Q3 2021 Panbela Therapeutics Inc Earnings Call

Good afternoon, ladies and gentlemen, and welcome to the <unk> Therapeutics third quarter 2021 earnings call. At this time, all participants have been placed on a listen only mode and we will open the floor for your questions and comments. After the presentation. It is now my pleasure to turn the floor over to your host James Carbonara, Sir the floor is yours.

Speaker 1: It is now my pleasure to turn the floor over to your host, James Carpenterra. So the floor is yours.

Thank you and once again welcome to <unk> third quarter 2021 earnings call with me on the call are Jennifer Simpson, Chief Executive Officer, and Sue <unk> Chief Financial Officer.

Speaker 2: Thank you. And once again, welcome to Panbella's third quarter 2021 earnings call. With me on the call are Jennifer Simpson, Chief Executive Officer, and Sue Horvath, Chief Financial Officer.

Before I turn the call over to Dr. Simpson. Please note that statements made on this call that are not historical facts may be forward looking statements significant risks and uncertainties that could cause actual results to differ from those expressed or implied in the forward looking statements are detailed in the company's annual report on Form 10-K and supplemented by subsequently.

Speaker 2: Please note that statements made on this call that are not historical facts may be forward-looking statements.

Speaker 2: Significant risks and uncertainties that could cause actual results to differ from those expressed or implied in the forward-looking statements are detailed in the company's annual report on Form 10-K and supplemented by subsequently filed reports on Form 10-Q , as well as in other reports that the company has filed with the SEC. Any forward-looking statements made on this call are made only as of today's date, and the company does not undertake any obligation to update or supplement any such statements to reflect subsequent developments.

<unk> reports on Form 10-Q, as well as in other reports that the company has filed with the SEC.

Any forward looking statements made on this call are made only as of today's date and the company does not undertake any obligation to update or supplement any such statements to reflect subsequent developments now I would like to turn the call over to Dr. Jennifer Simpson CEO.

Speaker 2: Now I would like to turn the call over to Dr. Jennifer Simpson, CEO Penn Ballot. Jennifer, please proceed.

Jennifer Please proceed.

Speaker 3: Thank you, everyone, for joining. I'll begin the call by touching on Q3 and recent significant accomplishments.

Thank you everyone for joining I'll begin the call by touching on Q3 and recent significant accomplishments.

Speaker 3: We will then follow with a review of the financial results, and then we will open it up for Q&A. So starting with the third...

Sue will then follow with a review of the financial results and then we will open it up for Q&A.

So starting with the third quarter and recent highlights.

Beginning with our current clinical trial, which I'll remind everyone is a phase <unk> study of the safety Tolerability and pharmacokinetics of SPP 101.

Speaker 3: Beginning with our current clinical trial, which I'll remind everyone, is a Phase 1a, 1b study of the safety, tolerability, and pharmacokinetics of SDP-101 when administered in combination with gensitabine and navpaclitaxel as first-line treatment of subjects with metastatic pancreatic ductal adenocarcinoma.

When administered in combination with Gemcitabine and Nab Paclitaxel as first line treatment of subjects with metastatic pancreatic ductal adenocarcinoma.

Speaker 3: Since completing enrollment in December 2020, 16 patients are in survival follow-up with two patients from cohort 2 now exceeding 26.9 and 28.7 months.

Since completing enrollment in December 2000, 2016 patients are in survival follow up with two patients from cohort two now exceeding $26 nine and $28 seven months.

Speaker 3: Median overall survival for Cohort 4 plus the Phase 1B portion has not yet been reached.

Median overall survival for cohort four plus the phase <unk> portion has not yet been reached.

Additionally, we remain focused on expanding our clinical development program.

Speaker 3: Additionally, we remain focused on expanding our clinical development program.

Speaker 3: With the increased level of polyamines and the relationship with mutation-driven cancer,

With the increased level of poly means and the relationship with mutation driven cancers, the possibilities across tumor types, such as lung glioblastoma colon breast gastric ovarian and others are being explored with the Johns Hopkins University School of Medicine.

Speaker 3: The possibilities across tumor types such as lung, glioblastoma, colon, breast, gastric, ovarian, and others are being explored with the Johns Hopkins University School of Medicine.

Speaker 3: Published research also suggests a relationship between the tumor microenvironment, immune cell response, and polyming metabolism, which is also being explored in our preclinical program with Johns Hopkins.

