U.S. markets open in 7 minutes

Edited Transcript of COB.U.V earnings conference call or presentation 12-Mar-20 9:00pm GMT

Q4 2019 CohBar Inc Earnings Call

MENLO PARK Mar 30, 2020 (Thomson StreetEvents) -- Edited Transcript of CohBar Inc earnings conference call or presentation Thursday, March 12, 2020 at 9:00:00pm GMT

TEXT version of Transcript


Corporate Participants


* Jeffrey F. Biunno

CohBar, Inc. - CFO, Treasurer & Secretary

* Jordyn Tarazi;Director of IR

* Kenneth C. Cundy

CohBar, Inc. - Chief Scientific Officer

* Steven B. Engle

CohBar, Inc. - CEO & Director




Operator [1]


Good afternoon. My name is Sherry, and I will be your conference operator today.

At this time, I would like to welcome everyone to CohBar's Fourth Quarter 2019 Financial Results Conference Call. (Operator Instructions) Please note, this conference is being recorded.

I would now like to turn the conference over to Jordyn Tarazi, Director of Investor Relations at CohBar.


Jordyn Tarazi;Director of IR, [2]


Thank you, Sherry, and thank you, everyone, for joining CohBar's Fourth Quarter 2019 Financial Results Conference Call. Joining me on today's call is Steve Engle, CohBar's Chief Executive Officer; Ken Cundy, CohBar's Chief Scientific Officer; and Jeff Biunno, CohBar's Chief Financial Officer.

CohBar's 10-K filing and financial results press release were issued earlier today and may be downloaded from our website at www.cohbar.com. If you're having issues joining the Webex, you can access the slide presentation from the homepage of CohBar's website.

Jeff will begin with an overview of the fourth quarter financial results, followed by a business and R&D update from Steve and Ken.

Before we begin, I'd like to take a moment to remind listeners that remarks on today's conference call may include forward-looking statements within the meaning of the securities laws. These forward-looking statements include, but are not limited to, statements regarding the company's plans and expectations for its lead CB4211 drug candidate program, including, but not limited to, expectations regarding the timing and progression of the CB4211 clinical trial and the expected timing of delivery of data, the therapeutic and commercial potential of the company's lead drug candidate, CB4211, and other mitochondria-based therapeutics; statements regarding ongoing and planned research and development activities, potential partnerships and our capital resources and our ability to fund our operations.

Forward-looking statements are based on current expectations, projections and interpretations that involve a number of risks and uncertainties that could cause actual results to differ materially from those anticipated by CohBar. These risks and uncertainties are described in our registration statements, reports and other filings with the Securities and Exchange Commission and applicable Canadian securities regulators, which are available on our website at cohbar.com, sec.gov and sedar.com as well as in the safe harbor statement including with today's press release.

You are cautioned 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. CohBar does not undertake 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 Jeff Biunno, CohBar's Chief Financial Officer. Jeff?


Jeffrey F. Biunno, CohBar, Inc. - CFO, Treasurer & Secretary [3]


Thank you, Jordyn. We'll now go to the agenda. Next slide. Okay. And the slide comes up -- yes, there's the forward-looking statements that Jordyn just reviewed, and here's our agenda for our fourth quarter discussion today.

Okay. Next slide, please. I want to thank everyone for joining us this afternoon. I will now provide you with a summary of our financial results for the fourth quarter ended December 31, 2019, compared to the fourth quarter ended December 31, 2018.

Total operating expenses in Q4 2019 were $3,570,000. That's compared to $4,096,000 in Q4 2018, a decrease of approximately $526,000. Operating expenses included noncash expenses of $638,000 for the quarter ended December 31, 2019, and $944,000 for the quarter ended December 31, 2018.

Net of the noncash expenses, total operating expenses in Q4 2019 were $2,932,000 as compared to $3,152,000 in Q4 2018, a decrease of approximately $220,000.

Noncash operating expenses include stock-based compensation and depreciation and amortization costs.

Research and development expenses were $1,898,000 in Q4 2019 compared to $2,086,000 in the prior year period, a decrease of approximately $188,000. The decrease in research and development expenses was primarily due to the timing of preclinical and clinical costs incurred in the prior year period. These decreases were partially offset by an increase in expenses related to our continuing development of peptides.

