see the individual tumor growth curves for each animal in the study and you can see again on the top-left that the tumors in the vehicle control group in Black all grew very rapidly.

On the bottom, right? You can see that animals that received m b t v analog one and temozolomide all showed a reduction in tumor growth.

I need to see that in the in the pink lines on the bottom right side of the slide next slide, please.

Now turning to our other peptide programs the anti-fibrotic peptides that we announced on our last call. This is the discovery of a family of MBT 2 analogs with the invetro evidence that MBT to reduces the production of biomarkers of fibrosis in cultured cells and inhibits the fiber-optic process of cell transition from fiber glass to my of fiberglass. We also shared data on the anti-fibrotic and anti-inflammatory effects of MBT 2 observed in the prophylactic Mouse model of idiopathic pulmonary fibrosis a model that involves immediately treating with our peptide after induction of fibrosis in the lungs by administering the drug bleomycin.

back in

Send the we announced that those anti-fibrotic and anti-inflammatory effects have been further extended to a therapeutic Mouse model of ipf where treatment was delayed until seven days. I was induced. We saw positive effects on all study outcomes indicating efficacy in the studying of established fibrosis.

Now that result also raises the potential for activity in other fibrotic diseases and evaluation of this new peptide family is ongoing with the goal of identifying a new drug candidate. I go to the next slide, please.

I'm not spend much time on this slide, but these are some of the data we previously shared on the prophylactic Mouse model of ipf showing that treatment with MBT to produce significant reductions in fibrosis and inflammation next slide, please

Here are the data from the therapeutic Mouse model of ipf where treatment was delayed until after fibrosis was established. The bars here are blue for normal animals with no induction of 5 that has red bars or animals given bleomycin to induce fibrosis followed by Placebo treatment. The green bars are data for Nintendo nib, which is one of the two current approved drugs for ipf. Clinically Nintendo games slows down the progression of ipf, but it also has significant off Target effects, including nausea and vomiting and anorexia nervosa.

The purple bars are mbc2 here. We saw positive effects on all study outcomes fibrosis information college and deposition and long wait on the bottom Edge. You can also see that we preserved the body weight that's normally lost after induction of fibrosis.

Now this result raises the potential for activity in other fibrotic diseases. And as I said, we're evaluating the peptide now with the goal of identifying a new drug candidate. Let's go to the next slide, please.

So this slide slide here is a high-level overview of our current R&D programs for m b t s c v 4211 our first clinical Canada day off is in the phase 1B stage of clinical testing for activity relevant to both Nash and obesity behind that is an expanding list of preclinical programs with data in various animal cuz he studies and these include the cxcr4 antagonist peptides for cancer and other indications analogs for fiber optic diseases such as ipf the MP3 analogs for cancer immunotherapy and the CB 5064 analogs for type 2 diabetes. And with that I'll hand the presentation back to Steve. Thanks, next line.

I want to take a moment and talk to you about the rationale behind our Pipeline and I want to begin with CB 4211. I would note that there's a large unmet medical need there are no approved drugs and Nash. There are also a few options for obesity. They're over thirty million u.s. Adults at risk and over a hundred million Americans of all ages are obese and patience, but I asked and lose their liver function and can end up with cirrhosis of the liver or even liver cancer.

and of course

The obese have a number of associations with other diseases such as cardiovascular disease type two diabetes and cancer itself.

As Ken indicated CB 4211 has a unique mechanism of action which enhances regulation by insulin and results in a reduction in liver fat.

What's important is that this approach is very different from the other companies in the space and it is why we believe some of the problems that other companies have experienced are unlikely to represent hurdles for us as a result. This is a novel approach that may be very attractive to Partners. Now as with many diseases Nash will likely require combined use multiple drugs in order to fully control the progression of disease given the high unmet need and the multiple mechanisms of pathology. We believe there is plenty of room for more than one compound further. We believe the first approval of a drug in this category will likely increase the confidence that other compounds like ours can eventually succeed.

Another item is that given our compounds apparent Synergy with marketed GOP one drugs makes us think that there will be interest from companies who are markets GOP one type drugs right now and because CB 4211 is effects on the foundational event in Nash, which is the accumulation of fat. We would expect at the fat producing effects would be expected to slow the disease progress at any stage of Nash.

We've had conversations with multiple large pharmaceutical companies in the last year and is clear to us that they are interested and they're waiting to see the results from the name is one B study as a result. We are taking a conservative stance and partnering this year until after the results are available and we were able to share them with the other companies next slide.

