Q2 2021 Precigen Inc Earnings Call

[music].

Good day and welcome to the prestige in second quarter and first half 2021 Flash financial results Conference call. All participants will be in listen only mode. Sydney assistance. Please signal conference specialists for a person historically you followed by zero.

After today's presentation there'll be an opportunity to ask questions to ask a question you May Press Star then 1 on your telephone keypad 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 President of Investor Relations. Please go ahead.

Thank you operator, and thank you for joining us today.

With me is Dr. Helen <unk>, President and CEO of precedent.

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 for.

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 impressive <unk> most recent SEC filings.

For a more complete discussion of these risks and uncertainties.

I will now turn the call over to <unk> <unk>.

Thanks, Steve and thank you everyone for taking the time to listen in today I Hope this call clients all of our stakeholders on desktop as well.

Extremely happy with.

Year to date progress achieving multiple clinical milestones in the first half day.

<unk> team continues to advance our portfolio rapidly and we 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 day here.

Today I am pleased to announce that presage on we'll 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 other 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.

<unk> 3005 Ultra car T is under evaluation in a phase <unk> clinical trial for the treatment of advanced recurrent platinum resistant to stage 3 for ovarian cancer.

That is subjects received <unk> 3005, infusion either via intraperitoneal or intravenous infusion.

Preliminary phase 1 data previously reported debt from the lowest to dose level of the IP on showed a favorable safety profile with no dose limiting toxicities neurotoxicity or cytokine release syndrome.

Encouraging expansion and persistence without Lynn for depletion and clinical activity as evidenced by regression in total target tumor burden.

Enrollment and dose level for of the IPR on dose level 3 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 on this program and anticipate the presentation of the interim data from the phase 1 dose escalation trial in the fourth quarter of 'twenty 'twenty 1.

Pier G. On 3006 Ultra car T is currently under evaluation in a phase <unk> clinical trial for the treatment of patients with relapsed or refractory acute myeloid leukemia or AML.

Study subjects received the PRT on 3006 infusion either with or without prior Lim for depletion.

<unk> 3006 was granted orphan drug designation for patients with AML by the FDA.

Preliminary phase 1 data previously reported for the 2 lowest dose levels in the non NIM for depletion cohort and the lowest dose level in the lymphoid depletion cohort.

<unk>, a favorable safety profile with no dlt's on neurotoxicity encouraging expansion and persistence of <unk> 3006, Ultra car T and clinical activity as evidenced by the reduction in AML tumor blast levels.

As reported at Ash last year, we observed long term stable disease in a non NIM for depletion patient with durable persistence.

We also reported an objective response complete response with incomplete hematologic recovery and a patient treated at the lowest dose with only 9 million Ultra car T. In the lymphoid depletion on.

Enrollment in dose level for of the non lymphoid depletion cohort and dose level 3 of the lymphoid depletion 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 'twenty 'twenty 1.

<unk> 2009, our off the shelf, adding diverse immunotherapy designed to target HPV 16 on HPV 18 is currently under evaluation in phase 1.2 clinical trial as a monotherapy or in combination with the bi functional.

Antibody Ventura force Alpha in patients with HPV associated cancers.

The trial is being conducted under the cooperative research and development agreement or credo with the National Cancer Institute.

Preliminary data reported from the phase 1 monotherapy dose escalation arm showed that pier G. In 2009 monotherapy was well tolerate debt with no DLT.

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 <unk> 2009, highlighting the differentiation of our AD platform to generate and boost durable and robust antigen specific.

<unk> immune responses.

We are extremely pleased with the trajectory of these trials to date.

Just to put the progress in perspective, we've reported dosing of the first patient in August of last year.

During the ongoing COVID-19 pandemic.

And then 1 year, we have enrolled 16 patients in this phase 1.2 trial.

Enrollment in the phase 1 monotherapy dose escalation arm is complete with all patients receiving multiple doses of <unk> 2009, as many at <unk> to date.

<unk> 2009 treatment was well tolerated with no DLT and the recommended dose for the phase II trial was identified.

Based on these findings the monotherapy arm of the phase III trial was initiated.

This phase II trial evaluates pier G in 2009.

<unk> adjuvant therapy for newly diagnosed Otto from shell or Sino nasal the squamous cell cancer patients.

First line treatment.

For patients have been enrolled in the phase 2 monotherapy on to date and the enrollment is ongoing.

Enrollment in the phase 1 combination on is also ongoing with 6 patients with recurrent or metastatic HPV associated cancers in growth to date, we anticipate the presentation of the interim phase 1 data in the fourth quarter of 2021.

<unk> 2012 is our off the shelf <unk> immunotherapy designed to elicit immune responses directed against sales infected with HPV 6 on HPV 11 for the treatment of recurrent respiratory papillomatosis or RFP on.

The rfps are rare difficult to treat and sometimes fatal neoplastic diseases of the upper and lower respiratory track.

There is no cure for the approximately 1500 per year newly diagnosed and 20000 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.

Our phase 1 clinical trial on PRT in 2012, other universe immunotherapy in adult patients with our RFP is ongoing.

The trial is being conducted under our credit out with the NCI.

This phase 1 trial is designed to follow a 3 plus 3 dose escalation of <unk> 2012 as on.

Adjuvant immunotherapy following a standard of care surgical removal of visible papilloma.

This study is designed to enroll 3 to 6 subjects at each dose level, followed by an expansion cohort with 12 patients treated at the maximum tolerated dose per.

<unk> to receive up to 4 injections of Pier G. In 2012. The primary objective of this study to determine safety and Tolerability and recommended phase II dose of <unk> 2012.

<unk> received.

FDA orphan drug designation for <unk> 2012 in patients with RP. 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 on.

For the IMD to initiate a phase 1 trial.

In March the first patient was dosed and I am pleased to announce that we have already completed enrollment in the dose escalation portion of the phase 1 trial.

Sequentially, we have commenced dosing in expansion cohorts.