Q3 2022 CohBar Inc Earnings Call

[music].

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

This time I would like to welcome everyone to <unk> third quarter 2022 financial results Conference call.

All lines have been placed on mute to eliminate background noise should you need assistance. Please signal conference specialist by pressing the star Keith <unk> zero.

After todays presentation, there will be an opportunity to ask questions.

To ask a question you May press Star then one on a touchtone phone.

To withdraw your question. Please press Star then two.

Please note. This event is being recorded I would now like to turn the conference over to Jordan Terrasi Director of Investor Relations. Please go ahead. Thank you operator, and thank you everyone for joining Cobalts third quarter 2022 financial results Conference call. Joining me on today's call is Dr. Joe Sarratt Cobos, Chief Executive Officer.

Jesse will now called ice Chief Financial Officer, and Dr. <unk> <unk> Senior Vice President of research. Following our collective remarks, we will conclude with Q&A at which time, Dr. Nick Floccus cobalt as acting Chief Medical Officer will also join us.

<unk> financial results press release was issued earlier today and may be downloaded from our website at Khobar Dot com.

Before we begin I'd like to take a moment to remind listeners that except for statements of historical facts. The remarks on today's conference call May include forward looking statements within the meaning of the securities laws.

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 cool bar. These risks and uncertainties are described in our registration statements.

And other filings with the Securities and Exchange Commission and applicable Canadian Securities regulators, which are available on our website at <unk> Dot com SEC dot Gov, and SEDAR dot com as well as in the Safe Harbor statement included 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 cobalt 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 Joe <unk>, Chief Executive Officer, Joe.

Thank you Jordan and thank you everyone for joining us this afternoon.

On today's call. After my introductory remarks, Kevin will comment on our ongoing preclinical activities for <unk> 50 133 program.

Jeff will then review our Q3 financial performance.

Cooper's approach to drug development is rooted in the belief that the amount of continental genome has the potential to serve as a powerful launching point for the development of a novel class of peptide therapeutics.

It is increasingly recognized with armada cadre of clean important role in regulating various biological processes well beyond their traditional function of the powerhouse. So.

Some of these mitochondrial effects are mediated by peptides encoded in the mitochondrial genome.

An area that prior to Kumar had been largely overlooked.

For example, a recent paper co authored by Dr. <unk> Cohen, one of <unk> founders describes novel monoclonal peptide term schmooze that may play a role in Alzheimers disease.

More research on this new peptide is still in the early stages. The advances such as these contribute to the growing body of research that further.

Further supports our underlying hypothesis.

<unk> genome is a fruitful source for the development of impactful Marvell therapeutics.

We believe that improved versions of many of these native mitochondrial peptides has the potential to treat a wide range of diseases.

Derivatives of natural peptides may have a better safety and Tolerability profile.

Cobalt has generated promising data from multiple in vitro and preclinical animal models.

Several different monoclonal peptide families in diverse areas, including metabolism fibrosis and inflammation.

Additionally, we demonstrated clinical proof of concept for our approach with positive data from our initial clinical trial of TV 42, 11 last year.

We continue to lead the best way to move that program forward is in the context of a partnership.

While we have faced many challenges across several areas of our business I remain pleased with our team's performance and the progress made on our key priorities.

Our top priority continues to be the advancement of CB <unk>.

38, <unk> towards the clinic.

This product candidate is being developed to treat idiopathic pulmonary fibrosis or IPF a.

Devastating progressive lung condition. Good despite the availability of two FDA approved therapies continues to have significant unmet need with substantial an unacceptably high morbidity and mortality.

Current therapies are also quite poorly tolerated.

Limiting treatment options for patients and physicians.

During the past quarter, we've been particularly focused on two key areas for this program.

Proving the CB 50, 133 formulations in furthering our understanding of the peptides target engagement.

As a reminder, we previously announced that we observed local skin reactions at the higher dose levels in our earlier toxicology studies in monkeys.

These reactions were not inflammatory in nature, but rather appeared to be the result of a peptide aggregation or gelling upon injection.

This phenomenon is not infrequently as seen in the early stages of development of peptide therapeutics and the team has been working to mitigate this issue by improving the formulation.

During our last quarterly update we mentioned that we had identified several promising formulations based on in vitro data and plan to test those in vivo.

This is an important step since enhanced in vitro stability does not always translate to improved in vivo performance.

Unfortunately that turned out to be true in this case. The formulations. We had identified continue to demonstrate evidence peptide aggregation upon and depot injection.

While disappointing as we have discussed previously it was always expected that these reformulation activities could be an iterative process.

We have since developed additional formulations that look encouraging in vitro.

<unk> from the earlier re formulations based on performance in the presence of physiological stress conditions.

We are now in the process of testing these newer formulations in animals and assuming that these formulations meet our in vivo performance targets, we remain on track to file our IND in the second half of 2023.

And in terms of progress on the business front on September 23, we completed a one for 30 reverse stock split and subsequently received confirmation from NASDAQ that Cooper has regained compliance with the $1 minimum bid price requirement.

By implementing the reverse split we have maintained our listing on the NASDAQ exchange.

[noise] affords us greater access to capital to further fund our pipeline improved liquidity for shareholders.

An increased chance of attracting high quality institutional investors and commercial partners.

I will now turn things over to Ken to provide additional detail on our CB 50, 133 activities during the third quarter Ken.

Thank you Joe as Joe mentioned this quarter, we continued to make progress on our preclinical development for <unk> 50 138 three.

Focusing on formulation work and elucidating its molecular target.

As we have previously discussed our initial formulation work focused on enhancing our understanding of the key physical properties of the peptide.

