GERMANTOWN - Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced first quarter 2023 financial results and business updates.

'Precigen continues to execute on our strategy to maintain corporate strength while advancing our most promising programs. This quarter, we successfully closed a public offering and more recently announced that Precigen has regained rights to two validated targets (CD19 and BCMA) that will further bolster our already robust UltraCAR-T portfolio and provides an opportunity to advance potential best-in-class UltraCAR-T drug candidates. We continue to advance our vision to transform the personalized cell therapy landscape using Precigen's library approach to build the most comprehensive clinical and preclinical CAR-T portfolios with antigen-specific targets spanning both hematological and solid tumors where there is high unmet medical need for cancer patients, including CD33, MUC16, ROR1, CD19, BCMA and MSLN,' said Helen Sabzevari, PhD, President and CEO of Precigen. 'We are pleased with the progress of our programs so far this year. We successfully dosed the first patient with PRGN-3007 and showcased preclinical data for our MSLN next generation UltraCAR-T at the 2023 AACR annual meeting. We also presented positive Phase 1 data for our PRGN-2012 AdenoVerse immunotherapy in RRP at our R&D day and completed enrollment in the Phase 2 study. Finally, we look forward to sharing additional data at the 2023 ASCO annual meeting for our PRGN-3005 UltraCAR-T and PRGN-2009 AdenoVerse immunotherapy.'

'We remain focused on strengthening our financial footing while containing costs to support our business objectives,' said Harry Thomasian Jr., CFO of Precigen. 'Our program of financial discipline, combined with a public offering and early retirement of most of our debt, has provided a solid cash runway to support priorities into late 2024.'

Program Highlights

Exclusive Rights to UltraCAR-T Targets, CD19 and BCMA, and IL-12 Gene Therapy

The Company amended its exclusive license agreement with Alaunos Therapeutics to bolster its portfolio and broaden strategic opportunities.

The Company regained exclusive rights to CD19 and B-cell maturation antigen (BCMA) targets to enable unencumbered development and commercialization of two validated targets utilizing the UltraCAR-T platform.

The Company also regained exclusive rights to its interleukin (IL)-12 gene therapy, including application through the off-the-shelf AdenoVerse immunotherapy platform, paving the way for potential future treatments in oncology given the important role of IL-12 cytokines in targeting many types of tumors such as human papillomavirus (HPV)-associated cancers.

PRGN-2012 AdenoVerse Immunotherapy in RRP

PRGN-2012 is an investigational off-the-shelf (OTS) AdenoVerse immunotherapy designed to elicit immune responses directed against cells infected with HPV 6 or HPV 11 for the treatment of RRP. The US Food and Drug Administration (FDA) granted orphan drug designation for PRGN-2012 for patients with recurrent respiratory papillomatosis (RRP).

The Company announced positive Phase 1 dose escalation and expansion cohort data (N=15) in January 2023 at its R&D Day virtual event.

The Company completed enrollment in the Phase 2 portion of the study (N=23) bringing the total number of enrolled patients to 35 at Dose Level 2. Patient follow up is ongoing.

The Company plans to outline the regulatory strategy as FDA discussions advance.

PRGN 2009 AdenoVerse Immunotherapy in HPV-associated Cancers

PRGN-2009 is an OTS investigational immunotherapy utilizing the AdenoVerse platform designed to activate the immune system to recognize and target HPV-positive (HPV+) solid tumors.

The Company completed enrollment in the Phase 1 monotherapy (N=6) and combination therapy (N=11) arms in patients with recurrent or metastatic HPV-associated cancers. An abstract for the clinical data of the PRGN-2009 Phase 1 study (Abstract # 2628) titled, 'Phase I evaluation of PRGN-2009 alone and in combination with bintrafusp alfa in patients (pts) with recurrent/metastatic (R/M) HPV-associated cancers (HPV-C)' has been selected for presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting on June 3, 2023 from 8:00 to 11:00 AM CT.

Enrollment was completed in the Phase 2 monotherapy arm with 20 evaluable patients in newly diagnosed oropharyngeal squamous cell carcinoma (OPSCC) patients. An interim clinical data presentation from the Phase 2 monotherapy arm is expected in the second half of 2023.

PRGN-3006 UltraCAR-T in AML

PRGN-3006 is an investigational multigenic, autologous chimeric antigen receptor T cell (CAR-T) therapy engineered to simultaneously express a CAR specifically targeting CD33, membrane bound IL-15 (mbIL15), and a kill switch. The FDA granted orphan drug designation and fast track designation for PRGN-3006 UltraCAR-T for patients with relapsed or refractory (r/r) acute myeloid leukemia (AML).

The Company completed the Phase 1 dose escalation study and announced positive data at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition. Subsequently, the Company initiated a multicenter Phase 1b dose expansion study of PRGN-3006. The Company received FDA clearance to incorporate repeat dosing in the Phase 1b trial. A Phase 1b clinical data presentation is expected in 2024.

PRGN-3005 UltraCAR-T in Ovarian Cancer

PRGN-3005 UltraCAR-T is an investigational multigenic, autologous CAR-T cell therapy engineered to express a CAR specifically targeting the unshed portion of MUC16, mbIL15, and a kill switch.

