Glen Allen Mar 29, 2020 (Thomson StreetEvents) -- Edited Transcript of Precigen Inc earnings conference call or presentation Monday, March 2, 2020 at 10:30:00pm GMT

Precigen, Inc. - President & CEO

Precigen, Inc. - VP of IR

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

Good day, and welcome to the Precigen Conference Call. (Operator Instructions) Please note that this event is being recorded. I would now like to turn the conference over to Steven Harasym. Please go ahead, sir.

Steven Harasym, Precigen, Inc. - VP of IR [2]

Thank you, operator. Welcome to the Precigen Fourth Quarter and Full Year 2019 Business and Update Call. I'm Steven Harasym, Vice President of Investor Relations. And I'm pleased to be joined today by Dr. Helen Sabzevari, President and CEO of Precigen; and Tom Samuelson, Vice President of Finance.

During today's call, as seen on Slide 2, 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 in Precigen 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. Helen Sabzevari. Helen?

Helen Sabzevari, Precigen, Inc. - President & CEO [3]

Thank you, Steve. Please go to Slide 3. I'm extremely pleased to be here today as we have made great progress even since our last public presentation at JP Morgan Health Care Conference in early January. We enter 2020 with renewed optimism about our ability to deliver on our aggressive goals and add value to shareholders.

Precigen's mission is to improve patient care through innovative gene and cell therapy-based approaches. I will review our carefully curated portfolio of unique solutions to unmet needs in health in greater detail. Our approaches are novel and designed to treat conditions that are both difficult to treat and have limited treatment options for patients.

Before we give a quick recap of the divestments and transactions that enabled us to advance towards our goal of becoming a dedicated health care company, I thought it would be useful to provide a recap of how far we have come in such a short time, as shown in Slide 3. In Q4 of 2018, we started on the path to becoming a stand-alone health care company by reacquiring the rights to our oncology assets from our former partners. In just under a year, we advanced 2 programs from inception into the clinic and developed a pipeline of promising product candidates in immuno-oncology, autoimmunity and infectious diseases. We also took the necessary steps to expand on an already robust IP estate. Finally, we consolidated the majority of our operation in our Maryland headquarters and continue to bolster our scientific team here.

We believe the transactions that occurred over the last several months put us firmly on the path to being able to devote our resources to advance our health care assets and become a major player in the gene and cell therapy field. As you may recall, this included divesting the majority of Intrexon's non-health care assets, my appointment as a CEO, and name change from Intrexon to Precigen, and associated stock ticker change to PGEN. We also sold our position in AquaBounty for approximately $21.6 million; sold our 50% interest in EnviroFlight to our former partner, Darling Ingredients for $12.2 million; completed the sale of several assets, including our non-health subsidiaries, Oxitec, Okanagan Specialty Fruits and AgBio and ILH Holdings for a combined $53 million-plus certain contingent payment rights. These now divested non-health businesses accounted for $46 million in net cash operating expenses and capital expenditure in 2019 and raised $35 million in capital through the issuance of equity.

Through the financial transaction, we achieved our previously stated cash position goals, allowing the company to deliver on several value-creating milestones in 2020. Furthermore, we are happy to report that the going concern qualifier has been removed from our financial statement. Based on a combination of our cash position and reduced spending, we anticipate current capital on hand will allow us to operate well into 2021.

In light of our transition to a more health-focused company, we are evaluating all aspects of our operating structure and will provide updates in our next quarterly call. Concurrently, I want to acknowledge the contributions of General Bostick, COO and President of Intrexon Bioengineering; and Tom Reed, Founder and CFO of Intrexon, both of whom are no longer at the company. We thank them for their contribution and services.

Moving ahead, I want to share how we plan to manage Precigen going forward on the next slide. Slide 4, please. With our focus firmly on health care, we have aligned the entire company to operate in accordance with 4 key principles. First is adhering to strict fiscal responsibility. We will responsibly allocate capital to maximize value creation for stakeholders. Fiscal responsibility for us is not just about saving, maintaining cash and cutting costs. It is also about allocating resources to the right areas to create value. You will note that in 2019, we spent $43.7 million on our 2 most advanced health care subsidiaries, Precigen and ActoBio. Collectively, the health portfolio spent significantly lower than our non-health portfolio.