General and administrative expenses were $1,672,000 in Q4 2019 compared to $2,010,000 in the prior year period, a decrease of approximately $338,000. The decrease in general and administrative expenses was primarily due to noncash stock-based compensation and severance costs related to the termination of our former CEO in the prior year period, partially offset by an increase in payroll-related accruals, legal fees, and D&O insurance premiums incurred in the current year period.

For the quarter ended December 31, 2019, CohBar reported a net loss of $3,717,000 or $0.09 per basic and diluted share compared to a net loss for the quarter ended December 31, 2018, of $4,190,000 or $0.10 per basic and diluted share. Net loss included a noncash expense of $743,000 for the quarter ended December 31, 2019, and $1,049,000 for the quarter ended December 31, 2018. Excluding the noncash expenses, CohBar's net loss was $2,974,000 for the quarter ended December 31, 2019, as compared to $3,141,000 for the quarter ended December 31, 2018.

Moving to the balance sheet. As of December 31, 2019, CohBar had $12.6 million in cash and cash equivalents compared to $22.2 million in cash and investments as of December 31, 2018. The cash burn for the quarter ended December 31, 2019, was approximately $2.2 million. We estimate that based on our cash and investments balance as of December 31, 2019, we have sufficient capital to finance our operations into the first quarter of 2020. This revised guidance is a result of delaying certain expenses which we do not expect to materially affect our R&D programs.

Subsequent to the year-end, the company decided to extend the expiration date of 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 30, 2020, to September 30, 2021, with the balance of the terms and conditions of the warrants remaining unchanged. Holders of these warrants should expect to receive paperwork in the next week or 2 from the company.

I will now turn the call over to Steve. Steve?


Steven B. Engle, CohBar, Inc. - CEO & Director [4]


Thanks, Jeff. Good afternoon, everyone, and thank you for joining us today.

Before I get started with the overview, I wanted to note that there's been a lot of news on the potential impact of the COVID-19 disease on businesses, and like most companies, we are monitoring the situation. It is not possible at this time to estimate the impact, if any, that COVID-19 could have on our business. It 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 and adapting to the changing conditions. In particular, we just announced that CohBar will be meeting with investors at the ROTH Conference next week, which ROTH has converted to virtual meetings. So we will keep moving forward.

Next slide. We have made substantial progress recently. We are up from 3 programs last summer to 5 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 in 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 confidence this 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 to regulate the key biological functions.

The breadth of our technology platform continues to expand. We have 1 program in NASH and obesity, 2 in cancer, 1 in fibrosis and 1 in type 2 diabetes. And all of this supports the potential for the platform to produce additional novel peptides.

Next slide. So we see ourselves as the leader in developing therapeutics from mitochondrial DNA. This is kind of the cornerstone slide for CohBar, and there may be some of you -- for some of you that know the story well.

Beginning with item 1, the discovery behind CohBar's technology is a finding that the mitochondria are more than powerhouses of the cell that we've learned in biology class and generate signals that affect cells, organs and systems across the body. And based on the last decade of research, mitochondrial dysfunction underlies multiple chronic and age-related diseases like NASH and obesity and some of the others.

CohBar has discovered over 100 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 100 keys up on the wall and we're bringing them down one at a time to find out what they do.

CB4211 is the first mitochondria-based therapeutic to be evaluated in a clinical study in humans. We believe that CB42 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, Ken Cundy, will discuss this further in his section.

In parallel, we generated an entirely new program of CXCR4 inhibitor and are continuing to progress on our evaluation of additional novel peptides targeting fibrotic diseases, immuno-oncology and type 2 diabetes. We plan to nominate one of these programs for IND-enabling studies leading to the clinic in 2020.

As we are leaders in development of mitochondria-based therapeutics, our IPO -- our IP portfolio is significant and continues to expand. And we have an experienced management team that is well leveraged by preclinical and clinical research organizations, outside experts and world-class founders. This provides strong talent and breadth on a timely basis with financial efficiency.