Published research also suggests the relationship between the tumor microenvironment immune response and timing metabolism, which is also being explored in our preclinical program with Johns Hopkins.

Speaker 3: Shifting gears to intellectual property, during the quarter we announced that we received an issue notification for a patent that focused on methods for producing SVP 101.

Shifting gears to intellectual property during the quarter, we announced that we received an issue notification for patent that focus on methods for producing SPP 101.

Speaker 3: This patent developed in collaboration with Singing International Limited, an integrated research development and manufacturing services company claims a novel process for the production of our lead investigational product, SPP 101.

This patent developed in collaboration with <unk> International Limited, an integrated research development and manufacturing services company claims a novel process for the production of our lead investigational product SPP 101.

Speaker 3: This reduces the number of synthetic steps for its production from 17 to 6 and provides patent coverage to 2039.

This reduces the number of synthetic steps for its production from 17th effects.

And provides patent coverage through 2039.

Speaker 3: This patent covering a shorter synthesis of SBP 101 provides many benefits, including the ability to manufacture a product with a reduced lead time.

This patent covering a shorter synthesis of SPP 101 provides many benefits, including the ability to manufacture products with reduced lead time.

Speaker 3: quicker access to drug supply, which facilitates expansion into additional indication.

Quicker access to drug supply, which facilitate expansion into additional indications.

And lastly enables a potentially scalable efficient and cost effective manufacturing process to be in place as soon as we are ready to commercialize upon approval.

Speaker 3: And lastly, enables a potentially scalable, efficient, and cost-effective manufacturing process to be in place as soon as we are ready to commercialize upon approval.

Also in Q3, we closed on a $10 million underwritten bought deal offering of our common stock, which provided important resources to keep us on the path of further developing and expanding the application of <unk> 101 and drive shareholder value.

Speaker 3: Also in Q3, we closed on a $10 million underwritten bought deal offering of our common stock, which provided important resources to keep us on the path of further developing and expanding the application of SVP 101 and Drive Shareholder Value.

At this point I would like to close by recapping, our milestones and.

Speaker 3: In pancreatic cancer, we intend to start a randomized trial by year-end, as well as a new adjuvant study in pancreatic cancer.

In pancreatic cancer, we intend to start a randomized trial by year end as well as the new adjuvant study in pancreatic cancer.

Speaker 3: Lastly, the preclinical investigation of additional tumor types may create other potential milestones.

Fleet the preclinical investigation of additional tumor types may create other potential milestone.

We expect our partnership with Johns Hopkins University School of Medicine, and other preclinical work will produce the preclinical data to support new development pathways across tumors outside of pancreatic cancer before year end.

Speaker 3: We expect our partnership with Johns Hopkins University School of Medicine. And other preclinical work will produce the preclinical bladdle to support new development pathways across tumors outside of Pagrata cancer before U.S.

In conclusion, we've made substantial progress in Q3 and year to date.

Speaker 3: In conclusion, we've made substantial progress in Q3 and year-to-date.

Speaker 3: We have advanced or lead indication in metastatic pancreatic cancer.

We have advanced our lead indication in metastatic pancreatic cancer.

Speaker 3: Also, we are progressing research to further augment our addressable market of pancreatic cancer patients.

Also we are progressing research to further augment our addressable market of pancreatic cancer patients.

Speaker 3: We anticipate updates if we achieve our milestones ahead and we'll share this news through press releases along the way. We're keen to grow shareholder-

We anticipate updates as we achieve our milestones ahead and we'll share this news through press releases along the way.

We're keen to grow shareholder value by further.

Speaker 3: due to lower non-cash employee compensation in 2021 versus 2022.

Kris.

Due to lower noncash employee compensation in 2021 versus 2020.

Research and development expenses were $1 3 million in the third quarter of 2021 compared to zero point $8 million in the third quarter of 2020.

Speaker 3: Research and development expenses for 1.3 million in the third quarter of 2021, compared to 0.8 million in the third quarter of 2020.

Speaker 3: This increases due to incremental manufacturing costs as we produce investigational products for our next clinical trial.

This increase was due to incremental manufacturing costs as we produce investigational products for our next clinical trial.

Speaker 3: Net loss in the third quarter of 2021, the $2.1 million or $0.16 per diluted share, compared to a net loss of $1.7 million or $0.21 per diluted share in the third quarter of 2020. A foreign currency loss of $0.3 million increased the operating loss in the third quarter of 2021.

