Full Press Release Details
Event Name: Precigen Second Quarter 2020 Financial Results Conference Call
Event Date: Monday, August 10, 2020, 4:30 PM Eastern Time
Steven Harasym; Precigen,
Inc.; Head of Investor Relations
Helen Sabzevari; Precigen, Inc.; President and Chief Executive Officer
Tom Samuelson; Precigen, Inc.; Head of Financial Strategy
Roy Buchanan, JMP Securities
Operator: Good afternoon.
Welcome to the Precigen Second Quarter and First Half 2020 Financial Results and Business Update Conference Call.
(Operator Instructions)
I would now like turn the conference over to Steven Harasym. Go ahead.
Steven Harasym: Thank you, operator. I am pleased to be joined today by Dr. Helen Sabzevari, President and CEO of Precigen; as well as Tom
Samuelson, Head of Financial Strategy.
Following our prepared remarks, we will open the call to Q&A.
Please turn to the next slide for our forward-looking statement. 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 the risk factors contained in Precigen s most recent SEC filings, for a more complete discussion of these risks and uncertainties.
I would now like to turn the call over to Dr. Sabzevari. Helen.
Helen Sabzevari: Thank you, Steve. I hope that this call finds all our listeners and their families safe and healthy as our nation continues to work
through the COVID-19 pandemic. At Precigen, the health and safety of our employees is of the utmost importance. Our R&D staff have been back in the office full time and are getting tested on a regular
basis. Employees are practicing appropriate safety measures, including social distancing, rigorous disinfection protocols and use of personal protective equipment while in our facility.
Despite these challenging times, our team has adjusted well to this new normal, and currently we remain on track to meet our previously stated clinical
milestones and data readouts this year. This is meaningful for our team, as we are able to execute on our mission to deliver novel treatment options to patients with unmet medical needs.
Next slide, please. I would like to begin by giving a brief financial update highlighting our continued
focus on fiscal and operational efficiency, all with the aim of increasing shareholder value.
In the second quarter of 2020, Precigen spending, which
includes Segment-Adjusted EBITDA plus corporate costs, was approximately $13 million, versus $30 million in the first quarter of 2020. This decrease was primarily attributable to suspending operations at MBP Titan and streamlining our
corporate functions to fit the narrower focus of the Company. We expect spend at MBP to continue to substantially reduce as we evaluate a strategic option for this platform.
Furthermore, our financial performance at both Trans Ova Genetics and Precigen Exemplar improved as a result of the efficiency measures we have implemented
with both entities, who were contributors of cash through Q2. These measures and other efforts have positioned us to operate comfortably into the late 2021 without the need for additional cash. Tom will provide additional details later in the call.
Next slide, please. Turning now to our UltraCAR-T platform. When we began this journey at Precigen, our vision was to develop a non-viral, rapid, autologous T-cell therapy that can be scaled up in a cost-effective manner that is accessible to any cancer patient. We identified three major technical
hurdles that we believed were essential to overcome in order for the non-viral Sleeping Beauty platform to cross the threshold of being commercially viable.
The first challenge was to be able to generate a homogeneous cell product that can expand in vivo and thus forego lengthy ex vivo expansion. We
achieved this by optimizing the non-viral system to simultaneously express three genes: an antigen-specific CAR, membrane-bound IL-15 and a kill switch using our
UltraVector platform, thus ensuring production of a homogeneous UltraCAR-T product, which we believe is an essential characteristic of a viable cell therapy. Membrane-bound IL-15 maintains younger
UltraCAR-T phenotypes with superior in vivo expansion and persistence and allows for the elimination of ex vivo expansion, while the kill switch improves the safety profile. I want to emphasize that the intellectual property around the
UltraVector platform and improvements to the non-viral system lie exclusively with the Precigen team.
challenge was to achieve feasibility of manufacturing UltraCAR-T using overnight gene transfer at medical centers. We accomplished this by developing an overnight decentralized manufacturing process without the need for CAR-T cell expansion outside the body, where we optimized the process to significantly improve the efficiency of non-viral gene transfer,
UltraCAR-T-cell viability, and the quality-control testing to address dosing and regulatory requirements for overnight manufacturing. As a result of these innovations, we have progressed the UltraCAR-T
platform through successful IND clearance and into the clinic with two first-in-class UltraCAR-T therapies.
