Q3 2022 Panbela Therapeutics Inc Earnings Call

Good day and welcome to the <unk> Therapeutics third quarter 2022 earnings call. At this time, all participants have been placed on a listen only mode and the floor will be open for questions and comments after the presentation. It.

It is now my pleasure to turn the floor over to your host James.

James Carbonara, James the floor is yours.

Thank you and once again welcome to <unk> third quarter 2022 earnings call with me on the call are Jennifer Simpson, Chief Executive Officer, and Sue <unk> Chief Financial Officer.

Before I turn the call over to Dr. Simpson. Please note that statements made on this call are not historical facts.

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 supplemented by subsequently filed quarterly 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 Jennifer Simpson CEO penned balance Jennifer. Please proceed.

Thank you and thank you everyone for joining.

I will begin the call with a review of our clinical development program recent accomplishments and upcoming milestones.

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

Starting with our Phase III program in August we announced the international expansion of our aspire trial.

We are waiting from <unk>, and Nab paclitaxel with or without islands salmon, which is our new generic name for <unk> hundred one.

Im treated metastatic pancreatic ductal adenocarcinoma into Australia, as well as the first patient enrolled.

We also announced a regulatory approval for the opening of trial sites in Spain, France and Italy.

With approximately 95 site plan throughout the United States, Europe , Australia, and South Korea, we are continuing to focus on site initiation and enrollment in order to ultimately deliver a more effective treatment for pancreatic cancer.

W disease with few treatment options.

We expect that a significant number of global sites will be opened by year end with the full complement of sites open by early to mid 2023.

The trial's sample size of 600 patients and the primary endpoint will be overall survival.

We will use overall survival for the interim analysis as well.

It is anticipated to take approximately 36 months for complete enrollment with the interim analysis still available in early 2024.

The interim analysis allows us to assess the merits of continuing this study as well as to ensure optimal resource utilization.

We are excited to have these recent approvals as we move forward towards the interim analysis expected in a little over one year from now.

Turning to familial adenomatous polyposis or at.

The registration trial with <unk> is anticipated to begin mid 2023 and is funded by our licensing partner <unk> therapeutics.

We are working closely with <unk> to ensure alignment with the FDA on all key aspects of the trial before the trial commences.

As the trial will utilize European clinical sites and we retain the rights outside of the U S and Canada, we will seek advice from the European authorities regarding the utilization of the registration trial for approval in Europe .

As a reminder, our prior phase III study evaluating a foreign Athena and so on that porcelain pogy versus either agent alone.

100% risk reduction in the need for surgery, and the lower gastrointestinal or Gi group.

As there are currently no approved drug therapies for the treatment of S&P. This data is exciting and a lower Gi group is intended to be the focus of the new registration trial.

Lastly, we in partnership with <unk> also have an ongoing phase III double blind placebo controlled trial of <unk>. The combination of a Florentine and sundar prevent recurrence of high risk abnormal and second primary colorectal cancers in patients with stage zero to three colon or rectal cancer.

This trial is known as the <unk> trial and is funded by the National Cancer Institute or NCI in collaboration with the southwest Oncology group also known as slog.

And we look forward to a futility analysis in the first half of 2023.

Moving to phase II studies first there is an ongoing trial in relapsed refractory neuroblastoma utilizing the Florida thing caches. This trial is funded through the children's oncology group or Cogs and the NCI.

We will also be starting in early 2023, a phase two trial and early onset type one diabetes utilizing a quantity and tablets. This study is supported by Indiana University and the juvenile diabetes Research Foundation or J D. RF.

In phase one development, we have three programs that we will be starting.

First opening by year end, we believe we will be evaluating a variety of crushing in combination with keytruda and the stick <unk> mutation population of non small cell lung cancer.

Nick 11 mutant non small cell lung cancer respond poorly to checkpoint inhibitors and bio informatic analysis suggests that alterations in polymer metabolic pathways may play a role in the resistance to immunotherapy.

In preclinical tumor models of Florida, the treatment improved anti PD, one efficacy by increasing tumor specific cytotoxic T cell population as well as increased expression of PD, one tumor associated CDA positive T cells.

The phase one portion is fully funded and we look forward to that trial, starting and it will be the first clinical proof of concept trial focused on the relationship between <unk> and immune system.

This trial is positive and opens the possibility for combining with a checkpoint inhibitor and other tumors as well as the possibility of combining with other immunotherapies such as car T therapy to improve response rates.

Our second Phase one program, which is scheduled to begin in the first half of 2023, we'll focus on the evaluation of IV <unk> in the platinum resistant ovarian cancer population.

As a reminder, we've collaborated with Johns Hopkins University School of Medicine to identify this indication.

Additionally, a poster on the treatment of immune competent mice injected with <unk> eight positive ovarian cancer with Ivy Zelman with preventive and showed a significantly prolonged survival and decrease in overall tumor burden.

The mature data was later published in the International Journal of molecular Sciences.

<unk> expanded potential of the timing analogue SPP 101, as a modulator of poly mean metabolism and cancer therapeutics.

The publication highlighted that in in vitro studies.

