Precigen, Inc.

Good day and welcome to the Presagen second quarter and first half 2021 financial results conference call. All participants will be in listen-only mode. Should you need assistance, please signal 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. To withdraw your question, please press star then two. Please note this 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 is Dr. Helen Sabzavary, President and CEO of Precision. Helen will provide an update on the significant progress we have made across our pipeline programs, after which I will review our second quarter and first half 2021 financial results. Following our prepared remarks, we will open the call to Q&A. Before we begin, let me briefly review our forward-looking statements. During today's call, we will make various forward-looking statements. Investors are cautioned that our forward-looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results or outcomes to differ materially from those indicated by our forward-looking statements. Please read the Safe Harbor Statement contained in this presentation 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 over to Dr. Sabzavari.

Thanks, Steve, and thank you, everyone, for taking the time to listen in today. I hope this call finds all of our stakeholders and their families well. We are extremely happy with our year-to-date progress, achieving multiple clinical milestones in the first half. The Precision team continues to advance our portfolio rapidly and will remain on track to meet or exceed our stated goals for this year with important clinical milestones and further data readouts anticipated in the second half of the year. Today, I'm pleased to announce that Precision will host an R&D update call on November 4th dedicated to reviewing progress made in advancing the company's clinical pipeline. This call will feature presentations from our investigators for several of our key clinical trials. Details about the call will be provided in the coming months. In addition, we anticipate further updates at medical conferences in the fourth quarter. I would now like to take you through some pipeline updates. PRGN 3005 Ultracar T is under evaluation in a phase 1, 1B clinical trial for the treatment of advanced recurrent platinum resistant stage 3, 4 ovarian cancer. Study subjects receive the PRGN 3005 infusion either via intraperitoneal or intravenous infusions. Preliminary phase one data previously reported from the lowest two-dose level of the IP arm showed a favorable safety profile with no dose-limiting toxicities, neurotoxicity, or cytokine release syndromes, encouraging expansion and persistence without lymphodepletion, and clinical activity as evidenced by regression in total target tumor burden. Enrollment in dose level four of the IPR and dose level three of the IVR in the phase one dose escalation portion of the trial is ongoing concurrently. We are enthused with the overall progress of this program and anticipate the presentation of the interim data from the phase one dose escalation trial in the fourth quarter of 2021. PRGN 3006 Ultracar-T is currently under evaluation in a Phase I-I-B clinical trial for the treatment of patients with relapse or refractory acute myeloid leukemia or AML. Study subjects received the PRGN 3006 infusion either with or without prior lymphodepletion. PRGN 3006 was granted orphan drug designation for patients with AML by the FDA. Preliminary phase one data previously reported for the two lowest dose levels in the non-lymphodepletion cohort and the lowest dose level in the lymphodepletion cohort showed a favorable safety profile with no DLTs or neurotoxicity encouraging expansion and persistence of PRGN3006 ultracar T, and clinical activity as evidenced by reduction in AML tumor blast levels. As reported at ASH last year, we observed long-term stable disease in a non-lymphodepletion patient with durable persistence. We also reported an objective response complete response with incomplete hematological recovery in a patient treated at the lowest dose with only 9 million ultracar T in the lymphodepletion arm. Enrollment in dose level four of the non-lymphodepletion cohort and dose level three of the lymphodepletion cohort is ongoing concurrently. This trial continues to progress exceedingly well and we anticipate the presentation of the interim Phase I data in the fourth quarter of 2021. PRGM-2009, our off-the-shelf adenovirus immunotherapy designed to target HPV-16 and HPV-18, is currently under evaluation in Phase I-II clinical trial as a monotherapy or in combination with a bifunctional antibody in patients with HPV-associated cancers. The trial is being conducted under the Cooperative Research and Development Agreement, or CRADA, with the National Cancer Institute. Preliminary data reported from the Phase I monotherapy dose escalation arm showed that PRG in 2009 monotherapy was well-tolerated with no DLTs. Preliminary correlative analysis from monotherapy patients treated at the lowest dose showed an increase in HPV-specific T cell response. Furthermore, an increase in the magnitude and the breadth of immune response