So now I like to talk about the rationale behind the preclinical programs as well as our priorities on those different programs in the pipeline. Currently, we think it is time to plan on maintaining our burn rate to the same level as last year fortunately the initial stages of Discovery and evaluation are not as expensive as the latter stage of going into the clinic now that we have additional programs. How do we decide about prioritizing spending on the programs? We're looking at several factors such Choice R&D requirements timing business opportunity and Market size currently the cxcr4 inhibitor and the anti-fibrotic programs have the highest priority of the preclinical programs. Let me explain why

in the case of CXC are

For for inhibitor program there is a high unmet medical need and the analogs are highly potent and selective to this receptor, especially when compared to the currently available and approved compound for stem cell mobilization as part of treating certain cancers certain companies are working on genetic defects of the cxcr4 pathway, which we believe may also be an interesting Target. We believe our cxcr4 inhibitor may be broadly applicable in cancer and in the particular genetic defect

And again has indicated we believe our anti-fibrotic program is demonstrated, both anti-fibrotic and anti-inflammatory effects in preclinical models and may have potential application a broad range of fibrotic diseases such as ipf but also kidney fibrosis both General and orphan ipf is a high-end package disease with only two approved drugs that are not particularly effective and do have side effects.

In regards to potential Partnerships for a preclinical programs. We are in the early stages of exploring possibilities in some indications, like oncology and fibrotic diseases recent deals have been occurring at an earlier stage of development. However, in our case, we're still in the very early stage of defining the indications and refining the activity of our cxcr4 Inhibitors and anti-fibrotic peptides.

Rest assured as we continue to move these assets forward. We plan to increase our partnering Outreach.

next slide

Now let me speak to the goals for 2020. These are our key plan goals first. We plan to complete the 1B stage of the 181b study and provide the results in the third quarter of 20 22nd. We expect to identify our next clinical candidate for pre-ind Studies by continuing Research into our for preclinical program. Third. We plan to maintain our financial Runway and ability to invest in our clinical and preclinical programs.

So is a public biotech company. We are of course Limited in what we can say about our plans for funding. However, we can't speak generally about our overall strategy off balance is several factors such as the amount and timing the market conditions both globally and in biotech the data readouts from our clinical and preclinical trials and maintaining adequate funds to ensure our ability to invest in our programs and dealing with risk factors and the relatively the relative cost of money and dilution.

Using this framework, we regularly evaluate our financing needs overall. We are looking to gain biotech focused institutional ownership and Faith coverage as well as increasing our cash position given the timing of the clinical study results in third-quarter. We plan to raise money prior to those results to bring us to continue to take the next steps in RCB 4211 program and while maintaining our investments in our preclinical programs.

Yes.

And earlier we are monitoring the recent volatility and the capital markets and staying in close contact with investors and bankers during this turbulent time as you might expect we have developed alternative plans to control costs in case Capital markets issues affect our financing plans. Currently. We haven't changed our plans going forward, but we are prepared to put the plan in place if it should be necessary.

And fourth we anticipate continuing our work to broaden that base of investors and secure research coverage where we are looking at the funds that home shares in our peers as well as looking at the institutional investors and even generalist looking for innovative solutions to chronic diseases and aging we've been very busy this year with one-on-one investor meetings as part of Road shows in New York Boston in San Francisco.

To give you an idea, for example, we had over twenty five meetings during the three days at the JPMorgan conference in January and over twenty five meetings over to TJ's at the Bayou CEO meeting in February as mentioned. We are continuing our efforts and adapting to the changing conditions and we will be meeting with investors at the Roth conference virtually next week to give you an idea of the response. We've been getting the overall feedback from investors. This is quite different from last summer many recognize that we've made substantial progress increasing and increasing the number of programs over the past year and especially know life is simply an ash company.

Many investors have expressed appreciation for the promise of our peptide portfolio.

Regarding the analyst coverage. We've met with over a dozen Wall Street Bank analysts over the past six months and found the reception generally positive especially with the increasing recognition of the impact mitochondrial dysfunction recent policy preclinical results in the cxcr4 inhibitor and anti-fibrotic programs has helped capture their attention off. This often is involved multiple meetings as you might expect and as we go through these the analysts become more comfortable with our technology and opportunity.

Of course analyst coverage often depends on establishing a banking relationship which depends on financing and it's discuss we anticipate expecting partnering activities around cohorts technology particularly after we have the 1B results as leaders in the mitochondrial Drive peptide development. We continue to expand our IP portfolio to maintain our leadership in mitochondrial based Therapeutics next slide. So we continue to realize the Khobar Vision recent academic research on mitochondria continues to expand the list of impacts of mitochondrial dysfunction off on multiple systems in the body such as the immune system and metabolic further new research is Illuminating the multiple connections between the mitochondria and the system's dead.

they are showing that might have

Condrey of peptides are a key component of Regulation and modulation.

We Believe Khobar is uniquely positioned to capitalize on these new scientific findings in the last year Cobra has made substantial progress increasing our preclinical program from 3 to 5 showing the therapeutic breath and potential the peptides and the potential of the platform to generate multiple shots on goal cobras technology and opportunity that has been well received by potential investors partners and analysts.

