Greetings and welcome to Panbela Therapeutics First 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. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host James Carbonara with Hayden IR.

Thank you. And once again welcome to Panbela's first quarter 2021 earnings call. With me on the call are Jennifer Simpson, Chief Executive Officer and to 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 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..

Thank you everyone for joining. I'll begin the call by touching on the first quarter and recent significant accomplishments. Sue will then follow up with a review of the financial results. And then we will open it up for Q&A.

So starting with the first quarter and recent highlights, at Panbela we remain focused on continuing advancement of SBP-101 for the treatment of patients with pancreatic cancer, and identifying additional cancer indications.

To that end, in February we provided an update on our current clinical trial, evaluating the safety and tolerability of SBP-101 when used in combination with standard of care agents gemcitabine and nab-paclitaxel or abraxane for first line treatment of patients with metastatic pancreatic ductal adenocarcinoma.

Consistent with that update, Panbela continued to be in communication with the trial investigators regarding the recommendation from the independent DSMB of the ongoing Phase I clinical trial to hold the administration of SBP-101 which was pending further review of visual disturbance adverse events.

I am pleased to also highlight that in April, the FDA lifted the partial clinical hold.

We agreed to include in the design of future studies, the exclusion of patients with a history of retinopathy or risk of retinal detachment and periodic ophthalmologists monitoring for all patients and in future dose finding studies, screening for retinal toxicity will be included.

With the partial clinical hold lifted, we are excited to move the pancreatic cancer program forward. Also in April, we announced that an abstract number 4127 for SBP-101 has been accepted with poster presentation at the American Society of Clinical Oncology or ASCO annual meeting, which will be held virtually this year from June 4 through 8, 2021.

The title is SBP-101 a polyamine 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 in the poster session titled Gastrointestinal Cancer, Gastroesophageal, Pancreatic, and Hepatobiliary.

Additional information can be found at conferences.asco.org. After presenting at ASCO 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 polyamine and relationship with mutation driven cancers, the possibilities across tumor types such as lung, glioblastoma, colon, breast, gastric and ovarian and others are being explored.

Published research also suggests relationship between the tumor microenvironment, immune cell response and polyamine metabolism. To learn more about how best to expand our clinical development program, in the first quarter, we announced a research agreement with Johns Hopkins University School of Medicine..

Thank you, Jennifer. General and administrative expenses were 1.1 million in the first quarter of 2021, compared to 0.5 million in the first quarter of 2020. The change is due primarily to incremental headcount and other increased costs associated with our NASDAQ listing including higher DNO insurance premiums.

Research and development expenses were also 1.1 million in the first quarter of 2021, compared 0.6 million in the first quarter of 2020. The change is due to incremental manufacturing cost as we produce investigational product for our next clinical trial.

Net loss in the first quarter of 2021 was 2.3 million or $0.23 per diluted share, compared to a net loss of 1.8 million, or $0.27 per diluted share in the first quarter of 2020. Total cash was 8.1 million as of March 31, 2021. Total current assets were 8.8 million and current liabilities were 1.3 million as of that same date.

There was no debt on the balance sheet as of March 31..

Yes. We will now be conducting a question-and-answer session. Our first question is from Robin 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 II study that would start mid this year. How might we expect the endpoints to change from a Phase I into a Phase II as we think about metastatic pancreatic cancer.

Hi, Robin, how are you this evening?.

I'm doing great..

Yeah, so I think that we have not finalized the design yet, but I would not see the endpoints necessarily changing that drastically. Looking at metastatic pancreatic cancer I think it's really - comes down to probably two primary endpoints either objective response rate or progression free survival.

So I think as we look to finalize that design, we'll make sure that we 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 neoadjuvant studies.

Rather than ask you directly about it, curious if you could point us to other studies that have been done in the neoadjuvant space, whether regarding the total number of cycles of treatment, the endpoints that have been used, and what kind of study designs that you've seen in the past that would make sense here?.

Sure. So in the neoadjuvant, space, I think there was one that was an intergroup study or proper group study with SWAG where they looked at use of gemcitabine and abraxane versus Folfirinox. And for us that was very helpful, because it showed no difference in terms of the outcomes.

So gem and abraxane, since we've - are comfortable in that combination is what makes sense for us moving forward. So that's one. I'm sure there's a couple others that kind of blanking right now, but I can certainly find some.

In terms of looking at endpoints one would certainly be pathologic complete response, so administering the chemotherapy and in our case, in conjunction with SBP-101 followed by surgery and looking to make sure that you have clean margins.

That's - that was one endpoint, certainly, in terms of following patients, that's a little bit - I think we have to look at the design there because things like survival that hopefully can be quite long. So that may be not something that we can incorporate as easily. But that that should give you a brief idea of kind of what the focus would be..

Okay, great, thank you.

And then perhaps looking at that SWAG study, can you talk about the histological improvements that we would typically expect to see today with a neoadjuvant versus without?.

I probably would have to look back to be able to answer that appropriately. So that's something if it's okay, I could follow up with you on that..

Yes, of course. Thank you. And then I guess the final question would just be around expenses, and how much will they need to ramp up as you begin these two additional studies? Thank you for the guidance so far, in terms of the cash and the burn there.

But what about thinking of these studies in totality, especially considering there is the partnership and then two new studies this year?.

Sure. Until we really have the full design of first the randomized trial and then second, the neoadjuvant, I'm kind of reluctant to guess in terms of the total cost. That said we have built some assumptions into the modeling, which leads us to conclude that the cash still will last us into 2022.

Trials won't begin to really ramp up until into the second half with cash being something that we probably won't see a lot of increase until much later into the year..

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

Thank you, Robin..

Thank you. Ladies and 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. Thank you very much for your participation and have a great day..