was reported with repeat administration of PRGEN 2009, highlighting the differentiation of our Adenoverse platform to generate and boost durable and robust antigen-specific immune responses. We are extremely pleased with the trajectory of this trial to date. Just to put the progress in perspective, we reported dosing of the first patient in August of last year during the ongoing COVID-19 pandemic. And in one year, We have enrolled 16 patients in this Phase I-II trial. Enrollment in the Phase I monotherapy dose escalation arm is complete, with all patients receiving multiple doses of PRGN 2009, as many as 13 to date. PRGN 2009 treatment was well-tolerated with no DLTs, and the recommended dose for the Phase II trial was identified. Based on these findings, the monotherapy arm of the Phase II trial was initiated. This Phase II trial evaluates PRGN 2009 as neoadjuvant therapy for newly diagnosed oropharyngeal or sinonasal squamous cell cancer patients as a first-line treatment. Four patients have been enrolled in the Phase II monotherapy arm to date, and the enrollment is ongoing. Enrollment in the Phase I combination arm is also ongoing with six patients with recurrent or metastatic HPV-associated cancers enrolled to date. We anticipate the presentation of the interim Phase I data in the fourth quarter of 2021. PRGN 2012 is our off-the-shelf adenovirus immunotherapy designed to elicit immune responses directed against cells infected with HPV6 or HPV11 for the treatment of recurrent respiratory papillomatosis, or RRP. RRP is a rare, difficult-to-treat, and sometimes fatal neoplastic disease of the upper and lower respiratory tracts. There is no cure for the approximately 1,500 per year newly diagnosed and 20,000 patients living with this disease in the U.S. The current standard of care is repeated surgical removal of papilloma lesions with some patients requiring in excess of 100 surgical procedures. A Phase I clinical trial of PRGN 2012 adenovirus immunotherapy in adult patients with RRP is ongoing. The trial is being conducted under a CRADA with NCI. This Phase I trial is designed to follow 3 plus 3 dose escalation of PRGN 2012 as an adjuvant immunotherapy following a standard-of-care surgical removal procedure of visible papillomas. The study is designed to enroll three to six subjects at each dose level, followed by an expansion cohort with 12 patients treated at the maximum tolerated dose. Patients receive up to four injections of PRG in 2012. The primary objective of the study is to determine safety and tolerability and recommended a Phase II dose of PRGN 2012. Presagen received FDA orphan drug designation for PRGN 2012 in patients with RRP. We are extremely excited about the progress of this trial and potential of this program, especially given the unmet medical need for these patients. we announced FDA clearance of the IND to initiate a Phase I trial. In March, the first patient was dosed, and I'm pleased to announce that we have already completed enrollment in the dose escalation portion of the Phase I trial. Subsequently, we have commenced dosing in expansion cohort of the trial at the maximum tolerated dose exceeding our goal for this year. AG019, Actobiotics, is an orally administered disease-modifying, antigen-specific immunotherapy for the prevention, delay, or reversal of type 1 diabetes, or T1D. AG019 is currently under evaluation in Phase 1b to a clinical trial, as monotherapy or in combination with tepolizumab for the treatment of early onset T1D in adults and adolescents. Enrollment and dosing in both the Phase 1B and Phase 2A portions of this study are complete. We were pleased to report that the primary endpoints of assessing safety and tolerability in both the Phase 1B monotherapy and the Phase IIa combination arms of the studies were met. No dose-related adverse events or serious adverse events were reported in either portion of this trial. In addition, positive top-line data from this clinical trial were presented at the Federation of Clinical Immunology Society's 2021 Virtual Annual Meeting by Dr. Kevin Harreld, of the Yale School of Medicine and principal investigator of this clinical trial. AG019 as a monotherapy and in combination showed a stabilization or increase of insulin C peptide levels, a biomarker for T1D disease progression. In addition, oral AG019 treatment induced antigen-specific tolerance in conjunction with the reduction of disease-specific T cell responses, suggesting the ability of AG019 to modulate a patient's immune system in a precise, antigen-specific manner to address the underlying cause of T1D. Based on Dr. Harold's presentation, these results are very encouraging and indicate the potential of AG019 to preserve insulin production in recent onset T1D patients. We are looking forward to advancing AG019 to assess the efficacy of prolonged treatment of oral AG019 for T1D patients. Our investigators plan to present additional data from this clinical trial at the European Association for the Study of Diabetes for EASD 57th Annual Meeting on October 1st. Now, I will turn the call over to Steve for an overview of our financial results.