Q2 2021 Panbela Therapeutics Inc Earnings Call

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Greetings and welcome to Penn download Therapeutics second quarter 2021 earnings call. At this time, all participants are in a listen only mode.

A question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad. As a reminder, this conference is being recorded I would now like to turn the conference call with your host James Carbonara with Investor Relations. Thank you you may begin.

Yeah.

Thank you and once again welcome to pay Enbrel, the second quarter of 2021 earnings call.

Being 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.

Risks and uncertainties that could cause actual results to differ from those expressed or implied in the forward looking statements are detailed in the Companys annual report on Form 10-K and supplement it 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 obligations to update or supplement any such statements reflect subsequent developments.

Now I would like to turn the call over to Dr. Jennifer Simpson CEO of Penn Bella Jennifer. Please proceed.

Thanks, Jayne and thank you everyone for joining I'll begin the call by touching on our second quarter and recent significant accomplishments.

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

Starting with Q2 and recent highlights I am pleased to share that in April the FDA lifted its partial clinical hold on our phase one b trial of SPP. One O. One when used in combination with standard of care agents, Gemcitabine and Nab paclitaxel or <unk> for the first line treatment of patients with metastatic.

We attic adenocarcinoma.

Enrolment in the phase one B trial completed in December of 2020, the hold have been temporarily applied pending further review of visual disturbances adverse events that were noted in early 2021.

We have agreed to include in the design of future studies, the exclusion of patients with a history of retinopathy or at risk of retinal detachment periodically ophthalmologist monitoring for all patients.

And in future dose finding studies screening for retinal toxicity will be included.

With the partial clinical hold lifted we were excited to continue advancing the pancreatic cancer program.

In June we presented that poster at <unk> sharing interim clinical data from cohort four and expansion.

The signals of efficacy reported support continued development of ICT 101, as an addition to the first line treatment for advanced pancreatic ductal adenocarcinoma.

And as neo adjuvant treatment for patients with potentially resectable disease.

The conclusion of the poster is that S. P. P. One O. One man him first line treatment with Gemcitabine and Nab paclitaxel for patients with metastatic pancreatic cancer.

We are encouraged by this conclusion, even under suboptimal conditions, including dose interruptions, which confounded results.

Cohorts two and three you did not have the dose interruptions that occurred with cohort four.

In cohort, two which utilize the same dose as cohort foreign expansion, we had an objective response rate of 71%.

Of note one subject converted from a partial response to complete response post the ask a poster presentation and one patient had no evidence of disease cannot be classified by resist as a complete response at these as the initial diagnosis of metastases with majoring surgery.

Although the numbers are small with two patients having no evidence of disease and a strong overall response rate, we look forward to initiating a randomized trial in metastatic pancreatic cancer as well as our neo adjuvant pancreatic program by year end.

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

As a reminder, with the increased level of poly means and the relationship with mutation driven cancers, the possibilities across tumor types such as lung.

Oh, sorry, Glioblastoma colon breast gastric ovarian and others are being explored.

Published research also suggests the relationship between the tumor microenvironment immune cell response, and telling me metabolism.

To understand more about how to optimally expand our clinical development program. We have an ongoing research agreement with Johns Hopkins University School of Medicine.

The partnership is designed to center around the broadened development about one to one <unk>.

Including activity in cell lines in addition to pancreatic cancer.

Biomarkers, informing diagnostics with therapeutic implications and potential combinations with checkpoint inhibitors.

We anticipate these efforts will yield preclinical data in the second half of this year, which is expected to inform additional development programs.

Shifting gears to Pembina will update at the corporate level during the second quarter Company founder Dr. Michael Collins retired as an employee of the company. Dr. Colin has continued to serve as a member of the board of directors and as a chair.

Dr. Collins commitment and leadership has been an enormous asset for Penn bowler from founding the company to advancing through the clinic and becoming CEO to his most recent role as executive Chairman.

His move from day to day active management as executive chairman, while retaining his roles as presiding member of the board as a chair is a positive all around and speaks to the strength of its executive team building and continued dedication.

Dr. Collins guidance in his role as chair will be critical as we continue to advance SPP one O one.

We announced on Monday that we received an issue notification for Pat in the U S 11098005.

