Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the Panbela Therapeutics First Quarter 2022 Earnings Call. At this time, all participants are in a listen-only mode. After management's prepared remarks, there will be a question-and-answer session.

I would now like to turn the call over to the host, James Carbonara, Investor Relations of Hayden. Please go ahead..

Thank you, and once again, welcome to Panbela’s first quarter 2022 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 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 of Panbela. Jennifer, please proceed..

Thank you, James. And thank you everyone for joining. I will begin the call by touching on Q1 and our recent significant accomplishments. Sue will then follow with the review of the financial results, and then we will open it up for Q&A.

So starting with Q1 and recent highlights, as we highlighted on our last earnings call in February, we entered into a definitive agreement to acquire Cancer Prevention Pharmaceuticals Incorporated, or CPP for short. A closing is expected to occur in the second quarter of 2022 subject to the satisfaction of customary closing conditions.

As we've shared, the combined company will have a much larger pipeline, targeting approximately a $5 billion aggregate market opportunity for the areas of initial focus.

Acquiring CPP will substantially advance our mission of treating diseases, where there is an unmet need through a diversified pipeline, addressing numerous targets and thus expanding the potential of the combined company.

During the SBP-101, just last week, we held an R&D Day and we were joined by leading experts from The Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins University School of Medicine for a deep dive on SBP-101 as a polyamine metabolism modulator in ovarian cancer.

Presenters included the following doctors, Deborah Armstrong, Director of Breast and Ovarian Surveillance Service and Professor of Oncology; Robert Casero, Associate Director for Shared Resources and Professor of Oncology; Stéphanie Gaillard, Director of Gynecologic Cancer Trials and Assistant Professor of Oncology; Cassandra Holbert, Postdoctoral fellow; and Tracy Murray Stewart, Cancer Biologist and Rare Disease Researcher.

The topics covered in the call included a preclinical data presentation, which was led by Dr. Holbert and a clinical presentation of the ovarian treatment landscape, which was led by Dr. Gaillard. The call was structured to help attendees gain a greater understanding of the potential of, and our clinical strategy for SBP-101 in ovarian cancer.

On a related note, one month earlier, we were pleased to announce a poster presentation, highlighting the results for SBP-101 in ovarian cancer at the American Association for Cancer Research or AACR, which took place April 8 through the 13 of this year.

Correspondingly, the work reflects our ongoing collaboration with Johns Hopkins University School of Medicine. The poster presentation points out that the treatment of immune competent mice injected with VDID8-positive ovarian cancer with SBP-101 was observed to significantly prolong survival and decrease overall tumor burden.

We remain grateful to our collaborators at the Johns Hopkins University School of Medicine who are on the leading-edge of cancer research. The results suggest that SBP-101 may have a role in the clinical management of ovarian cancer. This status supports our efforts to initiate an ovarian cancer clinical program this year.

We look forward to continuing our work with the Johns Hopkins School of Medicine to identify additional target tumors for future development programs in patients with unmet medical needs. Turning to our work in pancreatic cancer, earlier in the year, we announced the initiation of our global randomized trial.

This Phase 2 trial is a randomized double-blind placebo-controlled clinical trial for SBP-101 in combination with gemcitabine and nab-paclitaxel versus gemcitabine, nab-paclitaxel and placebo in patients with untreated metastatic pancreatic ductal adenocarcinoma and is referred to as the ASPIRE trial.

Summit Cancer Centers in Spokane, Washington was the first clinical site activated with Dr. Arvind Chaudhry serving as its Principal Investigator, approximately 60 to 70 additional sites are expected to be activated in 2022.

We have commenced screening for eligible patients with enrollment expected to complete in approximately 12 months after the first patient is enrolled, supporting the advancement into the ASPIRE trial was data announced in January of this year at the ASCO GI meeting, which included an objective response rate of 48%, a disease control rate of 76%, an immediate overall survival of 12 months, which at the time of the poster presentation was not yet final.

All exceeded historical rates reported for gemcitabine and nab-paclitaxel. Since the poster presentation, the median overall survival has been reached at 12.53 months and is now final. This is four months longer than what is typically seen with gemcitabine and nab-paclitaxel.

Last, we have also had two patients who have demonstrated long-term survival with the two patients from Cohort 2, one of which achieved 30.3 months, which is now final data. And the other is 33 months and is still alive. There are seven patients, one from Cohort 2 and six from Cohort 4 and the expansion that are still alive.

We are excited to continue development of SBP-101 in our global randomized study in metastatic pancreatic cancer, which I spoke about earlier. Also note, last year we completed preclinical work necessary to begin a new adjuvant trial.

We are working with the key opinion leaders to finalize the protocol and obtain the necessary institutional approvals to open this investigator-initiated trial in the second half of this year.

Regarding milestones, we announced the ASCO GI poster presentation in January and the research call to review the ovarian cancer data and ovarian cancer treatment standards. Additionally, in the first half of this year, we anticipate the first patient enrolled in our ASPIRE trial, as well as expansion to sites outside of the United States.

The satisfaction of conditions and closing of the CPP acquisition, the final data from our Phase 1 first-line metastatic pancreatic cancer study and the initiation of the ovarian cancer clinical program for SBP-101 around midyear.

In the second half of this year, we expect to announce that the neoadjuvant pancreatic cancer investigator-initiated trial will be open for enrollment. With the expected closing of the CPP transaction, we anticipate that additional milestones for 2022 will increase the flow of plan development activity and data.