The Company completed enrollment in the Phase 1 dose escalation cohorts of the intraperitoneal (IP) and intravenous (IV) arms without lymphodepletion as well as in the lymphodepletion cohort in the IV arm. An abstract for the clinical data of the PRGN-3005 Phase 1 dose escalation study (Abstract # 5590) titled, 'Phase 1/1b study of PRGN-3005 autologous UltraCAR-T cells manufactured overnight for infusion next day to advanced stage platinum resistant ovarian cancer patients' has been selected for presentation at the 2023 ASCO Annual Meeting on June 5, 2023 from 1:15 to 4:15 PM CT.

The Company initiated a Phase 1b dose expansion trial of PRGN-3005. The Company received FDA clearance to incorporate repeat dosing in the Phase 1b study. A Phase 1b clinical data presentation is expected in 2024.

PRGN-3007 UltraCAR-T in Advanced ROR1+ Hematological and Solid Tumors

PRGN-3007, based on the next generation of the UltraCAR-T platform, is an investigational multigenic, autologous CAR-T cell therapy engineered to express a CAR targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), mbIL15, a kill switch, and a novel mechanism for the intrinsic blockade of PD-1 gene expression.

The Company announced dosing of the first patient in the Phase 1/1b dose escalation/dose expansion study of PRGN-3007 in advanced ROR1-positive (ROR1+) hematological and solid tumors. The target patient population for the Phase 1/1b study includes hematological cancers (chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), and diffuse large B-cell lymphoma (DLBCL)) and solid tumors (triple negative breast cancer (TNBC)).

Next Generation UltraCAR-T Platform

The Company showcased advances in the UltraCAR-T platform with a preclinical data presentation for the next generation UltraCAR-T platform utilizing mesothelin (MSLN) CAR from Precigen's library of non-viral plasmids at the American Association for Cancer Research (AACR) Annual Meeting 2023. Enhancement of efficacy due to incorporation of a novel mechanism for PD-1 blockade in MSLN UltraCAR-T in preclinical models was presented in the abstract titled, 'Next Generation UltraCAR-T Cells with Intrinsic Checkpoint Inhibition and Overnight Manufacturing Overcome Suppressive Tumor Microenvironment Leading to Sustained Antitumor Activity.'

Financial Highlights

In January 2023, the Company completed an underwritten public offering of approximately 44 million shares of common stock, including a partial exercise of the underwriters' option to purchase additional shares, at a price to the public of $1.75 per share, which resulted in net proceeds to the Company of $72.8 million (after deducting underwriting discounts, fees and other expenses).

During the three months ended March 31, 2023, the Company successfully retired, through open market purchases, $29.5 million of outstanding convertible notes due in July 2023 at a discount to par bringing the total outstanding balance to $13.8 million. Any remaining outstanding convertible notes will be retired using the Company's restricted cash balance. Early retirements have saved the Company close to $7 million through retirements at discounts to par and reduced interest costs.

Cash, cash equivalents, short-term and long-term investments and restricted cash totaled $125.4 million as of March 31, 2023.

Selling, general and administrative (SG&A) costs decreased by 15% for the three months ended March 31, 2023 compared to the prior year period.

First Quarter 2023 Financial Results Compared to Prior Year Period

Research and development expenses increased $0.4 million, or 3%, from the three months ended March 31, 2022. This increase was primarily driven by a continued prioritization of clinical product candidates.

Total other income, net, increased $2.5 million over the three months ended March 31, 2022. This increase was primarily due to reduced interest expense associated with the Company's Convertible Notes as a significant portion of the original $200 million face value of the Convertible Notes has been retired. In addition, interest income increased due to higher interest rates on the Company's investments.

SG&A expenses decreased $2.1 million, or 15%, from the three months ended March 31, 2022. This decrease was primarily driven by a reduction in professional fees of $2 million, primarily due to decreased legal fees associated with certain litigation matters.

Total revenues decreased $3.7 million, or 66%, from the three months ended March 31, 2022. This decrease related to the recognition of revenue in the first quarter of 2022 related to agreements for which revenue was previously deferred that did not occur in the first quarter of 2023 of $1.0 million, as well as declines in services performed at Exemplar.

Loss from continuing operations was $22.7 million, or $(0.10) per basic and diluted share, compared to loss from continuing operations of $23.9 million, or $(0.12) per basic and diluted share, in Q1 2022.

Cautionary Statement Regarding Forward-Looking Statements

Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon the Company's current expectations and projections about future events and generally relate to plans, objectives, and expectations for the development of the Company's business, including the timing and progress of preclinical studies, clinical trials, discovery programs and related milestones, the promise of the Company's portfolio of therapies, and in particular its CAR-T and AdenoVerse therapies. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties, including the possibility that the timeline for the Company's clinical trials might be impacted by the COVID-19 pandemic, and actual future results may be materially different from the plans, objectives and expectations expressed in this press release. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Contact:

Steven M. Harasym

Tel: +1 (301) 556-9850

Email: investors@precigen.com

(C) 2023 Electronic News Publishing, source ENP Newswire