As Jeff stated, we had $12.6 million at the end of the fourth quarter. We've been spending less than $1 million monthly the last quarter 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 mitochondrial medicine. What is it? There's a growing awareness and recognition of the role of mitochondria, not only in producing energy within cells, but also in communicating among cells and in regulating and orchestrating the biological processes and systems that maintain the healthy balance that respond to disease and damage, replace aging cells and adapt to the changing environmental and energy requirements. This expanded the systemic role for mitochondria, how it affects health, aging and disease, and the therapeutic approaches to address its medical need is collectively what we're -- we've been referring to as the new arena of mitochondrial medicine.

It also includes the behaviors and the very significant role of mitochondrial dysfunction in diseases. As we've talked about, for example, with NASH, where mitochondrial dysfunction starts with obesity and liver fat, triggers 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, diseases become increasingly systemic, another aspect of mitochondrial medicine.

Next slide. We've seen the evidence of this in our own research and development activities. Our earlier peptide research demonstrated therapeutic potential for metabolic diseases, inflammation and cancer. And our CB4211 peptide targets NASH and obesity, both metabolic diseases, together with the inflammation that leads to fibrosis. And our more recent research and studies with our newer CXCR4 anti-fibrotic, immunotherapeutic and type 2 diabetes peptides target an even more diverse set of diseases, all with peptides originating within the mitochondrial genome. This diversity illustrates the broad role of mitochondria and mitochondrial dysfunction and further supports our belief in the potential 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 CohBar as a first mover and leader in this incredibly important new arena of mitochondrial medicine.

Now our Chief Science Officer, Ken Cundy, will share our clinical and preclinical progress. Ken?


Kenneth C. Cundy, CohBar, Inc. - Chief Scientific Officer [5]


Thank you, Steve. I will now give a brief update on our R&D programs, beginning with our CB4211 clinical program. Next slide, please.

So the CB4211 is currently in Phase Ia/Ib clinical testing as a potential treatment for NASH and obesity. The Phase Ia stage of the study is complete and involved a double-blind, placebo-controlled, single ascending dose, multiple ascending dose assessment of safety, tolerability and pharmacokinetics in healthy adults to select the most appropriate dose for the Phase Ib stage. No significant safety or tolerability issues were observed in the Phase Ia after restarting the study.

The ongoing Phase Ib part of the study is a double-blind, placebo-controlled evaluation of one dose level of CB4211 given once a day in obese subjects with NAFLD. This phase is designed to assess potential effects of CB4211 on liver fat, body weight and various biomarkers that are relevant to NASH, obesity and metabolic disease.

The Phase Ib stage is currently recruiting subjects. We have added 3 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 while still meeting all of the revised study entry criteria. All 4 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, the 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 Ib stage.

As stated on the last quarterly call, 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 CB4211. We plan to complete the ongoing Phase Ia/Ib study with readouts for NASH and obesity, as we said, in the third quarter of 2020. What we do next will depend on what we see from the Phase Ib data in terms of trends in liver fat reduction by MRI-PDFF and trends in biomarkers. This is a small study involving 4 weeks of treatment, so we will not be looking for the same outcomes as a larger Phase II study with a longer duration of 12 or 16 weeks.

In planning the development path for CB4211 in NASH, there are a number of factors that need to be considered. Based on the Phase Ib outcome, we will need to select the best dose regimen or regimens to take forward, the study design and duration, and we need to understand how the regulatory landscape is evolving around the most appropriate primary and secondary endpoints. We will need to select the most appropriate patient population for our drug, the right stage of fibrosis to study and carefully consider the potential contribution of diabetes and other co-morbidities in the NASH study population. We also need to conclude the process of Phase II preparations, which includes manufacturing, toxicology, et cetera.

It may be advantageous for us to consider running an additional short Phase Ib study, specifically in a diabetic population on a GLP-1 agonist, to take full advantage of potential synergy with CB4211 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 CB4211 in obesity and other alternative indications. 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 4 programs in the preclinical peptide stage. The first of these is an exciting new program that was only recently announced, MBT5 analogs for cancer and other indications. Now MBT5 analogs are a family of peptides that are highly potent and selective inhibitors of the CXC chemokine receptor type 4 or CXCR4. This is a key chemokine receptor that regulates the growth and metastasis of 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 study in an initial mouse model of aggressive 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 MBT2 analog peptides for fibrotic diseases. We previously shared data on the efficacy of MBT2 in a prophylactic mouse model of idiopathic pulmonary fibrosis or IPF. And in December, we announced that we have further demonstrated the efficacy of MBT2 in a therapeutic model of IPF where fibrosis is already established before the treatment has started. We'll also show some of those data today.