Chairman that FTP 101 reduced cellular viability across a broad range of cancer cell type with an exceptionally strong reduction in ovarian adenocarcinoma viability, resulting in a 42% increase in median survival and the needed a positive ovarian cancer mouse model.

The data supports efforts to initiate an ovarian cancer clinical program.

Lastly, we have completed preclinical work necessary to begin a pancreatic cancer Neo adjuvant investigator initiated trial, we are working with the key opinion leaders to finalize the protocol and obtain the necessary institutional approval to open a trial by early 2023.

Turning to milestones. In addition to continued execution of the various trials and our development program. We anticipate announcing final data from our phase one trial in untreated metastatic pancreatic cancer patients.

And early onset type one diabetes by year end or early 2023.

There will be final data from our previously completed gastric cancer prevention trial by year end or early 2023 as well as the futility analysis for the pace trial in the first half of 2023.

We also anticipate the phase one data from the <unk> Keytruda combination and stick 11, non small cell lung cancer trial by mid 2023, and the interim analysis from the aspire trial in early 2024.

In summary, we have made tremendous progress in Q3 and year to date, we are excited to enhance stockholder value as we move ahead into Q4 and onward by executing against our milestones.

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

Thank you Jennifer Jenny.

General and administrative expenses were $1 3 million in the third quarter of 2022 compared to $9 million in the third quarter of 2021. The change is due primarily to services and personnel costs associated with the acquisition and integration of cancer prevention pharmaceuticals or CPP.

Research and development expenses were $2 3 million in the third quarter of 2022 compared to $1 3 million in the third quarter of 2021.

The increase is due to spending on our clinical studies as we ramped up efforts to activate up to 95 clinical sites around the world and the aspire clinical trial.

As a reminder, the results for the nine months ended September 32022 included approximately $17 7 million in process research and development.

IP R&D represents the primary asset acquired as a result of the acquisition of CPP and GAAP accounting required writing off this asset to research and development expenses immediately after the acquisition in June .

Yeah.

Net loss in the third quarter of 2022 was $4 4 million or 21 cents per diluted share compared to a net loss of $2 1 million or 16 cents per diluted share in the third quarter of 2021.

Total cash was approximately <unk>.

10 billion as of September 32022.

That does not include gross proceeds of approximately $6 million from our public offering which priced on September 30th and closed early in October .

Total current assets were $1 8 million and current liabilities were $8 million as of the end of the quarter.

Also at September 32022, total non current assets consisting of cash deposits held by our contract research organization was $3 1 million.

As a result of the <unk> acquisition, we now have debt and accrued interest on our balance sheet totaling approximately $8 million at September 32022. This includes two notes with principal balances of $6 2 million and 650000, respectively.

Along with accrued interest both notes cruise simple interest at a rate of 5% per annum.

Looking to the cap table as of September 32022, we had $28 million of common shares outstanding.

And the increased shares reserved for options and warrants we were at 33 million shares.

The shares reserved number includes all outstanding equity awards, including stock options, which were held primarily by insiders and all warrants to purchase common stock.

After the public offering which closed on October 4th 2022, we had approximately 27 9 million common shares outstanding.

And including all shares reserved for options warrants, including pre funded warrants we were at 85 million shares.

Our cash used in operations for the nine months just ended totaled approximately $10 3 million.

During the first nine months the company paid $2 6 million of cash deposits to our global contract research organization, which will be held to pay clinical expenses at the end of the aspire trial.

This cash outlay for zero deposits is not expected to be repeated.

Ramped up activity in the randomized trial and costs associated with our acquisition drove the remaining increase in Kashi and operations.

We projected cash with the early Q4 capital raise will take us into Q1 of 2023, we.

We will continue to focus our cash on those items in our plan, which will drive value for our stockholders such as the aspire trial.

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

Certainly ladies and gentlemen, the floor is now open for questions.

I'd like to join the queue to ask a question at this time you May press star one on your telephone keypad to enter the queue. We do ask if lifting on speaker phone. This evening, but you pick up your handset while asking your question to provide optimal sound quality should you wish to remove yourself from Hugh you can press star two once again, ladies and gentlemen, that'll be star one.

To enter the queue ask a question at this time, please hold a moment, while we poll for questions.

We have a question from Tony Butler from Roth Capital Tony Your line is live. Please go ahead.

Jennifer.

Thank you very much first Jennifer the data that you will release.

<unk> finished one pancreatic trolls world.

Diabetes.

Trial is that going to be.

Could you just do you know how you might release that information for example.

Is it through a press release what would be on.

Cole.

And or is it possible.

We've had a clinical meeting thanks very much.

Thank you Tony.

Yes, actually we are focused on peer reviewed journals and the respective.

Areas of focus.

And as soon as those.

Those journals are.

Available for public alright.

Viewing we will also put out a press release highlighting the data in those in those trials.

Thank you Jennifer appreciate it.

Okay.

Thank you.

Once again, ladies and gentlemen, if you would like to enter the queue to ask a question you May press star one on your telephone keypad at this time.

And there are no further questions in queue at this time.

This will conclude today's conference call and webcast. We do thank you for your participation.

You may disconnect your phone lines at this time and have a wonderful day.

Thank you again for your participation.