Q3 2023 Panbela Therapeutics Inc Earnings Call

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Greetings and welcome to the Pan Bella Therapeutics third quarter 2023 earnings call. At this time, all participants are in a listen only mode and a question and answer session will follow the formal presentation.

They entered the queue anytime by pressing Star then one on your keypad should you wish to remove yourself from Q you can press Star then two please note. This conference is being recorded I will now turn the conference over to your host James Carbonara Investor Relations at Penn Bella James You may begin.

Thank you operator with me on the call are Jennifer Simpson, Chief Executive Officer, and Sue Horvath Chief Financial Officer.

Before I turn the call over to Doctor 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 supplemented by.

So 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.

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

Thank you James and thank you everyone for joining I'll begin the call with a review of our clinical development program.

An accomplishment.

Upcoming milestones.

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

So let's start with our phase III initiatives, specifically the acquire global clinical trial.

Spire is a global randomized double blind placebo controlled study designed to assess <unk> salmon or SPP 101 in conjunction with Gen <unk> and Nab paclitaxel for patients with untreated metastatic pancreatic ductal adenocarcinoma.

During Q3, we initiated enrollment in both the UK and Germany successfully activating olen headed in countries for the aspire trial, which are now actively enrolling patients.

Additionally in July the independent data safety monitoring board or the F&B.

Completed its scheduled safety review for treated patients in the trial and recommended the study's continuation without any change it.

This achievement alongside the full activation of all countries and D. F N B's Green light provides substantial encouragement at Paypal trial forward.

We anticipate interim data around midyear 2024.

Addressing familial adenomatous polyposis or F E P.

Ambarella is dedicated to working with the FDA EMA and the FEP community to move this initiative forward aiming to introduce a novel treatment option for patients.

Upon securing consensus on a global registration plan from the FDA and EMA, we intend to progress this endeavor, while adhering to our existing cost structure.

Maltais, Nancy will assess avenues to optimize the value of this asset.

Shifting focus to the pace trial is our phase III double blind placebo controlled study often povey.

This trial aimed to prevent the recurrence of high risk Adenomas and second primary colorectal cancers in patients diagnosed with stage zero to treat colorectal cancer.

The pace trial received funding from the NCI and is being performed in conjunction with the southwest oncology group also known as swap.

The study's purpose is to assess the combination of our flooring athene into ambac and reducing the three year of that rate of Adenomas and second primary colorectal cancers in patients previously treated prestigious zero through three colon or rectal cancer.

We successfully cleared a planned futility analysis and we will continue the study.

Transitioning to phase II studies in July we disclosed that we would be receiving a total of up to $9 $5 million in non dilutive funding through the divestiture of assets from the a Florentine pediatric neuroblastoma program for U S World met.

We look forward to collaborating with U S romance and the ongoing FDA review of a new drug approval.

Pam Bela has already received an initial upfront payment of $400000 and stands to receive further payments as U S. Roadmaps achieved key milestones related to a foreign Athena clinical advancement regulatory approval and commercial sales.

This agreement not only broadens our range of partner supported programs, but also holds the potential for significant development milestone payouts.

We warmly welcome U S World map to a network of partners dedicated to advancing our product candidates.

One final item on this program in partnership after the quarter ended the Fda's oncology drug Advisory Committee or <unk> voted that there was sufficient evidence to conclude our Florida D. R. D. F. M O reduces the risk of relapse in pediatric patients with high risk neuroblastoma, who are in remission and have completed.

<unk> multi agent multimodal therapy.

This recommendation is the first ever <unk> approval supported by a clinical trial that relied on an external control arm using patient level data extracted from another trial.

The FDA stated that the high unmet medical need for patients with neuroblastoma specific external control data source and the result of the propensity score matched analysis impacted their willingness to consider an external control design in this circumstance.

We view this ruling as additional validation of the potential clinical efficacy and safety of the drug and value that we expect to derive from its continued development.

Staying with phase II trials in September we entered into a clinical trial agreement for a phase II trial in castration resistant metastatic prostate cancer or CRP C.

The goal of the androgen and polyamine elimination alternating with extending or apex trial will be to evaluate a treatment with a combination of D. F M O or foreign Athene and hydro's testosterone will improve the prostate specific antigen or PSA response rate in patients with metastatic CRP C compared.

Historical controls.

The study is actively enrolling.

Leveraging preclinical models that demonstrate a potential role for poly means an androgen resistant prostate cancers. This clinical trial will determine if the addition of a Florida theme to the treatment regimen will demonstrate further efficacy in these difficult to treat patients.

If the trial is successful it opens the door for combining polyamine targeted therapies, such as the Florida, Dean and I will spend and with bipolar androgen therapy or bat therapy, as a new treatment option for metastatic CRP C.

There was a huge unmet need for new therapies for castration resistant metastatic prostate cancer patients.

