Good afternoon, ladies and gentlemen, and welcome to the Processa Pharmaceuticals Second Quarter 2022 Earnings Call. At this time, all participants have been placed on a listen-only mode, and we will open the floor for your questions and comments after the presentation.

It is now my pleasure to turn the floor over to your host, James Stanker, Chief Financial Officer of Processa Pharmaceuticals. Sir, the floor is yours..

Thank you, and welcome to Processa’s second quarter 2022 results and clinical pipeline update conference call. Joining me on the call today are our Chief Executive Officer, Dr. David Young; and our Chief Operating Officer, Mike Floyd. Shortly before this call, we filed our June 30, 2022 Form 10-Q.

I want to remind everyone that a PowerPoint presentation will accompany Dr. Young’s prepared remarks. To view the PowerPoint slides, please go to the Investor Relations section on our website or our earnings press release and click on the webcast link to follow along. I will start our call by reading the Safe Harbor statement.

This statement is made pursuant to the Safe Harbor for forward-looking statements described in the Private Securities Litigation Reform Act of 1995.

All statements made on this call with the exception of the historical facts, may be considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934.

Although, we believe expectations and assumptions reflected in these forward-looking statements are reasonable, we can make no assurances that such expectations will prove to be correct. Actual results may differ materially from those expressed or implied in forward-looking statements due to various risks and uncertainties.

For a discussion of such risks and uncertainties that could cause actual results to differ from those expressed or implied in the forward-looking statements, please see risk factors detailed in our Annual Report on Form 10-K. Any forward-looking statements included in this earnings call are made only as of the date of this call.

We do not undertake any obligation to update or supplement any forward-looking statements to reflect subsequent knowledge, events or circumstances. At this time, I will briefly touch on our published financial results, and then turn it over to Dr. Young to provide an update on our drug development activities, which will be followed by Q&A.

Our cash balance at June 30, 2022 was $12.1 million. We believe this will be sufficient to complete our 3 ongoing clinical trials and fund our operations into the third quarter of 2023. During the 6 months ended June 30, 2022, we spend cash for our 3 clinical trials and in our operations totaling $4.1 million.

This is significantly less than our GAAP net loss of $8.4 million due to the effect of non-cash items like amortization and stock-based compensation, and the application of amounts we had prepaid to our CROs last year.

As I noted, our net loss for the 6 months ended June 30, 2022 was $8.4 million or $0.53 per share, compared to a net loss of $5.3 million, or $0.35 per share for the same period of 2021. The increase in our net loss relates primarily to increase the clinical trial costs we incurred in our 3 ongoing trials.

For the 6 months ended June 30, 2022, we incurred $5.2 million in research and development costs, an increase of $2.1 million when compared to the same period of 2021.

We anticipate clinical trial costs will continue to increase for the rest of the year as our trials continue to progress and we fund development activities for the other drugs in our pipeline, as David will discuss.

During the 6 months ended June 30, 2022, our general and administrative expenses totaled $3.2 million, compared to $2.1 million for the same period of 2021. The increase related primarily to increases in non-cash or stock-based compensation costs, along with other operating and consulting costs.

We allocated $2.8 million of non-cash compensation between our R&D and G&A, with most of this costs being recorded as G&A. Our net cash used in operating activities for the 6 months ended June 30, 2022 decreased by $300,000 to $4.1 million compared to $4.4 million for the same period in 2021.

While we experienced GAAP costs related to our clinical trials and operations, we continue to make use of equity incentives to reduce our cash outflow in compensating our executive and development team, and we’re able to apply previously made advanced payments to our CROs against current trial costs.

As of June 30, 2022, we had 15.8 million common shares outstanding. That concludes my remarks. I’ll turn the call over to our CEO, David Young. David, please go ahead..

Thank you, Jim. Good evening. Thank you for joining us. Before I provide a quarterly update, I’d like to thank all of our staff and shareholders for their loyalty and support. Slide 3, please.

I would also like to acknowledge our 2 new board members, Khoso Baluch and James Neal, who attended the first Processa board meeting a few days ago, with our existing board members, Justin Yorke, our Chairman; Virgil Thompson, and Geraldine Pannu.

Today, I will briefly discuss our programs and the milestones we hope to achieve over the next 12 months. Then, I’m going to change the format of the call and address a couple of questions that we have been asked by investors over the last 6 to 9 months. So here we go. Next slide, please.