The third program discussed on our last call is the MBT3 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 CB5064 analogs for type 2 diabetes. This family of peptides interacts with the apelin receptor, a key receptor involved in energy homeostasis, cardiovascular function and other processes. We previously presented data on the CB5064 family at the 2019 American Diabetes Association meeting.

Now on today's call, I will focus on the 2 newest programs, the CXCR4 antagonist and the anti-fibrotic peptide, both of which have generated considerable interest. Next slide, please.

Now chemokine receptors are proteins that are found on the surface of cells that sends a corresponding chemical signal or chemokine and then send the message within the cell that can make the cell move towards the source. The 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 overexpressing 75% of human tumors.

In the setting of cancer, inhibition of CXCR4 leads to 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 number of orphan indications where CXCR4 is dysregulated.

What CohBar has discovered is a novel family of peptides that are CXCR4 antagonists, the MBT5 analogs. These novel peptides represent the first inhibitors of CXCR4 to be based on a peptide encoded in the mitochondrial genome, and that potentially offers a lower risk of off-target effects. Our MBT5 analogs are highly potent, they're able to inhibit CXCR4 at very low concentrations down in the low nanomolar range and they're highly selective to the CXCR4 target.

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 MBT5 Analog 1 was effective at enhancing chemotherapy in an aggressive mouse melanoma model, reducing the growth of tumors. In fact, the combination of MBT5 Analog 1 with the chemotherapeutic temozolomide significantly reduced mean tumor volume by 61% versus only 38% for treatment with temozolomide alone. So let's look at those data in more detail. Next slide.

Okay. In this slide, we see on the left the growth of the tumors over time after implantation in the mice and presented here as the average of 8 to 10 animals for each treatment. On the right, you see the individual tumor sizes at day 11 of the study. Now the black line and the dots that are black are 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 anti-PD-1 antibody, which is the mouse equivalent of the human drug, KEYTRUDA. The green line is treatment with a chemotherapeutic agent, temozolomide, alone. And as I said, that resulted in about a 31% reduction in the tumor volume compared to vehicle. Now treatment with MBT5 Analog 1 alone had a modest effect on tumor growth in the pink line, as expected, but when this particular peptide was combined with temozolomide, the purple line, it significantly enhanced the tumor effect -- antitumor effect, resulting in 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 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 MBT5 Analog 1 and temozolomide all showed a reduction in tumor growth and you can see that in the pink line 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 MBT2 analogs. We shared the in vitro evidence that MBT2 reduces the production of biomarkers of fibrosis in cultured cells and inhibits the fibrotic process of cell transition from fibroblast to myofibroblast.

We also shared data on the anti-fibrotic and anti-inflammatory effects of MBT2 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 lung by administering the drug, bleomycin. Back in December, we announced that those anti-fibrotic and anti-inflammatory effects had been further extended to a therapeutic mouse model of IPF where treatment was delayed until 7 days after fibrosis was induced. We saw positive effects on all study outcomes, indicating efficacy in the setting of established fibrosis.

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

I will 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 MBT2 produced 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 fibrosis. The red bars are animals given bleomycin to induce fibrosis followed by placebo treatment. The green bars are data for nintedanib, which is 1 of the 2 currently approved drugs for IPF. Clinically, nintedanib slows down the progression of IPF, but it also has significant off-target effects, including nausea, vomiting and anorexia. The purple bars are MBT2. Here, we saw positive effects on all study outcomes: Fibrosis, inflammation, collagen deposition and lung weight. On the bottom right, 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 are evaluating the peptide now with the goal of identifying a new drug candidate. Go to the next slide, please.

