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Precigen, inc (PGEN) Q2 2021 Earnings Call Transcript

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PGEN earnings call for the period ending June 30, 2021.

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Precigen, inc (PGEN -4.95%)
Q2 2021 Earnings Call
Aug 9, 2021, 4:05 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good day and welcome to the Precigen Second Quarter and First Half 2021 Financial Results Conference Call. [Operator Instructions] I would now like to turn the conference over to Steve Harasym, Vice President of Investor Relations. Please go ahead.

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Steven Harasym -- Head of Investor Relations

Thank you, operator, and thank you for joining us today. With me is Dr. Helen Sabzevari, President and CEO of Precigen. 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 Precigen's most recent SEC filings for a more complete discussion of these risks and uncertainties.

I will now turn the call over to Dr. Sabzevari.

Helen Sabzevari -- President and Chief Executive Officer

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 Precigen 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 Precigen 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 III-IV ovarian cancer. Study subjects received the PRGN-3005 infusion either via intraperitoneal or intravenous infusions. Preliminary Phase 1 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 syndrome, 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 IP arm and dose level three of the IV arm in the Phase 1 dose escalation portion of the trial is ongoing concurrently. We are in tune with the overall progress of this program and anticipate the presentation of the interim data from the Phase 1 dose escalation trial in the fourth quarter of 2021.

PRGN-3006 UltraCAR-T is currently under evaluation in a Phase 1/1b 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 1 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 PRGN-3006 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 1 data in the fourth quarter of 2021.

PRGN-2009 or off-the-shelf AdenoVerse immunotherapy designed to target HPV16 and HPV18 is currently under evaluation in Phase 1/Phase 2 clinical trial as a monotherapy or in combination with the bi-functional antibody, bintrafusp alfa, 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 1 monotherapy dose escalation arm showed that PRGN-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 PRGN-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 1/Phase 2 trial. Enrollment in the Phase 1 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 2 trial was identified.

Based on these findings, the monotherapy arm of the Phase 2 trial was initiated. This Phase 2 trial evaluates PRGN-2009 as neo-adjuvant therapy for newly diagnosed oropharyngeal or sinonasal squamous cell cancer patients as a first-line treatment. Four patients have been enrolled in the Phase 2 monotherapy arm to date and the enrollment is ongoing. Enrollment in the Phase 1 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 1 data in the fourth quarter of 2021.

PRGN-2012 is our off-the-shelf, AdenoVerse immunotherapy, designed to illicit 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 tract. 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.

The Phase 1 clinical trial of PRGN-2012 AdenoVerse immunotherapy in adult patients with RRP is ongoing. This trial is being conducted under a CRADA with the NCI. This Phase 1 trial is designed to follow three plus three dose escalation of PRGN-2012, as an adjuvant immunotherapy, following a standard of care surgical removal of visible papilloma. This study is designed to enroll three to six subject 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 PRGN-2012. The primary objective of this study is to determine safety and tolerability and recommended Phase 2 dose of PRGN-2012.

Precigen 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. In January we announced FDA clearance of the IND to initiate a Phase 1 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 1 trial.

Subsequently, we have commenced dosing in expansion cohorts 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/2a clinical trial as monotherapy or in combination with teplizumab 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 2a 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. Kevan Herold 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. Herold's presentation, these results are very encouraging and indicate the potential of AG019 to preserve insulin production in a 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's 57th Annual Meeting on October 1st.

Now I will turn the call over to Steve for an overview of our financial results.

Steven Harasym -- Head of Investor Relations

Thank you, Helen. I would like to briefly review our second quarter and first half financial highlights. In the six months ending June 30, 2021, net cash requirements for operating activities reduced from $24.2 million as compared to $41.5 million during the same period in 2020, even as the development of our clinical and preclinical pipeline accelerated. This improvement is primarily the result of efficiency measures we began implementing in 2020 and improved performance at both our Trans OVA and Precigen Exemplar subsidiaries, which both continue to be net contributors of capital to Precigen. We expect our net cash requirement to gradually increase in the coming quarters as our clinical programs continue to progress.

We are pleased with the strength of our balance sheet. We began Q3 2021 with $200.4 million in cash and investments and we reiterate our guidance and anticipate that our cash balance is sufficient to support our capital needs well into 2023.

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

Helen Sabzevari -- President and Chief Executive Officer

Thank you, Steve. Before we conclude, I wanted to provide you with a brief update on our CFO search. We are diligently working with our executive search firm and have identified a number of very highly qualified candidates and will communicate our decision in the near future.