Next slide, please. The third challenge was to develop a commercially viable process that can be scaled up to treat a large patient population across the
globe. Today s non-viral gene delivery approaches rely on commercially available electroporation devices, which have limitations due to the inverse relationship between system throughput and gene transfer
efficiency. This results
in a labor-intensive process and a manual handling of samples that increase contamination risk and pose challenges for scale-up and eventual
commercialization. As we advance toward initiating the expansion phases of our UltraCAR-T trials to investigate their efficacy in larger patient populations, the scalability of the process is of the utmost importance. I should emphasize that our
ultimate goal is to develop and commercialize treatments based on the UltraCAR-T platform.
Next slide, please. In order to address this challenge, we
have developed an exclusive electroporation device, UltraPorator, designed to scale up the manufacturing of our UltraCAR-T program at multiple medical centers. This is the third arm of our path toward developing a commercially viable UltraCAR-T
manufacturing platform.
The UltraPorator is a high-throughput system with a custom hardware and software solution capable of handling the electroporation
of billions of T cells in a matter of minutes, as compared to multiple hours of processing currently required. Furthermore, the semi-closed system minimizes handling requirements, significantly reduces contamination risk, and streamlines the
overnight manufacturing process. The FDA has cleared the use of UltraPorator as a manufacturing device for our clinical trials, and we have initiated the manufacturing of cGMP-compliant systems. We are currently in the process of technology transfer
to our clinical sites and expect to implement the system for the expansion phases of PRGN-3005, PRGN-3006 and the future UltraCAR-T clinical trials. Our progress so far with regulatory milestones and tech transfers under way is a testament to our
team s forward looking thinking, anticipating challenges and designing solutions in an aggressive timeline.
To take a step back and give you some
perspective, we believe that these innovations represent a pivotal advance in the field of personalized medicine, allowing us to bring the drug manufacturing process as close as possible to patients in a commercially viable and expedient way. We
will be updating you on additional milestones associated with the UltraPorator in the next several months.
Next slide, please. Turning to PRGN-3005, our
Phase 1 clinical trial in ovarian cancer targeting the unshed portion of MUC16 on cancer cells. In June, we presented preclinical data of PRGN-3005 UltraCAR-T at the AACR virtual annual meeting. The preclinical data demonstrated that a single
administration of PRGN-3005 was able to mount a durable antitumor response resulting in elimination of ovarian tumor burden for a second time after tumor re-challenge more than three months later. This study,
designed to simulate tumor relapse, highlights the persistence and functional capability of PRGN-3005 to reactivate after long periods without antigen stimulation.
In the clinic, we are enrolling patients in the Dose Level 3 of the IP arm of this trial and remain on track for an initial data readout from this arm
this year. Our confidence in our ability to successfully manufacture UltraCAR-T remains high, and we continue to have 100% manufacturing success as we are escalating to higher doses. We are very excited with the progress of PRGN-3005 UltraCAR-T in
Next slide, please. Now moving to PRGN-3006, our first-in-class candidate for relapsed or refractory AML. This Phase 1/1b trial continues to enroll patients concurrently in both the lymphodepletion and non-lymphodepletion arms. We have completed dosing the
third patient in the Dose Level 2 of the non-lymphodepletion arm. To date, we continue to have 100% manufacturing success and remain on track for an initial data readout this year. We are very excited with the progress of PRGN-3006 UltraCAR-T
in the clinic so far.
Next slide, please. Turning to PRGN-2009. In April, we announced that the FDA had cleared an investigational new drug application
to initiate a Phase 1/2 trial for PRGN-2009, our off-the-shelf investigational AdenoVerse immunotherapy designed to activate the immune system to recognize and target HPV-positive solid tumors.