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 <unk> hundred one.

Reduces the number of synthetic steps for its production from 17 to fix and provides patent coverage to 2039.

This is a landmark event for the company. This patent covering a shorter synthesis of SPP. One O. One provides many benefits, including the ability to manufacture the product with a reduced lead time.

Two a quicker access to drug supply facilitating expansion into additional indications.

And lastly enables a scalable efficient and cost effective manufacturing process for future commercialization.

The company expects to continue innovation and patent portfolio building as it develops its clinical programs.

Also in the second quarter <unk> was added to the Russell Microcap index.

Membership in the Russell Microcap index means automatic inclusion in the appropriate growth and value style indexes.

F T SEC Russell annually determined membership for its Russell indexes, primarily by objective market capitalization rankings and style attributes.

We are excited to be able to communicate our strategy and accomplish accomplishment with a broader investor audience.

Inclusion in the Microcap index will provide.

After quarter end in July we closed on a $10 million bought deal offering of our common stock, which provides important resources to keep us on the path of further developing and expanding the application of SPP, one O one and drive shareholder value.

At this point I would like to finish by reiterating our milestones.

In pancreatic cancer, we plan to initiate a randomized trial by year end as well as the Neo adjuvant study in pancreatic cancer by year end.

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

We anticipate our partnership with Johns Hopkins University School of Medicine, and other preclinical work that is ongoing will produce preclinical data to drive new development pathways across tumors. In addition to pancreatic cancer in the second half of this year.

In conclusion, we've taken significant steps in the second quarter and year to date, we have progressed our lead indication in metastatic pancreatic cancer. Additionally, we are advancing research to further increase our addressable market of pancreatic cancer and we expect to deliver updates as we reach a night or milestones.

Distribute this news through public announcements in parallel.

We're eager to increase shareholder value by further developing our lead indication and revealing in developing additional indications.

I will stop here and turn it over to Sue to review the financials.

Thank you Jennifer.

General and administrative expenses were $1.2 million in the second quarter of 2021 compared to zero point $7 million in the second quarter of 2020. The increase is due primarily to higher employee compensation and other increased costs associated with our NASDAQ listing, including higher D&O insurance premiums.

Research and development expenses were 1.0 million it in the second quarter of 2021 compared to zero point $4 million in the second quarter of 2020.

This increase is due to incremental manufacturing cost as we produce investigational product for our next clinical trial as well as spending on preclinical research.

Net loss in the second quarter of 2021 was 2.2 million or 22 cents per diluted share compared to a net loss of <unk> 4 million or six cents per diluted share in the second quarter of 2020.

Foreign currency gain of point 6 million reduced the operating loss for the second quarter of 2020.

Total cash and cash equivalents was $6.4 million as of June 30th 2021 not including the 9 million of net proceeds from our bought deal offering which closed on July 2nd for 3 million 333334 shares of common stock of <unk>.

Company at a price to the public of $3 per share before underwriting discounts and commissions.

Total current assets were $7.2 million and current liabilities were $1.4 million and there was no debt on the balance sheet as of June 30th 2021.

Looking at the cap table as of June 30th 2021 we had $10.1 million of common shares outstanding and on a fully diluted basis, we were at $17.8 million shares fully.

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 during.

During the quarter the outstanding warrants decreased by approximately 4.6 million expiring warrants.

On July 2021, the company completed the sale of three 3 million shares of common stock increasing our common shares outstanding to $13.4 million.

The fully diluted shares to $21.1 million.

Following that offering we believe that our available cash will allow us to wrap up the current clinical trial initiate a random trial randomized trial later in 2021 and invest preclinical dollars in other cancer indications, taking us into 2023.

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

Thank you at this time, we will conduct a question and answer session. If you will.

Like to ask a question. Please press star one on your telephone keypad.

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One moment, while we poll for our first question.

Our first question comes from Robin Garner with Craig Hallum. Please proceed.

Good evening and thank you for taking my questions I have a number of questions. If that's okay. The first is around your manufacturing process and how much are those changes.

Secondly change your yield for SPP went on one and should that change our cogs assumptions going forward.

Yeah.

Jennifer where you're going to take that or shall I.