The second operating principle is actively managing our portfolio with a strict adherence to data-driven go and no-go decisions. Third is focusing on rapid execution, moving our valuable portfolio of assets quickly into the clinic and advancing them into registration-enabling studies in accordance with the appropriate scientific, clinical and manufacturing standards. And finally, forming a strategic partnership to advance or divest assets in our portfolio where appropriate, noting our fiduciary duty to operate in the best interest of shareholders.

Since January, we have aligned our portfolio, streamlined our operations and optimized our organizational structures to improve operational efficiency, especially at the corporate level. We will continue to take additional efficiency measures across the organization, and we'll update you on our progress. I strongly believe that the most important way we can deliver value to shareholders is to create value to patients through rapid development of novel therapeutics that are safe, effective and address unmet medical needs in a fiscally responsible manner.

Before moving on to a review of the anticipated 2020 milestones for Precigen, on the next slide, we want to discuss our strategy for the remaining non-health assets. Slide 5, please. Our subsidiary MBP Titan's technology platform has the potential to upgrade natural gas to higher value carbon output through our Methane Bioconversion Platform. As we prioritize our health portfolio, the Board of Directors and I are committed to significantly reducing our non-health spending, specifically for MBP.

To this end, we have already implemented efficiency measures at MVP to achieve this goal and have already significantly reduced their capital requirements compared to last year. We will continue to evaluate further efficiency measures that support its ongoing operations while establishing clear fiscal guardrails on spending.

Our goal is to partner or ultimately sell this business. Whatever we do will be in the long-term interest of our stakeholders and adherence to our mission. We will continue to update you on our decision when we have new information to share.

Another non-health business in our portfolio, Trans Ova, is the industry leader in advanced reproductive technologies for the cattle industry. We considered divestiture of this non-health business, but ultimately elected to retain it because we believe it has more value than the offers we received.

Nevertheless, we continue to strategically evaluate options for this business. In the meantime, however, we have implemented efficiency and cost reduction measures, such that we will not contribute any additional capital towards Trans Ova and expect Trans Ova to return to being a net contributor of capital to Precigen this year.

Moving to the next slide. You can see the breadth of our health care organization. Slide 6, please. The new Precigen enters 2020 with a promising portfolio of investigational gene and cell therapies. Under the new 1 Precigen umbrella is our transformative UltraCAR-T, AdenoVerse immunotherapy and ActoBiotics Therapeutic platforms, which share a focus on developing innovative therapies in immuno-oncology, infectious diseases and autoimmune disorders. We also are advancing an innovative approach from our subsidiary, Triple-Gene, in heart failure.

Slide 7, please. Moving to the next slide, we see the breadth and the value of our clinical portfolio, which includes our internal as well as partnered programs, including later-stage assets in Phase II and Phase III clinical trials. Two important things to remember about our portfolio are that: first, we are advancing unique programs that represent substantial therapeutic class innovation; and second, we expect most of these programs to have important data readouts in 2020.

Following the release of new data, we intend to assess and further prioritize our pipeline to optimize cash resources. Beyond this clinical pipeline, we also have a portfolio of novel preclinical assets that will be assessed and funded according to strict science and data development analysis. Our most significant role for preclinical assets for 2020 is to initiate a Phase I trial of PRGN-2009, our new off-the-shelf AdenoVerse immunotherapy in HPV-positive cancers.

Slide 8, please. Before reviewing our many exciting milestones for 2020, I want to take a few moments on the next slide to provide an overview of one of our most promising therapeutic platforms, UltraCAR-T. We believe it holds the promise to revolutionize the CAR-T landscape and provide benefits to patients and the health care system at large for the following reasons. First, unlike conventional CAR-T, UltraCAR-T cells do not require lentivirus and long ex vivo expansion in manufacturing facilities. Instead, UltraCAR-T uses nonviral, rapid, overnight manufacturing at hospital. This overnight manufacturing brings the potential for repeat dosing of UltraCAR-T to patients as well. This manufacturing approach, we believe, brings the convenience of allogeneic CAR-T administration to autologous CAR-T treatment without the potential risk associated with the allogeneic CAR-T therapy.

Second, unlike conventional CAR-T, UltraCAR-T cells express membrane-bound IL-15, which provides higher potential to expand and persist in vivo and to maintain a younger, less differentiated state.

Conventional CAR-T cells have limited potential for expansion after administration due to long manufacturing process that requires T cell activation and expansion outside the body.