I would like to highlight that the design consideration differentiates PRGN-2009 from
competing vaccines and TCR-T cell approaches for the treatment of HPV-associated cancers. PRGN-2009 incorporates a multi-epitope design including novel antigen epitopes
to target both the HPV16 and HPV18 subtypes. Our approach is differentiated from other competitor HPV vaccines and TCR-T cell approaches. For example, TCR-T cells only
target a single epitope within E6 or E7 regions of HPV and are restricted in their applicability to a small patient population due to HLA restriction. PRGN-2009, based on our gorilla adenovector, is an off-the-shelf therapy that can be administered repeatedly, unlike other viral-based vaccines, to activate polyclonal HPV-specific T cells in vivo. This is in
contrast to TCR-T cells, which require lengthy and complex manufacturing process ex vivo prior to infusion and only target a single epitope of HPV.
PRGN-2009 is under development through a Cooperative Research and Development Agreement, or CRADA, with the National Cancer Institute, and NCI is currently
recruiting patients for the open-label trial despite ongoing COVID-19 challenges. We believe PRGN-2009 has the potential to be an attractive treatment option for other
HPV-associated malignancies, and we continue to evaluate the specific opportunities, including HPV-associated cervical cancer.
Next slide, please. AG019 is a first-in-class, disease-modifying,
antigen-specific, investigational immunotherapy for the prevention, delay or reversal of type 1 diabetes, a disease with no approved disease-modifying treatment. AG019 is being evaluated as a monotherapy or in combination with anti-CD3 antibody, teplizumab, in a Phase 1b/2a study. In early spring, we implemented a voluntary COVID-19-related pause for the last
remaining study cohort for the Phase 2a study, which is the combination arm in patients 12 to 17 years of age. The temporary pause has been lifted, and the trial is recruiting patients again.
Today, Precigen ActoBio announced positive top line results from the Phase 1b portion of the ongoing Phase 1b/2a study. Results from the Phase 1b portion,
which is the AG019 monotherapy arm, indicated that the primary endpoint for the study was met, with no serious or any severe Treatment-Emergent Adverse Events. Moreover, preliminary analysis six months after treatment initiation showed an
encouraging trend in insulin C-peptide levels, a common biomarker to measure pancreatic beta cell function. Furthermore, based on preliminary analysis, AG019 monotherapy shows an increase in the frequency of
islet-specific Tregs, a potential mechanistic indicator of therapeutic activity. We are very encouraged by these preliminary data and look forward to reporting additional data in the near future.
Next slide, please. Another exciting asset in our portfolio is INXN-4001, a novel gene therapy for heart
failure patients, which is being developed by our majority-owned Precigen Triple-Gene subsidiary. Last week, we announced six-month follow-up data from the ongoing Phase
1 study. We are encouraged that INXN-4001 was well tolerated, and the study successfully met the primary safety and feasibility endpoints with no product-related Adverse Events reported. Moreover, preliminary data showed an overall improvement in
patient-reported outcome at six months post-treatment. We look forward to sharing the final study results at the 12-month follow-up interval. We are evaluating a
strategic option to partner and finance the future development of this platform.
Finally, for an update for PRGN-5001, interest remains high in our
multifunctional therapeutic candidate for solid tumors. We look forward to updating you in the near future.
With that, I will now turn the call over to
Tom Samuelson to provide a financial update. Tom.
Tom Samuelson: Thank you, Helen, and good afternoon to our stakeholders on the call. Today we
report progress in reducing our capital requirements and maximizing our cash runway.
In Q2, Precigen required $13.1 million, a reduction of
$18.8 million, or 59%, versus Q2 19 and a reduction of $16.6 million, or 56%, versus our previous quarter, Q1 20. Unallocated corporate costs were $4.1 million, or 36%, lower than Q2 19, due in large part to a 25%
reduction in corporate employees and a decrease in professional fees as we streamlined our organization. Further savings were realized by our decision to suspend operations at MBP Titan and improve financial performance at operating subsidiaries
Trans Ova Genetics and Precigen Exemplar.
At the beginning of this year, we identified a number of initiatives at Trans Ova aimed at increasing
profitability, predominantly through growing out our high-margin service business and reducing various ancillary offerings and overhead costs. We are happy to report that despite ongoing economic challenges in the dairy and beef markets, H1 gross