Precigen, Inc.

And welcome to the Precision Second Quarter and First Half 2022 Financial Results Conference Call. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on your telephone keypad. And to withdraw your question, please press star then 2. 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 are Dr. Helen Sabzavari, President and CEO of Precision, and Harry Tomasi, our CFO. 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 second quarter and first half 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 or outcomes to differ materially from those indicated on the forward-looking statements. Please read the Safe Harbor statement contained in this presentation, as well as the risk factors contained in Presagen's most recent SEC filings, for a more complete discussion of the risks and uncertainties. I would now like to turn the call over to Dr. Zabzavary. Helen?

Thanks, Steve, and thanks to all of you for joining us today. We are all acutely aware of the seismic shifts that are shaping a new biopharma landscape. The rules of the past for biotech success in terms of access to capital, clinical trials, regulatory pathways, manufacturing, pricing, and commercializations are changing. Traditional funding methods have become more challenging, and supply chain issues have led to bottlenecks in traditional manufacturing approaches. Clinical trials that relied on centralized product manufacturing to supply products to sites were particularly hard hit, therefore creating the need for a new paradigm. Biotech companies are basically having to reinvent themselves for these new times. My goal today is for you to leave this call with an understanding of Precision's efforts over the last several years that we believe have enabled us to thrive in these uncertain times. Not only that, but we are one of the few companies that have advanced multiple first-in-class clinical platforms and clinical programs in a highly efficient and rapid way during the pandemic. Localizing our manufacturing process has allowed us to eliminate many of the costs and time constraints inherent to the traditional production methods for cell therapies. This enables us to adapt to the new biotech landscape while also providing a robust foundation for advancing new treatments for patients quickly. The key to success is a strategically focused business model designed to optimize resources and generate returns for the shareholders, and most importantly, treatments for many patients in need. The Precision Strategy consists of three core pillars as shown here. First, focus on markets with ultra-high unmet need. Our deep clinical pipeline intentionally prioritizes disease indications that require new approaches to treat underserved or unserved patient populations. Such indications usually offer potential for rapid development through accelerated regulatory approval pathways. The route to commercialization for these specialty indications includes a relatively focused prescriber base that could allow us to commercialize some of these products on our own. Over the last several years, we have carefully prioritized these indications within our pipeline. Next, we are optimizing our research, development, and manufacturing operations. Our approach employs resources such as cooperative research and development agreements, or CRADAs, and making early decisions to favor therapies with the higher probability of success. Our platform technologies are designed to address critical limitations in cells and gene therapy to reduce economic barriers to care. For example, our overnight Ultracar-T platform could enable cancer centers across the globe to deliver cutting-edge therapy to patients who require rapid treatment. We expect consistent manufacturing across multiple sites is expected to decrease cost and provide access to a larger patient population. And finally, we are pursuing differentiated therapies at potentially disruptive prices. Platforms that produce truly differentiated products with substantially lower COGS relative to CGT benchmarks could enable a compelling competitive value proposition in terms of us delivering better, faster, cheaper products. We have changed the paradigm in the development and manufacturing chain to realize efficiencies whenever possible. We believe this commitment to continuous improvement would yield cost savings to the health system at large. Let me now provide an update on our clinical portfolio, which can be seen on the next slide. First, our ultracar T trials. As previously announced, We received FAST-TRACK designation for PRGN-3006, our ultracar T therapy for acute myeloid leukemia, or AML, an indication with a high unmet need. FAST-TRACK designation can help expedite the FDA review process and facilitate product development. Enrollment is ongoing in the Phase 1B expansion arm at dose level 3 with lymphodepletion, and we plan to incorporate redosing this year as it's needed. We are pleased to announce activation