As you can see, we are entering a pivotal phase at Precigen as we head into the latter half of the year on pace to meet the clinical milestones we laid out in January. We are excited to be providing clinical updates at our upcoming R&D update call and scientific conferences as well as announcements around our preclinical pipeline and technology platform.

Operator, you may now open the line for questions.

Questions and Answers:

Operator

We will now begin the question-and-answer session. [Operator Instructions] It appears our first question comes from Nick Abbott of Wells Fargo. Please proceed.

Nick Abbott -- Wells Fargo Securities, LLC -- Analyst

Terrific. Thank you very much for taking our questions. Helen and team, congratulations on amazing progress for the first half of the year. In terms of 2012, might we expect to get initial data at the November 4th R&D update? And if so, what would you want to be presenting at that meeting? And then I have a quick follow-up as well. Thank you.

Helen Sabzevari -- President and Chief Executive Officer

It's great speaking to you, Nick, and thank you for the question. Definitely, 2012 is a program that, as I mentioned, have gone extremely rapidly. We are very excited about this program and the possibility for the patients. And the answer to your question is, absolutely, we are looking forward to presentation of the data by our investigator and at the R&D date and we will be providing data. As part of these R&D -- the reason that we are very excited about our R&D date is because we will be covering a number of data of outputs on various programs including 2012 and showing obviously the Phase 1 data which is safety and tolerability, but also speaking to this program and some of the observations on patients.

Nick Abbott -- Wells Fargo Securities, LLC -- Analyst

So not to try and put words in your mouth, Helen, but might you be commenting on need for surgery after 2012?

Helen Sabzevari -- President and Chief Executive Officer

I'm not going to say exactly the outline of what Dr. Clint Allen will be speaking about, but we will definitely provide much more color on the 2012 and the mechanisms, as well as basically the ongoing results that we are seeing on the patients.

Nick Abbott -- Wells Fargo Securities, LLC -- Analyst

Okay, terrific, and then just on the ActoBiotics program, AG019, I see that now you're committing to doing a clinical trial for longer-term treatment. Is this -- was this -- or was the plan -- I apologize if it was and I missed that, or is this a result of feedback from potential licensees or partners? And maybe you could just outline what your thoughts are and your goals for this trial.

Helen Sabzevari -- President and Chief Executive Officer

So definitely with AG019, after seeing the data from a Phase 1 b and 2a it became very clear that the monotherapy of AG019 by itself actually was quite promising. Obviously, the combination therapy was very good, but the monotherapy with just one cycle of treatment, which is really just eight weeks of taking orally the capsules, we showed almost similar results. And therefore this was very exciting, as we had mentioned, this is in discussion with our regulatory authorities and we are looking forward to move this program forward, obviously, especially as a monotherapy arm with the extended since we only have three registrations for eight weeks. Now obviously, because of the safety profile of AG019 which was very good, we believe that we can extend the treatment and also look into rapid discussion for basically this -- again the patients that they are in need of treatment in this arena and we can basically discuss fast ways with regulatory authorities to move this program forward.

Nick Abbott -- Wells Fargo Securities, LLC -- Analyst

Great, thanks and congrats again.

Helen Sabzevari -- President and Chief Executive Officer

Thank you very much, Nick.

Operator

Our next question comes from Jason Butler with JMP Securities. Jason, please proceed.

Helen Sabzevari -- President and Chief Executive Officer

Hi, Jason.

Jason Butler -- JMP Securities, LLC -- Analyst

Hi, Helen. Thanks for taking the questions. And I appreciate all the updates. I guess, just starting with a high-level question, can you give us any more granularity on which programs will get data from at the R&D event versus which would be data at medical meetings? Obviously, you expect to give 2012 data, but can you give us those details for any of the other programs? And I have a question on 2009.

Helen Sabzevari -- President and Chief Executive Officer

Sure, of course, one of the reasons for our date of the R&D is, as you can imagine some of the -- basically, the highlight is going to be coinciding with some of the congresses and we will be giving basically highlights on all of the platforms that we have been discussing, and we have already mentioned in our goals for 2021. So -- and the guidance that we are giving is we will be cover the interim data and obviously the timing that we have given for early November allows us to provide this data, the follow-ups, especially on some of the patients and the data has become more mature and will coincide with the clinical congresses and abstract releases at that time.