This led to the selection of interim formulations with favorable in vitro profiles for further in vivo assessment.

Based on in vitro analysis, we identified several interim formulation that support <unk> ability of CB $51 38, three and projected clinically relevant doses provided favorable extended stability profiles and exhibit reduce aggregation compared to the formulation we used in our prior toxicology studies.

We tested these formulations in vivo and disappointingly discovered that there was significant deposition of the peptide at the injection site due to persistent aggregation or gelling.

With these interim formulations.

As Joe mentioned formulation development is an iterative process, often requiring multiple rounds of in vitro and in vivo work to identify compositions that are both compatible with the physical properties of the drug substance and the route of administration.

To this end we've recently completed the in vitro phase of new formulation work for <unk> $51 33.

The in vitro profile for these most recent formulation should reduce propensity for aggregation following physiological stress.

We are now preparing to test these formulations in animals with the objective of identifying a formulation with performance characteristics that support a clinically relevant range of doses for IPF program.

We expect to have clarity in the near term regarding whether our novel formulations have sufficiently de risked the injection site reactions to enable submission of the IND in the second half of 2023 as planned.

On the discovery side, we're continuing to evaluate <unk> 50, 138, three's mechanism of action, including further clarifying the relevant molecular pathways.

In an effort to identify direct target engagement.

We're in the process of completing a broad cell surface receptor screen with CB <unk> hundred 33, and expect to have preliminary data in the near future.

Now I'll turn the call over to Jeff to discuss our Q3 financial performance Jeff.

Thank you Tim.

We ended Q3, 2022 with $18 $3 million in cash and investments at a quarterly burn rate of approximately $1 9 million.

And we have no debt.

Search and development expenses were $1 million in Q3 2022.

<unk> to $1 $6 million in the prior year period.

A decrease of approximately $600000.

The decrease in research and development expenses was primarily due to the timing of the expenses incurred for our research programs.

General administrative expenses were $1 $4 million in Q3 2022.

Compared to $1 8 million in the prior year period. The decrease was primarily due to lower stock based compensation costs.

For the quarter ended September 32022, cobalt reported a net loss of $2 4 million or <unk> 82 per basic and diluted share on a post split basis.

Compared to a net loss for the quarter ended September 32021 of three.

$3 4 million or $1 61 per basic and diluted share on a post split basis.

Net loss included noncash expenses of approximately $400000 for the quarter ended September 32022.

And approximately $700000 for the quarter ended September 32021.

Overall, we are pleased with our financial performance and we estimate that we have sufficient capital to finance our operations through the fourth quarter of 2023.

I'll now turn things back over to Joe Joe.

Thanks, Jeff This past year has been a challenging one for co bar, especially given the turbulence in the capital markets, which have had a disproportionate impact on micro cap biotech companies.

I am pleased with the way our team has remained focused on continuing to advance our programs and our science and we continue to believe in the power of the mitochondrial genome to deliver therapeutics to address underserved conditions that represent significant market opportunities such as IPF and Nash.

Throughout this year, we have made progress on advancing CB 15, 38, three towards IND filing as well as refining our clinical development program for this product candidate at.

At the same time as Jeff highlighted we continue to be prudent financially closely monitoring our cash spend while prioritizing activities that are expected to derisk key aspects of our IPF program, such as enhancing our understanding of target engagement and developing improved formulations to mitigate against injection site reactions and improve drug exposure.

After many months of effort, we now expect data on both of those fronts in the near future and we look forward to updating you on the outcome of those studies in subsequent calls.

Operator can you now please open the line for questions.

Thank you we will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone.

If you are using a speakerphone please pick up your handset before pressing the keys.

If at any time your question Thats been addressed and you would like to withdraw. Your question. Please press Star then two at this time, we will pause momentarily to assemble our roster.

And our first question will come from Kevin Oliver with Brookline Capital markets. Please go ahead.

Great. Thank you.

First apologies for the voice.

So I have two questions first.

You mentioned you will have data available in the near future.

Can you put more specificity on that is it possible we will see this data by year end or.

Sometime in 'twenty three.

Hi, Tom Thanks for the for the question yes.

Difficult to say the exact timing of data because certain things are dependent upon.

Our contract research partners.

So we are hoping to have that data by yearend, but not.

Not 100% sure when the timing of that will be.

Okay very good thank you.

Second question.

Is <unk>.

Given.

You're in the midst of the.

And in our process.

Uh huh.

Getting the formulation and the target engagement questions answered.

How many times can you iterate.

And still stay on track too.

File and IND.

In the second half of next year.

Yeah.

So the answer to that really depends on.

Sort of what the data we get back next our hope is that we think we have a belief based on the recent in vitro data that.

Kent was describing that these newest formulations will meet our final performance targets and as I mentioned, assuming that they do then we're on track.

Further.

Further work is required it really is going to depend on what does that data show us.

What is the performance that we're seeing and sort of how do we then figure out where we go from there.

So whether that further.

Required there would have an impact on the.

Timelines really will depend on what does the data show and how close or far are we.

From our we feel like we need to be in touch.

Difficult to answer without actually seeing the data first.

And sort of what data shows will sort of lead us to the south.

I'm going to answer on next steps and possible impacts from timing.

Yes.

Okay.

Okay Fair enough. Thank you that's all my questions.

Sure. Thank you.

This concludes our question and answer session I would like to turn the conference back over to Jeff <unk> CEO for any closing remarks.

Thank you everyone for joining us this afternoon I would like to thank our shareholders for their continued support and we look forward to keeping you updated on our future progress Matt would you. Please conclude the conference call.

Thank you. The conference has now concluded. Thank you for attending today's presentation you may now disconnect.