Net loss in the third quarter of 2021 was $2 1 million or <unk> 16 per diluted share compared to a net loss of $1 7 million or <unk> 21 per diluted share in the third quarter of 2020.

Foreign currency loss of zero point $3 million increased the operating loss in the third quarter of 2021.

Speaker 3: Total cash and cash equivalence was 14.1 million as of September 30th, 2021, inclusive of approximately 9.1 million of net proceeds from our bought deal offering which closed underlie second for $3,333,334 shares of common stock of the company at a price to the public $3 per share before underwriting discounts and commissions.

Total cash and cash equivalents was $14 1 million as of September 32021, inclusive of approximately $9 1 million of net proceeds from our bought deal offering which closed on July <unk> for 3 million 333330.

<unk> four shares of common stock of the company at a price to the public of $3 per share before underwriting discounts and commissions.

Speaker 3: total current assets were 14.7 million. In current liabilities were 1.3 million, and there was no debt on the balance sheet as of September 30th, 2021.

Total current assets were $14 7 million and current liabilities were 121 3 million and there was no debt on the balance sheet as of September 32021.

Looking to the cap table, we have $13 4 million of common shares outstanding.

Speaker 3: Looking to the cap table, we have 13.4 million of common shares outstanding. And on a fully diluted basis, we were at 21.0 million shares.

On a fully diluted basis, we were at 21.0 million shares.

Speaker 3: The fully diluted number includes all outstanding equity awards, including stack options, which are held by insiders, and warrants to purchase common stack held by investments.

The fully diluted number includes all outstanding equity awards, including stock options, which are held by insiders and warrants to purchase common stock held by investors.

Speaker 3: Our available cash following the offering, we believe will allow us to wrap up the current clinical trial, initiate a randomized trial by the end of this year, and invest pre-clinical dollars in other cancer indications.

Our available cash following the offering we believe will allow us to wrap up the current clinical trial initiate a randomized trial by the end of this year and invest preclinical dollars in other cancer indications.

Speaker 3: That concludes our prepared remarks. Operator, can you please open the phone lines for Q&A and poll for questions?

That concludes our prepared remarks, operator can you. Please open the phone lines for Q&A and poll for questions.

Speaker 1: Certainly. Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press Star One on your phone at this time. We do ask that while posing your question, please pick up your handset if you're listening on speakerphone to provide optimum sound quality.

Certainly ladies and gentlemen, the floor is now open for questions. If you have any questions or comments. Please press star one on your phone at this time, we do ask that will posing your question. Please pickup your handset if you're listening on speaker phone to provide optimum sound quality.

Speaker 1: Once again, if you have any questions or comments, please press star one on your phone.

Once again, if you have any questions or comments. Please press star one on your phone.

Speaker 1: Your first question is coming from Robin Garner from Craig Hallum. Your line is live.

Your first question is coming from Robin Garner from Craig Hallum. Your line is live.

Speaker 3: Good evening. Thank you for the update and a big congratulations to those two patients in the second cohort. I wanted to ask what is the nature of the data you expect to release by your end regarding the Johns Hopkins collaboration? Is there any other color?

Good evening.

You for the update and a big congratulations to those two patients in the second cohort.

Wanted to ask what is the nature of the data you expect to release by year end regarding the Johns Hopkins collaboration.

Is there any other color you can add as to what we might see.

Sure so.

Speaker 4: Sure. So, you know, Robin, thank you so much for that question. What we have been looking at is panels across many different tumor types. And what we are looking is to identify at least one tumor to start that shows activity that warrants moving into a development program. So it would be a phase one trial looking at the first part of next year.

Robyn. Thank you so much for that question, what we have been looking at is panels across many different tumor types.

What we are looking is to identify at least one tumor to start that.

That shows activity that warrants moving into a development program. So it would be a phase one trial looking at the first part of next year.

Speaker 4: So that's the start. As you can imagine, it's a pretty lengthy process.

So that's the the start.

If you can imagine that's a pretty late.

Lengthy process.

Speaker 4: and we anticipate that we won't stop at once, but the goal is to have at least one tumor identified that we would move into development, starting in the first half of next year.

We anticipate that we won't stop at one but the goal is to have at least one tumor identified that we would move into development.

Starting in the first half of next year.

Speaker 3: Okay, thank you. And can you comment at all about any sort of immuno oncology drug candidates and combinations with them? Is that something we might see by your end as well?