at the Mayo Clinic in Minnesota, a world-renowned cancer center, as an expansion site for the Phase 1B study of PRGN-3006. Tech transfer was successfully completed, and the FDA has cleared Mayo Clinic as a manufacturing site. We anticipate dosing the first patient at Mayo Clinic very soon. This is an important milestone for us and for the platform. As the only company to demonstrate proof of concept for a streamlined tech transfer and a scale-out of the decentralized ultracar team manufacturing using the ultra-operator at multiple medical centers. We anticipate activating additional sites over the next several months. Finally, we are excited to provide phase one data at major scientific conference in Q4 2022. As announced earlier, we have also completed enrollment in the dose escalation phase of both The intraperitoneal and intravenous arms of PRGN 3005 phase 1 trial are ultracar T for the treatment of advanced ovarian cancer. After dosing the first patient at dose level 1 in the IV arm, the FDA cleared moving directly to dose level 3. This allowed us to rapidly complete enrollment in the IV arm of the phase 1 dose escalation trial and introduce lymphodepletion at the dose level 3 of the IV arm, which has now completed dosing. Patient follow-up is ongoing, and we are looking forward to report the phase 1 data in the first half of 2023. The plan to initiate a multicenter expansion in a phase 1b trial of PRGN 3005 with tech transfer and site activations are underway at multiple centers. In addition, we intend to incorporate redosing in this trial as needed. Our next Ultracar-T trial, PRGN-3007, which is being evaluated in the treatment of advanced receptor tyrosine kinase, like orphan receptor 1 positive or ROR1 positive, hematological and solid tumors, uses our next-generation ultracar T technology and incorporates intrinsic PD-1 checkpoint inhibition in addition to the three effector genes, a CAR, membrane-bound IL-15, and a kill switch expressed in the first-generation ultracar T technology. The Phase Ib umbrella trial in ROR1-positive hematological tumors including chronic lymphocytic leukemia, CLL, mental cell leukemia, MCL, acute lymphoblastic leukemia, ALL, and diffuse large B-cell lymphoma, DLBCL, and solid tumors, including triple negative breast cancer, TNBC. Our team has been working diligently on the complex logistics of the first-in-class, next-generation Ultracar-T umbrella trial, which would allow for enrollment of up to five different indications across hematological and solid tumors and decentralized manufacturing. I'm pleased to report that we are on track to initiate dosing soon. Now, turning to our Adenoverse platform. PRGN 2012. Our adenoverse immunotherapy in recurrent respiratory papillomatosis, RRP, which began dosing in April of 2021, completed enrollment in Phase I study, which included both dose escalation and dose expansion, in less than nine months. Patient follow-up is ongoing. Last year, we provided an R&D update on our broader portfolio. This year, we are planning to provide more targeted updates and are excited to have the opportunity to present to you what we expect to be a compelling investigator-led presentation on the Phase I data in Q4. In addition, we have initiated dosing in the Phase II study and have enrolled 11 patients to date. We look forward to providing you with the regulatory updates as they become available, given the high unmet need of this indication. Finally, for an update on PRGN 2009, our adenovirus immunotherapy in human papillomavirus HPV-associated cancers Enrollment is now complete for six patients in the Phase I monotherapy and 11 patients in the combination therapy arms in patients with recurrent or metastatic HPV-associated cancers. Patient follow-up is ongoing, and we anticipate an investigator-led Phase I data presentation both in the mono and combo arm in the first half of 2023. Enrollment is ongoing in the Phase II monotherapy arm in newly diagnosed oropharyngeal squamous cell carcinoma patients with 17 patients enrolled to date. We believe this program has a broad potential as HPV-associated malignancies account for 5% of all cancers. We are evaluating potential opportunities in indications such as cervical, head and neck, and anal cancers. I would like to conclude this section with an update on AG019, our therapeutic candidate for type 1 diabetes using our actobiotics platform. We continue discussions on the design and manufacturing of the Phase III trial with both the EMA and FDA. Given the chronic nature of the disease, it will require significant investment in Phase III trials, which we believe it will be best served through a partnership. Meanwhile, partnership discussions are continuing, and we look forward to updating you on developments as they become available. I will now turn the call over to Harry, who will review the terms of the Transova cell, our cost reduction initiatives, and our second quarter 2022 financial highlights. Harry.