Jason Butler -- JMP Securities, LLC -- Analyst

Okay, great. And then for PRGN-2009, can you maybe just talk a little bit about how you're thinking about combination versus monotherapy path forward here? And then given the unmet need in sinonasal squamous cell cancer, could there be an expedited path to approval? And then just can you maybe speak to some of the factors that when it's determining dose and, for example, was dosing volume one of those factors? Thanks.

Helen Sabzevari -- President and Chief Executive Officer

Sure. So in regard to the PRGN-2009, as was mentioned, we -- this program has moved extremely rapidly. As you can see, we are already in Phase 2. We finished the safety Phase 1 data which will be presented as well as the dosing that really was the first primary perspective was looking at the any DLTs if we go to higher doses, which we have not observed any DLT. The volumes were not really necessarily the concept here because we originally have talked about in our CMC preparation that, obviously, design of volume that would be applicable and easy to be given, but mainly is about -- dosing was about do we see a DLT, which we have not seen on the highest level dose and can the mechanism of action enhance the T-cells upon redosing, which as we have reported, we have seen that and as part of the call we just mentioned that we have seen up to 13 to-date that we have been able to keep redosing the patients.

So you can see the power of the AdenoVerse platform versus other Adeno vectors that you can only give them once and we currently have patients that have received multiple and some surpassing the 13 times that they received it. So we are really excited and we got to the path forward for this, you're absolutely correct in the combination. As you know, a lot of the patients in various indications for instance, specifically in the cervical cancer, there is really no path forward for these patients. And we recognize that and with the power of the AdenoVerse off-the-shelf, we are anticipating and we are discussing pathways with path forward, I should say, with regulatory FDA to address for fast-tracking this treatment in combination. So -- and I apologize if I forgot part of your question, but if I did --

Jason Butler -- JMP Securities, LLC -- Analyst

No, that was absolutely -- that was great, very helpful. Thanks, Helen, and looking forward to the R&D Day. Thanks again.

Helen Sabzevari -- President and Chief Executive Officer

Absolutely. Thank you.

Operator

Next up we have been Ben Burnett of Stifel. Please go ahead.

Helen Sabzevari -- President and Chief Executive Officer

Hi, Ben.

Benjamin Burnett -- Stifel Financial Corp. -- Analyst

Hey, how are you? Thank you very much for taking our questions. I actually wanted to follow up just on an earlier discussion around AG019. And then I had another question on one of the CAR-T programs. But for AG019, have you talked about like the dosing schedule that you would assess here for some of the longer-term dosing? It feels like the data is supportive of daily dosing, but like the biomarker data would imply that you might be able to get away, something little bit more frequent. What are your thoughts are on that?

Helen Sabzevari -- President and Chief Executive Officer

Absolutely. Excellent question, Ben. Definitely, we -- both the safety and the mechanistic -- the data that we have, do support perhaps more continuous dosing and more cycles of dosing and this is exactly what we are discussing with the FDA and how we can -- as a monotherapy, based on the safety that we have seen and also the mechanism of action, we can increase the dosing and expand that. So you're absolutely correct. We think that that is the way to go, especially with the data that we saw, even with one cycle, not only we saw the C-peptide stabilization, but we showed that the autoreactive T-cells, basically going down which is exactly what you want, the inhibition of these T-cells. And this was just by giving eight weeks of the oral capsule. So we can definitely expand this to more continuous dosing.

Benjamin Burnett -- Stifel Financial Corp. -- Analyst

Okay, very interesting. And then a question on the -- just what to expect at this next AML PRGN-3006 update. I guess how should we think about like what we might learn in terms of durability, and in terms of the follow up that you might expect in that AML study? I mean, I'm assuming, to some degree, this will depend on how long -- how long ago patients were enrolled in the study, but just given the way that that CRi was handled in Cohort 1, I guess do you expect most physicians to likewise just seek a transplant after achieving a good response or could we get some data and learn something about the durability of UltraCAR-T at this first update?

Helen Sabzevari -- President and Chief Executive Officer

Okay. So let me just address the first what do -- what should we expect in our R&D. And definitely the -- we would be giving highlights and especially that that coincides also with the embargo being lifted on the scientific presentations that day, what we will be giving is obviously the durability, the kinetics between the lymphodepletion and non-lymphodepletion, by the way, and also more view on the clinical activity, which is quite exciting as we are seeing preliminary with what we have reported, and we will be continue reporting on those.