Okay. Thank you and can you comment at all about any sort of immuno oncology drug candidates in combination with them is that something we might see by year end as well.

Speaker 4: It's possible that may end up coming out in the early part of next year. We are looking at both pre-clinical programs, if you will. It just depends on how the experiments are moving forward and whether or not we'll have data for that by year end. It's very possible it'll be more into the early part of next year for that

It's possible that may end up coming out.

The early part of next year, we are looking at both preclinical program for if you will so it just depends on how the experiments are moving forward and whether or not we'll have data for that by year end. It is very possible. It will be more into the early part of next year for that portion.

Speaker 3: Okay, thank you. And then for my second question, excluding the two patients that are doing very well in cohort two, does cohort two have a medium survival that we can look at? I understand the rest of the study started later, but is there anything that we can learn from cohort two at this point?

Okay. Thank you and then for my second question, excluding the two patients that are doing very well in cohort two cohort two have a medium survival that we can look at I understand the.

The rest of the study started later, but is there anything that we can learn from cohort two at this point.

Speaker 4: Yeah, so if you look at the last ASCO present, post-recentation, the median survival was at 10.3 months. So that was just roughly about two months better than the

Yes. So if you look at the last <unk>, our present poster presentation. The medium survival with a 10 three months. So that was just roughly about two months better than the.

And what we see with Gemini <unk> at eight five months.

Speaker 4: than what we see with Gemini Braxin at 8.5 months. I think it is important to know there were only seven patients in that cohort. So, you know, those are very small numbers for us. We're really keeping an eye towards...

It is important to note there were only seven patients in that cohort.

So.

Those are very small numbers for us.

Really keeping an eye towards cohort foreign expansion because now youre looking at approximately 30 patients.

Speaker 4: cohort four in the expansion, because now you're looking at approximately 30 patients.

Speaker 4: which certainly will be a little bit more robust. But I do think it's important, you know, cohorts, you have the same dose that we're using in cohort four in the expansion. And to see that kind of tail is pretty impressive. So it's a nice signal to see this early. And we're looking forward to seeing the mature data from cohort four in the expansion. But all of which I think importantly Robin points to.

Which certainly will be a little bit more robust.

But I do think it's important cohort two has the same.

Most that we're using in cohort four and the expansion and to see that kind of Cal it's pretty impressive. So it's a nice signal to see this early.

And we're looking forward to seeing the mature data from cohort four and the expansion, but all of which I think importantly, robyn points too.

Speaker 4: the need to advance this program so they're looking at the randomized trial that will start by your end.

The need to advance this program.

Looking into the randomized trial that will start by year end.

Okay. Thank you.

Speaker 1: Thank you. Your next question is coming from Tony Butler from Ross Capital. Your line is live.

Thank you. Your next question is coming from Tony Butler from Roth Capital. Your line is live.

Jennifer.

Speaker 5: in the cohort two patients that are out of

And the and the cohort two patients.

Just.

Speaker 5: for a long time with survival benefit. Do they still have any tumor? No.

For a long time.

Survival benefit.

Do they still have.

<unk>.

Speaker 5: And if they do or are I assume they're still receiving scams. And then the question is, is that...

And.

I assume theres still receiving scale.

During the question and answer Scott.

Uh huh.

Speaker 5: amount of tumor that they may have as that fluctuated.

Amount of tumor that they have.

That fluctuates it's.

My first question.

Speaker 4: So, that I'd actually have to dig into, but my guess is yes, I'm sure they do have some level of tumor. Unfortunately, just the nature of metacetic pancreatic cancer is...

So Tony I thought I'd actually have to dig into but my guess is yes, I'm sure. They do have some level of tumor.

Unfortunately, just the nature of metastatic pancreatic cancer.

Is it one that it does tend to come back.

Speaker 4: is one that it does tend to come back. But I would have to dig into that a little bit further and to give you more information. I think for us the most important thing is that it's allowing the patients, the treatment that we gave the patients, it's allowing them to...

But I would have to dig into that a little bit further to give you more information.

For us the most important thing is that.

It's allowing the patients with treatment that we gave the patients it's allowing them to have an extended survival, we certainly know that tumor.

Speaker 4: have an extended survival. We certainly know that as tumor fluctuates, there may be other things that they try.

Tumor fluctuate there may be other things that they try.

Speaker 4: But the fact that we're looking at over 27 months, essentially, it's pretty impressive for this patient population.

But the fact that we're looking at over 27 months, essentially it's pretty pretty impressive for this patient population.