Allogeneic CAR-T cells are even more limited in their persistence potential since they are foreign and risk rejection by patients' immune system and the occurrence of the graft-versus-host disease.

Furthermore, allogeneic CAR-T cells requires severe lymphodepletion of patients, which also limits antigen-spreading potential. We believe membrane-bound IL-15 provides our UltraCAR-T cells with a higher potential for expansion and persistence in patients after administration than conventional CAR-T.

Third, we have built our UltraCAR-T platform such that all modified T cells express a kill switch. This engineering provides us with an ability to selectively eliminate UltraCAR-T cells by administration of a kill switch activator in the event of toxicity, thus improving the safety profile.

With the potential to advance precision medicine and disrupt the current CAR-T landscape, our vision for the UltraCAR-T platform is to build and validate a library of UltraCAR vectors to provide personalized autologous CAR-T treatment for any cancer patients in a rapid and cost-conscious manner. During 2020, we expect to report numerous data sets and achieve new milestones.

Slide 9, please. Looking at our advanced assets,

3005 is the first UltraCAR-T in solid tumors, targeting ovarian cancer in Phase I clinical study. We currently are enrolling the second cohort for the IP arm. To date, we continue to have 100% manufacturing success and the preliminary findings regarding UltraCAR-T kinetics, which includes expansion and persistence in patients treated in the lowest dose cohort are very encouraging. We know that everyone is eager to see these early data points, and we share their excitement. We will continue to evaluate the appropriate time to provide additional details. Presently, we expect to provide an initial readout from the IP arm in the second half of 2020. We are also planning to present preclinical data for 3005 at an upcoming medical meeting later this year.

Slide 10, please. 3006 is the first UltraCAR-T therapy be evaluated in hematological cancers. We recently received orphan drug status from the FDA for this program. We are currently enrolling the second cohort for the non-lymphodepletion arm and the first cohort for the lymphodepletion arm. As with 3005, we continue to have 100% manufacturing success and the preliminary findings regarding UltraCAR-T kinetics from the trial are very encouraging. We expect to provide an initial data readout in the second half of 2020.

We are very excited about the Phase II trial for AG013 for oral mucositis in head and neck cancer with our partner Oragenics as we believe that it will further validate our ActoBiotics platform across multiple indications. Using our platform in partnership with Oragenics, we are targeting oral mucositis, a severe and painful side effect of chemoradiation therapy, especially in patients with head and neck cancer. There are currently no drugs approved to prevent this condition in the cancer patient population. As a result, the FDA has given this program Fast Track status, which validates the urgent need for a treatment. AG013 is formulated as an oral rinse and used as mouthwash to deliver the trefoil factor 1 gene, which prevents mucosal tissue damage and induces subsequent repair of the lining of the mouth. Based on the encouraging Phase I data, AG013 is currently in a Phase II trial. Enrollment in this study was completed in the fourth quarter of 2019, and we are looking forward to reporting interim data from the Phase II trial in the first half of 2020. We also expect to report interim data from an ongoing clinical trial of AG019 in type I diabetes patients. AG019 is a first-in-class disease-modifying antigen-specific immunotherapy for the prevention, delay or reversal of type 1 diabetes with encouraging results in preclinical studies. Currently, AG019 is in a Phase Ib/IIa trial. The Phase IIa portion of the trial is now enrolling, and interim data readout is expected in the third quarter of 2020.

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 Triple-Gene subsidiary. We expect to complete the trial by the end of 2020. 2009 is an off-the-shelf AdenoVerse immunotherapy product candidate designed to activate the immune system to recognize and target HPV-positive solid tumors. This program is currently under development through a Cooperative Research and Development Agreement or CRADA with Dr. Jeffrey Schlom, a world renowned investigator in immuno-oncology at the NCI. We expect the NCI to start dosing patients in 2020.

I'll now turn the call over to Tom Samuelson to provide a financial update.