This slide provides you with a snapshot of the Processa highlights. As you know, Processa is a drug development company focused on improving the quality of life and/or survival of patients who have an unmet medical need condition. These are patients who either have no treatment options or need better treatment options.

Our approach is to use the regulatory science platform that we started to develop 30 years ago when we worked on 2 FDA contracts, determining the best way to answer and provide the answer to several FDA clinical and scientific regulatory questions. Our contracts led to the development of several FDA guidances.

We have in-licensed 5 drugs that target 5 different populations of patients, who have no treatment or need better treatment options. The potential market size for each drug is greater than $1 billion. And this means the Processa is providing each of our investors, 5 independent opportunities or shots on goal to have a blockbuster drug.

There’s just 1 of these drug reaches approval, we have a multibillion dollar company. 4 of the 5 drugs have IND with 3 of these 4 presently being evaluated in clinical trials. The drug development program was the fourth IND drug is being redefined prior to putting it into clinical study.

1 of the 3 drugs in clinical trial Next Generation Capecitabine or 6422 has been delayed, because we had to jump through a number of FDA and clinical site regulatory hoops actively modify the protocol based in our first interim analysis.

The second drug in clinical trial 499 has been enrolling patients slower than expected, and has been especially affected by COVID. To improve the enrollment rate, we began to implement supplemental patient enrollment programs in November of 2021.

These programs are designed to increase the number of eligible patients screened, which will hopefully increase the number of patients enrolled. The third drug in clinical trial is 12852. This drug has done very well in enrolling patients, and is expected to complete enrollment and data analysis in 2022. Next slide.

To remind everyone, Slide 5 describes the criteria that we’ve used to select the 5 drugs in our pipeline. I would like to point out only one key item on the slide. The second criteria in the red box states efficacy evidence.

This means that there is some clinical evidence of efficacy in the targeted population for each of the 5 drugs or for a drug with similar pharmacology.

If you look at the hundreds of other biotech companies, how many of the companies can say they have 5 potential $1 billion drug in their pipeline in all 5 drugs already have preliminary evidence of clinical efficacy in the targeted population. Next Slide. Now, let’s look at a summary of our pipeline.

I’d like to remind you that we have 3 drugs in clinical development, 6422 or Next Generation Capecitabine, 499, and 12852; and one drug 3117 with an IND, but we will not be initiating the clinical study until we have completed our development plan and met with the FDA to agree on a program. Next Slide.

This slide briefly summarize the status of each program and the key milestones expected during the next 12 months.

For Next Generation Capecitabine, we are now enrolling patients in Cohort 2B and 2C, which will provide us with the data needed to better understand the timeline of the irreversible inhibition and subsequent de novo formation of the enzyme DPD after 6422 administration.

We expect to complete this interim analysis, identify the maximum tolerated dose for Next Generation Capecitabine and meet with the FDA to determine the next stage of development during the next 12 months. Our hope is to initiate the next, Next Generation Capecitabine clinical trial before the end of 2023.

The other 2 drugs in clinical trials are 499 and 12852. As I previously stated, 499 has been significantly affected by COVID. We have had patients cancel screening, because they did not want to travel given COVID and patients who were to be screen cancelled, because they were affected by COVID.

Since most of these patients have lived with the ulcers for months or years, and many are diabetic, living with the ulcers for additional months is safer to many of these patients than getting COVID. In addition, new sites delayed initiation, because of COVID.

Even with the delays, we expect to complete enrollment of our interim analysis group of patients in 2022 with results available for the interim group in the first half of 2023, and analysis of the completed study sometime in 2023. We plan to finalize our potential paths to FDA approval and meet with the FDA in 2023.

The last drug presently in clinical trials is 12852. This trial is almost completely enrolled, we expect final top-line results before the end of 2022, so that we can move forward to the Phase 2B trial in 2023. Next Slide. Instead of going into more detail on each drug in our earnings call, we thought it would be helpful to our investors.

If we answered a couple of the questions that we often been asked.