So this slide here is a high-level overview of our current R&D programs for MBTs. CB4211, our first clinical candidate, is in the Phase Ib 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 efficacy studies and these include the CXCR4 antagonist peptides for cancer and other indications, the MBT2 analogs for fibrotic diseases such as IPF, the MBT3 analogs for cancer immunotherapy and the CB5064 analogs for type 2 diabetes.

And with that, I'll hand the presentation back to Steve.


Steven B. Engle, CohBar, Inc. - CEO & Director [6]


Thanks, Ken. Next slide.

I want to take a moment and talk to you about the rationale behind our pipeline, and I want to begin with CB4211. And I would note that there is a large unmet medical need. There are no approved drugs in NASH. There are also a few options for obesity. There are over 30 million U.S. adults at risk for NASH and over 100 million Americans of all ages are obese. And patients with NASH can 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 2 diabetes and cancer itself.

As Ken indicated, CB4211 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 NASH 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 of 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 compound's apparent synergy with marketed GLP-1 drugs makes us think that there will be interest from companies who are marketing GLP-1 type drugs right now. And because CB4211 has effects on the foundational event in NASH, which is the accumulation of liver fat, we would expect that the fat-reducing 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 it is clear to us that they are interested and they are waiting to see the results from the Phase Ib study. As a result, we are taking a conservative stance on partnering this year until after the results are available and we are able to share them with the other companies. Next slide.

So now I'd 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 prudent 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 stages 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 as 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 CXCR4 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 these particular genetic defects.

As Ken has indicated, we believe our anti-fibrotic program has demonstrated both anti-fibrotic and anti-inflammatory effects in preclinical models and may have potential application in a broad range of fibrotic diseases such as IPF, but also kidney fibrosis, both general and orphan. IPF is a high unmet need disease with only 2 approved drugs that are not particularly effective and do have side effects.

In regards to potential partnerships for our 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 are 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 planned goals. First, we plan to complete the Ib stage of the Ia/Ib study and provide the results in the third quarter of 2020. Second, we expect to identify our next clinical candidate for pre-IND studies by continuing research into our 4 preclinical programs. Third, we plan to maintain our financial runway and ability to invest in our clinical and preclinical programs.

So as a public biotech company, we are, of course, limited in what we can say about our plans for funding. However, we can speak generally about our overall strategy, which balances 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 research 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 allow us to continue to take the next steps in our CB4211 program and while maintaining our investments in our preclinical programs.

As mentioned earlier, we are monitoring the recent volatility in 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 market 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. We are looking at the funds that hold shares in our peers as well as looking at the institutional investors and even generalists 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 and San Francisco. To give you an idea, for example, we had over 25 meetings during the 3 days at the JPMorgan Conference in January and over 25 meetings over 2 days at the BIO 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 is quite different from last summer. Many recognize that we've made substantial progress increasing -- in increasing the number of programs over the past year and especially no longer view us as simply a NASH company. Many investors have expressed appreciation for the promise of our peptide portfolio.

Regarding analyst coverage, we've met with over a dozen Wall Street bank analysts over the past 6 months and found the reception generally positive, especially with the increasing recognition of the impact to mitochondrial dysfunction. Recent positive preclinical results in the CXCR4 inhibitor and anti-fibrotic programs has helped capture their attention. This often has 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. As discussed, we anticipate expanding partnering activities around CohBar's technology, particularly after we have the Ib results. As leaders in the mitochondrial-derived peptide development, we continue to expand our IP portfolio to maintain our leadership in mitochondria-based therapeutics. Next slide.

So we continue to realize the CohBar vision. Recent academic research on mitochondria continues to expand the list of impacts of mitochondrial dysfunction 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 these systems. They are showing that mitochondria-derived peptides are a key component of regulation and modulation. We believe CohBar is uniquely positioned to capitalize on these new scientific findings.

In the last year, CohBar has made substantial progress, increasing our preclinical programs from 3 to 5, showing the therapeutic breadth and potential to peptides and the potential of the platform to generate multiple shots on goal. CohBar's technology and opportunity has been well received by potential investors, partners and analysts. The company's fundamentals are strong and the management team is increasingly enthusiastic about its prospects. We continue to be on the frontlines of mitochondrial medicine. We are still at the early stage of realizing the full potential of the CohBar vision.

Now I would like to turn the line over to the operator to open the line for questions and answers.