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Tom Samuelson, [4]

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Thank you, Helen, and good evening, everyone. There are 3 key points that I would like to address today. First, as Helen mentioned, we've made material progress in narrowing the company's focus to our core health care programs and reducing our other capital requirements. A critical component of this pivot was the divestiture of a number of our legacy bioengineering assets, including our shares in AquaBounty for $86.8 million plus certain contingent payment rights, and the sale of $35 million of our common stock. The business is sold in these recent transactions accounted for $46 million in 2019 segment adjusted EBITDA losses, capital that can be redeployed towards our health care assets in 2020. Please recall that segment EBITDA, which is more fully defined in our 10-K, is generally the sum of net cash operating expenses and capital expenditures. The proceeds from these transactions, combined with the company's cash and short-term investments on hand, provide sufficient capital to remove the going concern qualification from our 2019 financial statements. We've adjusted our 2019 and prior financial statements to reflect the effects of these businesses as discontinued operations.

Second, we reported fourth quarter and full year 2019 revenues of $17 million and $90.7 million and consolidated financial results from continuing operations, as we continued our shift from the business model focused on collaboration and licensing revenues to one wholly focused on our internal programs primarily in human health. Despite pivoting away from a collaboration model, we continue to own the rights to certain legacy milestones and royalties. Any of these, if successful, could result in additional sources of capital for us without requiring any further obligations on our part.

Fourth quarter and full year segment EBITDA losses including corporate costs, were $37.8 million and $144.4 million, respectively. These annual losses included only $30.2 million at Precigen and $13.7 million at ActoBio. Among our retained bioengineering entities, MBP Titan and Trans Ova Genetics accounted for $36.7 million and $6.3 million, respectively. As Helen mentioned, we are fully committed to reducing spend at these entities and have already implemented efficiencies that should substantially reduce their capital requirements going forward. I would further highlight that the aforementioned $46 million in segment EBITDA losses from transacted assets does not include an allocation of general corporate costs, which we do not allocate to particular segments. More details on segment information can be found in the financial discussion in our 10-K.

Third, the 2019 consolidated loss attributable to Precigen shareholders of $322.3 million or $2.09 per share includes $116.2 million or $0.75 per share associated with the discontinued operations. We further incurred a noncash impairment charge of $29.6 million for the write-down of goodwill associated with our Trans Ova Genetics subsidiary.

As discussed, we've initiated efforts in 2020 to improve the financial performance of Trans Ova Genetics going forward.

In concluding the financial component of our call, I will again reiterate that Precigen is wholly committed to deploying our precious capital towards our highest value health care assets in 2020 and beyond. We look forward to providing regular updates as our targeted value-generating milestones are achieved.

I would now like to turn the call back to Helen for concluding remarks.

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Helen Sabzevari, Precigen, Inc. - President & CEO [5]

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Thank you, Tom. In closing our call today, I want to confirm our optimism about Precigen's potential to transform the health care landscape with our innovative and focused portfolio. I think you will agree that there has never been a more exciting and promising time at Precigen. As Precigen's CEO, you have my commitment to manage our company in a financially prudent, fiscally disciplined and transparent manner with the paramount goal of achieving our mission to bring novel treatment options to patients. If we do this, all of our stakeholders will benefit.

With that, we'll now open the line for questions. Operator, please begin.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question will come from Jason Butler of JMP Securities.

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Jason Nicholas Butler, JMP Securities LLC, Research Division - MD and Senior Research Analyst [2]

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Helen, first one, just on the UltraCAR-T trials for both 3005 and 3006, can you frame for us how we should think about the readouts later this year in terms of patient numbers and maturity of data? And maybe if not specifically in terms of numbers, then in terms of how it could inform next steps or potentially progression to pivotal studies?

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Helen Sabzevari, Precigen, Inc. - President & CEO [3]

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Thank you, Jason. Actually, we are very excited for this upcoming interim data. First of all, in regards to the ovarian cancer, the IP arm and in regard to the AML that we have non-lymphodepletion arm to report. As you might have seen in our slides, our trials currently are 3 plus 3 plus 3, there are 3 doses. And as we finish these doses, we obviously will be reporting on the safety and dose, which are the paramount aspects of the Phase I. But at the same token, as we have always emphasized what is the most important thing for us is also show that our manufacturing in vivo directing patients to show the persistence and also the expansion of T cells. So we are looking forward to show some of the interim data by the second half of 2020. And it's quite exciting for us as we go through this journey, and we continue to then expand these patients to Phase Ib.

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Jason Nicholas Butler, JMP Securities LLC, Research Division - MD and Senior Research Analyst [4]

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Great. And then I had a question on AG013 and the interim results upcoming. How should we think about the magnitude of treatment effect here in terms of what would be clinically important to patients? And then in terms of the oral mucositis endpoint, can you just talk to us about subjectivity of the endpoint and how you're controlling for that? And any expectations for either reduction in analgesic use or potential for prolong radiation dose?

