Q1 2021 Panbela Therapeutics Inc Earnings Call

Greetings and welcome to <unk> Therapeutics first quarter 2021 earnings call at this time, all participants on a listen only mode.

And answer session will follow the formal presentation and Furthermore.

And should require operator assistance during the conference. Please press star Zero and it's helpful to your debt.

As a reminder, this conference is being recorded I would now like to turn the conference over to your host James Carbonara Hayden IR.

Thank you and once again and welcome to <unk> first quarter 2021 and 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 <unk>.

Subsequently filed quarterly reports on form 10-Q, as well as and 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'd like to turn the call over to Dr. Jackson Sampson CEO of Pinball Jennifer. Please proceed.

Thank you everyone for joining I'll begin the call by touching on the first quarter and regions from Michigan and accomplishment.

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

So starting with the first quarter and recent highlights.

At <unk>, we remain focused on continuing advancement of SPP, one on one for the treatment of patients with pancreatic cancer and identifying additional cancer indications to that.

And in February we provided an update on our current clinical trial.

Valuing the safety and Tolerability of S E T. One O one.

When used in combination with standard of care agents, Gemcitabine, and Nab paclitaxel or <unk>.

For first line treatment of patients with metastatic pancreatic ductal adenocarcinoma.

Consistent with that update Penn Valley continue to be and communication with the trial investigators regarding the recommendation from the independent D. F N b on the ongoing phase one clinical trial to hold the administration of L. P. P. One and one which was pending further review of visual disturbance adverse events.

I am pleased to also highlight that in April the F. T. A lifted the partial clinical hold.

We agreed to include them and design of future studies.

And are patients with a history of retinopathy or at risk of retinal detachment and periodic ophthalmologist monitoring for all patients and and feature dose finding studies screening for retinal toxicity and will be included.

With the partial clinical hold lifted and.

And we are excited to move to pancreatic cancer program forward.

Also in April we announced that and abstract number for 127 O S. P. P. One and one has been accepted in a poster presentation at the American Society of clinical oncology or also annual meeting, which will be held virtually this year from June 4th through the eight 2021.

The title is S. P. P. One on one appallingly metabolic inhibitor administered in combination with Gemcitabine and Nab Paclitaxel showed signals of efficacy as first line treatment for subjects with metastatic pancreatic ductal adenocarcinoma.

This will be and the poster session titled gastrointestinal cancer, gastroesophageal pancreatic and hepatic failure.

Additional information can be found at conferences and stop as though dot org.

After presenting at Astro the poster will be available on our website and we look forward to sharing this information publicly.

Shifting gears a bit in addition to pancreatic cancer. We also remain committed to expanding our clinical development program.

To reiterate with the increased level of poly needs and our relationship with mutation driven cancers, the possibilities across tumor types, such as lung glioblastoma colon breast and gastric and ovarian and others are being explored.

Published research also suggests the relationship between the tumor microenvironment immune cell response and timing and metabolism.

To learn more about how best chips, and our clinical development program and.

And the first quarter, we announced a research agreement with Johns Hopkins University School of Medicine to.

And the partnership is designed to center around the broadened and development. That's P. P. One on one including activity and cell line. In addition to pancreatic cancer.

Biomarkers and forming diagnostics and therapeutic applications and.

Potential combinations with checkpoint inhibitors.

We expect these efforts will yield preclinical data and the second half of this year.

At this point I would like to finish by reiterating our milestone first topline data from the whole phase one trial will be available at the Ash annual meeting and the second quarter.

And secondly, we plan to initiate a randomized phase two trial and the middle of this year.

And Neo adjuvant study in pancreatic cancer and preclinical investigation of additional tumor types represent other potential milestones.

In fact, we expect our collaboration with Johns Hopkins University School of Medicine, and other preclinical work that is ongoing well youll preclinical data to inform future development pathways across tumors. In addition to pancreatic cancer again and the second half of this year.

And lastly, under the assumption that we confirmed the research literature to a compound a combination of FTP one on one and a checkpoint inhibitor is a prospect that will also be pursuing with great effort.

In summary, we've taken important steps from the first quarter and year to date, we have moved forward and our lead indication in metastatic pancreatic cancer.

Additionally, we have commissioned research to expand our addressable market beyond pancreatic cancer.

We plan to provide updates as we achieve our milestones and share. This news via press releases along the way.

And we're excited to increase the shareholder value by continuing to work and our lead indication and uncovering and pursuing these additional indications.

And I'll stop there and turn it over to Sue to review the financials.

Thank you Jennifer.