Oh, sorry about that I am Robyn so much.

Yeah. So you know the it we have seen a reduction in the or an improvement in deal I should say, but I think at this point, it's still too early to quantify them how that will translate in the cards. It will be a positive benefit for sure and we look forward to finalizing those numbers as.

We scale up their operations.

Okay. Thank you for that can you talk a little bit about the neo adjuvant study. That's starting later this year what are your goals for this study and can you share certain ideas about the design.

Yeah. So we are finalizing that right now, but you know the essentially we are looking at the combination with Jama Brac thing.

You know since that's what we have where we have our experienced at it at the moment.

So patients will receive you know a couple of cycles of Xiaomi <unk> SCP one O. One they will then move into surgery and we are looking at the different endpoint. One certainly of interest would be a pathologic complete response.

We'll probably look for more of those immediate.

Points, obviously things like survival would be a quite long and hopefully that's what we see as well.

You know so I think that it's pretty traditional in terms of what you would expect for them.

A trial in the neo adjuvant setting and that would be you know look to finalize that you know in the coming months. We we will certainly get that trial design out in the public domain.

Okay. Thank you and can you share your thoughts on enrollment for the for the randomized phase two will that be a little bit faster than the phase. One study just given your history of efficacy.

For metastatic patients now.

Yes, so the answer to that is yes, and I think it's a number of components actually you know you know when you whenever you start a phase one you know.

Sometimes you tend to keep the site small and contained but now that we have the efficacy signal we feel comfortable going to you know many additional sites.

You know, we're gonna look to have the enrollment and a a I would say a reasonably fast pace.

And so that becomes a function of sites and we will look to make sure. We have the requisite sites. So that we can get that enrollment done.

Any you know what I consider a reasonable time frame.

Okay. Thank you and my last question. If there's still time is there any background history or more information in general that you could share with us on that one patient with a complete response or actually either patient.

That had no evidence of disease.

Right Yeah.

It's interesting Robyn.

We've looked at there's nothing obvious that pops out for either of those patients.

Again, we are dealing with a small number of patients in total so I'm not sure that we would've seen something but it's something that.

We're certainly looking to see if there is anything.

You know, whether they had less tumor burden.

Federer nothing is it's popping out at the moment, but we're very excited that you know out of 29 patients. We had two patients with no evidence of disease.

That's pretty good in pancreatic cancer metastatic for sure.

Yeah really impressive results in a very rare finding indeed, so thank you so much and best of luck in Q3.

Thank you so much.

Our next question comes from Jason Mccarthy with Maxim Group. Please proceed.

Hey, it's Dave on the line for Jason Thanks for taking my question. So regarding additional tumor types or are currently being assessed can you shed some color on our.

On other potential indications at all you're currently looking into and you know, perhaps it was kind of further out in the future but can.

Can you provide some indication as to when we can expect additional.

Additional diseases and in clinical studies.

Sure thing today, Yeah. So one of the things we're very excited with our collaboration with Johns Hopkins University School of Medicine, Dr. Cassaro is very well known in the Polyamine field.

And you know for US knowing that you know poly means are you involved in and so many of these cancers and especially those cancers that are driven by oncology. So if you think about K Ras and met right. There youre looking at a you know.

A large percentage of of many of these tumor types have one or the other.

So.

But what we're doing is we're actually looking across all of the different tumor cell lines and identifying where we have activity.

And then it becomes a question of you know which ones make the most sense to pursue them and so we'll take a look at where we see.

Hum.

B.

Efficacy from Etsy, if you wanted one I should say within the cell lines. Obviously, we'll look at what's going on in the in the clinical space in terms of current critical clinical trials and we'll look at it from a commercial perspective, and then we'll make the decision on which ones to move forward with because obviously, what we want to do is you know.

Find tumors, where there are a few options for patients. So we can provide a benefit for the patients but also from a company perspective move into a space, where there is indeed, a need and not a space that so crowded it doesn't make sense.

Yeah.

And the one I would say I would say they've probably the why now is that you know we have seen in the pancreatic cancer program that we have had a nice signal and we do feel that this will translate into other cancers as well.