The first set of related questions is, what is management doing to deal with the progress of the programs, especially enrollment in 499 and 6422? And related questions are has Processa considered that the eligibility requirements to enroll in their trials may be too stringent? And is it possible that Processa is splitting resources across the drugs in the pipeline too much causing delays? Does the company need more resources? For 499, as I mentioned briefly in my earliest studies, in November of 2021, when we realized that identifying ulcerated NL patients for our study was coming a significant problem.

We initiated several supplemental enrollment programs to attract more patients to the study for screening and hopefully enrollment. For example, we implemented a program to pay for patient travel to the clinical site. We dropped non-performing sites and add a new site.

We tried to recruit patients beyond the database of the clinical site, and had a separate recruiting effort to bring our study to the attention of patients seen by other physicians. We evaluated the inclusion and exclusion criteria to make sure we were not too stringent.

And more recently, we launched the website to further inform potential study patients about our clinical study. For 6422 the land [ph] enrollment was less about patient recruitment, and more about having to jump through several regulatory hoops to modify the protocol.

Given that the de novo formation of DPD enzyme occurred much faster than the protocol was designed. The regulatory hoops at FDA in each clinical site took months and months to complete. Losing the momentum originally gained at the site and requiring us to reengage and refocus some sites are steady.

We have also added some supplemental patient enrollment programs to 6422 to expedite enrollment and increase the number of study sites. Our efforts are now being rewarded, as we are seeing patients added to the queue for screening.

Related to the delays, several investors know that we run a very lean ship and worry that we do not have the resources to run these studies efficiently.

I can assure all investors that we have a team that is experienced in running several programs and several clinical trials simultaneously, with most of us having worked together and prior successful companies. Nevertheless, over time, we have brought in additional staff to work on the clinical studies.

And if needed, we are ready to bring on more staff to expedite the development of each of our drugs.

The second set of related questions is, what is your plan for each asset? Do you plan to partner or out-license each asset and, if you do, when? And how do you plan to fund the next studies? Our plan is to out-license or partner each drug when the positives or benefits of the deal strongly outweigh the negatives or risk of the deal or not doing the deal.

We have no special ties to any of the drugs. And we would be willing to move any of our drugs if it’s best for Processa and our investors. In fact, a few companies have already expressed interest in licensing our drugs or partnering with us. These companies are waiting for the results of our present trials.

Regarding the funding of our next trials, funding will come from 2 potential sources, a licensing or partnership deal, and raising additional cash through an offering. I know that some investors are concerned about an offering and the dilution it will have on their holdings.

Let me address this by reminding you that, number one, the further along in clinical development drug is, the more likely to license or partner, and the more likely the drug is FDA approvable. All of which should increase the value of Processa.

Secondly, with the study for each of the 3 drugs, reading out over the next 12 months, starting with 12852, then 6422, and finally 499, and the anticipated positive news flow, we believe the value of Processa will increase.

Number three, our expectation is to raise money for new trials when the Processa market cap is higher, and we are receiving more credit for having multiple drugs and clinical government targeting $1 billion mark seat.

I want to again remind investors that the Processa team has invested cash and our salaries into Processa, making sure our goals are aligned with investors. Nobody has a more vested interest than us to create value for our shareholders. This is and always has been an equity play for all of us. This concludes my remarks.

I will now ask the operator to open the phone lines for Q&A. Operator, can you please poll for questions? Certainly,.

Certainly, ladies and gentlemen, the floor is now open for questions. [Operator Instructions] Your first question is coming from François Brisebois from Oppenheimer. Your line is live..

Hi. This is Daniel [ph] on for Franc. Thanks for taking the questions.

Just on 499, are you seeing that – is it the case that the screening failure rate is high? Or is it that even difficult to bring in patients for screening? What are you seeing?.

Hi, Daniel, thank you very much for the question. This is David. The screening rate is – the screening failure rate is not high. What’s happening is, we’re just not getting patients to even come to screening. There’s just very few patients coming into screening.

And again, a lot of was COVID, we are now starting to increase as we put in this – these other kinds of programs to increase the enrollment of patients or increase the visibility of our study among these patients. But, originally, it really was just very few patients knew about the study didn’t come in, not even for screening..

Great.

And are you starting to see an inbound and interest since the launch of the website?.

We are seeing some yes from the website plus – but also the things that we initiated in November of 2021. We knew it would take about 4 to 6 months after we initiated all these things. And so now, we’re also seeing something more patients realizing we have the study going on just from the things we initiated in November.