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Helen Sabzevari, Precigen, Inc. - President & CEO [5]

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Absolutely. Thank you. So our -- actually, the AG013 is a very exciting program for the platform of ActoBio. As you know, that ActoBio platform uses our elective delivery mechanisms for delivering different proteins, specifically to the mucosal linings. In the case of the oral mucositis, this is a devastating disease especially after the treatment of head and neck cancer patients with chemo and radiation. There are tremendous ulcers in the mouth, which is quite painful, and currently, there is really no treatment for this.

In the Phase I of the study that was done, we have designed the [elastics] in such a way that it delivers a gene that protects and also stimulates the lining of the mucosal lining of the mouth. And we had a very exciting results in the first Phase I showing reduction in the ulcers and actually the level of the pain. And now we have entered and actually finished enrollment of the patients in 2019 in a Phase II that it's done in a randomized fashion. So there is a placebo arm versus the treatment arm, which is quite important. And one aspect that is quite exciting based on the Phase I data, FDA has given us a Fast Track for this indication currently. And this is -- would be the first proof of this platform actually for ActoBio, which we also have exciting trial ongoing in the T1D, type 1 diabetes, which we are anticipating to actually report on in second half of 2020 using a similar actually platform, but delivering a proinsulin, and as well as IL-10, which suppresses the immune system, but actually, it helps the onset of -- it reduces onset of diabetes, and we had a very encouraging preclinical data, the Phase I data and now the Phase IIa will be reported in second half.

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Jason Nicholas Butler, JMP Securities LLC, Research Division - MD and Senior Research Analyst [6]

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Okay, great. That's helpful. And then just 1 last financial question, and sorry if I missed this in the prepared comments. But should we expect any further reorganization charges? And if so, how should we think about those in terms of cash versus noncash spend?

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Helen Sabzevari, Precigen, Inc. - President & CEO [7]

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So currently, I think we are not expecting any further reorganization charges. And as we mentioned by the end of January, all the assets will transfer to Third Security, and currently, we do not expect anything in that lab.

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Operator [8]

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(Operator Instructions) Our next question will come from Swayampakula Ramakanth from H.C. Wainwright.

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Swayampakula Ramakanth, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [9]

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This is RK from H.C. Wainwright. Helen, a couple of quick questions. For the non-oncology assets, AG019 and INXN-4001, what do you plan for these assets in the long term? The reason for that question is, as you can imagine, as these assets get into late-stage development, they could become cash-intensive because of the large clinical trials that you would need to conduct. Would these be assets that can become currency in terms of out licensing?

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Helen Sabzevari, Precigen, Inc. - President & CEO [10]

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Thank you, RK. Great question. So we agree. We have a portfolio of -- maybe I should just first give a few minutes on the reason that we have a portfolio that we have. The strength of our portfolio is that we are not a one-drug-product company. It becomes very important because when you are one-drug-product company, basically despite of what the science might be or might not be, you are committed somehow. Whereas the way we have arranged our portfolio is that it's in such a manner that we prioritize and make it go/no-go decision based on data, and we know the attrition of the portfolio. And therefore, it's very, very important that we keep a fiscal responsibility with very, very laser-focused decision-making to address our portfolio.

In regards to the assets that we have highlighted for this year, actually, this has been a principal factor behind it. We are looking at our data, we are evaluating the breadth of the data that comes in its totality. And then there will be decisions made that if these assets will go to the next levels of development or not. However, what is very important as the fourth pillar that I mentioned as part of our principle is a strategic partnership. And this is very, very important for us in our portfolio. And to your point, obviously, and I'm going to stress this over and over again. We will not take every asset forward ourselves. We will also look into strategic partnerships that will bring the most value for our shareholders. And I think this is a pillar for us that it would allow us to manage our portfolio accordingly and make the decisions with the right partners, with the right speed and with the right cash to make these things and move them forward. And definitely, as you have mentioned, this is one of our strategic responsibility and platforms that we have for these assets.

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Swayampakula Ramakanth, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [11]

Link:
Edited Transcript of XON earnings conference call or presentation 2-Mar-20 10:30pm GMT - Yahoo Finance

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