Speaker 5: Absolutely great. Second question is around the randomized, I guess, phase two trial, which you could blossom into something that at least could be registration, I guess, but

Absolutely agree.

Question is around the random ones.

I guess phase II trial, which.

Blossomed into something.

Okay.

Could be Registrational and Jeff.

Speaker 5: So there have been any thought, and this is to some degree related to one of the previous questions, but there have been any thoughts actually used.

So maybe I missed this to some degree.

Related to that.

One of the previous questions brings a renewed thoughts actually use.

Tom.

A three arm study so that you can following.

Speaker 5: a three arm study so that you combine.

<unk>.

101, plus.

Speaker 5: Pimpsley Pimbo versus 101 alone versus, again, versus generative care metal.

<unk>.

Versus 101 alone.

Thank you.

Tim versus standard of care, but we do have some.

101.

So thats a great question, Tony I think.

Speaker 4: That's a great question, Tony. I think one of the things is to make sure that we have given, which we have, great deals thought into the structure of this trial, if we would like it to serve possibly to support registration.

One of the things.

Is to make sure that.

We have given which we have great deal of thought into the structure of this trial.

If we would like it to serve.

<unk> to support registration.

Speaker 4: it's important to keep it pretty clean from a one-to-one standpoint.

Important to keep it pretty clean so number one to one standpoint.

Speaker 4: But I will tell you that given what

But I will tell you that.

Given what.

Speaker 4: You know, we're hoping on the preclinical research that is something that we will look to do and most likely, you know, in a phase one development program to combine with one of the immunoncology drugs.

We're hoping.

The preclinical research that is something that we will look to do and most likely in the phase one.

Phase one development program.

Combined with one of the immuno oncology drugs.

Speaker 4: And so we're focused on identifying that the potential change in tumor microenvironment, which tumor makes the most sense, and then subsequently which agents in the immunology space makes the most sense as well.

And so we're focused on identifying that.

That potential change in tumor microenvironment, which tumor makes the most sense and then subsequently which.

Which agents in the immuno oncology space makes the most sense as well.

Speaker 5: Thank you. And obviously I assume you may have begun some conversations with...

Okay. Thank you and obviously I assume.

You may have begun some conversations with.

Speaker 5: Marker Bristol to have that collaboration so you can receive drug otherwise, which would be very costly. Last question is around the second tumor type, if you will, and again, the relationship with Hopkins. And again, will you send out the oppressor lease? What the...

Merkel Bristol to have.

That collaboration so you can receive drug otherwise.

To note would be very costly.

Last questions around this.

Second the second tumor type if you will let me just on the relationship with Hopkins and again.

What are you seeing bill via press release, what the.

Phase one trial in warts tumor.

Speaker 5: Phase one trial and what's tumor, that might be that would begin in 2022. Would you send that out via press release? Because I asked because

Might be.

That would begin.

22 would you assume that that will be a press release.

I ask because.

Speaker 5: As you alluded to, the information that Hopkins is generating is very involved.

As you alluded to there.

The information that.

Hopkins is generating.

It's very involved and I guess to.

To the extent that.

Okay.

Speaker 5: You know, some of the criteria that they went through to actually get you confidence that

Some of the criteria that they.

They went through to actually give you confidence.

Speaker 5: The tumor X might be the most beneficial next step. I think it would be very important to all of us. So I guess the question really is around how much information would you give?

Tumor X might be the most beneficial next step.

I think could be very important to all of us. So I guess the question really is around how much information would you dip.

Turning that's that's a very good question and the answer is yes, we will figure out some form whether it's a press release or.

Speaker 4: Turning that to, that's a very good question. And the answer is yes, we will figure out some forum, whether it's a press release or maybe even a conference call, because I think it is very important to help this walk people through how we got to this point, why it makes the most sense, and why we're excited to begin the next development program in this tumor type. So absolutely. Definitely.???

Maybe even a conference call because I think it is very important to help walk people through how.

How we got to this point.

It makes the most sense and why we're excited to begin the next development program in this tumor type so absolutely.

Jennifer Thank you so much.

Certainly thank you Tony.

Thank you ladies and gentlemen at this time there are no further questions in the queue and I would like to thank you for your participation in today's program. You may disconnect. Your lines at this time.

Speaker 1: Thank you ladies and gentlemen. At this time there are no further questions in the queue and we would like to thank you for your participation in today's program. You may disconnect.

Okay.