And it’s just taking a little while for the patients to now notify us and contact us to be involved..

Okay. Thanks. That’s very helpful. Just a quick one on 6422, sorry, if you already mentioned this. But could you just remind us on what the new timeline is for the preliminary results? Originally, it was supposed to be mid-2022.

But could you just remind us what the new timeline is given the delays?.

Yeah. We think that it’s still going to be sometime this summer. We think that sometime in – whether it’s all – sometime in August or the beginning of September. We should have some results for the interim results from our new cohorts. The overall timeline to finish the study really hasn’t changed much.

So the overall timeline to finish the study is we feel that we will complete enrollment by the end of this year, which was our original timeline. And we believe we’ll have a maximum tolerated dose sometime at the end of this year or maybe January, February of next year..

Great. Thank you so much. Thanks for taking the questions..

Thank you..

Thank you. [Operator Instructions] Your next question is coming from Naz Rahman from Maxim Group. Your line is live..

Hi. Thanks for taking my question. I had a couple. So first, I want to start on 3117, the gemcitabine product.

Could you comment on the status of the progress of the macromolecule assay development? And B, do you have a timeline on when you could potentially meet with the FDA to determine a study protocol or a potential path forward if there is one?.

Sure. So in terms of the assay, we’re still working on the assay. We’re trying to determine where it’s best to take the sample, whether it’s a biopsy, whether it’s blood, and you look at circulating cancer cells. And so all of that’s going on as we speak. And the timing of finishing that we just don’t know.

We’re trying to figure out what’s the best way to do this. In terms of – after we get that a little farther along in terms of meeting with the FDA.

Let me note that in parallel, we’re kind of developing the different pathways to approval given depending on if we have an assay, if we don’t have an assay, if we have a circulating cancer cell assay versus a pancreatic biopsy. So we’re looking at all the potential options, and different pathways, and right now we’re developing those paths.

We expect to meet with the FDA sometime the beginning of 2023, we just don’t know exactly when, because we want to have the assay far enough along to present the assay to FDA. And since we’re not there with knowing what samples as well as the assay, we just don’t know when in the beginning of 2023, we’ll be meeting with the FDA..

Thanks for the color. My next question is actually on 12852 gastroparesis product.

As far as the data that’s expected at the end of the year, what can we expect to see in regards to the top-line data versus what we expect to see for the full analysis?.

Oh, that’s a good question. So the top-line data that will be receiving, and that will probably becoming before the end of the year, sometime in October, we hope. That will be more about the issue of, is the drug affecting gastric emptying rate. Because if you can increase most of these patients who have gastroparesis have slow gastric emptying rate.

So if you can increase the gastric emptying rate that should help the patient, the gastroparesis patient. So that’s the first thing we’ll be seeing sometime in October. In later on the year, we’ll see something about the actual symptoms, the symptomology.

Because even though you improve the gastric emptying rate in some of these patients, some patients the symptoms will change, some patients that symptoms will not change, also the patients could have different symptoms. So at the end of the year, we’ll be looking more at the top-line of what’s happening, because of symptoms.

In October, there will be more is the gastric emptying rate changing..

Quick question.

Could you remind us, if there’s an open-labeled portion to this study? Or our patients only being dosed or followed-up to 28 days?.

No. There is no open-labeled portions of the study at this time. Yeah. We decided we had a lot of data in normal healthy volunteers for this drug, which was done by Yuhan in South Korea. And so we decided just to try to quickly answer these questions, and then move on to a Phase 2B with FDA blessing [ph]..

Got it. Thanks for taking my questions..

Thanks, Naz..

Thank you. That concludes our Q&A session. I will now hand the conference back to David Young for closing remarks. Please go ahead..

Thank you very much for attending this. We – as I said in the beginning of the call, I really would like to thank our staff and our shareholders for their loyalty and support for everything they believe in us and are doing for us. And so thank you very much, everybody. I think there’s some really good things going to be coming around the corner.

And hopefully, you can wait then and see some nice news from Processa, both in terms of the [diminutive of] [ph] drugs and other things happening. So thank you very much. Appreciate it. Thank you, operator..

Thank you, ladies and gentlemen, this concludes today’s event. You may disconnect at this time and have a wonderful day. Thank you for your participation..