The companies found fundamentals are strong and the management team is increasingly enthusiastic about its prospects. We continue to be on the front lines of birth control medicine. We're still at the early stage of realizing the full potential of the Khobar vision.

No, I would like to turn the line over to the operator to open the line for questions and answers. Thank you. I see you would like to ask a question, please. Press star one on your telephone keypad. A confirmation tone will indicate your lines in the question queue. You may press star to if you would like to remove your question from the queue and for a participant using speaker appointment. It may be necessary to pick up your handset before pressing the start to use one moment while we pull for questions.

our first question

is from Tom Synder private investor, please proceed.

Yeah, hi. I just wanted to my first question actually Steve and you did a great job of answering it which was the white elephant in the room in relation to the the runway left. And and I was always wondering why there weren't more collaborations. But you you have done a phenomenal job of answering that even better than I anticipated. My second question is about the patent sweet home any of the provisional patent has been dropped or moved forward and the last question is and this is going to sound a little crazy. But can anybody tell me what John Stern does to add value to the company?

No, Tom, thank you. And I appreciate the compliments on handling the the white elephant in the room. I'll let Ken talk to the provisional patent then. Yes, so just so you have a picture of what we do here. I read the IP front. Can you hear me? Yes. Yes. Yes great. We we are maintaining our coverage of the entire area with a whole portfolio of provisional patents that as we evaluate assets and movement forward in in the discovery and development setting off. They will get transformed into pcts. And that's the process. We're we're in right now. That's perfect. Yeah great.

So Tom regarding John.

I mean John was the original CEO at the company as you know, and it's been here throughout the time. He has been a huge help in bringing me on board from last May this point in time and his my right-hand man and helping us get things done around here. Now, you may know that we we recently added Jordan Taurasi to help us with the brakes are kind of effort and John still has depth of knowledge there, but I would say that Jordan has been doing a wonderful job of helping both John and I moved forward in the area of investor relations. And so I think we're continuing to increase the amount of capacity that we can apply to the problems, but John wage absolutely critical in the last year in in helping me to make things happen.

Our next question is from Steve Carroll private investor, please proceed.

Hi, Steve, and Ken and others. I want to congratulate you on your recent discoveries and developments. Very exciting to hear. I have a question on the current month for the candidate and and and it's an ignorant type of question on how these things actually work. But God, can you explain when you talk about thirty million people in the United States that may be affected by Nash and and an equal number of people if not greater jobs that are suffering from obesity. What sort of problems are do we run into and and what do they look like in from the outsourced clinicians? What do they face and actually getting off?

Right. Thanks for the question. Yes. So let me clarify a little bit here. The people that take part in these studies are not your run-of-the-mill patience. They are people who are willing to volunteer for clinical study. And in our case, it's a clinical study that requires a commitment of time for being sequestered but also for being followed up for safety issue after the end of the study. So those volunteers have to be willing to come in and spend a lot of time on this study. They also have to meet a lot of other criteria that are not necessarily wage all patients and that is all the entry entry criteria for the study. And those are all listed on our clinicaltrials.gov less things. It's a long list so I won't go through them now, but if you take that you'll see that they have to be very clean with respect to what else they're doing. One of the meds. They're taking what their history is very specific in terms of Entry criteria around how much Liverpool

Where they're at on various metabolic markers as well. So that's the reason this is not just you know, scooping twenty subjects out of a a 30 million population wage. It's looking for a committed volunteers that can meet all of this long list of Entry criteria.

That's all thank you. Kenneth follow-up question would be again just for understanding is is the enrollment total enrollment subject to change a timing concern.

Well, we we are going to enroll them at the fastest rate we can and obviously we made a decision that that was more likely to happen with multiple sites, you know one advantage of multiple sites dead in the current climate is if things are interrupted for any reason having multiple sites open is always a better position to be in so, you know, this is the step would be taken to try and increase enrollment rate and that's where we come out right now with the projection for the third quarter.

Do you have to have full enrollment to actually get to start dosing? No, this is not how the study runs. This is a rolling enrollment. So we will, we will be enrolling them as they come along. Okay. Thank you. I appreciate your help. Sure. Thank you, Steve.

As a reminder to star one on your telephone keypad, if you would like to ask a question, we will buzz for a brief moment.

There are no further questions at this time. I would like to turn the conference back over to management for closing remarks. Thanks Sherry. So thank you all for joining us who are really excited today to go over all the great news and the progress. We've made not only in the last couple of months, but just for the whole year. So thanks for joining us and stay tuned more to come.

Thank you. This concludes today's conference. You may disconnect your lines at this time, and thank you for your participation.