In summary, we have made tremendous progress in Q1 and year-to-date. We are excited to enhance shareholder value as we move ahead in 2022, by executing against our state of milestones. I will stop here and turn it over to Sue to review the financials..

Thank you, Jennifer. General and administrative expenses were $1.8 million in the first quarter of 2022, compared to $1.1 million in the first quarter of 2021. The changes due to expenses, including legal and financial advisory fees associated with the acquisition of CPP.

Research and development expenses were $2.2 million in the first quarter of 2022, compared to $1.1 million in the first quarter of 2021. The change is due primarily to increased clinical trial costs as you prepare to expand a randomized study to approximately 60 to 70 sites around the world.

Net loss in the first quarter of 2022 was $3.7 million or $0.27 per diluted share, compared to a net loss of $2.3 million or $0.23 per diluted share in the first quarter of 2021. Total cash with $7.4 million as of March 31, 2022, total current assets were $7.9 million and current liabilities were $4.5 million as of that same date also.

At March 31, 2022 total non-current assets consisting of cash deposits held by our contract research organization with $3.2 million. There was no debt on the balance sheet as of March 31, 2022. Looking to the cap table, we have 13.4 million of common shares outstanding and including shares reserved for options and warrants.

We were at 21 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. Turning now to additional details regarding the definitive agreement to acquire CPP.

Under the terms of the agreement and plan of merger, the holders of CPP’s outstanding capital stock immediately prior to the merger will receive shares of common stock upon the closing of the mergers. Panbela shareholders are expected to retain a majority of the outstanding shares of the post-merger holding company.

CPP stockholders will be eligible to receive contingent cash payments, totaling a maximum of $60 million payable from future milestones and royalty payments associated with the potential approval and commercialization of the CPP lead asset.

We intend to close in the second quarter of 2022, subject to the approval of the issuance of securities in the transactions by our stockholders and satisfaction of other customary closing conditions. Our cash used in operations for the quarter just ended totaled approximately $4.5 million.

During the quarter, the company paid $2.6 million in cash deposits to our global contract research organization, which will be held to pay for clinical expenses at the end of the ASPIRE trial. This cash outlay for CRO deposits is not expected to repeat.

As discussed in our last earnings call, we project that cash will take us into Q4 of 2022 as we ramp activity in the randomized trial, prepare for expansion into a ovarian cancer development program and incur costs associated with our acquisition of CPP. We view all three to be positives that will add value.

CPP’s operations and development activities post-Closing are not expected to add significantly to our operating burn in 2022. That concludes our prepared remarks.

Operator, can you please open the phone lines for Q&A and poll for questions?.

Certainly. The floor is now open for questions. [Operator Instructions] Our first question is coming from Robin Garner of Craig-Hallum. Please pose your question. Your line is live..

Good evening and thank you for taking my question. Wanted to ask about the neoadjuvant study and what your timing thoughts are on how long it would take to enroll and when we might see data out of that program.

And then as a second part to that question on the neoadjuvant study, is the primary endpoint a much shorter endpoint given that patients are undergoing surgery after treatment?.

Thank you, Robin. Yes. So I'll start with the second question first. The primary endpoint will be shorter. We will certainly be looking at pathologic complete response disease control rate both before and post-surgery as well.

And then of course we'll follow things –standard things like progression-free survival but they will be shorter endpoints up front. In terms of the time to enroll, we are finalizing a protocol with the investigators right now.

So I think it's a little bit premature to give any guidance, but I do think it'll be starting our anticipation getting through the institutions, various scientific committees and such. That it'll be open for enrollment by year end. I certainly think we are hoping to have the enrollment completed within that year.

So the data most likely would not be until 2024. But once we have the final protocol, we can confirm sample size and timing..

Okay. Thank you very much..

Your next question is coming from Tony Butler of Roth Capital. Please pose your question. Your line is live..

Yes. Thanks. Jennifer, I was just curious on the trial was ASPIRE trial size, clinical trial size at 150 and at least Sue alluded to 60, 70 sites. But the question is what has the CRO guide – what do you think will be the division in U.S., non-U.S.

and are there Asian sites also – or an Asian site also that will enroll patients, some sort of division would be helpful. Thanks..

Certainly. Thank you, Tony. So I think the first thing is to clarify that is a randomized Phase 2. We have a portion of patients that will get us to that interim look. And so that's where you were referencing that roughly 150. The intent is to allow that interim look to serve two purposes, right.

The first is to make sure that we're seeing the activity that we believe is needed to be seen to continue for the patient's sake. And also from a company perspective, because this will also help us to ensure that we are not using resources unnecessarily, so the total sample size will be larger.

And that is something that as it's going through reviews in the various ethics committees countries, et cetera, we'll be able to finalize the total sample size in the near future. So to your other question, in terms of division, certainly, it's important to have U.S.

representation and we do have pretty much the majority of what we would consider the very important and active sites in the U.S., many of the NPI centers, as well as some of the other hospitals that are very active and see patient throughput. Europe as well, we will be looking at several European countries and Asia is on the horizon.

I would say that we are certainly looking at it. When you look at countries like Korea is certainly something that I think we are considering. So I would say, your predominant breakdown is going to be between the U.S. and Europe and Asia is certainly something they're considering.

And I should say, Australia of course, will be participating as they participated in our Phase 1 program as well..

That's helpful. Thank you.

Certainly. [Operator Instructions] There appear to be no further questions in queue at this time. Thank you, ladies and gentlemen, this does conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation..