Precigen, Inc.

Good day and welcome to the Presagen third quarter 2022 financial results conference call. Today, all participants will be in a listen only mode. Should you need assistance during today's call, please signal for a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. If you would like to withdraw your question, please press star then two. Please note that today's event is being recorded. I would now like to turn the conference over to Steve Harrison, Vice President of Investor Relations. Please go ahead.

Thank you, Operator, and thank you for joining us today. With me are Dr. Helen Sabzavari, President and CEO, and Harry Tomasian, CFO of Precision. Helen will provide an update on the significant progress we have made across our pipeline programs and highlight our anticipated upcoming milestones, after which Harry will review our third quarter 2022 financial results. Following our prepared remarks, we will open the call to Q&A. Before we begin, please note that during today's call, we will make various forward-looking statements. Investors are cautioned that such forward-looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ from those indicated by our forward-looking statements. Please read the Safe Harbor Statement in the press release, as well as risk factors contained in Presagen's most recent SEC filings, for a more complete discussion of these risks and uncertainties. I will now turn the call to Dr. Salisbury. Helen?

Thanks, Steve, and thank you for joining us today. I'm pleased to report to you today that Precision made significant progress during the third quarter of 2022 by focusing on the assets in our portfolio, offering the greatest potential for increasing shareholder value in the most efficient way possible. Focus is our mantra here at Precision, and our strategy is straightforward. First, we focus on markets with ultra-high unmet needs. The indications we are pursuing offer the potential for an accelerated regulatory and developmental pathway. Second, we continue focusing our research, development, and manufacturing operations by making early decisions to pursue therapies with higher probabilities of success. The ability to create consistent manufacturing at multiple sites also figures into our decision-making as we seek to decrease product costs and provide therapeutic access to a broader patient population. We need to move away from traditional concepts of centralized manufacturing, especially when we are dealing with patient populations suffering from diseases where earlier treatment makes a big difference. Finally, we are focused on advancing therapies that are not only differentiated in their utility, but also potentially in their pricing as we change the paradigm in manufacturing and development. I will talk about how our ultra-parader technology is proving to be a game changer when it comes to enabling overnight local manufacturing and distribution. We believe that we are entering a new era of value-based care and want to be ready with products that meet the future requirements of our healthcare system. Another area of focus is fiscal discipline. Thanks to our efforts, we have reduced the cost of SG&A and are now allocating further resources toward our clinical and commercialization efforts. I will now update you on our clinical programs. First, our adenoverse immunotherapy platform. For PRGN 2012 in recurrent respiratory papillomas or RRP, a devastating orphan disease with a severe unmet medical need as reoccurring surgeries remain the only option for these patients. The burden on these patients is immense. with many requiring hundreds of lifetime surgeries at a very high cost. Furthermore, recurring surgeries only temporarily treat the symptoms of RRP and do not lead to remission. These surgeries can actually worsen the condition of RRP over time, as it can increase the spread of the virus, leading to comorbidities, including significant breathing problems and loss of vocal function. There is an urgent need for a therapeutic treatment option such as a PRGN 2012. PRGN 2012 has been orphaned drug designation for the patients with RRP. We are extremely pleased with the rapid progress of this clinical program. To recap, We dosed the first patient on the phase one study in March 2021 during the highest heights of the COVID-19 pandemic. Enrollment and dosing are complete in the phase one dose escalation and dose expansion cohorts with 15 patients treated and 12-month follow-up is near completion. PRGN 2012 has demonstrated an excellent safety profile with all subjects receiving full treatment course with four PRGN 2012 administrations. There have been no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2. We are looking forward to presenting what we believe will be highly compelling safety and efficacy data from the dose escalation and expansion cohorts of PRG in 2012 at the virtual R&D event in early January 2023, which is time to coincide with the 41st annual J.P. Morgan Healthcare Conference. We believe there is a significant market opportunity for this drug in RRP. Our estimate of the US, EU adult and juvenile patient population is approaching 30,000 cases. We feel there are substantial case numbers outside of the US and EU that could bring the global population to over 75,000. We also believe that due to limited disease awareness, reported numbers could understate the true prevalence of this disease. This could present a market opportunity for the US and EU alone of over $1 billion. These are our preliminary estimates, and we plan