I think what becomes really important is to understand that at what dose the exact expansion and also the clinical activity -- in regard to the transplant, yes, the answer is, as we have seen with the CRi, the patient has achieved the complete response. This patient would have never had the chance to receive a transplant under normal circumstances. And this patient now receives a normal transplant and has gone very well and -- so with that in mind, that will be one of the option, but also as we are gathering more information and follow up on some of these patients that they have been treated, then we can look at other options that might be ongoing and transplant might be just one option.

Benjamin Burnett -- Stifel Financial Corp. -- Analyst

Okay, I understood. Looking forward to the data. Thank you.

Operator

And our next question comes from Swayampakula Ramakanth of H.C. Wainwright, please go ahead.

Helen Sabzevari -- President and Chief Executive Officer

Hi RK.

Swayampakula Ramakanth -- H.C. Wainwright & Co., LLC -- Analyst

Thank you. Hi, how are you doing, Helen?

Helen Sabzevari -- President and Chief Executive Officer

Good, thanks.

Swayampakula Ramakanth -- H.C. Wainwright & Co., LLC -- Analyst

Obviously, interesting progress so far and certainly looking for a number fourth. Just a quick question on PRGN-3005. You're looking at platinum-resistant ovarian cancer. As you know there are a few molecules in play for the specific population. So and just trying to see how -- what do you think about 3005 and what do you need to show now, so that you can quickly move to Phase 2, and also try to get it to the market at the earliest?

Helen Sabzevari -- President and Chief Executive Officer

Yeah, so for the ovarian cancer, as you can imagine, we are currently concurrently dosing both intraperitoneal and IV, especially the -- at the dose level three IV and dose level four intraperitoneal, which by implementing the UltraPorator, this has allowed us to scale up and what is going to be very interesting, this -- the comparison of these two arm and looking at not only the obviously safety and tolerability but also expansion, persistent, and designs of clinical activity. We're -- having said that, we have every intention to move this very rapidly to Phase 1b and in that setting, obviously, we would have the number of the patients that we can evaluate the effect on the -- and the clinical activity on number of the patients. To the point that you have raised, obviously this is a very, very difficult patient population. Even with the newest therapies that are coming, still the rates of any objective responses are extremely low. And we are looking forward to obviously generating the data as soon as possible, that we can have the discussions with the regulatory group.

One aspect that is very important to remember, and I think our investigator, Dr. Disis, always refers to this is, the point of doing the safety and tolerability as well as getting our kinetics is also to move this to a much faster to the front-line for the treatment of this patient, as opposed to the standing and waiting for at Stage IV because the power of the immune-oncology, as you know, all the treatments, and especially in the cell and gene therapy becomes even much more obvious as we move at front line. We, for instance, I can point out to our PRGN-2009, which we did the Phase 1 and our Phase 2 is in the front line immediately, in the adjuvant setting. So in the patients that they are -- basically have been diagnosed and they are receiving treatment and receiving our treatment as a. So that is our intention and for sure we are moving this rapidly and we will be analyzing the data from our IV versus the IP and then for the -- especially for the expansion phases and which arm would go much faster, those are the decisions that will be made this --

Swayampakula Ramakanth -- H.C. Wainwright & Co., LLC -- Analyst

Perfect. Thank you for that. I'm going to step back in the line and follow up with you later.

Helen Sabzevari -- President and Chief Executive Officer

Sure.

Operator

[Operator Instructions] Next question is coming from Justin Walsh from B. Riley. Please go ahead.

Helen Sabzevari -- President and Chief Executive Officer

Hi, Justin.

Justin Walsh -- B. Riley Securities, Inc. -- Analyst

Hi. Thanks for taking my questions. Can you maybe give us a qualitative sense of how well tolerated PRGN-2012 was, that is, did you complete the dose escalation so rapidly because you very quickly hit the DLT, or did you have very rapid enrollment?

Helen Sabzevari -- President and Chief Executive Officer

No, we at the -- actually the safety profile of 2012 -- of course, I'm giving away some of this, but the safety was very good handled. And we have not hit the DLT. And at the same token, parts of the rapid enrollment, as you know it was three to six patients per each dose and for our audience, usually, it's three to six in case that you need to add more patients or there are adverse events or there are DLTs that you have to go back, and obviously we didn't have to go to six per dose. We had a three plus three. We enrolled very rapidly and with a very good safety profile and now we have -- in expansion phase, as I mentioned in the call.