Previous clinical studies demonstrated the efficacy of that as a monotherapy and its ability to sensitize to subsequent androgen inhibition.

Preclinical studies show that Super physiological levels of androgen can up regulate ornithine decarboxylate, suggesting a roll off warranty as a combination therapy.

The trial will determine if modulating poly means can enhance the efficacy of <unk> therapy in these patients.

Continuing with phase two investigations the phase two trial for CPP onex or a foreign athene overseen by Indiana University School of Medicine, and financially supported by the juvenile diabetes Research Foundation or J D. R. F continues to enroll patients J.

<unk> stands at the foremost global entity propelling transformative breakthroughs for type one diabetes.

We are enthusiastic about backing the newly launched phase two trial for early stage type one diabetes run by Indiana University School of Medicine, and funded by J D. R F.

The objective is to create innovative and effective treatments for patients facing significant medical challenges.

This trial based upon the recently published Phase one trial and preclinical data in the journal cell reports medicine.

Investigated the mechanism of poly means and poly mean inhibition by CPP onex on beta cell stress that plays a role in the onset of type one diabetes.

Results showed that the F M O or quantity treatment may preserved beta cell function reflected by C peptide levels in patients with type one diabetes through the modulation of urinary poly means.

In particular putrescine.

According to <unk> at all although therapy of type one diabetes has improved the morbidity mortality and cost continue to impact the quality of life for those affected highlighting the need for safe and effective therapies that address the underlying pathology.

In phase one development, we have three programs that we will be starting we have an ongoing clinical trial partnership with Moffitt cancer Center, focusing on a phase <unk> program tailored for patients with stick 11 mutant non small cell lung cancer.

Initially the phase one trial aims to establish the highest tolerated dose of a Florida team while also assessing its effectiveness.

Currently we plan to progress into a phase III efficacy trial regus.

We expect excuse me, we expect to have data from the phase one trial early next year with the intention to commence the phase II trial immediately following completion of this phase one trial.

Concurrently our second phase one program set to commence later this year or early next year will center on the assessment of Ivo spending in the platinum resistant ovarian cancer demographics.

This effort exemplifies the company's continuous partnership with Johns Hopkins University School of Medicine.

Additionally, we have an ongoing collaborative research effort with the University of Texas, MD answers Anderson cancer Center, focusing on the evaluation of polyamine metabolic inhibitor therapies in conjunction with car T cell therapies using preclinical models.

This research aimed to determine whether treatments involving authority and or Ivo spending can enhance car T induced cytotoxicity against CD 19 positive large b cell lymphoma cell lines.

Oh metabolite panel create predominantly consisting of probably means was identified as a predictor of limited response to <unk>.

Anti CD 19 car T cell therapy in cases of relapsed refractory large b cell lymphoma.

Moreover, there was an observed upregulation of the <unk> uptake transport system in both large b cell lymphoma and multiple myeloma.

These findings collectively indicate the potential for targeted timing therapy in conjunction with car T therapies.

Recently, we announced that an abstract about SPP wanted one or Ivo sermon and CPP onex.

One X or authority research in multiple myeloma cell lines has been accepted for an online publication on the American Society of hematology or Ash meeting site and will be printed in the November supplemental issue of the journal blood.

And that will place a significant emphasis on piney modulation of the immune system.

Our initial clinical proof of concept involves timing therapy combined with a checkpoint inhibitor for stick 11 mutant non small cell lung cancer patients.

We are enthusiastic about extending this research collaboration to assess the potential advantages of poly means in immune modulation for hematologic malignancies.

Lastly, we're in the process of collaborating with key opinion leaders to complete the protocol for the new adjuvant pancreatic investigator initiative.

We're also in the final stages of obtaining the required institutional approval to launch this trial by the end of the year.

Briefly turning to IP, we fortified our intellectual property portfolio announcing the issuance of new patents in China and Australia for claims of a novel process for the production of SPP 101 developed in collaboration with <unk> International Limited.

Additionally, we announced the issuance of a new patent in Chile for claims of a novel process for the production of some Tobey developed in collaboration with Sanofi.

In closing despite a very challenging biotech market, we are committed to advancing our development program for the benefit of patients around the world.

To summarize our projected milestones as we continue to progress our development initiatives, we foresee the initiation of a new adjuvant pancreatic cancer trial and in the ovarian cancer trial by end of year early next year.

We anticipate the phase one non small cell lung cancer data early next year, which will guide the phase two segment of a non small cell lung cancer trial expected to be initiated immediately following the phase one trial.

Our focus for the program is to obtain feedback from the FDA and EMA for global harmonization on our registration protocol.

Additionally, we anticipate data on our timing metabolic inhibitors in combination with car T therapy, and preclinical lymphoma and multiple myeloma models.

Finally, we look forward to the interim analysis of the aspire trial mid year 2024.

To sum up Q3 and year to date, we have seen remarkable progress we are eager to continue creating value for our shareholders. As we move ahead in the coming months and into 2024.