to provide further details on the patient population burden of the disease on patients, and market opportunities during the data presentation. Dr. Clint Allen, senior investigator at NIH and a lead associate investigator for PRGN 2012 clinical trial, will lead the presentation. At the same time, I'm pleased to report that enrollment in the Phase II study is progressing rapidly with 16 patients enrolled to date. Given the high unmet medical need for this patient population, we have been in ongoing discussions to evaluate the various regulatory paths with FDA. Now for an update on PRGN 2009, our adenovirus immunotherapy in HPV-associated cancers. We completed enrollment in the phase one monotherapy and combination arm with six and 11 patients enrolled respectively. All patients were stage four recurrent or metastatic HPV-associated cancers and failed multiple prior therapies, including checkpoint inhibitors. Interim data. from the phase one combination arm demonstrated encouraging safety and efficacy with a 40% objective response rate, both complete and partial responses, in a patient population that had failed previous checkpoint inhibitor treatments. Patient follow-up is ongoing and we are looking forward to hosting an investigator-led Phase I data presentation in the first half of 2023. Enrollment is nearing completion in the Phase II monotherapy on in newly diagnosed oropharyngeal squamous cell carcinoma patients with 19 of 20 anticipated patient dose and patient follow-up ongoing. Based on our encouraging data thus far, PRGN 2009 immunotherapy has a broad potential to address the estimated 5% of all cancers which are attributed to HPV-associated malignancies, including cervical, head and neck, and anal cancers. Let's now turn to our Ultracar T trial. We completed enrollment for PRGN 3006 in the phase one dose escalation cohort of the phase one 1B study in relapsed refractory AML patients. Dr. David Solomon of Moffitt Cancer Center and the lead investigator for the PRGN 3006 study will present Phase I safety and efficacy data at ASH on December 12, 2022. We are encouraged by the results to date and are looking forward to the presentation in patients with relapsed refractory AMLs, which represents a potentially significant benefit to this patient population. The Phase Ib study of PRGN3006 Ultracar-T has been expanded to Mayo Clinic in Rochester, Minnesota, as the first of several new sites expected as part of the multicenter expansion of this study. And the first patient was successfully dosed at this expansion site. Additionally, as previously announced, we received FDA clearance to incorporate repeat dosing in the expansion phase of this study. This is an important milestone for Presagen, as well as for the field of immunotherapies, as it demonstrates the proof of concept for a scale-out of overnight decentralized ultracar T manufacturing using Ultraoperator. Site activation is in progress at several additional major cancer centers across the U.S. Ultraoperator is a game changer for the field and we are pleased that the renowned institutions such as the Mayo Clinic are partnering with us to advance its development. PRGN 3006 has been granted orphan drug designation as well as fast-track designation for patients with relapsed refractory AML. Now for PRGN 3005. are ultracarty treatment for advanced ovarian cancer. Enrollment is complete in the phase one dose escalation cohorts of the intraperitoneal and intravenous arms without lymphodepletion, as well as in the lymphodepletion cohort in the IV arm. Patient follow-up is ongoing, and we expect phase one data to be presented in the first half of 2023. You may recall that during our second quarter of 2022 call, we announced FDA's clearance to incorporate repeat dosing in this study. And we are pleased to report that the first patient has received a repeat dose via IV infusion. Enrollment is ongoing in the Phase 1B expansion study at dose level 3 with lymphodepletion prior to IV infusion. Site activation is in progress at multiple major cancer centers in the U.S., yet another point of validation for the scale-out of our overnight decentralized ultracar T manufacturing using UltraPerator. This is an extremely important study. There have been minimal therapeutic advances in this patient population with 10% or less response rate in ovarian cancer with current treatments. I participated in a panel at CITSE earlier this week with some of the prominent figures in the cell and gene therapy, including the CAR-T space. And it is clear that there remains significant unmet need and opportunity for innovation in solid tumors. We believe with our Ultra-CAR-T platform, we have a unique solution to address these limitations. Finally, our Ultracar T trial in PRGN 3007, which is being evaluated in the treatment of advanced ROR1-positive hematological and solid tumors. PRGN 3007 uses our next-generation Ultracar T technology and incorporate intrinsic PD-1 downregulation in addition to the three effector genes, a CAR, membrane-bound IL-15, and a KEL switch. Intrinsic blockade of PD-1 expression is aimed at addressing the inhibitory tumor microenvironment and eliminating the need for the checkpoint inhibitor combinations. The phase 1, 1B umbrella study in hematological and solid tumor is on track to initiate dosing this quarter. We look forward to an investigator-led trial in progress presentation of PRGN-3007 at ASH on December 11 of 2022. I will now turn the call over to Harry, who will review our third quarter's 2022 financial highlight. Harry?