Full Press Release Details
Precigen Reports First Quarter 2023 Financial
Results and Business Updates
Positive Phase 1 clinical data presented for PRGN-2012 AdenoVerse immunotherapy in RRP demonstrated favorable
safety profile and significant reduction in surgeries with 50% of the patients in Complete Response following treatment with PRGN-2012
Enrollment completed in the Phase 2 study of PRGN-2012 in RRP -
First patient dosed in Phase 1/1b dose escalation/dose expansion study of PRGN-3007, a next generation UltraCAR-T
incorporating PD-1 checkpoint inhibition, in advanced ROR1+ hematological and solid tumors -
Regained exclusive rights to validated CAR-T targets, CD19 and BCMA, to enable unencumbered development and commercialization
Latest clinical advancements for PRGN-3005 UltraCAR-T and PRGN-2009 off-the-shelf AdenoVerse
immunotherapy to be presented at the 2023 ASCO annual meeting in June -
Significantly strengthened balance sheet, raising $72.8 million, net of offering costs via a public offering of common stock
Retired an additional $29.5 million of outstanding convertible notes, leaving $13.8 million maturing on July 1, 2023, which
will be retired using the Company's restricted cash balance -
Cash, cash equivalents, short-term and long-term investments and restricted cash totaled $125.4 million as of March 31, 2023
GERMANTOWN, MD, May 10, 2023 - 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
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."
to UltraCAR-T Targets, CD19 and BCMA, and IL-12 Gene Therapy
PRGN-2012 AdenoVerse
Immunotherapy in RRP
PRGN 2009 AdenoVerse
Immunotherapy in HPV-associated Cancers
PRGN-3006 UltraCAR-T
PRGN-3005 UltraCAR-T
PRGN-3007 UltraCAR-T
in Advanced ROR1+ Hematological and Solid Tumors
Next Generation UltraCAR-T
Financial Highlights
First Quarter 2023 Financial Results Compared
to Prior Year Period
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.
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.
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.
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.
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.
Precigen: Advancing Medicine with Precision
Precigen (Nasdaq: PGEN) is a dedicated discovery
and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target
the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.
Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an
innovation engine progressing a preclinical and clinical pipeline of well-differentiated therapies toward clinical proof-of-concept and
Twitter @Precigen, LinkedIn or YouTube.
AdenoVerse Immunotherapy
Precigen's AdenoVerse immunotherapy platform utilizes
a library of proprietary adenovectors for the efficient gene delivery of therapeutic effectors, immunomodulators, and vaccine antigens
designed to modulate the immune system. Precigen's gorilla adenovectors, part of the AdenoVerse library, have potentially superior performance
characteristics as compared to current competition. AdenoVerse immunotherapies have been shown to generate high-level and durable antigen-specific
neutralizing antibodies and effector T cell immune responses as well as an ability to boost these antibody and T cell responses via repeat
administration. Superior performance characteristics and high yield manufacturing of AdenoVerse vectors combined with UltraVector
technology allows Precigen to engineer cutting-edge investigational gene therapies to treat complex diseases.
AdenoVerse Immunotherapy
Precigen's AdenoVerse Immunotherapy platform
is currently under clinical investigation in a Phase 1/2 study of PRGN-2009 AdenoVerse immunotherapy alone or in combination with anti-PDL1/TGF-Beta
Trap (M7824) in patients with HPV-associated cancers (NCT04432597) and
a Phase 2 study of PRGN-2012 AdenoVerse immunotherapy in patients with recurrent respiratory papillomatosis (NCT04724980).
PRGN-2012 has been granted Orphan Drug Designation in patients with RRP by the FDA.
UltraCAR-T is a multigenic autologous CAR-T platform
that utilizes Precigen's advanced non-viral Sleeping Beauty system to simultaneously express an antigen-specific CAR to specifically target
tumor cells, mbIL15 for enhanced in vivo expansion and persistence, and a kill switch to conditionally eliminate CAR-T cells for a potentially
improved safety profile. Precigen has advanced the UltraCAR-T platform to address the inhibitory tumor microenvironment by incorporating
a novel mechanism for intrinsic checkpoint blockade without the need for complex and expensive gene editing techniques. UltraCAR-T investigational
therapies are manufactured via Precigen's overnight manufacturing process using the proprietary UltraPorator electroporation
system at the medical center and administered to patients only one day following gene transfer. The overnight UltraCAR-T manufacturing
process does not use viral vectors and does not require ex vivo activation and expansion of T cells, potentially addressing major limitations
of current T cell therapies.
UltraCAR-T Clinical Program
The UltraCAR-T platform has shifted the autologous
CAR-T manufacturing paradigm using an advanced non-viral multigene delivery system and an overnight, decentralized manufacturing process
for administration of autologous CAR-T cells one day after gene transfer to reduce vein-to-vein time. Precigen's UltraCAR-T platform
is currently under clinical investigation for hematological and solid tumors, including a Phase 1/1b study of PRGN-3005 UltraCAR-T in
patients with advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer (NCT03907527),
a Phase 1/1b study of PRGN-3006 UltraCAR-T in patients with relapsed or refractory acute myeloid leukemia (AML) or higher risk myelodysplastic
syndrome (MDS) (NCT03927261) and a Phase 1/1b study of PRGN-3007 UltraCAR-T incorporating PD-1
checkpoint inhibition in patients with ROR1-positive (ROR1+) hematologic chronic lymphocytic leukemia (CLL), mantle cell lymphoma
(MCL), acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma (DLBCL) and solid tumor triple negative breast cancer (TNBC)
malignancies (NCT05694364). PRGN-3006 UltraCAR-T has been granted Orphan
Drug Designation and Fast Track Designation in patients with AML by the US Food and
Drug Administration (FDA).
UltraCAR-T Library Approach