I will now turn it over to Sue.

Thank you Jennifer.

General and administrative expenses for 1.1 million in the third quarter of 2023 compared to $1 3 million in the third quarter of 'twenty to 'twenty two.

Research and development expenses were $6 7 million in the third quarter of 2023 compared to $2 3 million in the third quarter of 2022.

All share and per share amounts of our common stock presented here and in our report 10-Q have been retroactively adjusted to reflect the reverse splits completed in January and June of 2023.

Net loss in the third quarter of 2023 with $7.8 million or $2.69 per diluted share compared to a net loss of $4 4 million or $257.36 per diluted share in the third quarter of 2022.

Total cash was approximately <unk> 9 million as of September 30th 2023.

Total current assets were one 9 million and current liabilities were $8 9 million as of the end of the quarter.

On September 30th total non current assets, consisting primarily of cash deposits held by our contract research organization were $8 7 million.

As a result of the CPP acquisition in Q2 of 2022 we added debt and accrued interest to our balance sheet during.

During the quarter ended September 32023, no debt our interest payments were made.

The principal balance remaining on the notes is $5 2 million and there is approximately 172000 of accrued and unpaid interest on the balance sheet.

Looking to the cap table as of September 30th 2023 we had approximately 3 million common shares outstanding and including shares reserved for options and warrants we were at a total of approximately 7.1 million shares.

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

Our cash used in operations for the nine months ended September 32023 totaled approximately $22 2 million.

Our quarterly burn rate for Q3 was approximately $6 7 million and included approximately 1 million paid to our Seattle for incremental deposits.

Cash used in operations for the nine months ended September 30th included.

Approximately $3 7 million in payments necessary to secure supply of standard of care chemotherapy agents for the aspire trial as well as 2.1 million in total payments made to increase those deposits held by our CRO for future clinical trial costs.

On November 2nd 2023, the company induced certain warrant holders to exercise their warrants for cash.

Proceeds received from this exercise totaled approximately one 9 million.

Approximately $2 1 million new shares were issued from this exercise and the holders received new warrants.

And the exercise the ability of those warrants is pending stockholder approval.

Operator can you. Please open the phone lines now for Q&A and poll for questions.

Currently the floor is now opened for questions. If you would like to join the queue to ask a question. At this time you May press star one on your telephone keypad.

If you're listening on speakerphone today, but you can pick up your handset to provide optimal sound quality once again that'll be star one to join the queue to ask a question at this time, please hold a moment, while we poll for questions.

And our first question today is coming from Jonathan Ourself from Roth.

Jonathan Your line is live please go ahead.

Thank you guys I was wondering Jennifer or can you help me better understand what's required to unlock and the remaining $9 1 million from the Florida divestiture to World U S World.

Stuff like estimate of timing or freeze in the first milestone.

Gross estimate.

Yeah. So you know if it's tied to approvals and commercial sales and.

Some other typical step physical advancement on what I can tell you is that they had an old Jack meeting on November one excuse me October 4th.

And as I mentioned in the remarks, it was a positive vote.

And that then typically singles communication with the FDA are in about four to six weeks from that time is when we would anticipate that they will hear from the FDA. So if it is a positive.

Vote for approval done.

That would start the clock in.

Probably are looking at sometime to bring in from you know not until next year.

Because at least it will be on the horizon.

Okay.

Did the 41 patient phase one trial results that you presented the endocrine Society later published.

Does that impact the enrollment of the trial at all was there any bump up from that.

I you know I'm not sure if I can say, specifically what I what I can tell you is that we have a great partner in Indiana University and it is a multi site center and they've been actively enrolling so I would anticipate.

Despite that would enroll relatively quickly.

Just because of.

Their commitment to this study.

Okay that is it thank you very much.

Thanks, so much Jonathan.

Thank you. Your next question is coming from John Guinee from HP way right.

Sorry, Joe Pantheon as my apologies Joe Your line is live. Please go ahead.

Hi. Thank you. This is Joe Oh, sorry, this is Josh on for Joe.

But about when Povey I was wondering if we could get any color on the extent of the discussions that you've made have been having with potential partners.

Yeah. So thanks, Josh you know one of the things that we think is really important is first to have that global harmonization for the registration pathway.

We've been in conversation well in dialogue with the FDA are working on the E. M. E. Once we have that that is probably a more optimal time to have those discussions. Because then we can we can have you know.

Our in our hand, what is needed to get an approval for that indication. So I would I would imagine that you know were hoping to kind of wrap that up either by year end early next year.

And then we'll be very active in and seeking someone to help us with that.

Perfect. Thank you so much.

Sure. Thank you.

Okay.

Thank you and there are no further questions in queue. At this time. This does conclude the Q&A session.

Today's conference call. We do thank you for your participation you may disconnect. Your phone lines at this time and have a wonderful day.