Alright, great. Thanks for that additional color and then just another quick question about just circle back to a pancreatic ductal adenocarcinoma I was just wondering if to your knowledge or was there anything unique to that indication.

Increases the likelihood of the onset of Retinopathy, you just you know given the issues.

The issues that you had with a visual disturbances with Oh.

We would ask that.

Right nothing specific to pancreatic cancer I think it's more on the patient side and so you know there are so many drugs out in the you know out there being prescribed both within oncology and outside of oncology that actually have visual adverse events are more plentiful I think.

The most people realize.

One of the things that by just incorporating some of the inclusion exclusion criteria, we feel very comfortable that this will be controlled and in mitigated.

Many many drugs have vision screening programs. So we will be very similar in that regard, but nothing unique to pancreatic cancer, it's more patient history.

Great. Thanks for the additional color I appreciate it.

Sure.

Thank you ladies and gentlemen at this time there are no further questions in queue and we would like to thank you for your participation on today's program and you may disconnect. Your lines. At this time, we do have a question that just came in from Tony Butler with Roth capital.

Please proceed Tony.

Thanks, very much sorry, Jennifer I Couldnt hit Star one quick enough.

Tony how are you out there.

Well, thank you very much thanks for.

We're not hitting the red button at the bottom of your phone.

[laughter].

I have three questions I'm, sorry, and I'm, just going to list them, they're very simple.

One is do you have a forum that youre considering for providing the data with doctor cause Ciros I'm.

Findings for example city I'm I'm, just making things up here or will you just create an announcement that's number one.

Number two is in the trials, but youll store and I'm respectful that those are still in development. They may change, but in Europe in your mind or are you thinking.

Size wise is this I'm I'm I'm going to make up a number 50.30 to 60 something like that is that the size or is it larger and then the third question is.

Hum.

At what point do you interchange your current or your new manufactured product.

You're currently manufactured product for clinical trials, and then I'm, sorry, I need to squeeze a fourth thing because it's weird from the literature and you've made the statement certainly to us when we first conversations.

Checkpoint inhibitors or.

Added there, they're synergistic activity with polyamine inhibitor.

When do you start to consider doing a trial with that combination is that I'm, making an assumption here next year, then because certainly it's very important.

Okay. Thank you Tony So I will take them in order. So are the first in terms of a forum for providing data that comes out of Johns Hopkins, we will be looking at the the best for them you know obviously the gold centre. It is if we can get this into some type of abstract with it for a medical meeting or a peer reviewed publication.

But based on when the timing is of those it may actually be more important for us to put out a company announcement. So we will look at you know kind of the timing of that based on when the information comes in.

Because I it is going to be important it'll be driving development programs forward. So we do want to make sure that that information is conveyed to the public as well so stay.

Stay tuned for that one.

In terms of the second question the trial to start.

Do we you are correct, we have not finalized it but it is fair to say, it's going to definitely be larger than 30 or 60, it's going to be more at a proper randomized trial, we want to make sure that given the signal that we've seen you know we did have some starts and stops right. We want to make sure that we have a very clean controlled trial that delivers what we believe ultimately.

<unk> will be the data needed to.

This program forward ultimately for registration. So you know we want to make sure. It's a proper randomized trial and that will be larger than 30 or 60 for sure.

B.

Next one we are going to use the new products for all clinical trials moving forward.

The Atlas, which is going to happen right out of the gate and the last question on checkpoint inhibitors that is actually part of the preclinical work that is.

Being conducted right now by the team at Johns Hopkins University School of Medicine. So we are looking at kind of if you call it too.

Two preclinical tracks. So one is just looking at the standard you know across the different cell lines, you know where do we have activity and what makes sense to move forward and the other is to look at the tumor microenvironment impact when we use them.

You know immunotherapy and SPP one O one in some type of combination. So we're evaluating both at the same time.

Certainly if we see something that validates what the literature has shown that will translate into a trial.

<unk> pretty much anything that will come out of that research with Johns Hopkins.

We we look to be able to announce by year end, but it would be a start that would happen early next year.

Jennifer Thanks, very much appreciate it.

Yeah. Thank you Tony.

Again at this time, we thank you for joining today's teleconference. You may disconnect. Your lines at this time and have a great day.