Peter Kinchley (PK) (Auxilius): Thank you for joining us today. Can you start by telling us about Incendia and your role there?

Peter Cincotta (PC) (Incendia): Incendia is a pre-commercial biotech company focused on oncology biologics. Our lead program, PRTH-101, is currently in Phase 1 clinical trials. I've been the Controller since May 2023, overseeing our financial operations, including accruals and financial reporting.

Our Phase 1 trial is more complex than others because our protocol involves multiple cohorts. There are lots of moving parts and the EDC mapping was quite complex, involving different pieces and ensuring they all mapped correctly to the protocol. So in general there's a lot going on.

I am a team of one in the finance department and a main goal of mine is accurate monthly accruals. We're not currently audited, but we will need to get audited at some point, and accruals are always on my mind because they are difficult to correct retrospectively. Initially, we did our accruals on a quarterly basis, but I wanted to transition to monthly accruals for our trial, which started back in Q2 of '23. This change was crucial to provide accurate monthly financial data to the leadership team and the board. 

PK: How did you first come across Auxilius and what attracted you to it?

PC: I first encountered Auxilius during my time at RSM, where we frequently discussed clinical trial accrual challenges with our clients' CFOs. We often asked CFOs, 'What's the one thing that keeps you up at night?' and a common response was clinical trial accruals. It's a complex area, especially in biotech, where accurate financial reporting is crucial but challenging due to the nature of the data involved. I met the Auxilius team at a conference, and their solution seemed perfectly tailored to address these issues, particularly in streamlining the accrual process without adding headcount.

PK: What specific issues did Auxilius help you solve?

PC: Auxilius significantly improved our ability to manage clinical trial accruals and forecasting. Before using Auxilius, we handled accruals quarterly, which wasn't ideal for providing timely financial data. Auxilius enabled us to shift to monthly accruals, offering more accurate and timely data.

The main value was two-fold: it enabled me to manage accruals and forecast processes without needing to hire additional staff, thus conserving our cash runway. Additionally, the team at Auxilius educated me on accurately booking investigator grant expenses using EDC data, which is the most reliable source for these accruals.

Ultimately, main value I see is definitely from the investigator standpoint - it's such a convoluted and complex process to gather all of this data and transform it into dollars. You know, there's dollars attached to each one of these visits, procedures, CT scans, all of these.

And having a tool to simply digest data that you drop in to generate "here's where my monthly accrual is" saves days worth of time in your month-end close, and then you can focus on other areas of the company.

Because  I report to the CEO, if I can efficiently and reliably produce those financial statements, I can focus on other requests that she needs from me. It makes me more flexible and opens up my time for other areas of the company. 

PK: Why did you decide implement Auxilius before upgrading your ERP?

PC: Yes, that's a good question. As I mentioned earlier, my main priority was getting our accruals right, which we can do using Auxilius even with our more basic accounting platform. You know, we don't require an audit, so there's nobody digging into our controls, so once we start thinking about going public, then we'd likely start to consider a more robust ERP. But for the time being, getting our accruals right and done quickly and accurately is my priority over implementing a fully baked ERP system.

PK: How was the implementation process with Auxilius?

PC: It was a great experience. Compared to other implementations that you might experience, there's such devotion from the Auxilius team behind the scenes. We had weekly meetings where they developed our integrations with QuickBooks and did the EDC mapping. We were able to run a parallel close during this period, allowing us to continue our regular financial processes without interruption. And then once we were ready to go live, it was easy to just make that switch and rely on Auxilius and start booking entries based on the Auxilius data that was coming in. It was fantastic.

I'm also really glad we implemented during our phase one trial. If we see positive results and quickly move into a phase 2 trial, we're likely using many of the same vendors, so all our mapping is already all set up and it'll be much easier to just go right into it as opposed to implementing while our even more complex phase 2 trial is already under way.

PK: How has Auxilius impacted your daily work?

PC: Right off the bat, we just had our board meeting last week. Because we have board meetings in the month after quarter close, in prior meetings I wouldn't even really able to produce the quarter close numbers by then. But now Auxilius enables me to produce 6/30 Q2 close numbers to present to the board. At this stage of our development, they're mainly concerned with our cash runway, but it was great and reassuring to be able to put together up-to-date investigator site cost and other numbers for the meeting.

PK: What would you have done if Auxilius wasn't available?

PC: Without Auxilius, we would likely have needed to expand our finance team which would have increased our operational costs significantly. Expansion of the team could easily cost the company an additional $200,000 annually in allocated time and overhead. Given that one of my priorities is keeping G&A costs low, and that investors want to keep their money focused on R&D, from an ROI and cost standpoint, Auxilius was a no-brainer.