General and administrative expenses were one 1 million and the first quarter of 2021 compared to half a million and the first quarter of 2020.

The change is due primarily to income out of head count and other increased costs associated with our NASDAQ listing, including higher D&O insurance premiums.

Research and development expenses were also $1 1 million and the first quarter of 2021 compared to <unk> 6 million and the first quarter of 2020.

The change is due to incremental and manufacturing cost as we produce investigational product for our next clinical trial.

Net loss and the first quarter of 2021 with 2.3 million or 23 cents per diluted share compared to a net loss of $1 8 million or 27 cents per diluted share and the first quarter of 2020.

Total cash was $8 1 million as of March 31st 2021 total current assets were 8.8 million and current liabilities were $1 3 million as of that same day. There was no debt on the balance sheet as of March 31st.

Looking to the cap table, we had $10 1 million of common shares outstanding and on a fully diluted basis, we were at 18.2 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 the quarter the outstanding warrants decreased by approximately <unk> 8 million through a combination of net cashless exercise extra.

Exercise for cash and exploration.

Our available cash we believe will allow us to complete the current clinical trial and initiate randomized trial and the middle of 'twenty, 'twenty, one and advanced preclinical and colors and other cancer indications, taking us into 2020 two.

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

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And please while we poll for questions.

Yeah.

Yeah.

Our first question.

Bob and garner with Craig Hallum. Please proceed.

Hi, Thank you for taking my questions and congratulations on moving your programs forward I'd like to first ask about the phase two study that would start mid this year, how might we expect to be and points to change from a phase one into a phase two as we think about that.

On a static pancreatic cancer.

Hi, Robyn how are you this evening.

I'm doing great.

Yeah, you know so I think that you know.

We have not finalized the design, yet, but I would not see the endpoints necessarily changing on that drastically looking back you know metastatic pancreatic cancer.

I think it really comes down to probably two primary endpoints.

And points either objective response rate or progression free survival. So I think as we look to finalize that design and we'll make sure that we and you.

And have an endpoint that makes the most sense given what we're pursuing.

Okay. Thank you and I'd like to ask a similar question around the Neo adjuvant studies.

Rather than ask you directly about it I'm curious if you could point us to other studies that have been done and the neo adjuvant space.

And whether regarding the total number of cycles of treatment and.

And the endpoints that have been used and and what kind of study design that you've seen in the past that would make sense here.

Sure. So in the Neo adjuvant space and I think there was one there was a intergroup study a poverty group study with Swags, where they looked at us on.

Gemcitabine and <unk> seen versus Bossier, Nox, and and you know for US that was very helpful. Because it showed no difference in terms of the outcome, so Jim and Abraxa and since we are comfortable and that combination is what makes sense for us moving forward.

So that's you know that's one I'm sure there's a couple of others on.

Kind of on blanking right now, but I can certainly find from you.

In terms of them looking at endpoints, one would certainly be a pathologic complete response.

So administering the chemotherapy and in our case in conjunction with S. E. T. One on one followed by surgery and looking to make sure that you have clean margins and that's that was one endpoint certainly in terms of following patients and that's a little bit you know I think we have to look at the <unk>.

As I'm, there because and things like survivals that hopefully can be quite long so that maybe not something that we can incorporate it easily but that that should give you at least idea.

And it kind of what the focus would be.

Okay, great. Thank you and then perhaps looking at that swap study can you talk about the histological improvements that we would typically expect to see today with the neo adjuvant and verses without.

You know I, probably would have to look back on it.

And to be able to answer that appropriately so on.

That's something if it's okay I can follow up with you on that.

And of course, Thank you and then I guess the final question would just be around expenses and and.

How much will they need to ramp up as you begin these two additional studies and.

Thank you for the guidance so far in terms of the cash and and the burn there, but what about thinking of these studies and totality, especially considering there is the partnership and then two new studies this year.

Sure and until we really have the full design of the of first the randomized trial and then second to the Neo adjuvant I Eh.

It's I'm kind of reluctant to guests in terms of the total cost.

And.

That said, we have built from assumptions are into the modeling, which leads us to conclude that the cash still well.

Well last us into 2020 two.

And you know rents trials won't begin to really ramp up until and to the second half with cash being something that we probably won't see a lot of increase until much later in the year.

Okay, great. Thank you congratulations again on continuing the programs and we're pretty excited to see the data at <unk> and any additional updates from the partnership later this year. Thank you so much.

Thank you Robyn.

Thank you.

Gentlemen, we have reached the end of the question and answer session and this will end today's conference you may disconnect. Your lines at this time.

You very much for your participation and have a great day.