Questions and Answers


Operator [1]


(Operator Instructions) Our first question is from [Tom Stender], private investor.


Unidentified Participant, [2]


I just wanted -- my first question, actually, Steven, you did a great job of answering it, which was the white elephant in the room in relation to the runway left. And I was always wondering why there weren't more collaborations, but you have done a phenomenal job of answering that even though -- than I anticipated.

My second question is about the patent suite. Have any of the provisional patents been dropped and moved forward?

And the last question is, and this is going to sound a little crazy, but can anybody tell me what Jon Stern does to add value to the company.


Steven B. Engle, CohBar, Inc. - CEO & Director [3]


[Tom], thank you, and I appreciate the compliments on handling the white elephant in the room. I'll let Ken talk to the provisional patent. Ken?


Kenneth C. Cundy, CohBar, Inc. - Chief Scientific Officer [4]


Yes. So just so you have a picture of what we do here around the IP front -- can you hear me?


Unidentified Participant, [5]


Yes, yes.


Kenneth C. Cundy, CohBar, Inc. - Chief Scientific Officer [6]


Yes, great. We are maintaining our coverage of the entire area with a whole portfolio of provisional patents that as we evaluate assets and move them forward in the discovery and development setting, they will get transformed into PCTs, and that's the process we're in right now.


Unidentified Participant, [7]


That's perfect. Yes, great.


Steven B. Engle, CohBar, Inc. - CEO & Director [8]


So [Tom], regarding Jon, I think Jon was the original CEO of the company, as you know, and has been here throughout the time period. He has been a huge help in bringing me on board from last May to this point in time and he is my right-hand man in helping us get things done around here. Now you may know that we recently added Jordyn Tarazi to help us with the IR kind of effort, and Jon still has a depth of knowledge there, but I would say that Jordyn has been doing a wonderful job of helping both Jon and I move forward in the area of investor relations. And so I think we are continuing to increase the amount of capacity that we can apply to the problems, but Jon has been absolutely critical in the last year in helping me to make things happen.


Operator [9]


Our next question is from [Steve Caro], private investor.


Unidentified Participant, [10]


Steve and Ken and others, I want to congratulate you on both your recent discoveries and developments. It's very exciting to hear.

I had a question on the current trial for our NASH candidate. And it's an ignorant type of question on how these things actually work. But can you explain, when you talk about 30 million people in the United States that may be affected by NASH and an equal number of people, if not greater, that are suffering from obesity, what sort of problems are -- do we run into? And what do they look like in -- from the outsourced clinicians? What do they face in actually getting enrollment?


Kenneth C. Cundy, CohBar, Inc. - Chief Scientific Officer [11]


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 patients. They are people who are willing to volunteer for a 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 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 asked of patients and that is on the entry criteria for the study, and those are all listed on our ClinicalTrials.gov listing. It's a long list, so I won't go through them now, but if you take a look at that, you'll see that they have to be very clean with respect to what else they are doing, what are the meds they are taking, what their history is. Very specific in terms of entry criteria around how much liver fat, where they're at on various metabolic markers as well. So that's the reason this is not just scooping 20 subjects out of a 30 million population. It is looking for committed volunteers that can meet all of this long list of entry criteria.


Unidentified Participant, [12]


Thank you, Ken. A follow-up question would be, again, just for understanding, is the enrollment -- total enrollment subject to a timing concern?


Kenneth C. Cundy, CohBar, Inc. - Chief Scientific Officer [13]


Well, 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. One advantage of multiple sites as well 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 this is the step we have taken to try and increase enrollment rate, and that's where we come out right now with the projection for the third quarter.


Unidentified Participant, [14]


Do you have to have full enrollment to actually get to start dosing?


Kenneth C. Cundy, CohBar, Inc. - Chief Scientific Officer [15]


No. This is not how the study runs. This is a rolling enrollment. So we will be enrolling them as they come along.


Operator [16]


(Operator Instructions) There are no further questions at this time. I would like to turn the conference back over to management for closing remarks.


Steven B. Engle, CohBar, Inc. - CEO & Director [17]


Thanks, Sherry. So thank you all for joining us. We 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.


Operator [18]


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