Justin Walsh -- B. Riley Securities, Inc. -- Analyst

Got it, I'm glad I got you to give something away. I'll give you one more on a high level. Maybe if you can just give us a little commentary on any ongoing BD efforts you have. Are you actively looking to acquire additional assets right now? And if so, is there a specific drug profile or indication that you're interested in?

Helen Sabzevari -- President and Chief Executive Officer

I think at this point we are really focusing on our portfolio and we are very focused for this year to very, very rapidly move our own portfolio forward and not only from perspective of taking it to the next level of the clinics, but also strategically how we manage our portfolio. And that's our focus for this coming year.

Justin Walsh -- B. Riley Securities, Inc. -- Analyst

Got it. Thank you for taking the questions.

Helen Sabzevari -- President and Chief Executive Officer

Sure. Thank you very much, Justin.

Operator

[Operator Instructions] Next question is going to come from Eric Joseph from J.P. Morgan. Please go ahead.

Helen Sabzevari -- President and Chief Executive Officer

Hi, Eric.

Eric Joseph -- J.P. Morgan Securities, Inc. -- Analyst

Hi, good evening. Thanks for taking the question. Just a couple on AG019. I'm curious to get a sense that whether at this point -- it sounds like you're contemplating a monotherapy path forward toward further development, potentially pivotal, is that correct or is there a combination regimen that you'd want to evaluate further? And then secondly, as it relates to the Phase 1b/2a data that you recently reported on, can you talk about I guess like CMIC control or stabilization of A1c to the extent that you track the measure? And is that something that we should be looking forward to at EASD?

Helen Sabzevari -- President and Chief Executive Officer

Yeah, great question. Thanks, Eric. So in regard to -- definitely we are pushing forward our monotherapy, and the reason for it is based on the data that we saw with a very limited cycle of treatment. It's eight weeks of only treatment and after a follow-up for 12 months, we saw not only stabilization of C-peptides, the mechanism of actions of basically increasing our T regulatory cells that they inhibit, autoreactive T-cells, the reduction in autoreactive. So the -- basically we saw parallel results that we had seen pre-clinically which is very encouraging and knowing the safety profile of our molecule as was presented in Phase 1 and Phase 2a, clearly that allows us to now be able to move to more of dosing or longer periods of dosing. So that is obviously of one fact.

In regards to the combination, of course, that is also a arm that we are considering and we will follow because we also showed that there was a synergistic expansion and advancement. So for us, we basically -- we can see that that also was very helpful. But in general, we would follow both but we are very excited about our monotherapy and other aspects was, as we reported, there was the HbA1c was a stabilized, which is -- this is another biomarker, that is very important in the T1D patients.

So collectively when you put all of that, we decided that we have a good path with our monotherapy as, with other treatments, with antibody even treatments, you have to treat for 12 days. It's in the hospital and it's associated with still immunosuppression, whereas with this AG019, this is just capsules that the patients take at home -- there is very easily -- and with a very good safety profile, and by the way, it allows the mechanisms of action. So for those reasons, this is how we have prioritized. And we are moving with AG019.

Eric Joseph -- J.P. Morgan Securities, Inc. -- Analyst

Okay, great. Thanks for taking the question.

Helen Sabzevari -- President and Chief Executive Officer

Of course. Thank you.

Operator

This concludes our question-and-answer session. At this time, I would now like to turn the conference back to Ms. Helen Sabzevari for any closing remarks.

Helen Sabzevari -- President and Chief Executive Officer

Thank you for taking the time to listen to our call and for the thoughtful questions. We look forward to providing updates at upcoming R&D Day and investor and scientific conferences. I wish everyone to stay healthy and safe. Thank you, operator.

Operator

[Operator Closing Remarks].

Duration: 42 minutes

Call participants:

Steven Harasym -- Head of Investor Relations

Helen Sabzevari -- President and Chief Executive Officer

Nick Abbott -- Wells Fargo Securities, LLC -- Analyst

Jason Butler -- JMP Securities, LLC -- Analyst

Benjamin Burnett -- Stifel Financial Corp. -- Analyst

Swayampakula Ramakanth -- H.C. Wainwright & Co., LLC -- Analyst

Justin Walsh -- B. Riley Securities, Inc. -- Analyst

Eric Joseph -- J.P. Morgan Securities, Inc. -- Analyst

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